国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 21.69 mg (Equivalent: atorvastatin, Qty 20 mg)
Sun Pharma ANZ Pty Ltd
atorvastatin calcium trihydrate
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; calcium carbonate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; Euphorbia antisyphilitica; polysorbate 80; hyprolose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc
Oral
100, 28, 30
(S4) Prescription Only Medicine
As an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,Indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.
Visual Identification: White to off-white, elliptical, film-coated tablets debossed with "AS20" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-09-23
TROVAS 1 TROVAS _Atorvastatin Calcium 10/20/40/80 mg Tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TROVAS. It does not contain all the available information. It does not take the place of talking to your doctor or 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 has weighed the risks of you taking TROVAS against the benefits it is expected to 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 TROVAS IS USED FOR TROVAS is used to lower high cholesterol levels in your blood. TROVAS also helps reduce the risk of having a heart attack or stroke in people who have high blood pressure and coronary heart disease (CHD) or who have multiple risk factors for CHD, including diabetes, a history of stroke, or small blood vessel disease. Cholesterol is a type of blood fat needed by the body for many things, such as building cell lining, making bile acids (which help to digest food) and some hormones. However, too much cholesterol can be a problem. Cholesterol is present in many foods and is also made in your body by the liver. If your body makes too much cholesterol or you have too much cholesterol in your diet, then its level may become too high. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. When you have high levels of 'bad' cholesterol in your blood, it may begin to 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard patches called plaque on the walls of your blood vessels, m 完全なドキュメントを読む
TROVAS PI V10 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION TROVAS Atorvastatin calcium 10, 20, 40 and 80 mg Tablets 1 NAME OF THE MEDICINE Atorvastatin calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TROVAS 10 mg tablet contain atorvastatin calcium equivalent to 10 mg atorvastatin TROVAS 20 mg tablet contain atorvastatin calcium equivalent to 20 mg atorvastatin TROVAS 40 mg tablet contain atorvastatin calcium equivalent to 40 mg atorvastatin TROVAS 80 mg tablet contain atorvastatin calcium equivalent to 80 mg atorvastatin Excipients with known effects: lactose monohydrate (the 10 mg, 20 mg, 40 mg and 80 mg contains lactose monohydrate). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TROVAS 10 mg tablets are white to off-white, elliptical, film-coated tablets debossed ‘AS10’ on one side and plain on the other side. TROVAS 20 mg tablets are white to off-white, elliptical, film-coated tablets debossed ‘AS20’ on one side and plain on the other side. TROVAS 40 mg tablets are white to off-white, elliptical, film-coated tablets debossed ‘AS40’ on one side and plain on the other side. TROVAS 80 mg tablets are white to off-white, elliptical, film-coated tablets debossed ‘AS80’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TROVAS is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. TROVAS is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, TROVAS PI V10 Page 2 of 20 peripheral vascular disease or existing asymptomatic CHD (see Section 5.1 PHARMACOLOGICAL PROPERTIES, CLINICAL T 完全なドキュメントを読む