FRAGMIN 3 Serious Warnings And Precautions Box

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Serious Warnings and Precautions

  • The multi-dose vial of Fragmin (25,000 IU/mL) contains benzyl alcohol (14 mg/mL) as a preservative. Benzyl alcohol has been associated with a potentially fatal “Gasping Syndrome” in neonates. Because benzyl alcohol may cross the placenta, Fragmin preserved with benzyl alcohol should not be used in pregnant women (see 7.1.1 Pregnant Women).
  • The multi-dose vial of Fragmin (25,000 IU/mL) which contains benzyl alcohol must not be used in premature or newborn babies.
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3 Serious Warnings And Precautions Box

Serious Warnings and Precautions

  • The multi-dose vial of Fragmin (25,000 IU/mL) contains benzyl alcohol (14 mg/mL) as a preservative. Benzyl alcohol has been associated with a potentially fatal “Gasping Syndrome” in neonates. Because benzyl alcohol may cross the placenta, Fragmin preserved with benzyl alcohol should not be used in pregnant women (see 7.1.1 Pregnant Women).
  • The multi-dose vial of Fragmin (25,000 IU/mL) which contains benzyl alcohol must not be used in premature or newborn babies.

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