Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
teriparatide
Eli Lilly Nederland B.V.
H05AA02
teriparatide
Calcium homeostasis
Osteoporosis; Osteoporosis, Postmenopausal
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral 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.
Revision: 24
Authorised
2003-06-10
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE USER FORSTEO 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION IN PRE-FILLED PEN teriparatide 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 FORSTEO is and what it is used for 2. What you need to know before you use FORSTEO 3. How to use FORSTEO 4. Possible side effects 5 How to store FORSTEO 6. Content of the pack and other information 1. WHAT FORSTEO IS AND WHAT IT IS USED FOR FORSTEO contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation. FORSTEO 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 corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FORSTEO DO NOT USE FORSTEO • if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6). • if you suffer from high calcium levels (pre-existing hypercalcaemia). • if you suffer from serious kidney problems. • if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones. • if you have certain bone diseases. If you have a bone disease, tell your doctor. • if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’s disease Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 80 microliters contains 20 micrograms of teriparatide*. One pre-filled pen of 2.4 mL contains 600 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FORSTEO 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 FORSTEO is 20 micrograms administered once daily. The maximum total duration of treatment with FORSTEO should be 24 months (see section 4.4). The 24-month course of FORSTEO should not be repeated over a patient’s lifetime. Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate. Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies. 3 Special populations _Patients with renal impairment _ FORSTEO must not be used in patients with severe renal impairment (see section 4.3.). In patients with moderate renal impairment, FORSTEO should be used with caution. No special caution is required for patients with mild renal impairment. _ _ _Patients with hepatic impairment _ No data are available in Pročitajte cijeli dokument