RIVA AZITHROMYCIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-03-2015
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Active ingredient:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE)
Available from:
LABORATOIRE RIVA INC.
ATC code:
J01FA10
INN (International Name):
AZITHROMYCIN
Dosage:
600MG
Pharmaceutical form:
TABLET
Composition:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) 600MG
Administration route:
ORAL
Units in package:
6
Prescription type:
Prescription
Therapeutic area:
OTHER MACROLIDES
Product summary:
Active ingredient group (AIG) number: 0126072005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2013-07-31
Summary of Product characteristics
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_RIVA-Azithromycin _
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PRODUCT MONOGRAPH
Pr
RIVA-AZITHROMYCIN
Azithromycin Tablets USP
250 mg and 600 mg
Antibiotic
LABORATOIRE RIVA INC.
660 Industriel blvd.
Blainville, Quebec, Canada.
J7C 3V4
www.labriva.com
Control No. 182319
Date of Revision:
March 17, 2015
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_RIVA-Azithromycin _
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_Page 2 of 56 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
..........................................................................................................
15
DOSAGE AND ADMINISTRATION
......................................................................................
19
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
...................................................
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