BOTULAX® (LETYBO®) 200u (Korean)

For blepharospasm, reconstituted BOTULAX® 200 is injected using a sterile, 27-30 gauge needle without electromyographic guidance. The initial recommended dose is 1.25-2.SU (0.05ml to 0.1 ml volume at each site) injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated.

At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient-usually defined as an effect that does not last longer than two months. However there appears to be little benefit obtainable from injecting more than 5.0U per site. Some tolerance may be found when the drug is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent. The cumulative dose of BOTULAX® 50/’100/200 treatment in a 30-day period should not exceed 200U.

It is indicated for the treatment of benign essential blepharospasm in patients 18 years of age and above.

• Active ingredient: Clostridium botulinum toxin type A (Strain: Clostridium botulinum CBFC26) {attached specifications) 200units(U)*
• Stabilizer: Human serum albumin (Korean Minimum Requirements for Biological Products) 1.0mg
• Tonic adjuster: Sodium chloride (KP) 1.8mg

* One unit (U) of BOTULAX® 50/100/200 corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice.

• Dilution Technique
  • Prior to injection, reconstitute freeze-dried BOTULAX® 200 with sterile normal saline without a preservative. 0.9% Sodium Chloride Injection is the recommended diluent.
  • Draw up the proper amount of diluent in the appropriate size syringe. Since the drug is denatured by bubbling or similar violent agitation, the diluent should be injected gently into the vial.
  • Discard the vial if a vacuum does not pull the diluent into the vial. Record the date and time of reconstitution on the space on the label.
  • BOTULAX® 200 should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTULAX® 200 should be stored in a refrigerator {2-8° C).
  • Reconstituted BOTULAX® 200 should be clear, colorless and free of particulate matter.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Because the drug and diluent do not contain any preservative, one vial of BOTULAX® 200 should be used for a single patient.

Contraindications

• BOTULAX® 200 should not be administered when;
  • The patients have known hypersensitivity to any ingredient in the formulation of BOTULAX® 200.
  • The patients have neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syTidrome or amyotrophic laternal sclerosis). [The diseases may be exacerbated due to the muscle relaxation activity of the drug.)
  • The patients are pregnant women, women of childbearing potential or nursing mothers.

After-care

• In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment.
• Each treatment lasts approximately three months, following which the procedure can be repeated.
• At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient-usually defined as an effect that does not last longer than two months.