APO-RANITIDINE SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-04-2019
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Active ingredient:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Available from:
APOTEX INC
ATC code:
A02BA02
INN (International Name):
RANITIDINE
Dosage:
75MG
Pharmaceutical form:
SOLUTION
Composition:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 75MG
Administration route:
ORAL
Units in package:
300ML
Prescription type:
Prescription
Therapeutic area:
HISTAMINE H2-ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0115150005; AHFS:
Authorization status:
APPROVED
Authorization date:
2006-06-01
Summary of Product characteristics
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_Page 1 of 25_
PRODUCT MONOGRAPH
PR
APO-RANITIDINE
RANITIDINE ORAL SOLUTION USP
(RANITIDINE AS RANITIDINE HYDROCHLORIDE)
15 MG/ML
HISTAMINE H
2
- RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
APRIL 30, 2019
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NUMBER 225930
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_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
..................................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
9
STORAGE AND STABILITY
..........................................................................................................
11
DOSAGE FORM, COMPOSITION AND PACKAGING
............................................................... 11
PART II: SCIEN
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