INFORMATION

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Indications and Usage of ALIAXIN® SV

ALIAXIN® SV (Superior Volume) is primarily indicated for volume restoration, filling cutaneous depressions, and wrinkles. It is particularly effective in facial reconstruction for patients with light-to-moderate lipodystrophies, such as those resulting from HIV treatment. This product is also suitable for enhancing cheeks, cheekbones, and facial contours, as well as filling very deep wrinkles.

• Volume restoration and filling of cutaneous depressions and wrinkles.
• Facial reconstruction for light-to-moderate lipodystrophies.
• Augmentation of cheeks, cheekbones, and facial contours.
• Effective for filling very deep wrinkles.

Composition of ALIAXIN® SV

ALIAXIN® SV is carefully formulated to ensure maximum effectiveness and safety. Its primary component is hyaluronic acid, known for its hydrating and volumizing properties.

• Hyaluronic acid: 25 mg/mL (cross-linked sodium hyaluronate).
• Physiological pH phosphate buffer: QS (quantum satis, sufficient quantity).

Description of ALIAXIN® SV

ALIAXIN® SV is a high-quality product that is both sterile and apyrogenic, ensuring patient safety and efficacy. It is derived from non-animal sources, making it suitable for a wide range of patients, including those with specific dietary restrictions or allergies.

• Sterile and apyrogenic.
• Derived from non-animal origin.
• Viscoelastic hyaluronic acid gel designed for subcutaneous injection.

Sterilization of ALIAXIN® SV

To ensure the utmost safety and efficacy, ALIAXIN® SV undergoes stringent sterilization processes.

• Syringes: Sterilized using moist heat.
• Needles: Sterilized using radiation.

Intended Use of ALIAXIN® SV

ALIAXIN® SV is intended to be injected into the subcutaneous layer to restore volume in the required proportions. This ensures a natural and youthful appearance, effectively addressing various facial imperfections.

• Injected into the subcutaneous layer.
• Used for volume restoration in facial areas.

Contraindications of ALIAXIN® SV

There are specific conditions and areas where ALIAXIN® SV should not be used to avoid adverse effects.

• Not for injections other than subcutaneous.
• Do not inject intravascularly.
• Avoid use in the periorbital and glabellar areas.

Do not use ALIAXIN® SV in the following cases:

• Known hypersensitivity to any components.
• History of severe allergies or anaphylactic shock.
• Combination with skin peeling treatment, laser treatment, ultrasound-based treatment, or techniques based on an active dermal response.
• Inflammatory and/or infectious cutaneous problems near the treatment area (e.g., acne, herpes) or tumors.

Do not inject in patients:

• With autoimmune diseases.
• With epilepsy not controlled by treatment.
• Who tend to develop hypertrophic scars.
• Suffering from porphyria.
• Who are pregnant or breastfeeding.
• Under 18 years of age.

Precautions for Use of ALIAXIN® SV

Before starting treatment, it is essential to thoroughly assess the patient’s medical history and inform them about the expected outcomes and potential side effects.

• Assess medical history thoroughly.
• Inform patients about predictable results and potential adverse effects.
• Avoid injecting in patients who have taken large doses of vitamin E, vitamin C, aspirin, anti-inflammatories, or anticoagulants.

Post-Treatment Care for ALIAXIN® SV

Proper care after treatment is crucial to ensure optimal results and minimize side effects. Patients should follow specific guidelines to enhance recovery and maintain the treatment’s effectiveness.

• Do not apply make-up within 12 hours post-injection.
• Avoid exposure to extreme temperatures (intense cold, sauna, hammam) or sunlight for two weeks post-treatment.
• Avoid sunbed sessions for one week post-treatment.
• Do not apply pressure to the treated area.

Dosage of ALIAXIN® SV

ALIAXIN® SV should only be injected by practitioners trained in the techniques of injecting filling products. The dosage must be carefully controlled to achieve the desired effects without over-correction.

• Injected by trained practitioners only.
• Dosage depends on the desired effect, without over-correction.
• Several injections may be required for a satisfactory result.
• Follow-up sessions may be needed to maintain the desired effect.

Mode of Administration of ALIAXIN® SV

Before injecting ALIAXIN® SV, the treatment area should be properly disinfected. The product should be administered using the provided sterile needles.

Before injection:

• Disinfect the treatment area.
• Remove air by gently pushing down on the plunger until a small amount of product appears at the needle’s tip.

Injection:

• Use the 27G needles provided in the box.
• Inject ALIAXIN® SV evenly into the subcutaneous layer.
• Avoid injecting too superficially or using excessive volume to prevent bumps.

After injection:

• Massage the treated area gently to ensure even distribution of the product.
• If there is a sensation of obstruction or pressure during the injection, stop and change the needle.

Side Effects of ALIAXIN® SV

Patients must be informed of potential side effects, which can range from mild to severe. Most side effects are transient, but some may require medical attention if they persist.

Common side effects include:

• Oedema.
• Haematoma.
• Erythema.
• Itchiness.
• Swelling.
• Pain or tenderness at the implant site.
• Induration or nodules at the injection point, potentially leading to granuloma.
• Cutaneous necrosis.
• Immediate hypersensitivity, possibly leading to anaphylactic shock.
• Dyschromia at the injection site.

Storage Condition of ALIAXIN® SV

Proper storage of ALIAXIN® SV is essential to maintain its efficacy and safety. The expiration date is indicated on the packaging, and the product should be stored under specific conditions.

• Store between 2°C and 25°C.
• Keep away from light.
• Do not freeze.