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EMTRIVA Capsule (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Emtriva 200 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 200 mg of emtricitabine. For the full list of excipients, see section 6.1.

Pharmaceutical form

Hard capsule. Each capsule has a white opaque body with a light blue opaque cap, of dimensions 19.4 mm x 6.9 mm. Each capsule is printed with 200 mg on the cap and GILEAD and [Gilead logo] on the body ...

Therapeutic indications

Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and children aged 4 months and over. This indication is based on studies in treatment-naïve ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Emtriva 200 mg hard capsules may be taken with or without food. Adults The recommended dose of Emtriva ...

Contraindications

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

Special warnings and precautions for use

General Emtricitabine is not recommended as monotherapy for the treatment of HIV infection. It must be used in combination with other antiretrovirals. Please also refer to the Summaries of Product Characteristics ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. In vitro, emtricitabine did not inhibit metabolism mediated by any of the following human CYP450 isoforms: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 and 3A4. ...

Fertility, pregnancy and lactation

Pregnancy A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine. Animal studies do not indicate ...

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, patients should be informed that dizziness has been reported during treatment with emtricitabine.

Undesirable effects

Summary of the safety profile In clinical trials of HIV infected adults, the most frequently occurring adverse reactions to emtricitabine were diarrhoea (14.0%), headache (10.2%), elevated creatine kinase ...

Overdose

Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed above (see section 4.8). If overdose occurs, the patient should be monitored for signs of toxicity and ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF09 Mechanism of action and pharmacodynamic effects Emtricitabine is a synthetic nucleoside analogue ...

Pharmacokinetic properties

Absorption Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose. In 20 HIV infected subjects receiving 200 ...

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, and toxicity to ...

List of excipients

Capsule contents: Crospovidone Magnesium stearate (E572) Microcrystalline cellulose (E460) Povidone (E1201) Capsule shell: Gelatin Indigotine (E132) Titanium dioxide (E171) Printing ink containing: Black ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure, containing 30 hard capsules. Blisters made of polychlorotrifluorethylene (PCTFE)/polyethylene (PE)/polyvinylchloride ...

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/1/03/261/001 EU/1/03/261/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 October 2003 Date of latest renewal: 22 September 2008

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: