ATORVASTATIN BIOKANOL 40 Milligram Film Coated Tablet
Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Характеристики продукта
(SPC)
21-05-2024
Некоторые документы для этого продукта в настоящее время недоступны, вы можете отправить запрос в нашу службу поддержки, и мы сообщим вам, как только мы сможем их получить.
Послать запрос.
Послать запрос.
Активный ингредиент:
ATORVASTATIN CALCIUM
Доступна с:
Biokanol Pharma GmbH
ИНН (Международная Имя):
ATORVASTATIN CALCIUM
дозировка:
40 Milligram
Фармацевтическая форма:
Film Coated Tablet
Тип рецепта:
Product subject to prescription which may be renewed (B)
Статус Авторизация:
Withdrawn
Дата Авторизация:
2013-11-11
Характеристики продукта
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Biokanol 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg atorvastatin ( equivalent to 41.45 mg atorvastatin calcium)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Atorvastatin 40 mg film-coated tablets are white to off-white, elliptic, biconvex, scored on one side and embossed with
“40” on the other side. The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol
(LDL-C), apolipoprotein B, and triglycerides in in adults, adolescents and children aged 10 years or older 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.
Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia
as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section
5.1), as an adjunct to correction of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue
on this diet during treatment with atorvastatin.
The dose should be individualised accordin
Прочитать полный документ
