PBSerum Hyaluronidase 10x5ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
PB Serum Hyaluronidase — the manufacturer's designation: pbserum Drain+ Hyaluronidase PB3000 — is a ready-to-use enzyme solution from Proteos Biotech (Spain), formulated with second-generation recombinant hyaluronidase PB3000 and free from components of animal origin. It belongs to the pbserum Plus line, registered by the manufacturer as a cosmetic for professional topical use. Box of 10 vials of 5 ml.
- Enzyme recombinant hyaluronidase PB3000
- Origin recombinant, free from animal components
- Contents 10 vials × 5 ml
- Format ready to use, no reconstitution
- Use topical — pbserum Plus line
Composition and technology
Active substance: hyaluronidase PB3000, a second-generation recombinant enzyme developed by Proteos Biotech, a Spanish biotechnology laboratory specialising in advanced recombinant enzymes.
Mechanism: hyaluronidase hydrolyses the glycosidic bonds of hyaluronic acid and breaks high-molecular-weight molecules into smaller fragments. The result is a reduction in the viscosity of the extracellular matrix in the treated area.
Advantage of the recombinant route: as it is obtained by recombinant expression and not by extraction from animal tissue (bovine or ovine testis), the preparation contains no accompanying animal proteins, which reduces the foreign protein load of the formulation.
Proteos Biotech does not publish in the range data sheet the enzyme activity in international units per vial; for that reason no IU figure is stated here.
Regulatory status — important information
Proteos Biotech states expressly regarding the line to which this reference belongs: "the products in the pbserum Plus line are registered as cosmetic products for topical use. They are not intended for medical use or for injectable application."
- It is therefore a cosmetic for professional topical use: it is neither a medical device nor a medicinal product.
- It is not injectable and must not be administered intradermally or subcutaneously.
- It does not cover the indication of correcting complications after hyaluronic acid fillers — nodules, overcorrection, Tyndall effect, vascular occlusion — for which the manufacturer maintains a separate line, pbserum HA Corrector (HA Partial Corrector and HA Total Corrector), intended for medical use.
In Spain, hyaluronidase intended for injectable administration in the correction of filler complications has the status of a medicinal product, with the prescription and traceability requirements that apply to that category. A topical cosmetic is not a substitute for it.
Comparison of the enzyme preparations in the catalogue
| PB Serum Hyaluronidase Drain+ PB3000 — Proteos Biotech (Spain) | Recombinant hyaluronidase PB3000, ready-to-use solution. 10 vials of 5 ml. pbserum Plus line: cosmetic for topical use, not injectable |
|---|---|
| HyaluronDase 1500 IU MediXa Srl (Italy) | Hyaluronidase + mannitol in powder form, 1,500 IU declared. 5 vials of 10 ml. Professional cosmetic for external use |
| Disolvidase 1500 IU Dermaqual (France) | Freeze-dried hyaluronidase, 1,500 IU declared. 5 sterile vials. Freeze-dried cosmetic preparation for professional topical use |
All three references share the same regulatory category: enzyme preparations for professional topical use, not injectable medicinal products. PB Serum is the only one of the three with a recombinant enzyme and the only one supplied as a ready-to-use solution, without prior reconstitution.
Indications and treatment areas
Effect declared by the manufacturer for Drain+: to contribute to a more uniform and balanced skin appearance in the treated areas.
- Face
- Body areas with an irregular appearance of the skin surface
Application technique
Professional topical application on intact, clean skin. Ready-to-use product: no reconstitution required.
Proteos Biotech does not publish in the public data sheet for the range the dose per application, the number of sessions or the interval between them. The binding regimen is the one set out in the documentation accompanying the product and in the manufacturer's official training.
Technical data
| Manufacturer | Proteos Biotech S.L., Spain |
|---|---|
| Manufacturer's designation | pbserum Drain+ Hyaluronidase PB3000 (pbserum Plus line) |
| Active substance | Recombinant hyaluronidase PB3000 |
| Origin of the enzyme | Recombinant, free from components of animal origin |
| Presentation | Box of 10 vials of 5 ml, ready-to-use solution |
| Route of application | Topical — not injectable |
| Classification | Cosmetic product for professional use |
| Use | Professional use only |
Storage and pack contents
- Box of 10 vials of 5 ml.
- Store as indicated on the pack, protected from direct light and heat sources. Do not freeze.
- Once the vial has been opened, use in accordance with the manufacturer's instructions.
- Do not use after the expiry date shown on the pack.
Contraindications and warnings
For topical use only. Do not inject. Avoid contact with the eyes and mucous membranes.
Hyaluronidase is a recognised allergen: hypersensitivity reactions, including severe reactions, have been described in association with its administration. Do not apply in case of known hypersensitivity to hyaluronidase or to any other component, or on skin with active infection, inflammation or lesion. Discontinue application if any skin reaction occurs.
Always consult the instructions for use included in the pack before application.
Cosmetic product for professional use, not injectable. Technical information based on the official documentation of Proteos Biotech / pbserum. This data sheet does not replace the instructions for use accompanying the product.