SOVALDI Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Sovaldi 400 mg film-coated tablets. Sovaldi 200 mg film-coated tablets.
Qualitative and quantitative composition
<u>Sovaldi 400 mg film-coated tablets:</u> Each film-coated tablet contains 400 mg of sofosbuvir. <u>Sovaldi 200 mg film-coated tablets:</u> Each film-coated tablet contains 200 mg of sofosbuvir. For the ...
Pharmaceutical form
Film-coated tablet. <u>Sovaldi 400 mg film-coated tablets:</u> Yellow, capsule-shaped, film-coated tablet of dimensions of approximately 20 mm x 9 mm, debossed on one side with GSI and 7977 on the other ...
Therapeutic indications
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). ...
Posology and method of administration
Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. Posology The recommended dose of Sovaldi in adults is one 400 mg tablet, taken orally, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, ...
Special warnings and precautions for use
General Sovaldi is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection. If the other medicinal ...
Interaction with other medicinal products and other forms of interaction
Sofosbuvir is a nucleotide prodrug. After oral administration of Sovaldi, sofosbuvir is rapidly absorbed and subject to extensive first-pass hepatic and intestinal metabolism. Intracellular hydrolytic ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female ...
Effects on ability to drive and use machines
Sovaldi has moderate influence on the ability to drive and use machines. Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment ...
Undesirable effects
Summary of the safety profile in adults Assessment of adverse reactions is based on pooled data from five Phase 3 clinical studies (both controlled and uncontrolled). Sovaldi has been studied in combination ...
Overdose
The highest documented dose of sofosbuvir was a single supratherapeutic dose of sofosbuvir 1,200 mg administered to 59 healthy subjects. In that study, there were no untoward effects observed at this dose ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antivirals for systemic use, direct-acting antiviral <b>ATC code:</b> J05AP08 Mechanism of action Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent ...
Pharmacokinetic properties
Sofosbuvir is a nucleotide prodrug that is extensively metabolised. The active metabolite is formed in hepatocytes and not observed in plasma. The predominant (>90%) metabolite, GS-331007, is inactive. ...
Preclinical safety data
In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog). Exposure to sofosbuvir ...
List of excipients
<u>Tablet core:</u> Mannitol (E421) Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b) <u>Film-coating:</u> Polyvinyl alcohol (E1203) ...
Incompatibilities
Not applicable.
Shelf life
6 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Sovaldi 400 mg tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester ...
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/1/13/894/001 EU/1/13/894/002 EU/1/13/894/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 January 2014 Date of latest renewal: 17 September 2018
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