ACT PEMETREXED POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

PEMETREXED (PEMETREXED DISODIUM)

Disponibbli minn:

ACTAVIS PHARMA COMPANY

Kodiċi ATC:

L01BA04

INN (Isem Internazzjonali):

PEMETREXED

Dożaġġ:

1000MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

PEMETREXED (PEMETREXED DISODIUM) 1000MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0150104003; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2018-07-24

Karatteristiċi tal-prodott

_ACT Pemetrexed (pemetrexed disodium for injection) 100 mg/vial, 500
mg/vial and 1000 mg/vial _
_Page 1 of 62_
PRODUCT MONOGRAPH
PR
ACT PEMETREXED
(pemetrexed disodium for injection)
100 mg, 500 mg, 1000 mg
pemetrexed per
vial
Antineoplastic Agent
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Preparation:
July 22, 2014
Submission Control No: 169453
_ACT Pemetrexed (pemetrexed disodium for injection) 100 mg/vial, 500
mg/vial and 1000 mg/vial _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRADICTIONS
..........................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTION
....................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS COMPOSITION AND PACKAGING
..............................................28
PART II: SCIENTIFIC INFORMATION
.......................................................................