ART FILLER LIPS SOFT

LIPS SOFT is a resorbable injectable gel for:
- A soft result.
- A comfortable treatment.
- High tissue integration.
- Tri-Hyal technology.

- FILLMED LABORATOIRES
- NAME: LIPS SOFT
- COMPOSITION: Cross-linked hyaluronic acid 25 mg, Lidocaine hydrochloride 3 mg, Phosphate buffer pH 7.2 QSP 1 g.
- PRESENTATION: 1 x 1 ml.
- INDICATIONS: Indicated for light volumising of the lips, redefinition of the lip contour and correction of fine perioral wrinkles.
- INJECTION DEPTH: Medium to deep injection into the dermis.
- NEEDLES: 2 x 30G½”.
- DURATION: 6 to 12 months, depending on individual factors such as age, skin type and lifestyle.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2 x 30G½”.
- Each pack contains 1 syringe of LIPS SOFT, 2 sterile 30G½” needles, disposable and reserved for LIPS SOFT injection, a package insert and 2 traceability labels.

Lips, medium and deep nasolabial folds, marionette lines.

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

- The use of LIPS SOFT is reserved for doctors trained in injection techniques.
- No clinical data are available on the efficacy and tolerance of injecting LIPS SOFT into an area previously treated with another filler product.
- There are no clinical data available on the efficacy and tolerance of LIPS SOFT 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 suitable preventive treatment before any injection.
- LIPS SOFT should be used with caution in patients with cardiac conduction disorders.
- LIPS SOFT 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 SOFT 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 SOFT 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.

The action of ART FILLER® products consists in correcting age-related changes in the skin structure: filling wrinkles and skin folds of the face, restoring volume. LIPS SOFT filler is an injectable implant indicated for increasing lip volume and enhancing lip contour, as well as for filling medium to deep nasolabial folds, with or without marionette lines by injection into the medium to deep dermis. The presence of lidocaine is intended to reduce the sensation of pain in the patient during treatment.

The contents of LIPS SOFT syringes are sterilised by moist heat. The 30G½” needles are sterilised by irradiation.

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