TAMIFLU 75 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

OSELTAMIVIR AS PHOSPHATE

可用日期:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC代码:

J05AH02

药物剂型:

CAPSULES

组成:

OSELTAMIVIR AS PHOSPHATE 75 MG

给药途径:

PER OS

处方类型:

Required

厂商:

HOFFMANN LA ROCHE LTD, SWITZERLAND

治疗组:

OSELTAMIVIR

治疗领域:

OSELTAMIVIR

疗效迹象:

- Treatment of uncomplicated acute illness due to influenza infection in adults patients and patients who weigh more than 40 kg who have been symptomatic for no more than 2 days. - Post exposure prevention in adults and patients who weight more the 40 kg 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 patients and patients who weigh more than 40 kg.

授权日期:

2010-05-31

资料单张

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

产品特点

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