In rats, at toxic maternal doses (600 mg / kg / day) during the last days of gestation and during lactation, they caused less survival, less weight gain and delayed development. (detachment of the pinna and opening of the ear canal) of the offspring (see section 4.6). These rat doses (600 mg / kg / day) are approximately 18 times the maximum dose. recommended in man based on mg / m2 (calculations assume an oral dose of 320 mg / day and a patient of 60 kg).