DEFINISSE TOUCH FILLER LIDO (1x1ml)

DEFINISSE

Injectable medical device

Cross-linked hyaluronic acid dermal filler with lidocaine for moderate to deep wrinkles and lip volume enhancement

Class III sterile, resorbable hyaluronic acid dermal filler medical device under European medical device regulations.
CE Marked (e.g. CE 023) indicating conformity with relevant safety and performance requirements.
Manufactured under a certified medical device Quality Management System (e.g. ISO 13485 or equivalent) implemented by RELIFE / Menarini Group or its manufacturing partners.
Supplied sterile with validated sterilisation and packaging processes; intended for single use only.
Full traceability through reference number, EAN code and batch/lot information on the syringe and outer packaging.
Professional Use Only product to be used in accordance with national and local regulations governing injectable medical devices and aesthetic medicine.

Class III sterile, resorbable hyaluronic acid dermal filler medical device under European medical device regulations.
CE Marked (e.g. CE 023) indicating conformity with relevant safety and performance requirements.
Manufactured under a certified medical device Quality Management System (e.g. ISO 13485 or equivalent) implemented by RELIFE / Menarini Group or its manufacturing partners.
Supplied sterile with validated sterilisation and packaging processes; intended for single use only.
Full traceability through reference number, EAN code and batch/lot information on the syringe and outer packaging.
Professional Use Only product to be used in accordance with national and local regulations governing injectable medical devices and aesthetic medicine.

Cross-linked hyaluronic acid dermal filler with lidocaine for moderate to deep wrinkles and lip volume enhancement

Description

DEFINISSE TOUCH FILLER LIDO (Relife / Menarini) is a CE-marked, sterile, resorbable cross-linked hyaluronic acid dermal filler with 0.3% lidocaine. The transparent, biodegradable, non-animal derived gel is produced using the proprietary XTR (EXCELLENT THREE DIMENSIONAL RETICULATION) crosslinking technology, which creates a stable and elastic 3D hyaluronic acid matrix. Formulated at 23 mg/ml cross-linked HA with lidocaine 0.3% and a crosslinking rate of 1/3, it is specifically designed for the correction of moderate to deep facial wrinkles and folds and for increasing lip volume. The filler is intended for injection into the medium to deep dermis and is supplied as a 1 ml pre-filled glass syringe with two 27G 1/2\ needles, for exclusive use by appropriately trained healthcare professionals.

Bnefits

Corrects moderate to deep facial wrinkles and folds (e.g. nasolabial folds, marionette lines) for a smoother appearance.
Enhances and restores lip volume while supporting natural expression and contour.
Cross-linked hyaluronic acid 23 mg/ml provides reliable volumising and contouring with a soft, refined finish.
Contains 0.3% lidocaine to reduce pain and improve comfort during injection.
XTR three-dimensional crosslinking technology with a 1/3 crosslinking rate offers a balance between softness, spreadability and support for subtle, natural-looking results.
Non-animal origin, biodegradable hyaluronic acid with a favourable safety profile when injected by trained professionals.
Pre-filled glass syringe allows precise dosing, good visibility of product and easy handling.
Part of the DEFINISSE filler range (Touch, Restore, Core, Hydrobooster), enabling tailored combination treatments for different depths and indications.
Provides immediate aesthetic improvement with clinically satisfactory outcomes in facial rejuvenation.
Formulated to help preserve facial expressiveness while achieving discreet aesthetic refinement.

Indications

Correction of moderate to deep facial wrinkles and folds, including nasolabial folds and marionette lines, in suitable anatomical areas.
Increase in lip volume and enhancement of lip contour and definition.
General facial contour refinement where medium-depth hyaluronic acid filler is appropriate (e.g. perioral region) as per the Instructions for Use.
Adult patients seeking non-surgical correction of age-related volume loss and wrinkles using hyaluronic acid dermal fillers, as determined suitable by the treating physician.

Composition

Cross-linked sodium hyaluronate (hyaluronic acid) 23 mg/ml, non-animal origin (BDDE-crosslinked).
Lidocaine hydrochloride 3 mg/ml (0.3%) as a local anaesthetic to reduce injection discomfort.
Physiological buffer solution with excipients q.s. to 1 ml (e.g. phosphate-buffered saline), as specified in the official Instructions for Use.
Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether), residual content within accepted safety limits.

Formulation

Transparent, viscoelastic cross-linked hyaluronic acid gel implant for injection into the medium to deep dermis.
HA concentration: 23 mg/ml; lidocaine concentration: 0.3%.
Produced with XTR (EXCELLENT THREE DIMENSIONAL RETICULATION) crosslinking technology, forming a stable, elastic 3D HA matrix.
Crosslinking rate: 1/3 (softer rheology within the DEFINISSE filler family, compared with Restore 2/3 and Core 3/3).
Biodegradable, non-animal origin hyaluronic acid obtained by bacterial fermentation.
Supplied as a sterile, apyrogenic gel in a single-use pre-filled glass syringe.

Packaging

1 x 1 ml pre-filled disposable glass syringe of DEFINISSE TOUCH FILLER LIDO.
2 x sterile 27G 1/2" needles for injection.
Blister pack containing syringe and needles to maintain sterility until use.
Outer carton printed with product name (DEFINISSE TOUCH FILLER LIDO (1x1ml)), brand (RELIFE DEFINISSE MENARINI GROUP), reference / EAN code 9003502003860 and classification details.
Instructions for Use (IFU) leaflet with full details on composition, indications, contraindications, precautions and recommended injection techniques.
Traceability labels (e.g. peel-off stickers) for inclusion in patient records and clinic documentation.

Usage

For medical use only. Intended exclusively for licensed healthcare professionals (e.g. dermatologists, plastic surgeons, aesthetic practitioners) trained in hyaluronic acid dermal filler injection techniques and facial anatomy.
Before treatment, obtain a full medical history including allergies (particularly to hyaluronic acid, lidocaine or amide-type local anaesthetics), bleeding disorders, autoimmune diseases and current medications.
Discuss treatment goals, expected results, possible side effects and alternative options with the patient and obtain informed consent.
Cleanse and disinfect the skin in the treatment area according to aseptic protocol.
Attach one of the supplied 27G 1/2" sterile needles to the pre-filled glass syringe using aseptic technique. Expel any air and ensure that the gel flows correctly.
Recommended injection depth: medium to deep dermis, as specified in the IFU, depending on the indication and anatomical site.
Inject slowly using appropriate techniques (e.g. linear threading, serial puncture, fanning) and aspirate according to clinic practice to minimise the risk of intravascular injection.
Avoid injection into or near blood vessels or in high-risk anatomical zones; if signs of vascular compromise (e.g. severe pain, blanching, livedo) occur, stop injection immediately and implement appropriate emergency management.
Do not overcorrect; take into account potential swelling and tissue accommodation when determining the amount of product to inject.
After injection, gently massage the treated area if necessary to ensure even product distribution and smooth contour, avoiding excessive pressure.
Provide post-procedure instructions such as avoiding intense heat or cold, strenuous exercise, alcohol consumption and make-up on the treated areas for at least 24 hours, and avoiding manipulation of the area unless advised.
Record the injected volume, treatment sites, batch/lot number and other relevant details in the patient’s medical record for traceability.
Dispose of used needles and syringes immediately in an approved sharps container in accordance with local regulations. Single use only; do not resterilise or reuse.

Contraindications

Known hypersensitivity or allergy to hyaluronic acid, lidocaine, local anaesthetics of the amide type, BDDE or any other component of the product.
History of severe anaphylactic reactions or multiple severe allergies, unless the benefit clearly outweighs the risk and appropriate precautions are taken.
Presence of active skin disease, inflammation or infection (e.g. acne, herpes simplex, dermatitis, cellulitis) at or near the intended injection site.
Systemic infection or febrile illness at the time of treatment.
Bleeding disorders or current use of anticoagulant or antiplatelet treatment where the risk of bleeding or haematoma is deemed unacceptable.
Autoimmune diseases, severe immunosuppression or connective tissue disorders where dermal filler treatment is considered inappropriate by the physician.
Pregnancy and breastfeeding, due to lack of sufficient safety data.
Use in patients under the minimum legal age for aesthetic procedures according to local regulations.
Intravascular injection is strictly contraindicated; filler must never be injected directly into blood vessels.

Adverse Effects

Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, bruising and mild discomfort.
Localised oedema or induration at injection sites, which generally resolves spontaneously.
Small haematomas or ecchymosis due to needle puncture of superficial vessels.
Temporary asymmetry, contour irregularities or palpable nodules, which may require clinical evaluation and, if needed, massage or additional management.
Inflammatory or hypersensitivity reactions such as prolonged swelling, erythema or induration; rare cases of more significant immune responses may occur.
Infection at the injection site or along the injection channel, potentially requiring antibiotic therapy and, in some cases, product removal.
Vascular compromise or occlusion if inadvertent intravascular injection occurs, which can lead to pain, blanching, livedo, tissue ischaemia or necrosis and, in rare cases, serious complications such as visual disturbance or blindness; immediate emergency management by experienced clinicians is required.
Rare granulomatous reactions or delayed nodular responses that may need long-term follow-up and treatment.
Any unexpected, severe or persistent adverse event should prompt prompt medical evaluation and appropriate management.

Storage Conditions

Store in the original unopened packaging in a clean, dry place at controlled room temperature as specified on the carton.
Protect from direct sunlight, excessive heat and freezing; do not freeze the product.
Keep the syringe inside its blister and outer carton until use to maintain sterility and traceability.
Do not use the product after the expiry date printed on the packaging.
Do not use if the packaging is damaged, opened or shows signs of compromised sterility.
Store out of reach of children and unauthorised persons; dispose of used syringes and needles as medical sharps waste according to local regulations.

Duration

Provides immediate correction upon injection, with effects on wrinkle correction and lip volume generally lasting for many months; exact duration depends on the treatment area, injection technique, individual metabolism and lifestyle, and should be assessed case by case by the treating physician.

Onset

Immediate visible improvement in wrinkle depth, lip volume and contour after injection, with final aesthetic appearance emerging once initial swelling and redness subside over the following days.