Trilipix Modified Release Capsules 45mg

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Choline Fenofibrate 59.6mg eqv Fenofibric Acid

Verfügbar ab:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC-Code:

C10AB11

Dosierung:

45mg

Darreichungsform:

CAPSULE, DELAYED RELEASE PELLETS

Zusammensetzung:

Choline Fenofibrate 59.6mg eqv Fenofibric Acid 45mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

Fournier Laboratories Ireland Limited

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2013-07-03

Gebrauchsinformation

Updated 19-Jun-2013 

Trilipix 135mg modified-release capsules are hard gelatin
capsules with a blue cap and a yellow 
body for oral administration. Each capsule contains choline
fenofibrate as the active medical 
ingredient, which is equivalent to 135 mg of the
corresponding fenofibric acid. 

Trilipix 45mg modified-release capsules are hard gelatin
capsules with a reddish brown cap and a 
yellow body for oral administration. Each capsule contains
choline fenofibrate as the active 
medical ingredient, which is equivalent to 45 mg of the corresponding
fenofibric acid. 

Trilipix 135mg Excipients (non medicinal ingredients): 
Capsule content: Hypromellose, povidone, hydroxypropyl
cellulose, colloidal silicon dioxide, 
sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl
citrate (E1505). 
Capsule shell Trilipix 135mg: Yellow iron oxide (E172), titanium
dioxide (E171), FD&C Blue 
number 2, gelatin. 

Trilipix 45mg Excipients (non medicinal ingredients): 
Capsule content: Hypromellose, povidone, hydroxypropyl
cellulose, colloidal silicon dioxide, 
sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl
citrate (E1505). 
Capsule shell Trilipix 45mg: Yellow iron oxide (E172), titanium
dioxide (E171), black iron oxide 
(E172), red iron oxide (E172), gelatin. 

INDICATIONS 
1. CO-ADMINISTRATION THERAPY WITH STATINS FOR THE TREATMENT OF MIXED
DYSLIPDEMIA 
Trilipix is indicated as an adjunct to diet in combination with a
statin to reduce triglyceride (TG) 
and increase HDL-C in patients with mixed dyslipidemia and coronary
heart disease (CHD) or a 
CHD risk equivalent who are on optimal statin therapy to achieve
their LDL-C goal.  

CHD risk equivalents comprise: 
- Other clinical forms of atherosclerotic disease (peripheral
arterial disease, abdominal aortic 
anueurysm, and symptomatic carotid artery disease); 
- Diabetes; 
- Multiple risk factors that confer a 10-year risk for CHD > 20%. 

2. TREAT

Fachinformation

CCDS Update: SOLID
1000305087v.5.0
Updated 7 December 2018
Trilipix 135mg modified-release capsules are hard gelatin capsules
with a blue cap and a yellow
body for oral administration. Each capsule contains choline
fenofibrate as the active medical
ingredient, which is equivalent to 135 mg of the corresponding
fenofibric acid.
Trilipix 45mg modified-release capsules are hard gelatin capsules with
a reddish brown cap and a
yellow body for oral administration. Each capsule contains choline
fenofibrate as the active
medical ingredient, which is equivalent to 45 mg of the corresponding
fenofibric acid.
Trilipix 135mg Excipients (non medicinal ingredients):
Capsule content: Hypromellose, povidone, hydroxypropyl cellulose,
colloidal silicon dioxide,
sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl
citrate (E1505).
Capsule shell Trilipix 135mg: Yellow iron oxide (E172), titanium
dioxide (E171), FD&C Blue
number 2, gelatin.
Trilipix 45mg Excipients (non medicinal ingredients):
Capsule content: Hypromellose, povidone, hydroxypropyl cellulose,
colloidal silicon dioxide,
sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl
citrate (E1505).
Capsule shell Trilipix 45mg: Yellow iron oxide (E172), titanium
dioxide (E171), black iron oxide
(E172), red iron oxide (E172), gelatin.
INDICATIONS
1. CO-ADMINISTRATION THERAPY WITH STATINS FOR THE TREATMENT OF MIXED
DYSLIPDEMIA
Trilipix is indicated as an adjunct to diet in combination with a
statin to reduce triglyceride (TG)
and increase HDL-C in patients with mixed dyslipidemia and coronary
heart disease (CHD) or a
CHD risk equivalent who are on optimal statin therapy to achieve their
LDL-C goal.
CHD risk equivalents comprise:
- Other clinical forms of atherosclerotic disease (peripheral arterial
disease, abdominal aortic
anueurysm, and symptomatic carotid artery disease);
- Diabetes;
- Multiple risk factors that confer a 10-year risk for CHD > 20%.
2. TREATMENT OF SEVERE HYPERTRIGLYCERIDEMIA
Trilipix is indicated as adjunctive therapy to diet to red