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SOVALDI Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Sovaldi 400 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 400 mg of sofosbuvir. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm, debossed on one side with GSI and 7977 on the other side.

Therapeutic indications

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4 and 5.1). For hepatitis ...

Posology and method of administration

Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. Posology Adults The recommended dose is one 400 mg tablet, taken orally, once daily ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. ...

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

Pharmacotherapeutic group: Antivirals for systemic use, direct-acting antiviral ATC code: J05AP08 Mechanism of action Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, ...

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

Tablet core: Mannitol (E421) Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b) Film-coating: Polyvinyl alcohol (E1203) Titanium dioxide ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 6 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Sovaldi 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 coil. ...

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

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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