البلد: أندونيسيا
اللغة: الإندونيسية
المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ORNITHINE ASPARTATE
COMBIPHAR - Indonesia
ORNITHINE ASPARTATE
3 G
GRANULA
DUS, 10 SACHET @ 5 G
MERZ - Germany
2017-07-25
HEPA-MERZ ® _GRANULATE_ L-ORNITHINE - L-ASPARTATE 3 g/5 g, Granules for oral solution COMPOSITION Each sachet with 5 g contains 3.0 g L-ornithine-L-as- partate. Excipients: Citric acid, saccharin sodium, sodium cyclamate, povidone 25, fructose, flavourings, orange yellow S (E110). INDICATIONS Treatment of concomitant disease and sequelae due to impaired hepatic detoxification activity (e.g.in cirrhosis of the liver) with the symptoms of latent and manifest hepatic encephalopathy. POSOLOGY AND METHOD OF ADMINISTRATION Granules for oral solution. The dissolved contents of 1–2 sachets of Hepa-Merz granules are taken up to 3 times daily. Hepa-Merz granules are dissolved in plenty of fluid (e.g. a glass of water, tea or juice) and taken with or after meals. The experiences on the use of the drug in children are limited. CONTRAINDICATIONS Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 ml can be used as a guideline value. Hepa-Merz granules must not be taken by patients with known hypersensitivity to L-ornithine-L-aspartate, orange yellow S or any of the excipients. WARNINGS AND PRECAUTIONS Hepa-Merz granules contain fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Hepa-Merz granules contain 1.13 g fructose per sachet (equivalent to 0.11CEU). This should be taken into account in patients with diabetes mellitus. Any possible fructose intolerabilities should be checked by the attending physician before treatment. Hepa-Merz granules may be harmful to the teeth (cari - es) in long-term use. No data are so far available on the use of the drug in children. INTERACTION None known PREGNANCY AND LACTATION _Pregnancy:_ No clinical data are available relating to intake of Hepa-Merz granules during pregnancy. No exhaustive animal studies have been performed for L-ornithi - ne-L-aspartate, to investigate its toxicity in relation to reproduction. Administration of Hepa-Merz granules during pregnancy should therefore be avoided. I اقرأ الوثيقة كاملة