VIMPAT Solution for infusion (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
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Vimpat 10 mg/ml solution for infusion.
Qualitative and quantitative composition
Each ml of solution for infusion contains 10 mg lacosamide. Each vial of 20 ml solution for infusion contains 200 mg lacosamide. <u>Excipients with known effect:</u> Each ml of solution for infusion contains ...
Pharmaceutical form
Solution for infusion. Clear, colourless solution.
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. Lacosamide therapy can be initiated with either oral administration (either tablets or ...
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 After intravenous administration, C<sub>max</sub> is reached at the end of infusion. The plasma concentration increases proportionally with dose after oral (100-800 mg) and intravenous (50-300 ...
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
Water for injections Sodium chloride Hydrochloric acid (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
3 years. Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with the diluents mentioned in 6.6 and stored in glass or PVC bags. From ...
Special precautions for storage
Do not store above 25°C. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Colourless type I glass vial with a chlorobutyl rubber closure coated with a fluoropolymer. Packs of 1x20 ml and 5x20 ml. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Product with particulate matter or discolouration should not be used. This medicinal product is for single use only, any unused solution should be discarded. Any unused medicinal product or waste material ...
Marketing authorization holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/08/470/016-017
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 August 2008 Date of latest renewal: 31 July 2013
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
