Levetiracetam Sun

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

levetiracetam

Saatavilla:

Sun Pharmaceutical Industries Europe B.V.

ATC-koodi:

N03AX14

INN (Kansainvälinen yleisnimi):

levetiracetam

Terapeuttinen ryhmä:

Other antiepileptics

Terapeuttinen alue:

Epilepsy

Käyttöaiheet:

Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-12-14

Pakkausseloste

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM SUN 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
levetiracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 or nurse.
-
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 Levetiracetam SUN is and what it is used for
2.
What you need to know before
you are given Levetiracetam SUN
3.
How Levetiracetam SUN is given
4.
Possible side effects
5.
How to store Levetiracetam SUN
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM SUN IS AND WHAT IS IT USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam SUN is used
-
on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to
treat a certain form of epilepsy. Epilepsy is a condition where the
patients have repeated fits
(seizures). Levetiracetam is used for the epilepsy form in which the
fits initially affect only one
side of the brain but could thereafter extend to larger areas on both
sides of the brain (partial
onset seizure with or without secondary generalisation). Levetiracetam
has been given to you by
your doctor to reduce the number of fits
-
with other antiepileptic medicines (add-on therapy) to treat:
-
partial onset seizures with or without generalisation in adults,
adolescents and children
from 4 years of age
-
myoclonic seizures (short, shock-like jerks of a muscle or group of
muscles) in adults and
adolescents from 12 years of age with juvenile myoclonic epilepsy
-
primary generalised tonic-clonic seizures (major fits, including loss
of consciousness) in
adults and adolescents from 12 years of age with idiopathic
generalised epilepsy (the type
of

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam SUN 100 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 mg of levetiracetam.
Each 5 ml vial contains 500 mg of levetiracetam.
Excipient with known effect
Each vial contains 19 mg of sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam SUN is indicated as monotherapy in the treatment of
partial onset seizures with or
without secondary generalisation in adults and adolescents from 16
years of age with newly diagnosed
epilepsy.
Levetiracetam SUN is indicated as adjunctive therapy
-
in the treatment of partial onset seizures with or without secondary
generalisation in adults,
adolescents and children from 4 years of age with epilepsy
-
in the treatment of myoclonic seizures in adults and adolescents from
12 years of age with
Juvenile Myoclonic Epilepsy
-
in the treatment of primary generalised tonic-clonic seizures in
adults and adolescents from 12
years of age with Idiopathic Generalised Epilepsy.
Levetiracetam SUN concentrate is an alternative for patients when oral
administration is temporarily
not feasible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Levetiracetam therapy can be initiated with either intravenous or oral
administration.
Conversion to or from oral to intravenous administration can be done
directly without titration. The
total daily dose and frequency of administration should be maintained.
_Partial onset seizures _
The recommended dosing for monotherapy (from 16 years of age) and
adjunctive therapy is the same;
as outlined below.
_ _
_All indications _
3
_Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg
or more_
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day of
treatment. However, a lower initial