PROMETRIUM CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

PROGESTERONE

متاح من:

ORGANON CANADA INC.

ATC رمز:

G03DA04

INN (الاسم الدولي):

PROGESTERONE

جرعة:

100MG

الشكل الصيدلاني:

CAPSULE

تركيب:

PROGESTERONE 100MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

28/100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PROGESTINS

ملخص المنتج:

Active ingredient group (AIG) number: 0106327002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2011-02-17

خصائص المنتج

Page 1 of 34
PRODUCT MONOGRAPH
PROMETRIUM
®
Progesterone capsules
100 mg
Progestin
Organon Canada Inc.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.organon.ca
Date of Revision:
March 29, 2021
Submission Control No: 249484
_ _
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Page 2 of 34
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL INFORMATION
..........................................................................20
CLINICAL TRIALS
..........................................................................................................21
TOXICOLOGY
..............................................................................................................