Additional Information

Description

Jeuveau® (prabotulinumtoxinA-xvfs) is a single dose vial, containing 100 US units and is preservative free. It’s a sterile intramuscular injection and is vacuum dried.

A single vial of Jeuveau® contains 100 botulinum toxin type A neurotoxin complexes, 0.5 mg of human serum albumin & 0.9 mg of NaCl. It has to be stored unopened in a refrigerator at 2-8 ? (36-46 ?). It is free from preservatives, so if opened, refrigerate it and use it within 24 hours after reconstitution.

Jeuveau® is recommended for adult patients to temporarily improve the look of mild to profound glabellar lines linked to procerus and corrugator muscle activation. PrabotulinumtoxinA-xvfs is AChE inhibitor/anti-cholinesterase and NMBA (neuro-muscular blocking agent). It is from the drug class of skeletal muscle relaxants.

The potency units of prabotulinumtoxinA-xvfs are highly peculiar in the utilization of assay methods and preparation. These potency units cannot be interchanged with other botulinum toxin product preparations, so the assay is specific.

2.5mL of diluent is added to a 100-unit vial, resulting in 4 dose units/0.1mL. The total dose of treatment is 20 units in 0.5mL. The reconstituted injection is colorless, clear and free from any particles, so in case of any particulate matter is noticed, do not use it.

Jeuveau® injection can cause dryness of the eyes, blurred vision, and dizziness lasting from hours to weeks. In such cases, do not drive a car or operate machinery and refrain from other dangerous activities. Patients must report the problem to their doctors if it persists.

Its use is prohibited if the patient is allergic to any of the ingredients or if they have an allergy to botulinum toxin or active skin infection at the intended injection site. Patients must inform their doctors of any atypical symptoms like difficulty breathing, speaking, or swallowing.

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Indications and Usage:

Jeuveau® is indicated in adult patients for the temporary improvement of moderate to severe glabellar lines caused by corrugator and/or procerus muscle activity.

Administration and Dosage:

Safe Use Instructions:

Jeuveau® (prabotulinumtoxinA-xvfs) injection potency Units are specific to the preparation and assay method used. Jeuveau® units of biological activity cannot be interchanged with other preparations of botulinum toxin products as Juveau is not equivalent to any other botulinum toxin product.

1. Jeuveau® should be administered more frequently than once every three months. The cumulative dose is taken into account.
2. The safe and effective use of Jeuveau® depends on proper product storage, dose selection, and reconstitution.
3. Physicians who administer Jeuveau® must be familiar with the relevant neuromuscular and/or orbital anatomy of the area involved. The physician should understand the affected area and any changes in anatomy caused by previous surgical procedures.

Techniques for Preparation and Dilution:

Jeuveau® is available in a 100-unit single-dose vial. Reconstitute each vacuum-dried vial of Jeuveau® with only sterile, preservative-free 0.9% Sodium Chloride Injection, USP, to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL.

Inject the diluent slowly into the vial. If a vacuum does not pull the vial, discard it. Remove any unused saline. Rotate the vial gently to combine Jeuveau® and 0.9% Sodium Chloride Injection USP.

Jeuveau® should be given within 24 hours of reconstitution. Do not freeze the reconstituted Jeuveau®, and any unused reconstituted Jeuveau® should be destroyed. Jeuveau® vials are only for single-dose use. It should only be used once after reconstitution.