Tamiflu
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
24-03-2023
Charakterystyka produktu
(SPC)
24-03-2023
Sprawozdanie z oceny publicznego
(PAR)
07-02-2019
Składnik aktywny:
oseltamivir
Dostępny od:
Roche Registration GmbH
Kod ATC:
J05AH02
INN (International Nazwa):
oseltamivir
Grupa terapeutyczna:
Antivirals for systemic use
Dziedzina terapeutyczna:
Influenza, Human
Wskazania:
Treatment of influenzaTamiflu 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 influenzaPost-exposure prevention in individuals 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 individuals one year of age or older.Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak.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. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.
Podsumowanie produktu:
Revision: 42
Status autoryzacji:
Authorised
Data autoryzacji:
2002-06-20
Ulotka dla pacjenta
65
B. PACKAGE LEAFLET
66
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMIFLU 30 MG HARD CAPSULES
oseltamivir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT TAMIFLU IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMIFLU
3.
HOW TO TAKE TAMIFLU
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TAMIFLU
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TAMIFLU IS AND WHAT IT IS USED FOR
•
Tamiflu is used for adults, adolescents, children and infants
(including full-term newborn
babies) for
TREATING FLU
(
_influenza_
). It can be used when you have flu symptoms, and the flu
virus is known to be going round in your community.
•
Tamiflu can also be prescribed for adults, adolescents, children and
infants above 1 year of age
for
PREVENTING FLU,
on a
case-by-case basis – for instance, if you have been in contact with
someone who has flu.
•
Tamiflu may be prescribed for adults, adolescents, children and infant
(including full-term
newborn babies) as
PREVENTIVE TREATMENT
in exceptional circumstances – for example, if there
is a global epidemic of flu (a flu
_pandemic_
) and the seasonal flu vaccine may not provide
sufficient protection.
Tamiflu contains
_oseltamivir_
, which belongs to a group of medicines named
_neuraminidase inhibitors_
.
These medicines prevent the flu virus from spreading inside the body.
They help to ease or prevent the
symptoms of the flu virus infection.
Influenza, usually called flu, is an infection caused by a virus. The
signs of flu often includ
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
situa
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