Atoris tablets film-coated

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

atorvastatin (atorvastatin calcium)

Sẵn có từ:

KRKA d.d.

Mã ATC:

C10AA05

INN (Tên quốc tế):

atorvastatin (atorvastatin calcium)

Liều dùng:

10mg

Dạng dược phẩm:

tablets film-coated

Các đơn vị trong gói:

(30/3x10/) in blister

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2016-05-24

Đặc tính sản phẩm

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