KAIMAX 100 UNITS

Kaimax is a botulinum toxin type A injection that is primarily used for cosmetic purposes, specifically for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) associated with muscle activity in adult patients aged 19 to 65 years. The product comes as a white or light yellow dried powder contained in a colorless glass vial. When diluted with saline, it transforms into a clear liquid suitable for injection.

[COMPOSITION] 1vial contains

Clostridium botulinum toxin type A (In-house)....... 100Units (U)

Human serum albumin (EP)..... 0.5mg

Sodium chloride (USP).......0.9mg

[DESCRIPTION]

White or light-yellow dried powder in colorless and clear glass vial and should becomecolorless transparent or light-yellow liquid when diluted with normal saline.

[INDICATIONS AND USAGE]

Kaimax (botulinum toxin type A for injection) is indicated: For the temporary improvement in the appearance of moderate to severe glabellar lines associatedwith corrugator muscle and/or procerus muscle activity in adult patients aged 19 to 65 years.

[DOSAGE AND ADMINISTRATION]

1. PREPARATION AND DILUTION METHODSDilute to 100U/2.5ml (4U/0.1 ml) with sterile, preservative-free 0.9% sodium chloride injection.

Dilution method:

Each vial of Kaimax is to be reconstituted sterile, preservative-free saline. 0.9% sodium chloride injection is the recommended diluent. Add an appropriate amount of diluent to a syringe. Slowly inject the diluent into the vial as this drug will become denatured if a foam or a similar agitation occurs. Discard the vial if the vial was not filled with diluent in vacuum condition. Record the date and time of dissolution on the label and allow it to be administered within 24 hours after dissolution. Once reconstitut- ed, Kaimax should be stored in a refrigerator at 2-8°C. When Kaimax is dissolved, it should be colorless and transparent and free from a foreign substance. Parenteral formulations should be examined for foreign substances and discoloration prior to administration. It is not recommended to use one vial for more than one patient since this drug and diluent contain no preservatives.

Dosage and Administration

 To prepare Kaimax for injection:

1. Dilute the powder with sterile, preservative-free 0.9% sodium chloride solution.
2. For 100 units, add 2.5 ml of saline; for 200 units, add 5 ml.
3. Gently swirl the vial to mix without shaking excessively.
4. Use within 24 hours after reconstitution and store in a refrigerator at temperatures between 2-8°C.

For treating glabellar lines, typically, a total dose of 20 units is administered through five injection points using a fine needle.

Mechanism of Action

Botulinum toxin works by inhibiting the release of acetylcholine at the neuromuscular junction, leading to temporary muscle paralysis. This effect smooths out wrinkles by preventing muscle contraction that contributes to their formation.

Safety and Precautions

 While Kaimax is generally safe when administered correctly, potential side effects include localized reactions at the injection site and systemic effects such as muscle weakness or dysphagia. It should not be used in individuals with known allergies to its components or those with neuromuscular disorders.

Storage Conditions

Kaimax should be stored refrigerated at temperatures between 2-8°C and has a shelf life of up to 36 months from the manufacturing date.