Keppra 500mg5ml concentrate for solution for infusion vials

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Levetiracetam

متاح من:

UCB Pharma Ltd

ATC رمز:

N03AX14

INN (الاسم الدولي):

Levetiracetam

جرعة:

100mg/1ml

الشكل الصيدلاني:

Solution for infusion

طريقة التعاطي:

Intravenous

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 04080100; GTIN: 5015313013093

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KEPPRA 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 Keppra is and what it is used for
2.
What you need to know before you are given Keppra
3.
How Keppra is given
4.
Possible side effects
5.
How to store Keppra
6.
Contents of the pack and other information
1.
WHAT KEPPRA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Keppra 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 with or without generalisation in 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 adolescent

خصائص المنتج

OBJECT 1
KEPPRA 100 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 02-Jan-2017 | UCB Pharma
Limited
1. Name of the medicinal product
Keppra 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
Keppra 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.
Keppra 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.
Keppra concentrate is an alternative for patients when oral
administration is temporarily not feasible.
4.2 Posology and method of administration
Posology
Keppra 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 twice daily after two weeks. The dose can be further
increased by 250 mg twice daily
every two weeks depending upon the clinical response. The max