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 QSP 1 g
One syringe contains 1 ml of LIPS.
CONTRAINDICATIONS
LIPS must not be injected:
- For injections other than intradermal.
- For the correction of superficial wrinkles.
- In the periorbital area (eyelid, crow's feet, dark circles).
- In your blood vessels.
- In a site where a non-absorbable filling implant has already been injected.
LIPS must not be used :
- In patients with a known hypersensitivity to Hyaluronic Acid, Lidocam and amide-type local anaesthetics.
- In patients with a history of autoimmune disease or receiving immunotherapy.
- Patients suffering from epilepsy not controlled by treatment.
- Patients with porphyria.
- Patients with a tendency to develop hypertrophic scars.
- In patients with a history of recurrent angina associated with rheumatic fever of the heart.
- In pregnant or milk feeding women.
- Children.
- In areas with inflammatory and/or infectious skin lesions (acne, herpes, etc.)
- In immediate association with laser treatment, deep chemical peeling or a dermrnaurae
PRECAUTIONS FOR USE
- LIPS should only be used by doctors trained in injection techniques.
- LIPS 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 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 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 allergy, and will have to ensure special monitoring of these patients at risk. In particular, it may be decided to propose a double test or suitable preventive treatment prior to any injection.
- LIPS should be used with caution in patients with cardiac conduction disorders.
- LIPS should be used very cautiously in patients with hepatocellular insufficiency with coagulation disorders and in patients treated with drugs which reduce or inhibit hepatic Metabolism which may lead to coagulation disorders.
- Patients should be given the following recommendations:
- 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 haematomas and bleeding during injection.
- Do not apply make-up for 12 hours after the injection.
- Avoid exposure to extreme temperatures (intense cold, sauna, steam room), as well as prolonged exposure to the Sun or ultraviolet rays for 2 weeks following the injection.
- 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 lidocaine and that he/she must take this into account.
- The attention of sportsmen and women is drawn to the fact that this product contains an active ingredient which may induce a positive reaction in anti-doping tests.
INCOMPATIBILITIES
There are incompatibilities between Hyaluronic Acid and quaternary ammonium compounds such as benzatkonium chloride solutions. This is why LIPS must never be placed in Contact with medical and surgical instruments treated with this type of product.
UNDESIRABLE EFFECTS
The doctor must inform the patient that there are potential undesirable effects associated with the implantation of this device, which may occur immediately or may be delayed. These include [but are not limited to]: inflammatory reactions (redness, oedema, erythema) which may be associated with itching and pain 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, mild spontaneous pain or pain on palpation 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 hyaturonic acid and/or lidocaine. These potential risks should be taken into account.
- The patient should inform the 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 should be reported to the distributor and/or manufacturer.
- Check the expiry date and integrity of the packaging before use. Do not use a syringe whose end cap has been opened or moved in 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 filler into a blood vessel in the Face may cause rare but serious side effects such as embolisation, which may 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 peri-nasal region of the forehead and the periorbital region are injected.
STORAGE CONDITIONS
Store between 2°C and 25°C, out of direct sunlight.
