ALIAXIN LV LIPS VOLUME (2x1ml) IBSA

ALIAXIN LV LIPS VOLUME (2x1ml) IBSA

MEDICAL DEVICE. Use of the product is exclusively reserved for a qualified doctor. The use of the product is exclusively reserved for medical personnel. Do not use for purposes other than those described in this leaflet.

DESCRIPTION

ALIAXIN LV LIPS VOLUME IBSA is an absorbable filler medical device (sterile nonpyrogenic and physiological gel) to be used for the correction of medium and deep sagging skin on the face and to increase the volume and contour of the lips. The main component is cross-linked hyaluronic acid of non-animal origin, produced by biofermentation.

INDICATION

ALIAXIN LV LIPS VOLUME IBSA 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:

• Nasolabial folds.
• Circumoral wrinkles.
• Facial and acne scars.
• Glabellar wrinkles.
• Forehead wrinkles.
• Areas of the face that require an enrichment of the facial tissue (cheeks, chin, cheekbones, lips) with temporary increase in volume by increasing the soft tissues.
The results of the intervention depend on the type of skin and the nature of imperfections; the slighter the imperfection, the better the result.

CHARACTERISTICS

• Molecular weight of hyaluronic acid: 1000 kDa, 2000 kDa.
• Concentration of cross-linked HA: 25 mg/ml.
• Natural HA concentration: 2.5 mg/ml.
• Rheological values: Flow 0.53, Lift 39 (Pa), Sculpt 0.28.
• HYDROACTION 2/4.
• LIFTACTION 4/5.

PRESENTATION

ALIAXIN LV LIPS VOLUME IBSA is available in 2 ml packaging. Each package contains:

• • Notice.
• • 2 sealed blister packs each containing 1 single dose/disposable sterile pre-filled syringe of 1 ml.
• • Adhesive label to stick on the patient file for product traceability.
• • 4 sterile needles (27G X 13mm TSK 0123 - 27G X 19mm TSK 0123).

INJECTION DEPTH

ALIAXIN LV LIPS VOLUME IBSA is injected into the skin tissue for extracellular matrix supplementation and intracutaneous volumetric increase, i.e. for the treatment of skin depressions due to wrinkles and scars.

IBSA DERMA

Founded by a group of Swiss biologists in 1945, IBSA – Institut Biochimie SA – has acquired unique experience in pharmaceutical research and technology. By focusing on the development of innovations that optimize existing molecules and therapeutic solutions, the company has experienced rapid growth and has also expanded internationally; today, its products are available in more than 80 countries on 5 continents. IBSA uses its experience and expertise in the pharmaceutical field to expand its business and develop medical devices for dermatology, based on hyaluronic acid, thus creating a brand dedicated to dermoesthetics: IBSA Derma. Thanks to its scientific expertise, continuous research, technological development and a modern production process, IBSA Derma has become the 'one of the leading pharmaceutical companies in the production of hyaluronic acid for dermo-aesthetic applications.

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. Every area of the face requires a personalized treatment. IBSA has created four 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.

• 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

The formulations of the ALIAXIN range with specific and different viscoelastic properties come from IBSA research. IBSA technology is able to guarantee different clinical results by using a combination of hyaluronic acid of different molecular weights while acting on the degree of cross-linking.

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.