Levetiracetam Fair-Med Healthcare 100mg/ml concentrate for solution for infusion

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

LEVETIRACETAM

Dostopno od:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

Koda artikla:

N03AX14

INN (mednarodno ime):

LEVETIRACETAM 100 mg/ml

Farmacevtska oblika:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sestava:

LEVETIRACETAM 100 mg/ml

Tip zastaranja:

POM

Terapevtsko območje:

ANTIEPILEPTICS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2012-03-12

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER 
_ _
LEVETIRACETAM FAIR-MED HEALTHCARE 100 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION 
Levetiracetam 

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Levetiracetam Fair-Med Healthcare 100 mg/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 

Excipients: 
Each dose contains 19.1 mg of sodium 

For a 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 Fair-Med Healthcare is indicated as monotherapy in the
treatment of partial onset 
seizures with or without secondary generalisation in patients from 16
years of age with newly 
diagnosed epilepsy. 

Levetiracetam Fair-Med Healthcare is indicated as adjunctive
therapy 
  in the treatment of partial onset seizures with or without
secondary generalisation in adults 
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.  

Levetiracetam Fair-Med Healthcare concentrate is an alternative for
patients when oral 
administration is temporarily not feasible. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Posology  

_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 clinical response.
The maximum dose is 1500 
mg twice daily. 

_Add-on therapy for Adults (≥18 years) and adolescents (12 to 17
years) weighing 50 kg or more _

The initi