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Hepsera 10 mg tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Gilead Sciences Ltd
Διεύθυνση Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
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Name of the medicinal product

Hepsera 10 mg tablets.

Qualitative and quantitative composition

Each tablet contains 10 mg adefovir dipivoxil. Excipient(s) with known effect: Each tablet contains 113 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with GILEAD and 10 on one side and a stylised shape of a liver on the other side.

Therapeutic indications

Hepsera is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of chronic hepatitis B. Posology Adults: The recommended dose of Hepsera is 10 mg (one tablet) once daily taken orally with or without ...

Contraindications

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

Special warnings and precautions for use

General: Patients should be advised that therapy with adefovir dipivoxil has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore appropriate precautions should ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. The potential for CYP450 mediated interactions involving adefovir with other medicinal products is low, based on the results of in vitro experiments ...

Pregnancy and lactation

The use of adefovir dipivoxil must be accompanied by the use of effective contraception. Pregnancy There are limited data on the use of adefovir dipivoxil in pregnant women. Studies in animals administered ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, based on the safety profile and mechanism of action, adefovir dipivoxil is expected to have no or negligible ...

Undesirable effects

a. Summary of the safety profile In patients with compensated liver disease, the most frequently reported adverse reactions during 48 weeks of adefovir dipivoxil therapy were asthenia (13 %), headache ...

Overdose

Administration of 500 mg adefovir dipivoxil daily for 2 weeks and 250 mg daily for 12 weeks has been associated with the gastrointestinal disorders listed above and anorexia. If overdose occurs, the patient ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF08 Mechanism of action and pharmacodynamic effects: Adefovir dipivoxil is an oral prodrug of adefovir, ...

Pharmacokinetic properties

Adefovir dipivoxil is a dipivaloyloxymethyl ester prodrug of the active substance adefovir, an acyclic nucleotide analogue which is actively transported into cells where it is converted by host enzymes ...

Preclinical safety data

The primary dose-limiting toxic effect associated with administration of adefovir dipivoxil in animals (mice, rats and monkeys) was renal tubular nephropathy characterised by histological alterations and/or ...

List of excipients

Pregelatinised starch Croscarmellose sodium Lactose monohydrate Talc Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

Nature and contents of container

Hepsera is supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure. Each bottle contains 30 tablets, silica gel desiccant and fibre packing material. The following pack sizes ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom

Marketing authorization number(s)

EU/1/03/251/001 EU/1/03/251/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 06 March 2003 Date of latest renewal: 06 March 2008

Date of revision of the text

08/2012
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