PROCYTOX POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CYCLOPHOSPHAMIDE

Διαθέσιμο από:

BAXTER CORPORATION

Φαρμακολογική κατηγορία (ATC):

L01AA01

INN (Διεθνής Όνομα):

CYCLOPHOSPHAMIDE

Δοσολογία:

2000MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

CYCLOPHOSPHAMIDE 2000MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2002-02-04

Αρχείο Π.Χ.Π.

_ _
_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
P