Levetiracetam 1A Pharma 100 mg/ml, drank

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVETIRACETAM 100 mg/ml

Beschikbaar vanaf:

1A Pharma GmbH Keltenring 1 + 3 82041 OBERHACHING (DUITSLAND)

ATC-code:

N03AX14

INN (Algemene Internationale Benaming):

LEVETIRACETAM 100 mg/ml

farmaceutische vorm:

Drank

Samenstelling:

ACESULFAAM KALIUM (E 950) ; BENZYLALCOHOL (E 1519) ; CITROENZUUR 1-WATER (E 330) ; FRAMBOZENSMAAKSTOF ; GLYCEROL (E 422) ; MALTITOL, VLOEIBAAR (E 965) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; PROPYLEENGLYCOL (E 1520) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD, ACESULFAAM KALIUM (E 950) ; CITROENZUUR 1-WATER (E 330) ; FRAMBOZENSMAAKSTOF ; GLYCEROL (E 422) ; MALTITOL, VLOEIBAAR (E 965) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Levetiracetam

Product samenvatting:

Hulpstoffen: ACESULFAAM KALIUM (E 950); CITROENZUUR 1-WATER (E 330); FRAMBOZENSMAAKSTOF; GLYCEROL (E 422); MALTITOL, VLOEIBAAR (E 965); METHYLPARAHYDROXYBENZOAAT (E 218); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD;

Autorisatie datum:

2011-11-25

Bijsluiter

1A Pharma
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Levetiracetam 1A Pharma 100 mg/ml, drank
RVG 108552
1313-v14
1.3.1.3 Bijsluiter
Maart 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
LEVETIRACETAM 1A PHARMA 100 MG/ML, DRANK
levetiracetam
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 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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
[Nationally completed name] 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, children
and infants from one month of age
▪
myoclonic seizures (short, shock-like jerks of

Productkenmerken

1A Pharma
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Levetiracetam 1A Pharma 100 mg/ml, drank
RVG 108552
1311-v14
1.3.1.1 Samenvatting van de Productkenmerken
September 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levetiracetam 1A Pharma 100 mg/ml, drank
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the oral solution contains 100 mg of levetiracetam.
Excipients with known effect
Each ml contains 300 mg maltitol liquid, 2.5 mg methyl
parahydroxybenzoate (E 218) and 1.6
microgram benzyl alcohol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
Clear liquid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Nationally completed name] 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.
[Nationally completed name] is indicated as adjunctive therapy
•
in the treatment of partial onset seizures with or without secondary
generalisation in
adults, adolescents, children and infants from 1 month 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Partial onset seizures _
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
or more _
1A Pharma
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Levetiracetam 1A Pharma 100 mg/ml, drank
RVG 108552
1311-v14
1.3.1.1 Samenvatting van de Productkenmerken
September 2023
_ _
_ _
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day of
treatment. However, a lower initial dose of 250 mg twice daily may be
given based on
physician assessment of seizure reducti