País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Teriparatide
Teva B.V.
H05AA; H05AA02
Teriparatide
20/80
Solution for injection in pre-filled pen
Product subject to prescription which may not be renewed (A)
Parathyroid hormones and analogues; teriparatide
Not marketed
2018-06-22
1 V3.0 – March 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER TERIPARATIDE TEVA 20 MICROGRAMS/80 MICROLITRES 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 Teriparatide Teva is and what it is used for 2. What you need to know before you use Teriparatide Teva 3. How to use Teriparatide Teva 4. Possible side effects 5. How to store Teriparatide Teva 6. Contents of the pack and other information 1. WHAT TERIPARATIDE TEVA IS AND WHAT IT IS USED FOR Teriparatide Teva contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation. Teriparatide Teva 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 TERIPARATIDE TEVA DO NOT USE TERIPARATIDE TEVA: • 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 unexplain Llegiu el document complet
Health Products Regulatory Authority 17 April 2019 CRN009091 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teriparatide Teva 20 micrograms/80 microlitres Solution for Injection in pre-filled pen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 80 microlitres 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 (1-34) 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 (injection). Colourless, clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teriparatide Teva 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 Teriparatide Teva is 20 micrograms administered once daily. The maximum total duration of treatment with Teriparatide Teva should be 24 months (see section 4.4). The 24-month course of teriparatide 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 teriparatide therapy, patients may be continued on other osteoporosis therapies. Special populations _Patients with renal impairment _ Teriparatide must not be used in patients with severe renal impairment (see section 4.3). In patients with moderate renal impairment, teriparatide should be used with caution. No special caution is required for patients with mild renal impairment. _Pat Llegiu el document complet