Pravachol

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

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下载 资料单张 (PIL)
30-09-2013
下载 产品特点 (SPC)
04-07-2017

有效成分:

Pravastatin sodium 20mg;  ;  ;  

可用日期:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN(国际名称):

Pravastatin sodium 20 mg

剂量:

20 mg

药物剂型:

Tablet

组成:

Active: Pravastatin sodium 20mg       Excipient: Croscarmellose sodium Iron oxide yellow Lactose monohydrate Magnesium oxide Magnesium stearate Microcrystalline cellulose Povidone

每包单位数:

Aluminium foil, blister, 30 tablets

类:

Prescription

处方类型:

Prescription

厂商:

Biocon Limited

疗效迹象:

1. In hypercholesterolemic patients without clinically evident coronary heart disease, PRAVACHOL is indicated as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. 2. PRAVACHOL is indicated for the reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. 3. PRAVACHOL is indicated as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease.

產品總結:

Package - Contents - Shelf Life: Aluminium foil, blister - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

授权日期:

1998-03-05

资料单张

                                NEW ZEALAND CONSUMER MEDICINE INFORMATION 
PRAVACHOL
®
 
_Pravastatin sodium _
 
 
CONSUMER MEDICINE INFORMATION
 
 
This medicine your doctor has prescribed for you is
called _PRAVACHOL_. The information in this leaflet will 
answer some of the questions you may have about _PRAVACHOL_. This
leaflet does not tell you everything 
about  _PRAVACHOL_.  Your doctor and pharmacist have been provided
with full information and can 
answer any questions you may have. 
This leaflet is no substitute for talking with your doctor or
pharmacist.  You should follow all advice from 
your doctor when being treated with this medicine.  This
information is not intended to replace your 
doctor's advice. 
You should read this leaflet carefully before
starting _PRAVACHOL_ and keep it in a safe place to refer to 
later. 
 
WHAT IS PRAVACHOL USED FOR? 
_PRAVACHOL_ is used to treat people who have had
a heart attack or an episode of unstable angina, or 
who have high blood cholesterol levels.  In these
people _PRAVACHOL_ can reduce the risk of further heart 
disease, reduce the possibility of needing a bypass operation, or
reduce the risk of having a stroke. 
_ _
_PRAVACHOL_ lowers high blood cholesterol levels (Doctors call this
hypercholesterolaemia). It is also 
used if your cholesterol levels are normal if you have had a heart
attack or an episode of unstable angina. 
 
_PRAVACHOL_ is used to treat heterozygous
familial hypercholesterolaemia in children and adolescent 
patients aged 8 years and older as an adjunct to diet and lifestyle
changes. 
 
If you have had a heart attack, an episode of unstable angina or you
have too much cholesterol in your 
blood, then you have an increased risk of a blood clot forming in
your blood vessels and causing a 
blockage.  Blood vessels that become blocked in this way can lead to
further heart disease, angina or 
stroke. 
 
_PRAVACHOL_ may be used to lower lipids in heart or
kidney transplant patients, who 
                                
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产品特点

                                PRAVACHOL- New Zealand Datasheet
Page 1 of 17
DATA SHEET
PRAVACHOL
_PRAVASTATIN TABLETS 10MG, 20MG, 40MG _
PRESENTATION
PRAVACHOL is available as yellow capsule shaped tablets containing
10mg, 20mg
or 40mg of PRAVASTATIN sodium. Inactive ingredients are lactose,
povidone
magnesium oxide microcrystalline cellulose, croscarmellose sodium
yellow iron
oxide and magnesium stearate.
USES
_ _
_ACTIONS _
PRAVACHOL (PRAVASTATIN Sodium, Squibb), designated chemically as
(3R,5R)-7-
[(1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-Hexahydro-6-hydroxy-2-methyl-8-[(S)-2-
methylbutyryloxy-1-naphthyl]]-3,5-dihydroxyheptanoic acid, sodium
salt, is one of a
new class of lipid-lowering compounds, the HMG-CoA reductase
inhibitors, that
reduce cholesterol biosynthesis. These agents are competitive
inhibitors of 3-
hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme
catalyzing
the early rate-limiting step in cholesterol biosynthesis, conversion
of HMG-CoA to
mevalonate.
As with other lipid-lowering therapy, PRAVACHOL is not indicated when
hypercholesterolaemia is due to hyperalphalipoproteinaemia (elevated
HDL-C). The
efficacy of pravastatin has not been evaluated in patients with
combined elevated
Total-C and hypertriglyceridaemia (>5.64 mmols/L) who may also have
elevated
intermediate density lipoproteins.
PRAVACHOL produces its lipid-lowering effect in two ways. First, as a
consequence
of its reversible inhibition of HMG-CoA reductase activity, it effects
modest
reductions in intracellular pools of cholesterol. This results in an
increase in the
number of LDL-receptors on cell surfaces and enhanced
receptor-mediated
catabolism and clearance of circulating LDL. Second, PRAVASTATIN
inhibits LDL
production by inhibiting hepatic synthesis of VLDL, the LDL precursor.
In vitro and
animal studies have shown that PRAVASTATIN, a hydrophilic HMG-CoA
reductase
inhibitor, is tissue selective such that inhibitor activity is highest
in those tissues with
the highest rates of cholesterol synthesis, such as the lier and ileum
(Table 1).
PRAVACHOL- 
                                
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