ART FILLER FINE LINES

FINE LINES 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: FINE LINES
- COMPOSITION: Cross-linked hyaluronic acid 20 mg, lidocaine hydrochloride 3 mg, phosphate buffer pH 7.2 QSP 1 g.
- PRESENTATION: 2 x 1ml.
- INDICATIONS: FINE LINES perfectly combats light wrinkles on the face, especially in areas with thin skin. Ideal for areas where the first signs of ageing are immediately visible. FINE LINES helps to restore a natural, fresh appearance.
- INJECTION DEPTH: Upper dermis.
- NEEDLES: 4 x 30G½”.
- DURATION: Clinically significant improvement from 12 to 18 months after treatment.
- USE: Strict medical use.

- Syringes: 2 x 1 ml.
- Needles: 4 x 30G½”.
- Each box contains two 1mL pre-filled disposable syringes of FINE LINES and 4 sterile 30G½” disposable needles reserved for injection of FINE LINES, a package insert and 4 traceability labels.

It is indicated for filling fine lines, superficial lines and small skin folds of the “crow's feet” on the forehead, upper lip and cheeks.

Cross-linked hyaluronic acid 20 mg, lidocaine hydrochloride 3 mg, phosphate buffer pH 7.2 QSP 1 g.

The use of FINE LINES is reserved for physicians trained in injection techniques.
No clinical data are available on the efficacy and tolerance of injecting FINE LINES into an area previously treated with another filler product.
No clinical data are available on the efficacy and tolerance of FINE LINES injection in patients with a history of multiple severe allergies or anaphylactic shock. The doctor will therefore have to decide on a case-by-case basis on the indication depending on the nature of the allergy and will have to 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.
FINE LINES should be used with caution in patients with cardiac conduction disorders.
FINE LINES 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 0.2 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 radiation 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.

FINE LINES must not be injected:
- For non-intradermal injections.
- In the eyelid.
- In the blood vessels.
- In a site where a non-absorbable filler implant has already been injected.
- Do not over-correct.
FINE LINES 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.

FINE LINES works by means of hyaluronic acid, which is the key component in the volume of the skin, acting as a filling substance with a natural moisturising action on the dermal tissues. FINE LINES is ideal for filling in fine facial wrinkles.

The contents of FINE LINES 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. FINE LINES must therefore never come into contact with medical/surgical instruments treated with this type of product.