LANLUMA X 630 mg (1x40ml)
Lanluma
Collagen biostimulator fillerPoly-L-lactic acid (PLLA) injectable for body contouring
Certifications
- CE Marked Class III medical device for the correction of depressed areas and body contouring via collagen stimulation
- Manufactured under ISO Compliant medical device quality management systems
- Biodegradable and biocompatible PLLA with a documented safety and performance profile in aesthetic medicine
- CE Marked Class III medical device for the correction of depressed areas and body contouring via collagen stimulation
- Manufactured under ISO Compliant medical device quality management systems
- Biodegradable and biocompatible PLLA with a documented safety and performance profile in aesthetic medicine
Poly-L-lactic acid (PLLA) injectable for body contouring
Description
LANLUMA X 630 mg (1x40ml) is a poly-L-lactic acid (PLLA) collagen-stimulating injectable implant from Sinclair, specifically developed for body contouring and volume restoration. Supplied as a lyophilised powder to be reconstituted with 40 ml of sterile water, Lanluma X is injected deeply or subcutaneously in larger body areas such as the buttocks, hips, arms and thighs. By stimulating the body’s own collagen production, it gradually increases volume, improves curves and contours, and enhances skin firmness and texture, with natural-looking results that can last for up to two years.
Bnefits
- Collagen biostimulator that restores volume by inducing the patient’s own collagen production rather than acting as a simple space-filling gel
- Specifically indicated for larger body areas such as the buttocks and other body contours
- Optimises curves and contours of the body, improving buttock shape, projection and roundness
- Improves firmness and texture of the skin in treated areas (e.g. thighs, arms, buttocks)
- Helps correct volume loss and depressed areas, including certain skin depressions and contour irregularities
- Gradual, natural-looking results appearing over 2–3 months with limited downtime for most patients
- Long-lasting effects, with clinical and commercial information indicating results of up to approximately 2 years
- Fast and simple preparation: ready for use after 10 minutes of shaking and at least 1 hour of hydration, and can be used for up to 72 hours post-reconstitution
- CE-marked Class III medical device with a documented favourable safety and efficacy profile
Indications
- Increase of volume in depressed areas of the body, particularly to correct skin depressions and atrophic zones
- Optimisation of body curves and contours, especially shaping and volumising the buttocks
- Improving firmness and texture of the skin on areas such as arms and thighs
- Body contouring and sculpting where deep or subcutaneous volume restoration via collagen stimulation is desired
Composition
- Poly-L-lactic acid (PLLA) 40.4%
- Sodium carboxymethyl cellulose (CMC) 25.4%
- Mannitol 34.2%
Formulation
- Lyophilised sterile powder in a 40 ml glass vial containing 630 mg of PLLA-based formulation
- Biodegradable, biocompatible poly-L-lactic acid microspheres with CMC and mannitol as excipients
- To be reconstituted with 40 ml of sterile water for injection before use to form a uniform, injectable suspension
- Intended for deep dermal or subcutaneous injection in body indications for volume restoration and contouring
Packaging
- Box containing 1 x 40 ml vial with 630 mg Lanluma X powder (PLLA-based collagen stimulator)
- Vial designed to be reconstituted with 40 ml sterile water for injection prior to administration
- Outer carton labelled with product name, PLLA dose, batch number, expiry date, CE mark and manufacturer details
Usage
- Lanluma X must only be used by suitably trained and qualified medical practitioners experienced in PLLA injection and body contouring procedures.
- Reconstitute the 630 mg Lanluma X vial with 40 ml of sterile water for injection following the official instructions for use (IFU).
- Add 40 ml of sterile water to the vial containing the dry powder, then shake vigorously for approximately 10 minutes.
- Allow the vial to stand for at least 1 hour to ensure complete hydration of the PLLA particles.
- Immediately before injection, strongly agitate the vial for about 1 minute to obtain a uniform translucent suspension.
- Draw the suspension into syringes and inject into the deep dermis or subcutaneous tissue in the indicated body areas (e.g. buttocks, hips, thighs, arms) using appropriate needles or cannulas, as per the IFU and practitioner training.
- Use fanning, threading or grid techniques to distribute the product evenly and avoid bolus deposits; aspirate in accordance with current best practice to minimise the risk of intravascular injection.
- Massage the treated area as recommended post-injection to help distribute the product and reduce the risk of nodules, and instruct patients on any at-home massage protocol if advised in the IFU.
- A typical treatment course may require one or more sessions spaced several weeks apart, depending on indication, volume deficit and desired outcome.
- Once reconstituted, Lanluma X can be used for up to 72 hours if stored according to the IFU; agitate before each use. Discard any remaining product after this period or at the end of the treatment session.
- Dispose of all used vials, syringes, needles and other materials in appropriate clinical sharps and waste containers; do not resterilise or reuse.
Contraindications
- Hypersensitivity to poly-L-lactic acid, sodium carboxymethyl cellulose, mannitol or any component of the formulation
- Presence of active skin infections, inflammation or disease at or near the intended injection sites
- History of hypertrophic scarring or keloid formation in the proposed treatment area
- Severe allergies or a history of anaphylactic reactions
- Autoimmune disorders or significant immune compromise unless carefully evaluated and approved by a physician
- Bleeding disorders or current significant anticoagulant/antiplatelet therapy without appropriate risk assessment
- Pregnancy and breastfeeding (use generally not recommended due to insufficient safety data)
- Use in contraindicated facial regions and planes (e.g. periorbital area, lips, nose, eyelids, glabella and superficial dermal layers) which are not indicated for Lanluma X
- Intravascular injection is strictly contraindicated due to risk of embolisation, tissue ischaemia and necrosis
Adverse Effects
- Common, usually transient injection-site reactions such as redness, swelling, tenderness, bruising, pain and itching
- Palpable nodules or papules in treated areas, particularly if product is not adequately diluted, dispersed or massaged; these are often subclinical and may resolve over time
- Induration or firmness in the treated tissue during the collagen stimulation phase
- Rare inflammatory or hypersensitivity reactions which may require medical management
- Very rare but serious complications from inadvertent intravascular injection, including vascular occlusion and tissue necrosis
- Small risk of infection at injection sites if aseptic technique and post-treatment care are not properly followed
Storage Conditions
- Store the unopened vial in its original packaging at a controlled room temperature as specified on the carton (typically between 2 °C and 25 °C).
- Protect from freezing, excessive heat, moisture and direct sunlight.
- After reconstitution, handle and store the vial according to the IFU and use within a maximum of 72 hours, agitating thoroughly before each use.
- Do not use the product after the expiry date printed on the vial and outer packaging.
- Discard any vial that appears damaged or compromised, or if sterility is in doubt.
Duration
Results usually appear gradually over 2\u20133 months as new collagen forms and stabilises, with effects lasting up to approximately 2 years after a completed treatment course, depending on patient factors and treatment plan.
Onset
Volume and contour improvements develop progressively; early changes may be noticed within weeks, with visible results typically apparent between 2 and 3 months after treatment as collagen neogenesis occurs.
