DYSPORT® 500u (Non-English)

DYSPORT® 500u (abobotulinumtoxinA) Product Information

DYSPORT® 500u is a botulinum toxin type A injectable for therapeutic and cosmetic purposes. It treats neuromuscular conditions such as spasticity and cervical dystonia and temporarily improves the appearance of wrinkles, such as glabellar lines. The formulation is specifically designed for intramuscular use, ensuring precise and effective treatment.

Key Features and Benefits of DYSPORT® 500u

DYSPORT® 500u is formulated to deliver safe and effective results through its key attributes:

• Versatility: Suitable for both therapeutic and cosmetic applications, addressing a wide range of indications.
• Prolonged Effectiveness: Results last 12–16 weeks for therapeutic treatments and up to 4 months for glabellar lines.
• Targeted Action: Provides precise neuromuscular blocking to relax overactive muscles.
• High Purity: Contains purified abobotulinumtoxinA in a single-use vial.

Reconstitution Chart for DYSPORT® 500u

Proper reconstitution of DYSPORT® 500u ensures effective administration. Use preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution:

• Dilution Guide:
  • 1 mL: 50 units per 0.1 mL.
  • 2 mL: 25 units per 0.1 mL.
  • 2.5 mL: 20 units per 0.1 mL.
  • 5 mL: 10 units per 0.1 mL.

Important Notes:

• After reconstitution, store the solution at 2–8°C and use it within 24 hours.
• Avoid freezing the reconstituted product.

Storage Information for DYSPORT® 500u

Proper storage is crucial to maintaining the product’s stability and efficacy:

• Store vials at 2–8°C before reconstitution.
• After reconstitution:
  • Keep the solution in a refrigerator at 2–8°C.
  • Protect from light and use within 24 hours.
• Do not freeze the reconstituted product.

Dosing for Different Indications of DYSPORT® 500u

DYSPORT® 500u offers flexible dosing based on the treatment area and condition. Common indications include:

• Cervical Dystonia:
  • Initial dose: 500 units divided across affected muscles.
  • Re-treatment: Every 12–16 weeks based on symptom recurrence.
  • Maximum dose: 1000 units per session.
• Glabellar Lines:
  • Dose: 50 units (10 units in 5 equally divided sites).
  • Re-treatment: No sooner than every 3 months.
• Upper Limb Spasticity in Adults:
  • Dose: 500–1000 units tailored to muscle size and spasticity severity.
  • Re-treatment: Intervals of no less than 12 weeks.
• Lower Limb Spasticity in Pediatric Patients (2 years and older):
  • Dose: 10–15 units/kg per limb.
  • Maximum dose: 30 units/kg or 1000 units per session.

Treatment Areas for DYSPORT® 500u

DYSPORT® 500u is used to target specific muscles in therapeutic and cosmetic treatments:

• Therapeutic Uses:
  • Cervical dystonia: Sternocleidomastoid and splenius capitis muscles.
  • Spasticity: Flexor and extensor muscles of the upper and lower limbs.
• Cosmetic Uses:
  • Glabellar lines: Corrugator and procerus muscles.

Each injection is carefully guided by anatomical knowledge and clinical technique to ensure optimal results.

Side Effects and Precautions of DYSPORT® 500u

Common Side Effects

• Cervical Dystonia:
  • Dysphagia (15%), muscular weakness (16%), and dry mouth (13%).
• Glabellar Lines:
  • Nasopharyngitis, headache, injection site discomfort, and eyelid ptosis (2% each).
• Spasticity:
  • Muscular weakness, fatigue, and pain at injection sites.

Precautions

• Contraindications:
  • Hypersensitivity to botulinum toxin or components such as cow’s milk protein.
  • Infection at the injection site.
• Warnings:
  • Avoid use in patients with neuromuscular disorders.
  • Effects may spread beyond the injection site, potentially causing serious symptoms such as dysphagia or respiratory issues.

Aftercare Following DYSPORT® 500u Treatment

Adhering to proper aftercare enhances treatment efficacy and minimizes side effects:

• Avoid manipulation: Do not massage or press the treated area for at least 4 hours post-injection.
• Limit strenuous activity: Refrain from physical exertion for 24 hours.
• Protect from UV exposure: Apply sunscreen if the treated area is exposed to sunlight.
• Monitor for signs of adverse reactions and contact a healthcare provider if concerns arise.

Drug Interactions with DYSPORT® 500u

Certain medications may amplify the effects of DYSPORT® 500u, requiring caution:

• Neuromuscular blockers: May enhance botulinum toxin effects.
• Anticholinergic drugs: Potentiate systemic anticholinergic side effects, such as dry mouth or blurred vision.
• Muscle relaxants: Increased risk of excessive muscle weakness when used concurrently.

Avoid administering DYSPORT® 500u alongside other botulinum toxin products to prevent exaggerated effects or complications.