MOGADON TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

NITRAZEPAM

Dostupné s:

AA PHARMA INC

ATC kód:

N05CD02

INN (Mezinárodní Name):

NITRAZEPAM

Dávkování:

10MG

Léková forma:

TABLET

Složení:

NITRAZEPAM 10MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Targeted (CDSA IV)

Terapeutické oblasti:

BENZODIAZEPINES

Přehled produktů:

Active ingredient group (AIG) number: 0114345002; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2013-09-16

Charakteristika produktu

Page 1 of 27
PRODUCT MONOGRAPH
MOGADON
®
Nitrazepam Tablets BP
5 mg, 10 mg
Hypnotic and Anticonvulsant
AA PHARMA INC.
DATE OF REVISION:
1156 Creditstone Road, Unit#1
August 12, 2021
Vaughan, Ontario
L4K 4N7
Control No: 248565
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
...............................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
..............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................15
PART II: SCIENTIFIC INFORMATION
.........................................................................
16
PHARMACEUTICAL INFORMATION
.................