Overdose : מינון יתר

4.9 Overdose

When applying Verrumal Solution to a 25 cm² area of skin, an amount of 0.2 g Verrumal Solution and therefore 1 mg of fluorouracil (FU) is applied. 1 mg of FU corresponds to a dose of 0.017 mg/kg of body weight with a person weighing 60 kg. Systemic intoxications occur with intravenous administration of 15 mg per kg body weight and are therefore ruled out as a result of this thousandfold safety profile. The safety profile also increases even more considerably as FU is not percutaneously resorbed to any significant degree from Verrumal Solution (see also Section 5.2).

As a serum level of barely over 5 mg/dl is reached after the percutaneous resorption of salicylic acid (also see Section 5.2), salicylate intoxications are practically ruled out if Verrumal Solution is used as prescribed (also see Section 5.2).

Early symptoms of salicylate intoxication can only occur with serum levels over 30 mg/dl. They include ringing in the ears, tinnitus with hearing difficulty, nosebleeds, nausea, vomiting, irritability a feeling of dryness with mucous membranes.

Therefore, systemic intoxications are unlikely for both active ingredients if applied to the skin as prescribed (see above). However, clearly exceeding the recommended frequency of application increases the frequency and the severity of local reactions at the site of application.

Children

Small children have a different ratio of body surface to body mass to adults. Therefore significantly exceeding the maximum recommended treatment area or treatment frequency increases the risk of salicylate intoxication, especially in small children.