Aubagio
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
17-08-2023
Valmisteyhteenveto
(SPC)
17-08-2023
Julkisesta arviointikertomuksesta
(PAR)
23-06-2021
Aktiivinen ainesosa:
Teriflunomide
Saatavilla:
Sanofi Winthrop Industrie
ATC-koodi:
L04AA31
INN (Kansainvälinen yleisnimi):
teriflunomide
Terapeuttinen ryhmä:
Selective immunosuppressants
Terapeuttinen alue:
Multiple Sclerosis
Käyttöaiheet:
AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Tuoteyhteenveto:
Revision: 26
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-08-26
Pakkausseloste
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _
AUBAGIO 7 MG FILM-COATED TABLETS
AUBAGIO 14 MG FILM-COATED TABLETS
teriflunomide
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 AUBAGIO is and what it is used for
2.
What you need to know before you take AUBAGIO
3.
How to take AUBAGIO
4.
Possible side effects
5.
How to store AUBAGIO
6.
Contents of the pack and other information
1.
WHAT AUBAGIO IS AND WHAT IT IS USED FOR
WHAT AUBAGIO IS
AUBAGIO contains the active substance teriflunomide which is an
immunomodulatory agent and adjusts the
immune system to limit its attack on the nervous system.
WHAT AUBAGIO IS USED FOR
AUBAGIO is used in adults and in children and adolescents (10 years of
age and older) to treat relapsing
remitting multiple sclerosis (MS).
WHAT MULTIPLE SCLEROSIS IS
MS is a long-term illness that affects the central nervous system
(CNS). The CNS is made up of the brain
and spinal cord. In multiple sclerosis, inflammation destroys the
protective sheath (called myelin) around the
nerves in the CNS. This loss of myelin is called demyelination. This
stops nerves from working properly.
People with relapsing form of multiple sclerosis will have repeated
attacks (relapses) of physical symptoms
caused by their nerves not working properly. These symptoms vary from
patient to patient but usually
involve:
-
difficulty walking
-
vision problems
-
balance problems.
Symptoms may disappear completely after the relapse is over, but over
time, some problems may remain
betwe
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AUBAGIO 7 mg film-coated tablets
AUBAGIO 14 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AUBAGIO 7
mg film-coated tablets
Each film-coated tablet contains 7 mg of teriflunomide.
_Excipient with known effect _
Each tablet contains 72 mg of lactose (as monohydrate).
AUBAGIO 14 mg film-coated tablets
Each film-coated tablet contains 14 mg of teriflunomide.
_Excipient with known effect _
Each tablet contains 72 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet)
AUBAGIO 7 mg film-coated tablets
Very light greenish-bluish grey to pale greenish-blue, hexagonal
film-coated 7.5 mm tablet with imprint on
one side (‘7’) and engraved with the corporate logo on other side.
AUBAGIO 14 mg film-coated tablets
Pale blue to pastel blue, pentagonal film-coated 7.5 mm tablet with
imprint on one side (‘14’) and engraved
with a corporate logo on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AUBAGIO is indicated for the treatment of adult patients and
paediatric patients aged 10 years and older
with relapsing remitting multiple sclerosis (MS) (please refer to
section 5.1 for important information on the
population for which efficacy has been established).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in the management of multiple
sclerosis.
3
Posology
_Adults _
In adults, the recommended dose of teriflunomide is 14 mg once daily.
_Paediatric population (10 years and older) _
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:
-
Paediatric patients with body weight >40 kg: 14 mg once daily.
-
Paediatric patients with body weight ≤40 kg: 7 mg once daily.
Paediatric patients who reach a stable body weight above 40 kg should
be switched to 14 mg once daily.
Film-coated tablets can be taken with or without fo
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