PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PEMETREXED (PEMETREXED DISODIUM)

Disponible depuis:

JAMP PHARMA CORPORATION

Code ATC:

L01BA04

DCI (Dénomination commune internationale):

PEMETREXED

Dosage:

100MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

PEMETREXED (PEMETREXED DISODIUM) 100MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2022-12-23

Résumé des caractéristiques du produit

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
Manufacturer’s Standard
Antineoplastic Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville,
Quebec
J4B 5H3, Canada
Date of Preparation:
December 22, 2022
Control Number:
250114
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
.............................................................................................
7
DRUG INTERACTIONS
.............................................................................................18
DOSAGE AND ADMINISTRATION
..........................................................................19
OVERDOSAGE
..........................................................................................................24
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
....................................