"Avemar pulvis" is a powder consisting of an aqueous extract of fermented wheat germ, with the drying aids maltodextrin and silicon dioxide, standardized to contain approximately 200 microg/g of the natural constituent 2,6-dimethoxy-p-benzoquinone. The results of toxicological and clinical studies of this product demonstrate its safety for its intended use as a dietary supplement ingredient in the United States. Avemar pulvis has been used in Hungary since 1998 and is approved in that country, as well as in the Czech Republic, Bulgaria, and Romania, as a "medical nutriment for cancer patients." Acute and subacute toxicity studies using rodents orally administered Avemar pulvis showed that dose levels (2000 to 3000 mg/kg body weight [bw]/day) exceeding the normal recommended oral dosage (8.5 g/day or 121 mg/kg bw/day for a 70-kg individual) by up to approximately 25-fold caused no adverse effects. The test substance showed no evidence of mutagenicity or genotoxicity in vitro or in vivo. Clinical studies using Avemar pulvis as a supplement to drug therapy in cancer patients at doses of 8.5 g/day not only showed no evidence of toxicity, but also showed a reduction in the side effects of chemotherapy. Overall, it was concluded that Avemar pulvis would not be expected to cause adverse effects under the conditions of its intended use as an ingredient in dietary supplements.
The visual information on ECT reduced the interns' negative attitudes, in general; however, acceptance of the treatment decreased in a subgroup of interns.
It is probable that only an insignificant amount of β‐cyclodextrin is absorbed in unchanged form from the intestinal tract. The oral administration of the conversion mixture (38% β‐cyclodextrin, 2.8% α‐cyclodextrin, the rest partially decomposed starch) to rats and dogs, as well as the crystalline β‐cyclodextrin (97%) at doses of 200, 400 and 600 mg/kg of bodyweight daily, according to the clinico‐biochemical tests has not caused significant changes. The pathological and histopathological studies performed after a 6 months treatment have not proved any observable changes. β‐Cyclodextrin proved not to be embryotoxic and teratogenic. The chromosoma test performed on rats treated for 6 months has not increased the incidence of spontaneous aberration and no change relating to mutation could be observed, either.
Considering the very high Hungarian suicide rate, the low referral rate in cases of severe suicidal intent and threat is surprising. The respondents also rarely considered ECT for NMS or severe depression. The discrepancy between current referral practices and standard recommendations could be decreased with more ECT training courses.
SUMMARYThe acute oral and parenteral LD-5o of beta-cyclodextrin was established on rats, mice and aog~.The long term toxicity studies were performed on rats and 2.~.dogs following the two weeks dose finding studies given the test substance by oral route. All of the animals were autopsied and the tissue samples were examined histopathologically in both experiments. Investigation of the effect of beta-cyclodextrin on hepatic drug metabolizing enzyme system of rats did not show any alteration in the activity.According to our results the beta-cyclodextrin given orally to rats and dogs did not cause any side effect during the long term toxicity stUdies.
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