Aliaxin GP Global Perform. Hyaluronic Acid 2X1Ml

Description
Resorbable medical device (sterile, apyrogenic, and physiological gel) to be used as a filler for the correction of medium and deep skin sagging of the face and for increasing the volume and contours 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:
• nasolabial folds;
• perioral wrinkles;
• acne and facial scars;
• glabellar wrinkles;
• forehead wrinkles;
• areas of the face that require enhancement of facial tissue (cheeks, chin, cheekbones, lips) with temporary volumetric increase through the growth of soft tissues.
The outcomes of the intervention depend on the skin type and the nature of the imperfections, with better results being achieved when the nature of the defect is less evident.
The product is intended solely for use by medical personnel. Do not use for applications other than those indicated in the leaflet.

Mode of use
Prior to any form of intervention with Aliaxin GP Global Performance, the physician must carry out 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 considering criteria related to lines and symmetries to follow.
Local anesthesia may be performed for lip treatments, in order to ensure the necessary comfort for the patient.
The physician must inform the patient in advance about the modalities of the intervention, its nature, warnings, precautions, and possible individual outcomes, potential adverse reactions, the expected duration of the implant, and the possibility of additional intervention for maintenance and/or detailed definition of the achieved result.
The area of intervention must be cleaned with antiseptic solutions before proceeding with the implant.

Remove the syringe from the blister, unscrew the cap, and attach the needle complete with protection. Only remove the latter just before the intervention. Hold the glass syringe and the luer-lock firmly between the thumb and index finger. 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 to screw until the thread makes contact with the body of the syringe. Check that the needle is correctly inserted into the thread. Failing to observe these precautions could result in the risk of the needle detaching and/or leakage from the luer-lock. With the syringe in one hand and the cap in the other, remove the needle protection by pulling decisively.
Aliaxin GP Global Performance is administered with a sterile needle (27G x 13 mm - 27G x 19 mm) compliant with Luer-Lock standards with standardized connections, included in the package.
The implant should be performed at the level of the mid/deep dermis; the procedure is at the physician's discretion and depends on the correction to be made and the implantation technique adopted.
At the end of the procedure, it is advisable to perform a gentle massage of the treated area to allow optimal distribution of the implant.

The volumetric graduation reported on the syringes is indicative: it is up to the physician's discretion the dosage to be used for the individual case.
The frequency with which to repeat the intervention depends on various factors related to both the patient's physiology (skin type, individual metabolism, anatomy, age) and lifestyle; another element to consider relates to the implantation techniques adopted.
For maintaining the obtained results, it is advisable to periodically repeat the intervention every 6-12 months.

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

Warnings
During the intervention, standard precautions must be taken in the case of percutaneous procedures. The risks are those common to infection related to the type of treatment. Aliaxin GP Global Performance should not be used on patients affected by:
• infectious or inflammatory processes near the area of intervention;
• known hypersensitivity to keloids;
• allergy to components;
• immune system disorders;
• chronic skin pathological states;
• disorders affecting coagulation factors or in the case of ongoing anticoagulant therapies.
It is advisable for the patient to avoid, near the time of treatment, taking substances (aspirin, NSAIDs, vitamin E) that act on blood fluidity, in order to minimize the possibility of bruising or bleeding in the injected areas.
The use of Aliaxin GP Global Performance must be absolutely excluded in the presence of breast, tendon, bone, or muscle implants.
After treatment, and until the complete absorption of swelling and redness, the implanted areas should not be exposed to excessive heat (sun, UV tanning sessions, laser), nor to intense cold.
After use, dispose of needles and syringes according to the procedures indicated for hospital waste.
As may happen in the case of percutaneous injection, the following phenomena may occur:
• inflammatory reactions (redness, edema, etc.), sometimes associated with itching and pain on touch;
• bruises;
• hardening or nodules at the injection site;
• discoloration of the skin at the injection site.
Such phenomena generally resolve within a few days. If they persist beyond a week, the patient should promptly consult their physician.
Aliaxin GP Global Performance should be used intradermally and must not be injected into blood vessels.
No phenomena of overdose or interaction with medications are known.
Do not use in a state of pregnancy.
Aliaxin GP Global Performance is available in sterile single-use packages. Reuse of the contents for subsequent applications or on different patients is prohibited.
The product should be used immediately after opening. The unused excess should be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectables, nor use other implants in conjunction with Aliaxin GP Global Performance.
Proceed with the implant in an aseptic environment observing the appropriate techniques.
Fill out the adhesive label present in the package and apply it to the patient file kept at the physician's office.
Keep out of reach of children.

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

Format
Package of 2 ml containing:
- instruction leaflet;
- 2 sealed blisters containing each 1 sterile pre-filled single-use syringe of 1 ml;
- adhesive stickers to apply to the patient file for product traceability;
- 4 sterile needles (27G x 13 mm - 27G x 19 mm).