TAMIFLU ORAL SUSPENSION POWDER FOR SUSPENSION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Commercializzato da:

HOFFMANN-LA ROCHE LIMITED

Codice ATC:

J05AH02

INN (Nome Internazionale):

OSELTAMIVIR

Dosaggio:

12MG

Forma farmaceutica:

POWDER FOR SUSPENSION

Composizione:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 12MG

Via di somministrazione:

ORAL

Confezione:

75ML

Tipo di ricetta:

Prescription

Area terapeutica:

NEURAMINIDASE INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0139501002; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2013-12-12

Scheda tecnica

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