Alluzience 200 Speywood Units/ml Solution for Injection, Vial
Alluzience
Medicinal productBotulinum toxin type A neuromodulator (ready-to-use liquid)
Certifications
- 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) for sterile biological medicines.
- Subject to pharmacovigilance monitoring, including reporting of suspected adverse reactions via the MHRA Yellow Card scheme.
- 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) for sterile biological medicines.
- Subject to pharmacovigilance monitoring, including reporting of suspected adverse reactions via the MHRA Yellow Card scheme.
Botulinum toxin type A neuromodulator (ready-to-use liquid)
Description
Alluzience 200 Speywood Units/ml Solution for Injection is a prescription-only, ready-to-use liquid formulation of botulinum toxin type A (abobotulinumtoxinA). Each glass vial contains 0.625 ml of clear, colourless solution at a concentration of 200 Speywood units/ml (125 Speywood units per vial). It is indicated for the 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. The innovative liquid formulation removes the need for reconstitution, supporting accurate dosing, reduced preparation time and consistent clinical outcomes, with effects that typically last up to around six months when administered by suitably qualified healthcare professionals.
Bnefits
- Ready-to-use liquid botulinum toxin type A; no reconstitution required.
- Fixed concentration of 200 Speywood units/ml (125 Speywood units per 0.625 ml vial) for predictable dosing.
- Indicated for temporary improvement of moderate to severe glabellar lines in appropriately selected adults.
- Long-lasting clinical effect, with many patients maintaining improvement for up to about six months.
- Pre-mixed liquid formulation reduces risk of dilution or reconstitution errors and streamlines clinic workflow.
- Designed with predictable diffusion characteristics to support controlled and natural-looking aesthetic results.
- Manufactured to high pharmaceutical standards with demonstrated efficacy and safety in clinical studies.
Indications
- Temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown 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 by physicians or suitably qualified healthcare professionals experienced 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.
- Speywood units are 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 with a shelf life of less than 12 months from date of manufacture, remaining stable when stored as indicated on the label.
Packaging
- Single-use glass vial containing 0.625 ml solution with 125 Speywood units of botulinum toxin type A (200 Speywood units/ml).
- Rubber stopper and aluminium seal.
- Outer carton containing the vial and package leaflet with full prescribing and safety information.
Usage
- Prescription-only medicine; administration must be performed by physicians or appropriately qualified healthcare professionals experienced in botulinum toxin use.
- Use each vial for a single patient and a single treatment session; discard any unused solution after use.
- Visually inspect the solution before administration; it should be clear, colourless and free of particulate matter.
- Withdraw the required volume using a sterile syringe and suitable needle in accordance with the Summary of Product Characteristics (SmPC) dosing recommendations.
- Inject intramuscularly into the glabellar complex muscles, following recommended injection points, depth and technique, using strict aseptic precautions.
- Respect the maximum recommended total dose per treatment session and do not repeat treatment more frequently than every 3 months.
- Inform patients about expected onset (within a few days), maximum effect (around 2 weeks), duration of effect (up to 4–6 months) and possible adverse reactions.
- Instruct patients to seek urgent medical advice if they experience symptoms suggestive of toxin spread (e.g. swallowing or breathing difficulties) or other serious adverse events.
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).
- Use in pregnant or breastfeeding women is not recommended due to limited data.
- Use in patients under 18 years of age or over 65 years for this indication is not recommended owing to insufficient data.
- Caution and clinical judgement required in patients with bleeding disorders or receiving anticoagulant therapy.
Adverse Effects
- Very common/common: headache, injection-site pain, erythema, swelling or bruising.
- Eyelid ptosis and brow ptosis.
- Localised muscle weakness or facial asymmetry in the treated area.
- Injection-site discomfort, tightness, pruritus or rash.
- Dry eye, eyelid oedema or visual disturbances.
- Rare but serious: potential spread of toxin effect leading to dysphagia, dysphonia, respiratory difficulty or generalised muscle weakness; such symptoms require immediate medical attention.
Storage Conditions
- Store in a refrigerator at 2°C to 8°C.
- Do not freeze.
- Keep vial in the outer carton to protect from light.
- Follow local product information for any permitted in-use time at room temperature and associated handling instructions.
- Keep out of the sight and reach of children.
- Do not use after the expiry date shown on the vial and outer packaging.
Duration
Most patients show improvement within 2 weeks of injection, with effects commonly lasting up to 4\u20136 months; repeat treatments should generally not be administered more often than every 3 months, based on individual clinical need and response.
Onset
Initial effect typically observed within 2\u20133 days after injection, with maximum effect usually reached within about 2 weeks.
