copy of FILLMED ART FILLER UNIVERSAL
FILORGA MEDICAL Art Filler UNIVERSAL
Hyaluronic acidi gel with lidocaine
4 needles 27G
2 pré-filled syringes of 1.2ml each
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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.
• Patients receiving anticoagulant therapy should be warned of the increased risk of hematomas and bleeding during injection.
• Do not apply any make-up for 12 hours after the injection.
• Avoid exposure to extreme temperatures (intense cold, sauna, steam room), as well as prolonged exposure to sunlight or ultraviolet light for 2 weeks after the injection.
- If the needle is stuck, 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 they should consider it.
- The attention of athletes should be drawn to the fact that this product contains an active ingredient that can induce a positive reaction in tests carried out during anti-doping controls.
INCOMPATIBILITY - FILLMED ART FILLER UNIVERSAL
There are incompatibilities between hyaluronic acid and quaternary ammonium compounds such as benzalkonium chloride solutions. Therefore, ART FILLER UNIVERSAL must never be put in contact with medical-surgical instruments treated with this type of product.
SIDE EFFECTS - FILLMED ART FILLER UNIVERSAL
The doctor should inform the patient that there are potential immediate or delayed adverse effects associated with the implantation of this device. These include (but are not limited to):
- Inflammatory reactions (redness, oedema, erythema) which may be associated with itching, superficial erosions in the crow's feet, pain at the pressure area, may occur after the injection. These reactions may persist for a week. In a limited number of cases, 1.6% (1/61) of subjects in the clinical study, mild spontaneous or palpation pain may persist for more than a week.
- Coloration or discoloration at the injection site.
- Indurations or nodules at the injection area.
- Low filling efficiency or low 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 risks should be taken into consideration.
- 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 treatment.
- Any other adverse effects related to the injection of ART FILLER UNIVERSAL should be reported to the distributor and/or manufacturer.
The origin is certified 100% French.
THE PRODUCTS SOLD ON THIS WEBSITE ARE PARA PHARMACEUTICAL PRODUCTS, THEY ARE THEREFORE OVER THE COUNTER AND DO NOT REQUIRE A PRESCRIPTION.
THIS PRODUCT IS A MEDICAL DEVICE. THS PRODUCT CANNOT BE RETURNED OR EXCHANGED.
Please note that the injection of this product requires a technical medical procedure that must be carried out by a doctor (doctor specialized in dermo aesthetics, dermatologist, plastic surgeon).
CAUTION: Unintentional injection of a filler into a blood vessel of the face can cause rare but serious side effects such as embolization which can lead to visual disturbances, blindness, necrosis of the skin and/or underlying tissue. These rare cases of embolization are mostly reported in the glabella, nose or peri-nasal area, forehead and peri-orbital area.
FILLMED laboratories are experts in hyaluronic acid. A custom-made production unit with the latest technology has been designed specifically for ART FILLER ®.
In accordance with strict quality requirements, the factory guarantees a manufacturing process that complies with strict international standards: ISO 14644-1 and ISO 13485. All syringes are inspected individually, manually and visually, one by one, ensuring maximum quality and safety standards.
FILLMED Laboratories invest in its innovative manufacturing, with 20% of turnover dedicated to R&D each year.
FILLMED plans scientific studies using the latest technology to prove the performance and safety of its products.
IN VITRO STUDIES (BASED ON CELL CULTURE):
Fillmed tests its products on primary human skin cells adapted to real-life everyday conditions such as aged fibroblasts obtained from wrinkle depths, skin cells under UV radiation or oxidative stress, to ensure the clinical effect of the products. Skin cells would be evaluated either for their morphology or for their activities/functions.
EX VIVO STUDIES (BASED ON THE TISSUE):
In order to meet the laboratory conditions best suited to real human skin, Fillmed tests its products on pieces of living human skin: these pieces, resulting from abdominoplasty or lifting surgery, can be kept from 24 hours to 3 weeks in the laboratory. After applying the products (topical or injections), Fillmed can then evaluate skin samples (biopsies) using all available methods such as conventional microscopes, electron microscopes, marker dosage, etc.
FILLMED plans various multi-centre, comparative, long-term studies with sufficient sample size to provide reliable data to assure practitioners and also patients about the safety and efficacy of FILLMED products. Through these studies, Fillmed has also been able to offer doctors the most accurate protocols.
Produit réservé aux professionnels de santé (médecin spécialisé en dermo esthétique, dermatologue, chirurgien plastique)
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