VIVACOR TABLET 5 mg

দেশ: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

ROSUVASTATIN CALCIUM 5.2 mg EQV ROSUVASTATIN

থেকে পাওয়া:

ASTRAZENECA SINGAPORE PTE LTD

এটিসি কোড:

C10AA07

ফার্মাসিউটিকাল ফর্ম:

TABLET, FILM COATED

রচনা:

ROSUVASTATIN CALCIUM 5.2 mg EQV ROSUVASTATIN 5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

IPR Pharmaceuticals, Inc (manufacturing)

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2015-05-15

পণ্য বৈশিষ্ট্য

1
VIVACOR
(rosuvastatin)
1.
NAME OF PHARMACEUTICAL PRODUCTS
VIVACOR
TM
5 mg, 10 mg, 20 mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin as
rosuvastatin calcium.
3.
PHARMACEUTICAL FORM
5 mg film-coated tablet - round, biconvex 7 mm, yellow coloured.
10 mg film-coated tablet - round, biconvex, 7 mm, pink coloured.
_ _
20 mg film-coated tablet - round, biconvex, 9 mm, pink coloured.
_ _
Tablets are impressed with ‘ZD4522’ and the tablet strength.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIVACOR
is
indicated
for
patients
with
primary
hypercholesterolaemia
and
mixed
dyslipidaemia
(including
Fredrickson
Type
IIa,
IIb;
and
heterozygous
familial
hypercholesterolaemia) as an adjunct to diet when response to diet and
exercise is inadequate.
VIVACOR is indicated to treat patients with primary
dysbetalipoproteinaemia (Fredrickson
Type III hyper lipoproteinaemia) as an adjunct to diet when response
to diet and exercise is
inadequate.
VIVACOR
reduces
elevated
LDL-cholesterol,
total
cholesterol
and
triglycerides
and
increases HDL-cholesterol, thereby enabling most patients to achieve
relevant treatment
guidelines. VIVACOR also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the
LDL-
C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and
increases ApoA-I.
VIVACOR is also indicated in patients with homozygous familial
hypercholesterolaemia,
either alone or as an adjunct to diet and other lipid lowering
treatments (e.g. LDL apheresis).
Primary prevention of cardiovascular disease: VIVACOR is indicated in
individuals without
clinically evident coronary heart disease but with an increased risk
of cardiovascular disease
based on age ≥ 50 years old in men and ≥ 60 years old in women,
hsCRP ≥ 2 mg/L, and the
presence of at least one additional cardiovascular disease risk factor
such as hypertension,
low HDL-C, smoking, or a family history of premature coronary heart
disease, VIVACOR is
indicated to:
• reduce the risk of stroke
• reduce