HEPA-MERZ INFUSION CONCENTRATE 5G10 ML

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

L-Ornithine-L-Aspartate

Disponible desde:

ARQON PTE. LTD.

Código ATC:

A05BA

formulario farmacéutico:

INFUSION, SOLUTION CONCENTRATE

Composición:

L-Ornithine-L-Aspartate 5g

Vía de administración:

INTRAVENOUS DRIP

tipo de receta:

Prescription Only

Fabricado por:

B. Braun Melsungen AG

Estado de Autorización:

ACTIVE

Fecha de autorización:

2018-11-09

Ficha técnica

HEPA-MERZ
®
5G/10ML
INFUSION CONCENTRATE
FORMULATION
Hepa-Merz concentrate for solution for infusion is a clear
solution.
Active substance: L-ornithine L-aspartate.
One ampoule of 10 ml contains 5 g L-ornithine L-aspartate.
Excipient: water for injections
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
For the treatment of hyperammonaemia in hepatic encephalopathy.
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).
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.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
At high doses of Hepa-Merz concentrate for solution for
infusion, serum and urine urea levels should be monitored.
If liver function is substantially impaired, the infusion rate must
be adjusted to the individual patient in order to prevent nausea
and vomiting.
_Paediatric population_
No data are so far available on the use of the drug in children.
INTERACTION WITH