国家: 瑞典
语言: 瑞典文
来源: Läkemedelsverket (Medical Products Agency)
lakosamid
G.L. Pharma GmbH
N03AX18
lacosamide
10 mg/ml
Sirap
sorbitol Hjälpämne; glycerol 85% Hjälpämne; lakosamid 10 mg Aktiv substans; metylparahydroxibensoat Hjälpämne
Receptbelagt
Förpacknings: Flaska, 100 ml (med doskopp och doseringsspruta); Flaska, 200 ml (med doskopp och doseringsspruta); Flaska, 300 ml (med doskopp och doseringsspruta); Flaska, 500 ml (med doskopp och doseringsspruta)
Godkänd
2018-06-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRELEMA 10 MG/ML SYRUP lacosamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Lacosamide] is and what it is used for 2. What you need to know before you take [Lacosamide] 3. How to take [Lacosamide] 4. Possible side effects 5. How to store [Lacosamide] 6. Contents of the pack and other information 1. WHAT [LACOSAMIDE] IS AND WHAT IT IS USED FOR WHAT [LACOSAMIDE] IS [Lacosamide] contains lacosamide. This belongs to a group of medicines called ‘antiepileptic medicines’. These medicines are used to treat epilepsy. You have been given this medicine to lower the number of fits (seizures) you have. WHAT [LACOSAMIDE] IS USED FOR - [Lacosamide] is used: - on its own and in association with other antiepileptic medicines in adults, adolescents and children aged 2 years and older to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain; - in association with other antiepileptic medicines in adults, adolescents and children aged 4 years and older to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [LACOSAMIDE] DO NOT TAKE [LACOSAMIDE] - i 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Trelema 10 mg/ml syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of syrup contains 10 mg lacosamide. Excipients with known effect: Each ml of syrup contains 187 mg sorbitol (E 420), 2.27 mg methyl hydroxybenzoate (E 218), and 1.35 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup A slightly viscous clear, colourless to yellow-brown liquid with the smell and taste of strawberries. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Lacosamide] is indicated as monotherapy and 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lacosamide must be taken twice a day (usually once in the morning and once in the evening). Lacosamide may be taken with or without food. If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose. _Adolescents and children weighing 50 kg or more, and adults_ The following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. More details are provided in the table below. Monotherapy Adjunctive therapy Starting dose 100 mg/day or 200 mg/day 100 mg/day Single loading dose (if applicable) 200 mg 200 mg Titration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervals Maximum recommended dose up to 600 mg/day up to 400 mg/day _Monotherapy_ The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day af 阅读完整的文件