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

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVETIRACETAM

Beschikbaar vanaf:

Hexal AG

ATC-code:

N03AX14

INN (Algemene Internationale Benaming):

LEVETIRACETAM

farmaceutische vorm:

Concentraat voor oplossing voor infusie

Samenstelling:

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

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Levetiracetam

Product samenvatting:

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

Autorisatie datum:

2011-12-29

Bijsluiter

Hexal A.G.
Page
1/7
Levetiracetam Sandoz infuus 100 mg/ml,
concentraat voor oplossing voor infusie
RVG 108507
1313-v6
1.3.1.3 Bijsluiter
Februari 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM HEXAL INFUUS 100 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR
INFUSIE
_ _
Levetiracetam

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Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levetiracetam Hexal infuus 100 mg/ml, 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(s) 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.
_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