FLUDARABINE PHOSPHATE INJECTION, USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

FLUDARABINE PHOSPHATE

Commercializzato da:

ACCORD HEALTHCARE INC

Codice ATC:

L01BB05

INN (Nome Internazionale):

FLUDARABINE

Dosaggio:

25MG

Forma farmaceutica:

SOLUTION

Composizione:

FLUDARABINE PHOSPHATE 25MG

Via di somministrazione:

INTRAVENOUS

Confezione:

2ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-03-11

Scheda tecnica

Page 1 of 55
PRODUCT MONOGRAPH
PR
FLUDARABINE PHOSPHATE INJECTION, USP
Fludarabine Phosphate
Sterile Solution
for Injection
25 mg/mL
(2 mL per vial)
USP
Antineoplastic
Accord Healthcare Inc.
3535 Boulevard St. Charles, Suite 704,
Kirkland, QC,
Canada, H9H 5B9
Date of Revision:
September 29, 2021
Submission
Control No: 253592
Page 2 of 55
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..................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND
ADMINISTRATION..............................................................................
13
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY............................................................
14
STORAGE AND
STABILITY..........................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
......................................................................
17
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 17
PART II: SCIENTIFIC INFORMATION
...........................................................................
18
PHARMACEUTICAL INFORMATION
........................................................................
18
CLINICAL
TRIALS............................................................