FILLMED MHA10

Descrizione

ART FILLER UNIVERSAL is a viscoelastic gel of injectable cross-linked hyaluronic acid of non-animal origin, slowly resorbable over time, colourless, transparent, sterile, pyrogen-free and physiological, from the FILLMED laboratories Filorga medical

ART FILLERS products are intended for the correction of changes in the structure of the skin due to ageing: filling of wrinkles and folds of the skin, restoration of volumes.

Indication – FILLMED ART FILLER UNIVERSAL

Medium to deep wrinkles, temples / nose / deep wrinkles around the mouth/lips

Injection depth – FILLMED ART FILLER UNIVERSAL

Injection into the medium to deep dermis

Inject with a 27G ½ needle

Composition – FILLMED ART FILLER UNIVERSAL

Cross-linked hyaluronic acid gel: 25mg/ml + 3mg/ml of lidocaine

Lidocaine is a local anaesthetic substance, to ensure optimal comfort during the injection session

Preservation – FILLMED ART FILLER UNIVERSAL

Controlled ambient temperature between 2 ºC and 25 ºC.

Do not use the product after the expiration date. The expiration date is printed on the product labels.

Elimination – FILLMED ART FILLER UNIVERSAL

Used or partially used syringes and needles should be considered as potentially contaminated medical waste. They should be handled and eliminated in accordance with the medical practices of the institution and the local regulations in application

Each box contains 2 syringes, 4 x 27G single-use sterile needles, instructions and 4 traceability labels. In order to ensure traceability of the product, one of the two labels should be placed in the patient’s file and the other should be given to the patient.

Precautions for use- FILLMED ART FILLER UNIVERSAL

ART FILLER UNIVERSAL must not be injected:

– Into blood vessels

– Into muscles

– In an area where a non-absorbable filler implant has already been injected.

– Do not over correct.

ART FILLER UNIVERSAL must not be used:

– In patients with known hypersensitivity to hyaluronic acid, lidocaine and local anaesthetics of the amide type.

– In patients with a history of autoimmune disease or receiving immunotherapy.

– In patients with epilepsy not controlled by treatment

– In patients with prophyria

– In patients with a tendency to develop hypertrophic scars.

– In patients with a history of recurrent sore throat associated with acute articular rheumatism with cardiac localization.

– In pregnant or nursing women

– In children

– In areas with inflammatory and/or infectious skin lesions (acne, herpes, etc.).

– In immediate combination with laser treatment, deep chemical peeling or dermabrasion

– ART FILLER UNIVERSAL must only be used by doctors qualified in injection techniques.

– ART FILLER UNIVERSAL is not recommended for injections other than subcutaneous, supra periosteal or deep dermal. The technique and depth of injection will vary depending on the treatment site.

– Do not inject into blood vessels, bones, tendons, ligaments or moles.

– There is no clinical data available on the efficacy and safety of injecting ART FILLER UNIVERSAL into an area that has already been treated with another dermal filler.

– There are no clinical data available on the efficacy and safety of ART FILLER UNIVERSAL injection in patients with a history of severe multiple 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 an adapted preventive treatment prior to any injection.

-ART FILLER UNIVERSAL should be used with caution in patients with cardiac conduction disorders.

-ART FILLER UNIVERSAL should be used with extreme caution in patients with hepatocellular insufficiency with coagulation disorders and in patients treated with drugs that decrease or inhibit hepatic metabolism which may lead to coagulation disorders.

– Do not inject more than 2ml of ART FILLER UNIVERSAL per treatment spot during each session.

– Patients should be given the following recommendations:

• Avoid taking aspirin and high doses of vitamins C and/or E the week before the injection.