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SPC: TAMIFLU Powder for oral suspension (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

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

Reports of overdoses with Tamiflu have been received from clinical trials and during post-marketing experience. In the majority of cases reporting overdose, no adverse events were reported. Adverse events ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH02 Oseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate). The active metabolite ...

Pharmacokinetic properties

General Information Absorption Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir phosphate (pro-drug) and is extensively converted by predominantly ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity. Results of the conventional rodent carcinogenicity studies ...

List of excipients

Sorbitol (E420) Sodium dihydrogen citrate (E331[a]) Xanthan gum (E415) Sodium benzoate (E211) Saccharin sodium (E954) Titanium dioxide (E171) Tutti frutti flavour (including maltodextrins [maize], propylene ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 4 years. After reconstitution, store below 25°C for 10 days.

Special precautions for storage

Do not store above 30°C. For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nature and contents of container

100 ml amber glass bottle (with child-resistant polypropylene screw cap, outer part: polyethylene; inner part: polypropylene; liner: polyethylene) with 13 g of powder for oral suspension, a plastic adapter ...

Special precautions for disposal and other handling

It is recommended that Tamiflu oral suspension should be reconstituted by the pharmacist prior to being dispensed to the patient. After reconstitution with 55 ml of water, the usable volume of oral suspension ...

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Marketing authorization number(s)

EU/1/02/222/005

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 November 2011 Date of last renewal: 22 May 2012

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