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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVETIRACETAM

Available from:

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

ATC code:

N03AX14

INN (International Name):

LEVETIRACETAM 100 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

LEVETIRACETAM 100 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Withdrawn

Authorization date:

2012-03-12

Patient Information leaflet

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

Read the complete document

Summary of Product characteristics

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