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4.1 Therapeutic indications
Tamiflu is indicated for the treatment of infants below children 6 to 12 months of age during a pandemic influenza outbreak. (see section 5.2).
- Tamiflu is indicated for post-exposure prevention of influenza in infants below 12 months of age during a pandemic influenza outbreak (see section 5.2).
Based on limited pharmacokinetic and safety data, Tamiflu can be used in infants below children 6 to 12 months of age for treatment during a pandemic influenza outbreak. The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.
4.2 Posology and method of administration
During situations when commercially manufactured Tamiflu oral suspension is not readily available, adults, adolescents or children who are unable to swallow capsules may receive appropriate doses of Tamiflu (see section 3 in Package Leaflet) by opening capsules and pouring the contents of capsules into a suitable, small amount (1 teaspoon maximum) of sweetened food product such as regular or sugar-free chocolate syrup, honey (only for children two years or older), light brown or table sugar dissolved in water, dessert toppings, sweetened condensed milk, apple sauce or yogurt to mask the bitter taste. The mixture should be stirred and the entire contents given to the patient. The mixture must be swallowed immediately after its preparation.
For children 6 to 12 months of age: Depending on the pathogenicity of the circulating influenza virus strain, children between 6 and 12 months of age can be treated with Tamiflu during a pandemic influenza outbreak, although the available data are
Ø For infants below 12 months of age: The recommended treatment dose for infants less than 12 months is between 2 mg/kg twice daily and 3 mg/kg twice daily during a pandemic influenza outbreak. This is based upon limited. Pharmacokinetic data indicatepharmacokinetic data indicating that a dosage of 3 mg/kg twice daily in children 6 to 12 months of age providesthese doses provide plasma drug exposures in the majority of patients similar to those shown to be clinically efficacious in children age one or older children and adults (see section 5.2). The following weight‑adjusted dosing regimens are recommended for treatment of infants below 1 year of age:
The recommended dose for treatment of children 6 to 12 months of age is 3 mg per kg body weight twice daily for 5 days for treatment
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Age
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Recommended dose for 5 days
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> 3 months to 12 months
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3 mg/kg twice daily
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> 1 month to 3 months
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2.5 mg/kg twice daily
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0 to 1 month*
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2 mg/kg twice daily
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* There is no data available regarding the administration of Tamiflu to infants less than one month of age.
Administration of Tamiflu to infants less than one year of age should be based upon the judgment of the physician after considering the potential benefit of treatment versus any potential risk to the infant.
Ø For infants below 12 months of age: The recommended prophylaxis dose for infants less than 12 months during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical data in children > 1 year of age and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza. The following weight‑adjusted dosing prophylaxis regimens are recommended for infants below 1 year of age:
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Age
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Recommended dose for 10 days
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> 3 months to 12 months
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3 mg/kg once daily
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> 1 month to 3 months
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2.5 mg/kg once daily
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0 to 1 month*
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2 mg/kg once daily
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* There is no data available regarding the administration of Tamiflu to infants less than one month of age.
Administration of Tamiflu to infants less than one year of age should be based upon the judgment of the physician after considering the potential benefit of prophylaxis versus any potential risk to the infant.
Prevention during an influenza epidemic in the community
The recommended dose fo |