Tamiflu powder for oral suspension

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

oseltamivir (oseltamivir phosphate)

Dostupné s:

F. Hoffmann-La Roche Ltd.

ATC kód:

J05AH02

INN (Mezinárodní Name):

oseltamivir (oseltamivir phosphate)

Dávkování:

6mg/ml

Léková forma:

powder for oral suspension

Jednotky v balení:

(1) glass bottle, plastic bottle adaptor, plastic measuring cup 55ml and oral dispenser

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2016-06-22

Informace pro uživatele

TAMIFL U
®
Oseltamivir
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Tamifl u is an antiviral agent.
1.2
TYPE OF DOSAGE FORM
Hard capsule.
30 mg capsule consisting of a light yellow opaque body bearing
the imprint “ROCHE” and a light yellow opaque cap bearing the
imprint “30 mg”. Imprints are blue.
45 mg capsule consisting of a grey opaque body bearing the
imprint “ROCHE” and a grey opaque cap bearing the imprint
“45 mg”. Imprints are blue.
75 mg capsule consisting of a grey opaque body bearing the
imprint “ROCHE” and a light yellow opaque cap bearing the
imprint “75 mg”. Imprints are blue.
Powder for oral suspension.
The powder is a granulate or clumped granulate with a white to
light yellow color.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
oseltamivir phosphate.
30 mg capsules, containing 39.4 mg oseltamivir phosphate
equivalent to 30 mg of oseltamivir.
45 mg capsules, containing 59.1 mg oseltamivir phosphate
equivalent to 45 mg of oseltamivir.
75 mg capsules, containing 98.5 mg oseltamivir phosphate
equivalent to 75 mg of oseltamivir.
Powder for oral suspension, which when constituted with water to
a concentration of 0.6% contains 6 mg/ml oseltamivir.
LIST OF EXCIPIENTS
Contains sorbitol and sodium benzoate.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Tamifl u is indicated for the treatment of infl uenza in adults and
children, including full-term neonates (see sections 2.2.1 Special
Dosage Instructions, 2.4 Warnings and Precautions, and
3.3 Preclinical Safety).
Tamifl u is indicated for the prophylaxis of infl uenza in adults and
children ≥1 year of age.
2.2
DOSAGE AND ADMINISTRATION
Tamifl u may be taken with or without food (see section
3.2 Pharmacokinetic Properties). However, Tamifl u taken with
food may enhance tolerability in some patients.
During situations when commercially
manufactured Tamifl u oral suspension
is not readily available, adults

Charakteristika produktu

1.
NAME OF THE MEDICINAL PRODUCT
Tamiflu 6 mg/ml powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each ml of reconstituted suspension contains 6 mg oseltamivir.
One bottle of reconstituted suspension (65 ml) contains 390 mg of
oseltamivir.
Excipients with known effect:
5 ml oseltamivir suspension delivers 0.9 g of sorbitol.
7.5 ml oseltamivir suspension delivers 1.3 g of sorbitol.
10 ml oseltamivir suspension delivers 1.7 g of sorbitol.
12.5 ml oseltamivir suspension delivers 2.1 g of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension
The powder is a granulate or clumped granulate with a white to light
yellow colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_Treatment of influenza_
In patients one year of age and older who present with symptoms
typical of influenza, when influenza
virus is circulating in the community. Efficacy has been demonstrated
when treatment is initiated
within two days of first onset of symptoms. This indication is based
on clinical studies of naturally
occurring influenza in which the predominant infection was influenza A
(see section 5.1).
Tamiflu is indicated for the treatment of infants less than 1 year of
age during a pandemic influenza
outbreak (see section 5.2).
The treating physician should take into account the pathogenicity of
the circulating strain and the
underlying condition of the patient to ensure there is a potential
benefit to the child.
_Prevention of influenza_
-
Post-exposure prevention in individuals 1 year of age or older
following contact with a
clinically diagnosed influenza case when influenza virus is
circulating in the community.
-
The appropriate use of Tamiflu for prevention of influenza should be
determined on a case by
case basis by the circumstances and the population requiring
protection. In exceptional
situations (e.g. in case of a mismatch between the circulating and
vaccine virus strains, and a
pandemic situation) seasonal prevention could be considered in