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Aqualyx Vial

Aqualyx Vial

Aqualyx

Injectable aesthetic medical device
  • CE Marked injectable agent for reduction of localised adiposity in Europe.
  • Manufactured under medical device quality standards by Marllor Biomedical in Italy.
  • Intended for use in accordance with European and local regulations governing injectable medical devices and intralipotherapy treatments.
Fat-dissolving / intralipotherapy solution

Description

Aqualyx is a CE-marked injectable fat-dissolving solution supplied here as a single 8 ml vial for professional use. It is an aqueous micro-gelatinous solution containing 12α-dihydroxy-5β-24-oico cholanic acid sodium salts (a modified bile acid compound related to deoxycholic acid) in a lactose-based delivery system with buffer, agarose and sodium chloride. Aqualyx is designed for intralipotherapy (injection lipolysis) to reduce small, localised fat deposits that are resistant to diet and exercise. When injected into subcutaneous fat by trained clinicians, it disrupts adipocyte cell membranes, allowing released lipids to be gradually eliminated by the body’s metabolic processes. It is used as a non-surgical alternative to procedures such as liposuction for body contouring.

Bnefits

  • Targets and reduces localised, diet- and exercise-resistant fat deposits without surgery.
  • Provides a non-surgical alternative or complement to liposuction for body contouring.
  • Aqueous, micro-gelatinous, biocompatible and biodegradable solution formulated specifically for intralipotherapy.
  • Active detergent compound (modified cholanic acid sodium salts / deoxycholate-based) emulsifies adipocyte cell membranes, enabling fat breakdown and clearance.
  • Can be used on multiple body areas, including chin, jowls, abdomen, flanks, hips, thighs, knees, upper arms and back rolls, according to clinical protocols.
  • CE-marked agent with clinical studies supporting effectiveness and safety for localised adiposity reduction when used appropriately.
  • Allows stepwise, progressive fat reduction across several treatment sessions rather than a single large intervention.
  • Administered in outpatient settings by trained healthcare professionals, with minimal downtime compared to surgical fat-removal procedures.

Indications

  • Localised subcutaneous fat deposits that are resistant to diet and exercise.
  • Small to moderate fat pockets in areas such as submental region (double chin), jowls, cheeks, upper arms, back rolls, bra rolls, abdomen, flanks, hips, outer and inner thighs, knees and peri-trochanteric region, according to practitioner assessment.
  • Patients seeking non-surgical body contouring and shaping rather than weight-loss treatment.
  • Adjunctive treatment to refine results after weight reduction or other body-contouring procedures when residual localised fat remains.

Composition

  • 12α-dihydroxy-5β-24-oico cholanic acid sodium salts (modified cholanic acid, deoxycholate-based detergent) as principal adipocytolytic agent
  • Lactose (slow-release carrier / delivery system)
  • Agarose (to provide micro-gelatinous structure)
  • Buffer solution (phosphate / bicarbonate buffer system)
  • Sodium chloride
  • Water for injections

Formulation

  • Hydrous, micro-gelatinous, injectable aqueous solution.
  • Deoxycholate-based detergent system (modified cholanic acid sodium salts) formulated with a lactose-based slow-release matrix and agarose gel structure.
  • Biocompatible and biodegradable solution intended for intralipotherapy in subcutaneous fat.
  • Supplied as a clear to slightly opalescent solution in sterile glass vials containing 8 ml.
  • Intended to be used undiluted or in line with the manufacturer’s protocol by trained clinicians.

Packaging

  • Single 8 ml glass vial (Aqualyx 1 x 8 ml) supplied as an individual unit from a multi-vial box.
  • Original manufacturer’s box format is typically 10 vials x 8 ml; pharmacy and wholesale partners may supply individual vials as single units.
  • Each vial is labelled with product name, batch number, expiry date and manufacturer details.
  • Supplied in secondary packaging with instructions-for-use leaflet in full pack configurations.

Usage

  • For professional use only; Aqualyx must be administered by suitably trained healthcare professionals familiar with intralipotherapy techniques and management of potential complications.
  • Used for injection into subcutaneous fat tissue only; not for intradermal, intramuscular or intravascular use.
  • Injection protocols (dose per area, needle type, depth, fan or grid patterns, and session intervals) should follow official training guidance and the manufacturer’s recommendations, adapted to patient anatomy and clinical judgement.
  • Typically delivered over a series of sessions spaced several weeks apart, depending on treatment area size, fat thickness and patient response.
  • Before treatment, a full medical history, examination and informed consent (including discussion of benefits, limitations and risks) should be obtained.
  • The treatment areas must be disinfected and aseptic technique strictly followed during the entire procedure.
  • Post-treatment, patients are usually advised about expected swelling, redness, tenderness and the need to avoid vigorous exercise, saunas or heat exposure for a short period after injections, according to clinic protocol.
  • Practitioners should avoid exceeding recommended total volume per session and per area and must be trained to recognise and manage adverse events.

Contraindications

  • Known hypersensitivity or allergy to any component of Aqualyx (e.g. cholanic acid/deoxycholate compounds, lactose or excipients).
  • Active skin or soft-tissue infection, inflammation or dermatitis at or near the proposed injection sites.
  • Pregnancy or breastfeeding, as elective fat-dissolving injections are generally contraindicated in these periods.
  • Severe systemic disease, uncontrolled diabetes, significant hepatic or renal impairment where additional metabolic load may be inappropriate, unless carefully evaluated by a physician.
  • Autoimmune disease or immunosuppression where wound healing or inflammatory responses may be altered, unless cleared by the treating physician.
  • History of severe anaphylactic reactions or multiple severe allergies to injectable medications.
  • Patients with unrealistic expectations or seeking overall weight loss rather than contouring of localised fat.
  • Known tendency to form hypertrophic scars or keloids when invasive procedures are performed in the treatment area.

Adverse Effects

  • Common, usually transient, local reactions such as pain or burning during and after injection, swelling, redness, warmth, bruising and tenderness in the treated area.
  • Temporary induration, nodularity or firmness of subcutaneous tissue at injection sites during the inflammatory and lipolytic phase.
  • Occasional pruritus, altered sensation or mild paraesthesia in the treated area.
  • Less common complications may include prolonged inflammation, local infection, skin contour irregularities, hyperpigmentation or, rarely, skin necrosis if injection is too superficial or vascular compromise occurs.
  • As with all injection procedures, there is a small risk of allergic or hypersensitivity reactions and, in extremely rare circumstances, serious adverse events that require prompt medical management.
  • Incorrect technique, use in inappropriate candidates or treatment outside clinical guidelines can significantly increase the risk of complications.

Storage Conditions

  • Store in original packaging to protect from light.
  • Keep at controlled room temperature as specified in the product leaflet (commonly between 2°C and 25°C); do not freeze.
  • Do not use after the expiry date printed on the vial and outer packaging.
  • Single-use vial; any unused portion after opening should be discarded in accordance with local regulations for clinical waste.
  • Keep out of the reach of children and store in a secure location accessible only to authorised personnel.

Duration

Fat reduction develops progressively over a course of multiple sessions, commonly 1\u20135 sessions per treated area spaced several weeks apart. Clinical improvement in contour and reduction in localised fat can persist long-term in conjunction with maintenance of stable body weight and lifestyle, as destroyed adipocytes are not expected to regenerate, although remaining fat cells can still enlarge with weight gain.

Onset

Initial changes such as post-procedural swelling and firmness are seen immediately after injection. Visible reduction in localised fat deposits typically becomes apparent within several weeks as inflammation subsides and adipocyte lysis and clearance progress, with final results usually evaluated several weeks after the last session.

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