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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

VEMLIDY Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Vemlidy 25 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. Excipient with known effect: Each tablet contains 95 mg lactose (as monohydrate). For the full ...

Pharmaceutical form

Film-coated tablet. Yellow, round, film-coated tablets, 8 mm in diameter, debossed with GSI on one side of the tablet and 25 on the other side of the tablet.

Therapeutic indications

Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg) (see section 5.1).

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of chronic hepatitis B. Posology Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once ...

Contraindications

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

Special warnings and precautions for use

HBV transmission Patients must be advised that Vemlidy does not prevent the risk of transmission of HBV to others through sexual contact or contamination with blood. Appropriate precautions must continue ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Vemlidy should not be co-administered with medicinal products containing tenofovir disoproxil fumarate, tenofovir alafenamide or adefovir dipivoxil. ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir 1,000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity associated with ...

Effects on ability to drive and use machines

Vemlidy has no or negligible influence on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with Vemlidy.

Undesirable effects

Summary of the safety profile Assessment of adverse reactions is based on pooled safety data from 2 controlled Phase 3 studies in which 866 HBV infected patients received tenofovir alafenamide 25 mg once ...

Overdose

If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with Vemlidy consists of general supportive measures including monitoring of vital signs ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiviral for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF13 Mechanism of action Tenofovir alafenamide is a phosphonamidate prodrug ...

Pharmacokinetic properties

Absorption Following oral administration of Vemlidy under fasted conditions in adult patients with chronic hepatitis B, peak plasma concentrations of tenofovir alafenamide were observed approximately 0.48 ...

Preclinical safety data

Non-clinical studies in rats and dogs revealed bone and kidney as the primary target organs of toxicity. Bone toxicity was observed as reduced BMD in rats and dogs at tenofovir exposures at least four ...

List of excipients

Tablet core: Lactose monohydrate Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b) Film-coating: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 4 years.

Special precautions for storage

Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

Nature and contents of container

Vemlidy tablets are packaged in high density polyethylene (HDPE) bottles and enclosed with a polypropylene continuous-thread, child-resistant cap, lined with an induction-activated aluminium foil liner. ...

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 Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization number(s)

EU/1/16/1154/001 EU/1/16/1154/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 09 January 2017

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