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Alluzience 2 x 125 Units Twin Pack

Alluzience 2 x 125 Units Twin Pack

Alluzience

Medicinal product
  • 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 injectables.
  • Subject to pharmacovigilance requirements including reporting of adverse events to the MHRA Yellow Card scheme and to Galderma.
Botulinum toxin type A neuromodulator (ready-to-use liquid)

Description

Alluzience 2 x 125 Units Twin Pack is a prescription-only, ready-to-use liquid formulation of botulinum toxin type A (abobotulinumtoxinA) developed by Galderma. Each twin pack contains two vials, each with 125 Speywood units in 0.625 ml of clear, colourless solution (200 Speywood units/ml). Alluzience is 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. Its pre-mixed liquid format eliminates the need for reconstitution, helping to minimise dilution errors, streamline clinic workflow and support precise, consistent dosing, with results that can last up to around six months when administered by appropriately qualified healthcare professionals.

Bnefits

  • Ready-to-use liquid formulation of botulinum toxin type A; no reconstitution required.
  • Each vial contains 125 Speywood units in 0.625 ml (200 Speywood units/ml) for consistent dosing.
  • Indicated for temporary improvement of moderate to severe glabellar lines in adults under 65 years.
  • Longer-lasting effect compared with many traditional toxins, with improvement often maintained for up to about six months.
  • Stable during its shelf life (less than 12 months from manufacture) when stored as indicated on the label.
  • Pre-mixed format reduces preparation time, minimises handling errors and simplifies clinic workflow.
  • Predictable diffusion profile designed for controlled aesthetic outcomes in the glabellar area.
  • Twin pack configuration (2 x 125 units) offers practical stock management for clinics performing multiple treatments.

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 or 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 of botulinum toxin type A in 0.625 ml solution.
  • Excipients include: L-histidine, sucrose, sodium chloride, polysorbate 80, hydrochloric acid (for pH adjustment), and water for injections.
  • Units are expressed as 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 liquid formulation.
  • Intended for intramuscular injection in the glabellar region by trained healthcare professionals.
  • Shelf life less than 12 months from date of manufacture, remaining stable when stored under label conditions.

Packaging

  • Twin pack containing 2 single-use glass vials.
  • Each vial contains 0.625 ml solution with 125 Speywood units of botulinum toxin type A.
  • Vials closed with rubber stoppers and sealed with aluminium caps.
  • Outer carton includes product labelling and package leaflet (instructions for use and safety information).

Usage

  • Prescription-only medicine; administration is restricted to physicians or appropriately qualified healthcare professionals experienced in the use of botulinum toxin.
  • Use each vial for a single patient and a single treatment session; discard any unused solution after treatment.
  • Before use, visually inspect the solution; 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 at recommended injection points and depth, using strict aseptic technique.
  • Observe recommended maximum total dose per treatment session and minimum interval between treatments (generally not less than 3 months).
  • Inform patients about expected onset (within a few days), time to maximum effect (around 2 weeks), typical duration of benefit and possible adverse effects.
  • Instruct patients to seek medical advice immediately if they experience symptoms suggestive of toxin spread or serious adverse reactions.
  • Adverse events in the UK should be reported via the MHRA Yellow Card scheme; adverse events should also be reported to Galderma Medical Information where required.

Contraindications

  • Hypersensitivity to botulinum toxin type A or to any of the excipients in the formulation.
  • 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 during pregnancy and breastfeeding is not recommended due to limited safety data.
  • Use in patients under 18 years of age or over 65 years for the glabellar line indication is not recommended because of insufficient data.
  • Caution is required in patients with bleeding disorders or those taking anticoagulant therapy due to risk of injection-site bleeding.

Adverse Effects

  • Very common or common: headache, injection-site pain, erythema, swelling or bruising.
  • Eyelid ptosis (drooping of the upper eyelid) and brow ptosis.
  • Localised muscle weakness, facial asymmetry or sensation of tightness in the treated area.
  • Dry eye, eyelid oedema or visual disturbances.
  • Localised skin reactions such as pruritus or rash.
  • As with all botulinum toxin products, there is a risk (usually very rare) of toxin spread from the injection site, potentially causing generalized muscle weakness, dysphagia, dysphonia or respiratory difficulties; such symptoms require immediate medical attention.

Storage Conditions

  • Store in a refrigerator at 2°C to 8°C.
  • Do not freeze.
  • Keep vials in the outer carton to protect from light.
  • Follow any specific guidance in the local product information regarding permitted time at room temperature and subsequent use/disposal.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the vial and outer carton.

Duration

Most patients experience improvement within 2 weeks of injection, with clinical effects commonly lasting up to about 4\u20136 months; repeat treatment should generally not be given more frequently than every 3 months and should be based on individual clinical need.

Onset

Initial effect is usually observed within 2\u20133 days after injection, with maximum effect typically seen within approximately 2 weeks.

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