PRAVALIP 10

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

PRAVASTATIN SODIUM

Dostępny od:

UNIPHARM LTD, ISRAEL

Kod ATC:

C10AA03

Forma farmaceutyczna:

TABLETS

Skład:

PRAVASTATIN SODIUM 10 MG

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

UNIPHARM LTD, ISRAEL

Dziedzina terapeutyczna:

PRAVASTATIN

Wskazania:

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 myocardial infarction and normal cholesterol levels. Pravastatin is indicated to: 1) Reduce the risk of recurrent myocardial infarction. 2)Reduce the risk of undergoing myocardial revascularization procedures. 3) Reduce the risk of stroke or transient ischemic attack (TIA). c) Hypercholesterolemia and mixed dyslipidemia: Pravastatin is indicated as an adjunct to diet to reduce elevated Total-C LDL-C and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb).

Data autoryzacji:

2020-03-31

Ulotka dla pacjenta

119108010
04E22
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 information on inactive and allergenic ingredients
see section 2 ”Important information about some of
the ingredients of the medicine“ and section 6 ”Further
Information“.
READ THE 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 for the treatment of your
ailment. Do not pass it on to others. It may harm them, even
if it seems to you that their ailment is similar.
THE MEDICINE IS NOT INTENDED FOR CHILDREN AND
ADOLESCENTS UNDER 18 YEARS OF AGE.
1. WHAT IS THE MEDICINE INTENDED FOR?
• Reduction of blood cholesterol and triglyceride levels.
• Reduction of the risk of myocardial infarction and
extension of life expectancy in patients who have high
cholesterol level with no evidence of coronary disease.
• Reduction of the risk of overall mortality by lowering
mortality due to heart diseases, and reduction of the
risk of heart attack in patients with atherosclerosis and
average or high cholesterol level.
Further information:
PRAVALIP is used to reduce high levels of ”bad“ cholesterol
and to increase levels of ”good“ cholesterol in the blood
when changes in diet and physical activity have failed to
adequately do this. While cholesterol is essential for the
proper functioning of the body, if its levels in the blood are too
high, it can accumulate on the walls of the arteries. Eventually,
blood vessels may become blocked. This condition is
called hardening of the arteries )atherosclerosis(. This
condition may lead to chest pain )angina pector

Charakterystyka produktu

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