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HSA Approval

HEPA-MERZ INFUSION CONCENTRATE 5G/10 ML

SIN15578P

HEPA-MERZ INFUSION CONCENTRATE 5G/10 ML

HEPA-MERZ INFUSION CONCENTRATE 5G/10 ML

November 9, 2018

ARQON PTE. LTD.

ARQON PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantARQON PTE. LTD.
Licence HolderARQON PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

L-Ornithine-L-Aspartate

5g

Documents

Package Inserts

Hepa-Merz Infusion PI Approved November 2018.docx

Approved: November 9, 2018

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