VOCABRIA Prolonged-release suspension for injection (2022)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

400 mg: Vocabria 400 mg prolonged-release suspension for injection. 600 mg: Vocabria 600 mg prolonged-release suspension for injection.

2. Qualitative and quantitative composition

400 mg: Each vial contains 400 mg cabotegravir in 2 mL. 600 mg: Each vial contains 600 mg cabotegravir in 3 mL. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Prolonged-release suspension for injection. White to light pink suspension.

4.1. Therapeutic indications

Vocabria injection is indicated, in combination with rilpivirine injection, for the 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. Each injection should be administered by a healthcare professional. Vocabria injection is indicated for the treatment ...

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

Risk of resistance following treatment discontinuation To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no ...

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

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

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 injection. The clinical status of the patient and the adverse reaction profile of Vocabria ...

4.8. Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions (ARs) from monthly dosing studies were injection site reactions (up to 84%), headache (up to 12%) and pyrexia4 (10%). ...

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

Pharmacotherapeutic group: Antiviral for systemic use, integrase inhibitor ATC code: 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 to high. In HIV-infected subjects participating in Phase III studies, ...

5.3. Preclinical safety data

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

6.1. List of excipients

Mannitol (E421) Polysorbate 20 (E432) Macrogol (E1521) Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

Unopened vial: 3 years. Shelf life of suspension in syringe: Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C. Once the suspension has been drawn into the ...

6.4. Special precautions for storage

Unopened vial: This medicinal product does not require any special storage conditions. Do not freeze. Suspension in syringe: For storage conditions after first opening of the product, see ...

6.5. Nature and contents of container

400 mg (2 mL vial): Brown 2 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with a dark grey plastic flip-cap. Each pack contains: 1 vial (400 mg), 1 graduated ...

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. Full instructions for use and handling of Vocabria injection are provided in the package leaflet ...

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf