XIAFLEX POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Boleh didapati daripada:

ENDO VENTURES LTD.

Kod ATC:

M09AB02

INN (Nama Antarabangsa):

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Dos:

0.9MG

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 0.9MG

Laluan pentadbiran:

INTRALESIONAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ENZYMES

Ringkasan produk:

Active ingredient group (AIG) number: 0153188001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2020-06-11

Ciri produk

_ _
_XIAFLEX_
_®_
_ Product Monograph _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XIAFLEX
®
(collagenase _clostridium histolyticum_)
Lyophilized powder for solution
0.9 mg/vial
Collagenase _clostridium histolyticum_
XIAFLEX SHOULD BE ADMINISTERED BY A HEALTH PROFESSIONAL:

EXPERIENCED IN INJECTION PROCEDURES OF THE HAND AND IN THE TREATMENT
OF PATIENTS
WITH DUPUYTREN’S CONTRACTURE, OR

APPROPRIATELY TRAINED IN THE CORRECT ADMINISTRATION OF THE MEDICINAL
PRODUCT AND
EXPERIENCED IN THE DIAGNOSIS AND TREATMENT OF MALE UROLOGICAL
DISEASES.
Endo Ventures Ltd.
First Floor, Minerva House,
Simmonscourt Road, Ballsbridge,
Dublin 4, Ireland
Distributor :
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
Montreal, H4M 2P2
Quebec, Canada
Date of Revision:
May 30, 2019
Version 4.0
Submission Control No: 225120
Date of Approval: June 6, 2019
_ _
_XIAFLEX_
_®_
_ Product Monograph _
_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................