Levetiracetam 500mg5ml concentrate for solution for infusion vials

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Levetiracetam

Verfügbar ab:

Wockhardt UK Ltd

ATC-Code:

N03AX14

INN (Internationale Bezeichnung):

Levetiracetam

Dosierung:

100mg/1ml

Darreichungsform:

Solution for infusion

Verabreichungsweg:

Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04080100; GTIN: 5012727911960

Gebrauchsinformation

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 s

Fachinformation

OBJECT 1
LEVETIRACETAM WOCKHARDT 100MG/ML CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 04-Aug-2017 | Wockhardt UK
Ltd
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 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 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 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 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 b