Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland tel: 00 800 4447 4447 (toll free) tel: +44 1604 549 952 e-mail: medinfo@amrytpharma.com
Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
The gel should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile non-adhesive wound dressing or applied to the dressing so that the gel is in direct contact with the wound. The gel should not be applied sparingly. It should not be rubbed in. The gel should be reapplied at each wound dressing change. The maximum total wound area treated in clinical studies was 5,300 cm² with a median total wound area of 735 cm². 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.
No studies have been conducted with Filsuvez in patients with renal or hepatic impairment. No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2).
No dose adjustment is required.
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.
For cutaneous application only.
Filsuvez should be applied to cleansed wounds. This medicinal product is not for ophthalmic use and should not be applied to mucous membranes.
Each tube is for single use only. The tube should be discarded after use.
Overdosing with Filsuvez is unlikely. No case of overdose has been reported when a maximum amount of 69 g was used on a daily basis for more than 90 days. No data have been generated to establish the effect of accidental ingestion of Filsuvez. Further management should be as clinically indicated.
4 years.
Once opened, the product should be used immediately and be discarded after use.
Store below 30°C.
White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and with a sealing compound in the fold. The tube is closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap. The tube is packed in a carton.
Pack sizes: 1 tube of 9.4 g or 23.4 g gel.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
