Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
EICOSAPENTAENOIC ACID DOCOSAHEXANOIC ACID
Seven Seas Ltd
EICOSAPENTAENOIC ACID DOCOSAHEXANOIC ACID
780/530 MG/5ml
Unknown
Product subject to prescription which may be renewed (B)
Withdrawn
2010-09-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MaxEPA Liquid 780 mg / 530 mg per 5 ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of liquid contains: Eicosapentaenoic Acid (EPA) 780 mg Docosahexaenoic Acid (DHA) 530 mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution. A clear golden oil. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in patients for whom a reduction in plasma triglyceride levels is judged to be desirable. It should be used in conjunction with appropriate dietary measures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: One 5ml spoonful to be taken twice daily with food. Neonates: The use of MaxEPA Liquid has not been established in neonates. Children: The use of MaxEPA Liquid has not been established in children. Elderly: As for adult dosage 4.3 CONTRAINDICATIONS There are no absolute contraindications for this product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients on MaxEPA Liquid should be maintained on a regular regime with monitoring of lipid biochemistry and coagulation factors. Do not exceed the recommended daily dose. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/09/2007_ _CRN 2039756_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION In view of the potential effect on bleeding time and platelet aggregation, great care should be exercised in patients on concomitant, anti-coagulant therapy or receiving other drugs which may affect coagulation factors, e.g.: aspirin, cephalosporins. 4.6 PREGNANCY AND LACTATION There is no experience of use during pregnancy or in breast feeding. Use should be avoided until further informatio Baca dokumen lengkapnya