Aliaxin EV 1x1ml

Injectable filler: for medical professionals only. Aliaxin EV is injected into the subcutaneous tissue (superficial layer; the final technique and dose are chosen by the practitioner). Do not inject into blood vessels. This pack variant contains 1 pre-filled 1 ml syringe and 27G × 13 mm and 27G × 19 mm needles.

What is Aliaxin EV 1 ml?

Aliaxin EV Essential Volume is a resorbable medical device in the form of a sterile, apyrogenic physiological gel. It is intended for the correction of deep facial cutaneous sagging and for volume increase. It belongs to the Aliaxin filler line by IBSA Farmaceutici Italia and is indicated where the treatment goal is volume restoration and contour improvement, rather than superficial filling of fine lines.

Composition

• Cross-linked hyaluronic acid: 25 mg/ml (also stated as 25 mg/g of gel in the instructions for use), the component responsible for the volumising effect.
• Phosphate-buffered saline and water for injections: gel vehicle, to 1 g.

The product does not contain lidocaine. If required, a local anaesthetic may be used separately at the physician’s discretion. The hyaluronic acid is of non-animal origin, produced by biofermentation.

Mechanism of action

The gel is injected into the subcutaneous tissue to supplement the extracellular matrix and increase tissue volume. It is used to treat cutaneous depressions caused by wrinkles, scarring and volume loss. The effect is temporary: the product is resorbable. After injection, a gentle massage of the treated area is recommended to distribute the product evenly.

Indications and treatment areas

Aliaxin EV is indicated for the treatment of imperfections in the following facial areas:

• nasolabial folds,
• post-traumatic and acne scars,
• areas requiring tissue enrichment and a temporary volume increase: cheeks, zygomatic area, chin,
• jawline contouring,
• temples (deep administration).

The outcome depends on skin type, anatomy and the nature of the imperfection.

Administration protocol

• Injection plane: subcutaneous tissue (superficial layer), with the final technique chosen by the physician.
• Rheological parameters: G′ 162, tan δ 0.15.
• Needles included: 27G × 13 mm and 27G × 19 mm (Luer-Lock), supplied in the pack.
• Dosage: the graduation on the syringe is indicative; the volume for each area is left to the practitioner.
• The treatment area must be cleansed with an antiseptic solution before implantation. After the procedure, a gentle massage of the treated area is advised.
• Do not mix with other injectable substances and do not perform other implants together with this product.

Duration of effect

Treatment intervals depend on factors such as skin type, metabolism, anatomy, age, lifestyle and the implantation technique used. To maintain the results obtained, it is advisable to repeat the treatment periodically, every 8-12 months.

Contraindications and precautions

Do not use in patients with infective or inflammatory processes near the treatment area, ongoing cutaneous allergies, known hypersensitivity to keloids, allergy to the components, immune-system disorders, serious pathological skin conditions, or coagulation disorders / ongoing anticoagulant therapy. Do not use in pregnancy. Do not inject into blood vessels, or in areas with mammary implants, or into tendons, bone or muscle.

Packaging and product data

• Pack (this shop variant): 1 sterile pre-filled 1 ml single-use syringe + 1 needle 27G × 13 mm + 1 needle 27G × 19 mm.
• EAN: 8033638950906.
• Storage: 2-28°C; do not freeze; protect from heat and light.
• Manufacturer: IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900 Lodi, Italy.

Frequently asked questions

How does Aliaxin EV differ from the other products in the Aliaxin line?

The entire Aliaxin line has the same hyaluronic acid concentration, 25 mg/ml, and the differences come from rheological properties and clinical indication. EV (Essential Volume) is intended for volume restoration and contouring (including cheeks, zygomatic area, jawline and chin). FL (Fine Lines) is for fine lines and lips; GP (Global Performance) for more versatile correction, including deeper folds; LV (Lips Volume) for lip volume; SR (Shape & Restore) for shaping and restoring the facial oval; SV (Superior Volume) for greater volumetry. Product selection is a matter for the practitioner.

What is the difference between the 1×1 ml and 2×1 ml packs?

This product is a single 1 ml pre-filled syringe with two needles (27G × 13 mm and 27G × 19 mm). The 2×1 ml variant contains two syringes and four needles (two of each size). The gel composition is the same. The manufacturer’s standard pack is typically the 2×1 ml set.

At what depth is Aliaxin EV injected?

The product is intended for injection into the subcutaneous tissue, in the superficial layer. The final technique and depth remain at the physician’s discretion and depend on the planned correction and the implantation method.

How long does the effect last?

The duration of the result is individual. To maintain the effect obtained, it is advisable to repeat the treatment periodically, every 8-12 months.

Does Aliaxin EV contain lidocaine?

No. The composition is cross-linked hyaluronic acid 25 mg/ml with phosphate-buffered saline and water for injections. A local anaesthetic may be used separately if the physician considers it appropriate.

Who may use this product?

Medical professionals only, in accordance with the current instructions for use and applicable regulations. By purchasing the product, you confirm that you are authorised to perform procedures that breach skin continuity.

Information for specialists

For use by medical professionals only. Before treatment, take an adequate history, assess the patient for contraindications, inform the patient about the nature of the procedure, possible adverse reactions and the expected duration of the result, and follow the current instructions for use.

Do not inject intravascularly. Do not mix with other injectable products. The pack is single-use and sterile: use immediately once opened, discard any remainder; do not use if the packaging is damaged. Glass syringe with Luer-Lock connection. Needles included: 27G × 13 mm and 27G × 19 mm.

Storage: 2-28°C, do not freeze, protect from heat and light. Until swelling and redness have resolved, treated areas should not be exposed to make-up, excessive heat (sun, UV, laser) or intense cold. Close to treatment the patient should avoid substances that affect blood fluidity (including acetylsalicylic acid, NSAIDs, vitamin E) to reduce the risk of bruising and bleeding.

Table of contents

• What is Aliaxin EV 1 ml?
• Composition and mechanism of action
• Indications, protocol and product data
• Frequently asked questions
• Information for specialists