Hyaluronidase 1500 IU 5x10ml
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.
HyaluronDase 1500 UI from MediXa Srl (Italy) is an enzymatic powder preparation based on hyaluronidase and mannitol, packaged in 5 vials of 10 ml. The manufacturer registers and labels it as a professional-use cosmetic for external application, whose stated function is to promote the diffusion of active ingredients into the skin. It is not registered as a medicinal product or as an injectable product.
- Enzyme hyaluronidase
- Declared activity 1,500 IU
- Excipient mannitol
- Contents 5 vials × 10 ml
- Use external — professional cosmetic
Composition and technology
- Active ingredient: hyaluronidase.
- Declared activity: 1,500 IU, the value from which the product takes its name.
- Other declared component: mannitol.
- Form: powdered enzyme, requiring dissolution before application.
Mechanism: hyaluronidase hydrolyses the glycosidic bonds of hyaluronic acid, breaking high-molecular-weight chains into smaller fragments. This depolymerisation reduces the viscosity of the extracellular matrix and is the basis of the function stated by the manufacturer: facilitating the diffusion of active components applied to the skin.
Regulatory status — important information
MediXa Srl classifies and labels HyaluronDase 1500 UI as a professional-use cosmetic, with the express indication "external use". Consequently:
- It is not a medicinal product and is not authorised as an injectable product.
- It must not be presented or used as a treatment for dissolving hyaluronic acid fillers by the intradermal or subcutaneous route, nor as an emergency measure in the event of vascular occlusion.
The distinction should be emphasised: in Spain, hyaluronidase intended for injectable administration — the resource used in correcting overcorrections, nodules or vascular complications after hyaluronic acid fillers — has the status of a medicinal product and is subject to the prescription, dispensing and traceability requirements of that category. A cosmetic for external use does not replace that medicinal product and does not cover that indication.
Warnings from the manufacturer's labelling: do not swallow; keep out of the reach of children; external use; cosmetic for professional application.
Comparison of the enzymatic preparations in the catalogue
| HyaluronDase 1500 UI MediXa Srl (Italy) | Hyaluronidase + mannitol in powder form, 1,500 IU declared. 5 vials of 10 ml. Professional cosmetic for external use |
|---|---|
| PB Serum Hialuronidasa 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 |
| Disolvidase 1500 UI Dermaqual (France) | Lyophilised hyaluronidase, 1,500 IU declared. 5 sterile vials. Lyophilised cosmetic preparation for professional topical use |
The three references we market share the same regulatory category: they are enzymatic preparations for professional topical use, not injectable medicinal products. The differences between them lie in the format (powder for dissolution versus ready-to-use solution), in the origin of the enzyme (recombinant in the case of PB Serum) and in the volume per vial.
Application
According to the manufacturer's instructions: apply gently to dry skin, after dissolving the contents of the vial, over the area to be treated. Professional use, in a clinical setting and on intact skin.
MediXa does not publish a dose, a number of applications or an interval between them. The binding regimen is the one set out in the documentation accompanying the product.
Technical data
| Manufacturer | MediXa Srl, Italy |
|---|---|
| Active ingredient | Hyaluronidase |
| Declared activity | 1,500 IU |
| Other components | Mannitol |
| Pharmaceutical form | Powder for dissolution |
| Presentation | 5 vials of 10 ml |
| Route of application | External / topical — not injectable |
| Classification | Cosmetic product for professional use |
| Use | Professional use only |
Storage and pack contents
- Box of 5 vials of 10 ml.
- Store protected from direct light and heat sources, as indicated on the packaging.
- Once dissolved, use in accordance with the manufacturer's instructions.
- Do not use after the expiry date stated on the packaging.
Contraindications and warnings
For external use only. Do not inject. Do not swallow. Keep out of the reach of children. Avoid contact with eyes and mucous membranes.
Hyaluronidase is a recognised allergen: hypersensitivity reactions, including severe reactions, have been reported in association with its administration. Do not apply in case of known hypersensitivity to hyaluronidase or to any other component, nor on skin with active infection, inflammation or lesions.
Always consult the instructions for use enclosed in the packaging before application.
Cosmetic product for professional use, not injectable. Technical information based on the documentation of the manufacturer MediXa Srl. This data sheet does not replace the instructions for use accompanying the product.