Aliaxin GP Global Performance 2 syringes of 1ml

Reabsorbable medical device (sterile, non-pyrogenic and physiological gel) to be used as a filler for the correction of medium and deep sagging skin on the face and for increasing the volume and contour of the lips.
The main component is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.
Aliaxin GP Global Performance is an injectable medical device indicated for the restoration of physiological volumes of the face and intended for the treatment of imperfections in the following areas of the face:< br /> • nasolabial folds;
• peribuccal wrinkles;
• acne and facial scars;
• glabellar wrinkles;
• forehead wrinkles;
• areas of the face that require enrichment of the facial tissue (cheeks, chin, cheekbones, lips) with temporary volumetric increase through growth of the soft tissues.
The results of the operation depend on the type of skin and the nature of the imperfections, with results the better the nature of the defect is less evident.
The product is intended for exclusive use by medical personnel. Do not use for applications other than those indicated in the information leaflet.

How to use
Before any form of intervention with Aliaxin GP Global Performance, the doctor must conduct an adequate medical history and an overall assessment of the patient's conditions, to ensure the absolute absence of contraindications to the implant. The areas to be treated must be identified and evaluated taking into account criteria relating to lines and symmetries to be followed.
Local anesthesia may be practiced for lip treatments, in order to guarantee the necessary comfort for the patient.
The doctor must inform the patient in advance about the methods of the intervention, its nature, warnings, precautions and possible individual outcomes, the potential adverse responses, the expected duration of the implant and the possibility of an additional intervention for maintenance and/or definition in detail of the result achieved.
The operation area must be cleansed with antiseptic solutions before proceeding with the implant.

Remove the syringe from the blister, unscrew the cap and mount the needle complete with protection. Remove the latter only before surgery. Hold the glass syringe and luer lock firmly between your thumb and forefinger. Grasp the protective cap and unscrew it. Remove the needle cap and firmly insert the needle thread onto the end of the syringe. Gently screw the needle clockwise. Continue screwing until the thread comes into contact with the body of the syringe. Check that the needle is inserted correctly into the thread. Failure to comply with these precautions could cause the risk of needle detachment and/or leakage from the luer-lock. With the syringe in one hand and the cap in the other, remove the needle guard by pulling firmly.
Aliaxin GP Global Performance is administered with a sterile needle (27G x 13 mm - 27G x 19 mm) compliant to Luer-Lock standards with normalized fittings, included in the package.
The implant should be carried out in correspondence with the medium/deep dermis; the procedure is however at the discretion of the doctor and depends on the correction you want to carry out and the implant method adopted.
At the end of the procedure it is advisable to perform a delicate massage of the treated area to allow optimal distribution of the implant.

The volumetric gradation shown on the syringes has indicative value: the dosage to be used for each individual case is up to the doctor's discretion.
The frequency with which to repeat the operation depends on different factors, concerning both the patient's physiology (skin type, individual metabolism, anatomy, age) and lifestyle; another element to consider is related to the implantation techniques adopted.
To maintain the results obtained it is advisable to repeat the operation periodically, every 6-12 months.

Components
Cross-linked hyaluronic acid 25 mg/g.
Phosphate buffer, water for solutions for injection 1 g.

Warnings
During the operation, the usual precautions in the case of percutaneous procedures must be taken. The risks are common ones of infection related to the type of treatment. Aliaxin GP Global Performance should not be used on patients suffering from:
• infectious or inflammatory processes close to the area of intervention;
• known hypersensitivity to keloids;
• allergy to the components;
/> • immune system disorders;
• chronic pathological conditions of the skin;
• disorders affecting coagulation factors or in the case of ongoing anticoagulant therapies.
The patient should avoid , in the vicinity of the treatment, the intake of substances (aspirin, NSAIDs, vitamin E) that act on the fluidity of the blood, in order to minimize the possibility of bruising or bleeding of the injected areas.
The use of Aliaxin GP Global Performance must be absolutely excluded where breast, tendon, bone or muscle implants are present.
After the treatment, and until swelling and redness are completely absorbed, the implanted areas should not be exposed to excessive heat (sun, sitting UV tanning, laser), or intense cold.
After use, dispose of needles and syringes according to the procedures indicated for hospital waste.
As can happen in the case of percutaneous injection, the following phenomena may occur:
• inflammatory reactions (redness, edema, etc.), sometimes associated with itching and pain to the touch;
• hematomas;
• hardening or nodules at the injection site;
• discoloration of the skin at the injection site.
These phenomena generally resolve within a few days. If they persist beyond a week, the patient must promptly contact his doctor.
Aliaxin GP Global Performance must be used intracutaneously and must not be injected into the blood vessels.
There are no known phenomena of overdose or interaction with medications.
Do not use if pregnant.
Aliaxin GP Global Performance is available in sterile disposable packs. Reuse of the contents for subsequent applications or on different patients is prohibited.
Once opened, the product must be used immediately. Unused excess must be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectables, or use other implants in conjunction with Aliaxin GP Global Performance.
Proceed to implant in an aseptic environment observing the appropriate techniques.
Fill in the adhesive label in the package and apply it to the patient card kept in the doctor's office.
Keep out of the reach of children.

Storage
Store between 2 °C and 28 °C. Do not freeze. Do not expose to heat sources.
Shelf life with intact packaging: 36 months.

Format
2 ml pack containing:
- information leaflet;
- 2 sealed blisters each containing 1 sterile 1 ml pre-filled single-dose/disposable syringe;
- adhesive tags to be applied to the patient's card for product traceability;
- 4 needles sterile (27G x 13 mm - 27G x 19 mm).