APO-NITRAZEPAM TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NITRAZEPAM

Предлага се от:

APOTEX INC

АТС код:

N05CD02

INN (Международно Name):

NITRAZEPAM

дозиране:

5MG

Лекарствена форма:

TABLET

Композиция:

NITRAZEPAM 5MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Targeted (CDSA IV)

Терапевтична област:

BENZODIAZEPINES

Каталог на резюме:

Active ingredient group (AIG) number: 0114345001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2002-01-21

Данни за продукта

Page 1 of 27
PRODUCT MONOGRAPH
APO-NITRAZEPAM
Nitrazepam Tablets BP
5 mg and 10 mg
Hypnotic and Anticonvulsant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
DATE OF REVISION:
March 24, 2022
Control No: 256493
Page 2 of 27
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
.................................................................................................10
POST-MARKET ADVERSE REACTIONS
......................................................................10
DRUG INTERACTIONS
..................................................................................................11
SERIOUS DRUG INTERACTIONS
.................................................................................11
DOSAGE AND ADMINISTRATION
...............................................................................11
DOSING CONSIDERATIONS
.........................................................................................11
OVERDOSAGE
...............................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
..............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................15
PART II: SCIENTIFIC INFORMATION
.........................................................................
16
PHARMACEUTICAL INFORMATION
...........................