ASACOL 800

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MESALAZINE

متاح من:

TRADIS GAT LTD

ATC رمز:

A07EC02

الشكل الصيدلاني:

TABLETS ENTERIC COATED

تركيب:

MESALAZINE 800 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TILLOTTS PHARMA AG, SWITZERLAND

المجموعة العلاجية:

MESALAZINE

المجال العلاجي:

MESALAZINE

الخصائص العلاجية:

Ulcerative colitis:-For the treatment of mild to moderate acute exacerbations. -For the maintenance of remission.Crohn's disease:-For the treatment of acute episodes.

تاريخ الترخيص:

2020-10-31

نشرة المعلومات

1.
NAME OF THE MEDICINAL PRODUCT
ASACOL® 800_ _mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains:
Mesalazine (5-aminosalicylic acid) 800 mg
Excipient with known effect: 152.8 mg lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Enteric coated Tablet.
Reddish to brownish oblong tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ _
_Ulcerative colitis: _
For the treatment of mild to moderate acute exacerbations. For the
maintenance of
remission.
_Crohn's disease: _
For the treatment of acute episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Ulcerative colitis: _
_Mild acute disease:_ 2.4 g (three tablets) once daily or in divided
doses, with
concomitant corticosteroid therapy to be taken when clinically
indicated.
_Moderate acute disease: _2.4 g to 4.8 g (three to six tablets) a day
in divided doses,
with concomitant corticosteroid therapy where clinically indicated.
2.4 g may be taken
once daily or in divided doses. Above 2.4 g daily should be taken in
divided doses.
The maximum adult dose should not exceed six tablets a day and not
exceed three
tablets taken together at any one time.
_Maintenance of remission_:_ _
1.2 to 2.4 g per day once daily or in divided doses.
_ _
_Crohn’s disease: _
2.4 g per day in divided doses._ _
Elderly population
Use in the elderly should be handled with caution and only for
patients having a normal renal
function.
Pediatric population
There is no specific dose recommendation for children.
Method of administration
The tablets should be taken before meals and must be swallowed whole
and preferably with
some liquid. They must not be chewed, crushed or broken before
swallowing.
4.3 CONTRA-INDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1
- Known hypersensitivity to salicylates
- Severe liver impairment.
- Severe renal impairment (GFR less than 30 mL/min/1.73 m2).
- Children under the age of 2 years.
4.4 SPECIAL WARNINGS AND PR

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
ASACOL® 800_ _mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains:
Mesalazine (5-aminosalicylic acid) 800 mg
Excipient with known effect: 152.8 mg lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Enteric coated Tablet.
Reddish to brownish oblong tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ _
_Ulcerative colitis: _
For the treatment of mild to moderate acute exacerbations. For the
maintenance of
remission.
_Crohn's disease: _
For the treatment of acute episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Ulcerative colitis: _
_Mild acute disease:_ 2.4 g (three tablets) once daily or in divided
doses, with
concomitant corticosteroid therapy to be taken when clinically
indicated.
_Moderate acute disease: _2.4 g to 4.8 g (three to six tablets) a day
in divided doses,
with concomitant corticosteroid therapy where clinically indicated.
2.4 g may be taken
once daily or in divided doses. Above 2.4 g daily should be taken in
divided doses.
The maximum adult dose should not exceed six tablets a day and not
exceed three
tablets taken together at any one time.
_Maintenance of remission_:_ _
1.2 to 2.4 g per day once daily or in divided doses.
_ _
_Crohn’s disease: _
2.4 g per day in divided doses._ _
Elderly population
Use in the elderly should be handled with caution and only for
patients having a normal renal
function.
Pediatric population
There is no specific dose recommendation for children.
Method of administration
The tablets should be taken before meals and must be swallowed whole
and preferably with
some liquid. They must not be chewed, crushed or broken before
swallowing.
4.3 CONTRA-INDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1
- Known hypersensitivity to salicylates
- Severe liver impairment.
- Severe renal impairment (GFR less than 30 mL/min/1.73 m2).
- Children under the age of 2 years.
4.4 SPECIAL WARNINGS AND PR