EMTRIVA Hard capsule (2023)
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 human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over. This indication ...
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. <em>In vitro</em>, emtricitabine did not inhibit metabolism mediated by any of the following human CYP450 isoforms: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 ...
Fertility, pregnancy and lactation
Pregnancy A moderate amount of data on pregnant women (between 300 and1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine. Animal studies do not ...
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
<b>Pharmacotherapeutic group:</b> Nucleoside and nucleotide reverse transcriptase inhibitors <b>ATC code:</b> J05AF09 Mechanism of action and pharmacodynamic effects Emtricitabine is a synthetic nucleoside ...
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
<u>Capsule contents:</u> Crospovidone Magnesium stearate (E572) Microcrystalline cellulose (E460) Povidone (E1201) <u>Capsule shell:</u> Gelatin Indigotine (E132) Titanium dioxide (E171) <u>Printing ink ...
Incompatibilities
Not applicable.
Shelf life
<u>Bottle:</u> 4 years. <u>Blister:</u> 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
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