TAMIFLU ORAL SUSPENSION POWDER FOR SUSPENSION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Osta kohe

Toote omadused Toote omadused (SPC)
21-06-2012

Toimeaine:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Saadav alates:

HOFFMANN-LA ROCHE LIMITED

ATC kood:

J05AH02

INN (Rahvusvaheline Nimetus):

OSELTAMIVIR

Annus:

12MG

Ravimvorm:

POWDER FOR SUSPENSION

Koostis:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 12MG

Manustamisviis:

ORAL

Ühikuid pakis:

75ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

NEURAMINIDASE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2013-12-12

Toote omadused

                                _ _
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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
_ _
_ _
_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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