Source: Marketing Authorisation Holder Publisher: Merz Pharmaceuticals GmbH, Eckenheimer Landstr. 100, 60318 Frankfurt am Main, Germany
Latent and manifest hepatic encephalopathy.
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 infusion concentrate can be mixed with the usual infusion solutions without any problem.
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 infusion concentrate must not be administered into an artery.
Experience in children is limited (see section 4.4).
So far signs of intoxication have not been observed following an overdose of L-ornithine L-aspartate.
Cases of overdose require symptomatic treatment.
3 years.
Do not store above 25ºC.
The concentrate to be made up into solution for infusion is presented in amber-coloured glass ampoules.
Original packs containing 5, 10, 25 and 30 ampoules of 10 ml infusion concentrate.
Not all pack sizes may be marketed.
No special requirements.
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