What is Matever - Levetiracetam?
Matever is a medicine that contains the active substance levetiracetam. It is available as tablets (250 mg, 500 mg, 750 mg and 1 000 mg) and as a concentrate to be made up into a solution for infusion (drip into a vein, 100 mg / ml).
Matever is a 'generic medicine'. This means that Matever is similar to a 'reference medicine' already authorized in the European Union (EU) called Keppra.
What is Matever used for?
Matever can be used on its own (alone) in patients from 16 years of age with newly diagnosed epilepsy, in the treatment of partial seizures with or without secondary generalization. It is a type of epilepsy in which "excessive electrical activity in one part of the brain causes symptoms such as sudden spasmodic movements of one part of the body, impaired hearing, smell or vision, numbness or a sudden sense of fear. Secondary generalization occurs." occurs when hyperactivity subsequently expands to the entire brain.
Matever may also be indicated as add-on therapy to other antiepileptic medicines in the treatment of:
- partial seizures with or without generalization in patients from one month of age;
- myoclonic seizures (short, jerky contractions of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
- primary generalized tonic-clonic seizures (more severe seizures, in which there is loss of consciousness) in patients from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to be of genetic origin).
The medicine can only be obtained with a prescription.
How is Matever used - Levetiracetam?
As monotherapy Matever should be given at a starting dose of 250 mg twice a day, which should be increased to 500 mg twice a day after two weeks. The dose may be further increased every two weeks based on the patient's response up to a maximum dose of 1,500 mg twice daily.
When Matever is added to another antiepileptic therapy, the starting dose in patients over 12 years of age who weigh more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. The starting dose, in patients between six months and 17 years of age who weigh less than 50 kg, is 10 mg per kilogram of body weight twice daily and can be increased up to 30 mg / kg twice daily. day.
Lower doses are used in patients who have problems with kidney function (such as elderly patients). Matever tablets should be swallowed with liquid. Matever can be given by infusion, at the same doses and frequency, when the oral solution or tablets cannot be used. Administration by infusion should be temporary.
How does Matever - Levetiracetam work?
The active substance in Matever, levetiracetam, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact modes of action of levetiracetam are not yet clear; however, levetiracetam appears to interfere with a protein (synaptic vesicle protein 2A) found in the space between nerves and intervenes in the release of chemical transmitters from nerve cells. to Matever to stabilize electrical activity in the brain and avoid seizures.
How has Matever been studied - Levetiracetam?
As Matever is a generic medicine, patient studies have been limited to tests to determine its bioequivalence to the reference medicine, Keppra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks associated with Matever - Levetiracetam?
Because Matever is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Matever - Levetiracetam been approved?
The CHMP concluded that, in accordance with EU requirements, Matever has been shown to have comparable quality and to be bioequivalent to Keppra. Therefore, the CHMP considered that, as in the case of Keppra, the benefits outweigh the identified risks and has recommended the granting of the marketing authorization for Matever.
More information about Matever - Levetiracetam
On 03 October 2011, the European Commission issued a "Marketing Authorization" for Matever, valid throughout the European Union.
For more information about Matever therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 08-2011
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