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Norxifen has been associated with changes in liver enzyme levels and with a spectrum of more severe liver abnormalities which in some cases were fatal, including fatty liver, cholestasis and hepatitis, liver failure, cirrhosis, and, hepatocellular injury including hepatic necrosis. The available studies have mainly been Norxifen
in postmenopausal women. Breast cancer: Adults: The recommended daily dose of Norxifen is normally 20mg. It is used as contraception to prevent pregnancy. In delayed microsurgical breast reconstruction Norxifen may increase the risk of microvascular flap complications. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses. Signs observed at the highest doses following studies to determine LD 50 in animals were respiratory difficulties and convulsions. In some Norxifen tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Preclinical safety data The information provided in Preclinical safety data of Norxifen is based on data of another medicine with exactly the same composition as the Norxifen of the medicine Tamoxifen.