What is Ebilfumin - oseltamivir used for and what is it used for?
Ebilfumin is an antiviral medicine that contains the active substance oseltamivir . It is used in the treatment or prevention of influenza in patients over one year of age:
- in the treatment of influenza, it can be used in patients who experience the symptoms, when it is known that the relative virus is circulating among the population;
- in the prevention of influenza, it can be used in patients who have been in contact with influenced people. Any recourse to Ebilfumin is generally assessed on a case by case basis. Ebilfumin can also be used as a preventive treatment in exceptional circumstances, for example if the seasonal flu vaccine does not provide sufficient protection and in the presence of a pandemic (a worldwide influenza epidemic).
During an influenza pandemic, Ebilfumin can also be used to treat or prevent flu in infants under the age of one year. It is up to the doctors to decide whether to administer Ebilfumin to newborns in this age group, depending on the severity of the illness triggered by the flu virus and the health status of the newborn himself, evaluating the likelihood that the latter may benefit from the medicine. Not being a substitute for influenza vaccination, Ebilfumin should be used according to official recommendations.
Ebilfumin is a "generic medicine". This means that Ebilfumin is similar to a 'reference medicine' already authorized in the European Union (EU) called Tamiflu. For more information on generic medicines, see the questions and answers by clicking here.
How is Ebilfumin - oseltamivir used?
Ebilfumin is available as capsules (30, 45 and 75 mg) and can only be obtained with a prescription. In the treatment of influenza, treatment with Ebilfumin should be started within the first two days after the onset of symptoms. The medicine is given as a single dose twice a day for five days. In the prevention of influenza, Ebilfumin treatment must be started within the first two days of contact with an affected person. The medicine is given in a single dose, once a day, for 10 days from such contact. If Ebilfumin is used during a flu epidemic, the dose can be given for up to six weeks. The dose of Ebilfumin is 75 mg for patients aged 13 and over and for children aged between one and 12 years with a body weight of more than 40 kg. For children weighing less than 40 kg, the dose is adjusted to the weight using the lower dose capsules (30 or 40 mg). For newborns or small children who are unable to swallow the capsules, the pharmacist can prepare a solution using the contents; alternatively, the contents of the capsules can be mixed at home with sweetened food. In the case of infants younger than one year, the solution prepared by a pharmacist is preferable to preparation at home, as the pharmacist can measure the dose more precisely. The dose to be administered to premature babies has not been defined. Doses may need to be reduced in patients with kidney problems. For all information, see the package leaflet
How does Ebilfumin - oseltamivir work?
The active substance in Ebilfumin, oseltamivir, acts specifically on the influenza virus, blocking certain enzymes on its surface known as neuraminidases. When neuraminidases are blocked, the virus cannot spread. Oseltamivir acts on the neuraminidases of influenza A (the most common) and B.
What studies have been performed on Ebilfumin - oseltamivir?
Because Ebilfumin is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Tamiflu. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Ebilfumin - oseltamivir?
Because Ebilfumin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Ebilfumin - oseltamivir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ebilfumin has been shown to have comparable quality and to be bioequivalent to Tamiflu. Therefore, the CHMP considered that, as in the case of Tamiflu, the benefits outweigh the identified risks and recommended to approve the use of Ebilfumin in the EU.
What measures are being taken to ensure the safe and effective use of Ebilfumin - oseltamivir?
A risk management plan has been developed to ensure that Ebilfumin is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ebilfumin, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Ebilfumin - oseltamivir
On 22 May 2014, the European Commission issued a marketing authorization for Ebilfumin, valid throughout the European Union. For more information about Ebilfumin therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 04-2014.
