ZEBINIX Tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zebinix 200 mg tablets.
Qualitative and quantitative composition
Each tablet contains 200 mg of eslicarbazepine acetate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White oblong tablets, engraved ESL 200 on one side and scored on the other side, with a length of 11 mm. The tablet can be divided into equal doses.
Therapeutic indications
Zebinix is indicated as: monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in adults, adolescents ...
Posology and method of administration
Posology Adults Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after ...
Contraindications
Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1. Second or third degree atrioventricular ...
Special warnings and precautions for use
Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications. A meta-analysis of randomised placebo-controlled trials ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation. <em>In vitro</em> eslicarbazepine ...
Fertility, pregnancy and lactation
Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy using an antiepileptic treatment, the prevalence of malformations ...
Effects on ability to drive and use machines
Zebinix has minor to moderate influence on the ability to drive and use machines. Some patients might experience dizziness, somnolence or visual disorders, particularly on initiation of treatment. Therefore, ...
Undesirable effects
Summary of the safety profile In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients ...
Overdose
Symptoms observed after an overdose of eslicarbazepine acetate are primarily associated with central nervous symptoms (e.g. seizures of all types, status epilepticus) and cardiac disorders (e.g. cardiac ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiepileptics, carboxamide derivatives ATC code: N03AF04 Mechanism of action The precise mechanisms of action of eslicarbazepine acetate are unknown. However, <em>in vitro</em> ...
Pharmacokinetic properties
Absorption Eslicarbazepine acetate is extensively converted to eslicarbazepine. Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration. ...
Preclinical safety data
Adverse reactions observed in animal studies occurred at exposure levels appreciably lower than the clinical exposure levels to eslicarbazepine (the principal and pharmacologically active metabolite of ...
List of excipients
Povidone K29/32 Croscarmellose sodium Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets. HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets. Not all pack sizes ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
BIAL-Portela & Ca SA, À Av. da Siderurgia Nacional, 4745-457, S. Mamede do Coronado, Portugal, tel: +351 22 986 61 00, fax: +351 22 986 61 99, e-mail: info@bial.com
Marketing authorization number(s)
EU/1/09/514/021-023
Date of first authorization / renewal of the authorization
Date of first authorisation: 21.04.2009 Date of latest renewal: 22.01.2014
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