MOGADON TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

NITRAZEPAM

제공처:

AA PHARMA INC

ATC 코드:

N05CD02

INN (국제 이름):

NITRAZEPAM

복용량:

5MG

약제 형태:

TABLET

구성:

NITRAZEPAM 5MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Targeted (CDSA IV)

치료 영역:

BENZODIAZEPINES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2013-09-16

제품 특성 요약

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