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Plasma protein fraction Pregnancy and Breastfeeding Warnings

Brand names: Octaplas, Plasma-Plex, Plasmanate, Plasmatein, Protenate

Plasma protein fraction Pregnancy Warnings

Use is not recommended unless clearly needed.

US FDA pregnancy category: Not assigned.

Risk Summary: Animal reproduction studies have not been conducted. It is not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Comments:
-The effects on the developing fetus are unknown.

It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Plasma protein fraction Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2013) "Product Information. Plasmanate (plasma protein fraction)." Bayer Pharmaceutical Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2013) "Product Information. Plasmanate (plasma protein fraction)." Bayer Pharmaceutical Inc

Further information

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