PENTASA SUPPOSITORIES

Israel - English - Ministry of Health

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Active ingredient:
MESALAZINE
Available from:
FERRING PHARMACEUTICALS LTD
ATC code:
A07EC02
Pharmaceutical form:
SUPPOSITORIES
Composition:
MESALAZINE 1000 MG
Administration route:
RECTAL
Prescription type:
Required
Manufactured by:
FERRING INTERNATIONAL CENTER SA, SWITZERLAND
Therapeutic group:
MESALAZINE
Therapeutic area:
MESALAZINE
Therapeutic indications:
Ulcerative proctitis.
Authorization number:
062 73 26904 00
Authorization date:
2014-01-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

06-09-2020

Patient leaflet in accordance with the Pharmacists’ Regulations

(Preparations) - 1986

This medicine is dispensed with a doctor’s prescription only

Pentasa Suppositories

1 gram

Composition:

Each suppository contains: 1 gr of mesalazine

Inactive ingredients: See section 6, ”Additional information”.

Read the entire leaflet carefully before you start using this

medicine.

This

leaflet

contains

concise

information

about

this

medicine. If you have any further questions, consult with your doctor

pharmacist.

This medicine has been prescribed to treat your illness. Do not pass it

on to others. It may harm them, even if it seems to you that their illness

is similar to yours.

1. What is this medicine intended for?

Pentasa Suppositories are indicated for the treatment of ulcerative

proctitis.

Therapeutic group: Anti-inflammatory medicine of the salicylates

class.

2. Before using this medicine

Do not use this medicine if you:

are sensitive (allergic) to mesalazine or to any of the other ingredients

of this medicine (see section 6).

are sensitive (allergic) to other salicylates (such as aspirin).

have severe liver or kidney failure.

Special warnings about using this medicine

Before treatment with this medicine, tell your doctor if you:

currently or previously had liver or kidney disease.

are taking medicines that may affect your kidney function, such as

azathioprine.

were ever allergic to a medicine containing sulphasalazine.

have a lung problem, particularly asthma.

During treatment with this medicine

If you suddenly start experiencing abdominal cramps, abdominal

pain ,fever, severe headache or rash, stop taking this medicine

and contact a doctor immediately.

Kidney

stones

develop

during

treatment

with

mesalazine.

Symptoms may include pain at the sides of your abdomen and

blood in urine. Ensure drinking a sufficient amount of liquids during

treatment

with

mesalazine.

Avoid dehydration while taking this medicine. Dehydration may occur

after prolonged vomiting and/or diarrhea, high fever or excessive

sweating. If this occurs, consult with your doctor or pharmacist as

soon as possible.

Tests and follow up

During treatment with the medicine, your doctor may refer you for

blood and urine tests to ensure that your renal function is normal.

Drug interactions

If you are taking or have recently taken other medicines, including

nonprescription medications and dietary supplements, tell your

doctor or pharmacist, particularly if you are taking:

azathioprine, 6-mercaptopurine or thioguanine.

anticoagulants (such as warfarin).

Pregnancy and breastfeeding

If you are pregnant, are planning to become pregnant, or if you are

breastfeeding, consult with your doctor or pharmacist before using

this medicine. There is limited experience with the use of mesalazine

during pregnancy and breastfeeding. The baby may develop allergic

reactions after breastfeeding, such as diarrhea. If your baby develops

diarrhea, stop breastfeeding.

Driving and using machines

The medicine has no known effect on the ability to drive and/or operate

machines.

. How to use this medicine?

Always use this medicine according to your doctor’s instructions.

Check with your doctor or pharmacist if you are not sure about your

dosage or about the mode of treatment with a medicinal product. The

dosage and mode of treatment will be determined by your doctor

only. For use in adults only, not recommended for use in children. The

recommended dosage for adults is usually no more than 1 suppository

per day before bedtime.

The medicine is intended for rectal treatment (via the anus). To

prolong the period during which the medicine remains in the body, it is

recommended to insert it before bedtime.

Do not exceed the recommended dose.

Manner of using Pentasa Suppositories:

Bowel emptying is advised prior to suppository insertion.

1. Separate a single suppository by tearing the blister along the

perforation.

2. Put a finger protector on the finger with which you will insert the

suppository.

3. Remove the suppository from the blister before insertion by

pushing the suppository through the blister.

4. To make the insertion easier, you can moisten the suppository with

some water.

. Insert the suppository gently and fully into the anus. It may be

easier to do it while lying down on one side and raising the other

knee.

6. Remain lying for a few minutes after insertion to help keep the

suppository in place. If the suppository comes out within the first

10 minutes, a new suppository should be inserted.

7. Dispose of the empty blister and used finger protector and wash

your hands.

If you have accidentally taken a higher dose. If you have accidentally

used more suppositories than you should, or if a child has accidentally

swallowed some of the medicine, immediately see a doctor or go to a

hospital emergency room and bring the medicine package with you.

If you forget to take the medicine. If you forgot to use this medicine

at the scheduled time, use it as soon as you remember, but maintain

an interval of at least 6 hours until your next dose.

Never take a double dose!

Adhere to the treatment as recommended by your doctor.

Even if your health improves, do not stop the treatment with this

medicine without consulting with your doctor or pharmacist.

Do not take medicines in the dark! Check the label and dose every

time you take a medicine. Wear glasses if you need them.

If you have any further questions about using this medicine, consult

with your doctor or pharmacist.

. Side effects

Like with all medicines, using Pentasa may cause side effects in

some users. Do not be alarmed by this list of side effects; you may not

experience any of them.

Following rectal administration, you may experience local side effects

such as itching, rectal discomfort and urge for bowel emptying.

Stop using this medicine and contact your doctor immediately in

the event of:

itching, skin rash, swelling of the face, lips or throat, difficulties

breathing or wheeziness (signs of an allergic reaction).

skin disorder due to an allergic reaction or infection (erythema

multiforme or Stevens-Johnson syndrome). Signs include severe

rash, blisters or red spots on the skin.

unexplained bleeding, bruising, skin rash, fever or sore throat (signs

of a blood system disorder).

a change in the amount or color of urine (signs of a kidney disorder).

chest pain, an increase in heartbeat or tiredness after exertion (signs

of a heart problem).

inflammation of the liver or liver failure. Symptoms include yellowing

of the eyes and/or skin, dark urine, abdominal pain, fever, tiredness

or nausea.

inflammation

pancreas.

Symptoms

include

back

and/or

abdominal

pain,

fever,

nausea

vomiting.

ulcerative colitis involving the entire colon.

Additional side effects

Common side effects – side effects affecting 1-10 in 100 users:

rash with or without itching

Rare side effects – side effects affecting 1-10 in 10,000 users:

vomiting

abdominal pain

nausea

diarrhea

headache

inflammation of the heart or membrane surrounding the heart

dizziness

flatulence

raised level of pancreatic enzymes

increased

sensitivity

your

skin

ultraviolet

light

(photosensitivity).

Very rare side effects – side effects affecting less than 1 in 10,000

users:

raised liver enzymes

hair loss (reversible)

joint and muscle pain

allergic reactions and fever

lupus erythematosis (an auto-immune disorder affecting the skin)

skin rash and blisters, such as erythema multiforme or Stevens-

Johnson

syndrome

decrease in sperm count (reversible)

blood disorders (decrease in red blood cell count)

tingling and numbness in the hands and feet

allergic and fibrotic lung reactions (including breathing difficulties)

decrease in kidney function or kidney failure

inflammation of the pancreas

pancolitis )a type of inflammatory bowel disease – )IBD( that affects

the entire lining of the colon)

Side effects of unknown frequency (cannot be estimated from the

available information):

kidney stones and associated kidney pain (see also section 2)

If you experience any side effect, if any side effect gets worse,

or if you experience a side effect not mentioned in this leaflet,

consult with your doctor.

Reporting side effects

You can report side effects to the Ministry of Health by following the

link ’Reporting Side Effects of Drug Treatment’ on the Ministry of

Health home page (www.health.gov.il) which links to an online form for

reporting side effects. You can also use this link:

https://sideeffects.health.gov.il

. How to store the medicine?

Prevent poisoning! To prevent poisoning, keep this, and all other

medicines, in a closed place, out of the reach and sight of children

and/or infants.

Do not induce vomiting unless explicitly instructed to do so by a

doctor.

Do not use the medicine after the expiry date (exp. date) which is

stated on the package. The expiry date refers to the last day of that

month.

Storage conditions

Store below 25˚C.

6. Additional information

In addition to the active ingredient, the suppositories also contains:

Povidone, macrogol 6000, magnesium stearate, talc

What the medicine looks like and contents of the pack:

Oblong, white to brown-yellowish speckled suppository. Each pack

contains 28 suppositories packed in blisters of 7 suppositories and 28

finger protectors.

Registration holder’s name and address: Ferring Pharmaceuticals

Ltd., 8 Hashita St., Industrial Park, Caesarea 3088900.

Manufacturer’s name and address: Ferring, Switzerland.

Revised in May 2020.

Registration number of the medicine in the Ministry of Health’s National

Drug Registry: 062 73 26904.

DOR-Supp-0720-03

1.

NAME OF THE MEDICINAL PRODUCT

Pentasa® Suppositories

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Pentasa suppository contains: 1g mesalazine

For full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Suppositories. Oblong, compressed white to light tan, speckled suppositories

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Treatment of Ulcerative Proctitis.

4.2

Posology and method of administration

1 suppository 1-2 times daily.

4.3

Contraindications

PENTASA is contraindicated in:

- patients with known hypersensitivity to to salicylates or any of the excipients

- patients with severe liver and/or renal impairment

4.4

Special warnings and precautions for use

Blood tests ( differential blood count; liver function parameters such as ALT or AST; serum

creatinine) and urinary status (dip sticks) should be determined prior to and during treatment,

at the discretion of the treating physician. As a guideline, follow-up tests are recommended

14 days after commencement of treatment, then a further two to three tests at intervals of 4

weeks.

If the findings are normal, follow-up tests should be carried out every three months. If

additional symptoms occur, these tests should be performed immediately.

Caution is recommended in patients with impaired liver function.

PENTASA should not be used in patients with impaired renal function. Mesalazine-induced

renal toxicity should be considered, if renal function deteriorates during treatment.

Patients with pulmonary disease, in particular asthma, should be very carefully monitored

during a course of treatment with Pentasa.

Patients with a history of adverse drug reactions to preparations containing sulphasalazine

(risk of allergy to salicylates) should be kept under close medical surveillance on

commencement of a course of treatment with PENTASA. Should PENTASA cause acute

intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache

and rash, the treatment should be discontinued immediately.

If a patient develops dehydration while on treatment with meclizine, normal electrolyte levels

and fluid balance should be restored as soon as possible.

Mesalazine induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have

been reported rarely. Treatment should be discontinued on suspicion or evidence of these

reactions.

Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a

100% mesalazine content. It is recommended to ensure adequate fluid intake during

treatment.

4.5

Interaction with other medicinal products and other forms of interaction

In patients who are concomitantly treated with azathioprine, or 6-mercaptopurine, or

thioguanine, a possible increase in the myelosuppressive effects of azathioprine, or 6-

mercaptopurine, or thioguanine should be taken into account.

There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.

4.6

Fertility, pregnancy and lactation

Pentasa should be used with caution during pregnancy and lactation only if the potential

benefit outweighs the possible risks in the opinion of the physician.

Pregnancy: Mesalazine is known to cross the placental barrier. There is no adequate data on

the use of PENTASA in pregnant women. However, data on a limited number of exposed

pregnancies indicate no adverse effect of mesalazine on the pregnancy or on the health of the

fetus/newborn child. To date no other relevant epidemiologic data are available

In one single case after long-term use of a high dose of mesalazine (2-4 g, orally)

during pregnancy, renal failure in a neonate was reported.

Animal studies on oral mesalazine do not indicate direct or indirect harmful effects

with respect to pregnancy, embryonic/fetal development, parturition or postnatal

development.

Blood disorders (leucopenia, thrombocytopenia, anaemia) have been reported in new-

borns of mothers being treated with PENTASA.

PENTASA should only be used during pregnancy if the potential benefit outweighs

the possible risk

Breast-feeding: N-acetyl-5-aminosalicylic acid and to a lesser degree

mesalazine is excreted

in breast milk. The mesalazine concentration in breast milk is lower than in maternal blood,

whereas the metabolite, acetyl-mesalazine appears in similar or increased concentrations.

There is limited experience of the use of oral mesalazine in lactating women available to date.

No controlled studies with PENTASA during breast-feeding have been carried out.

Hypersensitivity reactions such as diarrhoea in the infant cannot be excluded. Therefore,

PENTASA should only be used during breast-feeding, if the potential benefit outweighs the

possible risk. If the infant develops diarrhoea, breast-feeding should be discontinued.

4.7

Effects on ability to drive and use machines

No effects on the ability to drive and use machines have been observed.

4.8

Undesirable effects

Following rectal administration local reactions such as pruritis, rectal discomfort and urge

may occur.

Frequency of adverse effects, based on clinical trials and reports from post-marketing

surveillance

SOC

Common

≥1/100 to < 1/10

Rare

≥1/10,000 to ≤ 1/1,000

Very rare

≤ 1/10,000

Blood and the

lymphatic system

disorders

altered blood counts (anaemia,

aplastic anaemia,

agranulocytosis,

neutropenia, leukopenia

pancytopenia,

thrombocytopenia, and

eosinophilia (as part of an

allergic reaction),

Nervous system

disorders

Headache , dizziness

Peripheral neuropathy

Cardiac disorders

Myocarditis*

Pericarditis*

Respiratory,

thoracic and

mediastinal

disorders

allergic and fibrotic lung

reactions (incl. dyspnoea,

cough, bronchospasm,

alveolitis, pulmonary

eosinophilia, pulmonary

infiltration, pneumonitis)

Gastrointestinal

disorders

Diarrhoea,

Abdominal pain, Nausea,

Vomiting

Flatulence

Increased amylase

acute pancreatitis*

Renal and urinary

disorders (***)

impairment of renal

function**** (incl. acute and

chronic interstitial nephritis)*,

nephrotic syndrome, renal

insufficiency and urine

discolouration

Skin and

subcutaneous

tissue disorders

Rash (incl.

urticaria,

erythematous

rash)

Photosensitivity**

Alopecia (Reversible)

Erythema multiform, and

Stevens-Johnson Syndrome

(SJS)

Musculoskeletal

connective tissue

and bone

disorders

Myalgia, Arthralgia

Immune system

disorders

Hypersensitivity reactions

such as allergic exanthema,

drug fever

lupus erythematosus

syndrome,

pancolitis

Hepato-biliary

disorders

Changes in liver function

parameters (increase in

transaminases, and cholestasis

parameters), hepatitis*,

cholestatic hepatitis, cirrhosis,

hepatic failure

Reproductive

system disorders

Oligospermia (reversible)

* The mechanism of mesalazine induced myocarditis, pericarditis, pancreatitis, nephritis

and hepatitis is unknown, but it might be of allergic origin.

** Photosensitivity: More severe reactions are reported in patients with pre-existing

skin conditions such as atopic dermatitis and atopic eczema.

(***) Not known: Nephrolithiasis; see section 4.4 for further information.

**** Renal

failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in

patients developing renal dysfunction during treatment.

It is important to note that several of these disorders can also be attributed to be the

inflammatory bowel disease itself.

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.

Healthcare professionals are asked to report any suspected adverse reactions to the Ministry

of Health according to the National Regulation by using an online form

https://sideeffects.health.gov.il/

4.9

Overdose

Acute experience in animals:

Single oral doses of mesalazine of up to 5g/kg in pigs or a single intravenous dose of

mesalazine at 920mg/kg in rats were not lethal.

Human experience:

There are rare data on overdosage (e.g. intended suicide with high oral doses of

mesalazine), which do not indicate renal or hepatic toxicity.

Management of overdose

There is no specific antidote and treatment is symptomatic and supportive. The

treatment at hospital includes close monitoring of renal function.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties

Pharmacotherapeutic group: Intestinal anti-inflammatory agents.

ATC Code: A07 EC02

Mechanism of action and pharmacodynamic effects:

Mesalazine is recognised as the active moiety of sulphasalazine in the treatment of

ulcerative colitis

It is thought to act locally on the gut wall in inflammatory bowel disease, although its precise

mechanism of action has not been fully elucidated.

Increased leucocyte migration, abnormal cytokine production, increased production of

arachidonic acid metabolites, particularly leukotriene B4 and increased free radical formation

in the inflamed intestinal tissue are all present in patients with inflammatory bowel disease.

Mesalazine has in-vitro and in-vivo pharmacological effects that inhibit leucocyte

chemotaxis, decrease cytokine and leukotriene production and scavenge for free radicals. It is

currently unknown which, if any of these mechanisms play a predominant role in the clinical

efficacy of mesalazine.

5.2

Pharmacokinetic Properties

General characteristics of the active substance:

Disposition and local availability:

PENTASA suppositories

are designed to provide the distal part of the intestinal tract

with high concentrations of mesalazine and a low systemic absorption. Suppositories

are used to treat the rectum,

Biotransformation: Mesalazine is metabolised both pre-systemically by the intestinal mucosa

and systemically in the liver to N-acetyl mesalazine (acetyl mesalazine). The acetylation

seems to be independent of the acetylator phenotype of the patient. Some acetylation also

occurs through the action of colonic bacteria.

Acetyl mesalazine is thought to be clinically as well as toxicologically inactive, although this

remains to be confirmed.

Absorption:

The absorption following rectal administration is low, but depends on the

dose, the formulation and the extent of spread. Based on urine recoveries in

healthy volunteers under steady-state conditions given a daily dose of 2g (1g

x 2), approximately 10% of the dose is absorbed after administration of

suppositories.

Distribution: Mesalazine and acetyl mesalazine do not cross the blood-brain barrier. Protein

binding of mesalazine is approximately 50% and of acetyl mesalazine about 80%.

Elimination:

The plasma half-life of pure mesalazine is approximately 40 minutes and for acetyl

mesalazine approximately 70 minutes. Both substances are excreted in urine and

faeces. The urinary excretion consists mainly of acetyl mesalazine.

Characteristics in patients:

In patients with impaired liver and kidney functions, the resultant decrease in the rate of

elimination and increased systemic concentration of mesalazine may constitute an increased

risk of nephrotoxic adverse reactions.

5.3

Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that

already included in other sections of the SPC.

Pharmaceutical Particulars

List of excipients

Magnesium stearate, talc, povidone, macrogol 6000

Incompatibilities:

Not applicable

Shelf Life:

The expiry date of the product is indicated on the packaging

materials

Storage Conditions

Store bellow 25°C.

Nature and Contents of Container

Double aluminium foil blister strips of 7 suppositories each. Pack size: 28

Instructions for use/handling

No special requirements.

License Number

062 73 26904

Manufacturer:

Ferring, St-Prex ,Switzerland

License Holder

Ferring Pharmaceuticals Ltd 8, Hashita Street, Industrial Park Caesarea 38900

ISRAEL

Revised on May 2020

רבמצד

אפור

חקור

דבכנ

לש אפורלו ןכרצל םינולע יכ ךתעידיל איבהל םיצור ונא

םירישכת

Pentasa suppositories

םאתהב ונכדוע לולסמ" אשונב םירישכת םושירל הקלחמה רזוחל העדוה לש םינולעב תורמחהו םינולע ןוכדעל (היצקיפיטונ)

דע העשה תארוה לש הבחרהו הכראה םירישכת ךיראתל

31.12.2020

."

רישכת םש

Pentasa suppositories

:ליעפ רמוח

Each suppository of Pentasa suppositories contains

Mesalazine

:היוותה

Ulcerative proctitis

רוצמ םיפ

ולע םינ

.םינכדועמ

.םינמוסמ ונכדועש םיקלחה

תא תוליכמ ןניא תואלבטהש שיגדהל בושח .הטמ תואלבטב םיטרופמ תורמחה םיווהמה םיירקיע םינוכדע .םיפרוצמה םינולעב ןייעל שי םינוכדעה לכל .םינוכדעה לכ

הטמ הלבטב םיטרופמ םיירקיעה םינוכדעה

ל ןולעב אפור

ןוכדעה

קרפ

If a patient develops dehydration while on treatment with

mesalazine, normal electrolyte levels and fluid balance should be

restored as soon as possible.

Mesalazine induced cardiac hypersensitivity reactions (myocarditis

and pericarditis) have been reported rarely. Treatment should be

discontinued on suspicion or evidence of these reactions

4.4 Special warnings

and precautions for

use

Skin and subcutaneous tissue disorders

Rare >1/10,000 to <1/1,000:

Photosensitivity**

Very rare <1/10,000

: Alopecia (Reversible)

Erythema multiform, and Stevens-Johnson Syndrome (SJS)

(**) Photosensitivity: More severe reactions are reported in patients with

pre-existing skin conditions such as atopic dermatitis and atopic eczema.

Immune system disorders

Very rare <1/10,000

Hypersensitivity reactions such as allergic

exanthema, drug fever, lupus erythematosus syndrome,

pancolitis

4.8 Undesirable

effects

ןולעב

ןכרצ

ןוכדעה

קרפ ןיא

שמתשהל

הפורתב

התא םא

וא ןיזלסמל יגרלא

דחאל

יביכרממ

קרפ האר) הפורתה

םיטליצילסל יגרלא (ןירפסא ומכ) םירחא

לבוס

לשכמ

יתיילכ וא/ו ידבכ

רומח

תורהזא

תודחוימ

תועגונה

שומישל

הפורתב

:התא םא אפורל רפס הפורתב לופיטה ינפל

.הילכ וא דבכ תלחממ רבעב תלבס וא לבוס

ןירפויטוזא ןוגכ הילכה תוליעפ לע עיפשהל תולולעה תופורת לטונ

הליכמה הפורתל היגרלאמ םעפ יא תלבס

ןיזלספלוס

המטסא דחוימב ,תואירב היעבמ לבוס

הפורתב לופיטה ךלהמב

וא קזח שאר באכ ,םוח ,ןטב יבאכ ,ןטבב תותיוועמ ימואתפ ןפואב לובסל תלחתה םא .דימ אפורל הנפו הפורתה תליטנ תא קיספה החירפ

תואקה רחאל תורקל הלולע תושבייתהה .הפורתה תליטנ ןמזב תושבייתהמ ענמיהל שי וא אפורה םע ץעייתה הרוק הז םא .רתי תעזהו הובג םוח ,םיכשוממ םילושלש וא/ו .םדקהב חקורה

םא

התא

חקול

,

וא

םא

תחקל

הנורחאל

,

תופורת

תורחא

ללוכ

תופורת

אלל

םשרמ

יפסותו

הנוזת

,

רפס

לע

ךכ

אפורל

וא

חקורל

,

דחוימב

שי

עדייל

תא

אפורה

וא

חקורה

םא

התא

חקול

:

ןירפויטאזא

ןינאוגויט וא ןירופוטפקרמ

תופורת

דגנ

תשירק

(ןירפרוו המגודל) םד

ינפל

שומיש

הפורתב

.

םא

ךנה

ןוירה תננכתמ ,ןוירהב

וא

הקינמ

שי

ץעוויהל

אפורב

וא

חקורב

ינפל

שומישה

הפורתב

הקנהו ןוירה ןמזב ןיזלסמב שומישב לבגומ ןויסינ ונשי

חתפל לולע קוניתה תויגרלא תועפות

תא קיספהל שי לושלש חתפמ קוניתה םא .לושלש המגודל ,הקנה רחאל .הקנהה

ןוירה

הקנהו

:

דימת

שי

שמתשהל

יפל

תוארוה

אפורה

ךילע

קודבל

םע

אפורה

וא

חקורה

םא

ךניא

חוטב

ןונימה

ןפואו

לופיטה

ועבקי

לע

ידי

אפורה

.דבלב אל ,דבלב םירגובמב שומישל םידליב שומישל ץלמומ ןונימה .

םירגובמל לבוקמה

ךרדב

ללכ

אוה

אל

רתוי

הליתפמ

תחא

םויל

ינפל

הנישה

דציכ

שמתשת

הפורתב

?

ומכ

לכב

הפורת

שומישה

הסטנפב

לולע

םורגל

תועפותל

יאוול

קלחב

םישמתשמהמ

לא

להבית

ארקמל

תמישר

תועפות

יאוולה

ןכתי

אלו

לובסת

ףאמ

תחא

ןהמ

תועפות :יאוול

תועפות שוחל לולע התא ילטקר ןתמב תעבטה יפב תוחונ יאו דרג ומכ תוימוקמ יאוול .ןקורתהל ףחדה תשגרהו

שי

קיספהל

תא

הפורתב שומישה

תונפלו

דימ

אפורל

לש הרקמב

,דרג

,תירוע החירפ ןורגב וא םייתפשב ,םינפב תוחיפנ

המישנ יישק

םירוחרח וא

.תיגרלא הבוגת לש םינמיס ולא

) םוהיז וא תיגרלא הבוגתמ האצותכ רועב העיגפ

erythema multiform

וא

Stevens – Johnson syndrome

תויחופלש ,הרומח החירפ םיללוכ םינמיסה .( רועה לע תומודא תודוקנ וא

,תורובח ,רבסומ יתלב םומיד

םוח ,תירוע החירפ

ןורג באכ וא

לש םינמיס ולא םדה תכרעמב העיגפ

תומכב יוניש ןתשה לש עבצ וא

תיתיילכ העיגפל םינמיס

ץמאמ רחאל תופייעתהו בל תוקיפדב הילע ,הזחב באכ

היעב לש םינמיס ולא תיבבל

ןתש ,רועה וא/ו םייניעה לש הבהצה םיללוכ םינימסת .ידבכ לשכ וא דבכב תקלד .הליחב וא תופייע ,םוח ,ןטב באכ ,ההק

א/ו בג באכ םיללוכ םינימסתה בלבלב תקלד תואקהו תוליחב ,םוח ,ןטב ו

) יעמ תקלד

ulcerative colitis

ולוכ סגה יעמה תא תברעמה (

תועפות

יאוול

תופסונ

:

תועפות

תועפות ,תוחיכש יאוול

תועיפומש

ךותמ

ךותמ םישמתשמ

דרג ילב וא םע החירפ

תועפות

יאוול

ב תועיפומש תועפות ,תורידנ

ךותמ םישמתשמ

10,000

,תואקה

,ןטב באכ תוליחב ,לושלש , ,שאר באכ

,בלה םורקב וא בלב תקלד תרוחרחס

,םיזג

רועה לש תרבגומ תושיגר ,בלבל ימיזנא תמרב הילע (תויביטיסנסוטופ) לוגס הרטלוא רואל וא שמשל

תועפות

יאוול

תועיפומש

םיתיעל

תוחפב תועיפומש תועפות ,דאמ תורידנ ךותמ דחא שמתשממ

10,00

דבכ ימיזנא תמרב הילע ,(ךיפה) רעש תרישנ , םירירשב באכ ,םיקרפמבו ,םוחו תויגרלא תובוגת

lupus erythematosus

תינומיאוטוא הלחמ) המגודל ,רועה לע תויחופלשו החירפ ,(רועב תעגופה

erythema

multiforme

וא

Steven Jonson syndrome

ערזה תריפסב הדירי תכרעמב תוערפה ,(ךיפה) ,(םימודא םד יאת תריפסב הדירי המגודל) םדה היארב תויטורבפו תויגרלא תובוגת ,םיילגרבו םיידיב השוחת רסוחו ץוצקע

בלבלב תקלד ,יתיילכ לשכ וא יתיילכ דוקפתב הדרי ,(המישנ ישק ללוכ

ה םינולעה כדועמ םינ

חלשנ

.תוחקורה ףגא לש טנרטניאה רתאב םוסרפל

ןתינ

םג

ולעה תא לבקל םינ

קתועב

חישק

"

הינפ

לעבל

םושירה

תרבח

גנירפ

סלקיטואצמרפ

עב

"

בוחר

הטישה

הירסיק

,הכרבב

רוא

טוזוז ת

היצלוגר תלהנמ תוכיאו

גנירפ

סלקיטואצמרפ

עב

"

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