GLUCAGEN HYPOKIT

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

GLUCAGON (RECOMBINANT DNA ORIGIN) (GLUCAGON HYDROCHLORIDE)

Beschikbaar vanaf:

NOVO NORDISK CANADA INC

ATC-code:

H04AA01

INN (Algemene Internationale Benaming):

GLUCAGON

Dosering:

1MG

farmaceutische vorm:

KIT

Samenstelling:

GLUCAGON (RECOMBINANT DNA ORIGIN) (GLUCAGON HYDROCHLORIDE) 1MG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

1ML

Prescription-type:

Schedule D

Therapeutisch gebied:

GLYCOGENOLYTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0142861001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2009-09-17

Productkenmerken

_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_GLUCAGEN_
_®_
_ and GLUCAGEN_
_®_
_ HYPOKIT (glucagon) _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
GLUCAGEN
®
and
GLUCAGEN
® HYPOKIT
glucagon
ATC Code: H04AA01
Powder and solvent for solution for injection, 1 mg, Intramuscularly
Hyperglycemic Agent
Manufactured by: Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1 Canada
Distributed by: Paladin Labs Inc.
St-Laurent, QC H4M 2P2
Date of Initial Approval:
JUN-01-2016
Date of Revision:
FEB-01-2022
Submission Control No: 256817
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_GLUCAGEN_
_®_
_ and GLUCAGEN_
_®_
_ HYPOKIT (glucagon) _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................... 4
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.1
Dosing Considerations
...................................................................................