TAMIFLU 45 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

OSELTAMIVIR AS PHOSPHATE

Disponibil de la:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Codul ATC:

J05AH02

Forma farmaceutică:

CAPSULES

Compoziție:

OSELTAMIVIR AS PHOSPHATE 45 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Grupul Terapeutică:

OSELTAMIVIR

Zonă Terapeutică:

OSELTAMIVIR

Indicații terapeutice:

Treatment of influenza : Treatment of uncomplicated acute illness due to influenza infection in adults and children 1 year of age or older who have been symptomatic for no more than 2 days. Prophylaxis of influenza : Post exposure prevention in adults and children 1 year of age or older patients 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 1 year of age or older.

Data de autorizare:

2020-12-31

Prospect

Tamiflu PL Ver 3
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
(This medicine is dispensed with
a doctor’s prescription only)
TAMIFLU
TAMIFLU
TAMIFLU
30 MG
45 MG
75 MG
capsules
capsules
capsules
Each capsule
contains:
Each capsule
contains:
Each capsule
contains:
OSELTAMIVIR 30 MG
OSELTAMIVIR 45 MG OSELTAMIVIR 75 MG
* For information on inactive ingredients, see section 2
“Before using the medicine” and section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE. This leaflet contains concise information
about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do
not pass it on to others. It may harm them, even if it seems
to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Tamiflu is intended for the treatment of influenza in adults
and children 1 year of age or older, who have presented
influenza symptoms for no more than two days.
Tamiflu is intended to prevent influenza in adults and
children 1 year of age or older.
Tamiflu 75 mg capsules are intended for adults and
children weighing more than 40 kg only.
Tamiflu 30 mg and 45 mg capsules are intended for adults
and children one year of age and older.
THERAPEUTIC GROUP:
Tamiflu
contains
the
active
ingredient,
oseltamivir,
and belongs to a group of antiviral medicines named
“neuraminidase inhibitors”. These medicines prevent the
flu virus from spreading inside the body and help ease or
prevent symptoms of the flu virus infection.
Influenza is an infection caused by a virus. The signs of the
flu generally include a sudden fever (more than 37.8°C),
cough, runny or stuffy nose, headaches, muscle aches and
extreme tiredness. These symptoms can also be caused
by other infections. True influenza infection only occurs
during
annual
outbreaks
(epidemics)
when
flu
viruses
spread in the local community. When there is no outbreak
of in

Caracteristicilor produsului

1
Tamiflu PI version 2
TAMIFLU
®
r
Oseltamivir
CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
Tamiflu 30 mg
Tamiflu 45 mg
Tamiflu 75 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tamiflu 30 mg hard capsules
Each hard capsule contains oseltamivir (as 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 (as 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 (as 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
Tamiflu capsules
75 MG
is indicated for adults patients and patients who weight > 40 kg body
weight.
Tamiflu capsules
30 MG AND 45 MG
are indicated for adults and children 1 year of age or older.
_Treatment of influenza_
The treatment of uncomplicated acute illness due to influenza
infection in adults and children 1 year of age or
older who have been symptomatic for no more than 2 days.
2
_Prophylaxis of influenza_
-
Post-exposure prevention in adults and children 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 t