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NABOTA 200U 01
KFDA Approved
NABOTA® (JEUVEAU®)

NABOTA® (JEUVEAU®) 200u

Manufacturer: Daewoong Pharmaceutical Co. Ltd
Active Substance(s): BOTULINUM TOXIN TYPE A
Strength: 200u
Pack Size: 1 x 200 Units Vial
Accessories: Package insert

 

Nabota Botulinum toxin type A is indicated for the temporary improvement in the appearance of the upper respiratory tract (forehead lines, crow’s feet and forehead lines) in adults. Botulinum toxin type A (Nabota) is indicated for the prevention of headaches in adults with chronic migraine.

Toxin products

Vial may appear empty, which is normal. Toxins come as concentrated freeze-dried powder which looks like a transparent film at the bottom of the vial. This product must be reconstituted with saline before use.

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INFORMATION

NABOTA® (JEUVEAU®) 200u Product Information

NABOTA® (JEUVEAU®) 200u is a botulinum toxin type A injectable product designed to improve the appearance of moderate to severe glabellar lines (frown lines) in adults. It acts as a neuromuscular blocking agent, temporarily inhibiting the release of acetylcholine, which reduces muscle activity in targeted areas. The product is supplied as a vacuum-dried powder in single-use vials.

Key Features and Benefits of NABOTA® (JEUVEAU®) 200u

NABOTA® 100u offers a combination of efficacy and safety for cosmetic purposes:

  • Targeted Treatment: Effectively reduces glabellar lines by relaxing specific muscles.
  • Proven Efficacy: Delivers visible results within days, lasting up to 3–4 months.
  • Safe Formulation: Developed with purified botulinum toxin type A, ensuring high safety standards.
  • Minimal Downtime: Patients can return to normal activities shortly after treatment.

Reconstitution Chart for NABOTA® (JEUVEAU®) 200u

For botulinum toxin treatments like Nabota, reconstitution of the product is essential for accurate dosing. Use preservative-free 0.9% Sodium Chloride Injection, USP for dilution.

  • Dilution Instructions:
    • Add 2.5 mL of saline to achieve a concentration of 4 Units per 0.1 mL.
    • Inject the saline slowly into the vial to avoid foaming.
    • Gently swirl (do not shake) until the solution is clear and colorless.

Storage Post-Reconstitution:

To keep Nabota in the best condition for the patients’ use, the following instructions should be followed:

  • Keep refrigerated at 2–8°C.
  • Use the reconstituted solution within 24 hours.

Storage Information for NABOTA® (JEUVEAU®) 200u

Proper storage ensures Nabota’s stability and effectiveness:

  • Store unopened vials at 2–8°C in the original packaging to protect from light.
  • Do not freeze.
  • After reconstitution, store at 2–8°C and discard any unused solution after 24 hours.

Treatment Areas for NABOTA® (JEUVEAU®) 200u

The primary indication for NABOTA® 100u is the treatment of moderate to severe glabellar lines caused by the activity of the corrugator and procerus muscles.

  • Injection Sites:
    • Five sites: Two injections into each corrugator muscle and one into the procerus muscle.
    • Dose: 0.1 mL (4 Units) per site.
    • Total dose: 20 Units.

By targeting specific muscles, Nabota injections smooth the appearance of vertical frown lines while maintaining a natural look.

Dosing for NABOTA® (JEUVEAU®) 200u

Accurate dosing ensures efficacy of Nabota while minimizing risks:

  • Glabellar Lines:
    • Reconstitute to 4 Units/0.1 mL.
    • Administer 20 Units total into five injection sites.
    • Retreatment: No sooner than every 3 months.

Side Effects and Precautions for NABOTA® (JEUVEAU®) 200u

Common Side Effects

  • Headache: Reported in 9.3% of patients.
  • Eyelid Ptosis (Drooping): Affects approximately 2% of patients.
  • Upper Respiratory Tract Infection: Observed in 3% of patients.
  • Injection Site Reactions: Redness, swelling, or discomfort.

Precautions

  • Contraindications:
    • Hypersensitivity to botulinum toxin a or any component of the formulation.
    • Active infection at the injection site.
  • Warnings:
    • Toxin effects may spread beyond the injection site, causing symptoms like dysphagia or breathing difficulties.
    • Use with caution in patients with pre-existing neuromuscular disorders or compromised respiratory function.

Aftercare Following NABOTA® (JEUVEAU®) 200u Treatment

Adhering to aftercare recommendations enhances results and reduces complications:

  • Avoid touching or massaging the treated area for 4 hours post-injection.
  • Refrain from strenuous activities, excessive heat exposure, or lying down for at least 4–6 hours.
  • Use sunscreen to protect the treated area from UV exposure.
  • Monitor for adverse effects like drooping eyelids or difficulty swallowing and contact a healthcare provider if symptoms occur.

Drug Interactions with NABOTA® (JEUVEAU®) 200u

Certain medications can potentiate the effects of botulinum toxin:

  • Neuromuscular Blockers: Co-administration increases the risk of excessive muscle relaxation.
  • Aminoglycosides: May amplify toxin effects.
  • Anticholinergics: Can heighten side effects like dry mouth or vision changes.
  • Other Botulinum Toxins: Avoid using concurrently to prevent cumulative effects.

NABOTA® (JEUVEAU®) 200u Product Information

NABOTA® (JEUVEAU®) 200u is a botulinum toxin type A injectable product designed to improve the appearance of moderate to severe glabellar lines (frown lines) in adults. It acts as a neuromuscular blocking agent, temporarily inhibiting the release of acetylcholine, which reduces muscle activity in targeted areas. The product is supplied as a vacuum-dried powder in single-use vials.

Key Features and Benefits of NABOTA® (JEUVEAU®) 200u

NABOTA® 100u offers a combination of efficacy and safety for cosmetic purposes:

  • Targeted Treatment: Effectively reduces glabellar lines by relaxing specific muscles.
  • Proven Efficacy: Delivers visible results within days, lasting up to 3–4 months.
  • Safe Formulation: Developed with purified botulinum toxin type A, ensuring high safety standards.
  • Minimal Downtime: Patients can return to normal activities shortly after treatment.

Reconstitution Chart for NABOTA® (JEUVEAU®) 200u

For botulinum toxin treatments like Nabota, reconstitution of the product is essential for accurate dosing. Use preservative-free 0.9% Sodium Chloride Injection, USP for dilution.

  • Dilution Instructions:
    • Add 2.5 mL of saline to achieve a concentration of 4 Units per 0.1 mL.
    • Inject the saline slowly into the vial to avoid foaming.
    • Gently swirl (do not shake) until the solution is clear and colorless.

Storage Post-Reconstitution:

To keep Nabota in the best condition for the patients’ use, the following instructions should be followed:

  • Keep refrigerated at 2–8°C.
  • Use the reconstituted solution within 24 hours.

Storage Information for NABOTA® (JEUVEAU®) 200u

Proper storage ensures Nabota’s stability and effectiveness:

  • Store unopened vials at 2–8°C in the original packaging to protect from light.
  • Do not freeze.
  • After reconstitution, store at 2–8°C and discard any unused solution after 24 hours.

Treatment Areas for NABOTA® (JEUVEAU®) 200u

The primary indication for NABOTA® 100u is the treatment of moderate to severe glabellar lines caused by the activity of the corrugator and procerus muscles.

  • Injection Sites:
    • Five sites: Two injections into each corrugator muscle and one into the procerus muscle.
    • Dose: 0.1 mL (4 Units) per site.
    • Total dose: 20 Units.

By targeting specific muscles, Nabota injections smooth the appearance of vertical frown lines while maintaining a natural look.

Dosing for NABOTA® (JEUVEAU®) 200u

Accurate dosing ensures efficacy of Nabota while minimizing risks:

  • Glabellar Lines:
    • Reconstitute to 4 Units/0.1 mL.
    • Administer 20 Units total into five injection sites.
    • Retreatment: No sooner than every 3 months.

Side Effects and Precautions for NABOTA® (JEUVEAU®) 200u

Common Side Effects

  • Headache: Reported in 9.3% of patients.
  • Eyelid Ptosis (Drooping): Affects approximately 2% of patients.
  • Upper Respiratory Tract Infection: Observed in 3% of patients.
  • Injection Site Reactions: Redness, swelling, or discomfort.

Precautions

  • Contraindications:
    • Hypersensitivity to botulinum toxin a or any component of the formulation.
    • Active infection at the injection site.
  • Warnings:
    • Toxin effects may spread beyond the injection site, causing symptoms like dysphagia or breathing difficulties.
    • Use with caution in patients with pre-existing neuromuscular disorders or compromised respiratory function.

Aftercare Following NABOTA® (JEUVEAU®) 200u Treatment

Adhering to aftercare recommendations enhances results and reduces complications:

  • Avoid touching or massaging the treated area for 4 hours post-injection.
  • Refrain from strenuous activities, excessive heat exposure, or lying down for at least 4–6 hours.
  • Use sunscreen to protect the treated area from UV exposure.
  • Monitor for adverse effects like drooping eyelids or difficulty swallowing and contact a healthcare provider if symptoms occur.

Drug Interactions with NABOTA® (JEUVEAU®) 200u

Certain medications can potentiate the effects of botulinum toxin:

  • Neuromuscular Blockers: Co-administration increases the risk of excessive muscle relaxation.
  • Aminoglycosides: May amplify toxin effects.
  • Anticholinergics: Can heighten side effects like dry mouth or vision changes.
  • Other Botulinum Toxins: Avoid using concurrently to prevent cumulative effects.
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