DURATOCIN SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CARBETOCIN

متاح من:

FERRING INC

ATC رمز:

H01BB03

INN (الاسم الدولي):

CARBETOCIN

جرعة:

100MCG

الشكل الصيدلاني:

SOLUTION

تركيب:

CARBETOCIN 100MCG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

5X100MCG

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

OXYTOCICS

ملخص المنتج:

Active ingredient group (AIG) number: 0132909001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2021-05-18

خصائص المنتج

DURATOCIN (carbetocin injection)
Page 1 of 28
PRODUCT MONOGRAPH
Pr
DURATOCIN
®
(Carbetocin Injection)
1 mL ampoule – 100 mcg/mL Injection
For Intravenous Use Only
Uterotonic Agent
Ferring Inc.
200 Yorkland Boulevard
Suite 500
North York, ON
M2J 5C1
Date of Revision:
April 28, 2020
Submission Control No: 236432
DURATOCIN (carbetocin injection)
Page 2 of 28
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
TOXICOLOGY
........