Descrizione Clinica
Aliaxin SR
SHAPE AND RESTORE
Description
Reabsorbable medical device (sterile gel, apirogen and physiological) to be used as a filler for the correction of the mid and deep skin patches of the face and for the increase in volume and contour of the lips.
The main component is cross-linked hyaluronic acid of non-animal origin, produced by bacterial fermentation.
Aliaxin SR Shape & Restore 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:
• nose-labial folds;
• peribuccal wrinkles;
• acne and facial scars;
• glabellar wrinkles;
• front wrinkles;
• areas of the face requiring a enrichment of the facial tissue (guance, chin, cheekbones, lips) with temporary volumetric increase by increasing soft tissues.
The results of the intervention depend on the type of skin to the nature of imperfections, with results as much better as the nature of the defect is less evident.
The product is intended for exclusive use by medical staff. Do not use for applications other than those indicated in the leaflet.
Mode of use
Preliminary to any form of intervention with Aliaxin SR Shape & Restore, the doctor must conduct an adequate anamnesi and an overall assessment of the patient’s condition, to ensure the absolute absence of contraindications to the implant. The areas to be treated should be identified and evaluated taking into account criteria for lines and symmetries to be followed.
It can be practiced local anesthesia for labial treatments, in order to ensure the necessary comfort to the patient.
The doctor must in advance inform the patient about the procedures of the intervention, its nature, warnings, precautions and possible individual outcomes, the potential adverse responses, the time-consuming duration of the implant and the possibility of additional intervention for the maintenance and/or the definition in detail of the result achieved.
The area of the intervention must be maintained with antiseptic solutions before proceeding to the plant.
Extract the syringe from the blister, unscrew the cap and mount the full needle of protection. Remove the latter only before surgery. Weld the glass syringe and the luer-lock between the thumb and the index. Grab the protective cap and unscrew it. Remove the needle cap and firmly insert the needle thread on the end of the syringe. Gently screw the needle clockwise. Continue screwing until the thread enters into contact with the syringe body. Make sure the needle is correctly inserted into the thread. Failure to comply with these precautions could cause the risk of detachment of the needle and/or escape from the luer-lock. With the syringe in one hand and the hood in the other, remove the protection of the needle pulling decisively.
Aliaxin SR Shape & Restore is administered with a sterile needle (30G x 13 mm - 27G x 19 mm) in accordance with the Luer-Lock standard with standard fittings, including in the package.
The system should be carried out in accordance with the average/profund dermis; the procedure is however at the discretion of the doctor and depends on the correction you want to carry out and the methodical system adopted.
At the end of the procedure it is appropriate to perform a gentle massage of the treated area to allow an optimal distribution of the plant.
The volumetric gradation shown on the syringes has an indicative value: is at the discretion of the doctor the dosage to be used for the individual case.
The periodicity with which to repeat the intervention depends on different factors, regarding both the physiology of the patient (type of skin, individual metabolism, anatomy, age) and lifestyle; another element to be considered is related to the plant techniques adopted.
For the maintenance of the results obtained it is appropriate to repeat the intervention periodically, every 6-12 months.
Components
Cross-linked hyaluronic acid 25 mg/g.
Phosphate drum, water for injectable solutions 1 g.
Warnings
During the intervention, the usual precautions should be adopted in the case of percutaneous procedures. The risks are the common ones of infection related to the type of treatment. Aliaxin SR Shape & Restore should not be used on patients with:
• infectious or inflammatory processes close to the intervention area;
• hypersensitivity known to cheloids;
• allergy to components;
• immune system disorders;
• chronic pathological states of the skin;
• disorders of coagulation factors or in the case of anticoagulant therapies in progress.
It is appropriate for the patient to avoid, near the treatment, the intake of substances (aspirin, F.A.N.S., vitamin E) acting on the fluidity of the blood, in order to minimize the possibility of illiviation or bleeding of the injected areas.
The use of Aliaxin SR Shape & Restore is absolutely excluded where there are breast implants, blinds, bone, muscle.
Subsequent to the treatment, and until the complete absorption of swelling and redness, the implanted areas should not be exposed to excessive heat (sole, UV, laser tanned seats), nor to intense cold.
After use dispose of needles and syringes according to the procedures indicated for hospital waste.
As can happen in case of percutane injection, phenomena of:
• inflammatory reactions (redding, edema, etc.), sometimes associated with itching and touch pain;
• hematomas;
• hardening or nodules at the injection point;
• colouring of the skin at the injection point.
Such phenomena generally resolve in a few days. If they persist over the week, the patient must promptly contact his doctor.
Aliaxin SR Shape & Restore should be used intracutaneously and should not be injected into blood vessels.
No known phenomena of overdose or interaction with drugs.
Do not use in pregnancy.
Aliaxin SR Shape & Restore is available in sterile disposable packaging. Reuse of content for later applications or different patients is prohibited.
The product when opened must be used immediately. The unused excess should be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectables, or use other plants jointly with Aliaxin SR Shape & Restore.
Proceed to the plant in aseptic environment by observing the appropriate techniques.
Fill out the adhesive label present in the package and apply it to the patient card stored at the doctor’s office.
Keep out of reach of children.
Conservation
Store between 2 °C and 28 °C. Don't freeze. Do not expose to heat sources.
Validity of whole packaging: 36 months.
Format
Pack of 2 ml containing:
- leaflet;
- 2 sealed blisters containing each 1 sterile syringe of 1 ml pre-filled monodose/monouse;
- adhesive heels to be applied on the patient card for traceability of the product;
- 4 sterile needles (30G x 13 mm - 27G x 19 mm).
Reabsorbable medical device (sterile gel, apirogen and physiological) to be used as a filler for the correction of the mid and deep skin patches of the face and for the increase in volume and contour of the lips.
The main component is cross-linked hyaluronic acid of non-animal origin, produced by bacterial fermentation.
Aliaxin SR Shape & Restore 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:
• nose-labial folds;
• peribuccal wrinkles;
• acne and facial scars;
• glabellar wrinkles;
• front wrinkles;
• areas of the face requiring a enrichment of the facial tissue (guance, chin, cheekbones, lips) with temporary volumetric increase by increasing soft tissues.
The results of the intervention depend on the type of skin to the nature of imperfections, with results as much better as the nature of the defect is less evident.
The product is intended for exclusive use by medical staff. Do not use for applications other than those indicated in the leaflet.
Mode of use
Preliminary to any form of intervention with Aliaxin SR Shape & Restore, the doctor must conduct an adequate anamnesi and an overall assessment of the patient’s condition, to ensure the absolute absence of contraindications to the implant. The areas to be treated should be identified and evaluated taking into account criteria for lines and symmetries to be followed.
It can be practiced local anesthesia for labial treatments, in order to ensure the necessary comfort to the patient.
The doctor must in advance inform the patient about the procedures of the intervention, its nature, warnings, precautions and possible individual outcomes, the potential adverse responses, the time-consuming duration of the implant and the possibility of additional intervention for the maintenance and/or the definition in detail of the result achieved.
The area of the intervention must be maintained with antiseptic solutions before proceeding to the plant.
Extract the syringe from the blister, unscrew the cap and mount the full needle of protection. Remove the latter only before surgery. Weld the glass syringe and the luer-lock between the thumb and the index. Grab the protective cap and unscrew it. Remove the needle cap and firmly insert the needle thread on the end of the syringe. Gently screw the needle clockwise. Continue screwing until the thread enters into contact with the syringe body. Make sure the needle is correctly inserted into the thread. Failure to comply with these precautions could cause the risk of detachment of the needle and/or escape from the luer-lock. With the syringe in one hand and the hood in the other, remove the protection of the needle pulling decisively.
Aliaxin SR Shape & Restore is administered with a sterile needle (30G x 13 mm - 27G x 19 mm) in accordance with the Luer-Lock standard with standard fittings, including in the package.
The system should be carried out in accordance with the average/profund dermis; the procedure is however at the discretion of the doctor and depends on the correction you want to carry out and the methodical system adopted.
At the end of the procedure it is appropriate to perform a gentle massage of the treated area to allow an optimal distribution of the plant.
The volumetric gradation shown on the syringes has an indicative value: is at the discretion of the doctor the dosage to be used for the individual case.
The periodicity with which to repeat the intervention depends on different factors, regarding both the physiology of the patient (type of skin, individual metabolism, anatomy, age) and lifestyle; another element to be considered is related to the plant techniques adopted.
For the maintenance of the results obtained it is appropriate to repeat the intervention periodically, every 6-12 months.
Components
Cross-linked hyaluronic acid 25 mg/g.
Phosphate drum, water for injectable solutions 1 g.
Warnings
During the intervention, the usual precautions should be adopted in the case of percutaneous procedures. The risks are the common ones of infection related to the type of treatment. Aliaxin SR Shape & Restore should not be used on patients with:
• infectious or inflammatory processes close to the intervention area;
• hypersensitivity known to cheloids;
• allergy to components;
• immune system disorders;
• chronic pathological states of the skin;
• disorders of coagulation factors or in the case of anticoagulant therapies in progress.
It is appropriate for the patient to avoid, near the treatment, the intake of substances (aspirin, F.A.N.S., vitamin E) acting on the fluidity of the blood, in order to minimize the possibility of illiviation or bleeding of the injected areas.
The use of Aliaxin SR Shape & Restore is absolutely excluded where there are breast implants, blinds, bone, muscle.
Subsequent to the treatment, and until the complete absorption of swelling and redness, the implanted areas should not be exposed to excessive heat (sole, UV, laser tanned seats), nor to intense cold.
After use dispose of needles and syringes according to the procedures indicated for hospital waste.
As can happen in case of percutane injection, phenomena of:
• inflammatory reactions (redding, edema, etc.), sometimes associated with itching and touch pain;
• hematomas;
• hardening or nodules at the injection point;
• colouring of the skin at the injection point.
Such phenomena generally resolve in a few days. If they persist over the week, the patient must promptly contact his doctor.
Aliaxin SR Shape & Restore should be used intracutaneously and should not be injected into blood vessels.
No known phenomena of overdose or interaction with drugs.
Do not use in pregnancy.
Aliaxin SR Shape & Restore is available in sterile disposable packaging. Reuse of content for later applications or different patients is prohibited.
The product when opened must be used immediately. The unused excess should be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectables, or use other plants jointly with Aliaxin SR Shape & Restore.
Proceed to the plant in aseptic environment by observing the appropriate techniques.
Fill out the adhesive label present in the package and apply it to the patient card stored at the doctor’s office.
Keep out of reach of children.
Conservation
Store between 2 °C and 28 °C. Don't freeze. Do not expose to heat sources.
Validity of whole packaging: 36 months.
Format
Pack of 2 ml containing:
- leaflet;
- 2 sealed blisters containing each 1 sterile syringe of 1 ml pre-filled monodose/monouse;
- adhesive heels to be applied on the patient card for traceability of the product;
- 4 sterile needles (30G x 13 mm - 27G x 19 mm).
