Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
parathyroid hormone (rDNA)
NPS Pharma Holdings Limited
H05AA03
parathyroid hormone (rDNA)
Calcium homeostasis
Osteoporosis, Postmenopausal
Treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Revision: 4
Withdrawn
2006-04-24
19 B. PACKAGE LEAFLET Medicinal product no longer authorised 20 PACKAGE LEAFLET: INFORMATION FOR THE USER PREOTACT 100 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN A PRE-FILLED PEN Parathyroid hormone 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 your 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 WHAT IS IN THIS LEAFLET 1. What Preotact is and what it is used for : 2. What you need to know before you use Preotact 3. How to use Preotact 4. Possible side effects 5 How to store Preotact 6. Contents of the pack and other information 1. WHAT PREOTACT IS AND WHAT IT IS USED FOR Preotact is used to treat osteoporosis in women past menopause with high risk of fractures. Osteoporosis is a disease that causes bones to become thin and fragile. It is especially common in women after the menopause. The disease progresses gradually so you may not feel any symptoms at first. But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists. It may also cause back pain, loss of height, and a curved back. Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength. It has not been shown that Preotact reduces the risk of breaking your hip. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PREOTACT DO NOT USE PREOTACT • if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed in section 6); • if you shall have or previously have had radiation therapy to the skeleton; • if you have cancer of the bones; • if you suffer from high calcium levels in your blood or oth Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses. After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone produced in _Escherichia coli _ by recombinant DNA technology For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White to off-white powder and clear, colourless solvent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1). A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is 100 micrograms of parathyroid hormone administered once-daily Posology Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Data support continuous treatment with Preotact for up to 24 months (see section 4.4). Following treatment with Preotact patients can be treated with a bisphosphonate to further increase bone mineral density (see section 5.1). _Renal impairment _ _Special populations _ No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min). There is no data available in patients with severe renal impairment. Preotact should therefore not be used in patients with severe renal impairment (see section 4.3). _Hepatic impairment _ No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale). There is no data available in patients with severe hepatic impairment. Preotact should therefore not be used in patients with severe hepatic impairment (see s Citiți documentul complet