PENTASA SLOW RELEASE TABLETS 1 GRAM
Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
Taarifa za kipeperushi
(PIL)
08-08-2023
Tabia za bidhaa
(SPC)
08-08-2023
Ripoti ya Tathmini ya umma
(PAR)
04-12-2019
Viambatanisho vya kazi:
MESALAZINE
Inapatikana kutoka:
FERRING PHARMACEUTICALS LTD
ATC kanuni:
A07EC02
Dawa fomu:
TABLETS SLOW RELEASE
Tungo:
MESALAZINE 1 G
Njia ya uendeshaji:
PER OS
Dawa ya aina:
Required
Viwandani na:
FERRING INTERNATIONAL CENTER SA, SWITZERLAND
Kundi la matibabu:
MESALAZINE
Eneo la matibabu:
MESALAZINE
Matibabu dalili:
Mild to moderate ulcerative colitis. Crohn's disease.
Idhini ya tarehe:
2016-12-31
Taarifa za kipeperushi
-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
مكارت ببسب مروت( ةمذو وأ/و ،لوبلا يف مد
ضارعلأا نمضتت( ىلكلا يف تابارطضا
))لئاوسلا
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 )
IBD ( يباهتللاا يعملا ضرم نم عون( نولوقلل
يلك باهتلا
)ةظيلغلا ءاعملأا نم ةيلخادلا
)ساكعنلال لباق( رعشلا طقاست
لصافملا يف وأ تلاضعلا يف ملأ
امو بلقلا ،ىلكلا ،دلجلا ،لصافملا لثم
مسجلا نم ةفلتخم قطانم بيصي نأ نكمي
باهتلا
لاثم( رربم ريغو يعيبط ريغ فيزن
،ىمح
،بعت ،لصافملا ملاآ ضارعلأا لمشت( كلذ
ىلإ
ةديدشلا
روثبلاو ةديدشلا تافلآا كلذ يف امب(
دلجلا ىلع ةيناوجرأ عقب ،تامدك ،)فنلأا
في
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Tabia za bidhaa
Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Pentasa® slow release tablets, 500 mg
Pentasa® slow release tablets, 1 g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Mesalazine
Each Pentasa slow release, 500mg tablet contains: 500 mg mesalazine.
Each Pentasa slow release, 1g tablet contains: 1000 mg mesalazine.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pentasa slow release tablets 500 mg. White-grey to pale-brown, specked
round tablets, scored
and marked 500mg on one side and ‘PENTASA’ on the reverse side.
Pentasa slow release tablets 1 g. White-grey to pale-brown, specked
oval tablets, and marked
with ‘PENTASA’ on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderate ulcerative colitis and Crohn’s
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ULCERATIVE COLITIS
_Adults: _
Active treatment: Individual dosage, up to 4 g mesalazine once daily
or in two or three
divided doses.
Maintenance treatment: Recommended dosage, 2 g mesalazine once daily.
CROHN’S DISEASE
_Adults: _
Active treatment: Individual dosage, up to 4 g mesalazine daily in two
or three divided doses.
Maintenance treatment: Individual dosage, up to 4 g mesalazine daily
in two or three divided
doses.
PAEDIATRIC POPULATION
The safety and efficacy in children below 6 years have not been
established.
There is only limited documentation for an effect in children (age
6-18 years)
ULCERATIVE COLITIS
Children 6 years of age and older:
Active disease: 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:
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._ _
C
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