BUTRANS 5

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
BUPRENORPHINE
Available from:
RAFA LABORATORIES LTD
ATC code:
N02AE
Pharmaceutical form:
PATCHES MATRIX
Composition:
BUPRENORPHINE 5 MG
Administration route:
TRANSDERMAL
Prescription type:
Required
Manufactured by:
LTS LOHMANN THERAPIE SYSTEME AG, GERMANY
Therapeutic group:
ORIPAVINE DERIVATIVES
Therapeutic indications:
Treatment of moderate to severe opioid responsive chronic pain conditions which are not adequately responding to non-opioid analgesics.
Authorization number:
135 70 31151 00
Authorization date:
2011-12-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

22-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

03-02-2019

Patient Leaflet According to the Pharmacists' Regulations (Preparations) - 1986

This medicine is sold with a doctor's prescription only

BuTrans 5, BuTrans 10, BuTrans 15, BuTrans 20

Transdermal Matrix Patches

Active ingredient:

Each patch of Butrans 5 contains: Buprenorphine 5 mg and releases 5 mcg/hour.

Each patch of Butrans 10 contains: Buprenorphine 10 mg and releases 10 mcg/hour.

Each patch of Butrans 15 contains: Buprenorphine 15 mg and releases 15 mcg/hour.

Each patch of Butrans 20 contains: Buprenorphine 20 mg and releases 20 mcg/hour.

For a list of the other ingredients, please see section 6.

Read this entire leaflet carefully before using this medicine.

This leaflet contains concise information about the medicine. Keep this leaflet in case you need

to read it again. If you have any further questions, refer to the doctor or pharmacist.

This medicine has been prescribed for treating your condition. Do not pass it on to others. It may

harm them, even if it seems to you that their medical condition is similar to yours.

This medicine is intended for use in adults.

Medicines of the opioids group may cause addiction, especially with prolonged use and they

have a potential for misuse and overdose. A reaction to an overdose, may be manifested by

slow breathing and may even cause death. Make sure you know the name of the medicine, the

dosage that you take, how often you take it, the duration of treatment, potential side effects and

risks.

Additional information regarding the risk of dependence and addiction can be found at the

following link:

https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf

Taking this medicine along with medicines from the benzodiazepines group, other medicines which

depress the central nervous system (including drugs) or alcohol may cause a feeling of profound

drowsiness, breathing difficulties (respiratory depression), coma and death.

1. What is the medicine intended for?

This medicine is intended for relief of moderate to severe chronic pain that requires opioids.

Therapeutic group: Opioid analgesic.

2. Before using the medicine

Do not use the medicine if:

You are sensitive (allergic) to the active ingredient or to any of the other ingredients this medicine

contains (for a list of the other ingredients, please see section 6).

You suffer from myasthenia gravis (muscle weakness).

You suffer from severely impaired function of the respiratory system, or from damage to the

breathing center in your brain.

You are taking medicines from the monoamine oxidase inhibitor group, or if you have taken such a

medicine during the last two weeks.

You suffer from an opioid dependence.

Do not use Butrans as a withdrawal treatment from other opioids or drugs.

If you suffer or have suffered in the past from withdrawal symptoms (such as agitation, anxiety,

tremors, sweating) upon stopping alcohol consumption (delirium tremens).

Special warnings regarding use of this medicine:

Butrans patches contain buprenorphine, an opioid ingredient, and can potentially be abused. Do not

give Butrans to another person. Take precautions to prevent this medicine from reaching other

people.

Like all strong pain relievers, this medicine can cause addiction or dependence. See boxed warning

at the beginning of the leaflet.

This medicine is not intended to treat acute pain.

Ensure that the old patch is removed before applying a new patch.

If your breathing becomes shallow and weak, take the patch off and get medical help.

If you have just had surgery, inform your doctor before you start using this medicine.

Particular caution is required in cases of shock, or reduced level of consciousness for an unknown

reason.

In case of increase in body temperature, consult your doctor, because larger amounts of the active

ingredient might get absorbed.

From time to time check (by sight or touch) the place where the patch is applied, to make sure that it

is attached properly, is not loose, and has not fallen off. If the patch is not attached properly, attach it

to your skin using an adhesive bandage (around the edges of the patch). Do not try to remove the

patch and apply to some other area!

Before the treatment with Butrans (and during it) tell your doctor:

If you suffer or have suffered in the past from convulsion attacks or seizures.

If you suffer or have suffered in the past from impaired function of the respiratory system

(breathing problems) or severely impaired liver function.

If you suffer or have suffered in the past from mental problems.

If you suffer from a head injury, head trauma or increased intracranial pressure (for example as

a result of a brain disease), with symptoms which may include severe headache or nausea, this

is because Butrans may make these symptoms worse or mask the severity of the head injury.

If you suffer from dizziness or fainting.

If you have ever developed a dependence on or addiction to alcohol, drugs or medicines. See

also the section 'Do not use the medicine'.

Drug Interactions

If you are taking or have recently taken any other medicines, including non-prescription

medicines and nutritional supplements, please tell your doctor or pharmacist. Especially

inform your doctor or pharmacist if you are taking the following medicines (it should be noted that

the following list mentions the active ingredients of the medicines. If you are unsure whether you

are using any of these medicines, please consult your doctor or pharmacist):

Do not use Butrans if you are taking medicines from the monoamine oxidase inhibitor group (such

as tranylcypromine, phenelzine, isocarboxazid, moclobemide, linezolid), or if you have taken such

a medicine during the last two weeks.

Medicines that may reduce the effect of Butrans, such as: carbamazepine, phenobarbital, phenytoin

(also used to treat epilepsy), rifampicin (to treat tuberculosis).

Medicines that affect the central nervous system (which may increase the risk of side effects from

Butrans, e.g. drowsiness, nausea, faintness, slower and weaker breathing) such as: certain pain

relievers, certain anti-depressants, anti-anxiety medicines, psychiatric medicines, tranquilizers,

medicines to help you sleep; general anesthetics; medicines for treating high-blood pressure (such

as clonidine), other opioid medicines for relieving pain or treating cough (such as: morphine,

dextropropoxyphene, dextromethorphan, noscapine or codeine), certain antihistamines. See boxed

warning at the beginning of the leaflet.

Caution must be taken if in addition to Butrans you are also taking medicines from the

benzodiazepine group (intended to treat anxiety and induce sleep). Combined use of these

medicines with Butrans can cause serious

breathing problems. See boxed warning at the beginning

of the leaflet.

Use of this medicine and alcohol consumption:

Do not drink wine or other alcoholic beverages during treatment with this medicine. Consuming

alcohol can make some of this medicine's side effects worse and can make you feel unwell. In

addition consuming alcohol together with Butrans can affect your reaction time.

Pregnancy and breastfeeding:

Do not use Butrans if you are pregnant, think you might be pregnant, are planning a pregnancy

or are breastfeeding. In addition, Butrans should not be used in women that may become

pregnant who are not using appropriate contraception.

Use in children:

This medicine is not intended for children and adolescents under 18 years old.

3. How to use this medicine?

Always use according to the doctor's instructions. Check with the doctor or pharmacist if you are

not sure

regarding the dosage and the manner of treatment with the medicine.

Butrans patches have four different strengths: 5, 10, 15, and 20.

The dosage and the manner of treatment will be determined by the doctor only.

The standard dosage is usually:

Each patch is usually intended for seven consecutive days of treatment, and you should change

to a new patch every seven days, preferably always at the same time. As the maximum effect of

a given dose is achieved after 3 days, the doctor may change the patch dose if necessary after

3 to 7 days, until the correct dosage for pain relief is obtained. In any case, do not use more

than two patches at the same time, and up to a maximum dose of 40 micrograms per

hour.

Do not exceed the recommended dose.

Use this medicine at set intervals as determined by your doctor.

During the course of treatment, your doctor might tell you to use a higher or lower dosage, or a

combination of up to two patches. Do not cut or divide the patch.

If your doctor has advised you to take other pain relievers in addition to Butrans, strictly follow

the doctor's instructions, otherwise you will not get the full benefit of your Butrans treatment.

Consult your doctor if you feel that the medicine's effect is too weak or too strong.

Attention:

This medicine is intended for external use only.

Directions for use:

Ask for assistance if you cannot apply the patch yourself.

Driving and use of machinery:

Use of this medicine may impair alertness and your ability to react (for example in the event

of unexpected or sudden occurrences). This is particularly likely when you start treatment,

when increasing the dosage, in combination with alcohol, in combination with certain

medicines used to treat anxiety or to help you sleep.

Do not drive while using this medicine until you know how it affects you.

If you experience symptoms such as dizziness, drowsiness, blurred vision, do not drive or

operate machinery while using Butrans, and for 24 hours after removing the patch.

In any case, exercise caution when driving a vehicle, operating dangerous machinery, or

performing any activity that requires alertness (and for 24 hours after removing the patch).

Talk to your doctor or a pharmacist if you are not sure if it is safe for you to drive while using this

medicine.

a. Before applying the patch

Choosing the application site: choose a dry, clean place, where the skin is not irritated or red and

not injured, without large scars, and hairless (or nearly hairless), on the upper part of the body

(chest or back) or the outer part of the arms (see Illustration 1).

If needed, the hair on the intended application site can be cut off with scissors (do not shave).

Avoid applying the patch where the skin might fold.

If you need to clean the intended application site, use cold or lukewarm water only (not hot

water). Do not use soap, alcohol, oils, lotions, creams, ointments or anything abrasive on

your skin where you intend to apply the patch. These substances may prevent the patch

from sticking properly.

After a hot shower or bath or on hot and humid days – it is important to make sure that the

skin is completely dry and has cooled to its normal temperature, before applying the patch.

Illustration 1

b. Applying the patch

Open the sealed sachet and take out the patch. Apply the patch immediately after taking it

out of the sachet. Do not use the patch if the sealed sachet was not hermetically closed.

Carefully peel off one section of the protective aluminum foil covering the sticky side. Try not

to touch the sticky part of the patch.

Apply the patch to your skin in the place you chose, and remove the other section of foil

without touching the sticky side. Press the patch against your skin with the palm of your

hand for 30 seconds, making sure that the whole patch is in contact with your skin,

especially at the edges (see Illustration 2).

Write down the date and time you applied the patch.

Illustration 2

c. While the patch is attached to your skin

Usually you should wear the patch for seven consecutive days. At the beginning of

treatment or when pain intensity varies, the doctor may adjust the dose already after the

third day of wearing it, until the correct dosage for pain relief is obtained. Write down when

you applied the patch (date/day and time).

If you have applied the patch correctly, the chance of it coming off is small. If the patch

begins to peel off the skin, tape it down with an adhesive bandage or tape that can be used

on the skin (around the edges of the patch). Do not try to remove the patch and apply to

some other area!

Wait at least an hour after applying the patch before engaging in physical activity that

causes sweating, or before wetting the application site.

You may shower or swim while the patch is attached to the skin.

While using the patch, avoid exposure of the application site to an external heat source

such as a heating pad, hot-water bottle, electric blanket, lamps (e.g. heat lamps), sauna, hot

bath, hot tub, etc., in order to avoid increased absorption of the active ingredient from the

patch and/or damage to the patch's adhesiveness. In case of increase in body temperature,

consult your doctor.

If the patch falls off, apply another one instead. Apply the new patch to a different place on

the skin. Write down when you applied the new patch (date and time). Tell your doctor that

the patch fell off. Replace the new patch after seven days, or as instructed by your doctor.

d. Changing the patch

Remove the used patch and fold it in half with the sticky side facing inward.

Open a sachet containing a new patch and take the patch out. Put the used patch in the

empty sachet. Discard the used patch in a safe and concealed place, out of the reach of

children.

Even used patches still contain a certain amount of active ingredient which may harm

children or animals. So make sure the used patches are kept out of their reach and sight.

Apply the new patch on a different place on your body, in order to avoid skin irritation

or other problems. You may apply a new patch to the same place after 3 to 4 weeks.

It is advisable to change the patch at the same time of day.

e. Treatment duration

Your doctor will decide how long you will be treated with the patches. Do not stop treatment

without consulting your doctor. See the section 'If you stop using the medicine'.

Do not keep at home patches left over after completing treatment with Butrans. If you have

any patches left that you do not need, consult the pharmacist.

Tests and follow-up:

It is advisable to schedule a follow-up visit with your doctor a week or two after starting

treatment to make sure that the dosage that was determined is the best for you, and to

check whether you are suffering from any side effects from the medicine.

The doctor may monitor patients with liver diseases more closely.

During long-term treatment you should undergo periodic checkups to evaluate the continued

need for this medicine.

If you have accidentally used a higher dosage: If you discover that you have accidentally

used more patches than the doctor recommended, or if the patch accidentally stuck to a child or

to a person other than the patient, remove the patches immediately, and proceed immediately to

a doctor or a hospital emergency room with the package of the medicine. Signs of overdose may

include: excessive sleepiness, nausea, and vomiting. Breathing difficulties and loss of

consciousness may also occur.

If you forgot to apply the patch or forgot to change it:

If you forgot to apply the patch at the proper time, apply a patch as soon as you remember, and

write down when you applied the new patch (date and time). If you were very late changing the

patch, your pain may return. In this case, consult your doctor.

Never apply more patches than the doctor has determined to make up for the forgotten

application.

Continue with the treatment as recommended by the doctor. Even if your state of health

improves, do not stop treatment with this medicine without consulting your doctor.

If you stop using the medicine: If you stop using Butrans too soon, your pain may return. If

you want to stop using the medicine, consult your doctor. Your doctor will tell you how to

proceed and whether you can use other medicines.

Some people may experience side effects when they stop using strong pain relievers after a

long period of use. The risk of these effects happening is low, after stopping Butrans. However,

if you feel agitation, anxiety, nervousness, tremors, excessive motility (also of the muscles),

sleeping difficulties, digestive problems, consult your doctor.

The pain relieving effect of Butrans is maintained for some time after removal of the patch, so

do not start using other opioid medicines for 24 hours after removing the patch.

Do not use or take medicines in the dark! Check the label and the dose each time you use a

medicine. Wear glasses if you need them.

If you have any further questions regarding use of the medicine, consult your doctor or pharmacist.

4. Side effects

Like any medicine, using Butrans may cause side effects in some users. Do not be alarmed upon

reading the list of side effects. You may not suffer from any of them.

Side effects that require special attention:

Remove the patch and proceed immediately to get medical treatment if the following side

effects occur:

Breathing difficulties (to the point of respiratory depression), low blood pressure.

Allergic reaction (including severe allergic reaction, such as an anaphylactic reaction which is

rare). Symptoms include: sudden wheezing, breathing difficulties, swelling of the eyelids, face

or lips, rash and itch (which can be all over the body)

Stop treatment if you have a local allergic reaction with clear signs of swelling (rare).

Additional side effects:

Very common side effects (appear in more than one user out of ten):

headache, dizziness, drowsiness/sleepiness

constipation, nausea, vomiting

itchy skin, redness; skin reactions at the site of application: rash, redness, itch, inflammation

or swelling

Common side effects (appear in 1-10 users out of 100):

loss of appetite

confusion, depression, anxiety, insomnia, nervousness, tremors

shortness of breath

abdominal pain or discomfort, diarrhea, indigestion, dry mouth

sweating, rash

tiredness, unusual weakness, muscle weakness, swelling of the limbs (peripheral edema)

Uncommon side effects (appear in 1-10 users out of 1,000):

mood swings, restlessness, agitation, feeling extreme happiness (euphoria), hallucinations,

nightmares; sedation, sleep disorders, reduced sexual drive,

aggression

changes in taste, impaired speech, reduced sensitivity to pain or touch, loss of sensation

(numbness) or tingling

memory loss or impaired memory, migraines, fainting, problems with concentration or

coordination

dry eyes, blurred vision

ringing or buzzing in the ears, vertigo (feeling dizziness or spinning); flushing

high or low blood pressure, chest pain, fast or irregular heartbeat

cough, hiccups, wheezing

flatulence

weight loss

dry skin

urticaria (hives), muscle cramps, muscle pain

impairments in passing urine such as: difficulty starting to urinate, urinary leakage, urinary

retention

feeling extremely tired (fatigue), fever, chills, edema, increase in accidental injuries (e.g. falls)

withdrawal symptoms upon stopping treatment with the medicine (such as agitation, anxiety,

sweating, tremors)

impaired liver function (seen in blood tests)

Rare side effects (appear in 1-10 users out of 10,000):

angina pectoris

impaired sexual function such as erection problems; mental disorders

impaired balance

impaired vision, swelling of the eyelids or face, reduction in the size of the pupils

breathing difficulties, worsening of asthma, hyperventilation

blood-vessel dilation, flushing of the skin, feeling faint especially when standing up

difficulty swallowing, intestinal obstruction

swelling and irritation inside the nose (inflammation of the nose)

flu-like illness

dehydration

Very rare side effects (appear in less than one user out of 10,000):

drug dependence

muscle twitching

ear ache

blisters

Side effects of unknown frequency (effects whose frequency has not yet been determined):

convulsions or seizures

inflammation of the intestinal wall (symptoms of this may include: fever, vomiting, abdominal

pain or discomfort)

abdominal discomfort and spastic (colicky) pain which may be caused by biliary colic

feeling detached from oneself, addiction

Withdrawal symptoms in babies born to mothers who used Butrans during pregnancy. The

symptoms may include: high-pitched crying, irritability/restlessness, shaking (tremor), feeding

difficulties, sweating, lack of weight gain.

If any side effect occurs, if any side effect gets worse, or if you experience side effects that are

not mentioned in this leaflet, consult your doctor.

Side effects can be reported to the Ministry of Health (MoH) by clicking on the link "Reporting side

effects following medicinal treatment" on the MoH home page (www.health.gov.il) which links to the

online form for reporting side effects, or by following the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.

gov.il

5. How to store the medicine?

Avoid poisoning! This medicine especially, and any other medicine, must be stored in a

closed place out of the reach and sight of children and/or infants, to avoid poisoning.

Do not induce vomiting unless explicitly instructed to do so by the doctor.

Do not use the medicine after the expiry date (exp. date) stated on the package. The expiry date

refers to the last day of that month.

Storage conditions: store below

25°C

Make sure that the patches are stored in the original

aluminum sachet.

Do not use this medicine if the patch or its packaging are damaged.

6. Additional information

In addition to the active ingredient the patches also contain:

Levulinic acid, oleyl oleate, povidone K90, polyacrylate adhesive (with and without cross linker),

polyethylene terephthalates.

What does the medicine look like and what does the package contain?

Each package contains 2 beige colored transdermal patches. Each patch is packed in a separate

aluminum sachet.

Butrans 5: Square patches, 6.25 cm

. The back of the patch has 'BuTrans 5 μg/h' printed on it in

blue ink.

Butrans 10: Rectangular patches, 12.5 cm

. The back of the patch has 'BuTrans 10 μg/h' printed on

it in blue ink.

Butrans 15: Rectangular patches, 18.75 cm

. The back of the patch has 'BuTrans 15 μg/h' printed on

it in blue ink.

Butrans 20: Square patches, 25 cm

. The back of the patch has 'BuTrans 20 μg/h' printed on it in

blue ink.

Registration holder: Rafa Laboratories Ltd., P.O.Box 405, Jerusalem 9100301.

Manufacturer: Lohmann Therapie Systeme (LTS), Germany.

Medicine registration number in the National Medicines Registry of the Ministry of Health:

Butrans 5: 1357031151

Butrans 10: 1357131152

Butrans 15: 1579934931

Butrans 20: 1357231153

This leaflet was checked and approved by the Ministry of Health in March 2017, and was updated

according to the guidelines of the Ministry of Health in January 2019.

690007

BuTrans-DL-Feb 2017-JAN 2019 notif_ 04

Doctor leaflet

BuTrans 5, 10, 15, 20

Transdermal patch

1.

NAME OF THE MEDICINAL PRODUCT

BuTrans 5

transdermal patch

BuTrans 10

transdermal patch

BuTrans 15

transdermal patch

BuTrans 20

transdermal patch

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each

BuTrans 5

transdermal patch contains 5 mg buprenorphine.

Area containing active substance: 6.25 cm

Nominal release rate: 5 micrograms of buprenorphine per hour (over a period of 7 days).

Each

BuTrans 10

transdermal patch contains 10 mg buprenorphine.

Area containing active substance: 12.5 cm

Nominal release rate: 10 micrograms of buprenorphine per hour (over a period of 7 days).

Each

BuTrans 15

transdermal patch contains 15 mg buprenorphine.

Area containing active substance: 18.75 cm

Nominal release rate: 15 micrograms of buprenorphine per hour (over a period of 7 days).

Each

BuTrans 20

transdermal patch contains 20 mg buprenorphine.

Area containing active substance: 25 cm

Nominal release rate: 20 micrograms of buprenorphine per hour (over a period of 7 days).

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Transdermal patch.

Beige coloured patch with rounded corners.

Square patch marked:

BuTrans 5

μg/h,

Rectangular patch marked:

BuTrans 10

μg/h.

Rectangular patch marked:

BuTrans 15

μg/h.

Square patch marked:

BuTrans 20

μg/h.

4.

CLINICAL PARTICULARS

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS

DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including

alcohol, may result in profound sedation, respiratory depression, coma, and death [see section 4.4 & 4.5].

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are

inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

4.1.

Therapeutic Indications

Treatment of moderate to severe opioid responsive chronic pain conditions which are not adequately

responding to non-opioid analgesics.

4.2.

Posology and Method of Administration

Posology

BuTrans

should be administered every 7th day.

BuTrans

is not suitable for the treatment of acute pain.

Patients aged 18 years and over:

The lowest

BuTrans

dose (

BuTrans 5

μg/h transdermal patch) should be used as the initial dose.

Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the

current general condition and medical status of the patient.

Titration:

During initiation of treatment with

BuTrans

, short-acting supplemental analgesics may be required (see

section 4.5) as needed until analgesic efficacy with

BuTrans

is attained.

The dose of

BuTrans

may be titrated upwards as indicated after 3 days, when the maximum effect of a given

dose is established. Subsequent dosage increases may then be titrated based on the need for supplemental

pain relief and the patient’s analgesic response to the patch.

To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination

of patches should be applied in different places to achieve the desired dose. It is recommended that no more

than two patches are applied at the same time, up to (and including) a maximum total dose of

40 microgram/hour

BuTrans

. A new patch should not be applied to the same skin site for the subsequent 3-

4 weeks (see section 5.2). Patients should be carefully and regularly monitored to assess the optimum dose

and duration of treatment.

Conversion from opioids:

BuTrans

can be used as an alternative to treatment with other opioids. Such patients should be started on

the lowest available dose (

BuTrans 5

μg/h transdermal patch) and continue taking short-acting supplemental

analgesics (see section 4.5) during titration, as required.

Paediatric population:

The safety and efficacy of

BuTrans

in children below 18 years of age has not been established. No data are

available.

Elderly:

No dosage adjustment of

BuTrans

is required in elderly patients.

Renal impairment:

No special dose adjustment of

BuTrans

is necessary in patients with renal impairment.

Hepatic impairment:

Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients

with impaired liver function. Therefore patients with hepatic insufficiency should be carefully monitored

during treatment with

BuTrans

Patients with severe hepatic impairment may accumulate buprenorphine during

BuTrans

treatment.

Consideration of alternate therapy should be considered, and

BuTrans

should be used with caution, if at all,

in such patients.

Method of administration

Route of administration

Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces.

Patch application:

BuTrans

should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the

side of the chest, but not to any parts of the skin with large scars.

BuTrans

should be applied to a relatively

hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not

shaven.

If the application site must be cleaned, it should be done with clean water only. Soaps, alcohol, oils, lotions

or abrasive devices must not be used. The skin must be dry before the patch is applied.

BuTrans

should be

applied immediately after removal from the sealed sachet. Following removal of the protective layer, the

transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds,

making sure the contact is complete, especially around the edges. If the edges of the patch begin to peel off,

the edges may be taped down with suitable skin tape to ensure a 7 day period of wear.

The patch should be worn continuously for 7 days.

Bathing, showering, or swimming should not affect the patch. If a patch falls off, a new one should be

applied and worn for 7 days.

Duration of administration:

BuTrans

should under no circumstances be administered for longer than absolutely necessary. If long-term

pain treatment with

BuTrans

is necessary in view of the nature and severity of the illness, then careful and

regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to

what extent further treatment is necessary.

Discontinuation:

After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic

effect is maintained for a certain amount of time. This should be considered when therapy with

BuTrans

to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24

hours after removal of the patch. At present, only limited information is available on the starting dose of

other opioids administered after discontinuation of the transdermal patch (see section 4.5).

Patients with fever or exposed to external heat:

While wearing the patch, patients should be advised to avoid exposing the application site to external heat

sources, such as heating pads, electric blankets, heat lamps, sauna, hot tubs, and heated water beds, etc., as

an increase in absorption of buprenorphine may occur. When treating febrile patients, one should be aware

that fever may also increase absorption resulting in increased plasma concentrations of buprenorphine and

thereby increased risk of opioid reactions.

4.3.

Contraindications

BuTrans

is contraindicated in:

Patients with known hypersensitivity to the active substance buprenorphine or to any of the excipients

(see section 6.1).

Opioid dependent patients and for narcotic withdrawal treatment.

Conditions in which the respiratory centre and function are severely impaired or may become so.

Patients who are receiving MAO inhibitors or have taken them within the last two weeks (see section

4.5).

Patients suffering from myasthenia gravis.

Patients suffering from delirium tremens.

4.4.

Special warnings and precautions for use

BuTrans

should be used with particular caution in patients with acute alcohol intoxication, head injury,

shock, a reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial

pressure, or in patients with severe hepatic impairment (see section 4.2).

Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder.

Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous

route. A number of overdose deaths have occurred when addicts have intravenously abused buprenorphine,

usually with benzodiazepines concomitantly. Additional overdose deaths due to ethanol and benzodiazepines

in combination with buprenorphine have been reported.

Since CYP3A4 inhibitors may increase concentrations of buprenorphine (see section 4.5), patients already

treated with CYP3A4 inhibitors should have their dose of

BuTrans

carefully titrated since a reduced dosage

might be sufficient in these patients.

BuTrans

is not recommended for analgesia in the immediate post-operative period or in other situations

characterised by a narrow therapeutic index or a rapidly varying analgesic requirement.

Controlled human and animal studies indicate that buprenorphine has a lower dependence liability than pure

agonist analgesics. In humans limited euphorigenic effects have been observed with buprenorphine. This

may result in some abuse of the product and caution should be exercised when prescribing to patients known

to have, or suspected of having, a history of drug abuse or alcohol abuse or serious mental illness.

As with all opioids, chronic use of buprenorphine can result in the development of physical dependence.

Withdrawal (abstinence syndrome), when it occurs, is generally mild, begins after 2 days and may last up to

2 weeks. Withdrawal symptoms include agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and

gastrointestinal disorders.

BuTrans

should not be used at higher doses than recommended.

4.5.

Interaction with other medicinal products and other forms of interaction

BuTrans

must not be used concomitantly with MAOIs or in patients who have received MAOIs within the

previous two weeks (see section 4.3).

Effect of other active substances on the pharmacokinetics of buprenorphine:

Buprenorphine is primarily metabolised by glucuronidation and to a lesser extent (about 30%) by CYP3A4 .

Concomitant treatment with CYP3A4 inhibitors may lead to elevated plasma concentrations with intensified

efficacy of buprenorphine.

Studies with the CYP3A4 inhibitor ketoconazole did not produce clinically relevant increases in mean

maximum (Cmax) or total (AUC) buprenorphine exposure following

BuTrans

with ketoconazole as

compared to

BuTrans

alone.

The interaction between buprenorphine and CYP3A4 enzyme inducers has not been studied.

Co-administration of

BuTrans

and enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin and

rifampicin) could lead to increased clearance which might result in reduced efficacy.

Reductions in hepatic blood flow induced by some general anaesthetics (e.g. halothane) and other medicinal

products may result in a decreased rate of hepatic elimination of buprenorphine.

Pharmacodynamic interactions:

BuTrans

should be used cautiously with:

Other central nervous system depressants: other opioid derivatives (analgesics and antitussives containing

e.g. morphine, dextropropoxyphene, codeine, dextromethorphan or noscapine). Certain antidepressants,

sedative H1-receptor antagonists, alcohol, anxiolytics, neuroleptics, clonidine and related substances. These

combinations increase the CNS depressant activity.

Benzodiazepines: This combination can potentiate

respiratory depression of central origin (see section 4.4 BOX Warning).

At typical analgesic doses buprenorphine is described to function as a pure mu receptor agonist. In

BuTrans

clinical studies subjects receiving full mu agonist opioids (up to 90 mg oral morphine or oral morphine

equivalents per day) were transferred to

BuTrans

. There were no reports of abstinence syndrome or opioid

withdrawal during conversion from entry opioid to

BuTrans

(see section 4.4).

4.6.

Fertility, pregnancy and lactation

Pregnancy

There are no or limited amounts of data from the use of

BuTrans

in pregnant women. Studies in animals

have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in the neonate

even after a short period of administration. Prolonged use of buprenorphine during pregnancy can result in

neonatal opioid withdrawal syndrome.

Therefore

BuTrans

should not be used during pregnancy and in women of childbearing potential who are

not using effective contraception.

Breastfeeding

Buprenorphine is excreted in human milk. Studies in rats have shown that buprenorphine may inhibit

lactation. Available pharmacodynamic/ toxicological data in animals has shown excretion of buprenorphine

in milk

(see section 5.3)

. Therefore the use of

BuTrans

during lactation should be avoided.

Fertility

No human data on the effect of buprenorphine on fertility are available. In a fertility and early embryonic

development study, no effects on reproductive parameters were observed in male or female rats (see section

5.3).

4.7.

Effects on ability to drive and use machines

BuTrans

has a major influence on the ability to drive and use machines. Even when used according to

instructions,

BuTrans

may affect the patient’s reactions to such an extent that road safety and the ability to

operate machinery may be impaired. This applies particularly in the beginning of treatment and in

conjunction with other centrally acting substances including alcohol, tranquillisers, sedatives and hypnotics.

An individual recommendation should be given by the physician. A general restriction is not necessary in

cases where a stable dose is used.

Patients who are affected, and experience side effects (e.g. dizziness, drowsiness, blurred vision) during

treatment initiation or titration to a higher dose, should not drive or use machines, nor for at least 24 hours

after the patch has been removed.

This medicine can impair cognitive function and can affect a patient's ability to drive safely.

When prescribing this medicine, patients should be told:

The medicine is likely to affect your ability to drive.

Do not drive until you know how the medicine affects you.

4.8.

Undesirable effects

Serious adverse reactions that may be associated with

BuTrans

therapy in clinical use are similar to those

observed with other opioid analgesics, including respiratory depression (especially when used with other

CNS depressants) and hypotension (see section 4.4).

The following undesirable effects have occurred:

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000),

very rare (<1/10,000), not known (cannot be estimated from the available data).

System organ

class

MedDRA

Very common

(≥1/10)

Common

(≥1/100, <1/10)

Uncommon

(≥1/1000,

<1/100)

Rare (≥1/10,000,

<1/1000)

Very rare

(<1/10,000)

Not known (cannot

be estimated from

the available data)

Immune system

disorders

Hypersensitivity

Anaphylactic

reaction

Anaphylactoid

reaction

Metabolic and

nutritional

disorders

Anorexia

Dehydration

Psychiatric

disorders

Confusion

Depression

Insomnia

Nervousness

Anxiety

Affect liability

Sleep disorder

Restlessness

Agitation

Euphoric mood

Hallucinations

Libido decreased

Nightmares

Aggression

Psychotic

disorder

Drug

dependence

Mood swings

Depersonalisation

Nervous system

disorders

Headache

Dizziness

Somnolence

Tremor

Sedation

Dysgeusia

Dysarthria

Hypoaesthesia

Memory

impairment

Migraine

Syncope

Co-ordination

abnormal

Disturbance in

attention

Paraesthesia

Balance disorder

Speech disorder

Involuntary

muscle

contractions

Seizures

Eye disorders

Dry eye

Visual

Blurred vision

disturbance

Eyelid oedema

Miosis

Ear and labyrinth

disorders

Tinnitus

Vertigo

Ear pain

Cardiac disorders

Palpitations

Tachycardia

Angina pectoris

Vascular

disorders

Hypotension

Circulatory

collapse

Hypertension

Flushing

Vasodilatation

Orthostatic

hypotension

Respiratory,

thoracic and

mediastinal

disorders

Dyspnoea

Cough

Wheezing

Hiccups

Respiratory

depression

Respiratory

failure

Asthma

aggravated

Hyperventilation

Rhinitis

Gastrointestinal

disorders

Constipation

Nausea

Vomiting

Abdominal pain

Diarrhoea

Dyspepsia

Dry mouth

Flatulence

Dysphagia

Ileus

Diverticulitis

Hepatobiliary

disorders

Biliary colic

Skin and

subcutaneous

tissue disorders

Pruritus

Erythema

Rash

Sweating

Exanthema

Dry skin

Urticaria

Dermatitis

contact

Face oedema

Pustules

Vesicles

Musculoskeletal

and connective

tissue disorders

Muscular

weakness

Myalgia

Muscle spasms

Renal and

urinary disorders

Urinary

incontinence

Urinary retention

Urinary

hesitation

Reproductive

system and breast

disorders

Erectile

dysfunction

Sexual

dysfunction

General disorders

administration

site conditions

Application site

reaction

Tiredness

Asthenic

conditions

Peripheral

oedema

Fatigue

Pyrexia

Rigors

Oedema

Drug withdrawal

syndrome

Application site

dermatitis*

Chest pain

Influenza like

illness

Drug withdrawal

syndrome neonatal

Investigations

Alanine

aminotransferase

increased

Weight

decreased

Injury, poisoning

and procedural

complications

Accidental

injury

Fall

*In some cases delayed local allergic reactions occurred with marked signs of inflammation. In such cases

treatment with

BuTrans

should be terminated.

Includes application site erythema, application site oedema, application site pruritus, application site rash.

Buprenorphine has a low risk of physical dependence. After discontinuation of

BuTrans

, withdrawal

symptoms are unlikely. This may be

due to the very slow dissociation of buprenorphine from the opioid

receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30

hours after removal of the last patch). However, after long-term use of

BuTrans

, withdrawal symptoms

similar to those occurring during opioid withdrawal, cannot be entirely excluded. These symptoms include

agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation

by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il

4.9.

Overdose

Symptoms:

Symptoms similar to those of other centrally acting analgesics are to be expected. These include respiratory

depression, sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis.

Treatment:

Remove any patches from the patient’s skin. Establish and maintain a patent airway, assist or control

respiration as indicated and maintain adequate body temperature and fluid balance. Oxygen, intravenous

fluids, vasopressors and other supportive measures should be employed as indicated.

A specific opioid antagonist such as naloxone may reverse the effects of buprenorphine, although naloxone

may be less effective in reversing the effects of buprenorphine than other µ-opioid agonists. Treatment with

continuous intravenous naloxone should begin with the usual doses but high doses may be required.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics, opioids; ATC code: N02 AE01

Buprenorphine is a partial agonist opioid, acting at the mu opioid receptor. It also has antagonistic activity at

the kappa opioid receptor.

Efficacy has been demonstrated in seven pivotal phase III studies of up to 12 weeks duration in patients with

non-malignant pain of various aetiologies. These included patients with moderate and severe osteoarthritis

and back pain.

BuTrans

demonstrated clinically significant reductions in pain scores (approximately 3

points on the BS-11 scale) and significantly greater pain control compared with placebo.

A long term, open-label extension study (n=384) has also been performed in patients with non-malignant

pain. With chronic dosing, 63% of patients were maintained in pain control for 6 months, 39% of patients for

12 months, 13% of patients for 18 months and 6% for 21 months. Approximately 17% were stabilised on the

5 mg dose, 35% on the 10 mg dose and 48% on the 20 mg dose.

5.2.

Pharmacokinetic properties

There is evidence of enterohepatic recirculation.

Studies in non-pregnant and pregnant rats have shown that buprenorphine passes the blood-brain and

placental barriers. Concentrations in the brain (which contained only unchanged buprenorphine) after

parenteral administration were 2-3 times higher than after oral administration. After intramuscular or oral

administration buprenorphine apparently accumulates in the foetal gastrointestinal lumen – presumably due

to biliary excretion, as

enterohepatic circulation has not fully developed.

Each patch provides a steady delivery of buprenorphine for up to seven days, and steady state is achieved

during the second application period. After removal of

BuTrans

, buprenorphine concentrations decline,

with mean elimination half lives ranging from 31 to 45 hours.

Absorption:

Following

BuTrans

application, buprenorphine diffuses from the patch through the skin. In clinical

pharmacology studies, the median time for

BuTrans 10

μg/h to deliver detectable buprenorphine

concentrations (25 picograms/ml) was approximately 17 hours. Analysis of residual buprenorphine in

patches after 7-day use shows approximately 15% of the original load delivered. A study of bioavailability,

relative to intravenous administration, confirms that this amount is systemically absorbed. Buprenorphine

concentrations remain relatively constant during the 7-day patch application.

Application site:

A study in healthy subjects demonstrated that the pharmacokinetic profile of buprenorphine delivered by

BuTrans

is similar when applied to upper outer arm, upper chest, upper back or the side of the chest

(midaxillary line, 5th intercostal space). The absorption varies to some extent depending on the application

site and the exposure is at the most approximately 26 % higher when applied to the upper back compared to

the side of the chest.

In a study of healthy subjects receiving

BuTrans

repeatedly to the same site, an almost doubled exposure

was seen with a 14 day rest period

.

For this reason, rotation of application sites is recommended, and a new

patch should not be applied to the same skin site for 3-4 weeks.

In a study of healthy subjects, application of a heating pad directly on the transdermal patch caused a

transient 26 - 55% increase in blood concentrations of buprenorphine. Concentrations returned to normal

within 5 hours after the heat was removed. For this reason, applying direct heat sources such as hot water

bottles, heat pads or electric blankets directly to the patch is not recommended. A heating pad applied to a

BuTrans

site immediately after patch removal did not alter absorption from the skin depot.

Distribution:

Buprenorphine is approximately 96% bound to plasma proteins.

Studies of intravenous buprenorphine have shown a large volume of distribution, implying extensive

distribution of buprenorphine. In a study of intravenous buprenorphine in healthy subjects, the volume of

distribution at steady state was 430 L, reflecting the large volume of distribution and lipophilicity of the

active substance.

Following intravenous administration, buprenorphine and its metabolites are secreted into bile, and within

several minutes, distributed into the cerebrospinal fluid. Buprenorphine concentrations in the cerebrospinal

fluid appear to be approximately 15% to 25% of concurrent plasma concentrations.

Biotransformation and elimination:

Buprenorphine metabolism in the skin following

BuTrans

application is negligible. Following transdermal

application, buprenorphine is eliminated via hepatic metabolism, with subsequent biliary excretion and renal

excretion of soluble metabolites. Hepatic metabolism, through CYP3A4 and UGT1A1/1A3 enzymes, results

in two primary metabolites, norbuprenorphine and buprenorphine 3-O-glucuronide, respectively.

Norbuprenorphine is glucuronidated before elimination. Buprenorphine is also eliminated in the faeces. In a

study in post-operative patients, the total elimination of buprenorphine was shown to be approximately

55L /h.

Norbuprenorphine is the only known active metabolite of buprenorphine.

Effect of buprenorphine on the pharmacokinetics of other active substances:

Based on

in vitro

studies in human microsomes and hepatocytes, buprenorphine does not have the potential

to inhibit metabolism catalysed by the CYP450 enzymes CYP1A2, CYP2A6 and CYP3A4 at concentrations

obtained with use of

BuTrans 20

µg/h transdermal patch. The effect on metabolism catalysed by CYP2C8,

CYP2C9 and CYP2C19 has not been studied.

5.3.

Preclinical safety data

Reproductive and developmental toxicity

No effect on fertility or general reproductive performance was observed in rats treated with buprenorphine.

In embryofoetal developmental toxicity studies conducted in rats and rabbits using buprenorphine, no

embryofoetal toxicity effects were observed. In a rat pre- and post-natal developmental toxicity study with

buprenorphine there was pup mortality, decreased pup body weight and concomitant maternal reduced food

consumption and clinical signs.

Genotoxicity

A standard battery of genotoxicity tests indicated that buprenorphine is non-genotoxic.

Carcinogenicity

In long-term studies in rats and mice there was no evidence of any carcinogenic potential relevant for

humans.

Systemic toxicity and dermal toxicity

In single- and repeat-dose toxicity studies in rats, rabbits, guinea pigs, dogs and minipigs,

BuTrans

caused

minimal or no adverse systemic events, whereas skin irritation was observed in all species examined.

Toxicological data available did not indicate a sensitising potential of the additives of the transdermal

patches.

6.

PHARMACEUTICALS PARTICULARS

6.1.

List of excipients

Levulinic acid, oleyl oleate, povidone K90, DuroTak 387-2054 (polyacrylate adhesive with cross linker),

DuroTak 387-2051 (polyacrylate adhesive without cross linker), polyethylene terephthalate (web, 23µm,

100µm)

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4.

Special precautions for storage

Store below 25°C in the original sachet.

6.5.

Nature and contents of container

BuTrans 5, BuTrans 10, BuTrans 20

Sealed protective sachets (pouches) composed of a composite material: paper, low density

polyethylene film, aluminum and Surlyn. The Surlyn layer is in contact with product.

BuTrans 15

Sealed protective sachets (pouches), composed of two types of composite material:

Paper low density polyethylene film, aluminium and ethylene copolymer (Surlyn).

Paper polyethyleneterephthalate, polymer, aluminium and ethylene copolymer (Surlyn).

The Surlyn layer is in contact with product.

Pack Sizes: 2 transdermal patches.

6.6.

Special precautions for disposal and other handling

The patch should not be used if the seal is broken.

Disposal after use:

When changing the patch, the used patch should be removed, the adhesive layer folded inwards on itself, and

the patch disposed of safely and out of sight and reach of children.

7.

REGISTRATION HOLDER:

Rafa Laboratories Ltd, POB 405, Jerusalem 9100301

Registration no:

Butrans 5

: 135 70 31151

Butrans 10

: 135 71 31152

Butrans 15

: 157 99 34931

Butrans 20

: 135 72 31153

Manufactured by LTS Lohmann Therapie System, Germany.

The content of this leaflet was approved by the Ministry of Health in February 2017 and updated according to the guidelines of the

Ministry of Health in January 2019.

ראורבפ

2019

ה/אפור

,ה/דבכנ ת/חקור

atch

P

BuTrans Transdermal

-

םינולע ןוכדע

אפר תודבעמ מ"עב אפורלו ןכרצל םינולעה ונכדוע יכ םכתעידיל איבהל תשקבמ

ליעפ ביכרמ

:

Buprenorphine

:םיקזוח

BuTrans 5

BuTrans 10

, BuTrans 15

BuTrans 20

:היוותה

Treatment of moderate to severe opioid responsive chronic pain conditions which are not

adequately responding to non-opioid analgesics.

םינולעב םייתועמשמה םייונישה

הרהזא תובית תפסו

םידיאויפוא םירישכת לש םינולעב תואירבה דרשמ תשירד יפ לע

היצקארטניאל עגונב הרהזא תבית תפסו םע יאכדמ

םיניפזאידוזנב לוהוכלאו ,הקומע היצדסל ןוכיסה דודיח( )תוומו המוק ,יתמישנ יוכיד הרהזא תבית םג ןכרצל ןולעבו , תנכסל עגונב .רתי ןונימו תורכמתה

:ןוירה

ל( ןוירהב הפורתב תשמתשמ םאה םא שחרתהל הלולע דולייב הלימג תנומסת )םינורחאה םישדוחה תשולשב קר א

:ףסוה ןכרצל ןולעב העינמ יעצמאב תושמתשמ ןניאשו ןוירהל סנכיהל תויושעה םישנב סנרטובב שמתשהל ןיא .םיתואנ

:הגיהנ ףיעס

.)הגיהנה רשוכו תיביטינגוקה תלוכיה לע העיפשמש תויה( וילע העיפשמ הפורתה ךיא עדיי לפוטמהש דע גוהנל ןיא שיש דדוח אפורל ןולעב .ךכ לע לפוטמה תא עדייל

:יאוול תועפות

:ופסוה

Aggressio

Urinary incontinence

Urinary hesitation

Drug withdrawal syndrome neonatal

ולעב

פסוה ןכרצל

.הרמה לש קילוק ,רועה תמדאה ,הרומח תיגרלא הבוגתל אמגודכ תיטקליפאנא הבוגת םג

םיפסונ םייוניש

ןכרצל ןולעב

:תורהזא

שי

אדוול

הקבדמהש

הנשיה

תרסומ

ינפל

תקבדה

הקבדמ

םא ;השדח

ךתמישנ

תכפוה

תיחטש

השלחו

שי

ריסהל

תא

הקבדמה

לבקלו

הרזע

תיאופר

:תויתפורת ןיב תובוגת

:תיזכרמה םיבצעה תכרעמ לע תועיפשמה תופורת םע בולישב רימחהל תולולעש יאוול תועפותל תואמגוד ינונשי ,תו רתוי השלחו רתוי תיטיא המישנ ,ןופליע ,תוליחב

.םייתועמשמה םייונישה םינמוסמ םהב םינכדועמה םינולעל רושיק ב"צמ

םניאש םיפסונ םייוניש ויהש ןייצל שי .הרמחה םיווהמ

ולעב ןייעל שי אלמה עדימל םינ תומלשב

תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל וחלשנ םינולעה

www.health.gov.il

םלבקל םג ןתינו , מ תרבחל הינפ י"ע םיספדומ 'לטב מ"עב אפר תודבע

5893939

ל"אוד תבותכב וא

RA@rafa.co.il

,בר דובכב

רגמ

ץיבוקיוו לכימ

הנוממ תחקור

Doctor leaflet

BuTrans 5, 10, 15, 20

Transdermal patch

1.

NAME OF THE MEDICINAL PRODUCT

BuTrans 5

transdermal patch

BuTrans 10

transdermal patch

BuTrans 15

transdermal patch

BuTrans 20

transdermal patch

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each

BuTrans 5

transdermal patch contains 5 mg buprenorphine.

Area containing active substance: 6.25 cm

Nominal release rate: 5 micrograms of buprenorphine per hour (over a period of 7 days).

Each

BuTrans 10

transdermal patch contains 10 mg buprenorphine.

Area containing active substance: 12.5 cm

Nominal release rate: 10 micrograms of buprenorphine per hour (over a period of 7 days).

Each

BuTrans 15

transdermal patch contains 15 mg buprenorphine.

Area containing active substance: 18.75 cm

Nominal release rate: 15 micrograms of buprenorphine per hour (over a period of 7 days).

Each

BuTrans 20

transdermal patch contains 20 mg buprenorphine.

Area containing active substance: 25 cm

Nominal release rate: 20 micrograms of buprenorphine per hour (over a period of 7 days).

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Transdermal patch.

Beige coloured patch with rounded corners.

Square patch marked:

BuTrans 5

μg/h,

Rectangular patch marked:

BuTrans 10

μg/h.

Rectangular patch marked:

BuTrans 15

μg/h.

Square patch marked:

BuTrans 20

μg/h.

4.

CLINICAL PARTICULARS

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS

DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including

alcohol, may result in profound sedation, respiratory depression, coma, and death [see section 4.4 & 4.5].

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are

inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

4.1.

Therapeutic Indications

Treatment of moderate to severe opioid responsive chronic pain conditions which are not adequately

responding to non-opioid analgesics.

4.2.

Posology and Method of Administration

Posology

BuTrans

should be administered every 7th day.

BuTrans

is not suitable for the treatment of acute pain.

Patients aged 18 years and over:

The lowest

BuTrans

dose (

BuTrans 5

μg/h transdermal patch) should be used as the initial dose.

Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the

current general condition and medical status of the patient.

Titration:

During initiation of treatment with

BuTrans

, short-acting supplemental analgesics may be required (see

section 4.5) as needed until analgesic efficacy with

BuTrans

is attained.

The dose of

BuTrans

may be titrated upwards as indicated after 3 days, when the maximum effect of a given

dose is established. Subsequent dosage increases may then be titrated based on the need for supplemental

pain relief and the patient’s analgesic response to the patch.

To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination

of patches should be applied in different places to achieve the desired dose. It is recommended that no more

than two patches are applied at the same time, up to (and including) a maximum total dose of

40 microgram/hour

BuTrans

. A new patch should not be applied to the same skin site for the subsequent 3-

4 weeks (see section 5.2). Patients should be carefully and regularly monitored to assess the optimum dose

and duration of treatment.

Conversion from opioids:

BuTrans

can be used as an alternative to treatment with other opioids. Such patients should be started on

the lowest available dose (

BuTrans 5

μg/h transdermal patch) and continue taking short-acting supplemental

analgesics (see section 4.5) during titration, as required.

Paediatric population:

The safety and efficacy of

BuTrans

in children below 18 years of age has not been established. No data are

available.

Elderly:

No dosage adjustment of

BuTrans

is required in elderly patients.

Renal impairment:

No special dose adjustment of

BuTrans

is necessary in patients with renal impairment.

Hepatic impairment:

Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients

with impaired liver function. Therefore patients with hepatic insufficiency should be carefully monitored

during treatment with

BuTrans

Patients with severe hepatic impairment may accumulate buprenorphine during

BuTrans

treatment.

Consideration of alternate therapy should be considered, and

BuTrans

should be used with caution, if at all,

in such patients.

Method of administration

Route of administration

Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces.

Patch application:

BuTrans

should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the

side of the chest, but not to any parts of the skin with large scars.

BuTrans

should be applied to a relatively

hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not

shaven.

If the application site must be cleaned, it should be done with clean water only. Soaps, alcohol, oils, lotions

or abrasive devices must not be used. The skin must be dry before the patch is applied.

BuTrans

should be

applied immediately after removal from the sealed sachet. Following removal of the protective layer, the

transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds,

making sure the contact is complete, especially around the edges. If the edges of the patch begin to peel off,

the edges may be taped down with suitable skin tape to ensure a 7 day period of wear.

The patch should be worn continuously for 7 days.

Bathing, showering, or swimming should not affect the patch. If a patch falls off, a new one should be

applied and worn for 7 days.

Duration of administration:

BuTrans

should under no circumstances be administered for longer than absolutely necessary. If long-term

pain treatment with

BuTrans

is necessary in view of the nature and severity of the illness, then careful and

regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to

what extent further treatment is necessary.

Discontinuation:

After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic

effect is maintained for a certain amount of time. This should be considered when therapy with

BuTrans

to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24

hours after removal of the patch. At present, only limited information is available on the starting dose of

other opioids administered after discontinuation of the transdermal patch (see section 4.5).

Patients with fever or exposed to external heat:

While wearing the patch, patients should be advised to avoid exposing the application site to external heat

sources, such as heating pads, electric blankets, heat lamps, sauna, hot tubs, and heated water beds, etc., as

an increase in absorption of buprenorphine may occur. When treating febrile patients, one should be aware

that fever may also increase absorption resulting in increased plasma concentrations of buprenorphine and

thereby increased risk of opioid reactions.

4.3.

Contraindications

BuTrans

is contraindicated in:

Patients with known hypersensitivity to the active substance buprenorphine or to any of the excipients

(see section 6.1).

Opioid dependent patients and for narcotic withdrawal treatment.

Conditions in which the respiratory centre and function are severely impaired or may become so.

Patients who are receiving MAO inhibitors or have taken them within the last two weeks (see section

4.5).

Patients suffering from myasthenia gravis.

Patients suffering from delirium tremens.

4.4.

Special warnings and precautions for use

BuTrans

should be used with particular caution in patients with acute alcohol intoxication, head injury,

shock, a reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial

pressure, or in patients with severe hepatic impairment (see section 4.2).

Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder.

Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous

route. A number of overdose deaths have occurred when addicts have intravenously abused buprenorphine,

usually with benzodiazepines concomitantly. Additional overdose deaths due to ethanol and benzodiazepines

in combination with buprenorphine have been reported.

Since CYP3A4 inhibitors may increase concentrations of buprenorphine (see section 4.5), patients already

treated with CYP3A4 inhibitors should have their dose of

BuTrans

carefully titrated since a reduced dosage

might be sufficient in these patients.

BuTrans

is not recommended for analgesia in the immediate post-operative period or in other situations

characterised by a narrow therapeutic index or a rapidly varying analgesic requirement.

Controlled human and animal studies indicate that buprenorphine has a lower dependence liability than pure

agonist analgesics. In humans limited euphorigenic effects have been observed with buprenorphine. This

may result in some abuse of the product and caution should be exercised when prescribing to patients known

to have, or suspected of having, a history of drug abuse or alcohol abuse or serious mental illness.

As with all opioids, chronic use of buprenorphine can result in the development of physical dependence.

Withdrawal (abstinence syndrome), when it occurs, is generally mild, begins after 2 days and may last up to

2 weeks. Withdrawal symptoms include agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and

gastrointestinal disorders.

BuTrans

should not be used at higher doses than recommended.

4.5.

Interaction with other medicinal products and other forms of interaction

BuTrans

must not be used concomitantly with MAOIs or in patients who have received MAOIs within the

previous two weeks (see section 4.3).

Effect of other active substances on the pharmacokinetics of buprenorphine:

Buprenorphine is primarily metabolised by glucuronidation and to a lesser extent (about 30%) by CYP3A4 .

Concomitant treatment with CYP3A4 inhibitors may lead to elevated plasma concentrations with intensified

efficacy of buprenorphine.

Studies with the CYP3A4 inhibitor ketoconazole did not produce clinically relevant increases in mean

maximum (Cmax) or total (AUC) buprenorphine exposure following

BuTrans

with ketoconazole as

compared to

BuTrans

alone.

The interaction between buprenorphine and CYP3A4 enzyme inducers has not been studied.

Co-administration of

BuTrans

and enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin and

rifampicin) could lead to increased clearance which might result in reduced efficacy.

Reductions in hepatic blood flow induced by some general anaesthetics (e.g. halothane) and other medicinal

products may result in a decreased rate of hepatic elimination of buprenorphine.

Pharmacodynamic interactions:

BuTrans

should be used cautiously with:

Benzodiazepines: This combination can potentiate respiratory depression of central origin, with risk of death

in case of overdose

Other central nervous system depressants: other opioid derivatives (analgesics and antitussives containing

e.g. morphine, dextropropoxyphene, codeine, dextromethorphan or noscapine). Certain antidepressants,

sedative H1-receptor antagonists, alcohol, anxiolytics, neuroleptics, clonidine and related substances. These

combinations increase the CNS depressant activity.

Benzodiazepines: This combination can potentiate

respiratory depression of central origin (see section 4.4 BOX Warning).

At typical analgesic doses buprenorphine is described to function as a pure mu receptor agonist. In

BuTrans

clinical studies subjects receiving full mu agonist opioids (up to 90 mg oral morphine or oral morphine

equivalents per day) were transferred to

BuTrans

. There were no reports of abstinence syndrome or opioid

withdrawal during conversion from entry opioid to

BuTrans

(see section 4.4).

4.6.

Fertility, pregnancy and lactation

Pregnancy

There are no or limited amounts of data from the use of

BuTrans

in pregnant women. Studies in animals

have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in the neonate

even after a short period of administration. Prolonged use of buprenorphine during the last three months of

pregnancy can result in neonatal opioid withdrawal syndrome.

Therefore

BuTrans

should not be used during pregnancy and in women of childbearing potential who are

not using effective contraception.

Breastfeeding

Buprenorphine is excreted in human milk. Studies in rats have shown that buprenorphine may inhibit

lactation. Available pharmacodynamic/ toxicological data in animals has shown excretion of buprenorphine

in milk

(see section 5.3)

. Therefore the use of

BuTrans

during lactation should be avoided.

Fertility

No human data on the effect of buprenorphine on fertility are available. In a fertility and early embryonic

development study, no effects on reproductive parameters were observed in male or female rats (see section

5.3).

4.7.

Effects on ability to drive and use machines

BuTrans

has a major influence on the ability to drive and use machines. Even when used according to

instructions,

BuTrans

may affect the patient’s reactions to such an extent that road safety and the ability to

operate machinery may be impaired. This applies particularly in the beginning of treatment and in

conjunction with other centrally acting substances including alcohol, tranquillisers, sedatives and hypnotics.

An individual recommendation should be given by the physician. A general restriction is not necessary in

cases where a stable dose is used.

Patients who are affected, and experience side effects (e.g. dizziness, drowsiness, blurred vision) during

treatment initiation or titration to a higher dose, should not drive or use machines, nor for at least 24 hours

after the patch has been removed.

This medicine can impair cognitive function and can affect a patient's ability to drive safely.

When prescribing this medicine, patients should be told:

The medicine is likely to affect your ability to drive.

Do not drive until you know how the medicine affects you.

4.8.

Undesirable effects

Serious adverse reactions that may be associated with

BuTrans

therapy in clinical use are similar to those

observed with other opioid analgesics, including respiratory depression (especially when used with other

CNS depressants) and hypotension (see section 4.4).

The following undesirable effects have occurred:

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000),

very rare (<1/10,000), not known (cannot be estimated from the available data).

System organ

class

MedDRA

Very common

(≥1/10)

Common

(≥1/100, <1/10)

Uncommon

(≥1/1000,

<1/100)

Rare (≥1/10,000,

<1/1000)

Very rare

(<1/10,000)

Not known (cannot

be estimated from

the available data)

Immune system

disorders

Hypersensitivity

Anaphylactic

reaction

Anaphylactoid

reaction

Metabolic and

nutritional

disorders

Anorexia

Dehydration

Psychiatric

disorders

Confusion

Depression

Insomnia

Nervousness

Anxiety

Affect liability

Sleep disorder

Restlessness

Agitation

Euphoric mood

Hallucinations

Libido decreased

Nightmares

Aggression

Psychotic

disorder

Drug

dependence

Mood swings

Depersonalisation

Nervous system

disorders

Headache

Dizziness

Somnolence

Tremor

Sedation

Dysgeusia

Dysarthria

Hypoaesthesia

Memory

impairment

Migraine

Syncope

Co-ordination

abnormal

Disturbance in

Balance disorder

Speech disorder

Involuntary

muscle

contractions

Seizures

attention

Paraesthesia

Eye disorders

Dry eye

Blurred vision

Visual

disturbance

Eyelid oedema

Miosis

Ear and labyrinth

disorders

Tinnitus

Vertigo

Ear pain

Cardiac disorders

Palpitations

Tachycardia

Angina pectoris

Vascular

disorders

Hypotension

Circulatory

collapse

Hypertension

Flushing

Vasodilatation

Orthostatic

hypotension

Respiratory,

thoracic and

mediastinal

disorders

Dyspnoea

Cough

Wheezing

Hiccups

Respiratory

depression

Respiratory

failure

Asthma

aggravated

Hyperventilation

Rhinitis

Gastrointestinal

disorders

Constipation

Nausea

Vomiting

Abdominal pain

Diarrhoea

Dyspepsia

Dry mouth

Flatulence

Dysphagia

Ileus

Diverticulitis

Hepatobiliary

disorders

Biliary colic

Skin and

subcutaneous

tissue disorders

Pruritus

Erythema

Rash

Sweating

Exanthema

Dry skin

Urticaria

Dermatitis

contact

Face oedema

Pustules

Vesicles

Musculoskeletal

and connective

tissue disorders

Muscular

weakness

Myalgia

Muscle spasms

Renal and

urinary disorders

Urinary

incontinence

Urinary retention

Urinary

hesitation

Micturition

disorder

Reproductive

system and breast

disorders

Erectile

dysfunction

Sexual

dysfunction

General disorders

administration

site conditions

Application site

reaction

Tiredness

Asthenic

conditions

Peripheral

oedema

Fatigue

Pyrexia

Rigors

Oedema

Drug withdrawal

syndrome

Application site

dermatitis*

Chest pain

Influenza like

illness

Drug withdrawal

syndrome neonatal

Investigations

Alanine

aminotransferase

increased

Weight

decreased

Injury, poisoning

and procedural

Accidental

injury

complications

Fall

*In some cases delayed local allergic reactions occurred with marked signs of inflammation. In such cases

treatment with

BuTrans

should be terminated.

Includes application site erythema, application site oedema, application site pruritus, application site rash.

Buprenorphine has a low risk of physical dependence. After discontinuation of

BuTrans

, withdrawal

symptoms are unlikely. This may be

due to the very slow dissociation of buprenorphine from the opioid

receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30

hours after removal of the last patch). However, after long-term use of

BuTrans

, withdrawal symptoms

similar to those occurring during opioid withdrawal, cannot be entirely excluded. These symptoms include

agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation

by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il

4.9.

Overdose

Symptoms:

Symptoms similar to those of other centrally acting analgesics are to be expected. These include respiratory

depression, sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis.

Treatment:

Remove any patches from the patient’s skin. Establish and maintain a patent airway, assist or control

respiration as indicated and maintain adequate body temperature and fluid balance. Oxygen, intravenous

fluids, vasopressors and other supportive measures should be employed as indicated.

A specific opioid antagonist such as naloxone may reverse the effects of buprenorphine, although naloxone

may be less effective in reversing the effects of buprenorphine than other µ-opioid agonists. Treatment with

continuous intravenous naloxone should begin with the usual doses but high doses may be required.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics, opioids; ATC code: N02 AE01

Buprenorphine is a partial agonist opioid, acting at the mu opioid receptor. It also has antagonistic activity at

the kappa opioid receptor.

Efficacy has been demonstrated in seven pivotal phase III studies of up to 12 weeks duration in patients with

non-malignant pain of various aetiologies. These included patients with moderate and severe osteoarthritis

and back pain.

BuTrans

demonstrated clinically significant reductions in pain scores (approximately 3

points on the BS-11 scale) and significantly greater pain control compared with placebo.

A long term, open-label extension study (n=384) has also been performed in patients with non-malignant

pain. With chronic dosing, 63% of patients were maintained in pain control for 6 months, 39% of patients for

12 months, 13% of patients for 18 months and 6% for 21 months. Approximately 17% were stabilised on the

5 mg dose, 35% on the 10 mg dose and 48% on the 20 mg dose.

5.2.

Pharmacokinetic properties

There is evidence of enterohepatic recirculation.

Studies in non-pregnant and pregnant rats have shown that buprenorphine passes the blood-brain and

placental barriers. Concentrations in the brain (which contained only unchanged buprenorphine) after

parenteral administration were 2-3 times higher than after oral administration. After intramuscular or oral

administration buprenorphine apparently accumulates in the foetal gastrointestinal lumen – presumably due

to biliary excretion, as

enterohepatic circulation has not fully developed.

Each patch provides a steady delivery of buprenorphine for up to seven days, and steady state is achieved

during the second application period. After removal of

BuTrans

, buprenorphine concentrations decline,

with mean elimination half lives ranging from 31 to 45 hours.

Absorption:

Following

BuTrans

application, buprenorphine diffuses from the patch through the skin. In clinical

pharmacology studies, the median time for

BuTrans 10

μg/h to deliver detectable buprenorphine

concentrations (25 picograms/ml) was approximately 17 hours. Analysis of residual buprenorphine in

patches after 7-day use shows approximately 15% of the original load delivered. A study of bioavailability,

relative to intravenous administration, confirms that this amount is systemically absorbed. Buprenorphine

concentrations remain relatively constant during the 7-day patch application.

Application site:

A study in healthy subjects demonstrated that the pharmacokinetic profile of buprenorphine delivered by

BuTrans

is similar when applied to upper outer arm, upper chest, upper back or the side of the chest

(midaxillary line, 5th intercostal space). The absorption varies to some extent depending on the application

site and the exposure is at the most approximately 26 % higher when applied to the upper back compared to

the side of the chest.

In a study of healthy subjects receiving

BuTrans

repeatedly to the same site, an almost doubled exposure

was seen with a 14 day rest period

.

For this reason, rotation of application sites is recommended, and a new

patch should not be applied to the same skin site for 3-4 weeks.

In a study of healthy subjects, application of a heating pad directly on the transdermal patch caused a

transient 26 - 55% increase in blood concentrations of buprenorphine. Concentrations returned to normal

within 5 hours after the heat was removed. For this reason, applying direct heat sources such as hot water

bottles, heat pads or electric blankets directly to the patch is not recommended. A heating pad applied to a

BuTrans

site immediately after patch removal did not alter absorption from the skin depot.

Distribution:

Buprenorphine is approximately 96% bound to plasma proteins.

Studies of intravenous buprenorphine have shown a large volume of distribution, implying extensive

distribution of buprenorphine. In a study of intravenous buprenorphine in healthy subjects, the volume of

distribution at steady state was 430 L, reflecting the large volume of distribution and lipophilicity of the

active substance.

Following intravenous administration, buprenorphine and its metabolites are secreted into bile, and within

several minutes, distributed into the cerebrospinal fluid. Buprenorphine concentrations in the cerebrospinal

fluid appear to be approximately 15% to 25% of concurrent plasma concentrations.

Biotransformation and elimination:

Buprenorphine metabolism in the skin following

BuTrans

application is negligible. Following transdermal

application, buprenorphine is eliminated via hepatic metabolism, with subsequent biliary excretion and renal

excretion of soluble metabolites. Hepatic metabolism, through CYP3A4 and UGT1A1/1A3 enzymes, results

in two primary metabolites, norbuprenorphine and buprenorphine 3-O-glucuronide, respectively.

Norbuprenorphine is glucuronidated before elimination. Buprenorphine is also eliminated in the faeces. In a

study in post-operative patients, the total elimination of buprenorphine was shown to be approximately

55L /h.

Norbuprenorphine is the only known active metabolite of buprenorphine.

Effect of buprenorphine on the pharmacokinetics of other active substances:

Based on

in vitro

studies in human microsomes and hepatocytes, buprenorphine does not have the potential

to inhibit metabolism catalysed by the CYP450 enzymes CYP1A2, CYP2A6 and CYP3A4 at concentrations

obtained with use of

BuTrans 20

µg/h transdermal patch. The effect on metabolism catalysed by CYP2C8,

CYP2C9 and CYP2C19 has not been studied.

5.3.

Preclinical safety data

Reproductive and developmental toxicity

No effect on fertility or general reproductive performance was observed in rats treated with buprenorphine.

In embryofoetal developmental toxicity studies conducted in rats and rabbits using buprenorphine, no

embryofoetal toxicity effects were observed. In a rat pre- and post-natal developmental toxicity study with

buprenorphine there was pup mortality, decreased pup body weight and concomitant maternal reduced food

consumption and clinical signs.

Genotoxicity

A standard battery of genotoxicity tests indicated that buprenorphine is non-genotoxic.

Carcinogenicity

In long-term studies in rats and mice there was no evidence of any carcinogenic potential relevant for

humans.

Systemic toxicity and dermal toxicity

In single- and repeat-dose toxicity studies in rats, rabbits, guinea pigs, dogs and minipigs,

BuTrans

caused

minimal or no adverse systemic events, whereas skin irritation was observed in all species examined.

Toxicological data available did not indicate a sensitising potential of the additives of the transdermal

patches.

6.

PHARMACEUTICALS PARTICULARS

6.1.

List of excipients

Levulinic acid, oleyl oleate, povidone K90, DuroTak 387-2054 (polyacrylate adhesive with cross linker),

DuroTak 387-2051 (polyacrylate adhesive without cross linker), polyethylene terephthalate (web, 23µm,

100µm)

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4.

Special precautions for storage

Store below 25°C in the original sachet.

6.5.

Nature and contents of container

BuTrans 5, BuTrans 10, BuTrans 20

Sealed protective sachets (pouches) composed of a composite material: paper, low density

polyethylene film, aluminum and Surlyn. The Surlyn layer is in contact with product.

BuTrans 15

Sealed protective sachets (pouches), composed of two types of composite material:

Paper low density polyethylene film, aluminium and ethylene copolymer (Surlyn).

Paper polyethyleneterephthalate, polymer, aluminium and ethylene copolymer (Surlyn).

The Surlyn layer is in contact with product.

Pack Sizes: 2 transdermal patches.

6.6.

Special precautions for disposal and other handling

The patch should not be used if the seal is broken.

Disposal after use:

When changing the patch, the used patch should be removed, the adhesive layer folded inwards on itself, and

the patch disposed of safely and out of sight and reach of children.

7.

REGISTRATION HOLDER:

Rafa Laboratories Ltd, POB 405, Jerusalem 9100301

Registration no:

Butrans 5

: 135 70 31151

Butrans 10

: 135 71 31152

Butrans 15

: 157 99 34931

Butrans 20

: 135 72 31153

Manufactured by LTS Lohmann Therapie System, Germany.

The content of this leaflet was approved by the Ministry of Health in February 2017 and updated according to the guidelines of the

Ministry of Health in January 2019.

ו"משתה )םירישכת( םיחקורה תונקת יפל ןכרצל ןולע

-

1986

הפורת

קוושמ

דבלב אפור םשרמ יפ לע

סנרטוב

5

סנרטוב ,

10

,

סנרטוב

15

,

סנרטוב

20

תוקבדמ תוירוע

סקירטמ גוסמ

:ליעפה רמוחה

סנרטוב לש הקבדמ לכ

:הליכמ

ןיפרונרפוב

ג"מ

(Buprenorphine 5mg)

תררחשמו

.העשל ג"קמ

סנרטוב לש הקבדמ לכ

:הליכמ ןיפרונרפוב

ג"מ

(Buprenorphine 10mg)

תררחשמו

.העשל ג"קמ

סנרטוב לש הקבדמ לכ

:הליכמ ןיפרונרפוב

(Buprenorphine 15mg)

תררחשמו

.העשל ג"קמ

סנרטוב לש הקבדמ לכ

:הליכמ ןיפרונרפוב

ג"מ

(Buprenorphine 20mg)

תררחשמו

.העשל ג"קמ

םיביכרמה תמישרל םיפסונה

אר

ףיעס

הפורתב שמתשת םרטב ופוס דע ןולעה תא ןויעב ארק

.הפורתה לע יתיצמת עדימ ליכמ הז ןולע

בוש וב ןייעל ךרטצתש הרקמל ןולעה תא רומש

,תופסונ תולאש ךל שי םא .חקורה לא וא אפורה לא הנפ

לופיטל המשרנ וז הפורת ךבצמב יכ ךל הארנ םא וליפא םהל קיזהל הלולע איה .םירחאל התוא ריבעת לא . םבצמ יאופרה

.המוד

הפורתה םירגובמב שומישל תדעוימ

יפואה תחפשממ תופורת

די םי

לאיצנטופ תולעב ןניהו ,ךשוממ שומישב רקיעב ,תורכמתהל םורגל תולולע .תוומל םורגל ףאו תיטיא המישנב אטבתהל הלוכי רתי ןונימל הבוגת .רתי ןונימלו הערל שומישל

יאוולה תועפות ,לופיטה ךשמ ,ןתמה תורידת ,חקול ךנהש ןונימה ,הפורתה םש תא ריכמ ךנה יכ אדוו

םינוכיסהו טופה .םילאיצנ

:רושיקב אוצמל ןתינ תורכמתהו תולתל ןוכיסה תודוא ףסונ עדימ

https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_he.pdf

תואכדמה תורחא תופורת ,םיניפזאידוזנבה תחפשממ תופורת םע וז הפורת תליטנ תא תכרעמ

םיבצע

ללוכ( תיזכרמ )יתמישנ יוכיד( המישנ יישק ,הקומע תוינונשי תשוחתל םורגל הלולע לוהוכלא וא )םימס

.תוומו תמדרת

1

.

?הפורתה תדעוימ המל

.םידיאויפוא ןתמ םיכירצמה םיקזח דע םיינוניב םיינורכ םיבאכ ךוכישל תדעוימ הפורתה

:תיטיופרת הצובק

ידיאויפוא םיבאכ ךכשמ

2

.

הפורתב שומישה ינפל

הפורתב שמתשהל ןיא

םא

:

ליעפה רמוחל )יגרלא( שיגר התא

ליכמ רשא םיפסונה םיביכרמהמ דחא לכל וא

רישכתה םיביכרמה תמישרל( םיפסונה האר , ףיעס

התא לבוס

הינטסאיממ

סיברג

)םירירש תשלוח(

התא לבוס

יוקילמ

רומח דוקפתב

תכרעמ

המישנה

וא

חמב המישנה זכרמב העיגפ

התא לטונ

תופורת

תצובקמ

יבכעמ

זדיסקוא ןימאונומ םיזנאה םייעובשה ךלהמב וזכ הפורת תלטנ םא וא ,

.םינורחאה

מ לבוס התא ולת

םידיאויפואב

סנרטובב שמתשהל ןיא לופיטכ

הלימג

םידיאויפואמ

םירחא

םימסמ וא

התא לבוס

רבעב תלבס וא

תועפותמ

הלימג

תכירצ תקספה תובקעב )העזה ,דער ,הדרח ,טקש יא ןוגכ( לוהוכלא

delirium

tremens

ורתב שומישל תועגונה תודחוימ תורהזא :הפ

הערל שומישל לאיצנטופ תולעב ןניהו ,ידיאויפוא ביכרמ ,ןיפרונרפוב תוליכמ סנרטוב תוקבדמ

םדאל סנרטוב תתל ןיא .תורחא םיידיל הפורתה תעגה עונמל תנמ לע תוריהז יעצמא טוקנל שי .רחא

יככשמ לכב ומכ

םיבאכ

,םיקזח םורגל לולע רישכתה רכמתהל .תולת וא תו

תרגסמב הרהזא האר

.ןולעה תליחתב

.יטוקא באכב לופיטל תדעוימ הניא הפורתה

.השדח הקבדמ תקבדה ינפל תרסומ הנשיה הקבדמהש אדוול שי

תונוכמב שומישו הגיהנ

:

תונרעב םוגפל לולע וז הפורתב שומישה ויופצ יתלב תויושחרתה לש םירקמב אמגודל( הבוגתה תלוכיבו .)תוימואתפ וא ת תומייוסמ תופורת םע בולישב ,לוהוכלא םע בולישב ,ןונימה תיילעב ,לופיטה תליחתב :דחוימב שחרתהל הלולע וז העפות .הנישל וא הדרחב לופיטל תושמשמה

גוהנל ןיא הפורתב שומישה תעב ה דציכ עדתש דע אי

.ךילע העיפשמ

,םונמנ ,תרוחרחס ןוגכ תועפותב שח התא םא ר שוטשט ,היא ןיא

ךשמבו ,סנרטובב שומישה ןמזב תונוכמ ליעפהל וא גוהנל

.הקבדמה תרסה רחאל תועש

טוקנל שי הרקמ לכב תונרע תבייחמה תוליעפ לכבו תונכוסמ תונוכמ תלעפהב ,בכרב הגיהנב תוריהז

כ םג(

רחאל תועש .)הקבדמה תרסה

קור םע וא ,ךלש אפורה םע חחוש טב םאה חוטב אל התא םא ,ח .וז הפורתב שומישה ןמזב גוהנל ךליבשב חו

.תיאופר הרזע לבקלו הקבדמה תא ריסהל שי ,השלחו תיחטש תכפוה ךתמישנ םא

םא

הז

התע

תרבע

חותינ

ךילע

חוודל

לע

ךכ

אפורל

לפטמה

ינפל

תליחת

שומישה

הפורתב

מ תוריהז תשרדנ תדחוי בצמב

לש

קוש

וא

הדירי

תמרב

הרכהה

הביסמ

אל

הרורב

אפורה םע ץעייתהל שי ףוגה םוחב הילע לש הרקמב

רחאמ וי תולודג תויומכש .גפסיהל תולולע ליעפה רמוחה לש רת

( םעפ ידמ קודבל שי הייאר תועצמאב וא שושימ וב םוקמה תא ) תקבדומ יוארכ תדמצומ איהש אדוול ידכ ,הקבדמה

הניא לפנ אלשו היופר

הקבדמהש הדימב ,יוארכ תקבדומ הניא התוא דימצהל שי רועל

רטסלפ תועצמאב

)ביבסמ( ןיא . !רחא םוקמב קיבדהלו הקבדמה תא דירוהל תוסנל

לופיטה ינפל סנרטובב

)וכלהמבו(

אפורל רפס

לבוס התא םא רבעב תלבס וא

.םיסוכרפמ וא תותיווע יפקתהמ

םא לבוס התא וא יוקילמ רבעב תלבס

המישנה תכרעמ

)המישנ תויעב( דוקפתב רומח יוקילמ וא

דבכ

םא לבוס התא

רבעב תלבס וא תוישפנ תויעבמ

ךות ץחל וא שאר תלבח ,שאר תעיגפמ לבוס התא םא יתלגלוג

,)אמגודל תיחומ הלחממ האצותכ( רבגומ וא רומח שאר באכ לולכל םילוכי םהינימסתש וליחב

מ תאז

ןווי

וא וללה םינימסתה תא רימחהל לולע סנרטובש .שארה תלבח תרמוח תא ךסמל

תויופלעתה וא תורוחרחסמ לבוס התא םא

םא

תחתיפ םעפ יא תולת

תורכמתה וא לוהוכלאל וא םימס , תופורת

' ףיעס םג האר הפורתב שמתשהל ןיא

תויתפורת ןיב תובוגת

ופורת הנורחאל תחקל םא וא חקול התא םא תורחא ת

,

ךכ לע רפס ,הנוזת יפסותו םשרמ אלל תופורת ללוכ .חקורל וא אפורל

חקול התא םא חקורה וא אפורה תא עדייל שי דחוימב

תואבה תופורתה תא

המישרה יכ ןייצל שי( תופורתב םיליעפה םירמוחה תא תנייצמ ןלהלש

אנא וללה תופורתהמ תחאב שמתשמ התא םאה חוטב ךניא םא

רה םע ץעיית :)חקורה וא אפו

לטונ התא םא סנרטובב שמתשהל ןיא א ןימאונומ םיזנאה יבכעמ תצובקמ תופורת

( זדיסק ןוגכ ןימורפיצלינרט

,ןיזלנפ סקוברקוזיא

דילוזניל ,דימבולקומ ,די

םינורחאה םייעובשה ךלהמב וזכ הפורת תלטנ םא וא ,

מברק :ןוגכ סנרטוב לש העפשהה תא דירוהל תולולעה תופורת ,ןיפז ,לטיברבונפ ( ןיאוטינפ רתיה ןיב תושמשמה לופיטל היספליפאב

ןיציפמאפיר

לופיטל( )תפחשב

תיזכרמה םיבצעה תכרעמ לע תועיפשמה תופורת

סנרטוב לש יאוולה תועפותל ןוכיסה תא ריבגהל תולולעש

אמגודל רתוי השלחו רתוי תיטיא המישנ ,ןופליע ,תוליחב ,תוינונשי

:ןוגכ תופורת

,םיבאכ ךוכישל תומיוסמ ןואכיד ידגונ

םימיוסמ

הדרח ידגונ

תופורת תוירטאיכיספ

,העגרהל תופורת הנישל

תופורת תיללכ המדרהל

תופורת ב לופיטל רתי םד ץחל

,)ןידינולק ןוגכ(

ךוכישל תורחא תוידיאויפוא תופורת

ןיפרומ :ןוגכ( לועישב לופיטל וא באכ ,ןפיסקופורפורטסקד , סקד

מור פרות

ןיפקסונ ,ן

,)ןיאדוק וא

םינימטסיהיטנא

םימיוסמ

.ןולעה תליחתב תרגסמב הרהזא האר

שי טוקנל התא םא תוריהז

לטונ סנרטובל ףסונב הדרחב לופיטל תודעוימה( םיניפזאידוזנבה תחפשממ תופורת םג הניש תיירשהלו

לולע סנרטוב םע וללה תופורתה לש בלושמ שומיש . המישנ תויעבל םורגל תורומח

תויתועמשמ

תויהל תולולעש םייח תונכסמ וז החפשממ תופורת לטונ התא םא אפורה תא עדיל שי .רתי תנמ לש םירקמב

האר .ןולעה תליחתב תרגסמב הרהזא

:לוהוכלא תכירצו הפורתב שומיש

תוניי תותשל ןיא

.וז הפורתב לופיטה תפוקתב םיפירח תואקשמ וא

ב שומיש לח רימחהל לולע לוהוכלא תועפותמ ק לולעו הפורתה לש יאוולה שומיש ,ףסונב .ערב שוחל ךל םורגל והוכלאב

הל לולע סנרטוב םע דחי

ןמז לע עיפ .ךלש הבוגתה

:הקנהו ןוירה

הקינמ וא ןוירה תננכתמ ,ןוירהב תאש תבשוח ,ןוירהב תא םא סנרטובב שמתשהל ןיא

שמתשהל ןיא ,ןכ ומכ נרטובב םיתואנ העינמ יעצמאב תושמתשמ ןניאשו ןוירהל סנכיהל תויושעה םישנב ס

:םידליב שומיש

ניא וז הפורת

םידליל תדעוימ

םירגבתמו

ליגל תחתמ

3

?הפורתב שמתשת דציכ .

שמתשהל שי דימת ל םאתהב .אפורה תוארוה

חוטב ךניא םא חקורה וא אפורה םע קודבל ךילע

מל עגונב ןפואו ןוני הפורתב לופיטה

סנרטוב תוקבדמל

העברא :םינוש םיקזוח

לופיטה ןפואו ןונימה

.דבלב אפורה ידי לע ועבקי

ןונימה

לבוקמה

ךרדב

ללכ

אוה

:

םיפוצר םימי העבש לש לופיטל ללכ ךרדב תדעוימ תחא הקבדמ

םימי העבש לכ השדח הקבדמל ףילחהל שי

שה התואב יוצר םעפ לכב הע

ש רחאמ רחאל

םימי הנמה לש תיברימה העפשהה תגשומ

יושע אפורה תדימב ךרוצה ה תא תונשל הנמ רחאל הקבדמה לש

דע

םימ

ךוכישל ןוכנה ןונימה גשוי רשא דע

.םיבאכ לכב תינמז וב תוקבדמ יתשמ רתויב שמתשהל ןיא ,הרקמ

,

דעו הנמל יברימ

ת

לש

40

העשל םרגורקימ

.

תצלמומה הנמה לע רובעל ןיא

.לפטמה אפורה ידי לע עבקנש יפכ םיבוצק םינמזב וז הפורתב שמתשהל שי

יושע אפורה ,לופיטה ךלהמב

שמתשהל ךל תורוה רתוי ךומנ וא הובג ןונימב וא , דע לש בולישב תוקבדמ יתש

וא ךותחל ןיא קלחל קבדמה תא

אפורה םא

ךלש

ץעי

ךל

יככשמ תחקל

םיבאכ

םירחא

ףסונב

סנרטובל

בוקעל שי

תונדפקב

רחא

תוארוהה

לש

אפורה

תרחא

התא

אל

ןפואב סנרטובב לופיטהמ תלעות קיפת

.אלמ

.אפורה םע ץעייתה ,ידימ הקזח וא ידימ השלח הפורתה תעפשהש שח התא םא

:בל םיש

ינוציח שומישל תדעוימ וז הפורת

.דבלב

:שומישה ןפוא

יבדהל לוכי ךניא םא

.הרזע שקב ,ךמצעב הקבדמה תא

הקבדמה תקבדה ינפל .א

הקבדהה םוקמ תריחב

רוחבל שי םוקמב ,שבי

יקנ הרוגמ אל ,

םודא וא אלו עוצפ ו תולודג תוקלצ אלל , וא( רעיש אלל ןוילעה ףוגה גלפב ,)רעיש טעמ םע )בג וא הזח( קלחב וא

ה לש ינוציחה רויא האר( תועורז

םוקמב ,)חלגל אל( םיירפסמב רעישה תא רוזגל ןתינ ךרוצה תדימב ל דעוימה הקבדה רועה וב רוזאב הקבדהמ ענמה . .לפקתהל יושע

תא תוקנל ךירצו הדימב

ה םוקמ ל דעוימ םימב שמתשהל שי ,הקבדה םירשופ וא םירק דבלב

.)םימח אל( ןיא ,םינמש ,לוהוכלא ,ןובסב שמתשהל

וא תוחשמ ,םימרק ,םיבילחת םיפשפשמה םיעצמאב תא רועה

םוקמב

.הקבדמה תקבדהל דעוימה

ולא םירמוח

.יוארכ קבדיהל הקבדמהמ עונמל םילול

רחאל וא תחלקמ םיחלו םימח םימיב וא המח היטבמא

ררקתהו ןיטולחל שבי רועהש אדוול בושח .הקבדמה תקבדה ינפל ,הליגר הרוטרפמטל

רויא

הקבדמה תקבדה .ב

תיקשה תא חותפל שי

המוטאה

הקבדמה תא איצוהלו

תיקשהמ התאצוה םע דימ הקבדמה תא קיבדהל שי

.הרוגס התיה אל המוטאה תיקשה םא הקבדמב שמתשהל ןיא

ריסהל שי תוריהזב דחא קלח

םוינימולאמ ןגמה ריינ לש

קיבדה דצה תא הסכמה תוסנל שי .

אל

תעגל

קלחב

קיבדה

לש

קבדמה

שי דצב תעגל ילבמ ,םוינימולאה ריינ לש ינשה קלחה תא ריסהלו רחבנה םוקמב רועל הקבדמה תא דימצהל ךשמב הקבדמה לע ץוחלל שי .קיבדה

דחוימב ,םלשומ עגמהש אדוול תנמ לע דיה ףכ תועצמאב תוינש רויא האר( םיילושב

.הקבדמה תא תקבדהש העשהו ךיראתה תא בותכל שי

יא רו

רועל תקבדומ הקבדמהש ןמזב

םיפוצר םימי העבש ךשמל רועה לע הקבדמה תא ריאשהל שי בור יפ לע

תמצוע רשאכ וא לופיטה תליחתב ןוכנה ןונימה גשוי רשא דע ,הקבדהל ישילשה םויה רחאל רבכ ןונימה תא תונשל יושע אפורה ,הנתשמ באכה .םיבאכה ךוכישל שי

ת( הקבדהה ןמז תא בותכל .)העשו םוי/ךירא

םא

הקבדמה

יוארכ הקבדוה

.ךומנ לופית איהש יוכיסה

הקבדמהו הדימב

הליחתמ

ףלקתהל

רועהמ

שי

דימצהל

התוא

תועצמאב

רטסלפ

רועל םימיאתמה קבד יטרס וא

ביבסמ

ןיא

תוסנל

דירוהל

תא

הקבדמה

קיבדהלו

םוקמב

רחא

םוקמ תבטרה ינפל וא העזהל תמרוגה תינפוג תוליעפ ינפל ,הקבדמה תקבדה עגרמ העש תוחפל תוכחל שי

הקבדהה

ןתינ

ץחרתהל

וא

תוחשל

ןמזב

הקבדמהש

תדמצומ

רועל

,םומיח תירכ ןוגכ ינוציח םוח רוקמל הקבדהה םוקמ תפישחמ ענמיהל שי הקבדמב שומישה ןמזב ,םח קובקב תורונמ ,ילמשח ןידס תומח תויטבמא ,הנואס ,)םומיח תורונמ ןוגכ(

יזוק'ג

דכו המו

הגיפסמ ענמיהל תנמ לע הקבדמהמ ליעפה רמוחה לש תרבגומ

וא/ו .הקבדהה רשוכב םוגפל

ץעייתהל שי ףוגה םוחב הילע לש הרקמ .אפורה םע

.המוקמב תרחא םישל שי תלפונ הקבדמהש הרקמב תא

הקבדמה

השדחה

שי

קיבדהל

רחא םוקמב

רועה

שדחה הקבדהה ןמז תא םושרל שי

)העשו ךיראת(

תא .הלפנ הקבדמה יכ אפורה תא עדייל שי

םימי העבש רחאל ףילחהל שי השדחה הקבדמה

לע וא

אפורה ךל הרוהש המ יפ

הקבדמה תפלחה .ד

,תשמושמה הקבדמה תא רסה

התוא לפק םינפ יפלכ קיבדה דצהשכ םיינשל

חתפ הליכמה תיקש הקבדמ אצוהו השדח הקבדמה תא הנממ שמתשה . תיקשב הקירה הכותל סינכהל ידכ תשמושמה הקבדמה תא

ךלשה הקבדמה תא

תשמושמ

חוטבו רתסנ םוקמב

םידלי לש םדי גשיהמ קחרה

דמ םג

תומכ תוליכמ תושמושמ תוק תמיוסמ

וח לש לולעש ליעפ רמ

אדוול שי ןכ לע .תויחל וא םידליל קיזהל ושמושמ תוקבדמש וקחרוי ת גשיהמ םדי

.םתייאר

קיבדהל שי

רחא םוקמב השדחה הקבדמה תא

ב

,ףוג תורחא תויעב וא ירוע יוריג עונמל ידכב

רוזחל ןתינ

רחאל םוקמ ותואב הקבדמה תא קיבדהלו

דע

.תועובש

.הממיב העש התואב הקבדמה תא ףילחהל ץלמומ

ךשמ לופיטה

מב לפוטת הפוקת וזיאל טילחי אפורה .תוקבד ספהל ןיא אפורב ץעוויהל ילבמ לופיטה תא קי

האר

ףיעס

.'הפורתב שומישה תא קיספמ התא םא'

לופיטה םות רחאל ורתונש תוקבדמ תיבב רומשל ןיא סנרטובב ,ךרוצ ןהב ןיאש תוקבדמ וראשנ םא . .חקורה םע ץעייתה

:בקעמו תוקידב

ובש וא עובש רחאל אפורה םע בקעמ תשיגפ עובקל ץלמומ עבקנש ןונימהש אדוול ידכב לופיטה תליחתמ םייע .הפורתה לש ןהשלכ יאוול תועפותמ לבוס התא םאה קודבל ןכו ךרובע רתויב בוטה אוה

י ,דבכ תולחמ םע םילפוטמב .רתוי דומצ בקעמ עצבי אפורהו ןכת

ךשמתמה ךרוצה תא ךירעהל תנמ לע ,תויתפוקת תוכרעה רובעל ךילע ,חווט ךורא לופיט ךלהמב .הפורתב

םא תשמתשה

תועטב

ב

רתוי הובג ןונימ

וא אפורה תצלמהמ תוקבדמ רתויב תשמתשה תועטבש תיליג םא דליל הקבדנ הקבדמה תועטב םא

לפוטמה וניאש םדאל וא

תוקבדמה תא ריסהל שי

דימ

תונפל דימ וא אפורל תיב לש ןוימ רדחל

ו ,םילוח

בה

תא זירא

הפורתה

ינימסת לע רתי ןונימ הבר תוינונשי :לולכל םילו תוליחב , .הרכה ןדבואו המישנ יישק עיפוהל םילולע ןכ ומכ .תואקהו

תחכש םא הל הקבדמ קיבד א ףילחהל תחכש םא וא :התו

תחכש םא

קיבדהל

שי בוצקה ןמזב הקבדמה תא קיבדהל ,תרכזנשכ דימ הקבדמ שדחה הפלחהה ןמז תא בותכלו

)העשו ךיראת( א םא .

תרח תא דואמ

רוזחל לולע ךלש באכה ,הקבדמה תפלחה דעו ,הז הרקמב . םע ץעייתהל שי

.אפורה

תפסונ הקבדמ דימצהל ןיא ןפוא םושב

אפורה עבקש המל רבעמ לע תוצפל תנמ לע ,

ש הקבדה החכשנ

.אפורה ידי לע ץלמוהש יפכ לופיטב דימתהל שי

קיספהל ןיא ךתואירב בצמב רופיש לח םא םג תא לופיטה ל הפורתב םע תוצעייתה אל

.אפור

םא תא קיספמ התא שומישה

הפורתב

:

סנרטובב שומישה תא קיספמ התא םא

,תע םרטב לולע ךלש באכה .רוזחל

לכות םאהו גוהנל דציכ ךל הרוי אוה .אפורב ץעוויה הפורתב שומישה תא קיספהל ןיינועמ התא םא .תורחא תופורתב שמתשהל

ל תועפות תווחל םילולע םישנאהמ קלח ןוכיסה .םיקזח םיבאכ יככשמב ךשוממ שומיש לש הקספה תעב יאוו שומישה תקספה רחאל ולא תועפות תעפוהל סנרטובב ,תאז םע .ךומנ

טקש יא שח התאו הדימב

,תונבצע ,הדרח ,דער תמזגומ תויתעונת

)םירירשה לש םג( .אפורה םע ץעייתהל שי לוכיע תויעב ,הניש יישק ,

וב תעפשהב םיבאכה ךוכיש ךישממ סנרט המ ןמז ל ןיא ןכלו הקבדמה תרסה רחאל ל ליחתה הפורתב שמתשה ךשמב תרחא תידיאויפוא

הקבדמה תרסהמ תועש

!ךשוחב תופורת לוטיל וא שמתשהל ןיא

הנמהו תיוותה קודב םעפ לכב

שמתשמ התאש םייפקשמ בכרה .הפורתב םא התא .םהל קוקז

ב שומישל עגונב תופסונ תולאש ךל שי םא .חקורב וא אפורב ץעוויה ,הפורת

4

.

יאוול תועפות

שומישה ,הפורת לכב ומכ סנרטובב

תועפות תמישר ארקמל להבית לא .םישמתשמהמ קלחב יאוול תועפותל םורגל לולע .ןהמ תחא ףאמ לובסת אלו ןכתי .יאוולה

:תדחוימ תוסחייתה תובייחמה יאוול תועפות

הנפו הקבדמה תא רסה דימ

לופיט תלבקל

יאופר

:תואבה יאוולה תועפות עיפוהב

המישנ יישק

)יתמישנ יוכיד ידכ דע(

.ךומנ םד ץחל

תיגרלא הבוגת

הרומח תיגרלא הבוגת ללוכ(

תיטקליפאנא הבוגת ןוגכ

)הרידנ הניהש

:םיללוכ םינימסתה החירפ ,םייתפשה וא םינפה ,םייפעפעה תוחפנתה ,המישנ יישק ,המישנב םיימואתפ םיפוצפצ םילוכיש( דרגו .)ףוגה לכב תויהל

העיפומו הדימב לופיטה קספה תוחפנתה לש םירורב םינמיס םע תימוקמ תיגרלא הבוגת

.)רידנ(

תועפות

יאוול

תופסונ

תועפות

יאוול

תוחיכש

דואמ

תועיפומ( רתויב

שמתשממ

דחא

ךותמ

הרשע

:)

תרוחרחס ,שאר באכ

םונמנ

תוינונשי

תוריצע

ליחב תו אקה , תו

דר

רועב

םדוא

:הקבדהה םוקמב תוירוע תועפות החירפ

םדוא

,דרג תוחפנתה וא תקלד

תועפות

תוחיכש יאוול תועיפומ(

ב

1-10

םישמתשמ

ךותמ

100

:)

ןדבוא

ןובאת

לובלב

ןואכיד ,הדרח , הניש ידודנ

תונבצע דער ,

המישנ רצוק

באכ

וא תוחונ יא

,ןטב

לושלש

לוכיע תוערפה

הפב שבוי

עזה

החירפ ,

,תופייע השלוח ,הליגר אל םירירש תשלוח

םייפגב תוחיפנ

)תירפירפ תקצב(

( תוחיכש ןניאש יאוול תועפות תועיפומ

ב

10

-

1

ךותמ םישמתשמ

1,000

:)

תינוציק החמש תשוחת ,טקש יא ,החונמ רסוח ,חורה בצמב םייוניש

;םיטויס ,תויזה ,)הירופוא( היצדס

,)שוטשט( הניש תוערפה

ירי ינימה קשחב הד

,

תונפקות

,םעטב םייוניש םייוקיל ,עגמ וא באכל התוחפ תושיגר ,רובידב םיצוצקע וא השוחת דוביא

ןורכיז ןדבוא

ןורכיזב םייוקיל ו

,ןופליע ,תונרג

היצנידרואוקב וא זוכירב תויעב

,םייניעב שבוי היאר שוטשט

,םיינזואב םוזמז וא םילוצלצ וגיטרו

א תרוחרחס תשוחת רורחס ו

הקמסה

,הזחב םיבאכ ,ךומנ וא הובג םד ץחל רידס יתלב וא ריהמ קפוד

המישנב םיפוצפצ ,םיקוהיש ,לועיש

םיזג

לקשמב הדירי

רועב שבוי

,הירקיטרוא

םירירש יבאכ ,םירירש תויוצווכתה

ןתמב םייוקיל ןתש

ןוגכ הנתשהה תלועפב ליחתהל ישוק :

ןתש תפילד

ןתש תריצא

תלוכי רסוח

תא ןקורל אלמ ןפואב תיחופלשה

תינוציק תופייע

,תוקצב ,תורומרמצ ,םוח

)תוליפנ אמגודל( תונואתמ תועיגפב הילע

הפורתה תקספהב הלימג ינימסת

)דער ,העזה ,הדרח ,טקש יא ןוגכ(

םייוקיל בכ ידוקפתב

)םד תוקידבב םיארנ(

תורידנ יאוול תועפות תועיפומ(

ב

1-10

ךותמ םישמתשמ

10,000

:)

תקועת הזח

ןוגכ ינימה דוקפתב םייוקיל

הפקזב תויעב

תוישפנ תוערפה

לקשמה יווישב םייוקיל

םייוקיל היארב

םינושיאה לדוגב הדירי ,םינפה וא םייפעפעה תוחפנתה

המישנ יישק

רתי תמישנ ,המטסא תרמחה

,םד ילכ תבחרה

תמדאה

,רועה

קב דחוימב ןופליע תשוחת הדימעל המי

העילבב םיישק

םייעמ תמיסח

ותב יוריגו תוחיפנ

ףאה

)ףאב תקלד(

תעפש תיומד הלחמ

תושבייתה

( דואמ תורידנ יאוול תועפות תועיפומ

ךותמ דחא שמתשממ תוחפב

10,000

:)

הפורתב תולת

םירירש תותיווע

םיינזוא יבאכ

תויחופלש

תועפות

יאוול

ןתוחיכשש

הניא

העודי

)

תועפות

שש ןתוחיכ

םרט

העבקנ

:(

םיסוכרפ וא תותיווע

ינימסתש( יעמה ןפודב תקלד

)ןטבב תוחונ יא וא באכ ,תואקה ,םוח :לולכל םילוכי

ו תוחונ יא םייתיווע ןטב יבאכ

עובנל םילוכיש הרמה לש קילוקמ

תשוחת קותינ

ךמצעמ

תורכמתה

אל ודלונש תוקוניתב הלימג ינימסת

מתשהש תוהמ .ןוירהב סנרטובב וש

:לולכל םילוכי םינימסתה ,םרוצ יכב

,טקש יא/תונבצע םיישק ,דער

הלכאהב

העזה .לקשמב הילע רסוח ,

הניוצ אלש יאוול תעפותמ לבוס התא רשאכ וא ,הרימחמ יאוולה תועפותמ תחא םא ,יאוול תעפות העיפוה םא .אפורה םע ץעייתהל ךילע ,ןולעב

ןתינ

חוודל

לע

תועפות

יאוול

דרשמל

תואירבה

תועצמאב

הציחל

לע

רושיקה

"

חוויד

לע

תועפות

יאוול

בקע

לופיט

יתפורת

"

אצמנש

ףדב

תיבה

לש

רתא

דרשמ

תואירבה

(www.health.gov.il)

הנפמה

ספוטל

ןווקמה

חווידל

לע

תועפות

יאוול

וא

"

הסינכ

רושיקל

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il

5

?הפורתה תא ןסחאל ךיא .

!הלערה ענמ

וז הפורת דחוימב

ו

תרחא הפורת לכ

,

וחמ רוגס םוקמב רומשל שי םדי גשיהל ץ

ו

חווט יאר

י

םת לש לעו תוקונית וא/ו םידלי

הלערה ענמת ךכ ידי

.

.אפורהמ תשרופמ הארוה אלל האקהל םורגת לא

( הגופתה ךיראת ירחא הפורתב שמתשהל ןיא

(exp. date

םויל סחייתמ הגופתה ךיראת .הזיראה יבג לע עיפומה .שדוח ותוא לש ןורחאה

:ןוסחא יאנת ל תחתמ ןסחאל שי

.תירוקמה םוינימולאה תיקשב תורומש תוקבדמהש אדו

ןיא

שמתשהל

רישכתב

הרקמב

הקבדמהש

וא

התזירא

םימוגפ

6

ףסונ עדימ

,ליעפה רמוחה לע ףסונ תוקבדמה

ליכמ תו

םג

:

Levulinic acid, oleyl oleate, povidone K90, polyacrylate adhesive (with and without cross linker),

polyethylene terephthalates.

דציכ

תיארנ

הפורתה

המו

ןכות

הזיראה

?

לכב

הזירא

תוקבד

תוירוע

.ז'ב עבצב

לכ

הקבדמ

הזורא

תיקשב

םוינימולא

תדרפנ

סנרטוב

ןחטשש תויעוביר תוקבדמ :

6.25

.ר"מס

וידב עבטומ הקבדמה בגב לוחכ

'BuTrans 5 μg/h

סנרטוב

תוקבדמ : תוינבלמ טשש ןח

12.5

ר"מס וידב עבטומ הקבדמה בגב . לוחכ

'BuTrans 10 μg/h'

סנרטוב

ןחטשש תוינבלמ תוקבדמ :

18.75

לוחכ וידב עבטומ הקבדמה בגב .ר"מס

'BuTrans 15 μg/h'

סנרטוב

תוקבדמ : תויעוביר ןחטשש

ר"מס וידב עבטומ הקבדמה בגב . לוחכ

'BuTrans 20 μg/h'

:םושירה לעב

ר תודבעמ .ד.ת ,מ"עב אפ

םילשורי ,

91003

:ןרצי םטסיס יפרת ןמול

(LTS)

הינמרג

:תואירבה דרשמב יתכלממה תופורתה סקנפב הפורתה םושיר רפסמ

סנרטוב

1357031151

סנרטוב

1357131152

סנרטוב

1579934931

סנרטוב

1357231153

ואירבה דרשמ י"ע רשואו קדבנ הז ןולע

סרמב

2017

ןכדועו תואירבה דרשמ תוארוהל םאתהב ראוניב

2019

.םינימה ינשל תדעוימ הפורתה ךא ,רכז ןושלב חסונ הז ןולע האירקה תלקהו תוטשפה םשל

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