GLUCAGEN KIT

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GLUCAGON (RECOMBINANT DNA ORIGIN) (GLUCAGON HYDROCHLORIDE)

Disponibil de la:

NOVO NORDISK CANADA INC

Codul ATC:

H04AA01

INN (nume internaţional):

GLUCAGON

Dozare:

1MG

Forma farmaceutică:

KIT

Compoziție:

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

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

1ML

Tip de prescriptie medicala:

Schedule D

Zonă Terapeutică:

GLYCOGENOLYTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2009-09-17

Caracteristicilor produsului

_ _
_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
...................................................................................