VEMLIDY Film-coated tablet (2023)
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 (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.1).
Posology and method of administration
Therapy should be initiated by a physician experienced in the management of CHB. Posology Adults and paediatric patients at least 6 years of age and older weighing at least 25 kg: one tablet once daily. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hepatitis B Virus (HBV) transmission Patients must be advised that this medicinal product does not prevent the risk of transmission of HBV to others through sexual contact or contamination with blood. ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. This medicinal product should not be co-administered with medicinal products containing tenofovir disoproxil, tenofovir alafenamide or adefovir dipivoxil. ...
Fertility, pregnancy and lactation
Pregnancy A moderate amount of data on pregnant women exposed to tenofovir alafenamide (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity. Animal studies do not indicate ...
Effects on ability to drive and use machines
Vemlidy may have minor influence on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with tenofovir alafenamide.
Undesirable effects
Summary of the safety profile Assessment of adverse reactions is based on clinical study data and postmarketing data. In pooled safety data from 2 controlled Phase 3 studies (GS-US-320-0108 and GS-US-320-0110; ...
Overdose
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with tenofovir alafenamide consists of general supportive measures including monitoring ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiviral for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors <b>ATC code:</b> J05AF13 Mechanism of action Tenofovir alafenamide is a phosphonamidate ...
Pharmacokinetic properties
Absorption Following oral administration of tenofovir alafenamide under fasted conditions in adult patients with chronic hepatitis B, peak plasma concentrations of tenofovir alafenamide were observed approximately ...
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
<u>Tablet core:</u> Lactose monohydrate Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b) <u>Film-coating:</u> Polyvinyl alcohol (E1203) Titanium dioxide (E171) ...
Incompatibilities
Not applicable.
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
High density polyethylene (HDPE) bottles, enclosed with a polypropylene continuous-thread, child-resistant cap, lined with an induction-activated aluminium foil liner. Each bottle contains silica gel desiccant ...
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 Date of latest renewal: 16 December 2021
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