GEMCITABINE FOR INJECTION, USP POWDER

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Disponible depuis:

DR REDDY'S LABORATORIES LTD

Code ATC:

L01BC05

DCI (Dénomination commune internationale):

GEMCITABINE

Dosage:

1G

forme pharmaceutique:

POWDER

Composition:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G

Mode d'administration:

INTRAVENOUS

Unités en paquet:

50ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0133122003; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2022-07-13

Résumé des caractéristiques du produit

1
PRODUCT MONOGRAPH
PR
GEMCITABINE FOR INJECTION, USP
200 mg, 1 g or 2 g gemcitabine (as gemcitabine hydrochloride) per vial
Sterile lyophilized
powder
Antineoplastic Agent
Manufactured by:
DR. REDDY’S LABORATORIES LTD.
Bachupally–500 090 India
Imported and Distributed by:
DR. REDDY'S LABORATORIES CANADA INC.
Mississauga, Ontario L4W 4Y1 Canada
DATE OF PREPARATION:
February 6, 2015
DATE OF REVISION:
June 14, 2022
SUBMISSION CONTROL NO. 260011
2
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
...........................................................................................21
DOSAGE AND
ADMINISTRATION........................................................................22
OVERDOSAGE
..........................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
......................................................25
STORAGE AND
STABILITY...................................................................................
27
SPECIAL HANDLING
INSTRUCTIONS................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................27
PART II: SCIENTIFIC INFORMATION
........................................................................
29
PHARMACEUTICAL
INFORMATION..............................................................
29
CLINICAL
TRIALS............................................