PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PEMETREXED (PEMETREXED DISODIUM)

Pieejams no:

JAMP PHARMA CORPORATION

ATĶ kods:

L01BA04

SNN (starptautisko nepatentēto nosaukumu):

PEMETREXED

Deva:

100MG

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

PEMETREXED (PEMETREXED DISODIUM) 100MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

100

Receptes veids:

Prescription

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2022-12-23

Produkta apraksts

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
....................................