Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium, Quantity: 10.395 mg
Sun Pharma ANZ Pty Ltd
Rosuvastatin calcium
Tablet, film coated
Excipient Ingredients: sodium citrate dihydrate; magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400
Oral
28, 10, 7, 30, 90
(S4) Prescription Only Medicine
Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of Cardiovascular Events,Rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). Rosuvastatin is indicated to:,? Reduce the risk of nonfatal myocardial infarction,? Reduce the risk of nonfatal stroke,? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia,Rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding Heterozygous Familial Hypercholesterolaemia).,Prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.
Visual Identification: Light pink to pink round film coated tablets with RT2 debossed on one side and plain on other side; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-08-28
ROSUVASTATIN RBX TABLETS ROSUVASTATIN CALCIUM CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ROSUVASTATIN RBX. It does not contain all the information that is known about ROSUVASTATIN RBX. It does not take the place of talking to your doctor and pharmacist. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ROSUVASTATIN RBX 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 RBX IS USED FOR ROSUVASTATIN RBX is used to lower high cholesterol levels. Even though you may have normal cholesterol, ROSUVASTATIN RBX can also be used to reduce the risk of you having a stroke or heart attack if you are a man 50 or more years old or a woman 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. Your doctor may also do a blood test to measure a substance called C Reactive Protein to help decide if you should be given ROSUVASTATIN RBX for this use. Cholesterol and triglycerides Everyone has cholesterol and triglycerides in their blood. They are fatty substances needed by the body for many things. ROSUVASTATIN TABLETS CMI V6 Sept 2018 Page 1 of 10 Triglycerides are an energy source for the body. Cholesterol is used for such things as building cells, making bile acids (which help to digest foods) and making some hormones. There are different types of cholesterol. Too much of the Διαβάστε το πλήρες έγγραφο
ROSUVASTATIN RBX V8 Dec 2018 1 AUSTRALIAN PRODUCT INFORMATION ROSUVASTATIN RBX (ROSUVASTATIN CALCIUM) TABLETS 1 NAME OF THE MEDICINE Rosuvastatin calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ROSUVASTATIN RBX tablets contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin (as calcium). Rosuvastatin calcium is an amorphous solid, which is slightly soluble in water (7.8 mg/mL at 37°C) and slightly soluble in methanol and ethanol. It has a pKa of 4.6. Rosuvastatin calcium is the (3R, 5S, 6E) enantiomer. The formulation contains lactose and sugars. For the full list of excipients, see Section 6.1 L IST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM ROSUVASTATIN RBX tablets are presented in the following strengths: ROSUVASTATIN RBX 5 mg are light yellow to yellow, round, film-coated tablets with ‘RT 1’ debossed on one side and plain on other side. ROSUVASTATIN RBX 10 mg are light pink to pink, round, film-coated tablets with ‘RT 2’ debossed on one side and plain on other side. ROSUVASTATIN RBX 20 mg are light pink to pink, round, film-coated tablets with ‘RT 3’ debossed on one side and plain on other side. ROSUVASTATIN RBX 40 mg are light pink to pink, oval, film-coated tablets with ‘RT 4’ debossed on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ROSUVASTATIN RBX should be used as an adjunct to diet when the response to diet and exercise is inadequate. PREVENTION OF CARDIOVASCULAR EVENTS ROSUVASTATIN RBX is indicated for prevention of major cardiovascular events in men ≥ 50 years old and women ≥ 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). ROSUVASTATIN RBX is indicated to: • Reduce the risk of nonfatal myocardial infarction ROSUVASTATIN RBX V8 Dec 2018 2 • Reduce the risk of nonfatal stroke • Reduce the risk of coronary artery revascularisation procedures. IN PATIENTS WITH HYPE Διαβάστε το πλήρες έγγραφο