Levetiracetam 100 mg/ml Teva, concentraat voor oplossing voor infusie

Land: Nederland

Språk: nederlandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv ingrediens:

LEVETIRACETAM 100 mg/ml

Tilgjengelig fra:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC-kode:

N03AX14

INN (International Name):

LEVETIRACETAM 100 mg/ml

Legemiddelform:

Concentraat voor oplossing voor infusie

Sammensetning:

AZIJNZUUR (E 260), GECONCENTREERD ; NATRIUMACETAAT 3-WATER (E 262) ; NATRIUMCHLORIDE ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,

Administreringsrute:

Intraveneus gebruik

Terapeutisk område:

Levetiracetam

Produkt oppsummering:

Hulpstoffen: AZIJNZUUR (E 260), GECONCENTREERD; NATRIUMACETAAT 3-WATER (E 262); NATRIUMCHLORIDE; STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;

Autorisasjon dato:

2011-12-29

Informasjon til brukeren

Levetiracetam, NL/H/2194/001, 23.05.23
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rvg 108443 EU PIL IB/025 met NL info-tracked
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM 100 MG/ ML TEVA, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
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 is and what it is used for
2.
What you need to know before you are given
3.
How is given
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
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 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 juven

Preparatomtale

Levetiracetam, NL/H/2194/001, 23.05.23
Rvg 108443 EU SPC IB/025 met NL info-tracked
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Levetiracetam 100 mg/ ml Teva, concentraat voor oplossing voor infusie
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 19.1 mg 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
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.
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.
concentrate is an alternative for patients when oral
administration is
temporarily not feasible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
_Partial onset seizures _
Levetiracetam, NL/H/2194/001, 23.05.23
Rvg 108443 EU SPC IB/025 met NL info-tracked
The recommended dosing for monotherapy (from 16 years of age) and
adjunctive therapy is
the same; as outlined below.
_ _
_All indications _
_Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg