DYSPORT® 500u (Greek)

DYSPORT® 500u is an abobotulinumtoxinA formulation designed for therapeutic and aesthetic applications. It is an acetylcholine release inhibitor and neuromuscular blocking agent, primarily used to treat cervical dystonia, upper limb spasticity, lower limb spasticity in pediatric patients, and for the temporary improvement of glabellar lines. The product works by blocking nerve signals to muscles, reducing excessive contractions. Clinical studies support its effectiveness in improving muscle tone and reducing wrinkles. Safety measures include proper administration techniques and adherence to dosing guidelines to minimize adverse effects.

Key Features:

• Clinically Approved: Effective for treating dystonia, spasticity, and cosmetic indications
• Long-Lasting Effects: Results typically last 12 to 16 weeks, depending on the indication

Versatile Application: Used in both medical and aesthetic treatments

DYSPORT® 500u is supplied in single-use vials containing a freeze-dried powder for reconstitution. The vials are available in the following configurations:

• 500 Unit vial: Box containing 1 or 2 vials
• 300 Unit vial: Box containing 1 vial
• Unique Hologram Security Feature: Ensures authenticity of the product

Ingredients:

• Active Ingredient: AbobotulinumtoxinA (500 Units per vial)
• Excipients: Human albumin, lactose
• Dilution Medium: Reconstituted with preservative-free 0.9% Sodium Chloride Injection, USP

DYSPORT® 500u is indicated for multiple conditions. It is important to follow the specified indications to ensure safety and efficacy.

Indications:

• Cervical Dystonia: Treats abnormal head positioning and neck pain in adults
• Upper Limb Spasticity: Used in adults to reduce muscle stiffness
• Lower Limb Spasticity: For pediatric patients aged 2 years and older
• Glabellar Lines: Temporary improvement of moderate to severe frown lines in adults under 65 years

Contraindications:

• Hypersensitivity to any botulinum toxin product or excipients
• Allergy to cow’s milk protein
• Active infection at the injection site

Common Side Effects:

• Cervical Dystonia: Muscle weakness, dysphagia, dry mouth, fatigue
• Glabellar Lines: Headache, eyelid ptosis, injection site pain
• Upper Limb Spasticity: Urinary tract infections, dizziness, muscle pain

Lower Limb Spasticity (Pediatric Patients): Fever, muscle weakness, nausea

Proper reconstitution and administration ensure optimal results. DYSPORT® should only be administered by trained professionals.

Administration:

• Cervical Dystonia: Initial dose 500 Units, injected into affected muscles
• Upper Limb Spasticity: Dosage varies by muscle, severity, and prior response
• Lower Limb Spasticity (Pediatric Patients): 10-15 Units/kg per limb, with a maximum dose of 30 Units/kg or 1000 Units per session
• Glabellar Lines: 50 Units divided into five injections of 10 Units each
• Re-treatment: No sooner than 12 weeks after previous dose

Storage:

• Unopened vials: Stored at 2°C to 8°C (36°F to 46°F)
• After reconstitution: Use within 24 hours
• Protect from light
• Do not freeze after reconstitution

Following these guidelines ensures the efficacy and safety of DYSPORT® 500u.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.