GLUCAGEN KIT

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GLUCAGON (RECOMBINANT DNA ORIGIN) (GLUCAGON HYDROCHLORIDE)

제공처:

NOVO NORDISK CANADA INC

ATC 코드:

H04AA01

INN (국제 이름):

GLUCAGON

복용량:

1MG

약제 형태:

KIT

구성:

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

관리 경로:

INTRAMUSCULAR

패키지 단위:

1ML

처방전 유형:

Schedule D

치료 영역:

GLYCOGENOLYTIC AGENTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2009-09-17

제품 특성 요약

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