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DYSPORT® 500u (Non-English) Indications for Use

DYSPORT® 500u (Non-English)(abobotulinumtoxinA) is a botulinum toxin type A product indicated for various therapeutic and cosmetic applications. The primary uses include:

1. Cervical Dystonia: Treatment of adults with cervical dystonia, a condition causing abnormal neck muscle contractions.
2. Glabellar Lines: Temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) in adults under 65 years old.
3. Upper Limb Spasticity: Treatment of upper limb spasticity in adults, which is characterized by muscle stiffness and involuntary spasms.
4. Lower Limb Spasticity in Pediatric Patients: Management of lower limb spasticity in children aged 2 years and older.

• Mechanism of action: DYSPORT® 500u (Non-English)works by inhibiting the release of acetylcholine at the neuromuscular junction, leading to temporary muscle paralysis and reduced muscle tone, thereby treating both medical conditions and reducing the appearance of wrinkles.

DYSPORT® 500u (Non-English) Dosage Information

The dosage of DYSPORT® 500u (Non-English)varies depending on the indication and the specific muscles targeted for injection.

• Cervical Dystonia:
  • Initial dose: 500 Units injected intramuscularly across the affected muscles.
  • Retreatment every 12 to 16 weeks, adjusting doses between 250 and 1000 Units based on response.
• Glabellar Lines:
  • Total dose: 50 Units divided into five equal injections of 10 Units into the corrugator and procerus muscles.
  • Retreatment should not occur more frequently than every 3 months.
• Upper Limb Spasticity:
  • Dose: 500 to 1000 Units injected into the affected muscles based on muscle size and response.
  • Retreatment at intervals of 12 weeks or longer.
• Pediatric Lower Limb Spasticity:
  • Dose: 10 to 15 Units/kg per limb for unilateral injections and 20 to 30 Units/kg for bilateral injections.
  • Maximum dose: 1000 Units per session, spaced at least 12 weeks apart.

DYSPORT® 500u (Non-English) Side Effects and Precautions

Like all botulinum toxin products, DYSPORT® 500u (Non-English)carries risks related to the spread of toxin effects beyond the injection site. Symptoms may develop hours to weeks after injection and can include muscle weakness, difficulty breathing, and swallowing issues, which can be life-threatening.

• Common side effects:
  • Injection site reactions: pain, swelling, or bruising.
  • Upper respiratory tract infections.
  • Headache and fatigue.
• Serious side effects:
  • Dysphagia (difficulty swallowing), which occurs in up to 15% of patients with cervical dystonia.
  • Breathing difficulties, which are more likely in patients with pre-existing respiratory conditions.
  • Muscle weakness and ptosis (drooping of the eyelid) when used for cosmetic purposes.

Precautions:

• DYSPORT® 500u (Non-English)is contraindicated in individuals with hypersensitivity to botulinum toxin or cow’s milk protein, and in those with infection at the injection site.
• Use caution in patients with neuromuscular disorders such as myasthenia gravis, as they may be at increased risk of severe side effects like muscle weakness or breathing issues.

DYSPORT® 500u (Non-English) Clinical Studies or Real-World Outcomes

Clinical trials have demonstrated the efficacy of DYSPORT® 500u (Non-English)in treating the targeted conditions. Results vary depending on the condition but show consistent improvement in muscle tone, spasticity, and appearance of wrinkles.

• Cervical Dystonia:
  • A study showed that 61% of patients receiving 500 Units of DYSPORT® 500u (Non-English)had a significant reduction in symptoms, compared to 51% of placebo patients.
  • Effects typically last 12 to 16 weeks, with the peak effect occurring 2 to 4 weeks after injection.
• Glabellar Lines:
  • Clinical trials with over 398 patients showed that 48% of DYSPORT® 500u (Non-English)patients had noticeable improvement in glabellar lines compared to 33% in the placebo group.
  • The effect of DYSPORT® 500u (Non-English)for glabellar lines typically lasts up to 4 months.
• Upper Limb Spasticity:
  • In clinical trials, patients receiving doses between 500 and 1000 Units showed a reduction in muscle tone and spasticity, with improvements seen as early as 1 week post-injection.
• Pediatric Lower Limb Spasticity:
  • The most frequently observed side effects were upper respiratory tract infections and nasopharyngitis (inflammation of the nasal passages), occurring in over 10% of treated pediatric patients.

DYSPORT® 500u (Non-English) Drug Interactions

DYSPORT® 500u (Non-English)may interact with medications that affect neuromuscular function, increasing the risk of adverse effects.

• Aminoglycosides: These antibiotics can potentiate the effect of botulinum toxin, leading to exaggerated muscle weakness.
• Muscle relaxants: Caution is advised when using DYSPORT® 500u (Non-English)with drugs that relax muscles, as the combination may enhance the botulinum toxin’s effects.
• Anticholinergic medications: These drugs may increase systemic anticholinergic effects when used with DYSPORT®, leading to side effects such as blurred vision.

Special Considerations

• Pregnancy: DYSPORT® 500u (Non-English)should be used in pregnancy only if the benefits outweigh the risks, as there is limited data on its safety in pregnant women.
• Breastfeeding: It is unknown whether DYSPORT® 500u (Non-English)is excreted in human milk, so caution is recommended for nursing mothers.
• Elderly: Older patients should be carefully monitored for side effects, particularly if they have co-existing conditions.
• Pediatric use: The safety and efficacy of DYSPORT® 500u (Non-English)for spasticity in children under 2 years have not been established.