Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
parathyroid hormone
Takeda Pharmaceuticals International AG Ireland Branch
H05AA03
parathyroid hormone
Calcium homeostasis
Hypoparathyroidism
Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Revision: 16
Authorised
2017-04-24
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NATPAR 25 MICROGRAMS/DOSE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NATPAR 50 MICROGRAMS/DOSE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NATPAR 75 MICROGRAMS/DOSE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NATPAR 100 MICROGRAMS/DOSE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Parathyroid hormone 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 Natpar is and what it is used for 2. What you need to know before you use Natpar 3. How to use Natpar 4. Possible side effects 5. How to store Natpar 6. Contents of the pack and other information 7. Instructions for use 1. WHAT NATPAR IS AND WHAT IT IS USED FOR WHAT IS NATPAR? Natpar is a hormone replacement for adults with under-active parathyroid glands, a condition known as ‘hypoparathyroidism’. Hypoparathyroidism is a disease caused by low levels of parathyroid hormone, which is produced by the parathyroid glands in the neck. This hormone controls the amount of calcium and phosphate in the blood and urine. If your levels of parathyroid hormone are too low, you can have low blood calcium. Low calcium can cause symptoms in many parts of your body, including the bones, heart, skin, muscles, kidneys, brain and nerves. For a list of symptoms of low ca Прочетете целия документ
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 Natpar 25 micrograms/dose powder and solvent for solution for injection Natpar 50 micrograms/dose powder and solvent for solution for injection Natpar 75 micrograms/dose powder and solvent for solution for injection Natpar 100 micrograms/dose powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Natpar 25 micrograms Each dose contains 25 micrograms parathyroid hormone (rDNA)* in 71.4 microlitre solution following reconstitution. Each cartridge contains 350 micrograms parathyroid hormone (rDNA). Natpar 50 micrograms Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 700 micrograms parathyroid hormone (rDNA). Natpar 75 micrograms Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 1050 micrograms parathyroid hormone (rDNA). Natpar 100 micrograms Each dose contains 100 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 1400 micrograms parathyroid hormone (rDNA). *Parathyroid hormone (rDNA), produced in _E. coli_ using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone. Excipient(s) with known effect Each dose contains 0.32 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white and the solvent is a clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyro Прочетете целия документ