MOGADON TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

NITRAZEPAM

Verfügbar ab:

AA PHARMA INC

ATC-Code:

N05CD02

INN (Internationale Bezeichnung):

NITRAZEPAM

Dosierung:

5MG

Darreichungsform:

TABLET

Zusammensetzung:

NITRAZEPAM 5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Targeted (CDSA IV)

Therapiebereich:

BENZODIAZEPINES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2013-09-16

Fachinformation

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