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In the extended adjuvant setting for femara median duration of treatment 5 years and placebo median duration of treatment 3 years , respectively angina requiring surgery 0.
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In harmonising the contraindicationsthe CHMP decided against including two contraindications that were in the SmPCs of some EU countriesliver impairment and pre-operative use in patients whose receptor status is negative or unknownThe CHMP was of the view that it was more appropriate to include relevant warnings in section 4.4.
Exposure of an unborn child to this medication could cause birth defectsso you should not become pregnant while on this medicationEffective birth control is necessary during treatment if your menopause status has not been confirmedYou should not breastfeed while receiving this medication.
Get emergency medical help if you have signs of an allergic reaction to Femarahivesdifficult breathingswelling of your facelipstongueor throat.
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it is unclear, however, if in these cases the women were taking femara while pregnant or just took it prior to conception.