PENTASA ENEMA

Israel - English - Ministry of Health

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Active ingredient:
MESALAZINE
Available from:
FERRING PHARMACEUTICALS LTD
ATC code:
A07EC
Pharmaceutical form:
ENEMA
Composition:
MESALAZINE 1 G / 100 ML
Administration route:
RECTAL
Prescription type:
Required
Manufactured by:
FERRING GmbH ,GERMANY
Therapeutic group:
AMINOSALICYLIC ACID AND SIMILAR AGENTS
Therapeutic indications:
Ulcerative colitis - Chron's disease
Authorization number:
137 64 23871 00
Authorization date:
2012-11-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

18-05-2020

If you have accidentally taken a higher

dose. If you have accidentally used a higher

dose than needed or if a child has accidentally

swallowed the medicine, immediately refer to

a doctor or proceed to a hospital emergency

room and bring the package of the medicine

with you.

If you have forgotten to take the medicine.

If you forget to use the medicine at the required

time, use the next dose in the morning if it is

convenient, or the next night as usual. Do not

use two doses together to make up for the

forgotten dose.

Adhere

treatment

regimen

recommended by the doctor.

Even if there is an improvement in your health,

do not stop treatment with the medicine without

consulting the doctor or pharmacist.

Do not take medicines in the dark! Check

the label and the dose each time you take a

medicine. Wear glasses if you need them.

If you have further questions regarding

use of this medicine, consult the doctor or

pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Pentasa Enema

may cause side effects in some users. Do

not be alarmed when reading the list of side

effects. You may not suffer from any of them.

With rectal administration, you may

experience local side effects such as itching

and discomfort of the anus, and a feeling of

urgency to empty your bowels.

Stop using the medicine and consult a

doctor immediately in case of:

itching, skin rashes, swelling of the face,

lips or throat, difficulty in breathing or

wheeziness )signs of an allergic reaction(.

skin damage due to an allergic reaction or

infection )Erythema Multiforme or Stevens-

Johnson syndrome(. Signs include severe

rash, blisters or red splotches on the skin.

unexplained bleeding, bruising, skin rashes,

fever or sore throat )signs of blood disorder(.

change in the amount or color of urine )signs

of kidney impairment(.

chest pain, an increase in heartbeat and

fatigue 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, feeling tired or nausea.

inflammation of the pancreas. Symptoms

include back and/or abdominal pain, fever,

nausea and vomiting.

inflammation of the intestine )ulcerative

colitis( involving the entire large intestine.

Additional side effects:

Common side effects - effects that occur in

1-10 out of 100 users

Rash with or without itching

Rare side effects - effects that occur in 1-10

out of 10,000 users

Vomiting, abdominal pain, nausea, diarrhea,

headache, inflammation of the heart or area

surrounding the heart, dizziness, flatulence,

raised level of pancreatic enzymes, increased

skin sensitivity to sun or to ultraviolet light

)photosensitivity(

Side effects that occur very rarely - effects

that occur in fewer than 1 in 10,000 users

Raised level of liver enzymes, hair loss

)reversible(, muscle and joint pain, allergic

reactions and fever, lupus erythematosus )an

autoimmune disorder affecting the skin(, skin

rash and blisters, e.g., Erythema Multiforme or

Stevens-Johnson syndrome, reduced sperm

count )reversible(, blood disorders )e.g.,

reduced red blood cell count(, tingling and

numbness in the hands and feet, allergic and

fibrotic lung reactions )including breathing

problems(, reduced kidney function or kidney

failure, inflammation of the pancreas

Reporting side effects

Side effects can be reported to the Ministry

of Health by clicking on the link "Reporting

Side Effects of Drug Treatment" found on the

Ministry of Health homepage )www.health.

gov.il( that directs you to the online form for

reporting side effects, or by entering the link:

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

5. HOW TO STORE THE MEDICINE?

Avoid poisoning! This medicine as well as

any other medicine should be kept in a closed

place out of the reach of children and/or infants

in order to avoid poisoning.

Do not induce vomiting unless explicitly

instructed to do so by the doctor.

Do not use this medicine after the expiry date

)exp. date( which appears on the package. The

expiry date refers to the last day of that month.

Store below 25°C, in the original packaging.

6. FURTHER INFORMATION

In addition to the active ingredient, Pentasa

Enema also contains:

Disodium edetate, Sodium metabisulphite,

Sodium acetate, Hydrochloric acid, Purified

water

What the medicine looks like and the

contents of the pack:

The enema is a colorless to faint yellow

suspension presented in a plastic bottle.

The Pentasa Enema package contains 7

enema bottles and 7 plastic bags for disposal

of the empty bottles.

Registration holder and address:

Ferring Pharmaceuticals Ltd.,

8 Hashita St., Industrial Park, Caesarea

3088900.

Manufacturer name and address:

Ferring, Switzerland.

The format of this leaflet was determined by

the Ministry of Health and its content was

checked and approved by the Ministry of

Health in January 2008, and was updated in

accordance with Ministry of Health guidelines

in October 2019.

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health:

Pentasa Enema: 137 64 23871

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS )PREPARATIONS( - 1986

The medicine is dispensed with

a doctor’s prescription only

Pentasa Enema

Composition:

Each enema contains: mesalazine 1 g

Inactive ingredients - see Section 6

”Additional Information“.

Read this leaflet carefully in its entirety

before using the medicine.

This leaflet contains concise information

about the medicine. If you have further

questions, refer to the doctor or pharmacist.

This medicine has been prescribed to treat

your ailment. Do not pass it on to others. It

may harm them even if it seems to you that

their ailment is similar.

1. WHAT IS THE MEDICINE INTENDED

FOR?

For the treatment of inflammation of the

large intestine )Ulcerative Colitis( or Crohn’s

Disease.

Therapeutic group: An anti-inflammatory

medicine from the salicylate group.

2. BEFORE USING THE MEDICINE

Do not use this medicine if you:

are allergic to mesalazine or any of

the ingredients of this medicine )see

Section 6(

are allergic to other salicylates )for

example, aspirin(

suffer from severe liver or kidney

problems

Pentasa Enema is not suitable for use in

children

Special warnings regarding use of the

medicine

Tell the doctor before using the medicine if

you:

currently have, or have previously had liver

or kidney disease

are taking medicines that may affect kidney

function, e.g., azathioprine

have ever had an allergy to a medicine

called sulfasalazine

have lung problems, in particular asthma

While you are being treated with this medicine

If you suddenly start to experience

abdominal cramps, abdominal pain, fever,

severe headache or develop a rash - stop

using the medicine and refer to the doctor

immediately.

Take care to avoid dehydration while using

the medicine. Dehydration may result

following prolonged vomiting and/or diarrhea,

elevated fever and heavy sweating. If this

occurs, consult with the doctor or pharmacist

as soon as possible.

Tests and follow-up:

While you are using this medicine, your doctor

may send you for tests of kidney function.

If you are taking, or have recently

taken, other medicines, including non-

prescription medicines and nutritional

supplements, tell the doctor or

pharmacist; in particular inform the doctor

or pharmacist if you are taking:

- azathioprine, 6-mercaptopurine or

thioguanine.

- certain medicines that affect blood clotting

)antithrombotic or blood thinning medicines,

e.g., warfarin(.

Driving and using machines:

This medicine is not known to affect the ability

to drive and/or operate machines.

Pregnancy and breast-feeding:

If you are pregnant, are planning to become

pregnant or are breast-feeding, consult with

the doctor or pharmacist before using this

medicine. There is limited experience with

the use of mesalazine during pregnancy

and breast-feeding. The infant may develop

allergic reactions after breast-feeding, e.g.,

diarrhea. If the infant develops diarrhea,

breast-feeding should be discontinued.

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.

The dosage and treatment regimen will be

determined by the doctor only.

Recommended dosage unless otherwise

prescribed by your doctor: One enema in the

evening at bedtime.

Do not exceed the recommended dosage.

This medicine is not intended for children

except according to the doctor’s instructions.

How to use Pentasa Enema:

1. Remove

aluminium

foil

wrap

immediately before using the enema and

shake the bottle well )see Figure 1(.

2. To break the seal, twist the base of the

nozzle clockwise one full turn )the nozzle

should then be in the same direction as it

was before turning( )Figure 2(.

3. Put your hand inside one of the enclosed

plastic bags )Figure 3(.

4. Hold the bottle as shown in Figure 4.

5. To administer the medicine, lie on your

left side with your left leg straight and

your right leg bent forward for balance.

Carefully insert the applicator tip into the

anus )see Figure 5(. Exert steady and

stable hand pressure on the enema bottle

while introducing the medicine. The bottle

content should be applied within maximum

30-40 seconds.

6. Once the bottle is empty, withdraw the

applicator tip from the anus with the bottle

still compressed.

7. The enema should be retained in the bowel.

Remain relaxed in the administration

position for 5-10 minutes or until the urge to

pass the enema has disappeared )Figure

8. Roll the plastic bag to cover the empty

bottle. Discard it in the trash can and wash

your hands.

Pay attention: Pentasa Enema may stain

fabrics and bed linen.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 7

يف ءاودلا لوانت تيسن اذإ .ءاودلا لوانت تيسن اذإ اذإ حابصلا يف ةيلاتلا ةعرجلا لمعتسا ،ددحملا تقولا لمعتست لا .داتعملاك ةيلاتلا ةليللا يف وأ

احيرم رملأا ناك

يسنملا ةعرجلا ضوعت يكل

ةيوس نيتعرج .بيبطلا هب ىصوأ امك جلاعلا ىلع ةبظاوملا بجي زوجي لا ،ة

يحصلا كتلاح ىلع نسحت أرط ول ىتح وأ بيبطلا ةراشتسا نودب ءاودلاب جلاعلا نع فقوتلا . يلديصلا ءاودلا عباط نم ققحت !ةمتعلا يف ةيودلأا لوانتت لا .ءاود اهيف لوانتت ةرم لك يف ةيئاودلا ةعرجلا نمو .اهل ةجاحب تنك اذإ ةيبطلا تاراظنلا عض ،ءاودلا اذه لامعتسا لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا رشتسا ةيبناجلا ضارعلأا .4

يجرش ةنقح اساتنپ لامعتسا ببسي دق ،ءاود لك يف امك نم عزجت لا .نيلمعتسملا نم مسق ىدل ةيبناج

اضارعأ يناعت لاأ لمتحملا نم .ةيبناجلا ضارعلأا ةمئاق ةءارق .اهنم يأ نم ةيبناج ضارعأب رعشت دق يجرشلا ءاطعلإا دنع جرشلا ةحتف يف ةحار مدعو ةكح لثم ةيعضوم .طوغتلل ةجاحلاب روعشلاو

ً

اروف بيبطلا ىلإ هجوتلاو ءاودلا لامعتسا فاقيإ بجي :لاح يف ،قلحلا وأ نيتفشلاب ،هجولاب خافتنا ،يدلج ج

يهت ،ةكح لعف درل تاملاع( ةرخرخ وأ سفنتلا يف تابوعص .)يسسحت ثولت وأ يسسحت لعف درل

ةجيتن دلجلاب ةباصإ

Stevens– وأ erythema multiforme(

يهت لمشت تاملاعلا .)Johnson syndrome .دلجلا ىلع ءارمح طاقن وأ تلاصيوح ،ريطخ ملأ وأ ىمح ،يدلج ج

يهت ،تامدك ،رربم ريغ فيزن

.)مدلا زاهجب ةباصلإ تاملاع( قلح ةباصلإ تاملاع( لوبلا نول وأ ةيمك يف ريغت

.)ةيولك دهج دعب ءايعلإاو بلقلا تاقد عافترا ،ردصلا يف ملأ

.)ةيبلق ةلكشمل تاملاع( لمشت تاملاعلا .يدبك لشف وأ دبكلا يف باهتلا

،نطب ملأ ،نكاد لوب ،دلجلا وأ/و نينيعلا رارفصا .نايثغ وأ ءايعإ ،ىمح وأ/و رهظ ملأ لمشت تاملاعلا .سايركنبلا باهتلا

.تاؤيقتو نايثغ ،ىمح ،نطب

مضتي يذلاو )ulcerative colitis( يعم باهتلا

.هلماكب ظيلغلا يعملا :ةيفاضإ ةيبناج ضارعأ 10-1 ىدل رهظت ضارعأ ،ةعئاش ةيبناج ضارعأ

100 لك نم نيلمعتسم ةكح نودب وأ عم حفط

10-1 ىدل رهظت ضارعأ ،ةردان ةيبناج ضارعأ

10,000 لك نم نيلمعتسم باهتلا ،عادص ،لاهسإ ،نايثغ ،نطب ملأ ،تاؤيقت

عافترا ،تازاغ ،راود ،بلقلا ءاشغ وأ بلقلا ةطرفم دلج ةيساسح ،سايركنبلا تاميزنإ ىوتسمب )يئوض سسحت( يجسفنب قوفلا ءوضلل وأ سمشلل ضارعأ ،

ادج ةردان نايحأ يف رهظت ةيبناج ضارعأ

10,000 نم دحاو لمعتسم نم لقأ ىدل رهظت رعشلا طقاست ،دبكلا تاميزنإ ىوتسمب عافترا

لعف تادر ،لصافملاو تلاضعلاب ملأ ،)سوكع( lupus erythematosus ،ىمحو ةيسسحت تلاصيوحو حفط ،)دلجلا بيصي ةيتاذ ةعانم ضرم( erythema لاثملا ليبس ىلع ،دلجلا ىلع Stevens–Johnson وأ multiforme ،)سوكع( فاطنلا دادعتب ضافخنا ،syndrome ضافخنا لاثملا ليبس ىلع( مدلا زاهجب تابارطضا روعشلا نادقفو زخو ،)ءارمحلا مدلا ايلاخ دادعتب ةئرلاب ة

يفيلتو ةيسسحت لعف تادر ،نيمدقلاو نيديلاب ةيولكلا ةفيظولاب ضافخنا ،)سفنتلا تابوعص لمشي( سايركنبلاب باهتلا ،يولك لشف وأ ةيبناج ضارعأ نع غيلبتلا ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا نكمملا نم ضارعأ نع غيلبتلا" طبارلا ىلع طغضلا ةطساوب ةحفصلا يف دوجوملا "يئاود جلاع بقع ةيبناج www.health.gov.( ةحصلا ةرازو عقومب ةيسيئرلا ضارعأ نع غيلبتلل رشابملا جذومنلل كهجوي يذلا )il :طبارلا حفصت قيرط نع وأ ،ةيبناج

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

؟ءاودلا نيزخت ةيفيك .5 يف رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت عضرلا وأ/و لافطلأا يديأ لوانتم نع

اديعب قلغم ناكم

مستلا عنمت لكشلا اذهبو .بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ببست لا ةيحلاصلا خيرات ءاضقنا دعب ءاودلا لمعتست لا

خيرات ريشي .ةوبعلا ىلع رهظي يذلا )exp. date( .رهشلا سفن نم ريخلأا مويلا ىلإ ةيحلاصلا ةبلعلا يف ،ةيوئم ةجرد 25 ـلا نود نيزختلا بجي .ةيلصلأا ةيفاضإ تامولعم .6 كلذك

يجرش ةنقح اساتنپ يوتحي ةلاعفلا ةداملل ةفاضإ :ىلع

Disodium

edetate,

Sodium

metabisulphite, Sodium acetate,

Hydrochloric acid, Purified water

:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك حتاف رفصأ ىتح نوللا ميدع قلعم يه ة

يجرشلا ةنقحلا .ةيكيتسلاب ةنينق لخاد نقحلا نم ينانق 7 ىلع ة

يجرش ةنقح اساتنپ ةوبع يوتحت .ةغرافلا ينانقلا يمرل ةيكيتسلاب سايكأ 7و ة

يجرشلا :هناونعو زايتملاا بحاص ،ض.م لاكيتويسامراف چنيريف ايراسيق ،ةيعانصلا ةقطنملا ،8 اطيشه عراش

.3088900

:هناونعو ج

ِ

تنملا مسا .ارسيوس ،چنيريف متو ةحصلا ةرازو لبق نم ةرشنلا هذه ةغيص ديدحت مت ةحصلا ةرازو لبق نم هيلع ةقفاوملاو اهاوتحم صحف تاميلعتل

اقفو هليدعت متو ،2008 يناث نوناك خيراتب .2019 لوأ نيرشت خيراتب ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا ليجست مقر :ةحصلا ةرازو

137 64 23871

يجرش ةنقح اساتنپ ةرشنلا هذه ةغايص تمت ،ةءارقلا ليهستو طيسبتلل لاكل صصخ

م ءاودلا ،كلذ نم مغرلاب .ركذملا ةغيصب .نيسنجلا

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

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ______ ךיראת

13.11.2014

__

:םושירה רפסמו תילגנאב רישכת םש

PENTASA ENEMA

םושיר 'סמ ,

23871

PENTASA SLOW RELEASE GRANULES 1 GR

:םושיר רפסמ

29591

PENTASA SLOW RELEASE GRANULES 2 G

:םושיר רפסמ

31560

PENTASA SLOW RELEASE TABLETS 1 GRAM

םושיר 'סמ,

33401

PENTASA SLOW RELEASE TABLETS 500 MG

םושיר 'סמ

26905

PENTASA SUPPOSITORIES

םושיר 'סמ

26904

______ םושירה לעב םש

FERRING PHARMACEUTICALS LTD

__

! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט

THERAPEUTIC

INDICATION

Tablets 500 mg, 1000 mg,

Granules 1g, 2g :

Ulcerative Colitis

Treatment of active

disease;

Adults:

Individual

dosage, up to 4g daily in divided

doses.

4.2.1 Tablets 500 mg, 1000 mg,

Granules 1g, 2g :

Ulcerative Colitis

Adults:

Active treatment: Individual dosage, up

to 4 g mesalazine once daily or in two or

three divided doses.

Ulcerative Colitis

Treatment of active disease

;

Children: Individual dosage,

starting with 50 mg/kg

bodyweight

daily in divided doses

Maintenance treatment

:

Children: Individual dosage,

starting with 50 mg/kg

bodyweight

daily in divided doses

Ulcerative colitis

Treatment of active disease:

Children 6 years of age and older: To be

determined individually, starting with 30-

50 mg/kg/day in divided doses.

Maximum dose: 75 mg/kg/day in divided

doses. The total dose should not exceed 4

g/day (maximum adult dose).

Maintenance treatment:

Children 6 years of age and older: To be

determined individually, starting with 15-

30 mg/kg/day in divided doses. The total

dose should not exceed 2 g/day

(recommended adult dose).

It is generally recommended that half the

adult dose may be given to children up to

a body weight of 40 kg; and the normal

adult dose to those above 40 kg.

Crohn’s disease

Treatment of active disease:

Children: Individual dosage,

starting with 50 mg/kg bodyweight

daily in divided doses.

Maintenance treatment:

Children: Individual dosage,

starting with 50 mg/kg bodyweight

daily in divided doses.

Crohn’s disease

Treatment of active disease:

Children 6 years of age and older: To be

determined individually, starting with 30-

50 mg/kg/day in divided doses.

Maximum dose: 75 mg/kg/day in divided

doses. The total dose should not exceed 4

g/day (maximum adult dose).

Maintenance treatment:

Children 6 years of age and older: To be

determined individually, starting with 15-

30 mg/kg/day in divided doses. The total

dose should not exceed 2 g/day

(recommended adult dose).

It is generally recommended that half the

adult dose may be given to children up to

a body weight of 40 kg; and the normal

adult dose to those above 40 kg.

Special

warnings and

precautions

for use

Most Patients who are intolerant

or hypersensitive to

sulphasalazine are able to take

Pentasa® without risk of similar

reactions. However, caution is

recommended when treating

patients allergic to sulphasalazine

(risk of allergy to salicylates).

Most patients who are intolerant or

hypersensitive to sulphasalazine are able

to take Pentasa without risk of similar

reactions. However, caution is

recommended when treating patients

allergic to sulphasalazine (risk of allergy

to salicylates). In case of acute

intolerance reactions such as abdominal

cramps, acute abdominal pain, fever,

severe headache and rash, therapy should

be discontinued immediately.

Caution is recommended in

patients with impaired liver

function. The drug is not

recommended for use in patients

with renal impairment

Caution is recommended in patients with

impaired liver function. Liver function

parameters like ALT or AST should be

assessed prior to and during treatment, at

the discretion of the treating physician.

. The drug is not recommended

for use in patients with renal

impairment. The renal function

should be monitored regularly

(e.g. serum creatinine), especially

The drug is not recommended for use in

patients with renal impairment. The renal

function should be monitored regularly

(e.g. serum creatinine), especially during

the initial phase of treatment. Urinary

during the initial phase of

treatment. Mesalazine induced

nephrotoxicity should be

suspected in patients developing

renal dysfunction during

treatment. The concurrent use of

other known nephrotoxic agents,

such as NSAIDs and

Azathioprine, may increase the

risk of renal reactions.

Hypovolaemia is a risk factor in

the incidence of nephropathy, and

reversibility is dependent on the

duration of treatment. Creatinine

clearance calculation and urine

protein tests should be conducted

twice a year.

status (dip sticks) should be determined

prior to and during treatment at the

discretion of the treating physician.

Mesalazine induced nephrotoxicity

should be suspected in patients

developing renal dysfunction during

treatment. The concurrent use of other

known nephrotoxic agents should

increase monitoring frequency of renal

function.

Patients with pulmonary disease, in

particular asthma, should be very

carefully monitored during a course of

treatment.

Mesalazine-induced cardiac

hypersensitivity reactions (myo-

and pericarditis) have been

reported rarely. Serious blood

dyscrasias have been reported

very rarely with mesalazine.

Haematological investigations

should be performed if the patient

develops unexplained bleeding,

bruising, purpura, anaemia, fever

or sore throat. Concomitant

treatment with Mesalazine can

increase the risk of blood

dyscrasia in patients receiving

Azathioprine or 6-Mercaptopurine.

Treatment should be discontinued

on suspicion or evidence of these

adverse reactions.

Mesalazine induced cardiac

hypersensitivity reactions (myocarditis

and pericarditis) have been reported

rarely. Serious blood dyscrasias have

been reported very rarely with

mesalazine. Blood test for differential

blood count is recommended prior to and

during treatment, at the discretion of the

treating physician. As stated in the

interaction section 4.5, concomitant

treatment with mesalazine can increase

the risk of blood dyscrasia in patients

receiving azathioprine, 6-mercaptopurine

or thioguanine.. Treatment should be

discontinued on suspicion or evidence of

these adverse reactions.

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.

4.2

Intera

ctions

The concurrent use of mesalazine

with other known nephrotoxic

agents, such as NSAIDs and

Combination therapy with Pentasa and

azathioprine, 6-mercaptopurine or

azathioprine, may increase the

risk of renal reactions (see section

4.4).

Concomitant treatment with

mesalazine can increase the risk

of blood dyscrasia in patients

receiving azathioprine or 6-

mercaptopurine.

thioguanine, have in several studies

shown a higher frequency of

myelosuppressive effects,, and an

interaction seems to exist, however, the

mechanism behind the interaction is not

fully established. Regular monitoring of

white blood cells is recommended and

dosage regime of thiopurines should be

adjusted accordingly.

There is weak evidence that mesalazine

might decrease the anticoagulant effect of

warfarin.

Fertil

ity,

pregn

ancy

lactat

Pregnancy: Pentasa® should be

used with caution during

pregnancy and lactation and only

if the potential benefits outweigh

the possible hazards in the

opinion of the physician.

Mesalazine is known to cross the

placental barrier, but the limited

data available on the use of this

compound in pregnant women do

not allow assessment of possible

adverse effects. No teratogenic

effects have been observed in

animal studies.

Blood disorders (leucopenia,

thrombocytopenia, anaemia) have

been reported in new-borns of

mothers being treated with

Pentasa® .

Lactation: Exercise

caution when

administering to a nursing

woman.

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

4.6

Fertility, pregnancy and

lactation

Pentasa should be used with caution

during pregnancy and lactation and only

if the potential benefits outweigh the

possible hazards in the opinion of the

physician.

Mesalazine is known to cross the

placental barrier, and its concentration in

umbilical cord plasma is one tenth of the

concentration in maternal plasma. The

metabolite acetyl-mesalazine is found in

the same concentration in umbilical cord

and maternal plasma. From several

observational studies no teratogenic

effects are reported and there is no

evidence of significant risk of use in

humans. Animal studies on oral

mesalazine do not indicate direct or

indirect harmful effects with respect to

pregnancy, embryonic/foetal

development, parturition or postnatal

development. Blood disorders

(pancytopenia, leucopenia,

thrombocytopenia, anaemia) have been

reported in new-borns of mothers being

treated with Pentasa.

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.

Mesalazine is excreted in breast milk.

increased concentrations. There

is limited experience of the use of

oral mesalazine in lactating

women. No controlled studies with

Pentasa® during breast-feeding

have been carried out.

Hypersensitivity reactions like

diarrhoea in the infant cannot be

excluded.

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. No controlled

studies with Pentasa during breast-

feeding have been carried out.

Hypersensitivity reactions like diarrhoea

in the infant can not be excluded. If the

infant develops diarrhoea, breast-feeding

should be discontinued.

Animal data on mesalazine show no

effect on male and female fertility.

Oligospermia (reversible) has been

reported after use of mesalazine, see

section 4.8.

Undes

irable

effect

Rare

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

dizziness

Very rare

<1/10,000

Oligospermia (reversible)

Drug fever

תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ בוהצ עקר לע

.

ונמוס תורמחה רדגב םניאש םייוניש (ןולעב) םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב .טסקטה םוקימב ...ךיראתב ינורטקלא ראודב רבעוה

13.11.2014

....

תוכיאה תדועת ,םושירה תדועת) םושירה יאנת םע דחא הנקב םילוע םייונישה לכ

.(ינכדעה רישכתה יטרפ ספוטו

.םושירה יאנת תא םאות ,ןולעה תעצהב בותכה לכ

.םאתהב ןכדועמ אוהו ןכרצל ןולע םייק

__ :השקבל אתכמסא

____________ןכדועמ

ב"צמ אתכמסאה

____________דנלריא_ב תואירבה תויושר ידי לע רשוא ל"נה יונישה

םייוניש ןיא יכ הזב ריהצמ _סלקטיוצמרפ גניריפ_ תרבח לש הנוממה חקורה ,ינא , םיפסונ .ןולעה תעצהב ונמוסש הלא דבלמ

ןולעב עדימב תימינפ הריתס םירצוי םניא םייונישה יכ ריהצמ ינא

,היוותה תפסותל השקב תרגסמב ןולע ןוכדע :ןוגכ) תרחא תרגסמב ליבקמב לפוטמ אל הז ןולע .תאז ןייצל שי -תרחא תרגסמב ליבקמ לופיט םייקו הדימב . ('וכו הרמחה

(המיתחו םש) הנוממה חקורה תמיתח

___________________________

ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ(

05.2013

______ ךיראת

13.11.2014

__

:םושירה רפסמו תילגנאב רישכת םש

PENTASA SLOW RELEASE GRANULES 1 GR

:םושיר רפסמ

29591

PENTASA SLOW RELEASE GRANULES 2 G

:םושיר רפסמ

31560

______ םושירה לעב םש

FERRING PHARMACEUTICALS LTD

__

! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט שמתשהל ןיא םא הפורתב רישכתב שמתשהל ןיא תושיגר ךל העודי םא יביכרממ דחאל וא הפורתה .םיטליצילסל הפורתב שמתשהל ןיא ביכמ ת/לבוס ךניה םא הייטנמ וא יטפפ תויעבו םימומידל השירק העודי םא רישכתב שמתשהל ןיא יביכרממ דחאל תושיגר ךל .םיטליצילסל וא הפורתה ךניה םא הפורתב שמתשהל ןיא ת/לבוס הייטנמ וא יטפפ ביכמ השירק תויעבו םימומידל

לשכמ .רומח יתיילכ/ידבכ שמתשת דציכ הפורתב יפל שמתשהל שי דימת אפורה תוארוה וא אפורה םע קודבל ךילע .חוטב ךניא םא חקורה ועבקי לופיטה ןפואו ןונימה ןונימה . דבלב אפורה ידי לע :אוה ללכ ךרדב לבוקמה

תקלד

לש

יעמה

סגה

Ulcerative Colitis

לופיט

ףקתהב

ףירח

דע

רג

םויב

תונמב תוקלוחמ

לופיט

ךשוממ

רג

םעפ

םויב

הלחמ

"

ןהורק

Crohn’s Disease

לופיט

ףקתהב

ףירח

לופיטבו

ךשוממ

דע

רג

םויב

תונמב תוקלוחמ

הפורת

וז

הניא

תדעוימ ךרדב

ללכ

םידליל

תוקוניתו אלא

לע

יפ

תוארוה

אפורה

אפורה תוארוה יפל שמתשהל שי דימת ךניא םא חקורה וא אפורה םע קודבל ךילע .חוטב אפורה ידי לע ועבקי לופיטה ןפואו ןונימה :אוה ללכ ךרדב לבוקמה ןונימה . דבלב

תקלד

לש

יעמה

סגה

Ulcerative

Colitis

לופיט

ףקתהב

ףירח

דע

רג

םויב

ןתינ וא םויב תחא םעפ תחקל

תונמב תוקלוחמ

לופיט

ךשוממ

רג

םעפ

םויב

הלחמ

"

ןהורק

Crohn’s

Disease

לופיט

ףקתהב

ףירח

לופיטבו

ךשוממ

דע

רג

םויב

תונמב

תוקלוחמ

הפורת

וז

הניא

תדעוימ

ךרדב

ללכ

םידליל תוקוניתו

אלא

לע

יפ

תוארוה

אפורה

הפורתה לש תוליעיה לע לבגומ עדימ םייק ליגמ ) םידליב

דע

תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ בוהצ עקר לע

( ונמוס תורמחה רדגב םניאש םייוניש ןולעב םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב ) .טסקטה םוקימב .ךיראתב ינורטקלא ראודב רבעוה

13.11.2014

.

תדועת ,םושירה תדועת( םושירה יאנת םע דחא הנקב םילוע םייונישה לכ ספוטו תוכיאה

.)ינכדעה רישכתה יטרפ

.םושירה יאנת תא םאות ,ןולעה תעצהב בותכה לכ

.םאתהב ןכדועמ אוהו אפורל ןולע םייק

__ :השקבל אתכמסא

דנלריאמ

.ב"צמ אתכמסאה

_________דנלריא__ב תואירבה תויושר ידי לע רשוא ל"נה יונישה

יכ הזב ריהצמ __מ"עב סלקטיוצמרפ גניריפ_ תרבח לש הנוממה חקורה ,ינא ,םיפסונ םייוניש ןיא דבלמ

.ןולעה תעצהב ונמוסש הלא

ןולעב עדימב תימינפ הריתס םירצוי םניא םייונישה יכ ריהצמ ינא

תפסותל השקב תרגסמב ןולע ןוכדע :ןוגכ( תרחא תרגסמב ליבקמב לפוטמ אל הז ןולע .תאז ןייצל שי -תרחא תרגסמב ליבקמ לופיט םייקו הדימב . )'וכו הרמחה ,היוותה ___________________________: )המיתחו םש( הנוממה חקורה תמיתח

ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ(

05.2013

______ ךיראת

13.11.2014

__

:םושירה רפסמו תילגנאב רישכת םש

PENTASA SLOW RELEASE TABLETS 500 MG

םושיר 'סמ

26905

PENTASA SLOW RELEASE TABLETS 1 GRAM

םושיר 'סמ,

33401

______ םושירה לעב םש

FERRING PHARMACEUTICALS LTD

__

! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט שמתשהל ןיא םא הפורתב רישכתב שמתשהל ןיא תושיגר ךל העודי םא יביכרממ דחאל וא הפורתה .םיטליצילסל הפורתב שמתשהל ןיא ביכמ ת/לבוס ךניה םא הייטנמ וא יטפפ תויעבו םימומידל השירק העודי םא רישכתב שמתשהל ןיא יביכרממ דחאל תושיגר ךל .םיטליצילסל וא הפורתה ךניה םא הפורתב שמתשהל ןיא ת/לבוס הייטנמ וא יטפפ ביכמ השירק תויעבו םימומידל

לשכמ .רומח יתיילכ/ידבכ

שמתשת דציכ הפורתב יפל שמתשהל שי דימת אפורה תוארוה וא אפורה םע קודבל ךילע .חוטב ךניא םא חקורה ועבקי לופיטה ןפואו ןונימה ןונימה . דבלב אפורה ידי לע :אוה ללכ ךרדב לבוקמה

תקלד

לש

יעמה

סגה

Ulcerative Colitis

לופיט

ףקתהב

ףירח

דע

רג

םויב

תונמב תוקלוחמ

אפורה תוארוה יפל שמתשהל שי דימת ךניא םא חקורה וא אפורה םע קודבל ךילע .חוטב אפורה ידי לע ועבקי לופיטה ןפואו ןונימה :אוה ללכ ךרדב לבוקמה ןונימה . דבלב

תקלד

לש

יעמה

סגה

Ulcerative

Colitis

לופיט

ףקתהב

ףירח

דע

רג

םויב

ןתינ וא םויב תחא םעפ תחקל

תונמב תוקלוחמ

לופיט

ךשוממ

רג

םעפ

םויב

לופיט

ךשוממ

רג

םעפ

םויב

הלחמ

"

ןהורק

Crohn’s Disease

לופיט

ףקתהב

ףירח

לופיטבו

ךשוממ

דע

רג

םויב

תונמב תוקלוחמ

הפורת

וז

הניא

תדעוימ ךרדב

ללכ

םידליל

תוקוניתו אלא

לע

יפ

תוארוה

אפורה

הלחמ

"

ןהורק

Crohn’s

Disease

לופיט

ףקתהב

ףירח

לופיטבו

ךשוממ

דע

רג

םויב

תונמב

תוקלוחמ

הפורת

וז

הניא

תדעוימ

ךרדב

ללכ

םידליל תוקוניתו

אלא

לע

יפ

תוארוה

אפורה

הפורתה לש תוליעיה לע לבגומ עדימ םייק ליגמ ) םידליב

דע

יאולל תועפות .יאוול תועפות לש היוצרה תוליעפל ףסונב הב שומישה ןמזב ,הפורתה ,יאוול תועפשה עיפוהל תולולע ,שאר באכ ,הליחב ,לושלש :ןוגכ .השלוח ,תואקה ללכ ךרדב תופלוח ולא תועפות תפוקת רחאל רצק ןמז ךות .רישכתל תולגתסהה תועפותה םא אפורל תונפל שי .תודירטמ וא תופלוח ןניא תוסחייתה תובייחמה תועפות :תדחוימ ,תוילכב העיגפ ומכ תועפות ,רועב יוריג ,םוח ,ימד לושלש תושיגרו דואמ םיקזח ןטב יבאכ ולא םירקמב .תורידנ ןניה ,רתי .אפורל י/הנפו לופיט י/קספה ה/שיגרמ ךניה ובש הרקמ לכב ןולעב וניוצ אלש יאוול תועפות ךתשגרהב יוניש לח םא וא ,הז םע ץעייתהל ךילע תיללכה .דימ אפורה ליבקמה ףיעסל םאתהב ןכדוע הז ףיעס ( ןולעל םאתהבו תולונרג הסטנפ ב רשואמה )אפורל .יאוול תועפות תוילבט הסטנפב שומישה ,הפורת לכב ומכ קלחב יאוול תועפותל םורגל לולע תמישר ארקמל להבית לא .םישמתשמהמ תחא ףאמ לובסת אלו ןכתי .יאוולה תועפות .ןהמ אפורל דימ תונפלו שומישה תא קיספהל שי םא ומכ יאוול תועפות שי

העיגפ

תוילכב

לושלש

ימד

םוח

יוריג

רועב

יבאכ

ןטב םיקזח

דואמ

תושיגרו

רתי

ןניה הלא תועפות תורידנ

םירקמב

ולא

קספה

לופיט

הנפו

אפורל

ידיימ ןפואב םילוח תיבל וא אפורל תונפל שי תיגרלא הבוגת תחתפתמ םא

(

םירקמב חווד םידדוב

)

םינפה תוחפנתהל םורגל הלולעה ראווצהו

,

העילב וא המישנ יישק

.

תופסונ יאוול תועפות

תובורק םיתיעל תועיפומש יאוול תועפות

לושלש

ןטב יבאכ

הליחב

תואקה

באכ שאר

החירפ

תוקוחר םיתיעל תועיפומש יאוול תועפות

בלה לש תוקלד

סיטידרקוימ

סיטידרקירפ

המישנ רצוקל םורגל תולולעה

הזחב םיבאכ תוקזח בל תוקיפדו

תורידס יתלב וא תוריהמ

בלבלה לש תקלד

בג יבאכב אטבתהל היושע

םיפירח ןטב וא

תרוחרחס

םיזג

תורידנ םיתעל תועיפומש יאוול תועפות

םדה תכרעמב תורחא תוערפהו הימנא

הדירי םורגל הלולעה םימייוסמ םד יאת לש הריפסב םירבסומ יתלב םימומידל

תולבח

וא םוח ןורג באכ

דבכב תוערפה

תבהצה םיללוכ םינימסת ו רועה

ןיעה ןבול וא

הריהב האוצ

תוילכב תוערפה

ןתשב םד םיללוכ םינימסת

םילזונ תורבטצה וא

תיפקה היתפוריונ

ץוצקע םיללוכ םינימסת םייפגב השוחת רסוחו

תיגרלא תואיר תקלד

םיללוכ םינימסת לועיש

המישנה הנק תוצווכתה

תוחונ רסוח הזחב

המישנ ןמזב באכ

המישנ יישק

החיל החיל ףדועו תימד

רעיש תרישנ

ךיפה

םיקרפמבו םירירשב םיבאכ ןוגכ םינוש ףוג יקלח לע תועיפשמה תוקלד םיקרפמ

רוע

תוילכ

בל

םיללוכ םינימסת םיקרפמ יבאכ

תופייע

םוח

וא גירח םומיד רבסומ אל

תולבח

רועה לע םילוגס םימתכ

רועל תחתמ תודוקנ

באכל םורגל הלולעה בלה ביבס םילזונ תריצא הזחב ץחל וא ןתשה עבצ יוניש ערזה לזונב ערזה זוכירב הדירי

ךיפה

תיגרלא הבוגת בקע ןטב באכו ףירח לושלש יעמב רישכתל

יתלגלוג ךות םד ץחל לע םידדוב םיחוויד םנשי םירגבתמב

שאר באכ םניה םינימסת

הליחב

האקה

הייארב תוערפה

תוערפה העימשב

:תופסונ יאוול תועפות .השלוח ,תואקה ,שאר באכ ,הליחב ,לושלש רצק ןמז ךות ללכ ךרדב תופלוח ולא תועפות .רישכתל תולגתסהה תפוקת רחאל רשאכ וא ,הרימחמ יאוולה תועפותמ תחא םא ,ןולעב הרכזוה אלש יאוול תעפותמ לבוס התא .אפורה םע ץעייתהל ךילע תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ בוהצ עקר לע

( ונמוס תורמחה רדגב םניאש םייוניש ןולעב םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב ) .טסקטה םוקימב .ךיראתב ינורטקלא ראודב רבעוה

13.11.2014

.

תדועת ,םושירה תדועת( םושירה יאנת םע דחא הנקב םילוע םייונישה לכ ספוטו תוכיאה

.)ינכדעה רישכתה יטרפ

.םושירה יאנת תא םאות ,ןולעה תעצהב בותכה לכ

.םאתהב ןכדועמ אוהו אפורל ןולע םייק

__ :השקבל אתכמסא

________דנלריאמ

.ב"צמ אתכמסאה

_________דנלריא__ב תואירבה תויושר ידי לע רשוא ל"נה יונישה

יכ הזב ריהצמ __מ"עב סלקטיוצמרפ גניריפ_ תרבח לש הנוממה חקורה ,ינא ,םיפסונ םייוניש ןיא דבלמ

.ןולעה תעצהב ונמוסש הלא

ןולעב עדימב תימינפ הריתס םירצוי םניא םייונישה יכ ריהצמ ינא

תפסותל השקב תרגסמב ןולע ןוכדע :ןוגכ( תרחא תרגסמב ליבקמב לפוטמ אל הז ןולע .תאז ןייצל שי -תרחא תרגסמב ליבקמ לופיט םייקו הדימב . )'וכו הרמחה ,היוותה ___________________________: )המיתחו םש( הנוממה חקורה תמיתח

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