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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Hepsera 10 mg tablets (2012)

Εκδότης

Εκδότης Gilead Sciences Ltd
Διεύθυνση Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
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Περιεχόμενα

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 ...

Pharmaceutical form

Tablet. White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with ...

Therapeutic indications

Hepsera is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of chronic hepatitis B. Posology ...

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 ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. The potential for CYP450 mediated interactions ...

Pregnancy and lactation

The use of adefovir dipivoxil must be accompanied by the use of effective contraception. Pregnancy There ...

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 ...

Undesirable effects

a. Summary of the safety profile In patients with compensated liver disease, the most frequently reported ...

Overdose

Administration of 500 mg adefovir dipivoxil daily for 2 weeks and 250 mg daily for 12 weeks has been ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF08 ...

Pharmacokinetic properties

Adefovir dipivoxil is a dipivaloyloxymethyl ester prodrug of the active substance adefovir, an acyclic ...

Preclinical safety data

The primary dose-limiting toxic effect associated with administration of adefovir dipivoxil in animals ...

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 ...

Nature and contents of container

Hepsera is supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure. Each ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.