CARBETOCIN INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CARBETOCIN

Available from:

JUNO PHARMACEUTICALS CORP.

ATC code:

H01BB03

INN (International Name):

CARBETOCIN

Dosage:

100MCG

Pharmaceutical form:

SOLUTION

Composition:

CARBETOCIN 100MCG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

OXYTOCICS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2019-06-07

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CARBETOCIN INJECTION
1 mL solution in pre-filled syringes – 100 mcg / mL
For Intravenous (IV) Use Only
Uterotonic Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, ON
L5N 2X7
Date of Initial Authorization:
June 7, 2019
Date of Revision:
September 18, 2023
Submission Control No: 274705
Carbetocin Injection
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Carbetocin Injection
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RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................................
4
1.
INDICATIONS
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4
1.1
PEDIATRICS
...................................................................................................................................
4
1.2
GERIATRICS
...................................................................................................................................
4
2.
CONTRAINDICATIONS
..................................................................................................................
4
4.
DOSAGE AND ADMINISTRATION
..................................................................................................
4
4.4
ADMINISTRATION
.........................................................................................................................
5
5.
OVERDOSAGE
..............................................................................................................................
5
6.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................................... 5
7.
WARNINGS AND PRECAUTIONS
...................................................................................................
6
7.1
SPECIAL POPULATIONS
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7
7.1.1 PREGNANT WOMEN:
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