CE Marked Class III medical device for dermal injection in accordance with applicable EU medical device legislation
Manufactured in an ISO 13485 Certified pharmaceutical/medical device facility
Manufactured at an FDA Approved site in Italy for IBSA’s hyaluronic acid injectable products
Uses ultrapure, non Animal hyaluronic acid produced by a patented bio Fermentation process
CE Marked Class III medical device for dermal injection in accordance with applicable EU medical device legislation
Manufactured in an ISO 13485 Certified pharmaceutical/medical device facility
Manufactured at an FDA Approved site in Italy for IBSA’s hyaluronic acid injectable products
Uses ultrapure, non Animal hyaluronic acid produced by a patented bio Fermentation process
Dermal filler - hyaluronic acid
Description
Aliaxin SR Shape & Restore is a CE-marked, non-animal hyaluronic acid dermal filler from IBSA designed for facial remodelling and restoration of physiological facial volumes. The ultrapure, cross-linked HA gel provides natural-looking volume, contour definition and improvement of medium to deep wrinkles while maintaining skin hydration, tone and elasticity. The SR formulation is particularly suited to broad treatment areas and sensitive regions such as tear troughs and temples.
Bnefits
Dermal remodelling with restoration of natural facial contours and volumes
Replenishes facial fullness with soft, well-defined and natural-looking results
Improves skin tone, firmness and elasticity through hydrating HA gel
Effective on medium to deep wrinkles including nasolabial and glabellar lines
Suitable for broad facial areas and sensitive regions such as tear troughs and temples
High tissue integration for smooth, homogeneous results and low palpability
Ultrapure, non-animal hyaluronic acid produced by biofermentation
Long-lasting yet resorbable results typically lasting 6–12 months
Supports collagen and extracellular matrix regeneration, contributing to skin quality improvement
Indications
Facial remodelling and reshaping of broad facial areas
Restoration of physiological facial volume and contour definition
Correction of medium to deep wrinkles (e.g. nasolabial folds, marionette and glabellar lines)
Treatment of facial hollows such as tear troughs and infraorbital area (by suitably trained practitioners)
Volume restoration and contouring of temples and mid-face
Cheek and submalar volume enhancement
Jawline and lower-face contour refinement (selected cases)
Hydration and improvement of skin elasticity in treated areas
Lip contour and volume enhancement where indicated by the manufacturer
General facial rejuvenation in patients with signs of volume loss and early to moderate skin ageing
Non-animal origin hyaluronic acid (HA), produced by bacterial biofermentation (Streptococcus zooepidemicus)
Total hyaluronic acid concentration: 25 mg/ml
Cross-linked hyaluronic acid: 22.5 mg/ml
Natural (free) hyaluronic acid: 2.5 mg/ml
Polydensified monophasic HA gel with molecular weights around 500, 1000 and 2000 kDa
Physiological buffer solution (e.g. phosphate-buffered saline with sodium chloride and water for injections)
No lidocaine (lidocaine-free formulation)
Formulation
Sterile, pyrogen-free, viscoelastic monophasic hyaluronic acid gel for intradermal/subdermal injection
Non-animal origin cross-linked HA combined with free HA for both volumising and hydrating effects
CE-marked, resorbable combination medical device intended for single-patient, single-use
Pack content (typical): 2 pre-filled 1 ml glass syringes of Aliaxin SR gel in a sealed blister
Pack content (typical): 4 single-use sterile needles (commonly 27G and/or 30G as per pack), back-stops and traceability labels
Supplied with package insert containing full instructions for use and safety information
Packaging
Clinic box containing 2 x 1 ml pre-filled glass syringes
Each syringe supplied sterile in an individual blister pack
Includes single-use injection needles (e.g. 27G and 30G, depending on country presentation)
Includes backstops and peel-off traceability labels for patient records
Outer cardboard box with tamper-evident seals and product identification (batch number, expiry date, CE mark)
Intended for professional use only; single use, do not resterilise
Usage
For use only by appropriately trained and qualified healthcare professionals experienced in dermal filler injections.
Review the full Instructions for Use (IFU) supplied in the pack before treatment, including indications, contraindications and injection techniques.
Assess patient medical history, expectations and treatment indications; obtain informed consent prior to injection.
Clean and disinfect the treatment area according to clinical protocols to minimise infection risk.
Select appropriate needle or cannula and injection depth (typically mid to deep dermis or supraperiosteal plane, depending on indication and area) as recommended in the IFU.
Inject slowly using small aliquots and gentle, controlled pressure to avoid overcorrection and reduce the risk of vascular compromise.
Gently mould or contour the treated area immediately after injection where appropriate to achieve the desired shape.
Do not overcorrect; allow for initial swelling and natural integration of the product into the tissues.
Advise patients to avoid makeup, intense heat/cold exposure, strenuous exercise and manipulation of the treated area for at least 24 hours or as per local protocol.
Schedule follow-up to assess outcomes and determine if touch-up treatment is needed in line with recommended intervals.
Contraindications
Known hypersensitivity or allergy to hyaluronic acid or any component of the product
Presence of active skin disease, inflammation or infection (e.g. acne, herpes, dermatitis) at or near the injection site
History of severe anaphylactic reactions or multiple severe allergies
Simultaneous use with permanent or non-resorbable fillers in the same area (unless specifically assessed and approved by an experienced practitioner)
Patients with uncontrolled autoimmune diseases or immunodeficiency, unless assessed individually by a specialist
Bleeding disorders or patients on anticoagulant/antiplatelet therapy where injection risk is deemed unacceptable
Pregnant or breastfeeding women (use is generally not recommended due to lack of safety data)
Patients under the legal age of consent in the treating jurisdiction
Injection into blood vessels, eyelids, glabella central danger zone, or any contraindicated anatomical structures as per IFU
Adverse Effects
Transient injection-site reactions such as redness (erythema), swelling, tenderness, itching or pain
Bruising or haematoma at the injection site
Localised firmness, palpable nodules or lumps in the treated area
Asymmetry or over/undercorrection requiring adjustment
Rarely, delayed inflammatory reactions or granuloma formation
Very rare but serious events such as vascular occlusion, tissue necrosis or visual disturbances/visual loss if product is inadvertently injected into or compresses a blood vessel
Hypersensitivity or allergic-type reactions in susceptible individuals
Infection at the injection site if aseptic technique is not properly followed
Storage Conditions
Store in original packaging until use to protect from light and contamination.
Keep at controlled room temperature as specified in the product leaflet (typically between about 2°C and 25°C).
Do not freeze; do not expose to excessive heat or direct sunlight.
Do not use after the expiry date indicated on the packaging.
Single use only; once a syringe has been used on a patient, discard any unused product and used needles in approved sharps containers.
Duration
Effects are temporary and typically last around 6\u201312 months, depending on treatment area, injection technique, individual metabolism and lifestyle. Maintenance treatments can be performed as needed within this interval.
Onset
Immediate volumising and contouring effect at the end of the procedure, with further improvement over the following days to weeks as oedema subsides and the gel integrates and supports tissue remodelling.
