Levetiracetam Wockhardt 100mg/ml concentrate for solution for infusion

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

LEVETIRACETAM

제공처:

Wockhardt UK Limited

ATC 코드:

N03AX14

INN (국제 이름):

LEVETIRACETAM

약제 형태:

CONCENTRATE FOR SOLUTION FOR INFUSION

구성:

LEVETIRACETAM 100 milligram(s)/millilitre

처방전 유형:

POM

치료 영역:

ANTIEPILEPTICS

제품 요약:

Licence number in the source country: NOT APPLICAPABLE

승인 상태:

Authorised

승인 날짜:

2020-04-24

환자 정보 전단

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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 ons

제품 특성 요약

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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 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.
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_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.