PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PEMETREXED (PEMETREXED DISODIUM)

זמין מ:

JAMP PHARMA CORPORATION

קוד ATC:

L01BA04

INN (שם בינלאומי):

PEMETREXED

כמות:

100MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

PEMETREXED (PEMETREXED DISODIUM) 100MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

100

סוג מרשם:

Prescription

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2022-12-23

מאפייני מוצר

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