Fetal Risk

Active Ingredient Index

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1 alpha 25 - dihydroxycholecalciferol (Doses Exceeding The Recommended Dietary Allowance - RDA)

D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. This drug can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Group 5

Ausreichende Erfahrungen über die Anwendung beim Menschen liegen nicht vor.

Insufficient data are available on use in humans.

B3

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.