Omacor capsules soft

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

omega-3 triglycerides

Tilgjengelig fra:

Abbott Laboratories GmbH

ATC-kode:

C10AX06

INN (International Name):

omega-3 triglycerides

Dosering :

1000mg

Legemiddelform:

capsules soft

Enheter i pakken:

(28) in plastic container

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2018-03-20

Preparatomtale

Omega-3-acid ethyl esters
SUMMARY OF PRODUCT CHARACTERISTIC
Abbott
Confidential information
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This information is confidential
NAME OF THE MEDICINAL PRODUCT
Omacor®, 1000mg, capsules, soft
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”.
PHARMACEUTICAL FORM
Capsule, soft.
Soft, oblong, transparent gelatin capsules containing pale yellow oil.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Post Myocardial Infarction
Adjuvant treatment in secondary prevention after myocardial infarction
in addition to other
standard therapy (e.g. statins, antiplatelet medicinal products, beta
blockers, ACE inhibitors).
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.
POSOLOGY AND METHOD OF ADMINISTRATION
Post Myocardial Infarction
One capsule daily.
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.
CONTRAINDICATIONS
- hypersensitivity to the active substance, soy, peanuts, or other
components of the drug.
- pregnancy and lactation.
- children and adolescents under 18 years of age.
- old age (over 70 years old).
- severe liver failure.
- exogeno