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VOCABRIA Film-coated tablet (2022)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Vocabria 30 mg film-coated tablets.

2. Qualitative and quantitative composition

Each tablet contains cabotegravir sodium equivalent to 30 mg cabotegravir. <u>Excipient with known effect:</u> Each film-coated tablet contains 155 mg lactose (as monohydrate). For the full list of excipients, ...

3. Pharmaceutical form

Film-coated tablet (tablet). White, oval, film-coated tablets (approximately 8.0 mm by 14.3 mm), debossed with SV CTV on one side.

4.1. Therapeutic indications

Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 ...

4.2. Posology and method of administration

Vocabria should be prescribed by physicians experienced in the management of HIV infection. Vocabria tablets are indicated for the short-term treatment of HIV in combination with rilpivirine tablets, therefore, ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use with rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin or phenobarbital (see section ...

4.4. Special warnings and precautions for use

Baseline factors associated with virological failure Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following ...

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

Vocabria tablets, in combination with rilpivirine tablets, are indicated for the treatment of HIV-1, therefore, the prescribing information for rilpivirine tablets should be consulted for associated interactions. ...

4.6. Pregnancy and lactation

Pregnancy There are a limited amount of data from the use of cabotegravir in pregnant women. The effect of Vocabria on human pregnancy is unknown. Cabotegravir was not teratogenic when studied in pregnant ...

4.7. Effects on ability to drive and use machines

Patients should be informed that dizziness, fatigue and somnolence has been reported during treatment with Vocabria. The clinical status of the patient and the adverse reaction profile of Vocabria should ...

4.8. Undesirable effects

Summary of the safety profile The most frequently reported adverse reaction (ARs) from monthly dosing studies were headache (up to 12%) and pyrexia<sup>4</sup> (10%). The most frequently reported ARs, ...

4.9. Overdose

There is no specific treatment for Vocabria overdose. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Cabotegravir is known to be highly protein ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antiviral for systemic use, integrase inhibitor <b>ATC code:</b> J05AJ04 Mechanism of action Cabotegravir inhibits HIV integrase by binding to the integrase active site ...

5.2. Pharmacokinetic properties

Cabotegravir pharmacokinetics is similar between healthy and HIV-infected subjects. The PK variability of cabotegravir is moderate. In Phase I studies in healthy subjects, between-subject CVb% for AUC, ...

5.3. Preclinical safety data

Carcinogenesis and mutagenesis Cabotegravir was not mutagenic or clastogenic using <em>in vitro</em> tests in bacteria and cultured mammalian cells, and an <em>in vivo</em> rodent micronucleus assay. Cabotegravir ...

6.1. List of excipients

<u>Tablet core:</u> Lactose monohydrate Microcrystalline cellulose (E460) Hypromellose (E464) Sodium starch glycolate Magnesium stearate <u>Tablet coating:</u> Hypromellose (E464) Titanium dioxide (E171) ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner. Each bottle contains 30 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

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

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 17 December 2020

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