The composition may be subject to variations, so we advise you to always check the list on the purchased product.
COMPOSITION:
Cross-linked Hyaluronic Acid 25 mg
Lidocaine hydrochloride 3 mg
Phosphate buffer pH 7.2 OSP 1 g
One syringe contains 1 ml of LIPS SOFT.
CONTRAINDICATIONS
LIPS SOFT must not be injected:
- For injections other than intradermal.
- For the correction of superficial wrinkles.
- In the periorbital region (eyelid, crow's feet, dark circles).
- In blood vessels.
- In a site where a non-absorbable filling 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 autoimmune disease or receiving immunotherapy.
- In patients suffering from epilepsy not controlled by treatment.
- In patients with porphyria.
- In patients with a tendency to develop hypertrophic scars.
- In patients with a history of recurrent angina associated with rheumatic fever of cardiac origin.
- In pregnant or milk feeding women.
- Children.
- In areas with inflammatory and/or infectious skin lesions such as lacne, herpes...I.
- In immediate association with laser treatment, deep chemical peeling or dermabrasion.
PRECAUTIONS FOR USE
- LIPS SOFT should only be used by doctors trained in injection techniques.
- LIPS SOFT is not indicated for injections other than intra-dermal and into the mucosa of the Lips.
- Do not inject into blood vessels, bones, tendons, ligaments or moles.
- There are no clinical data available in terms of efficiency and tolerance when injecting LIPS SOFT into an area that has already been treated with another filling product.
- There are no clinical data available on the efficiency and tolerance of injecting LIPS SOFT in patients with a history of multiple severe allergies or anaphylactic shock. The doctor will therefore have to decide on the indication on a case-by-case basis, depending on the nature of the Allegy, and will have to monitor these at-risk patients closely. In particular, it may be decided to propose a double test or suitable preventive treatment prior to any
injection.
- LIPS SOFT should be used with caution in patients with cardiac conduction disorders.
- LIPS SOFT should be used with extreme caution in patients with hepatocellular insufficiency and coagulation disorders, and in patients treated with drugs that reduce or inhibit hepatic Metabolism, which may lead to coagulation disorders.
-Patients should be advised to
- Avoid taking aspirin or high doses of vitamins C and/or E during the week preceding the injection.
- Patients receiving anticoagulant treatment should be warned of the increased risk of herringbone formation and bleeding during injection.
- Do not apply make-up for 12 hours after the injection.
- Avoid exposure to extreme temperatures such as intense cold, saunas and steam baths, as well as prolonged exposure to the Sun or ultraviolet rays for 2 weeks following the injection.
UNDESIRABLE EFFECTS
The doctor must inform the patient that there are potential adverse effects associated with the implantation of this device, which may occur immediately or may be delayed. These may include (but are not limited to)l :
- Inflammatory reactions [redness, oedema, erythema' which may be associated with itching, Pains on pressure, may occur after injection. These reactions may persist for a week. In a limited number of cases, 1.6% (1/61) of subjects in the Clinique study, spontaneous or palpable mild tenderness may persist for more than a week.
- Haematomas.
- Colouring or discolouration at the injection site.
- Indurations or nodules at the injection site.
- Poor filling efficiency or filling effect.
- Cases of glabellar necrosis, abscess, granuloma, and immediate or delayed hypersensitivity have been reported following injections of Hyaluronic Acid and/or lidocaine. These potential
these potential risks.
- If the needle is blocked, do not increase the pressure on the plunger rod, stop the injection and replace the needle.
- The doctor's attention is drawn to the fact that this product contains Udocaine and must take this into account.
- Sportsmen and women should note that this product contains an active ingredient which may cause a positive reaction in tests carried out during anti-doping controls.
- Patients should inform their doctor as soon as possible if an inflammatory reaction persists beyond one week or if any other side-effects occur. The doctor should treat these with appropriate medication.
-Any other undesirable effects associated with the injection of LIPS SOFT should be reported to the distributor and/or manufacturer.
INCOMPATIBILITIES
There are incompatibilities between Hyaluronic Acid and quaternary ammonium compounds such as benzatkonium chloride solutions. This is why LIPS SOFT should never be placed in Contact with medical and surgical instruments treated with this type of product.
WARNINGS
- Check the expiry date and integrity of the packaging before use. Do not use a syringe whose end cap has been opened or removed from the blister pack.
- Do not reuse. Reuse involves risks (e.g. cross-contamination) for the patient.
- Do not re-sterilise.
- After use, discard the syringe and any remaining product. The needle should be disposed of in a special collection container. Refer to current guidelines for disposal.
- Never attempt to straighten a bent needle, but discard and replace it
-Inadvertent injection of a filling product into a blood vessel in the Face can cause rare but serious side-effects such as embolisation, which can lead to blurred vision, blindness and necrosis of the Skin and/or underlying tissues. These rare embolisation effects are mainly reported when the glabella, the nose or the perioral region of the forehead and the periorbital region are injected.
STORAGE CONDITIONS
Store between 2°C and 25°C, out of direct sunlight.
