Ebilfumin
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
01-06-2023
Valmisteyhteenveto
(SPC)
01-06-2023
Julkisesta arviointikertomuksesta
(PAR)
27-05-2019
Aktiivinen ainesosa:
oseltamivir
Saatavilla:
Actavis Group PTC ehf
ATC-koodi:
J05AH02
INN (Kansainvälinen yleisnimi):
oseltamivir
Terapeuttinen ryhmä:
Antivirals for systemic use, Neuraminidase inhibitors
Terapeuttinen alue:
Influenza, Human
Käyttöaiheet:
Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community.Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.Prevention of influenzaPost-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 Ebilfumin 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.Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC).Ebilfumin is not a substitute for influenza vaccination.
Tuoteyhteenveto:
Revision: 15
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-05-22
Pakkausseloste
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
EBILFUMIN 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 any 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 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 Ebilfumin is and what it is used for
2.
What you need to know before you take Ebilfumin
3.
How to take Ebilfumin
4.
Possible side effects
5.
How to store Ebilfumin
6.
Contents of the pack and other information
1.
WHAT EBILFUMIN IS AND WHAT IT IS USED FOR
•
Ebilfumin 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.
•
Ebilfumin 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.
•
Ebilfumin may be prescribed for adults, adolescents, children and
infants (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.
Ebilfumin 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
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ebilfumin 30 mg hard capsules
Ebilfumin 45 mg hard capsules
Ebilfumin 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ebilfumin 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.
Ebilfumin 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.
Ebilfumin 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
Ebilfumin 30 mg hard capsules
The hard capsule consists of a rich yellow body and cap bearing the
black imprint “OS 30”. Capsule
size: 4
The capsule contains a white granulated powder.
Ebilfumin 45 mg hard capsules
The hard capsule consists of a white opaque body and cap bearing the
black imprint “OS 45”. Capsule
size: 4
The capsule contains a white granulated powder.
Ebilfumin 75 mg hard capsules
The hard capsule consists of a white opaque body and a rich yellow cap
bearing the black imprint “OS
75”. Capsule size: 2
The capsule contains a white granulated powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of influenza _
Ebilfumin 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_
3
-
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 Ebilfumin for prevention of influenza should be
determined on a case
by case basis by the circumstances and the population requiring
protectio
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