DYSPORT® 500u (Slovakian)

DYSPORT® 500u is a botulinum toxin type A product designed for therapeutic and aesthetic applications. It is an acetylcholine release inhibitor and neuromuscular blocking agent used to treat muscle spasticity, cervical dystonia, and glabellar lines. The product works by blocking nerve signals to targeted muscles, reducing involuntary contractions or wrinkles. DYSPORT® is known for its long-lasting effects and high efficacy across various indications. It is administered intramuscularly by healthcare professionals trained in its use.

Key Features:

• Versatile Uses: Indicated for muscle spasticity, cervical dystonia, and glabellar lines.
• Fast Onset: Clinical effects typically observed within 2-3 days post-injection.
• Long-Lasting: Effects may last up to 16 weeks, depending on the indication.

DYSPORT® 500u is supplied in a single-use sterile vial containing a lyophilized powder for reconstitution. The packaging is designed to maintain the stability of the active ingredient. Each vial is clearly labeled with the product name, batch number, and expiration date.

Ingredients:

• Active Ingredient: AbobotulinumtoxinA, a purified botulinum toxin type A complex.
• Excipients: Human albumin and lactose monohydrate are included to stabilize the formulation.

Diluent: Preservative-free 0.9% sodium chloride is used for reconstitution before administration.

DYSPORT® 500u is approved for the treatment of several conditions, including both medical and aesthetic applications.

Approved Indications:

• Cervical Dystonia: Used to reduce neck muscle contractions in adults.
• Upper Limb Spasticity: Treats muscle stiffness in elbow, wrist, and finger flexors.
• Lower Limb Spasticity (Pediatrics): Approved for children aged 2 years and older.
• Glabellar Lines: Temporarily reduces the appearance of moderate to severe frown lines.

Contraindications:

• Hypersensitivity to botulinum toxin or any excipient.
• Infection at the proposed injection site.
• Neuromuscular Disorders, such as myasthenia gravis, which may increase sensitivity to the toxin.

Side Effects:

• Common: Injection site pain, headache, muscle weakness, nausea.
• Serious: Dysphagia, respiratory issues, eyelid ptosis.

Rare: Hypersensitivity reactions including anaphylaxis.

DYSPORT® 500u is administered intramuscularly by a trained healthcare professional. Dosage varies based on the indication and patient factors such as age and weight.

Administration Guidelines:

• Cervical Dystonia: 500 units divided among affected muscles.
• Upper Limb Spasticity: 500-1000 units, adjusted based on severity.
• Glabellar Lines: 50 units total, distributed into 5 equal injections of 10 units.
• Re-Treatment: Intervals should be at least 12 weeks apart.

Storage Recommendations:

• Store at 2°C to 8°C (36°F to 46°F) in refrigeration.
• Protect from light and avoid freezing.
• Use within 24 hours after reconstitution.
• Dispose of expired vials as medical waste.

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.