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    Γαληνός - Βιβλιογραφία - TAMIFLU Powder for oral suspension

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    lumidelino
    T PW

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    Γαληνός - Βιβλιογραφία - TAMIFLU Powder for oral suspension

    Uploaded by

    lumidelino
    15 views1 page
    T PW

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    © © All Rights Reserved

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    T PW

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    15 views1 page

    Γαληνός - Βιβλιογραφία - TAMIFLU Powder for oral suspension

    Uploaded by

    lumidelino
    T PW

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Name of the medicinal product

    Tamiflu 6 mg/ml powder for oral suspension.

    Qualitative and quantitative composition

    Each ml of reconstituted suspension contains oseltamivir phosphate equivalent to 6 mg of oseltamivir. One bottle of
    reconstituted suspension (65 ml) contains 390 mg of oseltamivir. Excipients with known ...

    Pharmaceutical form

    Powder for oral suspension. The powder is a granulate or clumped granulate with a white to light yellow colour.

    Therapeutic indications

    Treatment of influenza Tamiflu is indicated in adults and children including full term neonates who present with
    symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy ...

    Posology and method of administration

    Posology Tamiflu suspension and Tamiflu hard capsules are bioequivalent formulations. 75 mg doses can be
    administered as either one 75 mg capsule or one 30 mg capsule plus one 45 mg capsule or by administering ...

    Contraindications

    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

    Special warnings and precautions for use

    Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for efficacy of
    oseltamivir in any illness caused by agents other than influenza viruses (see section 5.1). ...

    Interaction with other medicinal products and other forms of interaction

    Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450
    and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions ...

    Fertility, pregnancy and lactation

    Pregnancy Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital
    malformations, including congenital heart defects. A large amount of data on oseltamivir exposure ...

    Effects on ability to drive and use machines

    Tamiflu has no influence on the ability to drive and use machines.

    Undesirable effects

    Summary of the safety profile The overall safety profile of Tamiflu is based on data from 6049 adult/adolescent and
    1473 paediatric patients treated with Tamiflu or placebo for influenza, and on data from ...

    Overdose

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