Tamiflu 75mg capsules hard

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

oseltamivir (oseltamivir phosphate)

متاح من:

F. Hoffmann La Roche Ltd.

ATC رمز:

J05AH02

INN (الاسم الدولي):

oseltamivir (oseltamivir phosphate)

جرعة:

75mg

الشكل الصيدلاني:

capsules hard

الوحدات في الحزمة:

(10/1x10/) blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2015-03-25

نشرة المعلومات

TAMIFLU
®
Oseltamivir
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Tamiflu 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)
Tamiflu is indicated for the treatment of influenza 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).
Tamiflu is indicated for the prophylaxis of influenza in adults and
children ≥1 year of age.
2.2
DOSAGE AND ADMINISTRATION
Tamiflu may be taken with or without food (see section 3.2
Pharmacokinetic Properties). However, Tamiflu taken with food
may enhance tolerability in some
patients.
During situations when commercially
manufactured Tamiflu oral suspension
is not readily available, adults,
adole

خصائص المنتج

1
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Tamiflu 30 mg hard capsules
Tamiflu 45 mg hard capsules
Tamiflu 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Tamiflu 30 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg
of oseltamivir.
For the full list of excipients, see section 6.1.
Tamiflu 45 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg
of oseltamivir.
For the full list of excipients, see section 6.1.
Tamiflu 75 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg
of oseltamivir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tamiflu 30 mg hard capsules
The hard capsule consists of a light yellow opaque body bearing the
imprint “ROCHE” and a light
yellow opaque cap bearing the imprint “30 mg”. Imprints are blue.
Tamiflu 45 mg hard capsules
The hard capsule consists of a grey opaque body bearing the imprint
“ROCHE” and a grey opaque cap
bearing the imprint “45 mg”. Imprints are blue.
Tamiflu 75 mg hard capsules
The hard capsule consists of a grey opaque body bearing the imprint
“ROCHE” and a light yellow
opaque cap bearing the imprint “75 mg”. Imprints are blue.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of influenza_
Tamiflu is indicated in adults and children including full term
neonates 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.
_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
2
situations (e.g. in case of a mismatch between t