APO-CYCLOBENZAPRINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

CYCLOBENZAPRINE HYDROCHLORIDE

Предлага се от:

APOTEX INC

АТС код:

M03BX08

INN (Международно Name):

CYCLOBENZAPRINE

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

CYCLOBENZAPRINE HYDROCHLORIDE 10MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2021-06-17

Данни за продукта

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