Alidya 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.
Alidya™ is the first injectable medical device formulated specifically for the prevention and treatment of gynoid lipodystrophy (cellulite). Developed by Prof. Pasquale Motolese, its formulation is based on an amino acid buffer system and a chelating agent (sodium EDTA) intended to solubilise and eliminate the extracellular toxic elements associated with vascular damage of the microcirculation. It is presented in lyophilised form and is reconstituted with its own solvent before the session.
- Lyophilisate 5 vials × 340 mg
- Solvent 5 vials × 10 ml
- Technique mesotherapy
- Protocol 7 weekly sessions on average
- Classification class III medical device
Composition and technology
Formulation declared by the manufacturer:
- Amino acid buffer system with sodium bicarbonate corrector.
- Polyamino acid gel with 1-4 glycosidic bonds.
- D-(+)-alpha-D-glucopyranose — osmolarity regulator.
- Sodium ethylenediaminetetraacetate (sodium EDTA) — chelating agent.
Action declared by the manufacturer:
- To solubilise and eliminate the extracellular toxic elements secondary to vascular damage of the microcirculation.
- To alkalinise the extracellular matrix.
- To improve tissue oxygenation.
- To provide the biological components for the restructuring of the extracellular matrix.
- To normalise the physiological function of the adipose tissue.
Alidya™ is not a lipolytic product. Its declared mechanism is one of chelation and restructuring of the extracellular matrix, not of destruction of the adipocyte.
Indications and treatment areas
Indication: prevention and treatment of gynoid lipodystrophy (cellulite), understood by the manufacturer as a chronic degenerative process of the subcutaneous adipose panniculus that manifests as an alteration of the skin surface.
Areas: the body areas affected by gynoid lipodystrophy.
Technique and treatment protocol
- Preparation: reconstitute the vial of lyophilised powder with the corresponding solvent vial before application.
- Technique: mesotherapy over the affected area.
- Frequency: weekly sessions.
- Number of sessions: an average of 7 sessions per treated area, up to a maximum of 12 treatments.
- Dosage: 1 to 2 vials per session, according to the extent of the area to be treated and the patient's body constitution.
Application exclusively by a qualified healthcare professional trained in the technique.
Technical data
| Manufacturer | GHIMAS S.p.A., Via Cimarosa 85, 40033 Casalecchio di Reno (BO), Italy |
|---|---|
| Licence holder / operational headquarters | Marllor Biomedical, Via Torconca 1, 47842 S. Giovanni in Marignano (RN), Italy |
| Formulation | Prof. Pasquale Motolese |
| Components | Amino acid buffer system with sodium bicarbonate, 1-4 glycosidic polyamino acid gel, D-(+)-alpha-D-glucopyranose, sodium EDTA |
| Pharmaceutical form | Lyophilised powder + solvent |
| Presentation | 5 vials of 340 mg of lyophilised powder + 5 vials of 10 ml of solvent |
| Route | Injectable, mesotherapy technique |
| Classification | Class III medical device with CE marking 0373 |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- The pack contains: 5 vials with 340 mg of lyophilised powder and 5 vials with 10 ml of solvent. Needles are not included.
- Storage: keep the vials in their original packaging, protected from direct light and from heat sources, in accordance with the indications on the packaging.
- Reconstituted product: prepare at the time of the session and use immediately. Do not keep the remainder.
- Do not use after the expiry date shown on the packaging.
- Sterile single-use vials. Do not reuse or resterilise.
Contraindications and warnings
Contraindications: known hypersensitivity to any of the components of the formula, including EDTA; pregnancy and breastfeeding; minors; active infection or inflammation in the area to be treated; coagulation disorders or anticoagulant therapy without prior assessment.
Warnings: do not inject intravascularly. As with any mesotherapy technique, there is a risk of local haematoma, erythema and oedema in the treated area. Reconstitute the lyophilisate only with the solvent supplied. Do not mix with other injectable products.
Always consult the instructions for use included in the pack before application. The technical documentation for this product is reserved for the medical profession.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the manufacturer's official documentation (Alidya™ technical brochure, Marllor Biomedical / GHIMAS S.p.A.). The manufacturer does not publish openly the complete list of contraindications or the exact storage conditions; this data sheet does not replace the instructions for use accompanying the product.