Country: European Union
Language: English
Source: EMA (European Medicines Agency)
teriparatide
EuroGenerics Holdings B.V.
H05AA02
teriparatide
Calcium homeostasis
Osteoporosis
Qutavina is indicated in adults.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 non-vertebral fractures but not hip fractures have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Withdrawn
2020-08-27
21 B. PACKAGE LEAFLET Medicinal product no longer authorised 22 PACKAGE LEAFLET: INFORMATION FOR THE USER QUTAVINA 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION IN PRE-FILLED PEN teriparatide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects 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 Qutavina is and what it is used for 2. What you need to know before you use Qutavina 3. How to use Qutavina 4. Possible side effects 5. How to store Qutavina 6. Contents of the pack and other information 1. WHAT QUTAVINA IS AND WHAT IT IS USED FOR Qutavina contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation. Qutavina 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 QUTAVINA DO NOT USE QUTAVINA 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 ca Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 Qutavina 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*. Each pre-filled pen of 2.7 mL contains 675 micrograms of teriparatide (corresponding to 250 micrograms per mL). *Teriparatide, rhPTH(1-34), produced in_ P. fluorescens_, 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 Qutavina 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 have 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 Qutavina is 20 micrograms administered once daily. The maximum total duration of treatment with Qutavina should be 24 months (see section 4.4). The 24-month course of Qutavina 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 Qutavina therapy, patients may be continued on other osteoporosis therapies. Medicinal product no longer authorised 3 _Special p Read the complete document