Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium
Sandoz Pty Ltd
Rosuvastatin calcium
Registered
ROSUVASTATIN SANDOZ ® 1 ROSUVASTATIN SANDOZ ® _Rosuvastatin calcium film coated tablet _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Rosuvastatin Sandoz. 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 this medicine 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 ROSUVASTATIN SANDOZ IS USED FOR This medicine is used to: Lower high blood cholesterol levels (hypercholesterolaemia). reduce the risk of you having a stroke or heart attack if you are a man 50 or more years old or a women 60 or more years old and have at least 2 risk factors for having a heart attack or stroke, such as high blood pressure, low levels of good cholesterol (HDL), smoking or a family history of premature coronary heart disease. It contains the active ingredient rosuvastatin calcium. Rosuvastatin calcium belongs to a group of medicines called HMG- CoA reductase inhibitors (also known as 'statins'). Everyone has cholesterol and triglycerides in their blood. They are fatty substances needed by the body for many things. There are different types of cholesterol. Too much of the "bad" cholesterol (LDL) can block the blood vessels that supply your heart and brain with blood, and can cause heart attack, angina and stroke. The "good" cholesterol (HDL) helps to remove the bad cholesterol from the blood vessels. High levels of triglycerides can be associated with a low level of "good" cholesterol and may increase the risk of heart disease. Rosuvastatin Sandoz works by reducing the level of "bad" cholesterol, and raises the "good" cholesterol when exercise and changes to diet are not enough on their own. Cholesterol is present in many foods and is also made by your bod Preberite celoten dokument
20180302-Rosuvastatin Sandoz-pi _ _ _ _ Page 1 of 27 PRODUCT INFORMATION ROSUVASTATIN SANDOZ ® 5MG, 10MG, 20MG, 40MG TABLETS NAME OF THE MEDICINE _ _ Generic name: Rosuvastatin, as rosuvastatin calcium. Chemical name: bis [( _E_ )-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3 _R_ , 5 _S_ )-3,5- dihydroxyhept-6-enoic acid] calcium salt. Chemical structure: CAS Number: 147098-20-2 Empirical formula: (C 22 H 27 FN 3 O 6 S) 2 Ca MW: 1001.14 DESCRIPTION _ _ Rosuvastatin Sandoz 5 mg tablets contain 5 mg rosuvastatin (as calcium). Rosuvastatin Sandoz 10 mg tablets contain 10 mg rosuvastatin (as calcium). Rosuvastatin Sandoz 20 mg tablets contain 20 mg rosuvastatin (as calcium). Rosuvastatin Sandoz 40 mg tablets contain 40 mg rosuvastatin (as calcium). Rosuvastatin calcium is an amorphous solid, which is slightly soluble in water (7.8 mg/mL at 37°C), methanol, and ethanol, and has a pKa of 4.6. Rosuvastatin calcium is the (3 _R_ ,5 _S_ ,6 _E_ ) enantiomer. Rosuvastatin Sandoz tablets also contain the inactive ingredients lactose, colloidal anhydrous silica, microcrystalline cellulose and silicon dioxide, maize starch, purified talc, sodium stearylfumarate, hypromellose, mannitol and macrogol 6000, (titanium 20180302-Rosuvastatin Sandoz-pi _ _ _ _ Page 2 of 27 dioxide, iron oxide yellow and iron oxide red; these colours are only present in tablets supplied in bottles). _ _ _ _ PHARMACOLOGY Rosuvastatin is a fully synthetic competitive inhibitor of 3-hydroxy-3-methyl-glutaryl- coenzyme A reductase (HMG-CoA reductase), the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated, with apolipoprotein B (ApoB), into very low density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues. VLDL particles are TG-rich. Cholesterol-rich low density lipoprotein (LDL) is formed from VLDL and is cleared primarily through the high affinity LDL Preberite celoten dokument