Birch bark extracts (betulin)

⚠️ NO MAXIMUM DOSE EXISTS IN THIS SPC, AND THE ONE AREA FIGURE IT CONTAINS IS NOT A CEILING. §4.2 states: 'The maximum total wound area treated in clinical studies was 5,300 cm2 with a median total wound area of 735 cm2.' That is a description of what was studied, not a licensed limit, so it has deliberately NOT been entered as maxDose. || PAEDIATRIC (§4.2, verbatim): 'The posology in paediatric patients (6 months and older) is the same as in adults. The safety and efficacy of Filsuvez in children aged less than 6 months have not been established. No data are available.' This is the label's own paediatric statement — the adult regimen unchanged from 6 months — and nothing has been scaled or derived. §4.8 adds that '70% (n=156) of patients randomised in the pivotal study were under the age of 18 with a median age of 12 years. 8% (n=17) of patients were below 4 years of age' (that sentence is cut off at the fetch limit). || SPECIAL POPULATIONS: renal or hepatic impairment — 'No studies have been conducted with Filsuvez in patients with renal or hepatic impairment. No dose adjustment or special considerations are anticipated'. Elderly — 'No dose adjustment is required.' || REVIEW OF TREATMENT (§4.2): 'If symptoms persist or worsen after use, or if wound complications occur, the patient's condition should be fully clinically assessed prior to continuation of treatment, and regularly re evaluated thereafter.' §4.4 adds for the less-evidenced EB subtypes: 'The quantity of clinical data from use of Filsuvez in patients with DDEB and JEB is limited... The patient's condition should be regularly evaluated to assess the benefit of continued treatment.' || CONCOMITANT TOPICALS (§4.5): 'Other topical products should not be concomitantly used together with Filsuvez but rather sequentially or alternatively depending on the clinical need.' || BIRCH POLLEN ALLERGY — a common misconception, addressed directly by §4.4: 'Filsuvez is safe to use for people who are allergic to birch pollen, as these allergens are not present in this medicinal product.'

NOT WEIGHT-BASED — the dose is a layer thickness, so dosePerKg is null and no weight calculation applies. §4.2, verbatim: 'The posology in paediatric patients (6 months and older) is the same as in adults. The safety and efficacy of Filsuvez in children aged less than 6 months have not been established. No data are available.' The adult instruction therefore applies unchanged from 6 months of age: apply to the wound surface at a thickness of approximately 1 mm, not sparingly, do not rub in, cover with a sterile non-adhesive dressing, reapply at each dressing change. This is the label's own paediatric statement; nothing has been scaled from the adult figure.