CARBETOCIN INJECTION SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CARBETOCIN

Tilgjengelig fra:

JUNO PHARMACEUTICALS CORP.

ATC-kode:

H01BB03

INN (International Name):

CARBETOCIN

Dosering :

100MCG

Legemiddelform:

SOLUTION

Sammensetning:

CARBETOCIN 100MCG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

OXYTOCICS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2019-06-07

Preparatomtale

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
...............................................................................................................................
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
.................................................................................................................
7
7.1.1 PREGNANT WOMEN:
.........................................