PMS-DICLOFENAC-MISOPROSTOL TABLET (DELAYED-RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DICLOFENAC SODIUM; MISOPROSTOL

متاح من:

PHARMASCIENCE INC

ATC رمز:

M01AB55

INN (الاسم الدولي):

DICLOFENAC, COMBINATIONS

جرعة:

75MG; 200MCG

الشكل الصيدلاني:

TABLET (DELAYED-RELEASE)

تركيب:

DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2013-10-01

خصائص المنتج

PRODUCT MONOGRAPH
PR
PMS-DICLOFENAC-MISOPROSTOL
Diclofenac Sodium and Misoprostol
Enteric-Coated Tablets, USP
50 mg diclofenac/200 mcg misoprostol
75 mg diclofenac/200 mcg misoprostol
NSAID WITH A MUCOSAL PROTECTIVE AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
June 1, 2022
Submission
Control No: 263143
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_pms-DICLOFENAC-MISOPROSTOL Product Monograph Page 2 of 55_
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
...........................................................................................
17
DRUG
INTERACTIONS............................................................................................
22
DOSAGE AND
ADMINISTRATION.........................................................................
26
OVERDOSAGE
.........................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND
STABILITY....................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 31
PART II: SCIENTIFIC
INFORMATION...........................................................................
32
PHARMACEUTICAL
INFORMATION.....................................................................
32
CLINICAL TRIALS
...................................................................................................
34
DE