GEMCITABINE FOR INJECTION, USP POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Pieejams no:

HOSPIRA HEALTHCARE ULC

ATĶ kods:

L01BC05

SNN (starptautisko nepatentēto nosaukumu):

GEMCITABINE

Deva:

2G

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2G

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

100ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0133122004; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2018-08-01

Produkta apraksts

_Gemcitabine for Injection, USP Product Monograph _
_Page 1 of 55_
PRODUCT MONOGRAPH
PR
GEMCITABINE FOR INJECTION, USP
200 mg, 1 g and 2 g gemcitabine (gemcitabine hydrochloride) per vial
Sterile
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
Hospira Healthcare Corporation
1111 Dr.-Frederik-Philips, Suite 600
Montreal, QC
H4M 2X6
Date of Revision: August 29, 2014
Control No: 177248
_ _
_Gemcitabine for Injection, USP 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
..............................................................................21
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
..................