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MAVIRET Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Maviret 100 mg/40 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir. <u>Excipient with known effect:</u> Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate). For the full list ...

3. Pharmaceutical form

Film-coated tablet (tablet). Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with NXT.

4.1. Therapeutic indications

Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4. and 5.1).

4.2. Posology and method of administration

Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology Adults and adolescents aged 12 to <18 years The recommended dose ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.4, and 5.2). Concomitant use with ...

4.4. Special warnings and precautions for use

Hepatitis B Virus reactivation Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should ...

4.5. Interaction with other medicinal products and other forms of interaction

Potential for Maviret to affect other medicinal products Glecaprevir and pibrentasvir are inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide ...

4.6. Pregnancy and lactation

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of glecaprevir or pibrentasvir in pregnant women. Studies in rats/mice with glecaprevir or pibrentasvir ...

4.7. Effects on ability to drive and use machines

Maviret has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The safety assessment of Maviret in subjects treated for 8, 12 or 16 weeks with compensated liver disease (with or without cirrhosis) was based on registrational Phase 2 and ...

4.9. Overdose

The highest documented doses administered to healthy volunteers is 1,200 mg once daily for 7 days for glecaprevir and 600 mg once daily for 10 days for pibrentasvir. Asymptomatic serum ALT elevations (>5x ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Direct-acting antiviral ATC code: J05AP57 glecaprevir and pibrentasvir Mechanism of action Maviret is a fixed-dose combination of two pan-genotypic, direct-acting antiviral agents, ...

5.2. Pharmacokinetic properties

The pharmacokinetic properties of the components of Maviret are provided in Table 11. Table 11. Pharmacokinetic properties of the components of Maviret in healthy adult subjects: &nbsp; Glecaprevir ...

5.3. Preclinical safety data

Glecaprevir and pibrentasvir were 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 ...

6.1. List of excipients

<u>Tablet core:</u> Copovidone (Type K 28) Vitamin E (tocopherol) polyethylene glycol succinate Silica, colloidal anhydrous Propylene glycol monocaprylate (Type II) Croscarmellose sodium Sodium stearyl ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Shelf life: 36 months.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

PVC/PE/PCTFE aluminium foil blister packs. Pack containing 84 (4 21) 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

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

8. Marketing authorization number(s)

EU/1/17/1213/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 26th July 2017

Πηγαίο έγγραφο

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