GRANISETRON HYDROCHLORIDE INJECTION SDZ SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GRANISETRON (GRANISETRON HYDROCHLORIDE)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

A04AA02

INN (국제 이름):

GRANISETRON

복용량:

1MG

약제 형태:

SOLUTION

구성:

GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG

관리 경로:

INTRAVENOUS

패키지 단위:

1ML/3ML

처방전 유형:

Prescription

치료 영역:

5-HT3 RECEPTOR ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0123183001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2019-08-01

제품 특성 요약

_Granisetron Hydrochloride Injection SDZ _
_Page 1 of 25 _
PRODUCT MONOGRAPH
PR
GRANISETRON HYDROCHLORIDE INJECTION SDZ
PRESERVATIVE FREE
Solution for Injection
1 mg/mL granisetron (as granisetron hydrochloride)
1 mL and 3 mL ampoules
Manufacture’s Standard
STERILE
ANTIEMETIC
(5-HT
3 RECEPTOR ANTAGONIST)
Sandoz Canada Inc.
Date of Revision: October 23, 2014
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 177134
_Granisetron Hydrochloride Injection SDZ _
_Page 2 of 25 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY
PRODUCT
INFORMATION
.................................................................................
3
INDICATIONS
AND
CLINICAL
USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
..........................................................................................
4
ADVERSE
REACTIONS
............................................................................................................
6
DRUG
INTERACTIONS
............................................................................................................
8
DOSAGE
AND
ADMINISTRATION
........................................................................................
9
OVERDOSAGE
........................................................................................................................
10
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
10
STORAGE
AND
STABILITY
..................................................................................................
12
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 13
PART II: SCIENTIFIC INFORMATION
................................................................................
1