البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
FINERENON
BAYER ISRAEL LTD
C03DA05
FILM COATED TABLETS
FINERENON 20 MG
PER OS
Required
BAYER AG, GERMANY
FINERENON
Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
2023-01-04
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only KERENDIA 10 MG KERENDIA 20 MG film-coated tablets ACTIVE INGREDIENT KERENDIA 10 MG: Each tablet contains 10 mg finerenone. KERENDIA 20 MG: Each tablet contains 20 mg finerenone. Inactive ingredients and allergens: see section 2 under ”Important information about some of this medicine’s ingredients” and section 6 ”Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your 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 to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes. THERAPEUTIC GROUP: diuretics, aldosterone antagonists. Kerendia contains the active substance finerenone. Finerenone works by blocking the action of certain hormones )mineralocorticoids( that can damage the kidneys, heart and blood vessels. Chronic kidney disease is a long-term condition. The kidneys keep getting worse at removing waste and fluids from the blood. Type 2 diabetes develops when the body cannot maintain normal blood sugar levels. The body does not produce enough of the hormone insulin or cannot use the insulin properly. This leads to a high level of sugar in the blood. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive )allergic( to the active ingredient or to any of the other ingredients in this medicine )see section 6(. You are taking medicines that belong to the group of strong CYP3A4 inhibitors, for example ITRACONAZOL اقرأ الوثيقة كاملة
1 FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Kerendia 10 mg Kerendia 20 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kerendia 10 mg film-coated tablets Each film-coated tablet contains 10 mg of finerenone. Kerendia 20 mg film-coated tablets Each film-coated tablet contains 20 mg of finerenone. For the full list of excipients, see section 12. 3. PHARMACEUTICAL FORM Kerendia 10 mg film-coated tablets Pink Film-coated tablet, oval oblong, diameter of 10 mm and radius of curvature of 3.4 mm, Marked with “10” on Top side, and “FI” on the Bottom side Kerendia 20 mg film-coated tablets Pale Yellow Film-coated tablet, oval oblong, diameter of 10 mm and radius of curvature of 3.4 mm, Marked with “20” on Top side, and “FI” on the Bottom side. 4. THERAPEUTIC INDICATIONS Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non- fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). 5. DOSAGE AND ADMINISTRATION 5.1 Prior to Initiation of Kerendia Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L _ [see Warnings and Precautions (7.1_ _)]. _ 5.2 Recommended Starting Dosage The recommended starting dose of Kerendia is based on eGFR and is presented in Table 1. 2 Table 1: Recommended Starting Dosage eGFR (mL/min/1.73m 2 ) Starting Dose ≥ 60 20 mg once daily ≥ 25 to < 60 10 mg once daily < 25 Not Recommended For patients who are unable to swallow whole tablets, Kerendia may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally _[see Clinical Pharmacology (13.3_ _)]_ . 5.3 Monitoring and Dose Adjustment The target daily dose of Kerendia is 20 mg. Measure serum potassium 4 weeks after initiating treatment and adjust dose (see Table 2); if serum potassium levels are اقرأ الوثيقة كاملة