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Dysport 500 Units Dual Vials (abobotulinumtoxinA)

Dysport 500 Units Dual Vials (abobotulinumtoxinA)

Dysport

Prescription medicinal product
  • Licensed medicinal product in the UK and other jurisdictions for specified therapeutic indications, with marketing authorisations granted by regulators such as MHRA, EMA and others, depending on country.
  • Manufactured in facilities operating under Good Manufacturing Practice (GMP) for sterile biological medicinal products.
  • Supplied as a prescription Only medicine; use is restricted to licensed healthcare professionals following approved SmPC/Prescribing Information and local laws.
  • Subject to pharmacovigilance and risk management plans overseen by relevant regulatory authorities.
Botulinum toxin type A powder for solution for injection

Description

Dysport is a prescription-only botulinum toxin type A product (abobotulinumtoxinA; clostridium botulinum type A toxin-haemagglutinin complex) supplied as a powder for solution for injection. Each vial contains 500 Ipsen units of the toxin complex, which, after reconstitution by a healthcare professional, is used for approved therapeutic indications such as focal spasticity, cervical dystonia and severe primary axillary hyperhidrosis, and in some markets for aesthetic treatment of moderate to severe glabellar lines (frown lines). Dysport works by blocking the release of acetylcholine at the neuromuscular junction, temporarily relaxing targeted muscles. It must only be prescribed, prepared and injected by appropriately trained clinicians in authorised clinical settings.

Bnefits

  • Well-established botulinum toxin type A product used worldwide in neurology, rehabilitation medicine and aesthetic medicine.
  • Temporarily reduces muscle activity in targeted areas by inhibiting acetylcholine release at the neuromuscular junction.
  • Can improve symptoms of focal spasticity and cervical dystonia and reduce severe underarm sweating (axillary hyperhidrosis) where indicated.
  • In aesthetic indications (where approved), softens the appearance of dynamic facial lines such as glabellar frown lines while aiming to maintain natural facial expression.
  • Supplied as a lyophilised powder allowing precise reconstitution and individualised dosing by clinicians.
  • Multiple vial strengths (e.g. 125, 300, 500 units) allow flexible treatment planning by healthcare professionals.
  • Backed by regulatory approvals and many years of clinical experience when used according to official product information.

Indications

  • Therapeutic indications vary by country and may include: treatment of focal spasticity in adults (e.g. upper and/or lower limb spasticity) and in paediatric patients with cerebral palsy; cervical dystonia (spasmodic torticollis) in adults; blepharospasm and hemifacial spasm; and severe primary hyperhidrosis of the axillae not adequately managed by topical treatments.
  • In some regions and under specific brand/label variants (e.g. Dysport Aesthetic), temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown lines between the eyebrows) in adults under 65 years of age.
  • All indications, dosing and injection patterns must follow the locally approved Summary of Product Characteristics (SmPC) or Prescribing Information and are restricted to prescription-only use under specialist supervision.

Composition

  • Active substance: Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA) 500 units per vial (Ipsen units; not interchangeable with units of other botulinum toxins).
  • Human serum albumin (approximately 125 micrograms per vial) as a stabiliser.
  • Lactose (typically 2.5 mg lactose or lactose monohydrate per vial) as an excipient.

Formulation

  • Sterile, lyophilised (freeze-dried) powder for solution for injection.
  • Presented in type I glass vials with a bromobutyl rubber stopper and an aluminium seal.
  • Reconstituted with preservative-free sodium chloride 0.9% solution for injection by a healthcare professional immediately prior to use.
  • No antimicrobial preservative present in the vial; reconstituted solution is intended for single-patient use only.

Packaging

  • Typical aesthetic/therapeutic presentation: carton containing 2 x 500 unit vials (dual vials), each vial with 500 Ipsen units of clostridium botulinum type A toxin-haemagglutinin complex in lyophilised form.
  • Other pack sizes/strengths available in some markets (e.g. single vials of 125 or 300 units).
  • Outer carton and vial labelling include product name, strength (units), batch number, expiry date, storage conditions and prescription-only status.
  • Supplied to hospitals, clinics and authorised prescribers through regulated pharmaceutical supply chains.

Usage

  • Dysport is a prescription-only medicine and must only be prescribed, reconstituted and administered by physicians or appropriately trained healthcare professionals with expertise in the relevant indication, anatomy and injection techniques.
  • The product is reconstituted with sterile sodium chloride 0.9% solution for injection according to the official Summary of Product Characteristics (SmPC) or local Prescribing Information; dilution volumes, injection sites and dosing units depend on indication, muscle(s) treated, patient factors and clinical judgement.
  • Dysport is administered by intramuscular or intradermal injection into specific muscles or areas (e.g. targeted muscles for spasticity, cervical dystonia or glabellar lines; axillary skin for hyperhidrosis) strictly in accordance with the approved product information and clinical guidelines.
  • Patients must not attempt to obtain, store, reconstitute or inject Dysport themselves. It is not for self-administration under any circumstances.
  • Before treatment, patients should be medically assessed for suitability, including comorbidities, concomitant medications and risk factors for botulinum toxin-related adverse events.
  • Following injection, patients should be monitored for potential side effects or signs of toxin spread, with instructions on when and how to seek urgent medical attention.
  • All handling, administration, and disposal of unused product and sharps must comply with local regulations for cytotoxic or biologically active medicinal products.
  • For detailed dosing, reconstitution and injection guidance, clinicians must consult the latest officially approved SmPC/Prescribing Information for their country; this information is not intended to replace professional training.

Contraindications

  • Hypersensitivity to botulinum toxin type A or to any of the excipients (human albumin, lactose).
  • Presence of infection or inflammation at the proposed injection site(s).
  • Generalised disorders of muscle activity such as myasthenia gravis, Lambert–Eaton myasthenic syndrome or other significant neuromuscular junction disorders, where use may increase risk of excessive muscle weakness.
  • Pregnancy and breastfeeding are generally considered cautionary; use only if the potential benefit justifies any potential risk, in line with official product information and medical judgement.
  • Any additional contraindications listed in the locally approved SmPC/Prescribing Information for specific therapeutic or aesthetic indications.

Adverse Effects

  • Local reactions at injection site such as pain, tenderness, bruising, swelling, erythema or mild bleeding.
  • Muscle weakness in the injected muscle(s) and, in some cases, in adjacent muscles depending on diffusion and dosing.
  • For cervical dystonia and other therapeutic uses: dysphagia (difficulty swallowing), neck weakness, dry mouth, dysphonia, and respiratory symptoms in susceptible individuals.
  • For aesthetic facial indications: headache, temporary eyelid ptosis (drooping), brow asymmetry, facial muscle weakness and injection-site discomfort.
  • Flu-like symptoms or general malaise in some patients after injection.
  • Hypersensitivity reactions including rash, pruritus, urticaria or, rarely, anaphylactic reactions.
  • Very rare but serious systemic effects from toxin spread away from the injection site, such as profound muscle weakness, dysphagia, aspiration pneumonia, breathing difficulties or respiratory compromise; urgent medical attention is required if such symptoms occur.
  • Development of neutralising antibodies to botulinum toxin, potentially leading to reduced effectiveness of treatment over time in some patients.

Storage Conditions

  • Unreconstituted vials should be stored in a refrigerator (typically 2–8 °C) in the hospital or clinic pharmacy in accordance with the official product information.
  • Do not freeze.
  • Keep vials in the outer carton to protect from light and to maintain appropriate temperature.
  • Once reconstituted, Dysport should be used within the time window specified in the SmPC/Prescribing Information; any unused solution should be discarded safely in line with local regulations.
  • Dysport vials must not be supplied to, or stored by, patients at home; all storage and handling must occur in authorised clinical settings.
  • Keep out of the sight and reach of unauthorised persons and children.

Duration

The duration of clinical effect varies by indication, dose, and patient. In many neuromuscular and aesthetic indications, effects typically become evident within days and last for several weeks to a few months, after which repeat treatment may be considered by the responsible clinician in line with official guidance. Long-term treatment schedules must be individualised and periodically reviewed by the prescriber.

Onset

Onset of action is usually observed within several days after injection, with peak effect generally seen within approximately 1\u20132 weeks for many indications. Exact timing and magnitude of response depend on dose, injection sites, individual patient factors and the condition being treated.

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