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BRIVIACT Film-coated tablets (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Briviact 10 mg film-coated tablets. Briviact 25 mg film-coated tablets. Briviact 50 mg film-coated tablets. Briviact 75 mg film-coated tablets. Briviact 100 mg film-coated tablets.

Qualitative and quantitative composition

Briviact 10 mg film-coated tablets: Each film-coated tablet contains 10 mg brivaracetam. Briviact 25 mg film-coated tablets: Each film-coated tablet contains 25 mg brivaracetam. Briviact 50 mg film-coated ...

Pharmaceutical form

Film-coated tablet (tablet). Briviact 10 mg film-coated tablets: White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with u10 on one side. Briviact 25 mg film-coated tablets: ...

Therapeutic indications

Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Posology and method of administration

Posology Adults The recommended starting dose is either 50 mg/day or 100 mg/day based on physician assessment of required seizure reduction versus potential side effects. The dose should be administered ...

Contraindications

Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications. A meta-analysis ...

Interaction with other medicinal products and other forms of interaction

Formal interaction studies have only been performed in adults. Pharmacodynamic interactions Concomitant treatment with levetiracetam In the clinical studies, although the numbers were limited, there was ...

Fertility, pregnancy and lactation

Women of childbearing potential Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy). If a woman decides to become pregnant, ...

Effects on ability to drive and use machines

Brivaracetam has minor or moderate influence on the ability to drive and use machines. Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other ...

Undesirable effects

Summary of the safety profile In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received brivaracetam, of whom 1,740 have been treated for ≥6 months,1,363 for ≥12 ...

Overdose

Symptoms There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam. Management ...

Pharmacodynamic properties

Pharmacotherapeutic group: antiepileptics, other antiepileptics ATC code: N03AX23 Mechanism of action Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane ...

Pharmacokinetic properties

Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same AUC, while the maximum plasma concentration is slightly higher after intravenous administration. Brivaracetam ...

Preclinical safety data

In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of the pharmacologically ...

List of excipients

Core Croscarmellose Sodium Lactose monohydrate Betadex Lactose anhydrous Magnesium stearate Coating Briviact 10 mg film-coated tablets: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Briviact ...

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

Briviact 10 mg film-coated tablets: Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE Aluminium blisters Packs of 14 1 and 100 1 film-coated ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Marketing authorization number(s)

EU/1/15/1073/001 EU/1/15/1073/002 EU/1/15/1073/003 EU/1/15/1073/004 EU/1/15/1073/005 EU/1/15/1073/006 EU/1/15/1073/007 EU/1/15/1073/008 EU/1/15/1073/009 EU/1/15/1073/010 EU/1/15/1073/011 EU/1/15/1073/012 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 14 January 2016

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