국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
asfotase alfa
Alexion Europe SAS
A16AB
asfotase alfa
Other alimentary tract and metabolism products,
Hypophosphatasia
Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.
Revision: 16
Authorised
2015-08-28
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER STRENSIQ 40 MG/ML SOLUTION FOR INJECTION (12 MG/0.3 ML 18 MG/0.45 ML 28 MG/0.7 ML 40 MG/1 ML) asfotase alfa 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 Strensiq is and what it is used for 2. What you need to know before you use Strensiq 3. How to use Strensiq 4. Possible side effects 5. How to store Strensiq 6. Contents of the pack and other information 1. WHAT STRENSIQ IS AND WHAT IT IS USED FOR WHAT IS STRENSIQ Strensiq is a medicine used to treat the inherited disease hypophosphatasia that started in childhood. It contains the active substance asfotase alfa. WHAT IS HYPOPHOSPHATASIA Patients with hypophosphatasia have low levels of an enzyme called alkaline phosphatase that is important for various body functions, including the proper hardening of bones and teeth. Patients have problems with bone growth and strength, which can lead to broken bones, bone pain, and difficulty walking, as well as difficulties with breathing and a risk of seizures (fits). WHAT IS STRENSIQ USED FOR The active substance in Strensiq can replace the missing enzyme (alkaline phosphatase) in hypophosphatasia. It is used for long-term enzyme replacement treatment to manage symptoms. WHAT BENEFITS OF STRENSIQ HAVE 전체 문서 읽기
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 Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Strensiq 40 mg/ml solution for injection Each ml of solution contains 40 mg of asfotase alfa*. Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40 mg/ml). Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40 mg/ml). Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40 mg/ml). Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40 mg/ml). Strensiq 100 mg/ml solution for injection Each ml of solution contains 100 mg of asfotase alfa*. Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100 mg/ml). * produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, slightly opalescent or opalescent, colourless to slightly yellow, aqueous solution; pH 7.4. A few small translucent or white particles may be present. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders. 3 Posology Recommended dosage regimen of asfotase alfa is 2 mg/kg of body weight administered subcutaneously three times per week, or a dosage regimen of 1 mg/kg of body weight administered subcutaneously six times per week. Maximum recommended dose of asfotas 전체 문서 읽기