HEPA-MERZ Concentrate for solution for infusion Ref.[50635] Active ingredients: 2,5-Diaminopentanoate

At high doses of Hepa-Merz infusion concentrate, 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.

No data are so far available on the use of the drug in children.

No interaction studies have been performed. Up to now interactions are not known.

There are no clinical data available on the use of Hepa-Merz infusion concentrate in pregnancy. L-ornithine L-aspartate has been investigated for reproduction toxicity only to a limited extent in experimental animal studies. The administration of Hepa-Merz infusion concentrate in pregnancy should therefore be avoided. If treatment with Hepa-Merz is nevertheless thought to be necessary, the benefits and risks should be carefully assessed.

It is not known whether L-ornithine L-aspartate passes into breast milk. Administration of Hepa-Merz should therefore be avoided during lactation. If treatment with Hepa-Merz is nevertheless thought to be necessary, the benefits and risks should be carefully assessed.

Depending on the underlying disease, the ability to drive and operate machines may also be impaired on treatment with L-ornithine L-aspartate.

Very common: (>1/10)
Common: (>1/100, <1/10)
Uncommon: (>1/1000, <1/100)
Rare: (>1/10000, <1/1000)
Very rare: (<1/10000), not known (cannot be estimated from the available data)

Gastrointestinal disorders

Uncommon: Nausea

Rare: Vomiting

Generally, however, these symptoms are transient, and do not necessitate discontinuation of treatment with this medicinal product. They disappear on reduction of the dose or infusion rate.

As no compatibility studies have been performed the medicinal product must not be mixed with other medicinal products.