País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Asfotase alfa
Alexion Pharma UK Ltd
A16AB13
Asfotase alfa
40mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5391527741350
1 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. 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 been shown in clinical studies Strensiq has shown Llegiu el document complet
OBJECT 1 STRENSIQ 40 MG/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 15-Mar-2018 | Alexion Pharma UK Ltd 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, colourless to slightly yellow, aqueous solution; pH 7.4. 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. 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. Refer to the dosing chart below for more details. Llegiu el document complet