MOGADON TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

NITRAZEPAM

Dostupno od:

AA PHARMA INC

ATC koda:

N05CD02

INN (International ime):

NITRAZEPAM

Doziranje:

5MG

Farmaceutski oblik:

TABLET

Sastav:

NITRAZEPAM 5MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Targeted (CDSA IV)

Područje terapije:

BENZODIAZEPINES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2013-09-16

Svojstava lijeka

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
.................