DESFERAL 2G POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DEFEROXAMINE MESYLATE

Dostopno od:

NOVARTIS PHARMACEUTICALS CANADA INC

Koda artikla:

V03AC01

INN (mednarodno ime):

DEFEROXAMINE

Odmerek:

2G

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

DEFEROXAMINE MESYLATE 2G

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

2G

Tip zastaranja:

Prescription

Terapevtsko območje:

HEAVY METAL ANTAGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0109208001; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2016-10-31

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
DESFERAL
®
(deferoxamine mesylate for injection, Novartis Std.)
Lyophilized powder
500 mg/vial and 2.0 g/vial
Iron and Aluminum Chelating Agent
Novartis Pharmaceuticals Canada Inc.
385 Bouchard blvd.
Dorval, QC, H9S 1A9
Date of Preparation:
December 20, 1972
Date of Revision:
October 2, 2015
Submission Control No: 182241
Pr_ _
DESFERAL
®
is a registered trademark
_ _
_ _
_Page 2 of 27_
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
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
DETAILED PHARMACOLOGY
.....................................................................