Aliaxin EV Essential Volume Hyaluronic Acid 2X1Ml

Description
Resorbable medical device (sterile, apyrogenic and physiological gel) to be used as a filler for the correction of deep skin sagging of the face 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 made in accordance with Directive 93/42/EEC MOD, intended for the treatment of imperfections in the following areas of the face:
• nasolabial folds;
• acne scars and post-traumatic scars;
• areas of the face that need enrichment of facial tissue (cheeks, chin, cheekbones) with temporary volumetric increase through soft tissue growth.
The outcomes of the intervention depend on skin type and the nature of imperfections, with better results when the nature of the defect is less apparent.
The product is intended for exclusive use by medical personnel. Do not use for applications other than those indicated in the leaflet.

Instructions for use
Prior to any form of intervention with Aliaxin EV Essential Volume, the physician must conduct an adequate medical history and a thorough assessment of the patient's conditions, to ensure the absolute absence of contraindications to implantation. The areas to be treated should be identified and evaluated considering criteria related to lines and symmetries to be followed. Local anesthesia may be performed to ensure necessary comfort for the patient.
The physician must inform the patient in advance about the methods of the intervention, its nature, warnings, precautions, and possible individual outcomes regarding potential adverse responses, the expected duration of the treatment, and the possibility of a supplementary intervention for maintenance and/or detailed definition of the achieved result.
The area of intervention should be cleansed with antiseptic solutions before proceeding with the injection.

Withdraw the syringe from the blister, unscrew the cap, and mount the needle complete with protection. Remove the latter only before the intervention. Hold the glass syringe and the luer-lock between the thumb and index finger. Grasp the protective cap and unscrew it. Remove the needle cap and securely screw the needle thread onto the syringe's end. Gently twist the needle clockwise. Continue twisting until the thread contacts the body of the syringe. Ensure the needle is correctly inserted into the thread. Failure to comply with these precautions could result in the risk of needle detachment and/or leaks from the luer-lock. With the syringe in one hand and the cap in the other, remove the needle protection by pulling decisively.

Aliaxin EV Essential Volume is administered with a sterile needle (27G x 13 mm - 27G x 19 mm) in accordance with Luer-Lock standards with standardized connectors, included in the package.
The injection should be performed at the level of the superficial subcutaneous layer; the procedure is at the physician's discretion and depends on the correction to be performed and the method adopted. At the end of the procedure, a gentle massage of the treated area is advisable to ensure optimal distribution of the product.

The volumetric grading indicated on the syringes is for reference; the dosage to be used for the individual case is at the physician’s discretion.
The frequency with which to repeat the intervention depends on various factors, regarding both the patient's physiology (skin type, individual metabolism, anatomy, age) and lifestyle; another element to consider relates to the implantation techniques adopted.
For the maintenance of achieved results, it is advisable to repeat the intervention periodically, every 8-12 months.

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

Warnings
During the intervention, the usual precautions for percutaneous procedures must be taken. The risks are those common to infections related to the type of treatment.
Aliaxin EV Essential Volume should not be used on patients suffering from:
• infectious or inflammatory processes near the intervention area;
• ongoing skin allergy;
• known hypersensitivity to keloids;
• allergy to the components;
• immune system disorders;
• chronic skin pathological conditions;
• disorders affecting coagulation factors or in the case of ongoing anticoagulant therapies.
It is advisable for the patient to avoid, close to the treatment, the intake of substances (aspirin, NSAIDs, vitamin E) that affect blood fluidity, in order to minimize the possibility of bruising or bleeding of the injected areas.
The use of Aliaxin EV Essential Volume should be completely excluded in areas where breast implants, tendons, bones, or muscles are present.
After the treatment, and until complete absorption of swelling and redness, the implanted areas should not be exposed to makeup, 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 can occur in the case of percutaneous injection, the following phenomena may be recorded:
• inflammatory reactions (redness, edema, etc.), sometimes associated with itching and tenderness;
• hematomas;
• hardening or nodules at the injection site;
• discoloration of the skin at the injection site.
Such phenomena generally resolve in a few days. If they persist beyond a week, the patient should promptly contact their physician.
Aliaxin EV Essential Volume should be used for intradermal injection and should not be injected into blood vessels.
There are no known phenomena of overdose or interaction with drugs.
Do not use in a state of pregnancy.
Aliaxin EV Essential Volume is available in sterile single-use packages.
Reusing the contents for subsequent applications or on different patients is prohibited.
The product, once opened, should be used immediately. 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 EV Essential Volume.
Proceed with the treatment in an aseptic environment observing appropriate techniques.
Complete the adhesive labels present in the package and apply one to the patient record kept at the physician's office and give 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 in intact packaging: 36 months.

Format
Package of 2 ml containing:
- leaflet;
- 2 sealed blisters each containing 1 pre-filled single-dose sterile syringe;
- adhesive tags to apply to the patient record for product traceability;
- 4 sterile needles (25G x 13 mm - 27G x 19 mm).