EPCLUSA Film-coated tablet (2023)
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Περιεχόμενα
1. Name of the medicinal product
Epclusa 400 mg/100 mg film-coated tablets. Epclusa 200 mg/50 mg film-coated tablets.
2. Qualitative and quantitative composition
<u>Epclusa 400 mg/100 mg film-coated tablets:</u> Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir. <u>Epclusa 200 mg/50 mg film-coated tablets:</u> Each film-coated tablet contains ...
3. Pharmaceutical form
Film-coated tablet. <u>Epclusa 400 mg/100 mg film-coated tablets:</u> Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with GSI and 7916 on the other side. <u> ...
4.1. Therapeutic indications
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
4.2. Posology and method of administration
Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Epclusa in adults is one 400 mg/100 mg ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, ...
4.4. Special warnings and precautions for use
Epclusa should not be administered concurrently with other medicinal products containing sofosbuvir. Severe bradycardia and heart block Life-threatening cases of severe bradycardia and heart block have ...
4.5. Interaction with other medicinal products and other forms of interaction
As Epclusa contains sofosbuvir and velpatasvir, any interactions that have been identified with these active substances individually may occur with Epclusa. Potential for Epclusa to affect other medicinal ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women. Sofosbuvir Animal studies do not indicate direct ...
4.7. Effects on ability to drive and use machines
Epclusa has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The safety profile of Epclusa has been determined in pooled Phase 3 clinical studies of patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and in the postmarketing setting. ...
4.9. Overdose
The highest documented doses of sofosbuvir and velpatasvir were a single dose of 1,200 mg and a single dose of 500 mg, respectively. In these healthy adult volunteer studies, there were no untoward effects ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antivirals for systemic use; Direct acting antiviral <b>ATC code:</b> J05AP55 Mechanism of action Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent ...
5.2. Pharmacokinetic properties
Absorption The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration ...
5.3. Preclinical safety data
Sofosbuvir Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity and exposure to the major metabolite GS-331007 was instead used to estimate exposure margins. ...
6.1. List of excipients
<u>Tablet core:</u> Copovidone (E1208) Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Magnesium stearate (E470b) <u>Film-coating:</u> Poly(vinyl alcohol) (E1203) Titanium dioxide (E171) ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil. Pack size of 1 bottle containing 28 film-coated tablets.
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/1/16/1116/001 EU/1/16/1116/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 06 July 2016 Date of latest renewal: 22 March 2021
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