GEMZAR (1GM/VIAL) POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Доступно од:

ELI LILLY CANADA INC

АТЦ код:

L01BC05

INN (Међународно име):

GEMCITABINE

Дозирање:

1G

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G

Пут администрације:

INTRAVENOUS

Јединице у пакету:

25ML TO 50ML

Тип рецептора:

Prescription

Терапеутска област:

ANTINEOPLASTIC AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0133122002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2015-11-01

Карактеристике производа

GEMZAR Product Monograph
Page 1 of 52
PRODUCT MONOGRAPH
Pr
GEMZAR
®
Gemcitabine Hydrochloride for Injection
200 mg or 1 g gemcitabine per vial
Antineoplastic Agent
© Eli Lilly Canada
3650 Danforth Ave.
Toronto, Ontario
M1N 2E8
1-888-545-5972
www.lilly.ca
Date of Revision:
April 28, 2014
Submission Control No. 171741
GEMZAR Product Monograph
Page 2 of 52
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................. 3
SUMMARY PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
4
ADVERSE REACTIONS
............................................................................................
8
DRUG INTERACTIONS
..........................................................................................
20
DOSAGE AND ADMINISTRATION
......................................................................
21
OVERDOSAGE
........................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 24
STORAGE AND STABILITY
..................................................................................
26
DOSAGE FORMS, COMPOSITION AND
PACKAGING...................................... 26
PART II: SCIENTIFIC INFORMATION
.......................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................. 27
CLINICAL TRIALS
..................................................................................................
27
DETAILED PHARMACOLOGY
.............................................................................
38
TOXICOLOGY..........