FLUDARABINE PHOSPHATE INJECTION LIQUID

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FLUDARABINE PHOSPHATE

Διαθέσιμο από:

OMEGA LABORATORIES LIMITED

Φαρμακολογική κατηγορία (ATC):

L01BB05

INN (Διεθνής Όνομα):

FLUDARABINE

Δοσολογία:

25MG

Φαρμακοτεχνική μορφή:

LIQUID

Σύνθεση:

FLUDARABINE PHOSPHATE 25MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

2ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-11-13

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
FLUDARABINE PHOSPHATE INJECTION
(25 mg/mL Fludarabine Phosphate)
Omega Standard
Antineoplastic Agent
Concentrate – Must be diluted before use
Omega Laboratories Ltd
11177 Hamon
Montréal, Québec
Canada
H3M 3E4
Date of Preparation:
November 6, 2013
Control Number: 147067
F
LUDARABINE
P
HOSPHATE
I
NJECTION
Product Monograph
Page 2 of 48
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
3
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
.................................................................................................
8
DRUG INTERACTIONS
...............................................................................................
10
DOSAGE AND ADMINISTRATION
...........................................................................
10
OVERDOSAGE
.............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 11
STORAGE AND STABILITY
.......................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
....................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 14
PART II: SCIENTIFIC INFORMATION
..........................................................................
15
PHARMACEUTICAL INFORMATION
.......................................................................
15
CLINICAL TRIALS
........................................................