PROCYTOX POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CYCLOPHOSPHAMIDE

Disponibil de la:

BAXTER CORPORATION

Codul ATC:

L01AA01

INN (nume internaţional):

CYCLOPHOSPHAMIDE

Dozare:

2000MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

CYCLOPHOSPHAMIDE 2000MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0107630004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2002-02-04

Caracteristicilor produsului

_ _
_PROCYTOX (Cyclophosphamide) _
_Page 1 of 65_
PRODUCT MONOGRAPH
Pr
PROCYTOX
Cyclophosphamide Tablets USP:
25 mg, 50 mg
Cyclophosphamide for injection:
200 mg, 500 mg, 1000 mg, 2000 mg (powder for injection) per vial
ANTINEOPLASTIC AGENT
Baxter Corporation
Mississauga, Ontario, L5N OC2
Date of Revision:
September 7, 2012
SUBMISSION CONTROL NO: 155509
Baxter and PROCYTOX are trademarks of Baxter International Inc., its
subsidiaries or affiliates.
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_PROCYTOX (Cyclophosphamide) _
_Page 2 of 65_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................43
ACTION AND CLINICAL PHARMACOLOGY
............................................................44
STORAGE AND STABILITY
..........................................................................................46
SPECIAL HANDLING INSTRUCTIONS
.......................................................................47
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................48
PART II: SCIENTIFIC INFORMATION
...............................................................................50
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