ALPHASTAT rosuvastatin (as calcium) 5 mg film-coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
28-11-2017

유효 성분:

rosuvastatin calcium, Quantity: 5.198 mg

제공처:

Viteia Pty Ltd

INN (International Name):

Rosuvastatin calcium

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: iron oxide red; crospovidone; light magnesium oxide; microcrystalline cellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin; allura red AC aluminium lake; quinoline yellow aluminium lake; indigo carmine aluminium lake

관리 경로:

Oral

패키지 단위:

30, 7

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

ALPHASTAT should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of Cardiovascular Events:- ALPHASTAT 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)., ALPHASTAT 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:- ALPHASTAT is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).,Prior to initiating therapy with ALPHASTAT, 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.

제품 요약:

Visual Identification: A yellow, film coated, round, biconvex tablet, debossed with 'M' on one side and 'RS' on other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2013-03-08