Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patiromer sorbitex calcium
Vifor Pharma UK Ltd
V03AE09
Patiromer sorbitex calcium
8.4gram
Powder
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF:
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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) 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 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 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 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. Veltassa is used to treat adults with high levels of potassium in their blood. Too much potassium in the blood can affect how your nerves control your 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 heart rhythm. Veltassa works by attaching to potassium in your gut. This prevents potassium from entering your bloodstream and lowers potassium levels in your blood back to normal. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VELTASSA DO NOT TAKE VELTASSA • if you are allergic to patiromer or any of the other ingredients of this medicine (listed in section 6). 2 WARNINGS AND PRECAUTIONS Tal Lire le document complet
OBJECT 1 VELTASSA (PATIROMER) Summary of Product Characteristics Updated 07-Aug-2017 | Vifor Fresenius Medical Care Renal Pharma UK Ltd 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 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 Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium) Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium) 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. 4.2 Posology and method of administration Posology The recommended starting dose is 8.4 g patiromer once daily. The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued. If a dose is missed, the missed dose should be taken as soon as possible on the same day. The missed dose should not be taken with the next dose. Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see section 4.5). The onset of action of Veltassa occurs 4 – 7 hours after administration. Veltassa should not replace emergency treatment for life threatening hyperkalaemia. _Patients on dialysis_ There is limited data on the use of Ve Lire le document complet