Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
patiromer sorbitex calcium
Vifor Fresenius Medical Care Renal Pharma France
V03AE09
patiromer
Drugs for treatment of hyperkalemia and hyperphosphatemia
Hyperkalemia
Veltassa is indicated for the treatment of hyperkalaemia in adults.
Revision: 7
Authorised
2017-07-19
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VELTASSA 1 G POWDER FOR ORAL SUSPENSION VELTASSA 8.4 G POWDER FOR ORAL SUSPENSION VELTASSA 16.8 G POWDER FOR ORAL SUSPENSION VELTASSA 25.2 G POWDER FOR ORAL SUSPENSION patiromer (as patiromer sorbitex calcium) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START TAKING 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 or your child 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 or your child 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 Veltassa is and what it is used for 2. What you need to know before you take Veltassa 3. How to take Veltassa 4. Possible side effects 5. How to store Veltassa 6. Contents of the pack and other information 1. WHAT VELTASSA IS AND WHAT IT IS USED FOR Veltassa is a medicine that contains the active substance patiromer. This medicine is used to treat adults and adolescents aged 12 to 17 years with high levels of potassium in their blood. Too much potassium in the blood can affect how nerves control muscles. This can lead to weakness or even paralysis. High potassium levels can also result in an abnormal heartbeat, which can cause serious effects on your or your child’s heart rhythm. This medicine works by attaching to potassium in the gut. This prevents potassium from entering the bloodstream and lowers potassium levels in blood back to normal. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VELTASSA _ _ DO NOT TAKE VELTASSA • if you or your child are allergic to patiromer or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Veltassa if you Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Veltassa 1 g powder for oral suspension Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension Veltassa 25.2 g powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Veltassa 1 g powder for oral suspension Each sachet contains 1 g patiromer (as patiromer sorbitex calcium) Veltassa 8.4 g powder for oral suspension Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium). Veltassa 16.8 g powder for oral suspension Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium). Veltassa 25.2 g powder for oral suspension Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. Off white to light brown powder, with occasional white particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Veltassa is indicated for the treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The onset of action of Veltassa occurs 4 – 7 hours after administration. It should not replace emergency treatment for life threatening hyperkalaemia (see section 4.4). Posology Veltassa is administrated once daily. The recommended starting dose of Veltassa varies with age. Multiple sachets may be used to achieve the desired dose. The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. Serum potassium should be monitored when clinically indicated (see section 4.4). The duration of treatment should be individualized by the treating physician based on the need of serum potassium management. If serum potassium falls below the desired range, the dose should be reduced or discontinued. 3 _ _ Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see section 4.5). _Adults_ The recommended starting dose is 8.4 g patiromer Прочетете целия документ