Omacor Soft Capsule 1000mg

Country: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

Omega-3-acid ethyl esters 90 (containing: Eicosapent (EPA) 460mg and doconexent (DHA) 380mg ethyl esters and α-tocopherol 4 mg)

থেকে পাওয়া:

DCH AURIGA SINGAPORE

এটিসি কোড:

C10AX06

ডোজ:

1000mg

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

Omega-3-acid ethyl esters 90 (containing: Eicosapent (EPA) 460mg and doconexent (DHA) 380mg ethyl esters and α-tocopherol 4 mg) 1000mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

Patheon Softgels B.V.

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2014-02-11

তথ্য লিফলেট

30042010 

1. 
NAME OF THE MEDICINAL PRODUCT 

Omacor
®
, 1000mg, soft capsules 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One capsule contains: 
1000 mg Omega-3-acid ethyl esters 90, containing eicosapentaenoic
acid (EPA) ethyl ester 
(460mg) and docosahexaenoic acid (DHA) ethyl ester (380mg). 
The total content of Omega-3-acids ethyl esters is about 90%. 

For a full list of excipients, see 6.1.

3. PHARMACEUTICAL 
FORM 

Capsule, soft. 
Soft, oblong, transparent gelatine capsules containing pale yellow
oil.

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Hypertriglyceridaemia 
Endogenous hypertriglyceridaemia: as a supplement to diet
when dietary measures alone are 
insufficient to produce an adequate response.  
- type IV in monotherapy, 
- type IIb in combination with statins, when control of triglycerides
is insufficient. 

Omacor is not indicated in exogenous hypertriglyceridaemia (type
1 hyperchylomicronaemia). 
There is only limited experience in secondary endogenous
hypertriglyceridaemia (especially 
uncontrolled diabetes). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Hypertriglyceridaemia 
The daily dose is 4 grams per day taken as a
single 4-gram dose (4 capsules) or as two 2-gram 
doses (2 capsules given twice daily). 

The capsules should be taken with food to avoid gastrointestinal
disturbances. 

30042010 
There is no information regarding the use of Omacor in children,
in elderly patients over 70 years 
of age, or in patients with hepatic impairment, and only limited
information regarding the use in 
patients with renal impairment.

4.3 CONTRAINDICATIONS 
Hypersensitivity to the active substance, to soya or to any of the
excipients.

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
WARNINGS 
During treatment with Omacor, there is a fall in thromboxane
A2 production.  
No significant effect has been observed on the other coagulation
f

পণ্য বৈশিষ্ট্য

1.
NAME OF THE MEDICINAL PRODUCT
Omacor
®
, 1000mg, soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains:
1000 mg Omega-3-acid ethyl esters 90, containing eicosapentaenoic acid
(EPA) ethyl ester
(460mg) and docosahexaenoic acid (DHA) ethyl ester (380mg).
The total content of Omega-3-acids ethyl esters is about 90%,
including also as antioxidant 4 mg
d
-
alpha-tocopherol (mixed with a vegetable oil e.g. soya oil).
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
Soft, oblong, transparent gelatine capsules containing pale yellow
oil.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertriglyceridaemia
Endogenous hypertriglyceridaemia: as a supplement to diet when dietary
measures alone are
insufficient to produce an adequate response.
- type IV in monotherapy,
- type IIb in combination with statins, when control of triglycerides
is insufficient.
Omacor is not indicated in exogenous hypertriglyceridaemia (type 1
hyperchylomicronaemia).
There is only limited experience in secondary endogenous
hypertriglyceridaemia (especially
uncontrolled diabetes).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Hypertriglyceridaemia
The daily dose is 4 grams per day taken as a single 4-gram dose (4
capsules) or as two 2-gram
doses (2 capsules given twice daily).
The capsules should be taken with food to avoid gastrointestinal
disturbances.
There is limited clinical data regarding the use of Omacor in elderly
patients over 70
years of age and patients with renal impairment (see section 4.4).
There is no information
regarding the use of Omacor in children and adolescents or in patients
with hepatic
impairment (see section 4.4).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to soya or to any of the
excipients
listed in section 6.1.
_ _
Omacor contains soya oil. If you are allergic to peanut or soya, do
not use this medicinal product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Omacor should be used with caution in patients with known sensitivity
or allergy to fi