Pravastatin Viatris

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Pravastatin sodium 10mg;  

Dostupno od:

Viatris Limited

Doziranje:

10 mg

Farmaceutski oblik:

Tablet

Sastav:

Active: Pravastatin sodium 10mg   Excipient: Croscarmellose sodium Iron oxide yellow Lactose monohydrate Light magnesium oxide Magnesium stearate Microcelac 100 Povidone

Tip recepta:

Prescription

Terapijske indikacije:

Pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, 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. · 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. · 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. · Coronary Artery Disease: In patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, CHD death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · Cerebrovascular Disease: In patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (TIAs). · Cardiac and Renal Transplantation: In patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients

Proizvod sažetak:

Package - Contents - Shelf Life: Blister pack, Al/Al foil - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Al/Al foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Datum autorizacije:

2017-01-11

Uputa o lijeku

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
PRAVASTATIN VIATRIS
_PRAVASTATIN SODIUM TABLETS 20 MG AND 40 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
PRAVASTATIN VIATRIS.
This leaflet answers some common
questions about PRAVASTATIN
VIATRIS.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
PRAVASTATIN VIATRIS against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT PRAVASTATIN
VIATRIS IS USED FOR
PRAVASTATIN VIATRIS is used to:
•
reduce the risk of heart
attacks, reduce the need for
treatment related to heart
blood vessels and to reduce
deaths related to the heart
blood vessels in patients
with high cholesterol levels
who already follow an
amended diet
•
treat high levels of
cholesterol where
measures to diet and
lifestyle changes were not
sufficient
•
reduce the incidences of
further heart diseases in
male patients less than 75
years of age with pre-
existing diseases related to
the heart blood vessels
when taken in addition to
dietary amendments
•
reduce the incidences of
further heart diseases and
reduce the need for
treatment related to heart
blood vessels in patients
who have had such
problems
•
reduce transplant rejection
and to improve survival
rates in heart or kidney
transplant patients who are
also being given
immunosuppressive
medicine
PRAVASTATIN VIATRIS contains
the active ingredient pravastatin
sodium. It belongs to a group of
medicines called HMG-CoA
reductase inhibitors.
It works by reducing the cholesterol
biosynthesis.
Your doctor may have prescribed
this medicine for another reason.
Cholesterol is a naturally occurring
substance in the body necessary for
normal growth. However, when you
have high levels of cholesterol it
ma

Svojstava lijeka

Page 1 of 22
NEW ZEALAND DATA SHEET
PRAVASTATIN VIATRIS
1. PRODUCT NAME
Pravastatin Viatris, 10 mg, 20 mg and 40 mg, tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains either 10 mg, 20 mg or 40 mg of pravastatin
sodium.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
10 mg: Yellow coloured, rounded, rectangular shaped, biconvex uncoated
tablet debossed with
‘PDT’ on one side and ‘10’ on the other side.
20 mg: Yellow coloured, rounded, rectangular shaped, biconvex uncoated
tablet debossed with
‘PDT’ on one side and ‘20’ on the other side.
40 mg: Yellow coloured, rounded, rectangular shaped, biconvex uncoated
tablet debossed with
‘PDT’ on one side and ‘40’ on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
In
hypercholesterolaemic
patients
without
clinically
evident
coronary
heart
disease,
Pravastatin Viatris 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.
•
Pravastatin Viatris is indicated for the reduction of elevated total
and LDL-cholesterol levels
in patients with primary hypercholesterolaemia when the response to
diet and other non-
pharmacological measures alone have been inadequate.
•
Pravastatin Viatris 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.
•
Coronary Artery Disease: In patients with a history of either
myocardial infarction or unstable
angina pectoris, Pravastatin Viatris is indicated to reduce the risk
for total mortality, CHD
death, recurrent coronary event (including myocardial infarction),
need for myocardial
revascularisation procedures, and need for hospitalisation.
Page 2 of 22
•
Cerebrovascular Disease: