Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
ASFOTASE ALFA
ALEXION PHARMA ISRAEL LTD
A16AB13
SOLUTION FOR INJECTION
ASFOTASE ALFA 40 MG / 1 ML
S.C
Required
ALEXION PHARMA GMBH, SWITZERLAND
ASFOTASE ALFA
Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.
2021-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS ’ REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied upon a physician's prescription only STRENSIQ ® 40 MG/ML SOLUTION FOR SUBCUTANEOUS INJECTION STRENSIQ ® 100 MG/ML SOLUTION FOR SUBCUTANEOUS INJECTION THE ACTIVE INGREDIENT AND ITS CONCENTRATION: Each 1 ml contains: asfotase alfa 40 mg THE ACTIVE INGREDIENT AND ITS CONCENTRATION: Each 1 ml contains: asfotase alfa 100 mg For the list of excipients, please see section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to your physician or pharmacist. This medicine has been prescribed for your illness. Do not pass it on to others. It may harm them, even if you think that their illness is similar to yours. In addition to the leaflet, there is a patient safety information card for Strensiq. This card contains important safety information that you need to know, before commencing treatment and during the course of the treatment with Strensiq and adhere to. Read the patient safety information card and this patient leaflet before commencing use of this medicine. Keep the card for further review, if necessary 1. WHAT IS THE MEDICINE USED FOR? Strensiq is a medicine used to treat the inherited disease hypophosphatasia that started in childhood. Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease. THERAPEUTIC GROUP: Other alimentary tract and metabolism products, Enzymes. 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). The active substance in S Lesen Sie das vollständige Dokument
1 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. Patient safety information card The marketing of Strensiq is subject to a risk management plan (RMP) including a ‘Patient safety information card’. The ‘Patient safety information card’, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 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. 2 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 bo Lesen Sie das vollständige Dokument