Levetiracetam Wockhardt 100mg/ml concentrate for solution for infusion

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Levetiracetam

Mevcut itibaren:

Wockhardt UK Limited

ATC kodu:

N03AX; N03AX14

INN (International Adı):

Levetiracetam

Doz:

100 milligram(s)/millilitre

Farmasötik formu:

Concentrate for solution for infusion

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik alanı:

Other antiepileptics; levetiracetam

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2014-12-05

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levetiracetam Wockhardt 100mg/ml concentrate for solution for infusion
Levetiracetam
(referred to as Levetiracetam concentrate for solution for infusion)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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, 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 of the 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 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 concentrate for solution for infusion 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:
-
partial onset seizures

Ürün özellikleri

Health Products Regulatory Authority
12 February 2020
CRN009G28
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Wockhardt 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(s) with known effect:
Each vial contains 19mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless, concentrate.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levetiracetam Wockhardt 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 Wockhardt concentrate for solution for infusion is
indicated as adjunctive therapy
- in the treatment of partial onset seizures with or without secondary
generalisation in adults adolescents, and children from
four yearsof 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 Wockhardt concentrate for solution for infusion
concentrate is an alternative for patients (adults and children
from 4 years of age) 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.
_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 in