Atoris tablets film-coated

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

atorvastatin (atorvastatin calcium)

متاح من:

KRKA d.d.

ATC رمز:

C10AA05

INN (الاسم الدولي):

atorvastatin (atorvastatin calcium)

جرعة:

10mg

الشكل الصيدلاني:

tablets film-coated

الوحدات في الحزمة:

(30/3x10/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2016-05-24

خصائص المنتج

1.3.1
Atorvastatin calcium
SPC, Labeling and Package Leaflet
AM
SmPCPIL156614_1
25.09.2020 – Updated: 25.09.2020
Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Atoris
®
10 mg film-coated tablets
Atoris
®
20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg or 20 mg atorvastatin as
atorvastatin calcium.
Excipient: lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets of 10 mg and 20 mg are
white,
round and biconvex tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atoris
®
is indicated as an adjunct to diet for reduction of elevated total
cholesterol (total-C), LDL-
cholesterol (LDL-C), apolipoprotein B, and triglycerides 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.
Atoris
®
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 adult 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 Atoris
®
and
should continue on this diet during treatment with Atoris
®
.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient
response.
CONFIDENTIAL
Atoris film-coated tablets 10 mg, 20 mg
VOL: 1; P: 18 / 51
1.3.1
Atorvastatin calcium
SPC, Labeling and Package Leafle