Description
Reabsorbable medical device (sterile, non-pyrogenic and physiological gel) to be used as a filler for the correction of deep facial skin sagging and for the restoration of volumes.
The main component is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.
Aliaxin EV Essential Volume is a medical device manufactured in accordance with to Directive 93/42/EEC MOD, intended for the treatment of imperfections in the following areas of the face:
• nasolabial folds;
• acne and post-traumatic scars;
• areas of the face that require enrichment of the facial tissue (cheeks, chin, cheekbones) 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 much better results the less obvious it is the nature of the defect.
The product is intended for the exclusive use of medical personnel. Do not use for applications other than those indicated in the information leaflet.

Mode instructions for use
Prior to any form of intervention with Aliaxin EV Essential Volume, the medical 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. It can local anesthesia should be practiced in order to guarantee the necessary comfort for the patient.
The doctor must inform the patient in advance about the modalities of the intervention, its nature, warnings, precautions and possible individual outcomes on potential adverse responses, the expected duration of treatment and the eventuality of of an additional intervention to maintain and/or define in detail the result achieved.
The area of the intervention must be cleansed with antiseptic solutions before proceeding with the injection.

Remove the syringe from the blister , unscrew the cap and fit 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 needle. 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 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 firmly.

Aliaxin EV Essential Volume is administered with a sterile needle (27G x 13 mm - 27G x 19 mm ) compliant with Luer-Lock standards with normalized fittings, included in the package.
The injection should be carried out at the superficial subcutaneous layer; the procedure is however, it is at the doctor's discretion and depends on the correction you want to carry out and the method adopted. At the end of the procedure it is It is advisable to perform a delicate massage of the treated area to allow optimal distribution of the product.

The volumetric gradation shown on the syringes is indicative; it's up to discretion from the doctor the dosage to be used for the individual case.
The frequency with which to repeat the operation depends on different factors, regarding both the patient's physiology (skin type, individual metabolism, anatomy, age) and lifestyle; another element to consider is relating to the implantation techniques adopted.
To maintain the results obtained, it is advisable to repeat the procedure periodically, every 8-12 months.

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

Warnings
During surgery, the usual precautions in the case of percutaneous procedures must be adopted. The risks are the common ones of infections related to the type of treatment.
Aliaxin EV Essential Volume should not be used on patients suffering from:
• infectious or inflammatory processes close to the area of intervention;
• current skin allergy;
• hypersensitivity note towards keloids;
• allergy to components;
• immune system disorders;
• chronic pathological conditions of the skin;
• disorders affecting coagulation factors or in the case of ongoing anticoagulant therapies.
It is advisable for the patient to avoid the of the treatment, the intake of substances (aspirin, NSAIDs, vitamin E) that act on the fluidity of the body. of blood, in order to minimize the possibility of of bruising or bleeding of the injected areas.
The use of Aliaxin EV Essential Volume must be absolutely excluded in areas where breast, tendon, bone or muscle implants are present.
After treatment, and until swelling is completely absorbed and redness, the implanted areas should not be exposed to make-up, excessive heat (sun, UV tanning sessions, laser), nor in intense cold.
After use, dispose of needles and syringes according to the procedures indicated for hospital waste.
How can you occur 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;
• coloration discoloration of the skin at the injection site.
These phenomena generally resolve within a few days. If they persist beyond a week, the patient will have to contact your doctor promptly.
Aliaxin EV Essential Volume must be used intracutaneously and must not be injected into blood vessels.
There are no known phenomena of overdose or interaction with drugs.
Do not use if pregnant .
Aliaxin EV Essential Volume is available in sterile disposable packaging.
It is Reuse of the contents for subsequent applications or on different patients is prohibited. Once opened, the product must be used immediately. Unused excess should be disposed of.
Do not use the product if the packaging is damaged. damaged.
Do not mix with other injectables, nor use other implants together with Aliaxin EV Essential Volume.
Proceed with the treatment in an aseptic environment observing the appropriate techniques.
Fill in the adhesive labels in the package and apply one to the patient card kept in the doctor's office and deliver the other to the patient.
Keep out of reach of children.

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

Format
2 ml pack containing:
- information leaflet;
- 2 sealed blisters each containing 1 sterile syringe 1 ml pre-filled single dose;
- adhesive labels to be applied to the patient card for traceability of the product;
- 4 sterile needles (25G x 13 mm - 27G x 19 mm).