ART FILLER LIPS

LIPS 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: LIPS
- COMPOSITION: Cross-linked hyaluronic acid 25 mg, lidocaine hydrochloride 3 mg, phosphate buffer pH 7.2 QSP 1 g.
- PRESENTATION: 2 x 1ml.
- INDICATIONS: LIPS is an injectable hyaluronic acid-based filler designed to shape, volumise and moisturise the lips.
- INJECTION DEPTH: In the medium to deep dermis.
- NEEDLES: 4 x 27G½”.
- DURATION: Clinically significant improvement from 12 to 18 months after treatment.
- USE: Strict medical use.

- Syringes: 2 x 1 ml.
- Needles: 4 x 27G½”.
- Each box contains two disposable pre-filled syringes of 1mL LIPS and 4 sterile 27G½” disposable needles reserved for LIPS injection, a package insert and 4 traceability labels.

It is indicated for lip contours, medium and deep nasolabial folds, and marionette lines.

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

The use of LIPS is reserved for doctors trained in injection techniques.
No clinical data are available on the efficacy and tolerance of injecting LIPS into an area previously treated with another filler product.
No clinical data are available on the efficacy and tolerance of LIPS injections for Fitzpatrick phototypes V and VI.
There are no clinical data available on the efficacy and tolerance of LIPS injection in patients with a history of multiple severe allergies or anaphylactic shock The physician 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.
LIPS should be used with caution in patients with cardiac conduction disorders.
LIPS 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 could 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.

LIPS 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.
LIPS 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.

LIPS is intended to be injected into the mucous membrane for the treatment of the lips and into the mid to deep dermis for the correction of skin folds.

The contents of LIPS 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. LIPS must therefore never come into contact with medical-surgical instruments treated with this type of product.