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EXVIERA Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Exviera 250 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate). Excipient with known effect: Each film-coated tablet contains 45 mg lactose (as monohydrate). For the full list of excipients, ...

Pharmaceutical form

Film-coated tablet (tablet). Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm and debossed on one side with AV2.

Therapeutic indications

Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific ...

Posology and method of administration

Treatment with dasabuvir should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. Posology The recommended dose is 250 mg of dasabuvir (one tablet) twice daily ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2). Use of ethinyloestradiol-containing ...

Special warnings and precautions for use

General Dasabuvir is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see section 4.2 and 5.1). ...

Interaction with other medicinal products and other forms of interaction

Dasabuvir must always be administered together with ombitasvir/paritaprevir/ritonavir. When coadministered they exert mutual effects on each other (see section 5.2). Therefore, the interaction profile ...

Fertility, pregnancy and lactation

Women of childbearing potential/contraception in males and females Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when dasabuvir is used with ribavirin. ...

Effects on ability to drive and use machines

Dasabuvir has no or negligible influence on the ability to drive and use machines. Patients should be informed that fatigue has been reported during treatment with dasabuvir in combination with ombitasvir/paritaprevir/ritonavir ...

Undesirable effects

Summary of the safety profile In subjects receiving dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue ...

Overdose

The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed. In ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals ATC code: J05AP09 Mechanism of action Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded ...

Pharmacokinetic properties

The pharmacokinetic properties of the combination of dasabuvir with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 18 shows ...

Preclinical safety data

Dasabuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays. ...

List of excipients

Tablet core: Microcrystalline cellulose (E460(i)) Lactose monohydrate Copovidone Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b) Film-coating: Poly(vinyl alcohol) (E1203) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PE/PCTFE aluminium foil blister packs. Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).

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

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Marketing authorization number(s)

EU/1/14/983/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 January 2015

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