BOCOUTURE® 50u (XEOMIN®)

Description

Name: BOCOUTURE® 50u (XEOMIN®)
Manufacturer: Merz Pharma
Active Substance(s): BOTULINUM TOXIN TYPE A
Strength: 50u
Pack Size: 50u – 1 vial
Accessories: 1 x 50u Powder Single Use Vial

BOCOUTURE® 50u (XEOMIN®) is a botulinum toxin type A injection used for medical and aesthetic applications. It is a neuromuscular blocking agent that inhibits acetylcholine release, effectively reducing muscle activity. The formulation is free from complexing proteins, which minimizes the risk of antibody formation and maintains consistent effectiveness. It is primarily used for treating upper limb spasticity, cervical dystonia, blepharospasm, and glabellar lines.

Key Features:

• Pure botulinum toxin type A, free from complexing proteins to reduce resistance risk.
• Long-lasting effects, typically up to 3 months, depending on the indication.

Versatile treatment options, suitable for therapeutic and cosmetic applications.

BOCOUTURE® 50u is supplied as a lyophilized powder in a single-use glass vial. The vial requires reconstitution before use and is available in 50-unit, 100-unit, and 200-unit strengths.

Ingredients:

• IncobotulinumtoxinA (Botulinum Toxin Type A): Blocks nerve signals to reduce muscle activity.
• Human Albumin (1 mg): Ensures stability and safety of the formulation.
• Sucrose (4.7 mg): Functions as a cryoprotectant to maintain potency.

BOCOUTURE® 50u is used in both medical and aesthetic treatments, helping to relax overactive muscles and smooth wrinkles.

Indications:

• Medical Uses:
  • Upper limb spasticity: Recommended dose up to 400 units per session.
  • Cervical dystonia: Initial dose of 120 units per session.
  • Blepharospasm: 1.25-2.5 units per injection site, based on previous botulinum toxin treatment.
• Aesthetic Uses:
  • Glabellar lines (frown lines): 20 units per session, divided into five injection sites.

Contraindications:

• Hypersensitivity to botulinum toxin or any ingredient in the formulation.
• Active infection at the injection site.
• Pregnant or breastfeeding women, due to insufficient safety data.

Side Effects:

• Common (≥5% of patients): Swelling, bruising, muscle weakness, headache.
• Less Common (1-5% of patients): Dysphagia, dry mouth, eyelid ptosis, injection site pain.
• Rare but serious: Difficulty breathing or swallowing, requiring medical attention.

BOCOUTURE® 50u is administered via intramuscular injection. The dosage, number of injections, and placement depend on the treatment area and indication.

Administration Technique:

1. Reconstitute the vial with preservative-free 0.9% sodium chloride solution.
2. Gently swirl to mix; do not shake.
3. Use a fine-gauge needle (e.g., 30G for aesthetics, 26G for medical applications).
4. Inject intramuscularly at the designated treatment sites.
5. Recommended intervals:
   • Upper limb spasticity, cervical dystonia, blepharospasm: Every 12 weeks.
   • Glabellar lines: Every 3 months.

Storage Guidelines:

• Store at 2°C to 8°C before reconstitution.
• Use within 24 hours after reconstitution.
• Do not freeze or expose to direct sunlight.

BOCOUTURE® 50u (XEOMIN®) offers a safe and effective botulinum toxin formulation with consistent results for both therapeutic and aesthetic applications.