Aliaxin FL 2x1ml
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.
ALIAXIN® FL Fine Lines from IBSA Derma is the most fluid reference in the Aliaxin range. With 25 mg/ml of cross-linked hyaluronic acid, 2.5 mg/ml of free hyaluronic acid and chains of 500 and 1,000 kDa, it reaches an elasticity value of 45 Pa — the lowest in the line — for work in the mid and deep dermis: fine lines, redefinition of the lip contour and perioral wrinkles. It is the only reference in the range supplied with 30G needles.
- Cross-linked HA 25 mg/ml
- Free HA 2.5 mg/ml
- Molecular weights 500 and 1,000 kDa
- Contents 2 syringes × 1 ml
- Needles 4 × 30G × 13 mm
Composition and technology
- Cross-linked hyaluronic acid: 25 mg/ml, of non-animal origin, obtained by bacterial fermentation.
- Free (non-cross-linked) hyaluronic acid: 2.5 mg/ml, for lubrication during injection and immediate hydration of the tissue.
- Molecular weights: 500 kDa and 1,000 kDa. These are the shortest chains in the range, and the reason why the gel is fluid enough to pass through a 30G needle and be deposited in the mid dermis without leaving a raised area.
- Cross-linking with BDDE at a low percentage: degree of cross-linking below 10 %, with a BDDE residue below 0.1 ppm.
- SHYALT technology: IBSA's proprietary method for obtaining ultrapure hyaluronic acid.
- Rheological profile: elasticity (lift) 45 Pa; flow 0.39; sculpt 0.23. Maximum fluidity and minimum projection in the range.
- The formulation does not include a local anaesthetic. For perioral and lip work, prior topical anaesthesia or nerve block is recommended.
Differences between the references in the Aliaxin range
| Aliaxin FL — Fine Lines | 25 mg/ml; 500 + 1,000 kDa; lift 45 Pa — mid/deep dermis: fine lines, lip contour, perioral wrinkles |
|---|---|
| Aliaxin GP — Global Performance | 25 mg/ml; 1,000 + 2,000 kDa; lift 95 Pa — deep dermis/subcutaneous: nasolabial fold, glabella, marionette lines, malar and chin volume |
| Aliaxin EV — Essential Volume | 25 mg/ml; 1,000 + 2,000 kDa; lift 162 Pa — deep subcutaneous: zygomatic region, jawline, temples |
| Aliaxin SV — Superior Volume | 25 mg/ml; 2,300 kDa; lift 295 Pa — deep/supraperiosteal plane: cheekbones, mandibular angle, chin |
| Aliaxin LV — Lips Volume | 25 mg/ml; 1,000 + 2,000 kDa — labial submucosa: lip volumising |
The five references share the same hyaluronic acid concentration (25 mg/ml cross-linked + 2.5 mg/ml free). What differentiates them is the combination of molecular weights and the resulting rheological behaviour, which determines the injection plane and the indication. In the lips, FL works the contour and the perioral lines and LV the volume of the lip body: they are complementary products, not alternatives.
Indications and treatment areas
Injectable implant indicated for the correction of superficial wrinkles and for detail work in the perioral region.
- Fine lines and superficial wrinkles
- Redefinition of the lip contour and of Cupid's bow
- Perioral wrinkles (barcode lines)
- Lip rehydration and refresh (lip refresh)
- Superficial glabellar wrinkles and mild nasolabial fold
- Shallow depressed facial scars
Because of its low elasticity, FL is not a volumising product: for volume restoration, GP, EV or SV should be used according to the plane.
Technique and treatment protocol
- Injection plane: mid to deep dermis; the final depth is at the practitioner's discretion according to the correction sought.
- Needles included: 4 × 30G × 13 mm.
- Technique: superficial linear retrograde injection, microdeposit or cross-hatching technique for fine lines; retrograde injection along the vermilion border for the lip contour.
- Aspiration and retrograde injection in accordance with the usual clinical protocol to minimise vascular risk.
- Avoid deposits that are too superficial, which may produce a Tyndall effect or visible irregularities.
- Never inject intravascularly. Do not apply in areas with permanent implants.
- Do not combine in the same session with laser, deep peeling or dermabrasion.
Technical data
| Manufacturer | IBSA Derma — IBSA Institut Biochimique SA, Switzerland |
|---|---|
| Active substance | Cross-linked hyaluronic acid 25 mg/ml + free hyaluronic acid 2.5 mg/ml |
| Molecular weights | 500 kDa and 1,000 kDa |
| Cross-linker | BDDE — degree of cross-linking < 10 %, residue < 0.1 ppm |
| Technology | SHYALT (ultrapure hyaluronic acid); Hydrolift® Action |
| Rheological profile | Lift 45 Pa; flow 0.39; sculpt 0.23 |
| Anaesthetic | Not contained |
| Presentation | 2 pre-filled syringes of 1.0 ml |
| Needles | 4 × 30G × 13 mm |
| Application plane | Mid / deep dermis |
| Classification | Medical device with CE marking |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C, in a dry place protected from direct sunlight. Do not freeze.
- Do not use after the expiry date shown on the packaging.
- Single-use product. Do not reuse or resterilise.
- The pack contains: 2 pre-filled syringes of 1.0 ml in a sterile blister, 4 sterile needles of 30G × 13 mm, package leaflet and adhesive traceability labels for the patient record.
Contraindications and warnings
Contraindications: known hypersensitivity to hyaluronic acid or to any of the components; active skin or mucosal infection or inflammation in the treatment area, including active labial herpes simplex; tendency to hypertrophic or keloid scarring; autoimmune diseases; coagulation disorders or anticoagulant or antiplatelet therapy; pregnancy and breastfeeding; under 18 years of age.
Warnings: do not inject intravascularly, intramuscularly or into tendons. Do not mix with other products in the same syringe. Do not apply over areas previously treated with permanent implants. Individual assessment in immunocompromised patients or in those with a history of multiple allergies.
Always consult the instructions for use included in the pack before application. The binding contraindications are those set out in the official documentation accompanying the product.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of IBSA Derma. This data sheet does not replace the instructions for use accompanying the product.