DYSPORT® 300u (Slovakian)

DYSPORT® 300u is a botulinum toxin type A used to treat muscle conditions and aesthetic concerns. It functions as a neuromuscular blocking agent that inhibits acetylcholine release, reducing muscle contractions. This injectable solution is widely used for both therapeutic and cosmetic purposes, including treating cervical dystonia, spasticity, and glabellar lines. DYSPORT® is known for its rapid onset of action, long-lasting effects, and high patient tolerance. The treatment duration varies based on the condition, with results typically lasting 3 to 6 months before re-administration is required.

Key Features:

• Effective for neuromuscular conditions such as cervical dystonia, upper limb spasticity, and pediatric lower limb spasticity
• Aesthetic applications, improving glabellar lines in patients under 65 years old
• Long-lasting results, typically 3 to 6 months before repeat treatments are necessary

DYSPORT® 300u is supplied in a sterile, single-use glass vial. Each vial contains 300 units of freeze-dried abobotulinumtoxinA. It is packaged in a box containing one vial, ensuring proper storage and protection against contamination. The product includes an authenticity hologram on the carton to prevent counterfeit use.

Ingredients:

• Active ingredient: AbobotulinumtoxinA (botulinum toxin type A)
• Excipients: Human albumin, lactose, and sodium chloride

DYSPORT® 300u is indicated for various neuromuscular and aesthetic conditions. It is primarily used in adult and pediatric patients for treating spasticity and dystonia, as well as for cosmetic enhancement. The contraindications include allergy to botulinum toxin, infection at the injection site, and neuromuscular disorders such as myasthenia gravis.

Approved Indications:

• Cervical dystonia in adults
• Upper limb spasticity in adults
• Lower limb spasticity in pediatric patients (2 years and older)
• Moderate to severe glabellar lines in patients under 65 years old

Contraindications:

• Hypersensitivity to botulinum toxin type A or formulation components
• Infection or inflammation at the injection site
• Pregnancy and breastfeeding are not recommended
• Neuromuscular disorders, including myasthenia gravis and Lambert-Eaton syndrome

Potential Side Effects:

• Common: Localized bruising, swelling, muscle weakness, and headache
• Serious but rare: Difficulty swallowing (dysphagia), breathing issues, and botulinum toxin spread effects

DYSPORT® 300u is administered as an intramuscular injection, and dosing varies based on the condition. The preparation involves reconstitution with preservative-free 0.9% sodium chloride injection before injection. Dilution instructions must be followed precisely to achieve the required concentration.

Administration Guidelines:

• For cervical dystonia: 500 Units as an initial dose, divided into affected muscles
• For upper limb spasticity: 1000 Units maximum per session, divided among multiple muscles
• For pediatric lower limb spasticity: 10-15 Units/kg per leg, with a maximum of 30 Units/kg per session
• For glabellar lines: 50 Units total, divided into five equal intramuscular injections

Storage Recommendations:

• Unopened vials: Store at 2°C to 8°C (36°F to 46°F), protected from light
• Reconstituted solution: Use immediately, or store at 2°C to 8°C and discard after 24 hours

Proper disposal: Follow medical waste disposal protocols to discard used vials and needles

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.