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Fat emulsion Pregnancy and Breastfeeding Warnings

Fat emulsion is also known as: Clinolipid, Intralipid, Liposyn II, Liposyn III, Nutrilipid, Omegaven, SMOFlipid

Fat emulsion Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Animal studies have not been conducted. Embryotoxicity and increased incidence of fetal skeletal variations were seen in one animal model receiving medium-chain fatty acid containing lipids similar to this product during organogenesis. There are no controlled data in human pregnancy.

AU TGA pregnancy category 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.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Fat emulsion Breastfeeding Warnings

Caution is recommended.
This drug should be used only if clearly needed.

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

See references

References for pregnancy information

  1. "Product Information. Smoflipid (fat emulsion, intravenous)." Fresenius Kabi USA, Lake Zurich, IL.
  2. "Product Information. Intralipid (fat emulsion, intravenous)." Baxter I.V. Systems Division, Round Lake, IL.
  3. "Product Information. Nutrilipid (fat emulsion, intravenous)." B. Braun Medical, Irvine, CA.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Smoflipid (fat emulsion, intravenous)." Fresenius Kabi USA, Lake Zurich, IL.
  2. "Product Information. Intralipid (fat emulsion, intravenous)." Baxter I.V. Systems Division, Round Lake, IL.
  3. "Product Information. Nutrilipid (fat emulsion, intravenous)." B. Braun Medical, Irvine, CA.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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