XIAFLEX POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Disponibil de la:

ENDO VENTURES LTD.

Codul ATC:

M09AB02

INN (nume internaţional):

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Dozare:

0.9MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 0.9MG

Calea de administrare:

INTRALESIONAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ENZYMES

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2020-06-11

Caracteristicilor produsului

_ _
_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
...............................................................