DEFINISSE RESTORE FILLER LIDO (1x1ml)

DEFINISSE

Injectable medical device

Cross-linked hyaluronic acid dermal filler with lidocaine for deep wrinkles, volume restoration and facial contouring

Class III sterile, resorbable hyaluronic acid dermal filler medical device under applicable European medical device regulations.
CE Marked (e.g. CE 023) demonstrating 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 and labelled for single use only.
Traceability ensured via reference number, EAN 13, UPC and lot / batch number on syringe and outer carton.
Professional Use Only product in accordance with national regulations for injectable medical devices and aesthetic procedures.

Class III sterile, resorbable hyaluronic acid dermal filler medical device under applicable European medical device regulations.
CE Marked (e.g. CE 023) demonstrating 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 and labelled for single use only.
Traceability ensured via reference number, EAN 13, UPC and lot / batch number on syringe and outer carton.
Professional Use Only product in accordance with national regulations for injectable medical devices and aesthetic procedures.

Cross-linked hyaluronic acid dermal filler with lidocaine for deep wrinkles, volume restoration and facial contouring

Description

DEFINISSE RESTORE 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 process, which creates a stable, elastic 3D hyaluronic acid matrix. Formulated at 23 mg/ml cross-linked HA with lidocaine 0.3%, it is designed for the correction of deep wrinkles, restoration of facial volumes and redefinition of facial contours. The filler is intended for injection into the deep dermis or subcutaneous tissue and is supplied as a 1 ml pre-filled glass syringe with two 27G 1/2\ needles for exclusive use by trained healthcare professionals.

Bnefits

Corrects deep wrinkles and folds, such as nasolabial folds and marionette lines, for a smoother facial appearance.
Restores lost facial volume in areas such as the midface, cheeks, chin and jawline.
Redefines and reshapes facial contours for a more harmonious and youthful profile.
Cross-linked hyaluronic acid 23 mg/ml provides structural support and long-lasting volumising effect.
Contains 0.3% lidocaine to improve patient comfort during injection.
XTR crosslinking technology provides a stable and elastic 3D HA matrix with a crosslinking rate of 2/3, balancing lift and spread for natural results.
Non-animal origin, biodegradable hyaluronic acid with a favourable safety profile when used by trained professionals.
Pre-filled glass syringe allows precise dosing, product traceability and high presentation quality.
Part of the DEFINISSE filler range, enabling tailored combination treatments with Touch, Core and Hydrobooster formulations.
Provides immediate aesthetic improvement with clinically satisfactory results reported in real-world facial rejuvenation studies.

Indications

Correction of deep wrinkles and folds (e.g. nasolabial folds, marionette lines) appropriate for deep dermal or subcutaneous fillers.
Restoration of facial volumes in areas affected by age-related volume loss, such as midface, cheeks, chin and jawline.
Redefinition and reshaping of facial contours for enhanced facial harmony.
Treatment of deep to very deep wrinkles in suitable anatomical areas as determined by the treating physician.
Use in adult patients seeking non-surgical facial rejuvenation using hyaluronic acid fillers, when deemed appropriate by a healthcare professional.

Composition

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

Formulation

Transparent, viscoelastic, cross-linked hyaluronic acid gel implant for injection into deep dermis or subcutaneous tissue.
HA concentration: 23 mg/ml, lidocaine 0.3%.
XTR (EXCELLENT THREE DIMENSIONAL RETICULATION) crosslinking technology creating a stable, elastic 3D HA matrix.
Crosslinking rate: 2/3 within the DEFINISSE filler range (Touch 1/3, Restore 2/3, Core 3/3).
Biodegradable, non-animal origin hyaluronic acid obtained from bacterial fermentation (e.g. Streptococcus equi).
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 RESTORE FILLER LIDO.
2 x sterile 27G 1/2" needles for injection.
Blister packaging containing the syringe and needles to maintain sterility.
Outer carton printed with product name, brand (RELIFE DEFINISSE MENARINI GROUP), reference 9003502003914, EAN-13 9003502003914 and UPC 30049000.
Instructions for Use (IFU) leaflet with detailed information on indications, contraindications, precautions and injection technique.
Traceability labels for inclusion in patient records and clinic documentation.

Usage

For medical use only. Intended exclusively for licensed healthcare professionals who have received specific training in hyaluronic acid filler injection techniques and facial anatomy.
Before treatment, take a thorough medical history including allergies (especially to hyaluronic acid, lidocaine or amide-type local anaesthetics), bleeding disorders, autoimmune disease and medications.
Obtain informed consent after discussing expected results, potential risks, adverse effects and alternative treatment options.
Cleanse and disinfect the treatment area using appropriate antiseptic protocol.
Attach one of the supplied 27G 1/2" sterile needles to the pre-filled glass syringe using aseptic technique. Expel air and check gel flow before injection.
Injection depth: deep dermis or subcutaneous tissue, depending on indication and anatomical site, as indicated in the IFU.
Inject slowly using appropriate techniques (e.g. linear threading, serial puncture, fanning) while aspirating according to clinical practice to reduce the risk of intravascular injection.
Avoid injection into blood vessels and high-risk anatomical areas; discontinue injection immediately if blanching, severe pain or other signs of vascular compromise appear, and follow emergency management protocols.
After injection, gently massage the treated area if necessary to ensure even distribution and smooth contour, avoiding excessive pressure.
Do not overcorrect; allow for tissue accommodation and possible oedema when assessing volume.
Provide post-treatment instructions: avoid intense heat or cold, vigorous exercise, alcohol and make-up on treated areas for at least 24 hours or as advised; avoid manipulating or massaging the area unless instructed.
Record product details (batch/lot number, injected volume, injection sites) in the patient’s medical record for traceability.
Dispose of used needles and syringes as clinical sharps 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 diseases, inflammation or infection (e.g. acne, herpes, dermatitis) 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 medication where the risk of bleeding or haematoma is considered unacceptable by the treating physician.
Autoimmune diseases, immunosuppression or connective tissue disorders where the physician considers dermal filler use inappropriate.
Pregnancy and breastfeeding, due to lack of sufficient safety data.
Use in patients under the minimum age for aesthetic procedures according to local regulations.
Intravascular injection or injection into areas with high risk of vascular compromise is strictly contraindicated.

Adverse Effects

Common, usually transient injection-site reactions such as redness, swelling, tenderness, pain, itching, bruising and mild discomfort.
Localised oedema, induration or palpable fullness at the injection site, which typically resolves spontaneously.
Small haematomas or ecchymosis due to needle trauma.
Temporary asymmetry, contour irregularities or nodules, which may require clinical assessment and, in some cases, massage or additional treatment.
Hypersensitivity reactions ranging from mild local inflammatory responses to rare more significant immune reactions.
Infection at the injection site or along the injection track, requiring appropriate medical treatment, and in some cases product removal.
Vascular compromise or occlusion if inadvertent intravascular injection occurs, potentially leading to pain, blanching, tissue ischaemia or necrosis, and in rare cases visual disturbance or blindness; these events require immediate emergency management by experienced clinicians.
Very rare risk of granuloma formation or delayed nodular reactions that may need prolonged management.
Any unexpected or persistent adverse event should prompt prompt evaluation by the treating physician.

Storage Conditions

Store in the original packaging in a clean, dry place at controlled room temperature as specified on the outer carton.
Protect from extremes of temperature; do not freeze and do not expose to excessive heat or direct sunlight.
Keep the syringe in its blister and carton until use to maintain sterility and traceability.
Do not use 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 after injection, with volumising and contouring effects that generally persist for many months; exact duration depends on factors such as treatment area, injection technique, patient metabolism and lifestyle, and should be evaluated individually by the treating physician.

Onset

Immediate visible improvement in wrinkle depth, volume and contour after injection, with final aesthetic appearance seen after initial post-injection swelling or redness resolves over the following days.