APO-CYCLOBENZAPRINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CYCLOBENZAPRINE HYDROCHLORIDE

Commercializzato da:

APOTEX INC

Codice ATC:

M03BX08

INN (Nome Internazionale):

CYCLOBENZAPRINE

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

CYCLOBENZAPRINE HYDROCHLORIDE 10MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0112363001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2021-06-17

Scheda tecnica

Page 1 of 19
PRODUCT MONOGRAPH
INCLUDING CONSUMER INFORMATION
PR APO-CYCLOBENZAPRINE
Cyclobenzaprine Hydrochloride Tablets USP
10 mg
SKELETAL MUSCLE RELAXANT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JUNE 16, 2021
TORONTO, ONTARIO
M9L 1T9
Submission Control No: 252375
Page 2 of 19
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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
.................................................................................................
6
DRUG INTERACTIONS
..................................................................................................
7
DOSAGE AND ADMINISTRATION
..................................................................................
7
OVERDOSAGE
.............................................................................................................
8
ACTIONS AND CLINICAL PHARMACOLOGY
.................................................................. 9
STORAGE AND STABILITY
...........................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 10
PART II: SCIENTIFIC INFORMATION
............................................................................
11
PHARMACEUTICAL INFORMATION
..............................................................................
11
CLINICAL TRIALS
......................................................................................................
112
DETAILED PHARMACOLOGY
........................................