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Transamin Side Effects

The main side effects reported in 2,954 patients in clinical trial (including double blind trial) were anorexia in 0.61% (18 cases), nausea in 0.41% (12 . cases), vomiting in 0.20% (6 cases), pyrosis in 0.17% (5 cases), itching in 0.07% (2 cases) and rash in 0.07% (2 cases).

Non Clinical Test
Metabolism
When 14C-Tranexamic acid was administered intravenously to rats, it was almost all excreted in the unchanged form.

Distribution
When 14C-Tranexamic acid was administered orally to mice, concentration in most organs reached peak value as well as the blood concentration after 2 hours. Levels in kidney and liver were higher, and those of other organ were lower than the blood concentration.

Acute toxicity
The LD50, values of oral administration were mom than 10g/kg in mice and rats, and more than 5.0 g/kg in dogs.

Chronic toxicity:
When Tranexamic acid was administered orally to rats for 6 months continuously and their general condition, blood, organs, etc., were examined, no abnormalities were seen upto a dose of 1.5 g/kg, but at doses of 3 g/kg or higher, diarrhoea appeared, and at 4 g /kg the body weight gain was inhibited only in in males.

Fetal test
In oral administration test, no teratogenetic action was seen at dose of 1.5 g/kg in mice.

Carcinogenicity
In a carcinogenicity test performed by administering 2.5% or 5% of Transamin mixed with the feed for 19
months, no carcinogenicity was observed.

Mutagenicity
No mutagenicity was seen in the Rec-assey, Ames test, chromosome test, or dominant lethality test.

Passage through the placenta
When 14C-Tranexamic acid was administered intravenously to pregnant rats, transfer the fetuses was confirmed, and the concentrations in whole blood of the fetal tissue and fetal were the same as or less than those in the whole blood of the mothers.

Transfer to mother's Milk
When 40mg/kg of 14C-Tranexamic acid was administered intravenously to rats, transfer to mother's milk was seen at concentrations of 6.1 ug/ml one hour and 0.2 mg/ml 24 hours after administration.

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