국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
amifampridine phosphate
SERB SA
N07XX05
amifampridine
Other nervous system drugs
Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Authorised
2022-05-19
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER AMIFAMPRIDINE SERB 10 MG TABLETS amifampridine 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 Amifampridine SERB is and what it is used for 2. What you need to know before you take Amifampridine SERB 3. How to take Amifampridine SERB 4. Possible side effects 5. How to store Amifampridine SERB 6. Contents of the pack and other information 1. WHAT AMIFAMPRIDINE SERB IS AND WHAT IT IS USED FOR Amifampridine SERB contains the active substance amifampridine. Amifampridine SERB is used to treat symptoms of a disease of the nerves and the muscles called Lambert-Eaton myasthenic syndrome or LEMS in adults. This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness. It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS). In patients suffering from this disease, a chemical substance called acetylcholine, which communicates nerve impulses to muscles is not released normally and the muscle doesn't receive some or all of the nerve's signals. Amifampridine SERB works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIFAMPRIDINE SERB DO NOT TAKE AMIFAMPRIDINE SERB If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6). If you have uncontrolled asthma If you are e 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Amifampridine SERB 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, round tablet of approximately 10 mm, flat-faced on one side and scored on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. Posology Amifampridine SERB should be given in divided doses, three or four times a day. The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day. No single dose should exceed 20 mg. Tablets are to be taken with food. Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state. If treatment is discontinued, patients may experience some of the symptoms of LEMS. _Renal or hepatic impairment _ Amifampridine SERB should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function. For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days. If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2). _Paediatric population_ The safety and efficacy of Amifampridine SERB in children aged 0 to 17 years has not been establish 전체 문서 읽기