Geplaatst: 22-12-20 14:09 https://www.ema.europa.eu/en/documents/ ... nal_en.pdf
Citaat:13. Ivermectin is widely used in humans for treatment of onchocerciasis and other parasitic diseases
at single or repeated doses of 0.15 to 800 mg/kg bw. Tolerance to the compound has been
assessed in healthy volunteers and in patients; adverse effects are usually mild and transient. In
particular, no effects on the central nervous system were observed. The main effects noted in field
and community based trials have been those arising from the death of the parasites, the so-called
Mazzotti reaction, which is characterised by arthralgia, pruritis, fever, hypertension, tachycardia,
headache and ocular changes. Neither in these studies nor during treatment for other parasitic
diseases has a subset of atypically sensitive individuals been detected. Furthermore, the adverse
effects experienced by the small number of persons accidentally exposed to doses (often of
veterinary preparations) higher than customary human doses are in keeping with those noted in
test animals.
A double blind, randomised, placebo controlled clinical trial was conducted to assess the safety
and tolerability of oral subacute repeat doses of up to 1.2 mg/kg bw and an acute dose of
2.0 mg/kg bw in 68 healthy adult male and female human subjects as a treatment for headlice. No
treatment related signs of toxicity were observed and in particular, there were no signs of
neurotoxicity such as emesis, mydriasis (measured by pupillometry) or ataxia, that were predicted
to be the most sensitive potential adverse effects based on the laboratory animal studies. A
conservative NOEL of 420 µg/kg bw was identified.
However, it was considered that the human study could not be used to establish the ADI because
the dosing regimen used. As indicated in paragraph 3 above, the time to reach steady state would
be much longer than the maximum treatment period used (7 days). The plasma steady state
concentration would be at least 1.5-fold higher than the levels achieved after administration on
days 1, 3, and 7 only. The relation of these kinetics to central nervous system concentrations is
unknown.
je zou bijna denken dat er een virus rondwaart. 
