Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
AMIFAMPRIDINE
MEDISON PHARMA LTD
N07XX05
TABLETS
AMIFAMPRIDINE 10 MG
PER OS
Required
SERB S.A., BELGIUM
AMIFAMPRIDINE
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults
2022-01-31
ךיראת : 270/702/27 םושירה רפסמו תילגנאב רישכת םש : 146-29-33301-01 FIRDAPSE TABLETS םושירה לעב םש : מ"עב המראפ ןוסידמ ! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Carcinogenicity risk Amifampridine has not been fully tested in carcinogenicity models, and the carcinogenicity risk associated with treatment has not been determined. The use of amifampridine in patients with the non- paraneoplastic form of LEMS should only be commenced following a thorough assessment of the risk-benefit to the patient. Carcinogenicity risk Amifampridine has not been fully tested in carcinogenicity models, and the carcinogenicity risk associated with treatment has not been determined. The use of amifampridine in patients with the non-paraneoplastic form of LEMS should only be commenced following a thorough assessment of the risk-benefit to the patient. In a 2-year dietary carcinogenicity study, benign and malignant Schwannomas have been observed in rats treated with amifampridine (see section 5.3). Amifampridine was not genotoxic in a standard battery of _in vitro_ and _in vivo_ tests. The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time. Most Schwannomas are benign and asymptomatic. They can present in many locations, therefore the clinical presentation can be varied. A diagnosis of Schwannoma should be considered for patients who present with symptoms such as a mass that is painful on palpation or symptoms similar to a compressive neuropathy. Schwannomas are generally slow-growing and can exist for months to years without producing symptoms. The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma. Amifampridine should be used with caution in patients with an increased risk of Schwannomas, such as patients with past Đọc toàn bộ tài liệu
1 Physician Prescribing Information 1. NAME OF THE MEDICINAL PRODUCT FIRDAPSE 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, flat-faced on one side and scored on the other side. The tablets can be divided into equal halves. 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 FIRDAPSE 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 _ 2 FIRDAPSE 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 FIRDAPSE in children aged 0 to 17 years has not been established. No data are available. Method of administration For oral use only. 4.3 CONTRAIND Đọc toàn bộ tài liệu