LIVALO FILM-COATED TABLETS 4MG

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Pitavastatin Calcium Hydrate 4.4mg eqv Pitavastatin Calcium

Tilgjengelig fra:

DKSH SINGAPORE PTE. LTD.

ATC-kode:

C10AA08

Legemiddelform:

TABLET, FILM COATED

Sammensetning:

Pitavastatin Calcium Hydrate 4.4mg eqv Pitavastatin Calcium 4.00mg

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

KOWA COMPANY, LTD., Nagoya Factory

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2019-11-22

Preparatomtale

KOWA COMPANY, LTD.
LIVALO FILM-COATED TABLETS 2MG/ LIVALO FILM-COATED TABLETS 4MG
1. NAME OF THE MEDICINAL PRODUCT
LIVALO Film-coated Tablets 2mg / LIVALO Film-coated Tablets 4mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Each tablet contains 2.0mg (for LIVALO Film-coated
Tablets 2mg) or 4.0mg (for LIVALO Film-coated Tablets 4mg)
of pitavastatin calcium (as hydrate)
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
LIVALO Film-coated Tablets 2mg: Slightly light-colored yellow-red,
round and scored film-coated tablet embossed “Kowa 202” on
one face and scored on the reverse. LIVALO Film-coated Tablets 2mg can
be divided into equal halves.
LIVALO Film-coated Tablets 4mg: Light-colored yellow, round and scored
film-coated tablet embossed “Kowa 203” on one face and
scored on the reverse. LIVALO Film-coated Tablets 4mg can be divided
into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Patients with primary hyperlipidemia including familial
hypercholesterolaemia or mixed dyslipidemia as an adjunctive therapy
to
diet to reduce elevated total cholesterol (TC), low-density
lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo-B),
triglycerides
(TG),
and
to
increase
high-density
lipoprotein cholesterol
(HDL-C)
and
children
aged
10
years
and
older
with familial
hypercholesterolemia when response to diet and other
non-pharmacological measures are inadequate.
Since there is no experience of use in homozygous cases of familial
hypercholesterolemia, administration of LIVALO should be
considered as a treatment supplementary to non-drug therapy such as
LDL-apheresis and only when treatment with LIVALO is
judged indispensable.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only and should be swallowed whole tablet, or half tablet
of 2mg if requiring 1mg of pitavastatin calcium. If halving of
tablets is necessary, the tablets should only be halved when a dose is
required. LIVALO can be taken at any time of the day with or
without food. It is desirable that