ALVOSTAT FILM COATED TABLETS 20MG

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

Rosuvastatin calcium 20.8000mg eqv. Rosuvastatin free acid

Prieinama:

LOTUS INTERNATIONAL PTE. LTD.

ATC kodas:

C10AA07

Vaisto forma:

TABLET, FILM COATED

Sudėtis:

Rosuvastatin calcium 20.8000mg eqv. Rosuvastatin free acid 20mg

Vartojimo būdas:

ORAL

Recepto tipas:

Prescription Only

Pagaminta:

ADAMED Pharma S.A.

Autorizacija statusas:

ACTIVE

Leidimo data:

2016-04-29

Prekės savybės

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PACKAGE INSERT
1 NAME OF THE MEDICINAL PRODUCT
ALVOSTAT 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg Rosuvastatin (as Rosuvastatin calcium).
Each tablet contains 182.880 mg lactose monohydrate.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are round, biconvex, dark pink film-coated tablets, debossed
with ‘20’ on one side, (9 mm in
diameter).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults with primary hypercholesterolaemia (type IIa) or mixed
dyslipidaemia (type IIb) as an adjunct
to diet when response to diet and other non-pharmacological treatments
(e.g. exercise, weight
reduction) is inadequate.
Homozygous familial hypercholesterolaemia as an adjunct to diet and
other lipid lowering treatments
(e.g. LDL apheresis) or if such treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Primary prevention of cardiovascular disease: ALVOSTAT is indicated in
individuals without
clinically evident coronary heart disease but with an increased risk
of cardiovascular disease based on
age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2
mg/L, and the presence of at least
one additional cardiovascular disease risk factor such as
hypertension, low HDL-C, smoking, or a
family history of premature coronary heart disease ALVOSTAT is
indicated to:
•
reduce the risk of stroke
•
reduce the risk of myocardial infarction
•
reduce the risk of arterial revascularization procedures
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before treatment initiation the patient should be placed on a standard
cholesterol-lowering diet that
should continue during treatment. The dose should be individualised
according to the goal of therapy
and patient response, using current consensus guidelines.
ALVOSTAT may be given at any time of day, with or without food.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 or 10 mg orally once daily in both
stati