Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
ezetimibe, Quantity: 10 mg; simvastatin, Quantity: 10 mg
ORGANON PHARMA PTY LTD
Ezetimibe,Simvastatin
Tablet, uncoated
Excipient Ingredients: hypromellose; citric acid monohydrate; lactose monohydrate; microcrystalline cellulose; propyl gallate; croscarmellose sodium; magnesium stearate; butylated hydroxyanisole
Oral
30 tablets, 10 tablets, 5 tablets
(S4) Prescription Only Medicine
Adults (greater than or equal to 18 years),Prevention of cardiovascular disease,ZEKLEN is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Section 5.1 Pharmacodynamic Properties, Clinical trials).,Primary hypercholesterolaemia,ZEKLEN is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,- Patients not appropriately controlled with a statin or ezetimibe alone.,- Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH),ZEKLEN is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Children and adolescents 10-17 years,(pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche),Heterozygous Familial Hypercholesterolaemia (HeFH),ZEKLEN is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,- Patients not appropriately controlled with a statin or ezetimibe alone.,- Patients already treated with a statin and ezetimibe,Homozygous Familial Hypercholesterolaemia (HoFH),ZEKLEN is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Visual Identification: White to off-white, capsule shaped, biconvex compressed tablet with "311" marked on the tablet; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-11-25
ZEKLEN ® _Ezetimibe/Simvastatin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ZEKLEN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ZEKLEN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZEKLEN IS USED FOR ZEKLEN helps to lower cholesterol and triglyceride levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. _CHOLESTEROL_ Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called 'bad' cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build- up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called 'good' cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. _TRIGLYCERIDES_ Triglycerides are another form of fat in your blood that may increase your risk for heart disease. _HOW ZEKLEN WORKS_ ZEKLEN reduces elevated total- cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. ZEKLEN works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. ZEKLEN does not help you lose weight. If you have heart disease and a history of heart attack or hospitalisation for unstable angina (chest pain), ZEKLEN reduces the risk of heart attack, stroke, surgery to increase h Διαβάστε το πλήρες έγγραφο
Page 1 of 40 AUSTRALIAN PRODUCT INFORMATION ZEKLEN ® (EZETIMIBE AND SIMVASTATIN) TABLETS 1 NAME OF THE MEDICINE Ezetimibe Simvastatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ZEKLEN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (ZEKLEN 10/10), 20 mg of simvastatin (ZEKLEN 10/20), 40 mg of simvastatin (ZEKLEN 10/40), or 80 mg of simvastatin (ZEKLEN 10/80). EZETIMIBE Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. SIMVASTATIN Simvastatin is a white to off-white, non-hygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. List of excipients with known effects: - lactose (as monohydrate) For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ZEKLEN is available in the following presentations: ZEKLEN 10/10: [10mg Ezetimibe/ 10mg Simvastatin]: White to off-white, capsule shaped, biconvex compressed tablet marked with “311”. ZEKLEN 10/20 [10mg Ezetimibe/ 20mg Simvastatin]: White to off-white, capsule shaped, biconvex compressed tablet marked with “312”. ZEKLEN 10/40 [10mg Ezetimibe/ 40mg Simvastatin]: White to off-white, capsule shaped, biconvex compressed tablet marked with “313”. ZEKLEN 10/80 [10mg Ezetimibe/ 80mg Simvastatin]: White to off-white, capsule shaped, biconvex compressed tablet marked with “315”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Page 2 of 40 _ADULTS (≥18 YEARS) _ _ _ _PREVENTION OF CARDIOVASCULAR DISEASE _ ZEKLEN is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS)._ _ _PRIMARY HYPERCHOLESTEROLA Διαβάστε το πλήρες έγγραφο