PROCYTOX TAB 50MG TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CYCLOPHOSPHAMIDE

Dostępny od:

BAXTER CORPORATION

Kod ATC:

L01AA01

INN (International Nazwa):

CYCLOPHOSPHAMIDE

Dawkowanie:

50MG

Forma farmaceutyczna:

TABLET

Skład:

CYCLOPHOSPHAMIDE 50MG

Droga podania:

ORAL

Sztuk w opakowaniu:

50/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0107630001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2002-02-04

Charakterystyka produktu

_ _
_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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