ALIAXIN SR SHAPE & RESTORE (2x1ml) IBSA

ALIAXIN SR SHAPE & RESTORE (2x1ml) IBSA

ALIAXIN SR SHAPE & RESTORE IBSA IS A MEDICAL INJECTABLE DEVICE FOR Qualified members of the medical profession only. ALIAXIN SR SHAPE & RESTORE IBSA is a reabsorbable medical device (physiological, apyrogenous sterile gel) to be used as a filler for the correction of medium and deep facial cutaneous sagging and to increase the volume and contours of the lips. The principle component is cross-linked Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.

PRESENTATION

ALIAXIN SR SHAPE & RESTORE IBSA is available in 2 ml packaging. Each package contains:

• • Instructions for use. The product is intended for medical personnel only. Do not use for purposes other than those described in this leaflet.
• • 2 sealed blisters, each containing 1 sterile pre-filled single-dose/disposable syringe of 1 ml.
• • Adhesive label to be stuck on the patient's file for product traceability.
• • 4 sterile needles (30G X 13mm TSK 0123 - 27G X 19mm TSK 0123).

DESCRIPTION

• Indications: Forehead, temples (superficial), Malar area. For tear trough and broad areas, as well as facial contour definition with a long-lasting effect.
• Hyaluronic Acid molecular weights: 500 kDa, 1000 kDa, 2000 kDa.
• Cross-linked HA concentration: 25 mg/ml.
• Natural HA concentration: 2.5 mg/ml.
• Rheologicial values: Flow 0.53, Lift 39 (Pa), Sculpt 0.28.
• Hydro action 4/4.
• Lift action 3/5

INDICATION

ALIAXIN SR SHAPE & RESTORE is indicated for the restoration of the physiological volumes of the face and intended for the treatment of imperfections of the following areas of the face and for other areas as well as for the definition of the contour of the face:

• Naso-labial folds.
• Perioral walks.
• Facial and acne scars.
• Glabellar rides.
• Frontal walks.
• Areas of the face that have increased an enrichment of the facial tissue (cheeks, chin, cheekbones, lips) with temporary increase in volume by soft tissue growth.

INJECTION DEPTH

ALIAXIN SR SHAPE & RESTORE IBSA is administered using a sterile needle (30G X 13mm - 27G X 19mm) provided and equipped with a standard Luer-Lock system. The implantation must be performed at the level of the middle/deep dermis; however, the procedure is left to the discretion of the physician and depends on the correction desired and the implantation method adopted. The volume indicated on the syringe is indicative and the dose to be used for each individual case remains at the discretion of the doctor. To maintain the results obtained, it is advisable to repeat the procedure every 6 to 12 months.

ALIAXIN RANGE

The complete intradermal dermal filler range containing ultrapure Hyaluronic Acid with the ability seamlessly integrate into the skin. A non-invasive, innovative treatment for natural contouring, lifting and hydration. Every area of the face requires a personalised treatment. IBSA has created six different formulations using different molecular weights with specific visco-elastic properties, offering a complete product line for the simultaneous treatment of 12 different facial areas. The Aliaxin range takes full advantage of the HA characteristics, supporting not only LIFT (filling) action but also HYDRO action through rehydration and tissue stimulation. 

• ALIAXIN SR SHAPE & RESTORE For tear trough and broad areas, as well as facial contour definition with a long-lasting effect.
• ALIAXIN FL LIPS “Fine lines” – Specific treatments for fine lines with an ideal viscosity for restoring firmness and natural definition. Also used to define the vermillion border of the lips.
• ALIAXIN GP GLOBAL PERFORMANCE “Global performance” – Ideal for treating the most common facial imperfections, offering a corrective and prolonged action for wrinkles and more pronounced folds (nasolabial folds, nose, chin, lip augmentation and cheeks).
• ALIAXIN LV LIPS VOLUME
• ALIAXIN EV ESSENTIAL VOLUME  “Essential volume” – Ideal for subcutaneous implants, restoring facial volume and its symmetries with natural results, thanks to an optimal lifting capacity.
• ALIAXIN SV SUPERIOR VOLUME

DETAILS

ALIAXIN dermal filler. ALIAXIN  is a range of monophasic dermal fillers containing a combination of well-defined molecular weights of hyaluronic acid to achieve different biological and mechanical effects. The main characteristics of ALIAXIN are high tissue integration and stability, which gives natural but at the same time long-lasting results. It is manufactured by IBSA Farmaceutici Italia at an FDA-approved US site in Italy, and distributed in the UK and Ireland by HA-Derma Ltd.
GENERIC NAME
Non-animal hyaluronic acid (HA).
WHAT DOES IT CONTAIN?
IBSA's Hyaluronic Acid is an ultrapure grade hyaluronic acid, produced by a patented bio-fermentation process, from Streptococcus Zooepidemicus, which ranks worldwide as "Premium Grade" in terms of purity, safety and its high resistance to thermal production processes.
COMPOSITION
The ALIAXIN cross-linking process results in a ready-to-use gel without the need for fragmentation or additional handling, with low percentage cross-linking (<10%) and low BDDE residue (<0.1ppm). All this makes the final product safer and easier to inject thanks to the optimization of the viscoelastic characteristics.
IS A SKIN TEST NECESSARY BEFORE THE TREATMENT?
No allergy test necessary.
IS IT TEMPORARY OR PERMANENT?
Hyaluronic acid is completely broken down in the skin over a period of months, ultimately leaving no trace of the filler.
LICENSE STATUS
Medical device. CE marking.
USE
Qualified members of the medical profession only.