Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing voor infusie

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

LEVETIRACETAM 100 mg/ml

Dostopno od:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Koda artikla:

N03AX14

INN (mednarodno ime):

LEVETIRACETAM 100 mg/ml

Farmacevtska oblika:

Concentraat voor oplossing voor infusie

Sestava:

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

Pot uporabe:

Intraveneus gebruik

Terapevtsko območje:

Levetiracetam

Povzetek izdelek:

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

Datum dovoljenje:

2011-12-29

Navodilo za uporabo

Hexal A.G.
Page 1/8
Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing voor
infusie
RVG 108505
1313-v12
1.3.1.3 Bijsluiter
September 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
LEVETIRACETAM SANDOZ INFUUS 100 MG/ML, 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 or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. 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 use[Nationally completed name]
3.
How to use [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 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 y

Lastnosti izdelka

1
Hexal AG.
Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing
voor infusie
Page 1/17
RVG 108505
1311-v11
1.3.1.1 Samenvatting van de Productkenmerken
September 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing voor
infusie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml concentrate for solution for infusion contains 100 mg of
levetiracetam.
Each vial of 5 ml contains 500 mg of levetiracetam.
Excipient with known effect
Each vial contains 19.1 mg of sodium.
One ml of concentrate contains 3.82 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
[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, 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.
[Nationally completed name] is an alternative for patients when oral
administration is temporarily not
feasible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
[Nationally completed name] 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 _
The recommended dosing for monotherapy (from 16 years