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Aliaxin® GP

Aliaxin® GP

Aliaxin

Medical aesthetic product
  • CE Marked Class III medical device for aesthetic injection.
  • Manufactured in an FDA Approved facility in Italy under IBSA Farmaceutici Italia.
Dermal filler \u2014 hyaluronic acid

Description

Aliaxin® GP Global Performance is a resorbable hyaluronic-acid dermal filler for the correction of medium to deep facial cutaneous sagging and for increasing the volume and contour of the lips. It is a sterile, non-pyrogenic, physiological gel implant based on cross-linked, non-animal hyaluronic acid produced by biofermentation, with added natural (non-cross-linked) HA. Designed for ‘global performance’, it treats common facial imperfections, providing a prolonged corrective effect for pronounced wrinkles and folds (such as nasolabial folds, nose and chin contouring, glabellar and frontal lines), while restoring localised facial volume in areas such as cheeks, cheekbones, chin and lips. The product shows high tissue integration and stability, resulting in natural yet long-lasting outcomes.

Bnefits

  • Corrects medium and deep facial wrinkles and sagging (e.g. nasolabial folds, glabellar and frontal lines).
  • Enhances and restores localised facial volume in cheeks, chin, cheekbones and lips.
  • Increases lip volume and improves lip contour for aesthetic refinement.
  • Provides prolonged lifting and corrective action due to optimised HA cross-linking and rheology.
  • High tissue integration and stability for natural, harmonious results.
  • Non-animal, ultrapure HA produced by patented biofermentation, with low BDDE residue and low cross-linking percentage.
  • Does not require prior skin testing and is fully resorbable over time (temporary filler).

Indications

  • Restoration of physiological facial volumes.
  • Correction of medium and deep facial cutaneous sagging.
  • Treatment of nasolabial folds.
  • Treatment of perioral wrinkles.
  • Treatment of glabellar lines.
  • Treatment of frontal (forehead) wrinkles.
  • Correction of facial and acne scars.
  • Areas requiring enrichment of facial tissue (cheeks, chin, cheekbones, lips) with temporary increase in volume.
  • Lip augmentation and contour enhancement.

Composition

  • Cross-linked hyaluronic acid (non-animal origin) 25 mg/ml.
  • Natural (non cross-linked) hyaluronic acid 2.5 mg/ml.
  • Molecular weights of HA: 1,000 kDa and 2,000 kDa.
  • Phosphate buffer.
  • Water for injectable solutions.
  • Very low BDDE residue (<0.1 ppm).
  • Overall cross-linking degree <10%.

Formulation

  • Monophasic, sterile, non-pyrogenic, physiological HA gel.
  • Ready-to-use, pre-filled syringes (no fragmentation or additional handling required).
  • Optimised viscoelastic properties for flow, lift and sculpt capacity (Flow 0.53, Lift 39 Pa, Sculpt 0.28).
  • Hydrolift/Hydroaction and Liftaction profile suitable for medium to deep corrections.

Packaging

  • Total volume: 2 ml (2 × 1 ml pre-filled single-use sterile syringes).
  • 2 sealed blister packs, each containing 1 disposable sterile pre-filled syringe of 1 ml.
  • 4 sterile needles: 27G × 13 mm (TSK 0123) and 27G × 19 mm (TSK 0123).
  • Adhesive labels for patient file traceability.
  • Instructions for use insert.

Usage

  • Use is strictly reserved for qualified medical doctors trained in dermal filler injections.
  • Inspect packaging integrity and expiry date before use; do not use if packaging is damaged or after expiry.
  • Disinfect the treatment area and maintain strict aseptic technique.
  • Inject into the skin tissue (mid to deep dermis / superficial subcutis) for supplementation of the extracellular matrix and intracutaneous volumetric increase.
  • Adapt injection depth, technique (e.g. linear threading, serial puncture, fanning) and volume according to indication, treatment area and patient-specific anatomy.
  • After injection, gently massage the treated area if required to ensure even distribution and optimal contour.
  • Inform the patient about common, usually transient post-treatment reactions (redness, swelling, tenderness, bruising) and provide post-care instructions (avoid extreme temperatures, heavy exercise, and manipulation of the area for a short period).
  • Single-use device: dispose of any unused product, syringes and needles according to local medical waste regulations.

Contraindications

  • Known hypersensitivity to hyaluronic acid or any component of the filler.
  • Presence of active infection, inflammation or skin disease at or near the intended injection site.
  • Patients with a history of severe allergies or anaphylactic reactions.
  • Pregnancy and breastfeeding (use is not recommended).
  • Severe autoimmune diseases or immune system disorders (at the physician’s discretion).
  • Concurrent use of certain anticoagulant or antiplatelet therapies may increase bruising risk (careful assessment required).

Adverse Effects

  • Transient erythema (redness), swelling, pain, itching, discolouration or tenderness at the injection site.
  • Bruising or hematoma at injection sites.
  • Palpable lumps or nodules, usually transient.
  • Rare but serious complications such as infection, granuloma formation, vascular occlusion or necrosis if injected intravascularly.
  • Hypersensitivity or allergic reactions in susceptible individuals.

Storage Conditions

  • Store between 2°C and 28°C.
  • Do not freeze.
  • Keep in the original blister/packaging and protect from light.
  • Do not use after the expiration date indicated on the packaging.

Duration

Typically 6\u201312 months depending on treatment area, degree of correction, patient age, skin type and lifestyle.

Onset

Immediate

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