a total treatment dose of 20 Units in 0.5 mL (see Table 1). Slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull thediluent into the vial. Dispose of any unused saline. Gently mix JEUVEAU with 0.9% Sodium Chloride Injection USP by rotating the vial.

JEUVEAU should be administered within 24 hours after reconstitution. During this time period, unused reconstituted JEUVEAU should bestored in a refrigerator between 2° to 8°C (36°F to 46°F) in the original carton to protect from light for up to 24 hours until time of use. Do not

freeze reconstituted JEUVEAU. JEUVEAU vials are for single-dose only. After reconstitution, JEUVEAU should be used for only oneinjection session and for only one patient. Discard any remaining solution after administration.

Table 1. Dilution Instructions for JEUVEAU Vials (100 Units)

Diluent* Added to 100 Unit Vial Resulting Dose Units per 0.1 mL2.5 mL 4 Units

*Preservative-free 0.9% Sodium Chloride Injection, USP

Reconstituted JEUVEAU should be clear, colorless, and free of particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted JEUVEAU should be a clear, colorless solution, free of particulate 

matter, otherwise it should not be injected.

2.3 Administration

Glabellar facial lines arise from the activity of the corrugator and orbicularis oculi muscles. These muscles move the brow medially and theprocerus and depressor supercilii pull the brow inferiorly. This creates a frown or “furrowed brow”. The location, size, and use of the musclesvary markedly among individuals. Lines induced by facial expression occur perpendicular to the direction of action of contracting facial

muscles. An effective dose for facial lines is determined by gross observation of the patient’s ability to activate the superficial musclesinjected.

In order to reduce the complication of eyelid ptosis the following steps should be taken:

•Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.

•Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.

•Ensure the injected volume/dose is accurate and where feasible kept to a minimum.

•Avoid injecting toxin closer than 1 centimeter above the central eyebrow.

Draw at least 0.5 mL of the properly reconstituted toxin into a sterile syringe and expel any air bubbles in the syringe barrel. Remove theneedle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle. Inject a dose of 0.1 mL (4

Units) intramuscularly into each of five sites, the inferomedial and superior middle of each corrugator and one in the mid-line of the procerusmuscle for a total dose of 20 Units (See Figure 1).

Figure 1: 

3 DOSAGE FORMS AND STRENGTHS

•For injection: 100 Units, vacuum-dried powder in a single-dose vial for reconstitution with preservative-free 0.9% Sodium Chloride

Injection, USP.

4 CONTRAINDICATIONS