Ziglip tablets 145mg tablets

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

fenofibrate

Доступно од:

Alkaloid AD Skopje

АТЦ код:

C10AB05

INN (Међународно име):

fenofibrate

Дозирање:

145mg

Фармацеутски облик:

tablets

Јединице у пакету:

(30/3x10/) in blister

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2023-03-10

Карактеристике производа

Ziglip
®
145 mg tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ZIGLIP
®
145 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 145 mg fenofibrate (nanoparticles).
Excipients with known effect: Lactose anhydrous 444.1 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White to off-white biconvex oblong tablets, debossed with “F” on
one side and “145” on the
other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ziglip 145 mg is indicated as an adjunct to diet and other
non-pharmacological treatment (e.g.
exercise, weight reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL
cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not
tolerated.
- Mixed hyperlipidaemia in patients at high cardiovascular risk in
addition to a statin when
triglycerides and HDL cholesterol are not adequately controlled.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dietary measures initiated before therapy should be continued.
Response to therapy should be
monitored by determination of serum lipid values. If an adequate
response has not been achieved
after several months (e.g. 3 months), complementary or different
therapeutic measures should be
considered.
Ziglip
®
145 mg tablets
Summary of Product Characteristics
2
_Posology: _
Adults:
The recommended dose is one tablet containing 145 mg fenofibrate taken
once daily.
Special populations
Elderly patients (≥ 65 years old) No dose adjustment is necessary.
The usual dose is
recommended, except for decreased renal function with estimated
glomerular filtration rate < 60
mL/min/1.73 (see Patients with renal impairment).
Patients with renal impairment:
Fenofibrate should not be used if severe renal impairment, defined as
eGFR <30 mL/min per
1.73 m
2
, is present.
If eGFR is between 30 and 59 mL/min per 1.73 m
2
, the dose of fenofibrate should not exceed
100 mg standard or 67 mg micronized on