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HYALUAL Xela Rederm 2.2% 1x2ml

HYALUAL Xela Rederm 2.2% 1x2ml

HYALUAL

Injectable skin booster / mesotherapy
  • Classified and marketed as a CE Marked injectable medical device based on non Crosslinked hyaluronic acid and sodium succinate.
  • Manufactured in Italy in accordance with international quality management standards for medical devices (e.g. ISO 13485), as stated in manufacturer and distributor technical documentation.
  • Formulation uses only components of natural origin already present in the human body, supporting high biocompatibility and a favourable safety profile when used as directed.
  • Intended exclusively for professional use in line with medical device and aesthetic medicine regulations in the EU/UK and other markets where authorised.
Non-crosslinked hyaluronic acid and succinic acid redermalization injectable

Description

HYALUAL Xela Rederm 2.2% is an advanced redermalization injectable based on a patented combination of non-crosslinked high-molecular-weight hyaluronic acid (2.2%) and succinic acid in the form of sodium succinate (1.6%). Designed for comprehensive skin rejuvenation, it improves skin quality by targeting three key ageing mechanisms: dehydration, free-radical damage and energy deficit at the cellular level. Used intradermally on the face, neck, décolleté and selected body areas, Xela Rederm 2.2% provides intensive hydration, lifting and tightening of the dermis, softens deep lines and folds, improves lip contour, reduces acne scarring and hyperpigmentation, and restores youthful density and elasticity.

Bnefits

  • Provides a lifting and firming effect, improving skin density and correcting gravitational ptosis.
  • Intensively hydrates and restores the water balance of the dermis via high-molecular-weight hyaluronic acid (2.2%).
  • Improves skin quality by tightening and restructuring the dermis, reducing the depth of folds and wrinkles.
  • Reduces signs of ageing, including deep lines, laxity and loss of elasticity.
  • Helps correct hyperpigmentation, melasma, uneven tone and post-acne discoloration.
  • Softens pitted acne scars and improves overall skin texture and smoothness.
  • Stimulates collagen and elastin synthesis and improves microcirculation through sodium succinate (succinic acid).
  • Provides antioxidant protection and supports cellular energy metabolism, slowing age-related changes.
  • Delivers noticeable improvement after a course of three treatments, with results that can last many months.

Indications

  • Comprehensive rejuvenation of the face, neck and décolleté.
  • Deep skin folds and lines (e.g. nasolabial folds, marionette lines, perioral lines).
  • Gravitational ptosis and loss of facial contour definition.
  • Pitted acne scars and textural irregularities.
  • Hyperpigmentation, melasma and post-inflammatory discoloration.
  • Photoageing and uneven skin tone.
  • Dehydrated, dull, “tired” or smoker’s skin lacking radiance.
  • Loss of skin density, elasticity and firmness on face and selected body areas (e.g. hands).
  • Perioral zone and lip contour restoration.

Composition

  • High-molecular-weight non-crosslinked hyaluronic acid 2.2% (22 mg/ml).
  • Succinic acid (sodium succinate) 1.6% (16 mg/ml).
  • Buffered aqueous solution (water for injection, sodium chloride and standard excipients suitable for injectable medical devices).
  • No lidocaine.

Formulation

  • Sterile, pyrogen-free, non-crosslinked injectable solution of high-molecular-weight hyaluronic acid combined with sodium succinate.
  • Double Synergic Effect Technology providing synergistic action of HA (hydration, volume, matrix support) and succinic acid (antioxidant, microcirculation and metabolic support).
  • Physiological composition using components naturally present in the human body for high biocompatibility and safety.
  • Supplied as a single-use prefilled glass syringe containing 2 ml of solution (1x2 ml).

Packaging

  • Box containing 1 x 2 ml prefilled sterile glass syringe of Xela Rederm 2.2%.
  • Set of sterile needles (typically 30G) supplied with the syringe depending on distributor.
  • Sterile blister packaging for syringe and needles.
  • Instructions for use / product leaflet with treatment protocols, indications, contraindications and safety information.

Usage

  • For professional use only: administer only by suitably trained medical or aesthetic practitioners experienced in intradermal injections.
  • Conduct a full medical history, discuss expectations and obtain informed consent before treatment.
  • Cleanse and disinfect the treatment area thoroughly; topical anaesthetic may be applied according to clinic protocol.
  • Inject Xela Rederm 2.2% intradermally using appropriate technique (commonly linear/fanning on the face and nodular technique on the body), with small aliquots placed along lines, folds, perioral area, cheeks, forehead, neck, décolleté or other indicated zones.
  • Avoid intravascular injection; aspirate according to clinic policy in high-risk areas and use cautious, low-pressure injection.
  • A standard treatment course usually consists of 3 procedures performed at 2-week intervals; for maintenance, repeat after 6–9 months with either monthly top-ups or another 3-treatment course, as per clinical judgement and patient needs.
  • After injection, gently massage the treated areas only if required to distribute the product evenly, avoiding excessive pressure around delicate structures.
  • Advise patients to avoid makeup on treated areas for several hours, and to avoid saunas, extreme heat or cold, intense exercise and alcohol for 24–48 hours post-procedure.
  • Instruct patients to use broad-spectrum sunscreen daily and gentle skincare to maintain results and minimise risk of post-treatment pigmentation.
  • Always refer to the latest official Xela Rederm 2.2% instructions for use for detailed protocols, depth, injection patterns and combination options with other procedures.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, succinic acid/sodium succinate or any component of the product.
  • Acute or chronic skin infections, inflammatory lesions, or dermatological diseases (e.g. active herpes simplex, severe acne flare, dermatitis) at or near the intended injection site.
  • Autoimmune diseases or significant systemic illness where injectable aesthetic procedures are considered unsafe by the treating physician.
  • Bleeding disorders or current use of significant anticoagulant/antiplatelet therapy where injection-related bleeding risk is not acceptable (subject to prescriber risk assessment).
  • History of severe allergic reactions or anaphylaxis.
  • Pregnancy or breastfeeding (generally contraindicated due to lack of safety data).
  • Known tendency to keloid or hypertrophic scarring in the treatment area, unless carefully evaluated and justified.
  • Recent aggressive cosmetic procedures (deep chemical peels, ablative laser resurfacing, dermabrasion) on the intended treatment area without adequate healing time.
  • Any other condition or medication that, in the opinion of the practitioner, makes redermalization treatment inappropriate.

Adverse Effects

  • Common, usually transient injection-site reactions including redness, swelling, tenderness, bruising, itching or mild pain.
  • Small papules or nodules at injection points that usually resolve spontaneously as the product integrates into the skin.
  • Temporary oedema, particularly in delicate areas (e.g. periorbital region) if treated.
  • Haematoma or ecchymosis at injection sites.
  • Local inflammatory or hypersensitivity reactions; in rare cases, delayed inflammatory or granulomatous reactions may occur.
  • Very rare risk of infection if aseptic technique or aftercare is inadequate, potentially requiring medical treatment.
  • As with any injectable near blood vessels, rare but serious vascular complications are possible if product is inadvertently injected intravascularly, potentially leading to tissue ischaemia or necrosis; practitioners must follow safe injection protocols and be prepared to manage complications.
  • Transient asymmetry or irregularity that may require observation or, rarely, correction.

Storage Conditions

  • Store at a controlled room temperature as specified by the manufacturer, typically between 2°C and 25°C.
  • Do not freeze; protect from excessive heat and direct sunlight.
  • Keep in the original outer carton until use to protect from light and maintain sterility.
  • Do not use after the expiry date printed on the packaging.
  • Do not use if the blister, syringe or needle packaging is damaged or has been previously opened.
  • Single-use medical device: any unused product, syringe and needles must be discarded immediately after treatment according to local regulations for sharps and clinical waste.

Duration

Clinical and distributor information indicates that results after a course of Xela Rederm 2.2% typically last around 6\u20139 months, with some sources reporting durability of approximately 8 months or longer depending on age, skin condition, lifestyle and maintenance treatments.

Onset

Improved hydration and skin plumpness from the hyaluronic acid component are usually visible immediately after treatment. The succinic acid (sodium succinate) effect on regeneration, texture and pigmentation becomes more evident from about 2 weeks onward, with optimal results typically recorded after three treatments spaced 2 weeks apart.

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