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SPC: TAMIFLU Capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tamiflu 30 mg hard capsules. Tamiflu 45 mg hard capsules. Tamiflu 75 mg hard capsules.

Qualitative and quantitative composition

Tamiflu 30 mg hard capsules: Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir. For the full list of excipients, see section 6.1. Tamiflu 45 mg hard capsules: Each hard ...

Pharmaceutical form

Tamiflu 30 mg hard capsules: The hard capsule consists of a light yellow opaque body bearing the imprint ROCHE and a light yellow opaque cap bearing the imprint 30 mg. Imprints are blue. Tamiflu 45 mg ...

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 hard capsules and Tamiflu suspension 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

Tamiflu 30 mg hard capsules Capsule core: Pregelatinised starch (derived from maize starch) Talc Povidone Croscarmellose sodium Sodium stearyl fumarate Capsule shell: Gelatin Yellow iron oxide (E172) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life Tamiflu 30 mg hard capsules: 7 years. Tamiflu 45 mg hard capsules: 7 years. Tamiflu 75 mg hard capsules: 10 years. Storage of the pharmacy compounded suspension: Shelf life of 10 days when stored ...

Special precautions for storage

Do not store above 25°C. For storage conditions of the pharmacy compounded suspension, see section 6.3.

Nature and contents of container

Triplex blister pack (PVC/PE/PVDC, sealed with aluminium foil). Pack-size 10 capsules.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements. Extemporaneous formulation When Tamiflu powder for oral suspension is not available Commercially manufactured ...

Marketing authorization holder

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

Marketing authorization number(s)

Tamiflu 30 mg hard capsules: EU/1/02/222/003 Tamiflu 45 mg hard capsules: EU/1/02/222/004 Tamiflu 75 mg hard capsules: EU/1/02/222/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 June 2002 Date of last renewal: 22 May 2012

Πηγαίο έγγραφο

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