Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INFUSION, SOLUTION CONCENTRATE
**Posology and method of administration** Unless otherwise indicated, patients may be given up to 4 ampoules per day. With incipient clouding of consciousness (precoma) or clouding of consciousness (coma), up to 8 ampoules may be given in 24 hours, depending on the severity of the condition. The ampoules are added to an infusion solution before use, and infused in this form. Hepa-Merz concentrate for solution for infusion can be mixed with the usual infusion solutions. So far no peculiarities have been observed with regard to miscibility. However, the ampoules should be admixed to the infusion solution only immediately before application. For venous tolerability, however, no more than 6 ampoules should be dissolved per 500 ml infusion. The maximum infusion rate is 5 g L-ornithine L-aspartate (corresponding to the content of 1 ampoule) per hour. Hepa-Merz concentrate for solution for infusion must not be administered into an artery. _Paediatric population_ Experience in children is limited (see section Special warnings and special precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
INTRAVENOUS DRIP
Medical Information
**Therapeutic indications** For the treatment of hyperammonaemia in hepatic encephalopathy.
**Contraindications** - Hypersensitivity to L-ornithine L-aspartate. - Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 ml can be used as a guidance value.
A05BA
肝病治疗药
Manufacturer Information
ARQON PTE. LTD.
B. Braun Melsungen AG
Active Ingredients
Documents
Package Inserts
Hepa-Merz Infusion PI Approved November 2018.docx
Approved: November 9, 2018