البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DIFELIKEFALIN AS ACETATE
CTS LTD
V03AX04
SOLUTION FOR INJECTION
DIFELIKEFALIN AS ACETATE 50 MCG / 1 ML
I.V
Required
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA, FRANCE
DIFELIKEFALIN
Korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis
2023-06-27
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only KORSUVA SOLUTION FOR INJECTION 50 MICROGRAMS/ 1 ML ACTIVE INGREDIENT AND ITS CONCENTRATION: Each 1 ml of solution contains 50 mcg of difelikefalin. Inactive and allergenic ingredients in the preparation – for the list of inactive and allergenic ingredients in the preparation - see Section 6. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or 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? Korsuva is used to treat moderate to severe itching related to chronic kidney disease in adults who undergo hemodialysis. THERAPEUTIC GROUP: All other therapeutic products Korsuva contains the active substance difelikefalin. Korsuva acts on targets in the body called kappa-opioid receptors, which are involved in controlling the perception of itching. By stimulating these receptors on nerve and immune cells outside the brain, Korsuva relieves the itching sensation caused by chronic kidney disease. The active substance difelikefalin does not cross the blood-brain barrier (a natural barrier between blood vessels and the brain), reducing the risk of side effects. 2. BEFORE USING THIS MEDICINE: DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to difelikefalin, or to any of the other ingredients contained in the medicine (see Section 6). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Before the treatment with Korsuva, tell the doctor or nurse if: you have an increased level of potassium in your blood you have or have had heart weakness or arrhythmia (irregular heartbeat) you have reduced function of the blood-brain barrier (for example, due to cancer in the br اقرأ الوثيقة كاملة
2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kosruva 50 micrograms/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 1 mL contains 50 micrograms difelikefalin (as acetate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution, free from particles (pH 4.5). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kosruva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Korsuva should be restricted for in-centre haemodialysis use only. Korsuva is intended for use by healthcare professionals experienced in the diagnosis and treatment of conditions for which difelikefalin is indicated. Causes of pruritus other than chronic kidney disease should be excluded before initiating treatment with difelikefalin. Posology Difelikefalin is administered 3 times per week by intravenous bolus injection into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back or after rinse-back. The recommended dose of difelikefalin is 0.5 micrograms/kg dry body weight (i.e., the target postdialysis weight). The total dose volume (mL) required from the vial should be calculated as follows: 0.01 × dry body weight (kg), rounded to the nearest tenth (0.1 mL). For patients with a dry body weight equal to or above 195 kg the recommended dose is 100 micrograms (2 mL). Injection volumes are detailed in the table below: WEIGHT RANGE (Dry body weight in kg) INJECTION VOLUME 1 (mL) 40 – 44 0.4 45 – 54 0.5 55 – 64 0.6 65 – 74 0.7 75 – 84 0.8 85 – 94 0.9 3 95 – 104 1.0 105 – 114 1.1 115 – 124 1.2 125 – 134 1.3 135 – 144 1.4 145 – 154 1.5 155 – 164 1.6 165 – 174 1.7 175 – 184 1.8 185 – 194 1.9 ≥ 195 2.0 1 More than 1 vial may be necessary if an injection volume of more than 1 mL is required. An effect of difelik اقرأ الوثيقة كاملة