PROCYTOX POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CYCLOPHOSPHAMIDE

Tersedia dari:

BAXTER CORPORATION

Kode ATC:

L01AA01

INN (Nama Internasional):

CYCLOPHOSPHAMIDE

Dosis:

2000MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

CYCLOPHOSPHAMIDE 2000MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100ML

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2002-02-04

Karakteristik produk

_ _
_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.
_ _
_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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