TAMIFLU

Riik: Indoneesia

keel: indoneesia

Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Toimeaine:

OSELTAMIVIR PHOSPHATE

Saadav alates:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Rahvusvaheline Nimetus):

OSELTAMIVIR PHOSPHATE

Annus:

98,5 MG

Ravimvorm:

KAPSUL

Ühikuid pakis:

DUS,1 BLISTER @ 10 KAPSUL

Valmistatud:

DELPHARM MILANO S.R.L - Italy

Loa andmise kuupäev:

2022-01-03

Toote omadused

Draft_Tamiflu_PI_MAT_CDS13.0_EN_v1
Page 1 of 15
Tamiflu
P
®
Oseltamivir
_______________________________________________________________________
Antiviral
1.
DESCRIPTION
1.1 Therapeutic/Pharmacologic Class of Drug
Tamiflu is an anti-viral agent
1.2 Type of Dosage Form
Capsule, hard
The hard 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.
1.3 Route of Administration
Oral
1.4 Sterile/Radioactive Statement
Not applicable
1.5 Qualitative and Quantitative Composition
Active ingredient: oseltamivir phosphate.
Capsules containing 98.5 mg oseltamivir phosphate equivalent to 75 mg
of oseltamivir.
2.
CLINICAL
PARTICULARS
2.1 Therapeutic Indication(s)
U
Treatment of influenza
U
in adults and children one year of age or 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 3.1 Pharmacodynamic
Properties).
U
Prevention of influenza

Post exposure prevention in adults and children one 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 adults
and children one years
of age or older.
U
Tamiflu is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza
should be determined on the
basis of official recommendations taking into consideration
variability of