GEMCITABINE SUN FOR INJECTION POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Dostopno od:

TARO PHARMACEUTICALS INC

Koda artikla:

L01BC05

INN (mednarodno ime):

GEMCITABINE

Odmerek:

1G

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G

Pot uporabe:

INTRAVENOUS

Enote v paketu:

50ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-09-13

Lastnosti izdelka

Gemcitabine SUN for Injection Product Monograph
Page 1 of 55
PRODUCT MONOGRAPH
PR
GEMCITABINE SUN FOR INJECTION
Gemcitabine for Injection, Manufacturer’s Standard
200 mg and 1 g gemcitabine (as gemcitabine hydrochloride) per vial
Sterile lyophilized powder
For intravenous use only
Antineoplastic Agent
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
October 26, 2021
Brampton, Ontario
L6T 1C1
Control No: 252769
Gemcitabine SUN for Injection Product Monograph
Page 2 of 55 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
................................................................28
PHARMACEUTICAL INFORMATION
.........................................................28
CLINICAL TRIALS
.......................................................................................28
DETAILED PHARMACOLOGY
.......................................