The composition may be subject to variations, so we advise you to always check the list on the purchased product.
COMPOSITION/
Cross-linked hya(uronic acid 25 mg
Lidocaine hydrochloride 3 mg
Phosphate buffer p1-17.2 QSP 1 g
One syringe contains 1.2 ml of UNIVERSAL.
CONTRAINDICATIONS
UNIVERSAL 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.
UNIVERSAL must not be used:
- In patients with known hypersensitivity to Hyaluronic Acid, lidocam and amide-type local anaesthetics.
- In patients with a history of autoimmune disease or receiving irnmunotl,erapy.
- 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 (acne, herpes, etc.) - In immediate association with laser treatment, deep chemical peeling or dermabrasion
PRECAUTIONS FOR USE
- UNIVERSAL should only be used by doctors trained in injection techniques.
-UNIVERSAL 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 on the efficiency and tolerance of injecting UNIVERSAL into an area that has already been treated with another filling product.
-There are no clinical data available in terms of efficiency and tolerance for the injection of UNIVERSAL 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.
-UNIVERSAL should be used with caution in patients with cardiac conduction disorders.
-UNIVERSAL 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 Utrijectioil.
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, hammam), as well as prolonged exposure to the Sun or ultra-violet 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 lidocene and must take this into account.
- Athletes' attention is drawn to the fact that this product contains an active ingredient which may induce a positive reaction in tests carried out during anti-doping controls.
INCOMPATIBILITIES
There are incompatibilities between Hyaluronic Acid and quaternary ammonium compounds such as benzalkonium chloride solutions. This is why UNIVERSAL must never be placed in Contact with medical-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, 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, 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 Hyaluronic Acid and/or lidocene. 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 adverse reactions related to the injection of UNIVERSAL should be reported to the distributor and/or manufacturer.
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 must 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 can cause rare but serious side effects such as embolisation, which can lead to blurred vision, blindness, necrosis of the Skin and/or underlying tissues. These rare embolisation effects are mainly reported during injection of the glabella, the nose or the perillase region of the forehead and the periorbital region.
STORAGE CONDITIONS
Store between 2°C and 25°C, out of direct sunlight.
