ATRIPLA Film-coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Atripla 600 mg/200 mg/245 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. Pink, capsule-shaped, film-coated tablet, of dimensions 20 mm x 10.4 mm, debossed with 123 on one side, plain on the other side.
4.1. Therapeutic indications
Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 ...
4.2. Posology and method of administration
Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Adults The recommended dose of Atripla is one tablet taken orally once daily. If a patient misses a dose ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Severe hepatic impairment (CPT, Class C) (see section 5.2). Co-administration with terfenadine, astemizole, ...
4.4. Special warnings and precautions for use
Co-administration with other medicinal products As a fixed combination, Atripla should not be administered concomitantly with other medicinal products containing the same active components, emtricitabine ...
4.5. Interaction with other medicinal products and other forms of interaction
As Atripla contains efavirenz, emtricitabine and tenofovir disoproxil, any interactions that have been identified with these agents individually may occur with Atripla. Interaction studies with these agents ...
4.6. Pregnancy and lactation
Women of childbearing potential (see below and section 5.3) Pregnancy should be avoided in women receiving Atripla. Women of childbearing potential should undergo pregnancy testing before initiation of ...
4.7. 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, dizziness has been reported during treatment with efavirenz, emtricitabine and tenofovir disoproxil. Efavirenz ...
4.8. Undesirable effects
Summary of the safety profile The combination of efavirenz, emtricitabine and tenofovir disoproxil has been studied in 460 patients either as the fixed-dose combination tablet Atripla (study AI266073) ...
4.9. Overdose
Some patients accidentally taking 600 mg efavirenz twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions. If overdose occurs, the patient ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiviral for systemic use, antivirals for treatment of HIV infections, combinations <b>ATC code:</b> J05AR06 Mechanism of action and pharmacodynamic effects Efavirenz ...
5.2. Pharmacokinetic properties
The separate pharmaceutical forms of efavirenz, emtricitabine and tenofovir disoproxil were used to determine the pharmacokinetics of efavirenz, emtricitabine and tenofovir disoproxil, administered separately ...
5.3. Preclinical safety data
Efavirenz Non-clinical safety pharmacology studies on efavirenz reveal no special hazard for humans. In repeated-dose toxicity studies, biliary hyperplasia was observed in cynomolgus monkeys given efavirenz ...
6.1. List of excipients
<u>Tablet core:</u> Croscarmellose sodium Hyprolose Magnesium stearate (E572) Microcrystalline cellulose (E460) Sodium laurilsulfate <u>Film-coating:</u> Iron oxide black Iron oxide red Macrogol 3350 ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 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 child-resistant closure containing 30 film-coated tablets and silica gel desiccant. <u>The following pack sizes are available:</u> outer cartons ...
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/1/07/430/001 EU/1/07/430/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 13 December 2007 Date of latest renewal: 17 September 2012
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