GEMCITABINE FOR INJECTION POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Dostopno od:

ACCORD HEALTHCARE INC

Koda artikla:

L01BC05

INN (mednarodno ime):

GEMCITABINE

Odmerek:

200MG

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0133122001; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2020-01-17

Lastnosti izdelka

Gemcitabine for Injection Product Monograph
Page 1 of 53
PRODUCT MONOGRAPH
PR
GEMCITABINE FOR INJECTION
200 mg, 1 g and 2 g gemcitabine (as gemcitabine hydrochloride) per
vial
House Std.
Antineoplastic Agent
Accord Healthcare Inc.
3535 Boul. St. Charles
Suite 704
Kirkland, QC
H9H5B9
Canada
DATE OF REVISION:
September 29, 2014
SUBMISSION CONTROL NO: 178090
Gemcitabine for Injection Product Monograph
Page 2 of 53
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…………….………………………………………………..7
DRUG
INTERACTION………………………………………………………………19
DOSAGE AND
ADMINISTRATION………………………………………………..20
OVERDOSAGE………………………………………………………………………23
ACTION AND CLINICAL
PHARMACOLOGY……………………………………23
STORAGE AND
STABILITY………………………………………………….…….25
DOSAGE FORMS, COMPOSITION AND
PACKAGING………………………….25
PART II: SCIENTIFIC
INFORMATION………………………………………………. 26
PHARMACEUTICAL
INFORMATION…………………………………………….26
CLINICAL
TRIAL……………………………………………………………………27
DETAILED
PHARMACOLOGY…………………………………………………….38
TOXICOLOGY……………………………………………………………………….39
REFERENCES………………………………………………………………………..44
PART II