DESCRIPTION
It appears as a lyophilized white powder for injection in a colorless transparent vial and should become colorless transparent liquid when the diluent (normal saline) is added.
Dosage and Administration
PREPARATION AND DILUTION TECHNIQUE
Reconstitute ReNtox™ with sterile, preservative-free saline diluent (0.9% Sodium Chloride) to make 100 U/2.5 ml (4 U/0.1 ml). [Dilution Technique] Prior to intramuscular injection, reconstitute each freezedried vial of ReNtox™ with sterile, preservative-free saline diluent. Draw up the proper amount of saline diluent in the syringe of appropriate size. Since this product 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. Gently mix ReNtox™ with the saline diluent by rotating the vial. Record the date and time of reconstitution on the space of the label.
The product should be administered within 24 hours after reconstitution. During this period, reconstituted product should be stored in a refrigerator (2-8°). Reconstituted product 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 this product and the diluent do not contain any preservative, one vial of this product should be used for a single patient.
INJECTION
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 20 U. (Please see the picture below) To reduce the complication of ptosis, avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Injections into inner corrugators muscle and central eyebrow should be placed at least 1 cm above the bony supraorbital ridge. Careful attention should be paid to avoid injection of ReNtoxrM into the blood vessel. To prevent exudation below the orbital ridge, be sure to firmly place the thumb or index finger below the orbital ridge, prior to injection. The needle should be toward the upper center during injection and careful attention should be paid to inject accurate volume. Glabellar facial lines arise from the activity of corrugator muscle and orbicularis oculi muscle. These muscles move the brow medially, and the procerus muscle and depressor supercilia muscle pull the brow inferiorly. This creates a frown or glabellar lines. The location, size, and use of the muscles vary markedly among individuals. An effective does for facial lines is determined by gross observation of the patient’s ability to activate the superficial muscles injected. Each treatment lasts approximately 3~4 months. More frequent injection of ReNtox™ is not recommended because the safety and efficacy are not established.