Extavia
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
16-01-2023
Charakterystyka produktu
(SPC)
16-01-2023
Sprawozdanie z oceny publicznego
(PAR)
06-01-2020
Składnik aktywny:
interferon beta-1b
Dostępny od:
Novartis Europharm Limited
Kod ATC:
L03AB08
INN (International Nazwa):
interferon beta-1b
Grupa terapeutyczna:
Immunostimulants,
Dziedzina terapeutyczna:
Multiple Sclerosis
Wskazania:
Extavia is indicated for the treatment of:patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Podsumowanie produktu:
Revision: 25
Status autoryzacji:
Authorised
Data autoryzacji:
2008-05-20
Ulotka dla pacjenta
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXTAVIA 250 MICROGRAM/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
interferon beta-1b
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Extavia is and what it is used for
2.
What you need to know before you use Extavia
3.
How to use Extavia
4.
Possible side effects
5.
How to store Extavia
6.
Contents of the pack and other information
Annex – self-injection procedure
1.
WHAT EXTAVIA IS AND WHAT IT IS USED FOR
WHAT EXTAVIA IS
Extavia is a type of medicine known as interferon used to treat
multiple sclerosis. Interferons are
proteins produced by the body that help it fight against attacks on
the immune system such as viral
infections.
HOW EXTAVIA WORKS
MULTIPLE SCLEROSIS (MS)
is a long-term condition that affects the central nervous system
(CNS),
particularly the functioning of the brain and spinal cord. In MS,
inflammation destroys the protective
sheath (called myelin) around the nerves of the CNS and stops the
nerves from working properly. This
is called demyelination.
The exact cause of MS is unknown. An abnormal response by the body’s
immune system is thought to
play an important part in the process which damages the CNS.
THE DAMAGE TO THE CNS
can occur within an MS attack (relapse). It can cause temporary
disability,
such as difficulty walking. Symptoms may disappear completely or
partly.
Interferon beta-1b has been shown to change the response of the immune
system and to help to reduce
disease activity.
HOW
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Extavia 250 microgram/ml powder and solvent for solution for
injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Extavia contains 300 microgram (9.6 million IU) of recombinant
interferon beta-1b per vial*.
After reconstitution, each ml contains 250 microgram (8.0 million IU)
of recombinant interferon beta-
1b.
* produced by genetic engineering from strain of
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder - white to off-white in colour.
Solvent - clear/colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Extavia is indicated for the treatment of:
•
Patients with a single demyelinating event with an active inflammatory
process, if it is severe
enough to warrant treatment with intravenous corticosteroids, if
alternative diagnoses have been
excluded, and if they are determined to be at high risk of developing
clinically definite multiple
sclerosis (see section 5.1).
•
Patients with relapsing remitting multiple sclerosis and two or more
relapses within the last two
years.
•
Patients with secondary progressive multiple sclerosis with active
disease, evidenced by
relapses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment with Extavia should be initiated under the supervision
of a physician experienced in the
treatment of the disease.
Posology
_Adults and adolescents from 12-17 years of age _
The recommended dose of Extavia is 250 microgram (8.0 million IU),
contained in 1 ml of the
reconstituted solution (see section 6.6), to be injected
subcutaneously every other day.
Generally, dose titration is recommended at the start of treatment.
Patients should be started at 62.5 microgram (0.25 ml) subcutaneously
every other day, and increased
slowly to a dose of 250 microgram (1.0 ml) every other day (see Table
A). The titration period may be
adjusted, if any significant adverse reaction occurs. In order to
obtain
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