GEMCITABINE FOR INJECTION CONCENTRATE 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:

100MG

Farmacevtska oblika:

SOLUTION

Sestava:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 100MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

2/10/15/20ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0133122006; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2017-08-07

Lastnosti izdelka

_ Gemcitabine for Injection Concentrate - Product Monograph _
_Page 1 of 54 _
PRODUCT MONOGRAPH
PR
GEMCITABINE FOR INJECTION CONCENTRATE
SOLUTION FOR INTRAVENOUS INFUSION
DILUTE BEFORE USE
100 mg/mL gemcitabine (as gemcitabine hydrochloride)
House Std.
Antineoplastic Agent
Accord Healthcare Inc.
3535 Boul. St. Charles Suite 704
Kirkland, Quebec H9H 5B9
Canada
DATE OF REVISION:
4 April 2014
SUBMISSION CONTROL NO: 160458
_ Gemcitabine for Injection Concentrate - Product Monograph _
_Page 2 of 54 _
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
INTERACTIONS…………..…………………………………………….………22
DOSAGE AND
ADMINISTRATION…………………………………………………...22
OVERDOSAGE……………………………………………………………….…………25
ACTION AND CLINICAL
PHARMACOLOGY…………………………….…………25
STORAGE AND
STABILITY…………………………………………………….…….27
DOSAGE FORMS, COMPOSITION AND
PACKAGING…………………………….27
PART II: SCIENTIFIC
INFORMATION……………..……………………………. 28
PHARMACEUTICAL
INFORMATION……………………………………………….28
CLINICAL
TRIALS………….…………………………………………………………29
DETAILED
PHARMACOLOGY……………………………………………...……….40
TOXICOLOGY…………………………………………………………...…………….41
REFERENCES……�