NABOTA POWDER FOR SOLUTION FOR INJECTION 100 UNITS/VIAL [SIN16680P]

Product Info

NABOTA POWDER FOR SOLUTION FOR INJECTION 100 UNITS/VIAL

[SIN16680P]

4.1 Therapeutic indications
Temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) associated with corrugator muscle and/or procerus muscle activities, in adults below 65 years of age.

4.2 Posology and method of administration
For intramuscular use only.
Reconstitute by diluting with preservative-free, sterile saline solution to make 100units/2.5mL (4units/0.1mL). Using a sterile 30-gauge needle, inject a dose of 0.1mL into each of the 5 injection sites: 2 injections in each corrugator muscle and 1 injection in the procerus muscle for a total dose of 20 Units.

Physical manipulation (such as rubbing) of the injection site in the immediate post-administration period should be avoided.

In order to reduce the complication of ptosis, injections near the levator palpebrae superioris muscle must be avoided, particularly in patients with larger brow-depressor complexes (depressor supercilii). 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 this product into the blood vessel. The thumb or index finger should be placed firmly below the orbital rim in order to prevent extravasation below the orbital rim. The needle should be oriented superiorly and medially during the 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 supercilii muscle pull the brow inferiorly. This creates a frown or “furrowed brow”. The location, size, and use of the muscles vary markedly among individuals. An effective dose for facial lines is determined by gross observation of the patient’s ability to activate the superficial muscles injected.

Each treatment lasts approximately three to four months. More frequent injection of this product is not recommended because the safety and efficacy are not established.

Typically, the initial doses of botulinum toxin induce chemical denervation of the injected muscles one to two days after injection, increasing in intensity during the first week.

Elderly patients
NABOTA is not recommended for use in patients over 65 years of age.

Preparation and Dilution Technique
Prior to injection, reconstitute the product with a preservative-free, sterile saline. 0.9% sodium chloride injection is the recommended diluent. Draw up the proper amount of 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. Record the date and time of reconstitution on the label. This product should be administered within 24 hours after reconstitution. During this period, reconstituted product should be stored in a refrigerator (2–8°C). Reconstituted product should be clear, colourless 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 treatment only during a single session.

4.3 Contraindications

• Patients who are hypersensitive to any ingredient in the formulation of this product

• Patients who have neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis). The diseases may be exacerbated due to the muscle relaxation activity of this drug product.

• Pregnant women, women of childbearing potential or nursing mothers.

• Infection or inflammation at the proposed injection sites.