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DESCOVY Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Descovy 200 mg/10 mg film-coated tablets.

2. Qualitative and quantitative composition

Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.

3. Pharmaceutical form

Film-coated tablet. Grey, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with GSI on one side and 210 on the other side of the tablet.

4.1. Therapeutic indications

Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency ...

4.2. Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Adults and adolescents aged 12 years and older, weighing at least 35 kg Descovy should be administered ...

4.3. Contraindications

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

4.4. Special warnings and precautions for use

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission ...

4.5. Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Descovy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no adequate and well-controlled studies of Descovy or its components in pregnant women. There are no or limited data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide ...

4.7. Effects on ability to drive and use machines

Patients should be informed that dizziness has been reported during treatment with Descovy.

4.8. Undesirable effects

Summary of the safety profile Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 3,112 HIV-1 infected patients received medicinal products containing ...

4.9. Overdose

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

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antiviral for systemic use; antivirals for treatment of HIV infections, combinations <b>ATC code:</b> J05AR17 Mechanism of action Emtricitabine is a nucleoside reverse ...

5.2. Pharmacokinetic properties

Absorption Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose. Following multiple dose oral administration ...

5.3. Preclinical safety data

Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction ...

6.1. List of excipients

<u>Tablet core:</u> Microcrystalline cellulose Croscarmellose sodium Magnesium stearate <u>Film-coating:</u> Polyvinyl alcohol Titanium dioxide Macrogol 3350 Talc Iron oxide black (E172)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets. Each bottle ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

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

8. Marketing authorization number(s)

EU/1/16/1099/001 EU/1/16/1099/002 EU/1/16/1099/005

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 21 April 2016

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