Country: Սինգապուր
language: անգլերեն
source: HSA (Health Sciences Authority)
Omega-3-acid ethyl esters 90 (containing: Eicosapent (EPA) 460mg and doconexent (DHA) 380mg ethyl esters and α-tocopherol 4 mg)
DCH AURIGA SINGAPORE
C10AX06
1000mg
CAPSULE
Omega-3-acid ethyl esters 90 (containing: Eicosapent (EPA) 460mg and doconexent (DHA) 380mg ethyl esters and α-tocopherol 4 mg) 1000mg
ORAL
Prescription Only
Patheon Softgels B.V.
ACTIVE
2014-02-11
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 read_full_document
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 read_full_document