Alluzience Single Vial 125 Speywood Units

Alluzience

Medicinal product

Botulinum toxin type A neuromodulator (ready-to-use liquid)

Prescription Only medicinal product authorised in the UK and EU for the aesthetic treatment of glabellar lines.
Manufactured in accordance with Good Manufacturing Practice (GMP) and relevant medicinal product regulations for injectable biological products.

Prescription Only medicinal product authorised in the UK and EU for the aesthetic treatment of glabellar lines.
Manufactured in accordance with Good Manufacturing Practice (GMP) and relevant medicinal product regulations for injectable biological products.

Botulinum toxin type A neuromodulator (ready-to-use liquid)

Description

Alluzience Single Vial 125iu is a prescription-only, ready-to-use liquid formulation of botulinum toxin type A (abobotulinumtoxinA) indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown lines between the eyebrows) at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact. Each vial contains 125 Speywood units of Clostridium botulinum type A toxin-haemagglutinin complex in 0.625 ml of clear, colourless solution (200 Speywood units/ml). As a pre-mixed neuromodulator, Alluzience removes the need for reconstitution, supporting precise, consistent dosing and streamlined clinic workflows, with effects that typically last up to around six months.

Bnefits

First ready-to-use liquid botulinum toxin type A neuromodulator in Europe, eliminating the need for reconstitution.
Each vial contains a fixed concentration (200 Speywood units/ml; 125 units per 0.625 ml vial) for consistent dosing.
Indicated for temporary improvement of moderate to severe glabellar lines in adults under 65 years.
Long-lasting clinical effect, with many patients maintaining improvement for up to about six months.
Predictable diffusion profile designed for controlled aesthetic outcomes in the glabellar region.
Liquid format reduces risk of dilution errors, saves preparation time and minimises product handling.
Single-vial 125-unit presentation is convenient for individual treatment sessions and helps reduce wastage.
Manufactured to high pharmaceutical standards, with demonstrated efficacy and safety in controlled clinical trials.

Indications

Temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.
Use only in appropriately selected adults and only by physicians with suitable qualifications and experience in the use of botulinum toxin.

Composition

Active substance: Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA) 200 Speywood units/ml.
Each vial contains 125 Speywood units in 0.625 ml of solution.
Excipients: L-histidine, sucrose, sodium chloride, polysorbate 80, hydrochloric acid (for pH adjustment), water for injections.
Units of botulinum toxin are Speywood units specific to this preparation and are not interchangeable with units of other botulinum toxin products.

Formulation

Ready-to-use, clear, colourless solution for injection.
Concentration: 200 Speywood units/ml (125 Speywood units in 0.625 ml per vial).
Sterile, preservative-free solution for intramuscular injection in the glabellar region.
Liquid formulation designed to remain stable throughout a shelf life of less than 12 months from date of manufacture when stored as labelled.

Packaging

Single-use glass vial containing 0.625 ml solution with 125 Speywood units of botulinum toxin type A.
Vial stoppered with a rubber closure and sealed with an aluminium cap.
Outer carton includes 1 vial (single-vial presentation) with package leaflet; other commercial pack sizes (e.g. twin packs, multipacks) may also be available.

Usage

Prescription-only medicine; administration is restricted to physicians or appropriately qualified healthcare professionals experienced in the use of botulinum toxin.
Use a vial for a single patient and a single treatment session; discard any unused solution after use.
Inspect the solution visually before use; it should be clear, colourless and free from particulate matter.
Draw up the required volume using a sterile syringe and appropriate needle, following the dosing guidance in the official Summary of Product Characteristics (SmPC).
Administer by intramuscular injection into the glabellar complex muscles using standard aseptic technique and appropriate injection points and depth.
Treatment intervals should be determined by the physician based on individual patient response; repeat treatment should not be more frequent than every 3 months.
Do not exceed the maximum total dose per treatment session as specified in the SmPC and prescribing information.
Patients should be informed about expected onset and duration of effect, possible adverse reactions and when to seek medical advice.

Contraindications

Hypersensitivity to botulinum toxin type A or to any of the excipients.
Presence of infection or inflammation at the proposed injection sites.
Generalised disorders of muscle activity such as myasthenia gravis, Lambert–Eaton myasthenic syndrome or amyotrophic lateral sclerosis (ALS).
Pregnancy and breastfeeding (use is not recommended; refer to SmPC for details).
Use in patients with known bleeding disorders should be carefully evaluated due to injection-related bleeding risk.
Use in patients under 18 years of age or over 65 years for this indication is not recommended due to insufficient data.

Adverse Effects

Very common and common reactions include headache and injection-site reactions (pain, erythema, swelling).
Eyelid ptosis (drooping of the upper eyelid) and brow ptosis.
Injection-site bruising, discomfort or haematoma.
Facial asymmetry, muscle weakness in the injected area, or sensation of tightness.
Dry eye, eyelid oedema or visual disturbances have been reported.
Localised skin reactions such as pruritus or rash.
As with all botulinum toxin products, there is a theoretical risk of toxin spread from the injection site, potentially leading to systemic symptoms such as generalized muscle weakness, dysphagia or breathing difficulties; such events are very rare and require urgent medical attention.

Storage Conditions

Store in a refrigerator at 2°C to 8°C.
Do not freeze.
Keep the vial in the outer carton to protect from light.
Once removed from the refrigerator, unopened vials may generally be kept at temperatures up to 25°C for a limited period (e.g. up to 12 hours) as specified in the local product literature, after which they should not be returned to the refrigerator and must be discarded if not used.
Keep out of the sight and reach of children.
Do not use after the expiry date shown on the vial and carton.

Duration

In clinical studies, most patients show improvement within days, with the maximum effect typically observed within about 2 weeks and a duration of response commonly lasting up to 4\u20136 months. Retreatments should generally not be given more frequently than every 3 months.