Finished product reference
Allogenic Skin Derived Keratinocyte
Patch · Topical · 300000 cells/1 cm2 · 60 CM3
- List code
- 53434
- Pharmacologic class
- Allogeneic cell-based skin substitute (cultured keratinocyte sheet)
What it is and how it works
Sheets or patches of cultured allogeneic human epidermal keratinocytes applied to wounds. The cells provide temporary coverage and release growth factors and cytokines that promote re-epithelialisation by the patient's own keratinocytes; the allogeneic cells are gradually replaced.
Indications
Promotion of healing of partial-thickness burns, donor sites and chronic skin ulcers as an adjunct to standard wound care.
Dosage and administration (summary)
Applied topically to the cleaned, debrided wound by a specialist according to protocol; frequency depends on wound response.
Contraindications
Infected wounds; hypersensitivity to components of the product or culture medium.
Warnings and precautions
Ensure adequate wound bed preparation and infection control before application. As a human cell-derived product, a theoretical risk of infectious disease transmission exists despite donor screening. Handle aseptically according to the manufacturer's instructions.
Storage and supply
Store and transport according to the manufacturer's instructions for living cell products; usually short shelf life.
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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