מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
sodium zirconium cyclosilicate
AstraZeneca AB
V03AE10
sodium zirconium cyclosilicate
All other therapeutic products
Hyperkalemia
Lokelma is indicated for the treatment of hyperkalaemia in adult patients.
Revision: 9
Authorised
2018-03-22
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOKELMA 5 G POWDER FOR ORAL SUSPENSION LOKELMA 10 G POWDER FOR ORAL SUSPENSION sodium zirconium cyclosilicate 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lokelma is and what it is used for 2. What you need to know before you take Lokelma 3. How to take Lokelma 4. Possible side effects 5. How to store Lokelma 6. Contents of the pack and other information 1. WHAT LOKELMA IS AND WHAT IT IS USED FOR Lokelma contains the active substance sodium zirconium cyclosilicate. Lokelma is used to treat hyperkalaemia in adults. Hyperkalaemia means that there is a high level of potassium in the blood. Lokelma lowers the high levels of potassium in your body and helps to keep it at a normal level. As Lokelma passes through your stomach and gut it attaches to potassium and the two are carried together out of the body in your stools, lowering the amount of potassium in the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOKELMA DO NOT TAKE LOKELMA If you are allergic to the active substance. WARNINGS AND PRECAUTIONS Monitoring Your doctor or nurse will check your blood potassium level when you start taking this medicine: This is to make sure you are getting the correct dose. The dose may be raised or lowered based on your blood potassium level. Treatment may be stopped if your blood potassium level becomes too low. Tell your doctor or nurse if you are taking any medicines which can change your blood potassium lev קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lokelma 5 g powder for oral suspension Each sachet contains 5 g sodium zirconium cyclosilicate Each 5 g sachet contains approximately 400 mg sodium. Lokelma 10 g powder for oral suspension Each sachet contains 10 g sodium zirconium cyclosilicate Each 10 g sachet contains approximately 800 mg sodium. 3. PHARMACEUTICAL FORM Powder for oral suspension White to grey powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lokelma is indicated for the treatment of hyperkalaemia in adult patients (see section 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Correction phase _ The recommended starting dose of Lokelma is 10 g, administered three times a day orally as a suspension in water. When normokalaemia is achieved, the maintenance regimen should be followed (see below). Typically, normokalaemia is achieved within 24 to 48 hours. If patients are still hyperkalaemic after 48 hours of treatment, the same regimen can be continued for an additional 24 hours. If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered. _Maintenance phase_ When normokalaemia has been achieved, the minimal effective dose of Lokelma to prevent recurrence of hyperkalaemia should be established. A starting dose of 5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level. No more than 10 g once daily should be used for maintenance therapy. Serum potassium levels should be monitored regularly during treatment (see section 4.4). _Missed dose_ If a patient misses a dose they should be instructed to take the next usual dose at their normal time. 3 _Special populations_ _Patients with renal impairment_ No changes from the normal doses are required for patients with renal impai קרא את המסמך השלם