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Dalteparin Pregnancy and Breastfeeding Warnings

Dalteparin is also known as: Fragmin

Dalteparin Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. There are no controlled data in human pregnancy. Uncontrolled human pregnancy data indicate no fetal or neonatal toxicity. Therapeutic failures have been reported in pregnant women with prosthetic heart valves on full anticoagulant doses of low molecular weight heparin. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: B

Dalteparin Breastfeeding Warnings

AU and UK: Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Use is considered acceptable; caution is recommended. Excreted into human milk: Yes Comments: This drug has been used without apparent harmful effects in the nursing infant.

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