VIMPAT Syrup (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Vimpat 10 mg/ml syrup.
Qualitative and quantitative composition
Each ml of syrup contains 10 mg lacosamide. 1 bottle of 200 ml contains 2,000 mg lacosamide. Excipients with known effect: Each ml of Vimpat syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl ...
Pharmaceutical form
Syrup. A slightly viscous clear, colourless to yellow-brown liquid.
Therapeutic indications
Vimpat is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Vimpat is indicated ...
Posology and method of administration
Posology The physician should prescribe the most appropriate formulation and strength according to weight and dose. The recommended posology for adults, adolescents and children from 2 years of age is ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known second- or third-degree atrioventricular (AV) block.
Special warnings and precautions for use
Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. A meta-analysis of randomised placebo-controlled ...
Interaction with other medicinal products and other forms of interaction
Lacosamide should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) and in ...
Fertility, pregnancy and lactation
Women of childbearing potential Physicians should discuss family planning and contraception with women of childbearing potential taking lacosamide (see Pregnancy). If a woman decides to become pregnant, ...
Effects on ability to drive and use machines
Lacosamide has minor to moderate influence on the ability to drive and use machines. Lacosamide treatment has been associated with dizziness or blurred vision. Accordingly, patients should be advised not ...
Undesirable effects
Summary of safety profile Based on the analysis of pooled placebo-controlled clinical studies in adjunctive therapy in 1,308 patients with partial-onset seizures, a total of 61.9% of patients randomised ...
Overdose
Symptoms Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system. The types of adverse reactions experienced by patients ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antiepileptics, other antiepileptics <b>ATC code:</b> N03AX18 Mechanism of action The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a ...
Pharmacokinetic properties
Absorption Lacosamide is rapidly and completely absorbed after oral administration. The oral bioavailability of lacosamide tablets is approximately 100%. Following oral administration, the plasma concentration ...
Preclinical safety data
In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only marginally higher than those observed in patients, which leaves low or non-existing margins to human exposure. ...
List of excipients
Glycerol (E422) Carmellose sodium Sorbitol liquid (crystallizing) (E420) Polyethylene glycol 4000 Sodium chloride Citric acid, anhydrous Acesulfame potassium (E950) Sodium methyl parahydroxybenzoate (E219) ...
Incompatibilities
Not applicable.
Shelf life
3 years. <u>After first opening:</u> 6 months.
Special precautions for storage
Do not refrigerate.
Nature and contents of container
A 200 ml amber glass bottle with white polypropylene screw cap, a 30 ml measuring cup and a 10 ml oral syringe (black graduation marks) with an adaptor. One full 30 ml measuring cup corresponds to 300 ...
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
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/08/470/018
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 August 2008 Date of latest renewal: 31 July 2013
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