Table 1 Information about drug excipients contraindicated in HFI patients from labelling and package leaflets (EMA/CHMP/302,620/2017).
Excipient | Route of administration | Threshold | Comments on the labelling |
|---|---|---|---|
Fructose Sorbitol (E 420) | Intravenous (IV) | Zero | Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary. Babies and young children (below two years of age) may not yet be diagnosed with HFI. Medicines containing fructose/sorbitol given intravenously may be life-threatening and are contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available. A detailed history of HFI symptoms has to be taken for each patient prior to being given this medicinal product. |
Oral, parenteral (other than IV) | 5 mg/kg/day | Patients with rare hereditary problems of fructose intolerance should not take this medicine. | |
Invert sugar | Oral | Zero | |
Isomaltitol (isomalt) (E 953) | |||
Lactitol (E 966) | |||
Maltitol (E 965), maltitol liquid (hydrogenated glucose syrup) | |||
Sucrose |