What is Ebilfumin - oseltamivir 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 have symptoms, when the related virus is known to be circulating in the population;
- in the prevention of influenza, it can be used in patients who have been in contact with people with the flu. Ebilfumin is usually 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 (global flu epidemic).
During a flu pandemic, Ebilfumin can also be used to treat or prevent influenza in infants under the age of one year. It is up to doctors to decide whether to give Ebilfumin to infants in this age group, depending on the severity of the disease. triggered by the flu virus and the state of health of the infant himself, evaluating the likelihood that the latter may benefit from the drug. As it is not a substitute for flu 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 used - oseltamivir?
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 of the onset of symptoms. The medicine is given in a single dose twice a day for five days. In the prevention of influenza, treatment with Ebilfumin should be started within the first two days of contact with an affected person. The medicine is administered in a single dose, once a day, for 10 days after such contact. If Ebilfumin is used during a "flu outbreak, the dose can be given for up to six weeks. The dose of Ebilfumin is 75 mg for patients 13 years of age and older and for children aged 13 years and older. aged between one and 12 years with a body weight greater than 40 kg. For children weighing less than 40 kg, the dose is adjusted to the weight using the lower strength capsules (30 or 40 mg). For infants or children 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. solution prepared by a pharmacist is preferable to preparation at home, as the pharmacist can measure the dose more accurately. The dose to be given to premature babies has not been defined. In patients with kidney disease p Doses may need to be reduced. For all information, see the package leaflet
How does Ebilfumin - oseltamivir work?
The active substance in Ebilfumin, oseltamivir, acts specifically on the influenza virus by blocking certain enzymes on its surface, known as neuraminidases. When neuraminidases are blocked, the virus cannot spread. Oseltamivir acts on the neuraminidases of influenza viruses. influenza A (the most common) and B.
How has Ebilfumin been studied - oseltamivir?
As Ebilfumin is a generic medicine, patient studies 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 the active substance 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 taken as being the same as the reference medicine's.
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 that Ebilfumin be approved for use 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 added to the summary of product characteristics and package leaflet for Ebilfumin, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
Other information about Ebilfumin - oseltamivir
On 22 May 2014, the European Commission granted a "Marketing Authorization" for Ebilfumin, valid throughout the European Union. For more information on Ebilfumin therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. The full EPAR version of the reference medicine can also be found on the Agency's website. Last update of this summary: 04-2014.
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