Hepa-Merz Use In Pregnancy & Lactation

Granules: No clinical data are available relating to intake of L-Ornithine-L-Aspartate (Hepa-Merz) granules during pregnancy. No exhaustive animal studies have been performed for L-Ornithine-L-Aspartate, to investigate its toxicity in relation to reproduction. Administration of L-Ornithine-L-Aspartate (Hepa-Merz) granules during pregnancy should therefore be avoided. If, however, treatment with L-Ornithine-L-Aspartate (Hepa-Merz) granules is considered necessary, careful consideration should be given to the benefit versus risk ratio. It is not known whether L-Ornithine-L-Aspartate is excreted into the breastmilk. Administration of L-Ornithine-L-Aspartate (Hepa-Merz) granules should therefore be avoided during lactation. If, however, treatment with L-Ornithine-L-Aspartate (Hepa-Merz) granules is considered necessary, careful consideration should be given to the benefit versus risk ratio.
Infusion: There are no clinical data available on the use of L-Ornithine-L-Aspartate (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 (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). The administration of L-Ornithine-L-Aspartate (Hepa-Merz) infusion concentrate in pregnancy should therefore be avoided. If treatment with L-Ornithine-L-Aspartate (Hepa-Merz) infusion concentrate 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 breastmilk. Administration of L-Ornithine-L-Aspartate (Hepa-Merz) should therefore be avoided during lactation. If treatment with L-Ornithine-L-Aspartate (Hepa-Merz) is nevertheless thought to be necessary, the benefits and risks should be carefully assessed.