Dysport® 500U Non English 

Description

Name: DYSPORT® 500u (Non-English)
Manufacturer: Galderma
Active Substance(s): BOTULINUM TOXIN TYPE A
Strength: 500u
Pack Size: 5 x 3mg pre-filled pen
Accessories: 1 x 500u Vial

Dysport® 500U is an injectable neuromodulator containing abobotulinumtoxinA, a purified botulinum toxin type A. It is indicated for therapeutic and aesthetic applications, including the treatment of cervical dystonia, upper limb spasticity in adults, and pediatric lower limb spasticity. The mechanism of action involves blocking acetylcholine release, leading to muscle relaxation and symptom relief. Dysport® is known for a faster onset of action compared to some other botulinum toxin formulations, making it a preferred choice in clinical settings.

Key Features:

• Clinically proven efficacy in reducing muscle spasticity and improving function.
• Versatile applications in both medical and aesthetic treatments.
• Faster diffusion compared to other botulinum toxin products, covering a broader treatment area.

Dysport® 500U is supplied as a freeze-dried powder for reconstitution. The packaging includes a single-use, sterile vial containing 500 units of lyophilized abobotulinumtoxinA. The product is intended for intramuscular injection after reconstitution with preservative-free 0.9% sodium chloride solution.

Ingredients:

• Active ingredient: AbobotulinumtoxinA (500 Units)
• Excipients:
  • Human serum albumin (125 mcg)
  • Lactose (2.5 mg)

Dysport® may contain trace amounts of cow’s milk proteins, making it contraindicated in individuals with severe milk protein allergies .

Dysport® 500U is indicated for the treatment of:

• Cervical dystonia in adults to reduce abnormal head positioning and neck pain.
• Upper limb spasticity in adults, helping to improve movement and muscle tone.
• Pediatric lower limb spasticity in children 2 years and older to improve walking ability .

Contraindications:

• Allergy to botulinum toxin or any component of Dysport®.
• Active infections at the injection site.
• Neuromuscular disorders such as myasthenia gravis, which can increase the risk of adverse effects .

Side Effects:

Common side effects include:

• Muscle weakness, injection site pain, headache, and nausea.
• Rare complications such as difficulty swallowing, breathing problems, and generalized muscle weakness due to toxin spread.

In pediatric patients, fatigue and respiratory infections may occur more frequently .

Dysport® 500U is administered via intramuscular injection. The dilution and dosage depend on the treatment indication.

Administration Guidelines:

• Cervical dystonia: Initial dose of 500U, divided among affected muscles. Re-treatment may be necessary every 12-16 weeks.
• Upper limb spasticity: Doses range from 500U to 1000U, divided among targeted muscles.
• Pediatric lower limb spasticity: The recommended total dose is 10-15U/kg per limb, not exceeding 1000U per session .

Storage Instructions:

• Store at 2°C to 8°C (36°F to 46°F).
• Do not freeze after reconstitution.
• Use within 24 hours after reconstitution .

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.