The composition may be subject to variations, so we advise you to always check the list on the purchased product.
Composition:
- Sodium hyaluronate (18mg/ml concentration)
- Glycerol (1,2,3-propantriol) 20mg/L
- Phosphate citrate buffer pH 6.8-7.6 qsp
Exclusion criteria:
The device should not be used in :
- patients with a tendency to develop hypertrophic or keloid scars and with pigmentation disorders.
- Patients with a history of autoimmune diseases or who are undergoing immunity treatment.
- Patients with a known hypersensitivity to Hyaluronic Acid.
- Patients who have already had permanent fillers injected into the area to be treated.
- Pregnant or Milk feeding women.
- Patients under 18 years of age.
Patients taking anticoagulants or platelet aggregation inhibitors (e.g. acetylsalicylic acid) must not be treated with the device without consulting their doctor. The device must not be used in areas with skin reactions or inflammatory and/or infectious processes (e.g. acne, herpes, etc.). The device must not be used in association with laser treatment, chemical peeling or dermabrasion.
Precautions for use :
This device should only be administered by a doctor familiar with intradermal injections to Cosmetics Flax. Sensitive skin may be pre-treated with a cream or local anaesthetic. After use, dispose of the syringe, remaining product and needle in a special container.
Adverse reactions: Physicians should inform patients of any adverse reactions and/or incompatibilities potentially associated with the implantation of this device, which may occur immediately or at a later date. The following reactions and adverse reactions have been observed with the device or similar products:
- Bleeding during and after injection
- Edema
- rhythm without swelling that disappears within a week or, in extreme cases, after no more than 2 months
- Hypersensitivity to sodium hyaluionate
- Haematoma
- Indurations or nodules at the injection site
- Inflammation which may be associated with itching and sensitivity to pressure for up to a week after injection
- Pain during injection
- Papules
- Swelling of the tear ducts
- Transient pain or discolouration at the injection site.
Patients should inform their doctor as soon as possible of any inflammatory reaction lasting more than one week or of the appearance of any other side effect The doctor should treat these side effects appropriately.Any other adverse effects associated with the injection of the device should be reported to the distributor and/or manufacturer
Warnings:
Check the integrity of the syringe and the expiry date before use.
Do not use a syringe with an open or displaced protective cap inside the protective packaging.
Only use syringes or needles supplied by the manufacturer
Do not handle or twist the needle.
Do not reuse; quality and sterility can only be guaranteed for a syringe in its original packaging. Reuse of the device entails a risk of infection for patients or users. If the 30 G and 1/2" needle is obstinate, do not increase the pressure on the plunger rod but interrupt the injection and replace the needle.
There are no clinical data (efficiency, Tolérance) available concerning the injection of the device into an area already treated with another filling product.
Do not inject into blood vessels, bones, tendons, ligaments, nerves or muscles.
Do not inject the device into nevi. Do not use an automated injection system to inject this product. Patients should be advised not to apply make-up for 12 hours after the injection and to avoid prolonged exposure to Sun and UV light and the use of saunas or Turkish baths for one week after the injection. To avoid any risk of mobility of the product, the patient should be advised not to massage the treatment site in the days following the injection. There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds such as benzalkonium chloride solutions. The device must therefore never be placed in contact with these substances or with medical and surgical instruments which have been in contact with these substances.
Storage: The device must be stored between 2-25°C / 36-77°F in a dry place in the original packaging, protected from light, heat and frost. Handle with care.
The list of ingredients may be subject to variations, so we advise you always to check the list on the product purchased.
