NU-RANIT TAB 300MG TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

제공처:

NU-PHARM INC

ATC 코드:

A02BA02

INN (International Name):

RANITIDINE

복용량:

300MG

약제 형태:

TABLET

구성:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

HISTAMINE H2-ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0115150001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2012-09-04

제품 특성 요약

Page 1 of 25
PRODUCT MONOGRAPH
PR
NU-RANIT
RANITIDINE TABLETS USP
150 MG AND 300 MG RANITIDINE (AS RANITIDINE HYDROCHLORIDE)
HISTAMINE H
2
- RECEPTOR ANTAGONIST
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
JANUARY 27, 2009
Richmond Hill, Ontario
L4B 1E4
_ _
Control # 127275
Page 2 of 25
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
.........................................................................................................
5
DRUG
INTERACTIONS..........................................................................................................
6
DOSAGE AND ADMINISTRATION
.....................................................................................
7
OVERDOSAGE........................................................................................................................
8
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
9
STORAGE AND STABILITY
...............................................................................................
11
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................... 11
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL INFORMATION
...............................................................................
12
CLINICAL
TRIALS............................................................................................................