DOVATO Film-coated tablet (2023)

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Περιεχόμενα

1. Name of the medicinal product

Dovato 50 mg/300 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet (tablet). Oval, biconvex, white, film coated tablet, approximately 18.5 9.5 mm, debossed with SV 137 on one face.

4.1. Therapeutic indications

Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance ...

4.2. Posology and method of administration

Dovato should be prescribed by physicians experienced in the management of HIV infection. Posology Adults and adolescents (above 12 years of age weighing at least 40 kg). The recommended dose of Dovato ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Co-administration with medicinal products with narrow therapeutic windows, that are substrates of organic cation ...

4.4. Special warnings and precautions for use

Hypersensitivity reactions Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver ...

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

No drug interaction studies have been conducted using Dovato. Dovato contains dolutegravir and lamivudine, therefore any interactions identified for these individually are relevant to Dovato. No clinically ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential (WOCBP) should be counselled about the potential risk of neural tube defects with dolutegravir (a component of Dovato, see below), including ...

4.7. Effects on ability to drive and use machines

Dovato has no or negligible influence on the ability to drive and use machines. Patients should be informed that dizziness and somnolence has been reported during treatment with dolutegravir. The clinical ...

4.8. Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%). The most severe adverse reaction reported with dolutegravir ...

4.9. Overdose

No specific symptoms or signs have been identified following acute overdose with dolutegravir or lamivudine, apart from those listed as adverse reactions. There is no specific treatment for an overdose ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations ATC code: J05AR25 Mechanism of action Dolutegravir inhibits HIV integrase ...

5.2. Pharmacokinetic properties

When administered in fasted state, bioequivalence regarding Cmax was achieved for dolutegravir, when comparing Dovato to dolutegravir 50 mg co-administered with lamivudine 300 mg. Dolutegravir ...

5.3. Preclinical safety data

There are no data available on the effects of the combination of dolutegravir and lamivudine in animals. Carcinogenesis and mutagenesis Dolutegravir was not mutagenic or clastogenic using in vitro ...

6.1. List of excipients

Tablet core: Microcrystalline cellulose Sodium starch glycolate Magnesium Stearate Mannitol (E421) Povidone (K29/32) Sodium stearyl fumarate Tablet coating: Hypromellose (E464) Macrogol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Bottle pack: 3 years. Blister pack: 2 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Bottle pack: Opaque, white HDPE (high density polyethylene) bottles closed with child-resistant polypropylene closures, with a polyethylene faced induction heat seal liner. Each pack consists of ...

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

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

8. Marketing authorization number(s)

EU/1/19/1370/001 EU/1/19/1370/002 EU/1/19/1370/003 EU/1/19/1370/004

9. Date of first authorization / renewal of the authorization

Date of first authorization: 1st July 2019

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