PENTASA SUPPOSITORIES

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

MESALAZINE

Disponível em:

FERRING PHARMACEUTICALS LTD

Código ATC:

A07EC02

Forma farmacêutica:

SUPPOSITORIES

Composição:

MESALAZINE 1000 MG

Via de administração:

RECTAL

Tipo de prescrição:

Required

Fabricado por:

FERRING INTERNATIONAL CENTER SA, SWITZERLAND

Grupo terapêutico:

MESALAZINE

Área terapêutica:

MESALAZINE

Indicações terapêuticas:

Ulcerative proctitis.

Data de autorização:

2014-01-31

Folheto informativo - Bula

عادص
حفط
تازاغ
جرشلا ةحتف يف جاعزنا
ةليمحتلا لاخدإ ناكم يف جيهت
:
10,000 لصأ نم نيلمعتسم 1-10 ىدل رهظت ضارعأ -
ةردان ةيبناج ضارعأ
ببسي نأ نكمي )رومأتلا باهتلاو بلقلا
ةلضع باهتلا( بلقلا نم ةنيعم قطانم يف
باهتلا
)مظتنم ريغو عيرس بلق ناقفخ( ناقفخلا وأ
ردصلا ملأو سفنتلا قيض
)نطب عاجوأ وأ/و رهظ ملأ ضارعلأا نمضتت(
سايركنبلا باهتلا
ةخود
)تايركسلا مضه ىلع دعاسي ميزنإ(
زلايم
َ
لأا ىوتسم عافترا
-يئوض س
ّ
سحت( يجسفنبلا
قوف
ءوضلا
هاجتو سمشلا
هاجت
ةطرفم ةيدلج ةيساسح
(Photosensitivity
نم دحاو لمعتسم نم لقأ ىدل رهظت ضارعأ -
ادج ةردان نايحأ يف رهظت ةيبناج ضارعأ
:
10,000 لصأ
افيزن ببست دق يتلاو ،مدلا ايلاخ عاونأ
ضعب يف ضافخنا( ىرخأ مد تابارطضاو مدلا
رقف
)قلحلا يف ملاآو ىمح ،تامدك ،ببسلا
لوهجم
زارب وأ/و )نينيعلا وأ/و دلجلا رارفصا(
ناقري ضارعلأا نمضتت( دبكلا يف تابارطضا
)نوللا حتاف
))لئاوسلا مكارت ببسب مروت( ةمذو وأ/و
،لوبلا يف مد ضارعلأا نمضتت( ىلكلا يف
تابارطضا
زخو ضارعلأا نمضتت .نيقاسلاو نيديلا
باصعأ يف رثؤت ةلاح( يطيحم يبصع للاتعا
)ساسحلإا صقنو
نمضتت( ةئرلا بدنت وأ ةئرلاب طيحملا
ءاشغلا باهتلا ،ةئرلا يف ف
ّ
يلتو ةيسسحت لعف دودر
يف ملأ وأ ةحار مدع ،)bronchospasm( ةيسفنتلا
كلاسملا جنشت ،لاعس ضارعلأا
)ديازتم وأ/و يومد مغلب ،سفنتلا ءانثأ
ردصلا
ةقبطلا لكب اررض قحلي يذلا

Características técnicas

Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Pentasa® Suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pentasa suppository contains: 1g mesalazine
For a 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.
Method of administration
For rectal use.
A visit to the toilet is recommended before administration of
suppositories.
See separate instructions for use.
4.3
CONTRAINDICATIONS
PENTASA is contraindicated in:
- patients with known hypersensitivity to
mesalazine,
salicylates or any of the excipients
,
listed in section 6.1
- patients with severe liver and/or renal impairment
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is recommended when treating patients allergic to
sulphasalazine (risk of allergy to
salicylates). Severe cutaneous adverse reactions (SCARs), including
drug reaction with
eosinophilia and systemic symptoms (DRESS),
Stevens-Johnson syndrome (SJS) and
toxic epidermal necrolysis (TEN), have been reported in association
with mesalazine
treatment. In case of acute symptoms of intolerance i.e. abdominal
cramps, abdominal pain,
fever and severe headache and/or the first appearance of signs and
symptoms of severe skin
reactions, such as skin rash, mucosal lesions, or any other signs of
hypersensitivity, the
treatment should be discontinued immediately.
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 impaired renal
function and in patients
with haemorrhagic diathesis. Baseline renal function measurement is
required in all patients
initiating treatment with mesalazine. Urinary status (dip sticks)
should be determined prior to
and during t