RANITIDINE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Mevcut itibaren:

PRO DOC LIMITEE

ATC kodu:

A02BA02

INN (International Adı):

RANITIDINE

Doz:

300MG

Farmasötik formu:

TABLET

Kompozisyon:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/30

Reçete türü:

Prescription

Terapötik alanı:

HISTAMINE H2-ANTAGONISTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2023-07-10

Ürün özellikleri

_ _
RANITIDINE_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR RANITIDINE
Ranitidine Tablets, USP
150 mg & 300 mg ranitidine (as ranitidine hydrochloride)
Histamine H
2
-receptor antagonist
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
September 18, 2019
Submission Control No: 229390
RANITIDINE_ _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
................................................................................13
PHARMACEUTICAL INFORMATION
..........................................................................13
CLINICAL TRIALS
..........................................................................................................14
DETAILED PHARMACOLOGY
................