MYLAN-TIZANIDINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

TIZANIDINE (TIZANIDINE HYDROCHLORIDE)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

M03BX02

DCI (Dénomination commune internationale):

TIZANIDINE

Dosage:

4MG

forme pharmaceutique:

TABLET

Composition:

TIZANIDINE (TIZANIDINE HYDROCHLORIDE) 4MG

Mode d'administration:

ORAL

Unités en paquet:

150

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Descriptif du produit:

Active ingredient group (AIG) number: 0135342001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2017-01-09

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
MYLAN-TIZANIDINE
TIZANIDINE HYDROCHLORIDE TABLETS
4 MG
ANTISPASTIC AGENT
Mylan Pharmaceuticals ULC
DATE OF REVISION
85 Advance Road,
April 19, 2013
Etobicoke, ON
M8Z 2S6
Control number: 161061
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
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 18
PART II: SCIENTIFIC INFORMATION
....................................................................................
19
PHARMACEUTICAL INFORMATION
.................................................................................
19
CLINICAL TRIALS
.................................................................................................................
20
DETAILED PHARMACOLOGY
..........................