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The vaccine may be administered to pregnant women following an assessment of the risks and benefits.
The safety of Fluarix Tetra when administered to pregnant women has not been evaluated in clinical trials.
When administered during pregnancy, safety data on inactivated seasonal influenza vaccines based on systematic literature review, and available post-marketing data on Fluarix Tetra, do not indicate an increased risk of adverse pregnancy outcomes.
Animal studies with Fluarix Tetra do not indicate direct or indirect harmful effects with respect to reproductive and developmental toxicity (see Pharmacology: Toxicology: Non-Clinical Information under Actions).
The safety of Fluarix Tetra when administered to breast-feeding women has not been evaluated. It is unknown whether Fluarix Tetra is excreted in human breast milk.
Fluarix Tetra should only be used during breast-feeding when the possible advantages outweigh the potential risks.
