PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Inapatikana kutoka:

ACCORD HEALTHCARE INC

ATC kanuni:

L01BA04

INN (Jina la Kimataifa):

PEMETREXED

Kipimo:

100MG

Dawa fomu:

POWDER FOR SOLUTION

Tungo:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

10ML

Dawa ya aina:

Prescription

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0150104002; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2016-05-20

Tabia za bidhaa

_Pemetrexed disodium for Injection - Product Monograph _
_Page 1 of 61_
PRODUCT MONOGRAPH
PR
PEMETREXED DISODIUM FOR INJECTION
100 mg or 500 mg pemetrexed per vial (as Pemetrexed Disodium
hemipentahydrate)
Antineoplastic Agent
Accord Healthcare Inc.
3535 Boul St. Charles, Suite 704, Kirkland, QC,
H9H 5B9, Canada
Date of Preparation:
March 12, 2015
Submission Control No: 176618
_Pemetrexed disodium for Injection - Product Monograph _
_Page 2 of 61_
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
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................19
PREPARATION AND ADMINISTRATION PRECAUTIONS:
.....................................23
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
................................................