BRINTELLIX Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Brintellix 5 mg film-coated tablets. Brintellix 10 mg film-coated tablets. Brintellix 15 mg film-coated tablets. Brintellix 20 mg film-coated tablets.
Qualitative and quantitative composition
Brintellix 5 mg film-coated tablets: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine. Brintellix 10 mg film-coated tablets: Each film-coated tablet contains vortioxetine ...
Pharmaceutical form
Film-coated tablet (tablet). Brintellix 5 mg film-coated tablets: Pink, almond-shaped (5 8.4 mm) film-coated tablet engraved with TL on one side and 5 on the other side. Brintellix 10 mg film-coated tablets: ...
Therapeutic indications
Brintellix is indicated for the treatment of major depressive episodes in adults.
Posology and method of administration
Posology The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (see section ...
Special warnings and precautions for use
Use in paediatric population Brintellix is not recommended for the treatment of depression in patients aged less than 18 years since the safety and efficacy of vortioxetine have not been established in ...
Interaction with other medicinal products and other forms of interaction
Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9 (see section 5.2). Potential for other medicinal products ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of vortioxetine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The following symptoms may occur in the newborn after ...
Effects on ability to drive and use machines
Brintellix has no or negligible influence on the ability to drive and use machines. However, as adverse reactions such as dizziness have been reported, patients should exercise caution when driving or ...
Undesirable effects
Summary of the safety profile The most common adverse reaction was nausea. Tabulated list of adverse reactions Adverse reactions are listed below using the following convention: very common (≥1/10); common ...
Overdose
Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants ATC code: N06AX26 Mechanism of action The mechanism of action of vortioxetine is thought to be related to its direct modulation of serotonergic ...
Pharmacokinetic properties
Absorption Vortioxetine is slowly, but well absorbed after oral administration and the peak plasma concentration is reached within 7 to 11 hours. Following multiple dosing of 5, 10, or 20 mg/day, mean ...
Preclinical safety data
Administration of vortioxetine in the general toxicity studies in mice, rats and dogs was mainly associated with CNS-related clinical signs. These included salivation (rat and dog), pupil dilatation (dog), ...
List of excipients
Brintellix 5 mg film-coated tablets Tablet core: Mannitol Microcrystalline cellulose Hydroxypropylcellulose Sodium starch glycolate (type A) Magnesium stearate Tablet coating: Hypromellose Macrogol 400 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Brintellix 5 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister. Pack sizes of 14, 28 and 98 film-coated tablets. Perforated unit dose blisters: PVC/PVdC/aluminium. Pack sizes of 56 ...
Special precautions for disposal and other handling
This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
Marketing authorization number(s)
EU/1/13/891/027-035 EU/1/13/891/040
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 December 2013
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