Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Metreleptin
Amryt Pharmaceuticals DAC
A16AA
metreleptin
Other alimentary tract and metabolism products,
Lipodystrophy, Familial Partial
Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and abovewith confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
Revision: 9
Authorised
2018-07-29
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MYALEPTA 3 MG POWDER FOR SOLUTION FOR INJECTION metreleptin This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Myalepta is and what it is used for 2. What you need to know before you use Myalepta 3. How to use Myalepta 4. Possible side effects 5. How to store Myalepta 6. Contents of the pack and other information 1. WHAT MYALEPTA IS AND WHAT IT IS USED FOR Myalepta contains the active substance metreleptin. Metreleptin is similar to a human hormone called leptin. WHAT MYALEPTA IS USED FOR Myalepta is used to treat the complications of not having enough leptin in patients with lipodystrophy. It is used in adults, adolescents and children 2 years or over: - who have generalised lipodystrophy (the whole of your body does not have enough fatty tissue) It is used, when other treatments have been ineffective, in adults, and adolescents 12 years or over: - who have partial lipodystrophy which is inherited (also called congenital or familial lipodystrophy) - or partial lipodystrophy has been caused by your body’s response to something such as a viral illness (also called acquired lipodystrophy) HOW MYALEPTA WORKS Natural leptin is produced by fatty tissue and has many functions in the body including Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Myalepta 3 mg powder for solution for injection. Myalepta 5.8 mg powder for solution for injection. Myalepta 11.3 mg powder for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Myalepta 3 mg powder for solution for injection Each vial contains 3 mg of metreleptin*. After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin. Myalepta 5.8 mg powder for solution for injection Each vial contains 5.8 mg of metreleptin*. After reconstitution with 1.1 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin. Myalepta 11.3 mg powder for solution for injection Each vial contains 11.3 mg of metreleptin*. After reconstitution with 2.2 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin. *Metreleptin is a recombinant human leptin analogue (produced in Escherichia coli cells by recombinant DNA technology to form recombinant methionyl-human leptin). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection (powder for injection). White lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above 3 • with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabo Прочетете целия документ