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Aliaxin® SR

Aliaxin® SR

Aliaxin

Medical aesthetic product
  • CE Marked Class III medical device for professional use.
Dermal filler \u2014 hyaluronic acid (shape & restore / contouring)

Description

Aliaxin® SR Shape & Restore is a resorbable, sterile, non-pyrogenic hyaluronic acid gel filler designed for dermal remodelling, treatment of medium and deep facial cutaneous sagging and restoration of facial contours. It is indicated for broad areas (such as forehead, temples and cheeks) and for defining facial contours while improving skin quality. The gel contains cross-linked, non-animal hyaluronic acid produced by biofermentation, with added natural HA, and is formulated to provide high tissue integration, hydration and a long-lasting but fully reversible shaping and volume-restoring effect.

Bnefits

  • Suitable for wide treatment areas including forehead, temples (superficial) and malar/cheek regions.
  • Provides dermal remodelling and restoration of physiological facial volumes with natural, well-defined contours.
  • Improves skin tone, firmness and elasticity while counteracting skin laxity.
  • High tissue integration and stability for smooth, natural-looking and long-lasting results.
  • Combines cross-linked and natural hyaluronic acid to deliver both volumising and hydrating (Hydroaction) effects.
  • Monophasic, ready-to-use HA gel with optimised rheology (flow, lift, sculpt) for controlled injection and contouring.
  • Non-animal, ultrapure HA produced by patented bio-fermentation with low cross-linking percentage and very low BDDE residue.

Indications

  • Restoration of physiological facial volumes.
  • Dermal remodelling and facial contour definition in broad areas.
  • Forehead and superficial temple treatment.
  • Cheeks and malar area volumisation and contouring.
  • Nasolabial folds.
  • Perioral/circumoral wrinkles.
  • Glabellar (frown) lines.
  • Frontal (forehead) wrinkles.
  • Facial and acne scars.
  • Areas requiring enrichment of facial tissue (cheeks, chin, cheekbones, lips) with temporary soft-tissue volume increase.

Composition

  • Cross-linked hyaluronic acid (non-animal origin) 25 mg/ml (total HA).
  • Natural (non-cross-linked) hyaluronic acid 2.5 mg/ml (within total 25 mg/ml).
  • Hyaluronic acid molecular weights: 500 kDa, 1000 kDa and 2000 kDa.
  • Phosphate buffer.
  • Water for injectable solutions.
  • Cross-linking agent: BDDE with low percentage cross-linking (<10%) and low BDDE residue (<0.1 ppm).

Formulation

  • Monophasic, sterile, apyrogenic physiological HA gel.
  • Ready-to-use pre-filled syringes; no fragmentation or additional handling required.
  • Rheological profile (IBSA Aliaxin range): Flow 0.53, Lift 39 Pa, Sculpt 0.28.
  • Hydroaction 4/4 (strong hydrating and bio-restructuring effect).
  • Liftaction 3/5 (lifting and contouring performance).

Packaging

  • Total volume: 2 ml (2 × 1 ml pre-filled disposable sterile syringes).
  • 2 sealed blister packs, each containing one 1 ml syringe.
  • 4 single-use sterile needles: 30G × 13 mm (½") and 27G × 19 mm (¾").
  • Instruction leaflet (instructions for use).
  • Adhesive traceability labels for patient file and record keeping.

Usage

  • Use exclusively by qualified members of the medical profession trained in dermal filler injections.
  • Before use, check the integrity of the packaging and expiry date; do not use if damaged or expired.
  • Disinfect the treatment area and follow strict aseptic technique.
  • Attach one of the supplied sterile needles (30G × 13 mm or 27G × 19 mm) using the Luer-Lock system, ensuring it is firmly secured.
  • Inject into the middle to deep dermis according to indication and anatomical location; for contouring/broad areas, use appropriate linear threading, fanning or retrograde techniques.
  • Adjust the injected volume to the degree of correction required, avoiding overcorrection.
  • Gently massage the treated area if needed to ensure homogeneous gel distribution and smooth contours.
  • Provide post-treatment advice, including avoiding excessive heat or cold, vigorous exercise, alcohol and manipulation of treated areas for a recommended period.
  • Single-use product: discard any remaining gel, syringes and needles as clinical waste after treatment.

Contraindications

  • Hypersensitivity to hyaluronic acid or any component of the formulation.
  • Active skin infection, inflammation or disease at or near the intended injection site.
  • History of severe allergies or anaphylactic reactions.
  • Pregnancy and breastfeeding (use not recommended).
  • Severe autoimmune or immunological disorders (subject to physician assessment).
  • Patients under 18 years of age.

Adverse Effects

  • Transient redness (erythema), swelling, tenderness or pain at the injection site.
  • Bruising or hematoma.
  • Itching or transient skin discolouration.
  • Palpable nodules or lumps, usually resolving spontaneously or with massage.
  • Rare complications such as infection, granuloma formation, vascular occlusion or tissue necrosis if product is inadvertently injected intravascularly.
  • Hypersensitivity or allergic reactions in susceptible individuals.

Storage Conditions

  • Store between 2°C and 25–28°C (as indicated on product packaging).
  • Do not freeze.
  • Keep syringes in their original blister and outer packaging, protected from light.
  • Do not use after the expiry date printed on the packaging.

Duration

Typically around 6\u201312 months, depending on treatment area, patient age, skin type, metabolism and lifestyle factors.

Onset

Immediate

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