FLUDARABINE PHOSPHATE INJECTION, USP SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FLUDARABINE PHOSPHATE

Pieejams no:

ACCORD HEALTHCARE INC

ATĶ kods:

L01BB05

SNN (starptautisko nepatentēto nosaukumu):

FLUDARABINE

Deva:

25MG

Zāļu forma:

SOLUTION

Kompozīcija:

FLUDARABINE PHOSPHATE 25MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

2ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2015-03-11

Produkta apraksts

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............................................................