GRANISETRON HYDROCHLORIDE INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GRANISETRON (GRANISETRON HYDROCHLORIDE)

제공처:

STRIDES PHARMA CANADA INC

ATC 코드:

A04AA02

INN (국제 이름):

GRANISETRON

복용량:

1MG

약제 형태:

SOLUTION

구성:

GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG

관리 경로:

INTRAVENOUS

패키지 단위:

1/3/4ML

처방전 유형:

Prescription

치료 영역:

5-HT3 RECEPTOR ANTAGONISTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2020-08-18

제품 특성 요약

_Page 1 of 21 _
PRODUCT MONOGRAPH
PR
GRANISETRON HYDROCHLORIDE INJECTION
Granisetron Hydrochloride
1 mg / mL granisetron as hydrochloride, 1 mL, 3mL and 4 mL vials
Sterile Solution for Intravenous Injection
ANTIEMETIC
(5-HT
3 RECEPTOR ANTAGONIST)
STRIDES PHARMA CANADA INC.
DATE OF REVISION:
1565, Boul. Lionel-Boulet
April 5, 2023
Varennes, Quebec
Canada, J3X 1P7
CONTROL NO. 269164
_Page 2 of 21 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
5
DRUG
INTERACTIONS.....................................................................................................
7
DOSAGE AND ADMINISTRATION
.................................................................................
8
OVERDOSAGE
...................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 9
STORAGE AND STABILITY
............................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 11
PART II: SCIENTIFIC INFORMATION
..................................................................................
12
PHARMACEUTICAL INFORMATION
............................................................................
12
CLINICAL TRIALS
...........................................................