البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
VERICIGUAT
BAYER ISRAEL LTD, ISRAEL
C01DX22
FILM COATED TABLETS
VERICIGUAT 5 MG
PER OS
Required
BAYER AG., GERMANY
VERICIGUAT
Verquvo is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.
2022-02-09
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only VERQUVO ® 2.5 MG FILM-COATED TABLETS VERQUVO ® 5 MG FILM-COATED TABLETS VERQUVO ® 10 MG FILM-COATED TABLETS ACTIVE INGREDIENT Each tablet contains: vericiguat 2.5 mg vericiguat 5 mg vericiguat 10 mg 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 to treat your illness. 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? Verquvo is intended to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics, in adults with symptomatic chronic heart failure and ejection fraction (EF, amount of blood pumped with each heartbeat) less than 45%. THERAPEUTIC GROUP: vasodilators for heart disease, soluble guanylate cyclase stimulator. Heart failure is a condition in which your heart is weak and cannot pump enough blood to your body. Some common symptoms of heart failure are shortness of breath, tiredness, or swelling caused by a build-up of fluid. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to the active ingredient vericiguat or to any of the other ingredients of this medicine (see section 6 ‘Additional information’) • you are taking any medicines that contain another SOLUBLE GUANYLATE CYCLASE STIMULATOR, such as riociguat used to treat high blood pressure in the lungs If any of the above applies to you, TALK TO YOUR DOCTOR FIRST and do not take this m اقرأ الوثيقة كاملة
1 RESTRICTED 1. NAME OF THE MEDICINAL PRODUCT Verquvo 2.5 mg film-coated tablets Verquvo 5 mg film-coated tablets Verquvo 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Verquvo 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg vericiguat. _Excipient with known effect _ Each film-coated tablet contains 58.14 mg lactose (as monohydrate), see section 4.4. Verquvo 5 mg film-coated tablets Each film-coated tablet contains 5 mg vericiguat. _Excipient with known effect _ Each film-coated tablet contains 55.59 mg lactose (as monohydrate), see section 4.4. Verquvo 10 mg film-coated tablets Each film-coated tablet contains 10 mg vericiguat. _Excipient with known effect _ Each film-coated tablet contains 111.15 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Verquvo 2.5 mg film-coated tablets Round, biconvex, white film-coated tablet with a diameter of 7 mm, marked with “2.5” on one side and “VC” on the other side. Verquvo 5 mg film-coated tablets Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, marked with “5” on one side and “VC” on the other side. Verquvo 10 mg film-coated tablets Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, marked with “10” on one side and “VC” on the other side. 2 RESTRICTED 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Verquvo is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%. (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Vericiguat is administered in conjunction with other heart failure therapies. Before starting vericiguat, care should be taken to optimise volume status and diuretic therapy to stabilise patients after the decompensation event, particularly in p اقرأ الوثيقة كاملة