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The manufacturers of certain testosterone products (., AndroGel and Striant) state that their products are contraindicated in patients with soybean, soy, or soya lecithin hypersensitivity because they are derived partially from soy plants. There is a risk of serious hypersensitivity reactions or anaphylaxis with the use of testosterone undecanoate (Aveed) oil for injection. These allergic reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose. Observe patients in the healthcare setting for 30 minutes after an Aveed injection in order to provide appropriate medical treatment in the event of serious hypersensitivity reactions or anaphylaxis. The Aveed injection contains benzyl benzoate, the ester of benzyl alcohol and benzoic acid, and refined castor oil. Therefore, testosterone undecanoate use is contraindicated in patients with polyoxyethylated castor oil hypersensitivity, benzoic acid hypersensitivity, or benzyl alcohol hypersensitivity. Patients with suspected hypersensitivity reactions should not be re-treated with testosterone undecanoate injection.
The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate compared with - in the placebo/formoterol group). The mean number of days on oral corticosteroids/patient during the 12 months was slightly reduced in the budesonide/formoterol group (7-8 days/patient/year compared with 11-12 and 9-12 days in the placebo and formoterol groups, respectively). For changes in lung-function parameters, such as FEV 1, budesonide/formoterol was not superior to treatment with formoterol alone.