البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
pravastatin sodium, Quantity: 80 mg
Generic Health Pty Ltd
pravastatin sodium
Tablet, film coated
Excipient Ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow
Oral
30 tablets
(S4) Prescription Only Medicine
1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with Pravastatin generichealth, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. Pravastatin generichealth is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/L) serum cholesterol levels. 3. Pravastatin generichealth is indicated in patients with unstable angina pectoris (see Clinical Trials). 4. Pravastatin generichealth is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 years and older (see Clinical Trials).
Visual Identification: yellow coloured, oval shaped, biconvex, film coated tablets debossed with '80' on one side and 'PRV' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2008-07-07
CONSUMER MEDICINE INFORMATION PRAVASTATIN GENERICHEALTH (PRAVASTATIN SODIUM) FILM-COATED TABLET WHAT IS IN THIS LEAFLET The information in this leaflet will answer some of the questions you may have about Pravastatin generichealth. This leaflet does not tell you everything about this medicine. Your doctor and pharmacist have been provided with full information and can answer any questions you may have. This leaflet is no substitute for talking with your doctor or pharmacist. You should follow all advice from your doctor when being treated with this medicine.. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. You should read this leaflet carefully before starting Pravastatin generichealth and keep it in a safe place to refer to later. WHAT PRAVASTATIN GENERICHEALTH IS USED FOR Pravastatin generichealth is used to treat people who have had a heart attack or an episode of unstable angina, or who have high blood cholesterol levels. In these people Pravastatin generichealth can reduce the risk of further heart disease, reduce the possibility of needing a bypass operation, or reduce the risk of having a stroke. Pravastatin generichealth lowers high blood cholesterol levels (doctors call this hypercholesterolaemia). It is also used if your cholesterol levels are normal if you have had a heart attack or an episode of unstable angina. Pravastatin generichealth is used to treat heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older as an adjunct to diet and lifestyle changes. If you have had a heart attack, an episode of unstable angina or you have too much cholesterol in your blood, then you have an increased risk of a blood clot forming in your blood vessels and causing a blockage. Blood vessels that become blocked in this way can lead to further heart disease, angina or stroke. Pravastatin generichealth may be used to lower lipids in heart or kidney transplant patients, who are also being given immunosuppressive medicine. Pravastatin generi اقرأ الوثيقة كاملة
AUSTRALIAN PRODUCT INFORMATION – PRAVASTATIN GENERICHEALTH (PRAVASTATIN SODIUM) FILM-COATED TABLET 1 NAME OF THE MEDICINE Pravastatin sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg, 20 mg or 80 mg of pravastatin sodium. List of excipients with known effect: Lactose monohydrate, sodium bicarbonate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Pravastatin generichealth 10 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets debossed with ‘10’ on one side and plain on the other side. Pravastatin generichealth 20 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets debossed with ‘20’ on one side and plain on the other side. Pravastatin generichealth 80 mg tablets: Yellow coloured, oval shaped, biconvex, film-coated tablets debossed with ‘80’ on one side and ‘PRV’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with Pravastatin generichealth, secondary causes of hypercholesterolaemia (eg. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. Pravastatin generichealth is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/L) serum cholesterol levels. 3. Pravastatin generichealth is indicated in patients with unstable angina pectoris (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS). 4. Pravastatin generichealth is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 years and older (See SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS). 4.2 DOSE AND METHOD OF ADMINISTRATION Prior to initiating Pravastatin generichealth tablets, the patient should be اقرأ الوثيقة كاملة