Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
abaloparatide
Theramex Ireland Limited
H05AA04
abaloparatide
Calcium homeostasis
Osteoporosis, Postmenopausal; Osteoporosis
Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Revision: 2
Authorised
2022-12-12
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER ELADYNOS 80 MICROGRAMS/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN abaloparatide 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 Eladynos is and what it is used for 2. What you need to know before you use Eladynos 3. How to use Eladynos 4. Possible side effects 5. How to store Eladynos 6. Contents of the pack and other information 1. WHAT ELADYNOS IS AND WHAT IT IS USED FOR E ladynos contains the active substance abaloparatide. It is used to treat osteoporosis in women after menopause. Osteoporosis is especially common in women after menopause. The disease causes bones to become thin and fragile. If you have osteoporosis, you are more likely to break bones, especially in your spine, hips and wrists. This medicine is used to make bone stronger and less likely to break. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ELADYNOS DO NOT USE ELADYNOS IF YOU • are allergic to abaloparatide or any of the other ingredients of this medicine (listed in section 6) • are pregnant or breast-feeding • are still able to get pregnant • have high blood calcium levels • have severely reduced kidney function • have unexplained high blood levels of the enzyme alkaline phosphatase • have had radiation therapy involving yo Aqra d-dokument sħiħ
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 Eladynos 80 micrograms/dose solution for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (40 microliters) contains 80 micrograms of abaloparatide. Each pre-filled pen contains 3 mg of abaloparatide in 1.5 mL of solution (corresponding to 2 milligrams per mL). 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 Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 80 micrograms once daily. The maximum total duration of treatment with abaloparatide should be 18 months (see sections 4.4 and 5.1). Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Following cessation of abaloparatide therapy, patients may be continued on other osteoporosis therapies such as bisphosphonates. _Missed dose _ If a patient forgets or cannot administer their dose at the usual time, it can be injected within 12 hours of the normally scheduled time. Patients should not administer more than one injection in the same day and should not try to make up for a missed dose. T 3 _Special populations _ _Elderly patients _ Dose a djustment based on age is not required (see section 5.2). _Renal impairment _ Abaloparatide must not be used in patients with severe renal impairment including patients with end-stage renal disease (see section 4.3). In patients with mild to moderate renal impairment, dose-based adjustment is not required (see section 5.2). _Hepatic impairment _ No data are available in Aqra d-dokument sħiħ