Aliaxin GP Global Performance is areabsorbable medicinal product (physiological apyrogenous sterile gel) to be used as a filler for the correction of medium anddeep folds and wrinkles. The principle component is cross-linked Hyaluronic Acid of non-animal origin,produced by bacterial fermentation.

COMPOSITION
Cross-linked hyaluronicacid……………………………25 mg/ml
Phosphate buffer, Water for injectable solutions……………1 g

PACKAGE

Aliaxin GP Global Performance is available in a 2ml package. Each packagecontains:
• package insert leaflet
• 2 sealed blisters, each containing 1 sterile pre-filled mono-use syringe of 1 ml, tobe assembled with the backstop supplied;
• Adhesive labels to stick to the patient’s medical record for product traceability.
• 4 sterile needles (27 G Sterimedix CE 0120).

MODALITY OF ACTION

Aliaxin GP Global Performance must be injected into the cutaneous tissue forthe supplementation of the extra-cellular root and the intra-cutaneous volumetricincrease, that is, for the treatment of cutaneous depressions caused by wrinklesand scarring.

AREAS OF USE

Aliaxin GP Global Performance is an injectable medical device designed to restorephysiological localized facial volume and indicated for the treatment of imperfections in thefollowing areas of the face:
• Nasolabial folds
• Wrinkles around the mouth
• Facial and acne scars
• Glabellar wrinkles
• Wrinkles on the forehead
• Areas of the face which require enrichment of the facial tissue (cheeks, chin, cheekbones) with temporary volumetric increase through growth of the soft tissues.
The outcome of the treatment depends on the type of skin and the nature of theimperfection: the less evident the imperfection, the better the result.

INSTRUCTIONS FOR USE

Before any form of intervention with Aliaxin GP Global Performance, the doctormust carry out an adequate case history and a comprehensive assessment of theconditions of the patient, in order to guarantee the total absence of contraindicationsto the implant.

1) The areas to be treated must be identified and evaluated bearing in mind the criteriarelative to lines and symmetries to follow.
2) The doctor must inform the patient in advance of the modalities of the intervention,its nature, warnings, precautions and possible individual outcomes, potentialadverse responses, the expected duration of the implant and the eventuality of asupplementary intervention for the maintenance and/or definition in detail of theachieved result.
3) The area of intervention must be cleansed with antiseptic solution before proceedingto the implant.
4) Extract the syringe from the blister pack, unscrew the top and assemble the needletogether with the protection. The latter is only to be removed right before theintervention. Aliaxin GP Global Performance is administered with a sterile needle(27G) in compliance with the Luer-Lock standards with normalized connections,which is included in the pack.
5) The implantation must be carried out in correspondence to the medium/deepdermis the procedure is, however, at the discretion of the doctor and depends onthe correction desired and the method of implantation adopted.
6) At the end of the procedure it is advisable to carry out a delicate massage of thetreated area in order to allow for better distribution of the implant.

DOSAGE AND ADMINISTRATION

The volumetric grading printed on the syringe has an indicative value: it is left tothe doctor’s discretion to choose the dosage to be used for each individual case.
The intervals at which the treatment should be repeated depend on various factors,regarding both the physiology of the patient (type of skin, individual metabolism,anatomy, age) and their lifestyle. Another element to consider is relative to theimplant techniques used. For maintenance of the obtained results it is advisable torepeat the treatment periodically, every 12 months.

PRECAUTIONS

During the treatment the usual precautions in the case of percutaneous proceduresmust be adopted. The risks are the common ones of infection relative tothe type of treatment.
Aliaxin GP-Global Performance- must not be used on patients affected by:

• Infective or inflammatory processes near the area of intervention
• Known hypersensitivity to cheloids
• Allergy to the components
• Immune system illnesses
• Serious pathological skin conditions
• Problems with coagulation or anti-coagulating therapies in progress.

Close to treatment the patient should avoid consumption of substances which acton blood fluidity (aspirin, NSAID, Vitamin E), in order to minimise the possibility ofbruising or bleeding of the injected areas.
Aliaxin GP- Global Performance- may not be implemented in areas where there are mammary, tendon, bone or muscular implants present.
Following the treatment, and until the complete absorption of swelling and reddening,the implanted areas must not be exposed to excessive heat (sun, UV tanningsessions or laser) or intense cold.
After use, needles and syringes must be disposed of according to the proceduresindicated for hospital waste.

ADVERSE REACTIONS, WARNINGS AND CONTRAINDICATIONS

As with any percutaneous injection, there can be incidents of:
• Inflammatory reactions (reddening, edema, etc), sometimes associated with itchingand pain to the touch
• Hematoma
• Hardening or nodules at the point of injection
• Colouring or Discolouring of the skin at the point of injection
These reactions usually disappear within a few days. If they persist for more thana week the patient should contact their doctor immediately.
Aliaxin GP – Global Performance- is an intra cutaneous injection and must not beinjected into blood vessels.
There are no reports of problems due to excessive doses or interaction withother medicines.

Do not use in pregnancy.

Aliaxin GP -Global Performance- is available in single dose sterile packages.
The product must not be reused for future applications or on other patients.
Once open the product must be used immediately.
Any remaining product must be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectable substances and do not carry out other implantstogether with Aliaxin GP Global Performance.
The implant must be carried out in an aseptic environment observing the appropriatetechniques.
Fill in the adhesive label contained in the box and stick it to the patient’s medicalrecords kept at the doctor’s surgery.
Keep out of the reach of children.
STORAGE
Aliaxin GP -Global Performance- must be stored at a temperature between 2° and28°C. Do not freeze. Do not expose to heat.