FLUDARABINE PHOSPHATE INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FLUDARABINE PHOSPHATE

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

L01BB05

DCI (Dénomination commune internationale):

FLUDARABINE

Dosage:

25MG

forme pharmaceutique:

SOLUTION

Composition:

FLUDARABINE PHOSPHATE 25MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

2ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0123842003; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2022-02-28

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
Pr
FLUDARABINE PHOSPHATE INJECTION
Mylan Standard
(Fludarabine Phosphate)
25 mg/mL
(2 mL per vial)
Antineoplastic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
June 24, 2014
Submission Control No: 174683
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..................................................................................................