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Tetanus immune globulin Pregnancy and Breastfeeding Warnings

Tetanus immune globulin is also known as: BayTet, Hyper-Tet, HyperTET S/D

Tetanus immune globulin Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

Animal studies are not available. There are no controlled data in human pregnancy.

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 decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Tetanus immune globulin Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-Immunoglobulins are excreted in breast milk and may transfer protective antibodies to the child; it is unknown if this applies to this drug.
-Clinical experience with immune globulins suggests no harmful effects on the child are to be expected.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  2. "Product Information. Hypertet S/D (tetanus immune globulin)." Bayer Inc, Toronto, ON.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Hypertet S/D (tetanus immune globulin)." Bayer Inc, Toronto, ON.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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