Aliaxin FL –Lips- is a reabsorbable medicinal product (physiological, apyrogenoussterile gel) to be used as a filler for increasing the volume and contours of the lips.
The principlecomponent is cross-linked Hyaluronic Acid of non-animal origin, producedby bacterial fermentation.

COMPOSITION
Cross-linked hyaluronic acid………………………………….. 25 mg/g
Phosphate buffer, Water for injectable solutions…………..1 g

PACKAGE
Aliaxin FL –Lips- is available in a 2ml package. Each package contains:
• 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 – 30 G Sterimedix CE 0120).

MODALITY OF ACTION

Aliaxin FL –Lips- must be injected into the cutaneous and mucosal tissues for the supplementationof the extra-cellular root and the intra-cutaneous volumetric increase, that is, forthe treatment of cutaneous and/or mucosal depressions caused by wrinkles and scarring.

AREAS OF USE

Aliaxin FL –Lips- is an injectable medical device designed to restore physiologicalvolume and indicated for the treatment of imperfections in the following areas:
• Lips
• Vermillion border
• Oral commissures
• Perioral wrinkles
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 FL – Lips-, the doctor must carry out anadequate case history and a comprehensive assessment of the conditions of thepatient, in order to guarantee the total absence of contraindications to the implant.
The areas to be treated must be identified and evaluated bearing in mind the criteriarelative to lines and symmetries to follow.
Local anesthetic may be used for treatment to the lips, in order to guarantee thenecessary comfort to the patient.
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.
The area of intervention must be cleansed with antiseptic solution before proceedingto the implant.
Extract the syringe from the blister pack, unscrew the top and assemble theneedle together with the protection. The latter is only to be removed right beforethe intervention.
Aliaxin FL –Lips- is administered with a sterile needle (27G – 30 G) in compliancewith the Luer-Lock standards with normalized connections, which is included inthe pack.
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.
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 to repeat the treatment periodically, every 6-12 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 FL –Lips- 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 minimize the possibility ofbruising or bleeding of the injected areas.
Aliaxin FL –Lips- may not be implemented in areas where there are mammary tendons,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
• Coloringor discoloring 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 FL –Lips- is an intra cutaneous injection and must not be injected intoblood vessels.
There are no reports of problems due to excessive doses or interaction withother medicines.
Do not use in pregnancy.
Aliaxin FL –Lips- 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 FL –Lips-.
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 FL -Lips- must be stored at temperaturebetween 2°and 28°C.

Do not freeze. Do not expose to heat.