APO-MEDROXY TABLETS

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MEDROXYPROGESTERONE ACETATE

متاح من:

APOTEX INC

ATC رمز:

G03DA02

INN (الاسم الدولي):

MEDROXYPROGESTERONE

جرعة:

5MG

الشكل الصيدلاني:

TABLET

تركيب:

MEDROXYPROGESTERONE ACETATE 5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PROGESTINS

ملخص المنتج:

Active ingredient group (AIG) number: 0106339005; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2001-11-02

خصائص المنتج

Page 1 of 39
PRODUCT MONOGRAPH
Pr
APO-MEDROXY
(MEDROXYPROGESTERONE ACETATE TABLETS USP)
2.5 MG, 5 MG, 10 MG AND 100 MG
PROGESTIN
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Date of Revision:
M9L 1T9
July 21, 2017
CONTROL NO. 207292
Page 2 of 39
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
13
DRUG INTERACTIONS
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
19
STORAGE AND STABILITY
...............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 23
PART II: SCIENTIFIC INFORMATION
.............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL TRIALS
...............................................................................................................
24
DETAILED PHARMACOLOGY
.................................