NU-RANIT TAB 150MG TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Dostupné s:

NU-PHARM INC

ATC kód:

A02BA02

INN (Mezinárodní Name):

RANITIDINE

Dávkování:

150MG

Léková forma:

TABLET

Složení:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Podání:

ORAL

Jednotky v balení:

100/500

Druh předpisu:

Prescription

Terapeutické oblasti:

HISTAMINE H2-ANTAGONISTS

Přehled produktů:

Active ingredient group (AIG) number: 0115150002; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2012-09-04

Charakteristika produktu

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