ART FILLER UNIVERSAL

UNIVERSAL is an injectable, resorbable gel:
- Viscoelastic based on cross-linked hyaluronic acid of non-animal origin.
- Colourless, transparent, sterile, apyrogenic and physiological.
- Containing 0.3 % by mass of lidocaine hydrochloride for its anaesthetising properties.
- Tri Hyal® Technology.

- FILLMED LABORATOIRES
- NAME: UNIVERSAL
- COMPOSITION: Cross-linked hyaluronic acid 25 mg, lidocaine hydrochloride 3 mg, phosphate buffer pH 7.2 QSP 1 g.
- PRESENTATION: 2 x 1.2ml.
- INDICATIONS: UNIVERSAL is a hyaluronic acid-based dermal filler indicated for the treatment of medium to deep wrinkles of the face. Thanks to Tri-Hyal® Technology, it combines three forms of hyaluronic acid: long and very long chains, which create a natural and flexible network, giving a modelling and volumising effect. Free hyaluronic acid, which provides smoothing action and improves skin quality. Its formula guarantees optimal comfort during injection and harmonious integration into the tissues.
- INJECTION DEPTH: In the medium to deep dermis.
- NEEDLES: 4 x 27G½”.
- DURATION: Clinically significant improvement 18 months after treatment.
- USE: Strict medical use.

- Syringes: 2 x 1.2 ml.
- Needles: 4 x 27G½”.
- Each box contains two 1.2mL pre-filled disposable syringes of UNIVERSAL and 4 sterile 27G½” disposable injection needles of UNIVERSAL, a package insert and 4 traceability labels.

Medium to deep nasolabial folds, marionette lines, lip contour and volume.

Cross-linked hyaluronic acid 25 mg, lidocaine hydrochloride 3 mg, phosphate buffer pH 7.2 QSP 1 g.

The use of UNIVERSAL is reserved for doctors trained in injection techniques.
No clinical data are available on the efficacy and tolerance of injecting UNIVERSAL into an area previously treated with another filler product.
No clinical data are available on the efficacy and tolerance of UNIVERSAL injection in patients with a history of multiple severe allergies or anaphylactic shock. The doctor must therefore decide on a case-by-case basis on the indication depending on the nature of the allergy and must ensure special monitoring of such patients at risk. In particular, it may be decided to propose a double test or a suitable preventive treatment before any injection.
UNIVERSAL should be used with caution in patients with cardiac conduction disorders.
UNIVERSAL should be used with the utmost caution in patients with hepatocellular insufficiency with coagulation disorders, as well as in patients treated with drugs that reduce or inhibit hepatic metabolism and may therefore cause coagulation disorders.
The injection volume depends on the level of correction required and is at the discretion of the physician. The recommended dose per treatment site is 1 mL. A maximum of two treatment sessions per year is recommended. Possible touch-up sessions allow the desired level of correction to be maintained. The maximum recommended dose per year is 15 mL. No data are available on the safety of injecting more than 15 mL of ART FILLER® dermal fillers per 70 kg body mass per year.
Patients should receive the following recommendations:
- Avoid taking aspirin, high-dose vitamin C and/or E in the week before the injection.
- Patients undergoing anticoagulant treatment should be warned of the increased risk of bruising and bleeding during injection.
- Do not apply make-up for 12 hours after the injection.
- Avoid exposure to extreme temperatures (intense cold, sauna, Turkish bath), as well as prolonged exposure to the sun and ultraviolet rays for 2 weeks after the injection.
If the needle is obstructed, do not increase the pressure on the piston rod but stop injection and replace the needle.
The physician's attention is drawn to the fact that this product contains lidocaine and should therefore be duly taken into account.
Athletes' attention is drawn to the fact that this product contains an active ingredient that may induce a positive reaction in doping tests.

UNIVERSAL must not be injected:
- For non-intradermal injections.
- For the correction of superficial wrinkles.
- In the periorbital region (eyelid, crow's feet, dark circles).
- In the blood vessels.
- In a site where a non-absorbable filler implant has already been injected.
- Do not overcorrect.
UNIVERSAL must not be used:
- In patients with known hypersensitivity to hyaluronic acid, lidocaine and amide-type local anaesthetics.
- In patients with a history of auto-immune disease or undergoing immunotherapy.
- In patients with epilepsy that is not controlled by treatment.
- In patients with porphyria.
- In patients with a tendency to develop hypertrophic scars.
- In patients with a history of relapsing angina associated with acute joint rheumatism with cardiac localisation.
- In pregnant or breastfeeding women.
- In children.
- In areas with inflammatory and/or infected skin lesions (acne, herpes, etc.).
- In direct association with a treatment by laser, deep chemical peeling or dermabrasion.

UNIVERSAL is suitable for filling medium to deep wrinkles and for increasing the volume and outlining the lips, improving their appearance.

The contents of UNIVERSAL syringes are sterilised by moist heat. The 27G½” needles are sterilised by irradiation.

INCOMPATIBILITY
There are incompatibilities between hyaluronic acid and quaternary ammonium compounds such as benzalkonium chloride solutions. UNIVERSAL must therefore never come into contact with medical/surgical instruments treated with this type of product.