What is Levetiracetam Hospira and what is it used for?
Levetiracetam Hospira is a medicine that contains the active substance levetiracetam. Levetiracetam Hospira can be used as monotherapy (alone) in patients from 16 years of age with newly diagnosed epilepsy, in the treatment of partial seizures with or without secondary generalization. This type of epilepsy is evidenced by "excessive electrical activity in one part of the brain, with symptoms such as sudden spasmodic movements of a part of the body, impaired hearing, smell or sight, numbness or a sudden sense of fear. Secondary generalization occurs. when the hyperactivity subsequently expands to the whole brain. Levetiracetam Hospira may also be indicated as add-on therapy to other antiepileptic medicinal products in the treatment of:
- partial seizures with or without generalization in patients from four years 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).
Levetiracetam Hospira is a 'generic' medicine. This means that Levetiracetam Hospira is similar to a 'reference medicine' already authorized in the European Union (EU) called Keppra. For more information on generic medicines, please see the questions and answers by clicking here.
How is Levetiracetam Hospira used - levetiracetam?
Levetiracetam Hospira can only be obtained with a prescription and is available as a concentrate (100 mg / ml) for solution for infusion (drip into a vein). As monotherapy Levetiracetam Hospira should be administered at a starting dose of 250 mg twice daily, which should be increased to 500 mg twice daily after two weeks. The dose may be further increased every two weeks based on the patient's response up to a maximum of 1,500 mg twice daily. When Levetiracetam Hospira is added to another antiepileptic therapy, the starting dose in patients over 12 years of age, weighing 50 kg or more, is 500 mg twice daily. The daily dose may be increased up to 1 500 mg twice daily. The starting dose in patients 4 to 17 years of age who weigh less than 50 kg is 10 mg per kilogram of body weight twice daily, which can be increased up to 30. mg / kg twice daily Lower doses are used in subjects with impaired renal function Levetiracetam Hospira as an intravenous infusion should only be administered temporarily when oral therapy is not possible.
How does Levetiracetam Hospira work - levetiracetam?
The active substance in Levetiracetam Hospira, levetiracetam, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact mode of action of levetiracetam is not yet fully known, however the drug appears to interfere with a protein called synaptic vesicle protein 2A in the space between nerves that is involved in the release of chemical transmitters from nerve cells. allows Levetiracetam Hospira to stabilize electrical activity in the brain and prevent seizures.
How has Levetiracetam Hospira - levetiracetam been studied?
The company provided data on levetiracetam from the published literature. No additional studies were needed in patients as Levetiracetam Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.
What are the risks and benefits associated with Levetiracetam Hospira - levetiracetam?
Since Levetiracetam Hospira 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 Levetiracetam Hospira - levetiracetam been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Levetiracetam Hospira 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 recommended that Levetiracetam Hospira be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Levetiracetam Hospira - levetiracetam?
A risk management plan has been developed to ensure that Levetiracetam Hospira is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Levetiracetam Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
More information about Levetiracetam Hospira - levetiracetam
On 08 January 2014, the European Commission granted a "Marketing Authorization" for Levetiracetam Hospira, valid throughout the European Union. For more information on Levetiracetam Hospira therapy, read the package leaflet (included with the EPAR) or consult 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: 01-2014
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