Change to indication and dosage of the medicinal product with active substance oseltamivir (Tamiflu) in children below 12 months of age during the pandemic influenza
The Agency for Medicinal Products and Medical Devices accepted the changes to the information on the medicinal product Tamiflu (oseltamivir). The changes are accepted for all approved pharmaceutical forms and doses of the medicinal product Tamiflu:
- Tamiflu 30 mg hard capsules
- Tamiflu 45 mg hard capsules
- Tamiflu 75 mg hard capsules
- Tamiflu 12 mg/ml powder for oral suspension
Under the Agency approval, all pharmaceutical forms and doses of the medicinal product Tamiflu may be used in treatment of children below 12 months of age during the outbreak of the flu pandemic, and for prevention of flu in children below 12 months of age following their exposure to the agent causing the flu during the pandemic.
The change relates to the information on dosage of the medicinal product since preparation of the improvised form of the medicinal product (suspension) from Tamiflu capsules 30 mg, 45 mg and 75 mg has been approved, and to introduction of recommendations for dosage thereof in treatment of children below 1 year of age. The instruction on preparation of suspension for adult persons and children above 1 year of age who cannot swallow the capsule, as well as for children below 1 year of age, has been stated in the section 4.2. Dosage and administration of the Summary of product characteristics, or in the section 3 (three) of the Patient information leaflet.
The summary and the leaflet contain new information on the positive benefit-risk ratio for use of the medicinal product in pregnant women and breastfeeding women.
According to the recommendation, the medicinal product oseltamivir should be used in children younger than 1 year of age only during the period of pandemic influenza.
In accordance with the accepted changes, a new summary of product characteristics and the patient information leaflet have been approved, and they can be accessed from the medicinal products database of the Agency.