MaiLi Volume with Lidocaine (4 x 1ml)
MaiLi
Medical device – dermal fillerCross-linked hyaluronic acid volumizing dermal filler with lidocaine
Certifications
- CE Marked Class III medical device under European medical device regulations for hyaluronic acid dermal fillers with lidocaine.
- Manufactured under ISO 13485 Compliant quality management systems for medical devices.
- Developed and controlled in line with regulatory requirements for injectable HA fillers, including biocompatibility, sterility and stability testing.
- Subject to ongoing post Market surveillance and clinical performance evaluation as part of Sinclair Pharma’s quality and safety systems.
- CE Marked Class III medical device under European medical device regulations for hyaluronic acid dermal fillers with lidocaine.
- Manufactured under ISO 13485 Compliant quality management systems for medical devices.
- Developed and controlled in line with regulatory requirements for injectable HA fillers, including biocompatibility, sterility and stability testing.
- Subject to ongoing post Market surveillance and clinical performance evaluation as part of Sinclair Pharma’s quality and safety systems.
Cross-linked hyaluronic acid volumizing dermal filler with lidocaine
Description
MaiLi Volume with Lidocaine (4 x 1ml) is a versatile, volumizing hyaluronic acid dermal filler from Sinclair Pharma, developed using patented OxiFree Smart Spring technology. With a HA concentration of 21 mg/ml and lidocaine 3 mg/ml, it is designed to rejuvenate and revitalise the face by restoring malleable fullness and refined contours. MaiLi Volume is specifically indicated for volumising the cheeks and temples, contouring facial features, filling and smoothing deep skin depressions, and for facial reconstruction of volume loss such as HIV-associated lipoatrophy. The highly elastic, spring-like gel provides strong lift and structural support while preserving natural facial expression, often requiring less product to achieve optimal aesthetic outcomes. It is supplied as four 1 ml pre-filled syringes and is intended exclusively for injection by trained medical professionals.
Bnefits
- Provides robust volumisation of cheeks, temples and other midface and upper-face areas.
- Contours and sculpts facial features while maintaining natural expression.
- Effectively fills and smooths deep facial skin depressions and folds.
- Indicated for facial reconstruction in areas with volume loss, including HIV-associated lipoatrophy.
- OxiFree Smart Spring technology preserves long HA chains, creating an elastic gel that moves naturally with facial dynamics.
- High projection and lifting capacity mean less product is needed for comparable volumising results.
- Contains 3 mg/ml lidocaine to improve patient comfort during injection.
- Delivers long-lasting, natural-looking outcomes, typically around 12 months or longer depending on patient and treatment area.
Indications
- Volumisation of the cheeks and temples.
- Contour and definition of facial features requiring structural support and fullness.
- Aesthetic treatment of pronounced/deep facial skin depressions.
- Facial reconstruction of structural defects of congenital or medical origin, including volume loss due to HIV-associated lipoatrophy.
- General restoration and augmentation of facial tissue volume to address age-related or disease-related volume loss.
- Subcutaneous or supraperiosteal volumising in areas indicated in the product instructions for use.
Composition
- Cross-linked hyaluronic acid (sodium hyaluronate): 21 mg/ml.
- Lidocaine hydrochloride (local anaesthetic): 3 mg/ml (0.3%).
- Phosphate buffer solution q.s. to 1 ml (including buffer salts and water for injection).
- Crosslinking agent: 1,4-Butanediol Diglycidyl Ether (BDDE).
- Sterile, pyrogen-free, viscoelastic injectable HA gel.
Formulation
- Sterile, apyrogenic, cross-linked hyaluronic acid gel with lidocaine for injection.
- HA concentration: 21 mg/ml; lidocaine: 3 mg/ml.
- Manufactured using OxiFree cross-linking technology to preserve long HA chains and provide a spring-like, elastic gel.
- Intended injection depth: subcutaneous fat tissue or supraperiosteal area, depending on indication and treatment plan.
- Supplied as single-use pre-filled 1 ml syringes for professional use only.
Packaging
- Box containing 4 pre-filled 1 ml syringes of MaiLi Volume with Lidocaine.
- 4 x 27G ½" needles (or equivalent) supplied for injection as per pack configuration.
- Each syringe individually packed in sterile blister packaging.
- Outer carton labelled with product name, HA and lidocaine concentrations, batch/lot number, expiry date and regulatory marks.
- Package insert/instructions for use providing indications, injection depth, precautions and adverse effects.
Usage
- For use only by appropriately trained and qualified healthcare professionals experienced in facial anatomy and dermal filler injection techniques.
- Perform a full medical history, indication assessment and informed consent prior to treatment.
- Use strict aseptic technique; thoroughly cleanse and disinfect the treatment area before injection.
- Inject into the recommended tissue planes (subcutaneous fat tissue or supraperiosteal area) according to the instructions for use and clinical judgement.
- Administer slowly in small aliquots with minimal pressure, continually monitoring tissue response to minimise the risk of intravascular injection or overcorrection.
- Avoid injection into or near blood vessels; in anatomical high-risk areas, use extra caution and appropriate technique (needle or cannula) as per local practice.
- Gently massage the treated area after injection if required to distribute the gel evenly and achieve the desired contour, unless contraindicated.
- Advise patients to avoid strenuous exercise, exposure to extreme heat or cold, alcohol consumption, and manipulation or massage of the treated area for a recommended period after treatment.
- Record product details (including batch/lot number and injection sites) in the patient’s medical record for traceability.
- Single-use only: discard any unused product and all used needles/syringes immediately after treatment in approved sharps containers.
Contraindications
- Known hypersensitivity to hyaluronic acid, lidocaine, BDDE or any component of the formulation.
- History of severe allergic reactions or anaphylaxis, particularly to local anaesthetics of the amide type.
- Active skin infection, inflammation or dermatologic disease at or near the intended injection site.
- Tendency to develop hypertrophic scars or keloids in the proposed treatment area.
- Bleeding disorders or use of anticoagulant/antiplatelet therapy where the treating clinician deems the risk unacceptable.
- Autoimmune or systemic diseases where the safety of HA fillers is uncertain, unless assessed and deemed appropriate by an experienced physician.
- Pregnancy and breastfeeding (use is generally not recommended due to lack of safety data).
- Use in patients under 18 years of age unless allowed by local regulations and supported by clinical judgement.
- Known hypersensitivity or intolerance to lidocaine or other amide-type local anaesthetics.
- Intravascular injection or injection into high-risk vascular territories where safe technique and anatomy knowledge cannot be ensured.
Adverse Effects
- Common, usually transient reactions at the injection site: redness, swelling, pain, tenderness, warmth, itching and bruising.
- Temporary lumps, nodules or irregularities, which may require massage or, rarely, further clinical management.
- Injection-site haematoma or ecchymosis.
- Transient firmness, overcorrection or asymmetry immediately after treatment due to swelling or product distribution.
- Infection at the injection site, potentially including abscess or biofilm formation, particularly if aseptic technique is not strictly observed.
- Hypersensitivity or inflammatory reactions such as prolonged swelling, erythema, induration, or rare granuloma formation.
- Vascular occlusion or embolisation if product is inadvertently injected into or compresses a blood vessel, potentially causing blanching, severe pain, livedo reticularis, tissue ischaemia or necrosis.
- Very rare but serious complications such as visual disturbance, vision loss or neurological events when vascular compromise occurs in high-risk regions.
- Local or systemic adverse reactions to lidocaine, including rash, pruritus, dizziness, palpitations or, very rarely, severe allergic reaction.
Storage Conditions
- Store according to the temperature range stated on the packaging, typically between 2°C and 25°C; do not freeze.
- Keep in the original outer carton to protect from light and maintain sterility until use.
- Do not use after the expiry date printed on the packaging and syringes.
- Do not use if the blister or packaging is damaged or previously opened.
- Do not use if the gel appears discoloured, cloudy or contains visible particles.
- Store out of the sight and reach of children.
- Single-use medical device; discard opened or partially used syringes and all needles in accordance with local sharps and clinical waste regulations.
Duration
Typically administered as a single treatment session; volumising effects are generally long-lasting, commonly around 12 months and in some patients up to 18 months, depending on area treated, injection technique, volume used, metabolism and lifestyle factors.
Onset
Immediate visible restoration of volume and contour following injection; final aesthetic result becomes more apparent as transient swelling and redness resolve over several days.
