Indication:
For healthcare professionals to use as an adjuvant to standard wound care for chronic, non-healing wounds in adults, including Diabetic Foot Ulcers (DFU), Venous Leg Ulcers (VLU), and post-operative/trauma wounds (HSPC Class 2 & 3).
Contraindications:
- Ischemic wounds before revascularization.
- Neoplastic wounds.
- Active infections requiring surgery (e.g., abscesses).
- Underlying osteomyelitis.
- Chronic wounds classified as Class 4 or 5 (HSPC).
Direction for use:
- Preparation: Must be prepared and administered by trained healthcare professionals under sterile conditions.
- Reconstitution: Reconstitute with sterile 0.9% Normal Saline and use immediately or store at 2–8°C for up to 12 hours. Discard unused solution after 12 hours.
- Application: Apply to the wound bed/peri-secondary:**12 weeks. (Optional: Local anesthetic may be used for sensitive patients.)
Precautions:
- Consultation: Consult a provider before use if pregnant, breastfeeding, or for pediatric patients (safety not established).
- Infection Control: Do not use on wounds with uncontrolled infection; debridement/antibiotics required first.
- Allergies: Discontinue use if allergic reactions occur.
- Use: For single-patient use only; discard unused portion after 12 hours post-reconstitution.
Recommended Storage:
- Storage: Store unopened vials at 2–8°C in a dry, dark place (Do not freeze). Protect from light/moisture.
- Shelf Life: 24 months from the manufacturing date.
Ingredients:
Bioprotein from Mesenchymal Stromal Cell Secretome, Mannitol, Sodium Chloride.
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