MaiLi Precise with Lidocaine (4 x 1ml)
MaiLi
Medical device – dermal fillerCross-linked hyaluronic acid dermal filler for fine lines, lips and tear trough
Certifications
- CE Marked Class III medical device under the European medical device regulatory framework for hyaluronic acid dermal fillers.
- Manufactured under ISO 13485 Compliant quality management systems for medical devices.
- Conforms to applicable European and UK requirements for injectable HA fillers containing lidocaine, including labelling, safety and post Market surveillance obligations.
- Backed by clinical performance and safety evaluations aligned with regulatory standards for soft tissue augmentation devices.
- CE Marked Class III medical device under the European medical device regulatory framework for hyaluronic acid dermal fillers.
- Manufactured under ISO 13485 Compliant quality management systems for medical devices.
- Conforms to applicable European and UK requirements for injectable HA fillers containing lidocaine, including labelling, safety and post Market surveillance obligations.
- Backed by clinical performance and safety evaluations aligned with regulatory standards for soft tissue augmentation devices.
Cross-linked hyaluronic acid dermal filler for fine lines, lips and tear trough
Description
MaiLi Precise with Lidocaine (4 x 1ml) is a premium, cross-linked hyaluronic acid dermal filler from Sinclair Pharma designed as an advanced skin-finishing treatment. Using patented OxiFree technology, it preserves long-chain hyaluronic acid to create an elastic, ‘Smart Springs’ gel that smooths fine lines and medium skin depressions while maintaining natural facial expression. With a concentration of 15 mg/ml HA and 3 mg/ml lidocaine, MaiLi Precise is optimised for the treatment of fine wrinkles, lip definition and enhancement, and tear-trough correction for under-eye bags and dark circles. It can also be used for facial reconstruction of structural defects and scar tissue. The product delivers long-lasting radiance and a youthful appearance, with results typically lasting up to around 12 months. It is supplied as four 1 ml pre-filled syringes for use by trained aesthetic professionals.
Bnefits
- Smooths fine lines and wrinkles for a refined, youthful skin finish.
- Effective for aesthetic treatment of fine wrinkles and medium skin depressions.
- Specially suited for tear-trough correction to improve under-eye bags and dark circles in appropriately selected patients.
- Defines and enhances lip contours with natural-looking results.
- Supports facial reconstruction of structural defects and scar tissue treatment.
- OxiFree ‘Smart Springs’ technology preserves long HA chains, providing a supple, highly elastic gel that moves naturally with facial expression.
- Requires less product for comparable clinical outcomes due to high elasticity and projection capability.
- Contains 3 mg/ml lidocaine to improve injection comfort.
- Long-lasting results, commonly up to 12 months, depending on patient and treatment area.
Indications
- Aesthetic treatment of fine lines and medium skin depressions in the face.
- Finishing treatment to smooth wrinkles and improve overall skin radiance.
- Lip definition, contouring and enhancement.
- Facial reconstruction of structural defects of congenital or medical origin, including scar tissue.
- Treatment of the periorbital area (tear trough) to help with deep eye bags and dark circles by appropriately trained specialists.
- Soft tissue augmentation in areas requiring subtle volumisation and refinement while preserving natural expression.
Composition
- Cross-linked hyaluronic acid (HA) 15 mg/ml (non-animal origin).
- Lidocaine hydrochloride 3 mg/ml (0.3%) to reduce injection-related pain.
- 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 isotonicity.
- Sterile, pyrogen-free, viscoelastic HA gel intended for single-patient use.
Formulation
- Sterile, apyrogenic, cross-linked hyaluronic acid gel with lidocaine for injection.
- Concentration: 15 mg/ml HA and 3 mg/ml lidocaine.
- OxiFree technology preserves long HA chains, creating an elastic ‘Smart Springs’ gel.
- Intended injection depth: intradermal or into the labial mucosa; in tear trough and other delicate regions, injection should be performed only by specialists familiar with the anatomy.
- Single-use pre-filled syringes for professional use only.
Packaging
- Box containing 4 pre-filled 1 ml syringes of MaiLi Precise with Lidocaine.
- Each syringe is supplied with a 30G needle (4 x 30G needles per box).
- Sterile blister or equivalent packaging to maintain sterility until opening.
- Outer packaging with product name, batch/lot number, expiry date and regulatory marks.
- Package insert/instructions for use with indications, contraindications and handling instructions.
Usage
- For professional use only; must be injected by appropriately trained and qualified healthcare professionals experienced in dermal filler techniques and facial anatomy.
- Obtain a full medical history and assess indications, expectations and risk factors prior to treatment.
- Use aseptic technique: thoroughly disinfect the treatment area and avoid injecting through inflamed or infected skin.
- Inject into the recommended tissue planes (typically intradermal or into the labial mucosa, and appropriate planes in the periorbital region) following the product’s instructions for use.
- For tear-trough and periorbital treatments, only specialists specifically trained in this technique and well-versed in periorbital anatomy should perform injections.
- Inject slowly in small aliquots, using minimal pressure, and continually observe tissue response to reduce the risk of adverse events and intravascular injection.
- Gently massage the area if needed to ensure even distribution of the gel and achieve the desired contour, unless contraindicated.
- Advise patients to avoid make-up, intense heat or cold exposure, vigorous exercise and manipulation of the treated area for a period recommended in the aftercare guidelines.
- Document the batch/lot number and injection sites in the patient record for traceability.
- Discard any unused product, needles and syringes as clinical/sharps waste after single-patient use.
Contraindications
- Known hypersensitivity to hyaluronic acid, lidocaine, BDDE or any of the excipients.
- History of severe allergic reactions or anaphylaxis, particularly to local anaesthetics of the amide type.
- Active infection, inflammation or skin disease (e.g. acne, herpes, dermatitis) at or near the injection site.
- Tendency to develop hypertrophic scars or keloids in the treatment area.
- Bleeding disorders or current use of anticoagulant/antiplatelet therapy where the treating clinician considers the risk unacceptable.
- Autoimmune disorders or uncontrolled systemic disease where the safety of HA fillers is uncertain, unless assessed as suitable by an experienced physician.
- Pregnancy and breastfeeding (generally not recommended due to lack of safety data).
- Use in patients under 18 years of age unless permitted by local regulations and clinical judgement.
- Known hypersensitivity or intolerance to lidocaine or other amide-type local anaesthetics.
- Injection into blood vessels or in areas of high vascular risk where safe technique and expertise are not assured.
Adverse Effects
- Common transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, warmth and bruising.
- Temporary lumps, nodules or irregularities at the injection site, which may require massage or, rarely, further management.
- Injection-site haematoma or ecchymosis.
- Transient asymmetry or firmness due to swelling or localised gel distribution immediately after treatment.
- Infection at the injection site, potentially leading to abscess or biofilm formation, particularly if aseptic technique is not maintained.
- Hypersensitivity or inflammatory reactions, including prolonged swelling, erythema or induration; rare delayed reactions or granuloma formation.
- Vascular compromise if unintentional intravascular injection or compression occurs, potentially causing blanching, severe pain, livedo reticularis, tissue ischaemia or necrosis.
- Very rare but serious events such as embolisation leading to visual disturbance, vision loss or neurological symptoms when injected in high-risk areas.
- Allergic or adverse reactions to lidocaine, including local or systemic symptoms such as rash, dizziness, palpitations or, rarely, severe allergic responses.
Storage Conditions
- Store according to label instructions, typically between 2°C and 25°C; do not freeze.
- Keep syringes in their original packaging to protect from light and contamination 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 if the gel appears discoloured, cloudy or contains visible particles.
- Store out of the sight and reach of children.
- Single-use only; discard any unused product and all used medical devices as clinical and sharps waste in accordance with local regulations.
Duration
Typically performed as a single treatment session; clinical effects are visible immediately, with results commonly lasting up to approximately 12 months depending on treatment area, injection technique, product volume and patient-specific factors.
Onset
Visible improvement is usually immediate after injection, with final results becoming more apparent as transient swelling and redness subside over several days.
