Gamunex-c Pregnancy Warnings
Safety has not been established during pregnancy; use during pregnancy only if clearly needed.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned
Animal studies have not been conducted. There are no controlled data in human pregnancy. Immune globulin intravenous only crosses the human placenta in significant amounts after 32 weeks gestation; placental transfer is a function of both dose and gestational age.
AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
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