PRAVASTATIN SODIUM

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

PRAVASTATIN SODIUM

Dostupno od:

Accord Healthcare Limited

ATC koda:

C10AA03

INN (International ime):

PRAVASTATIN SODIUM

Doziranje:

20 Milligram

Farmaceutski oblik:

Tablets

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

pravastatin

Status autorizacije:

Marketed

Datum autorizacije:

2008-09-26

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg pravastatin sodium.
Excipient: Lactose monohydrate 143.31 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pravastatin Tablets 20 mg: Yellow colored, rounded rectangular shaped,
biconvex, uncoated tablets debossed 'PDT'
on
one side and '20'
on the other 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 (eg. exercise, weight reduction)
is inadequate.
_Primary prevention_
Reduction of cardiovascular mortality and morbidity in patients with
moderate or severe hypercholesterolaemia and at
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-patient
receiving immunosuppressive therapy following solid
organ transplantation (see sections 4.2, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating Pravastatin Tablets,
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 sodium is administered orally once daily preferably in the
evening with or without food.
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