PEMETREXED FOR INJECTION, USP POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PEMETREXED (PEMETREXED DISODIUM)

Disponibil de la:

DR REDDY'S LABORATORIES LTD

Codul ATC:

L01BA04

INN (nume internaţional):

PEMETREXED

Dozare:

100MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

PEMETREXED (PEMETREXED DISODIUM) 100MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

10ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-05-04

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
Pr
PEMETREXED FOR INJECTION, USP
100 mg or 500 mg pemetrexed (as pemetrexed disodium)
per vial
Sterile Lyophilized
Powder
Antineoplastic Agent
Manufactured by:
DATE OF INITIAL APPROVAL:
DR. REDDY’S LABORATORIES
LTD.,
April 12, 2017
Bachupally–500 090 India
Imported and Distributed by: DATE OF REVISION:
DR. REDDY’S LABORATORIES CANADA INC.,
May 3, 2022
Mississauga, ON L4W 4Y1 Canada
CONTROL NO: 259095
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFO R MATI ON ...................................................... 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
INFO R MATI ON ..........................................................................
29
PHARMACEUTICAL
INFORMATION
........