MaiLi Precise with Lidocaine (4 x 1ml)

MaiLi

Medical device – dermal filler

Cross-linked hyaluronic acid dermal filler for fine lines, lips and tear trough

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.