Finished product reference
Allogeneic Cultured Keratinocytes and Fibroblasts In Bovine Collagen
Patch · Topical · 300000 cells/1 cm2
- List code
- 53435
- Pharmacologic class
- Bioengineered living skin substitute (cell-based wound therapy)
What it is and how it works
A bilayered construct of allogeneic neonatal foreskin-derived fibroblasts in a bovine type I collagen matrix covered by a stratified layer of allogeneic keratinocytes. It provides a temporary biological wound cover and secretes growth factors, cytokines and extracellular matrix components that stimulate host wound healing.
Indications
Treatment of chronic non-healing wounds such as venous leg ulcers and diabetic foot ulcers that have not responded to standard wound care.
Dosage and administration (summary)
Applied topically to the prepared wound bed by a trained wound-care specialist according to protocol; reapplication is determined by wound response.
Contraindications
Clinically infected wounds; known hypersensitivity to bovine collagen or to components of the shipping medium.
Warnings and precautions
Wounds must be debrided and free of infection before application. Not for use on wounds with sinus tracts or exposed bone without specialist supervision. Handle aseptically and apply within the stated shelf life.
Storage and supply
Supplied as a living product; keep in its sealed container at the controlled room temperature specified by the manufacturer, do not refrigerate or freeze, and use before expiry.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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