SANDOZ DICLOFENAC MISOPROSTOL TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DICLOFENAC SODIUM; MISOPROSTOL

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

M01AB55

INN (الاسم الدولي):

DICLOFENAC, COMBINATIONS

جرعة:

75MG; 200MCG

الشكل الصيدلاني:

TABLET

تركيب:

DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/250/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0222885004; AHFS:

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2021-04-21

خصائص المنتج

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_Sandoz DiclofenacMisoprostol _
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PRODUCT MONOGRAPH
Pr
SANDOZ DICLOFENAC MISOPROSTOL
Diclofenac Sodium and Misoprostol Enteric-Coated Tablets
50 mg diclofenac sodium / 200 mcg misoprostol
75 mg diclofenac sodium / 200 mcg misoprostol
NSAID with a Mucosal Protective Agent
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Revision:
March 19, 2015
Control no.: 182760
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_Sandoz DiclofenacMisoprostol _
_Page 2 of 48_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY
PRODUCT
INFORMATION
.................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS
AND
PRECAUTIONS
..........................................................................................
5
ADVERSE
REACTIONS
..........................................................................................................
15
DRUG
INTERACTIONS
...........................................................................................................
18
DOSAGE
AND
ADMINISTRATION
.......................................................................................
22
OVERDOSAGE
.........................................................................................................................
23
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
24
STORAGE
AND
STABILITY...................................................................................................
26
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 26
PART II: SCIENTIFIC INFORMATION
................................................................................
28
PHARMACEUTICAL
INFORMATION
........