CARBETOCIN INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CARBETOCIN

Tersedia dari:

JUNO PHARMACEUTICALS CORP.

Kode ATC:

H01BB03

INN (Nama Internasional):

CARBETOCIN

Dosis:

100MCG

Bentuk farmasi:

SOLUTION

Komposisi:

CARBETOCIN 100MCG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

OXYTOCICS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2019-06-07

Karakteristik produk

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:
.........................................