Features & Benefits

• Patented Technology

> NABOTA® was developed with Daewoong's 30 years of
experience in biotechnology.
> NABOTA® ensures the quality of international
standards via its own patented purification process,
    — Patent registration KR 10—1339349 (Patented in 2013)

• Reduced Impurity

> NABOTA® is a highly purified product manufactured with
a patented purification process from which impurities are
removed as much as possible.

• Overseas Expansion

> Excellence in the quality of NABOTA® has led to contracts to
export the finished product to about 90 countries including
the United States and 28 European countries.

Features & Benefits

• Main Ingredient 

> Clostridium Botulinum Toxin Type A

• Dosage Form

> Freeze-dried white powder for reconstitution with sterile, 0.9% sodium chloride solution with preservative-free

• Indication

> Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients aged 19-65 years old

• Dosage & Administration (Glabellar Lines)

> Reconstitute this product with preservative-free, sterile saline to make 100U/2.5ml (4U/0.1 ml) and using a 30-gauge needle, inject a dose of 0.1 ml into each of 5 sites, 2 in each corrugators muscle and 1 in procerus muscle, for a total of 20U

• Strength

> Clostridium Botulinum Toxin Type A 100 Units / 200 Units

Features & Benefits

• Composition
• 50U_Each vial contalns

- Active Ingredient: Clostridium botulinum toxdn type A (Strain: Clostidium botullnum CBFC26)
{attached specifications) SOunits(U}*
- Stabilizer: Human serum albumin (Korean Minimum Requirements for Biological Products) 0.25mg
- Tonic adjuster: Sodium chloride (KP} 0.45mg

• 100U_Each vial contains

- Active ingredient: Clostridium botulinum toxin type A (train: Clostridium botulinum CBFC26)
{attached specifications) 1 00units(U)*
- Stabilizer: Human serum albumin (Korean Minimum Requirements for Biological Products) 0.5mg
- Tonic adjuster: Sodium chloride (KP) 0.8¢mg

• 200U_Each vial contains

- Active Ingredient: Clostridium botullnum toxin type A (Strain: Clostridium botullnum 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® 50/1 00/200 corresponds to the calculated median intraperitoneal lethal dose {LD50} In mice.

• Description

It appears as a lyophilized white powder for injection in a colorless transparent vial and shouki become
coloriess transparent liquid when the diluent (physiological saline) is added.

• Indication

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

• Dosage & Administration

For blepharospasm, reconstituted BO-TULAX® 50/100/200 (see Dilution Table) Is Injected using a sterile, 27-30 gauge needie without electromyographic guidance. The initial recommended dose is 1.25-2.5U {(0.05mL to 0.1mL volume at each site) injacted 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 Initlal 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 BO-TULAX® 60/100/200 treatment In a 30-day period should not exceed 200U.

• Dilution Technique

Prior to injection, reconstitute freeze-dried BO-TULAX® 50/100/200 with sterile normal saline without a preservative. 0.9%. Sodium Chloride Injection is the recommended diluent. Draw up the proper ammount of diluent in the siza 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. BO-TULAX® 50/1 should be administered within 24 hours after reconstitution. During this time period, reconstituted BO-TULAX® 50/100/200 should be stored in a refrigerator (2-8°C). Reconstituted BO-TULAX® 50/100/200 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 BO-TULAX® 50/100/200 should be used for a single patient