Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
teriparatide
Strides Pharma (Cyprus) Limited
H05AA02
teriparatide
Calcium homeostasis
Osteoporosis; Osteoporosis, Postmenopausal
Kauliv is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).,
Revision: 1
Authorised
2023-01-12
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER KAULIV 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION teriparatide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side affects 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kauliv is and what it is used for 2. What you need to know before you use Kauliv? 3. How to use Kauliv 4. Possible side effects 5. How to store Kauliv? 6. Contents of the pack and other information 1. WHAT KAULIV IS AND WHAT IT IS USED FOR Kauliv contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation. Kauliv is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving medicines called corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KAULIV DO NOT USE KAULIV • if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6). • if you have high levels of calcium in your blood (pre-existing hypercalcaemia). • if you suffer from serious kidney problems. • if you have ever had bone cancer or if other cancers have spread (metastasised) to your bone Olvassa el a teljes dokumentumot
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 Kauliv 20 micrograms/80 microliters solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 80 microliters contains 20 micrograms of teriparatide*. Each cartridge of 3 mL of solution contains 750 micrograms of teriparatide (corresponding to 250 micrograms per mL). *Teriparatide, rhPTH (1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Colourless, clear solution for injection. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Kauliv is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non- vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Kauliv is 20 micrograms administered once daily. Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate. The maximum total duration of treatment with teriparatide should be 24 months (see section 4.4). The 24-month course of teriparatide should not be repeated over a patient’s lifetime. Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies. _Special populations _ _ _ 3 _Elderly _ Dose adjustment based on age is not required (see Olvassa el a teljes dokumentumot