MaiLi Define with Lidocaine (4 x 1ml)
MaiLi
Medical device – Class III hyaluronic acid dermal fillerCross-linked hyaluronic acid dermal filler with lidocaine for lips, wrinkles and facial volume
Certifications
- CE marked Class III medical device under the European medical device regulatory framework (CE 2797).
- Developed and manufactured in compliance with ISO 13485 quality management standards for medical devices.
- Subject to post Market surveillance and clinical performance evaluation as required for CE Marked injectable HA fillers.
- Conforms to applicable European and UK regulations for hyaluronic acid dermal fillers containing lidocaine, including labelling and safety requirements.
- Backed by clinical investigations and published data supporting safety and performance within the indicated uses.
- CE marked Class III medical device under the European medical device regulatory framework (CE 2797).
- Developed and manufactured in compliance with ISO 13485 quality management standards for medical devices.
- Subject to post Market surveillance and clinical performance evaluation as required for CE Marked injectable HA fillers.
- Conforms to applicable European and UK regulations for hyaluronic acid dermal fillers containing lidocaine, including labelling and safety requirements.
- Backed by clinical investigations and published data supporting safety and performance within the indicated uses.
Cross-linked hyaluronic acid dermal filler with lidocaine for lips, wrinkles and facial volume
Description
MaiLi Define with Lidocaine (4 x 1ml) is a premium, cross-linked hyaluronic acid dermal filler from Sinclair Pharma, designed specifically to define, enhance and contour facial features while maintaining natural, dynamic expression. The gel uses patented OxiFree technology to preserve long-chain hyaluronic acid and create a highly elastic, spring-like gel that provides strong projection with supple, natural movement. With a concentration of 18 mg/ml HA and 3 mg/ml lidocaine, MaiLi Define is optimised for lip definition and augmentation, filling deep wrinkles and folds, refining facial contours and addressing structural defects such as scar tissue. It is supplied as four 1 ml pre-filled syringes, each individually packed with a 30G needle for precise injection into the deep dermis or subcutaneous tissue by trained medical professionals. Results are immediate, with typical longevity up to around 12 months (and in some cases longer), depending on the treatment area, product volume and patient-specific factors.
Bnefits
- Specially formulated for lip definition, enhancement and volumisation, while preserving natural facial expression.
- Effectively fills deep wrinkles and folds such as nasolabial folds and marionette lines for smoother facial contours.
- Indicated for facial reconstruction of structural defects, including scar tissue correction.
- Uses OxiFree technology to preserve long HA chains, giving a highly elastic, spring-like gel that requires less product for comparable clinical outcomes.
- Contains 18 mg/ml cross-linked hyaluronic acid for robust volumising and contouring with a soft, flexible feel.
- Includes 3 mg/ml lidocaine to improve patient comfort during and after injection.
- Long-lasting results, typically up to 12 months in many treatment areas, with sustained lip and contour definition.
- Supplied as four pre-filled 1 ml syringes, each with a 30G needle, supporting precise, controlled injections by trained professionals.
- Backed by clinical evaluation and CE marking as a Class III medical device for aesthetic use.
Indications
- Definition and enhancement of the lips, including lip contouring and volumisation.
- Correction and filling of deep wrinkles and folds (e.g. nasolabial folds, marionette lines).
- Facial reconstruction of structural defects, including treatment of scar tissue.
- Restoration or enhancement of facial volume and contour in areas requiring medium to deep injection (such as perioral region and selected midface areas), according to the product’s instructions for use.
- Aesthetic correction of pronounced skin depressions where a cross-linked HA filler is appropriate.
- Use in adult patients for aesthetic correction under the care of appropriately trained medical professionals.
Composition
- Cross-linked hyaluronic acid (HA) 18 mg/ml (non-animal origin).
- Lidocaine hydrochloride 3 mg/ml (0.3%) as a local anaesthetic to reduce injection discomfort.
- Crosslinking agent: 1,4-Butanediol Diglycidyl Ether (BDDE).
- Physiological buffer and excipients (e.g. phosphate buffer, sodium chloride, water for injection) to maintain pH and tonicity.
- Sterile, pyrogen-free, viscoelastic HA gel intended for single-patient use.
Formulation
- Sterile, apyrogenic, cross-linked hyaluronic acid gel with lidocaine for injection.
- Concentration: 18 mg/ml HA, 3 mg/ml lidocaine (0.3%).
- Technology: OxiFree HA technology designed to preserve long HA chains and provide a spring-like, elastic gel.
- Intended injection planes: deep dermis, subcutaneous tissue or appropriate perioral/lip planes as specified in the instructions for use.
- For single-use only; each pre-filled syringe is intended for one patient and one-time use.
Packaging
- Box containing 4 pre-filled 1 ml syringes of MaiLi Define with Lidocaine.
- Each syringe is individually packaged and supplied with a 30G needle (4 x 30G needles per box).
- Includes package leaflet/instructions for use with safety information, indications and handling instructions.
- Traceability labels on syringes and box to allow recording of batch/lot number in patient records.
- Sterile blister packaging designed to maintain product sterility until opening.
Usage
- For professional use only; must be injected exclusively by appropriately trained and qualified healthcare professionals with experience in hyaluronic acid filler injections and facial anatomy.
- Perform a full medical history, examination and risk assessment (including vascular risk areas and prior aesthetic procedures) before treatment.
- Inject into the recommended tissue planes (typically deep dermis or subcutaneous tissue, and appropriate planes within the lips) following the official instructions for use and established aesthetic injection techniques.
- Use aseptic technique; disinfect the skin thoroughly before injection and avoid injecting through areas of active skin disease or infection.
- Inject slowly and carefully using small aliquots; avoid high-pressure injection and always take care to minimise the risk of intravascular injection (for example by appropriate needle positioning, slow injection, and continuous observation of tissue response).
- Do not inject into blood vessels; immediately stop injection and follow emergency management protocols if there are signs of vascular compromise (e.g. blanching, severe pain, colour change, vision changes).
- Massage the treated area gently if recommended in the instructions for use to distribute the gel evenly and achieve the desired contour.
- Advise patients about expected transient reactions such as swelling, redness and bruising, and instruct them to avoid extreme temperatures, intense exercise, make-up and massage in the treated area for a period specified in the aftercare guidance.
- Do not use in combination with laser treatment, chemical peels or other aggressive skin treatments in the same area immediately before or after injection unless supported by clinical guidance.
- Discard any unused product, needles and syringes after treatment in accordance with local sharps and clinical waste regulations.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, lidocaine, local anaesthetics of the amide type, BDDE or any of the excipients.
- History of severe allergic reactions or anaphylaxis, or multiple severe allergies, unless carefully assessed and managed by a specialist.
- Active infection, inflammation, dermatitis, acne, herpetic lesions or other skin disease at or near the planned injection site.
- Tendency to develop hypertrophic scars or keloids in the treatment area.
- Known bleeding disorders, significant coagulation abnormalities or current use of anticoagulant/antiplatelet therapy where the risk of bleeding or bruising is judged unacceptable by the treating clinician.
- Autoimmune diseases or uncontrolled systemic disease where the safety of HA fillers is uncertain, unless specifically assessed as suitable by an experienced physician.
- Pregnancy and breastfeeding (use is generally not recommended due to lack of safety data).
- Use in minors (patients under 18 years of age) unless specifically authorised under local regulations and clinical guidance.
- Previous permanent or temporary fillers in the intended treatment area where interactions or irregularities may occur, unless carefully evaluated.
- Known hypersensitivity to lidocaine or other amide-type local anaesthetics (in such cases, a non-lidocaine formulation or alternative treatment should be considered).
Adverse Effects
- Common, usually transient local reactions: redness (erythema), swelling (oedema), tenderness, itching, pain, warmth and bruising at the injection site.
- Palpable or visible lumps, nodules or irregularities in the treated area, which may require massage, conservative management or, rarely, hyaluronidase treatment.
- Injection-site haematoma or ecchymosis.
- Temporary firmness or mild asymmetry immediately after treatment due to swelling or product distribution.
- Hypersensitivity reactions including prolonged swelling, erythema or induration; in rare cases, delayed inflammatory reactions.
- Infection (including abscess or biofilm formation) if aseptic technique is not strictly followed or due to contamination; may require antibiotics or further intervention.
- Vascular occlusion or embolisation leading to blanching, severe pain, livedo reticularis, tissue ischaemia or necrosis if product is inadvertently injected intravascularly; emergency management may include hyaluronidase, vasodilatory measures and supportive care.
- Very rare but serious complications such as visual disturbance, vision loss, stroke or neurological symptoms associated with filler embolisation in high-risk areas.
- Allergic or adverse reactions to lidocaine, such as local or systemic symptoms (e.g. dizziness, palpitations, or in extreme cases, allergic response).
- Other delayed or rare adverse events as listed in the product’s instructions for use and post-marketing safety documentation.
Storage Conditions
- Store according to the temperature range specified on the packaging, typically between 2°C and 25°C; do not freeze.
- Keep syringes in the original packaging to protect from light and contamination until use.
- Do not use if the packaging is damaged, the blister is opened, or the tamper-evident seal is broken before use.
- Do not use the product after the expiry date printed on the box and syringes.
- Do not use if the gel appears discoloured, cloudy, or contains visible particles.
- Store out of the reach and sight of children.
- Single-use only; any unused product, opened syringes and used needles must be disposed of safely as clinical/sharps waste after treatment.
Duration
Clinical effects are typically visible immediately after injection, with results commonly lasting up to approximately 12 months in many patients and treatment areas; exact duration depends on the area treated, injection technique, volume used, patient metabolism and lifestyle, and may be shorter or longer on an individual basis.
Onset
Immediate visible volumisation and contouring after injection, with final results usually apparent once initial swelling and redness subside over several days; minor refinement of appearance may continue for 1\u20132 weeks post-treatment.
