Levetiracetam 100mg/ml concentrate for solution for infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Levetiracetam

Commercializzato da:

Intrapharm Laboratories Limited

Codice ATC:

N03AX14

INN (Nome Internazionale):

Levetiracetam

Dosaggio:

100 milligram(s)/millilitre

Forma farmaceutica:

Concentrate for solution for infusion

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

levetiracetam

Data dell'autorizzazione:

2018-10-26

Foglio illustrativo

SAME SIZE ARTWORK
SIZE: 210 mm x 320 mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM 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 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 Levetiracetam concentrate for solution for infusion is and
what it is
used for
2. What you need to know before you are given Levetiracetam
concentrate for
solution for infusion
3. How Levetiracetam concentrate for solution for infusion is given
4. Possible side effects
5. How to store Levetiracetam concentrate for solution for infusion
6. Contents of the pack and other information
1. WHAT LEVETIRACETAM CONCENTRATE FOR SOLUTION FOR INFUSION IS AND
WHAT IT IS
USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in
epilepsy).
Levetiracetam 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.

as an add-on to other antiepileptic medicines to treat:


Scheda tecnica

Health Products Regulatory Authority
31 October 2018
CRN008K4T
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam 100mg/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 concentrate for solution for infusion 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 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 concentrate for solution for infusion is an alternative
for patients when
oral administration is temporarily not feasible.
Health Products Regulatory Authority
31 October 2018
CRN008K4T
Page 2 of 22
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.
_Monotherapy for adults and adolescents from 16 years of age _
The recommended starting dose is 250 mg twice daily which should be
increased to
an initial therapeutic dose of 500 mg twic