LITORVA 40

Страна: Израиль

Язык: английский

Источник: Ministry of Health

Активный ингредиент:

ATORVASTATIN AS CALCIUM

Доступна с:

DEXCEL PHARMA TECHNOLOGIES LTD

код АТС:

C10AA05

Фармацевтическая форма:

TABLETS

состав:

ATORVASTATIN AS CALCIUM 40 MG

Администрация маршрут:

PER OS

Тип рецепта:

Required

Производитель:

DEXCEL LTD, ISRAEL

Терапевтическая группа:

ATORVASTATIN

Терапевтические области:

ATORVASTATIN

Терапевтические показания :

Litorva is indicated as an adjunct to diet for reduction of elevated total cholesterol LDL- cholesterol apolipoprotein B and triglycerides and to increase HDL Cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types IIa and IIb of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Litorva is also indicated to reduce total-C and LDL -C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. LDL apheresis) or if such treatments are unavailable. Pediatric patients (10-17 years of age) : Atorvastatin is indicated as an adjunct to diet to reduce total -C LDL-C and apo B levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. LDL-C remains >or = 190 mg/dl or 2. LDL-C remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient. Prevention of cardiovascular and/or cerebrovascular event sush as MI or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. In patients with clinically evident coronary heart disease, Litorva is indicated to : Reduce the risk of non-fatal myocardial infarction. Reduce the risk of fatal and non fatal stroke. Reduce the risk for revascularization procedures. Reduce the risk of hospitalization for CHF. Reduce the risk of angina.

Дата Авторизация:

2016-01-31

тонкая брошюра

1
Patient package insert according to Pharmacists’ Regulations
(Preparations) – 1986
This medicine can be sold with a physician’s prescription only
LITORVA
®
10, 20, 40, 80 MG, TABLETS
Each tablet contains atorvastatin
(
as calcium
)
at a dosage of 10, 20, 40, or 80 mg
respectively.
Inactive ingredients and allergens in the medicine - see section 6
"Additional information" and
in section 2 "Important information about some of the ingredients of
this medicine".
Read this entire leaflet carefully before using this medicine. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
the doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if you think that their medical condition is similar.
1. What is the medicine intended for?
•
To reduce the blood lipid levels
(
cholesterol and triglycerides
)
and to increase HDL.
•
To prevent cardiovascular diseases
(
e.g., myocardial infarction or stroke
)
in patients
at high risk for a primary event.
•
In patients with a coronary heart disease, Litorva reduces the risk of
the occurrence
of myocardial infarction, stroke, hospitalization due to heart
failure, angina pectoris
and/or the need for catheterization.
Therapeutic group: Statins - HMG-CoA reductase enzyme inhibitors.
2. Before using the medicine
Do not use the medicine if:
Special warnings regarding the use of the medicine
Before the treatment with Litorva, tell the doctor if:
• you suffer from unexplained muscle aches or weakness.
• you drink more than two glasses of alcohol daily.
• you suffer from diabetes.
• you suffer from thyroid problems.
• you suffer from kidney problems.
• you suffered from a stroke.
• you are pregnant or are planning to become pregnant.
• you are breastfeeding or are planning to breastfeed.
Children and adolescents
This medicine is usually not intended for children under 10 years of
age and girls who have
not yet started menstruating.
Tests and follow-up
Before