Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
omega-3 triglycerides
Abbott Laboratories GmbH
C10AX06
omega-3 triglycerides
1000mg
capsules soft
(28) in plastic container
Prescription
Registered
2023-04-21
Omega-3-acid ethyl esters SUMMARY OF PRODUCT CHARACTERISTIC Abbott Confidential information 1/6 This information is confidential 1. NAME OF THE MEDICINAL PRODUCT Omacor ® , 1000mg, capsules, soft 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains: Omega-3-acid ethyl esters 90 – 1000 mg, comprising eicosapentaenoic acid (EPA) ethyl ester (460mg) and docosahexaenoic acid (DHA) ethyl ester (380mg) The total contents of Omega-3-acids ethyl esters is about 90%. For the full list of excipients, see section “List of excipients”. 3. PHARMACEUTICAL FORM Capsule, soft. Soft, oblong, transparent gelatin 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/III in combination with statins, when control of triglycerides is insufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hypertriglyceridaemia Initial treatment two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily. The capsules may be taken with food to avoid gastrointestinal disturbances. There is no information regarding the use of Omacor ® in children and adolescents, in elderly patients over 70 years of age, or in patients with hepatic impairment (see section “Special warnings and precautions for use”), and only limited information regarding the use in patients with renal impairment. 4.3 CONTRAINDICATIONS - hypersensitivity to the active substance, soy, peanuts, or other components of the drug. - pregnancy and lactation - children and adolescents up to 18 years of age - old age (over 70 years old) - severe liver failure - exogenous hypertriglyceridemia (hyperchylomicronemia type 1) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Omacor ® should be used with caution in patients with known sensitivity or allergy to fish. Because of the moderate increase in bleeding ti read_full_document