ПАР - англійська - South African Health Products Regulatory Authority (SAHPRA)

the premier pharmaceutical co ltd - capsule - each capsule contains clofibrate 500 mg

Канада - англійська - Health Canada

ayerst laboratories - clofibrate - capsule - 500mg - clofibrate 500mg - fribic acid derivatives

Канада - англійська - Health Canada

novopharm limited - clofibrate - capsule - 500mg - clofibrate 500mg - fribic acid derivatives

Канада - англійська - Health Canada

wyeth-ayerst canada inc. - clofibrate - capsule - 1g - clofibrate 1g - fribic acid derivatives

Канада - англійська - Health Canada

wyeth-ayerst canada inc. - clofibrate - capsule - 500mg - clofibrate 500mg - fribic acid derivatives

Нова Зеландія - англійська - Medsafe (Medicines Safety Authority)

astrazeneca limited - clofibrate 500mg - liquid filled capsule - 500 mg - active: clofibrate 500mg excipient: amaranth gelatin glycerol sodium ethyl hydroxybenzoate sodium propyl hydroxybenzoate

Нова Зеландія - англійська - Medsafe (Medicines Safety Authority)

ebos group ltd - clofibrate 500mg - capsule - 500 mg - active: clofibrate 500mg

Нова Зеландія - англійська - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - clofibrate 500mg - capsule - 500 mg - active: clofibrate 500mg

Саудівська Аравія - англійська - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astrazeneca - clofibrate - capsule - 500 mg

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - gemfibrozil, quantity: 600 mg - tablet, film coated - excipient ingredients: polysorbate 80; sodium lauryl sulfate; crospovidone; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; croscarmellose sodium; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 8000; triacetin; polydextrose - ausgem is indicated as an adjunct to diet and other therapeutic measures for the following conditions: -severe hypertiglyceridamia (types iv and v) in those who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. -dyslipidaemia associated with diabetes. -reduction of risk of coronary heart disease in patients with type iia and iib hypercholesterolaemia. beacause of potential toxicity such as malignancy, gallbladder disease, abnormal pain leading to appendectomy and other abdominal surgeries, an increased incidence in non-coronary mortality and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefits of gemfibrozil in treating type iia patients with elevation of ldl-cholesterol only are not likely to outweigh the risks. in a subgroup analysis of patients in the helsinki heart study with above-median hdl-cholesterol values at baseline (>1.2mmol/l), both gemfibrozil and placebo subgroups had similar incidences of serious coronary events. note: ausgem is indicated when exercise, weight loss and specific dietary or other non-drug measures, for example, limiting alcohol intake have failed. other medical disorders such as hypothyroidism and diabetes should be controlled as much as possible. periodic determinations of serum lipids should be obtained during treatment with ausgem. the drug should be withdrawn or additional therapy instituted if the lipid response is deemed inadequate after 3 months.