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Dysport® 500iu Dual Vial Botulinum Toxin

Dysport® 500iu Dual Vial Botulinum Toxin

Dysport

Aesthetic Medicine
  • UK Licensed prescription Only medicine (POM) with Marketing Authorisation for Dysport 500 units powder for solution for injection.
  • Manufactured in facilities operating in accordance with Good Manufacturing Practice (GMP).
  • Subject to ongoing safety and quality monitoring by the Medicines and Healthcare products Regulatory Agency (MHRA) and other national regulators.
  • Distributed in the UK by Medisave UK Ltd, an MHRA Registered wholesale dealer (WDA licence) operating ISO 9001 quality management and ISO 14001 environmental management systems.
Botulinum toxin type A injectable (abobotulinumtoxinA)

Description

Dysport® 500iu Dual Vial Botulinum Toxin is a prescription-only medicine containing clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA). It is supplied as a sterile, lyophilised powder for solution for injection and is presented in a pack of two 500 IU single-dose vials (2 × 500 units). In the UK, this presentation is licensed for the symptomatic treatment of persistent severe primary hyperhidrosis of the axillae (underarm excessive sweating) that does not respond adequately to topical antiperspirants or antihidrotic treatments. When injected intradermally into the axillary region by a suitably trained healthcare professional, Dysport reduces sweat production by blocking cholinergic nerve transmission to eccrine sweat glands, providing a temporary reduction in excessive sweating and improvement in quality of life. Although Dysport is widely used in aesthetic medicine to reduce dynamic facial lines, this particular product is not licensed in the UK for aesthetic indications, and any such use would be off-label, with the prescriber assuming full responsibility for patient care, monitoring and follow-up. The product is restricted to professional purchase and adult use only.

Bnefits

  • Clinically proven botulinum toxin type A (abobotulinumtoxinA) formulation for severe primary axillary hyperhidrosis that is resistant to topical therapies.
  • Provides a significant and sustained reduction in underarm sweating, improving comfort and quality of life for appropriate patients.
  • Dual 500 IU vial presentation (2 × 500 units) offers flexibility for treating both axillae and for tailoring dose based on clinical need.
  • Well-characterised safety and efficacy profile with many years of post-marketing clinical experience in therapeutic and aesthetic settings.
  • Professional-only, prescription medicine supplied via an MHRA-registered UK pharmaceutical wholesaler.
  • Lyophilised powder formulation allows controlled reconstitution and dosing by trained clinicians in accordance with the SmPC.

Indications

  • Symptomatic treatment of persistent severe primary hyperhidrosis of the axillae (underarms) in adults, which interferes with daily activities and does not respond adequately to topical treatment with antiperspirants or antihidrotics.
  • Other therapeutic indications for Dysport 500 units powder for solution for injection (such as focal spasticity, cervical dystonia, blepharospasm and hemifacial spasm, and certain bladder indications) are detailed in the full Summary of Product Characteristics; use must follow local licensing and guidance.
  • Any aesthetic use (e.g. treatment of facial lines) in the UK is off-label for this product and must be undertaken only by appropriately qualified prescribers who accept full responsibility for such use.

Composition

  • Active substance (per vial): 500 units clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
  • Excipient: Human serum albumin approximately 125 micrograms per vial.
  • Excipient: Lactose monohydrate approximately 2.5 mg per vial.
  • The vial does not contain preservatives; reconstitution must be performed with sterile 0.9% sodium chloride solution for injection (not supplied in the vial).

Formulation

  • Pharmaceutical form: Powder for solution for injection.
  • Sterile, white lyophilised powder in a clear Type I glass vial with rubber stopper and aluminium seal.
  • Intended for intradermal or intramuscular administration after reconstitution by a suitably trained healthcare professional.

Packaging

  • Outer carton containing 1 box with 2 × 500 IU single-dose glass vials of Dysport powder for solution for injection.
  • Each vial contains 500 units of clostridium botulinum type A toxin-haemagglutinin complex with excipients human serum albumin and lactose monohydrate.
  • Professional-only pack supplied through pharmaceutical channels; not for home or private use.
  • Pack is labelled with batch number, expiry date, storage instructions and licensing information.

Usage

  • Dysport 500iu Dual Vial Botulinum Toxin is a prescription-only medicine that must only be prescribed and administered by physicians or appropriately qualified healthcare professionals experienced in the use of botulinum toxin and in the management of primary axillary hyperhidrosis.
  • The product is supplied as a lyophilised powder and must be reconstituted with sterile 0.9% sodium chloride solution for injection using aseptic technique, strictly following the official Summary of Product Characteristics (SmPC) or local product information.
  • For the indication of severe primary hyperhidrosis of the axillae, Dysport is administered by intradermal injection into the affected underarm areas; dosing regimen, injection pattern and retreatment intervals must follow the SmPC and relevant clinical guidelines.
  • Dysport must not be self-administered by patients and is not suitable for home use; it should only be used in appropriate clinical settings with facilities to manage potential adverse reactions.
  • Any use for aesthetic indications in the UK (for example, treatment of facial lines) is off-label for this pack; prescribers undertaking such use are fully responsible for dose selection, injection technique, patient consent, monitoring and follow-up, and must comply with all local regulations and professional standards.
  • Discard any unused reconstituted solution according to local requirements for botulinum toxin and hazardous biological waste after the in-use period specified in the product information.

Contraindications

  • Known hypersensitivity to clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA) or to any of the excipients such as human serum albumin or lactose.
  • Presence of infection or inflammation at the proposed injection sites in the axillae.
  • Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert–Eaton myasthenic syndrome or other significant neuromuscular junction disorders), in line with cautions and contraindications for other clostridium botulinum type A toxins.
  • Patients with a history of serious adverse reaction or hypersensitivity to any botulinum toxin product.
  • Use during pregnancy and breastfeeding is generally not recommended; treatment should only be considered if the potential benefit justifies the potential risk in accordance with the SmPC and local guidance.
  • Any other contraindications, warnings and precautions listed in the full Summary of Product Characteristics should be carefully reviewed before prescribing.

Adverse Effects

  • Injection site reactions such as pain, bruising, erythema, swelling or discomfort at the axillary injection sites.
  • Localised muscle weakness near the injection area.
  • Compensatory sweating in other body areas (reported with botulinum toxin treatment for hyperhidrosis).
  • Systemic symptoms such as headache, fatigue or flu-like symptoms.
  • Neuromuscular effects related to distant spread of toxin, such as generalised muscle weakness or, rarely, dysphagia or breathing difficulties, particularly if recommended dose and technique are not followed.
  • Allergic or hypersensitivity reactions, including rash, pruritus or urticaria; very rare cases of severe allergic reactions have been reported with botulinum toxin type A products.
  • Formation of neutralising antibodies leading to reduced clinical response after repeated treatments (uncommon).
  • The full list and frequency of adverse reactions are detailed in the official SmPC and patient information leaflet and should be reviewed before use.

Storage Conditions

  • Unopened vials should be stored in a refrigerator at 2–8 °C in the original outer carton to protect from light.
  • Do not freeze unopened vials.
  • After reconstitution, the solution should generally be kept at 2–8 °C and used within the in-use period specified in the product information; any unused solution must be discarded thereafter.
  • Keep out of the sight and reach of children.
  • Handle and dispose of vials, needles, syringes and any unused product as potentially hazardous biological waste, following local regulations for botulinum toxin-containing medicines.

Duration

For severe primary axillary hyperhidrosis, clinical benefit from a single treatment session typically lasts several months, with many patients experiencing reduced sweating for approximately 4\u20136 months before retreatment is considered. Duration can vary depending on dose, injection technique and individual patient response.

Onset

Improvement in sweating is generally observed within a few days after injection, with maximal effect often occurring within about 1\u20132 weeks.

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