ART FILLER with Lidocaine

FILLMED

Hyaluronic acid dermal filler

Facial volumising injectable filler with lidocaine

CE Marked Class III medical device for intradermal and subcutaneous injection in accordance with EU medical device regulations (MDR 2017/745 and/or legacy MDD as applicable at time of manufacture).
Manufactured in Europe by FILLMED Laboratories under ISO 13485 Certified quality management system for medical devices.
Sterile, pyrogen Free injectable gel produced under Good Manufacturing Practice (GMP) and international standards ISO 14644 and ISO 13485.
Supplied with full traceability (batch number, EAN13 code 3401564093519, reference 6409351) and device labelling compliant with European regulatory requirements.

CE Marked Class III medical device for intradermal and subcutaneous injection in accordance with EU medical device regulations (MDR 2017/745 and/or legacy MDD as applicable at time of manufacture).
Manufactured in Europe by FILLMED Laboratories under ISO 13485 Certified quality management system for medical devices.
Sterile, pyrogen Free injectable gel produced under Good Manufacturing Practice (GMP) and international standards ISO 14644 and ISO 13485.
Supplied with full traceability (batch number, EAN13 code 3401564093519, reference 6409351) and device labelling compliant with European regulatory requirements.

Facial volumising injectable filler with lidocaine

Description

ART FILLER VOLUME (2 x 1.2 ml) with Lidocaine is a CE-marked, sterile, resorbable hyaluronic acid dermal filler from Laboratoires FILLMED, designed specifically to restore and enhance facial volume and contours. Using Tri-Hyal Technology, the gel combines very long, long and free hyaluronic acid chains to provide strong volumising power, tissue integration and smooth, sculptable texture. With a high HA concentration of 25 mg/ml and 0.3% lidocaine for patient comfort, this viscoelastic, non-animal, pyrogen-free gel is indicated for subcutaneous, supraperiosteal or deep dermal injection to treat sunken areas and deep skin depressions, particularly in the mid-face, cheeks, temples, chin and jawline. It delivers natural-looking, long-lasting volume restoration and contouring when injected by appropriately trained medical professionals.

Bnefits

High volumising capacity with 25 mg/ml cross-linked hyaluronic acid for restoration and creation of facial volume
Tri-Hyal Technology (combination of very long, long and free HA chains) for sculpting, volumising and smoothing effects with excellent tissue integration
Easy-to-shape, cohesive gel texture that allows precise facial sculpting and natural-looking results tailored to individual anatomy
Indicated for restoration of volume in the mid-face, mandibular angle, chin, jawline and temples, and for correction of deep skin depressions
Contains 0.3% lidocaine to improve injection comfort and reduce pain during treatment
Non-animal origin hyaluronic acid, sterile, colourless, viscoelastic and pyrogen-free gel
Durable aesthetic results, with improvements typically maintained for up to around 18 months depending on patient and technique
Supplied in ergonomic 1.2 ml syringes with an exclusive FILLMED design for precise, comfortable injection and optimal control
CE-marked Class III medical device manufactured to ISO 13485 quality standards in Europe

Indications

Restoration of facial volumes in the middle third of the face
Volumisation of sunken areas such as cheeks and temples
Definition and contouring of the mandibular angle and jawline
Chin projection and shaping
Correction of deep skin depressions due to ageing, lipoatrophy or structural volume loss
General facial sculpting where deep volumising filler is indicated, in adults treated by trained medical professionals

Composition

Cross-linked hyaluronic acid (non-animal origin) 25 mg/ml
Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic
Tri-Hyal Technology: blend of very long-chain HA, long-chain HA and free HA to optimise cohesion, elasticity and distribution
Sterile, pyrogen-free, colourless, viscoelastic physiological gel
pH approximately 7.2 (as per technical data)
Residual cross-linking agent (e.g. BDDE) below regulatory limits for hyaluronic acid fillers

Formulation

Injectable hyaluronic acid dermal filler gel for single-use only
Non-animal origin, cross-linked HA with 0.3% lidocaine
Viscoelastic, cohesive, easy-to-shape gel designed for deep dermal, subcutaneous or supraperiosteal injection
Supplied sterile in pre-filled glass or plastic syringes, ready to use with supplied needles
Slowly resorbable over time, integrating into surrounding tissues while maintaining volume and contour

Packaging

Box containing 2 pre-filled syringes, each with 1.2 ml of ART FILLER VOLUME gel (total 2.4 ml)
4 sterile single-use needles (typically 27G ½"; some distributors may list 25G) supplied for injection
Traceability labels for patient records and device tracking
Product leaflet/instructions for use (IFU) included in the box
Ergonomic 1.2 ml syringes specifically designed for FILLMED ART FILLER range with wide thumb rest, 360° finger grip and integrated luer lock

Usage

For medical use only; ART FILLER VOLUME is a Class III injectable medical device that must be used exclusively by physicians or suitably qualified medical practitioners who have received specific training in hyaluronic acid filler injection techniques.
Before treatment, take a full medical history, assess indications and contraindications, and obtain informed consent. Examine facial anatomy, degree of volume loss and desired aesthetic outcome.
Disinfect the treatment area thoroughly and maintain strict aseptic technique throughout the procedure.
ART FILLER VOLUME is indicated for deep injections into the deep dermis, subcutaneous layer or supraperiosteal plane, depending on treatment area and desired effect.
Recommended injection techniques include linear retro-tracing (threading), bolus, fan or cross-hatching methods, using the supplied needles or appropriate cannulas as per practitioner preference and IFU.
Typical treatment areas include mid-face (cheeks, zygomatic region), temples, chin and jawline; inject slowly, avoiding intravascular injection and high-risk vascular areas.
After injection, gently massage the treated area to ensure even distribution and smooth contour, while avoiding excessive pressure.
Do not over-correct during the initial session; additional touch-up treatments may be performed after clinical evaluation once initial swelling has subsided.
Post-treatment, advise patients to avoid makeup for approximately 12 hours and to avoid saunas, intense heat, sun exposure and strenuous exercise for 24–48 hours.
Ensure the product is not reused; discard any unused gel and used needles according to local sharps and clinical waste regulations.

Contraindications

Hypersensitivity or allergy to hyaluronic acid, lidocaine or any other component of the product (including amide-type local anaesthetics).
Patients with a history of severe allergic reactions or anaphylaxis.
Injection into or near sites of active skin disease or inflammation (e.g. infection, herpes, acne flare, dermatitis) in the treatment area.
Autoimmune diseases or patients receiving immunosuppressive therapy, unless assessed and approved by a specialist in accordance with local guidelines.
Coagulation disorders, use of anticoagulant or antiplatelet therapy that cannot be safely paused, or known bleeding disorders, where the risk of bruising/haematoma is significant.
Pregnancy and breastfeeding (use is generally contraindicated or not recommended due to lack of safety data).
Patients under 18 years of age.
Injection into blood vessels or highly vascularised areas, or into areas previously treated with permanent or non-resorbable fillers.
Use in patients with active systemic infection, uncontrolled chronic disease or significant immune compromise without appropriate specialist evaluation.

Adverse Effects

Common transient injection-site reactions: redness (erythema), swelling (oedema), tenderness, pain, itching, bruising or slight bleeding at the injection site.
Localised lumps or nodules, asymmetry or irregularities, usually manageable with massage or follow-up treatment.
Less common reactions: inflammatory nodules, induration, hypersensitivity reactions or granuloma formation, which may require medical management.
Rare but serious complications include vascular occlusion (intra-arterial or intra-venous injection) leading to tissue ischaemia or necrosis, visual disturbance or blindness, which require urgent recognition and management.
Infection at the injection site, particularly if aseptic technique is not strictly followed.
Local anaesthetic (lidocaine) related reactions in sensitive individuals, such as dizziness or allergic response, though rare at the doses present in the product.

Storage Conditions

Store between 2°C and 25°C in a cool, dry place.
Do not freeze.
Keep the syringes in their original blister and outer packaging until use to maintain sterility and protect from light.
Protect from direct sunlight and heat sources.
Do not use after the expiry date indicated on the packaging.
Do not use if the packaging, blister or syringe appears damaged, opened or compromised.

Duration

Clinical and distributor data suggest that results from ART FILLER VOLUME typically last up to approximately 12\u201318 months, depending on factors such as injection technique, treated area, dose, patient metabolism and lifestyle. Maintenance sessions are usually recommended every 12\u201318 months or as clinically indicated to sustain volume and contour.

Onset

Visible volumising and contouring effects are immediate following injection due to the presence of hyaluronic acid gel, with final results becoming more apparent once any initial swelling or redness subsides over the following days.