Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
Recombinant salmon calcitonin
Unigene UK Ltd.
H05BA01
recombinant salmon calcitonin
Calcium homeostasis
Hypercalcemia; Osteitis Deformans; Bone Resorption
Calcitonin is indicated for:Prevention of acute bone loss due to sudden immobilisation such as in patients with recentosteoporotic fracturesPaget's diseaseHypercalcaemia of malignancy
Withdrawn
1999-01-11
Medicinal product no longer authorised 16 B. PACKAGE LEAFLET Medicinal product no longer authorised 17 PACKAGE LEAFLET Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What FORCALTONIN is and what it is used for 2. Before you use FORCALTONIN 3. How to use FORCALTONIN 4. Possible side effects 5. Storing FORCALTONIN FORCALTONIN 100 IU Solution for Injection, recombinant salmon calcitonin - The active substance is recombinant salmon calcitonin. Each ampoule contains 100 IU (15 micrograms in 1.0 ml) of recombinant salmon calcitonin. The salmon calcitonin contained in Forcaltonin is not made by a conventional, chemical method but by genetic engineering. However, the structure of the active substance of FORCALTONIN is the same as that of chemically synthesised salmon calcitonin. The effects of recombinant salmon calcitonin on the body have also been shown to be equivalent to those of synthetic salmon calcitonin. - The other ingredients are acetic acid, glacial, sodium acetate trihydrate, sodium chloride and water for injections. The Marketing Authorisation Holder for FORCALTONIN is Unigene UK Limited, 191 Sparrows Herne, Bushey Heath, Hertfordshire WD23 1AJ, UK. The manufacturer is FAMAR S.A., 7 P. Marinopoulou Str., 174 56 Alimos, Athens, Greece. 1. WHAT FORCALTONIN IS AND WHAT IT IS USED FOR FORCALTONIN is a solution for injection. The solution is clear, colourless and sterile. It is contained in a glass ampoule. Each ampoule of FORCALTONIN contains 1 ml of solution with 100 International Units (IU) of the active substance. This corresponds to about 15 micrograms of recombinant salmon calcitonin. Each pack contains 10 ampoules. The active substance of FORCALTONIN is recombinant salmon calcit Διαβάστε το πλήρες έγγραφο
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Forcaltonin 100 IU solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule of Forcaltonin 100 IU contains 100 International Units (IU) corresponding to approximately 15 micrograms recombinant salmon calcitonin (produced by recombinant DNA technology in _Escherichia coli) _in 1 ml of an acetate buffer. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear colourless solution 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Calcitonin is indicated for: • Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures • Paget’s disease • Hypercalcaemia of malignancy 4.2 Posology and method of administration For subcutaneous, intramuscular or intravenous infusion (product specific) use in individuals aged 18 years or more. Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. _Prevention of acute bone loss: _ The recommended dosage is 100 I.U. daily or 50 I.U. twice daily for 2 to 4 weeks, administered subcutaneously or intramuscularly. The dose may be reduced to 50 I.U. daily at the start of remobilisation. The treatment should be maintained until patients are fully mobilized. _Paget’s disease: _ The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement. Dosage is to be adjusted to the individual patient’s needs. The duration of treatment depends on the indication for treatment and the patient´s response. The effect of calcitonin may be monitored by measurement of suitable markers of bone remodeling, such as serum alkaline Medicinal product no longer authorised 3 phosphatase or urinary hydroxyproline or de Διαβάστε το πλήρες έγγραφο