HARVONI Film-coated tablet (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Harvoni 90 mg/400 mg film-coated tablets. Harvoni 45 mg/200 mg film-coated tablets.

2. Qualitative and quantitative composition

Harvoni 90 mg/400 mg film-coated tablets Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir. Excipients with known effect: Each film-coated tablet contains 157 mg of lactose ...

3. Pharmaceutical form

Film-coated tablet. Harvoni 90 mg/400 mg film-coated tablets: Orange, diamond-shaped, film-coated tablet of dimensions of approximately 19 mm x 10 mm, debossed with GSI on one side and 7985 on the ...

4.1. Therapeutic indications

Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype-specific ...

4.2. Posology and method of administration

Harvoni treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. Posology The recommended dose of Harvoni in adults is 90 mg/400 mg once daily with ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Co-administration with rosuvastatin (see section 4.5). Use with strong P-gp inducers Medicinal products that ...

4.4. Special warnings and precautions for use

Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir. Genotype-specific activity Concerning recommended regimens with different HCV genotypes, see section ...

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

As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni. Potential for Harvoni to affect other medicinal ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / contraception in males and females When Harvoni is used in combination with ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners ...

4.7. Effects on ability to drive and use machines

Harvoni (administered alone or in combination with ribavirin) has no or negligible influence on the ability to drive and use machines. However, patients should be advised that fatigue was more common in ...

4.8. Undesirable effects

Summary of the safety profile in adults The safety assessment of Harvoni was mainly based on pooled Phase 3 clinical studies, without a control, in 1952 patients who received Harvoni for 8, 12 or 24 weeks, ...

4.9. Overdose

The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively. In these healthy volunteer studies, there were no untoward effects ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Direct-acting antiviral ATC code: J05AP51 Mechanism of action Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication ...

5.2. Pharmacokinetic properties

Absorption Following oral administration of ledipasvir/sofosbuvir to HCV-infected patients, ledipasvir median peak plasma concentration was observed at 4.0 hours post-dose. Sofosbuvir was absorbed quickly ...

5.3. Preclinical safety data

Ledipasvir No target organs of toxicity were identified in rat and dog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose. Ledipasvir was ...

6.1. List of excipients

Tablet core: Copovidone Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Film-coating: Polyvinyl alcohol Titanium dioxide ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

6 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Harvoni 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. ...

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. This medicinal product may pose a risk to the environment (see section 5.3).

7. Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

8. Marketing authorization number(s)

EU/1/14/958/001 EU/1/14/958/002 EU/1/14/958/003

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 17 November 2014 Date of latest renewal: 01 August 2019

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