PRAVALIP 20

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PRAVASTATIN SODIUM

Available from:

UNIPHARM LTD, ISRAEL

ATC code:

C10AA03

Pharmaceutical form:

TABLETS

Composition:

PRAVASTATIN SODIUM 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Therapeutic area:

PRAVASTATIN

Therapeutic indications:

Pravastatin is indicated as a component of multiple risk factor intervention in those individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia . Pravastatin should be used in addition to a diet and other nonpharmacological measures alone has been inadequate. Primary prevention of coronary events: In hypercholesterolemic patients wihthout clinically evident coronary heart disease pravastatin is indicated to: 1) Reduce the risk of myocardial infarcton. 2) Reduce the risk for revascularization. 3) Reduce the risk of deaths due to cardiovascular causes with no increase in death non-cardiovascular causes. Secondary prevention of cardiovascular events: a) Atherosclerosis: In hypercholesterolemic patients with clinically evident coronary artery disease including prior MI pravastatin is indicated to: 1)Slow the progression of coronary atherosclerosis. 2) Reduce the risk of acute coronary events. b) Myocardial infarction: in patients with previous my

Authorization date:

2010-04-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed
with a doctor’s prescription only
PRAVALIP 10; 20; 40
TABLETS
COMPOSITION:
Each PRAVALIP 10 tablet contains:
Pravastatin sodium 10 mg
Each PRAVALIP 20 tablet contains:
Pravastatin sodium 20 mg
Each PRAVALIP 40 tablet contains:
Pravastatin sodium 40 mg
For the list of inactive ingredients, please see
section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat
your ailment. Do not pass it on to others. It
may harm them, even if it seems to you that
their ailment is similar.
This medicine is not intended for use in
children and adolescents under 18 years of
age.
THERAPEUTIC GROUP: Pravastatin belongs to
a group of medicines called “statins”. Statins
inhibit the activity of the HMG-CoA reductase
enzyme.
1. WHAT IS THE MEDICINE INTENDED FOR?
Reduction
of
cholesterol,
LDL-C
and
triglyceride levels, and increase in HDL-C
levels. In hypercholesterolemic patients
and with no evidence of coronary disease,
pravastatin reduces the risk of myocardial
infarction and extends the life expectancy.
In
patients
with
atherosclerosis
and
average )normal( or high cholesterol level,
pravastatin reduces the risk of overall mortality
and of mortality due to heart diseases,
and reduces the risk of heart attack; in
hypercholesterolemic patients, pravastatin
reduces the risk of angina pectoris.
2. BEFORE USING THE MEDICINE
DO NOT USE THE PREPARATION IF:
• you are pregnant, planning to become
pregnant or are breastfeeding.
• you are sensitive )allergic( to pravastatin
or to any of the additional ingredients
contained in the medicine )listed in section
6(.
• you are suffering from active liver disease
or from unexplained, persistent elevations
in liver function test results.
119108010
03D20
SPECIAL WARNINGS REGARDING USE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT:
TESTOMAX 50 mg
TESTOMAX 25 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
TESTOMAX 50 mg: Testosterone 0.05 g per 5 g sachet
TESTOMAX 25 mg: Testosterone 0.025 g per 2.5 g sachet
For excipients, see 6.1.
3. PHARMACEUTICAL FORM: Gel
Clear, transparent colorless gel,
.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Testosterone replacement therapy for males hypogonadism when
testosterone
deficiency has been confirmed by clinical features and biochemical
tests.
4.2 POSOLOGY AND ADMINISTRATION ROUTE
Cutaneous use
_Adults and elderly _
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone)
applied once daily,
at about the same time, preferably in the morning. The daily dose
should be adjusted
by the doctor depending on the clinical or laboratory response in
individual patients,
not exceeding 10 g of gel per day. The adjustment of posology should
be achieved
by 2.5 g of gel steps.
The application should be administered by the patient himself, onto
clean, dry,
healthy skin over the shoulders, or both arms or abdomen.
After opening the sachet, the total content must be extracted from the
sachet and
applied immediately onto the skin. The gel has just to be simply
spread on the skin
gently as a thin layer. It is not necessary to rub it on the skin.
Allow drying for at least
3-5 minutes before dressing. Wash hands with soap and water after
applications.
Do not apply to the genital areas as the high alcohol content may
cause local
irritation.
Steady state plasma testosterone concentrations are reached
approximately on the
2nd day of treatment with Testomax. In order to adjust the
testosterone dose, serum
testosterone concentrations must be measured in the morning before
application
from the 3rd day on after starting treatment (one week seems
reasonable). The dose
may be reduced if the plasma testosterone concentrations are raised
above the
desired level. If the concentrations are low, the dosage may be
increased, not
exceeding 10 g of gel per