NOVO-AZITHROMYCIN PEDIATRIC POWDER FOR SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-10-2016
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Active ingredient:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)
Available from:
TEVA CANADA LIMITED
ATC code:
J01FA10
INN (International Name):
AZITHROMYCIN
Dosage:
200MG
Pharmaceutical form:
POWDER FOR SUSPENSION
Composition:
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 200MG
Administration route:
ORAL
Units in package:
15/22.5ML
Prescription type:
Prescription
Therapeutic area:
OTHER MACROLIDES
Product summary:
Active ingredient group (AIG) number: 0126072003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-11-28
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
NOVO-AZITHROMYCIN
Azithromycin Tablets 250 mg
Azithromycin (as Azithromycin monohydrate hemiethanolate)
PR
NOVO-AZITHROMYCIN PEDIATRIC
Azithromycin Powder for Oral Suspension
100 mg*/5 mL and 200 mg*/ 5mL
*
Azithromycin (as Azithromycin monohydrate hemiethanolate)
ANTIBIOTIC
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No: 198791
Date of Revision:
October 07, 2016
_Novo-Azithromycin Product Monograph _
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_Page 2 _
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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
..............................................................................................
10
DRUG
INTERACTIONS...............................................................................................
16
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 25
STORAGE AND
STABILITY.......................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
.............................................................................
30
PHARMACEUTICAL INFORMATION
.......................................................................
30
CLINICAL TRIALS
.........................................
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