TAMIFLU ORAL SUSPENSION POWDER FOR SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-06-2012
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Active ingredient:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
Available from:
HOFFMANN-LA ROCHE LIMITED
ATC code:
J05AH02
INN (International Name):
OSELTAMIVIR
Dosage:
12MG
Pharmaceutical form:
POWDER FOR SUSPENSION
Composition:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 12MG
Administration route:
ORAL
Units in package:
75ML
Prescription type:
Prescription
Therapeutic area:
NEURAMINIDASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0139501002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2013-12-12
Summary of Product characteristics
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_Page 1 of 53_
PRODUCT MONOGRAPH
PR
TAMIFLU
®
oseltamivir capsule
30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate)
oseltamivir powder for oral suspension
6 mg/mL and 12 mg/mL oseltamivir (as oseltamivir phosphate) when
reconstituted
Antiviral Agent
Hoffmann-La Roche Limited
2455 Meadowpine Boulevard
Mississauga, Ontario
L5N 6L7
Date of Revision:
June 12, 2012
www.rochecanada.com
SUBMISSION CONTROL NO: 155227
Manufactured under license from Gilead Sciences Inc.
®
Trade-Mark of F. Hoffmann-La Roche AG, used under license
©
Copyright 1999-2012 by Hoffmann-La Roche Limited
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_Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
..................................................................
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