Medesthetics

NOV-DEC 2015

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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incobotulinumtoxinA Try XEOMIN in your practice. Call a Merz representative for a FREE sample. Copyright © 2015 Merz North America, Inc. All rights reserved. MERZ AESTHETICS and the MERZ AESTHETICS logo are trademarks and XEOMIN is a registered trademark of Merz Pharma GmbH & Co. KGaA. Botox is a registered trademark of Allergan, Inc. ML01388-00 XEOMIN is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s), as injection could lead to severe local or disseminated infection. WA S RECA S • The potency units of XEOMIN are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of XEOMIN cannot be compared to or converted into units of any other botulinum toxin products. • Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted. • Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing diffi culties. Patients with pre-existing swallowing or breathing diffi culties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube and aspiration may result from severe dysphagia [See Boxed Warning]. • Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN. In order to reduce the complication of ptosis the following steps should be taken: » avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes; » corrugator injections should be placed at least 1 cm above the bony supraorbital ridge. • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically signifi cant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN. • XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD have ever been reported for albumin. ADVERSE REAC S Glabellar Lines: The most commonly observed adverse reaction (incidence * 2% of patients and greater than placebo) for XEOMIN was Headache (5.4%). AC Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. US REG A CY Pregnancy Category C: There are no adequate and well- controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefi t justifi es the potential risk to the fetus. PEDIATRIC USE The safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established. CO A AT Please see Brief Summary of full Prescribing Information on the following pages. IMPORT AFETY ORMA C )

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