KAIMAX 100 UNITS

Detailed Product Description

[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.