TAMIFLU ORAL SUSPENSION POWDER FOR SUSPENSION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Boleh didapati daripada:

HOFFMANN-LA ROCHE LIMITED

Kod ATC:

J05AH02

INN (Nama Antarabangsa):

OSELTAMIVIR

Dos:

12MG

Borang farmaseutikal:

POWDER FOR SUSPENSION

Komposisi:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 12MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

75ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

NEURAMINIDASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2013-12-12

Ciri produk

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