Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
PATIROMER AS SORBITEX CALCIUM
CTS LTD
V03AE09
POWDER FOR SUSPENSION
PATIROMER AS SORBITEX CALCIUM 16.8 G
PER OS
Required
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD., SWITZERLAND
PATIROMER CALCIUM
Veltassa is indicated for the treatment of hyperkalaemia in adults
2023-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only VELTASSA 8.4 G POWDER FOR ORAL SUSPENSION. VELTASSA 16.8 G POWDER FOR ORAL SUSPENSION. Each sachet contains 8.4 g of patiromer (as patiromer sorbitex calcium). Each sachet contains 16.8 g of patiromer (as patiromer sorbitex calcium). For a list of inactive ingredients in the preparation – see section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Veltassa is used to treat adults with high levels of potassium in their blood. Too much potassium in the blood can affect the way your nerves control your muscles. This can lead to weakness or even paralysis. High potassium levels can result in abnormal heartbeat, which can severely affect your heart rhythm. Veltassa binds to potassium in your gut. This way Veltassa prevents potassium from reaching the blood and lowers potassium blood levels back to normal. THERAPEUTIC CLASS: Medicines for treatment of hyperkalemia and hyperphosphatemia. 2. BEFORE USING THE MEDICINE: DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to patiromer or any other ingredient of this medicine (see section 6). SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE: BEFORE TREATMENT WITH VELTASSA, INFORM THE DOCTOR IF: You have problems swallowing. You have severe stomach or bowel problems. You have had major surgery in your stomach or bowel. CHILDREN AND ADOLESCENTS Do not give Veltassa to children under 18 years of age, as it has not been studied in this age group. TESTS AND FOLLOW-UP Taking Veltassa may lead to low magnesium levels in the blood. Your doctor will check your magnesium leve Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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) 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. It should not replace emergency treatment for life-threatening hyperkalaemia. _ _ _Special population _ _ _ _Elderly population (≥65 years of age) _ No special dose and administration guidelines are recommended for this population. 2 _Patients on dialysis _ There is limited data on the use of Veltassa in patients on dialysis. No special dose and administration guidelines were applied to these patients in clinical studies. _Paediatric population _ The safety and efficacy of Veltassa in children aged under 18 years have not yet Læs hele dokumentet