PRAVASTATIN SODIUM 10 Milligram Tablets
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
31-05-2024
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Ingredient activ:
PRAVASTATIN SODIUM
Disponibil de la:
Bristol-Myers Squibb Pharmaceuticals Ltd
INN (nume internaţional):
PRAVASTATIN SODIUM
Dozare:
10 Milligram
Forma farmaceutică:
Tablets
Statutul autorizaţiei:
Withdrawn
Data de autorizare:
2008-04-18
Caracteristicilor produsului
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Pravastatin Sodium 10 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, capsule shaped biconvex scored tablet, with a ‘10’ engraved on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERCHOLESTEROLAEMIA
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and
other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
PRIMARY PREVENTION
Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolaemia and at
a high risk of a first cardiovascular event, as an adjunct to diet (see section 5.1).
SECONDARY PREVENTION
Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable
angina pectoris and with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors
(see section 5.1).
POST TRANSPLANTATION
Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid
organ transplantation (see sections 4.2, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Prior to initiating PRAVASTATIN, secondary causes of hypercholesterolaemia should be excluded and patients should
be placed on a standard lipid-lowering diet which should be continued during treatment.
PRAVASTATIN is administered orally once daily preferably in the evening with or without food.
HYPERCHOLESTEROLAEMIA: the recommended dose range is 10-40mg once daily. The therapeutic response is seen within
a week and the full effect of a given dose occurs within four weeks, th
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