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Injection Workbook for Chronic Migraine Chronic for Workbook Injection Bleed: Live: Doc. Size: File Location:File Aesthetics Studio AD/Designer: Client: Introduction This workbook is designed to help you learn and apply the proven BOTOX® Injection Paradigm. It also contains information to help injectors identify appropriate BOTOX® candidates, understand + 0.125” w 8.75" xh11.25" w 8.75" Bret P Bret Botox CM procedure-related anatomy, manage patient expectations, and integrate the procedure into the practice. Reference material accompanying this workbook: Reconstitution pocket guide NOTES: Studio Artist:Studio Kristina K Output Scale: Output T r a f fi c M g rNumber: : Job know if weneed to “reset” content margins and let vendor re-do any adjustments. See Omar for any questions.( 100% Steve S 153331 — ) Die lines do not print. Creep adjustments le; waiting done by vendor on Michelle are still Mto review in fi and let Studio Q/C Check: Size: Page Print Prod Mgr: Description: TbldO Michelle M Michelle Cover Update Workbook Injection Date: Revision #: Revision Brand Lead: Output:Final IMPORTANT SAFETY INFORMATION (continued) CONTRAINDICATIONS 02/25/2016 collect Omar H CMYK +PMS 144 BOTOX® is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. WARNINGS AND PRECAUTIONS Lack of Interchangeability Between Botulinum Toxin Products The potency Units of BOTOX® are specifi c to the preparation and assay method utilized. They X are not interchangeable with other preparations of botulinum toxin products and, therefore, Comp Mech Lite Mechanical Units of biological activity of BOTOX® cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specifi c assay method. Spread of Toxin Effect See Boxed Warning. No defi nitive serious adverse event reports of distant spread of toxin effect associated with BOTOX® for 2 chronic migraine at the labeled dose have been reported. Please see additional Important Safety Information about BOTOX about Information Safety Important additional see Please on following pages. following on APC55BL15 153331 APC55BL15 1-800-44-BOTOX BOTOXReimbursementSolutions.com AccessBSC.com BOTOXMedical.com/ChronicMigraine ® © 2015 Allergan. All rights reserved. All trademarks are the property of their respective owners. respective their of property the are trademarks All reserved. rights All Allergan. 2015 © those used to treat cervical dystonia and spasticity and at lower doses. lower at and spasticity and dystonia cervical treat to used those in approved indications, cases of spread of effect have been reported at doses comparable to to comparable doses at reported been have effect of spread of cases indications, approved in predispose them to these symptoms. In unapproved uses, including spasticity in children, and and children, in spasticity including uses, unapproved In symptoms. these to them predispose 26. Analysis Program Savings 2014; December to January Inc., Allergan, le, fi on Data Analysis. Policy Preventives Inc.; Allergan, and other conditions, particularly in those patients who have an underlying condition that would would that condition underlying an have who patients those in particularly conditions, other and 25. 24. Data on fi le, le, fi on Data 2010;50(8):1273-1277. Headache migraine. in pain neck of prevalence The Y. Nie Y, Truong AG, Finkel C, Millen S, Ford AH, Calhoun 23. 22. Data on fi le, Allergan, Inc.; Summary of Clinical Safety. Safety. Clinical of Summary Inc.; Allergan, le, fi on Data Report. Final 2 PREEMPT Inc.; Allergan, le, fi on Data Report. Final 1 PREEMPT Inc.; Allergan, in children treated for spasticity, but symptoms can also occur in adults treated for spasticity spasticity for treated adults in occur also can symptoms but spasticity, for treated children in 21. 20. Data on fi le, le, fi on Data 2006. Wilkins; & Williams Lippincott MD: Baltimore, ed. 28th . Dictionary Medical Stedman’s 2011. Publishing-USA; Medical People’s CT: 19. 3rd ed. Shelton, Shelton, ed. 3rd Surgery. Maxillofacial and Oral of Principles Peterson’s P. Waite P, Larsen GE, Ghali M, Miloro 2008. Livingstone; Churchill England: London, threatening, and there have been reports of death. The risk of symptoms is probably greatest greatest probably is symptoms of risk The death. of reports been have there and threatening, 18. 40th ed. ed. 40th . Practice Clinical of Basis Anatomical The Anatomy: Gray’s ed. S, Standring 2005;45(4):293-307. Headache trial. placebo-controlled double-blind, been reported hours to weeks after injection. Swallowing and breathing diffi culties can be life life be can culties diffi breathing and Swallowing injection. after weeks to hours reported been ) for the prophylactic treatment of chronic daily headache: a randomized, randomized, a headache: daily chronic of treatment prophylactic the for ) (BOTOX A type toxin Botulinum Group. Study CDH R, Gibson J, Turkel C; BOTOX C; Turkel J, Gibson R, ® ® 17. Mathew NT, Frishberg BM, Gawel M, Dimitrova Dimitrova M, Gawel BM, Frishberg NT, Mathew 2005;80(9):1126-1137. Proc Clin Mayo trial. placebo-controlled double-blind, randomized, a headache: dysphonia, dysarthria, urinary incontinence, and breathing diffi culties. These symptoms have have symptoms These culties. diffi breathing and incontinence, urinary dysarthria, dysphonia, SD, Stark SR, Lucas SM, Christie SN, DeGryse RE, Turkel CC; BoNTA-039 Study Group. Botulinum toxin type A for the prophylactic treatment of chronic daily daily chronic of treatment prophylactic the for A type toxin Botulinum Group. Study BoNTA-039 CC; Turkel RE, DeGryse SN, Christie SM, Lucas SR, Stark SD, effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphagia, ptosis, diplopia, weakness, muscle generalized asthenia, include may These effects. 16. Silberstein Silberstein 2007;47(4):486-499. Headache study. exploratory placebo-controlled double-blind, randomized, a migraine: episodic of treatment prophylactic 15. North American Episodic Migraine Study Group. Botulinum toxin type A A type toxin Botulinum Group. Study Migraine Episodic American North Aurora SK, Gawel M, Brandes JL, Pokta S, VanDenburgh AM; BOTOX AM; VanDenburgh S, Pokta JL, Brandes M, Gawel SK, Aurora 492-503. ® may spread from the area of injection to produce symptoms consistent with botulinum toxin toxin botulinum with consistent symptoms produce to injection of area the from spread may . 2007;27(6): . Cephalalgia headaches. migraine episodic of prophylaxis the for (BoNTA) A type toxin botulinum of treatments multiple of study group parallel Schoenen J, Pascual J, Lei X, Thompson C; for the European BoNTA Headache Study Group. A multicentre, double-blind, randomized, placebo-controlled, placebo-controlled, randomized, double-blind, multicentre, A Group. Study Headache BoNTA European the for C; Thompson X, Lei J, Pascual J, Schoenen and all botulinum toxin products products toxin botulinum all and Postmarketing reports indicate that the effects of BOTOX of effects the that indicate reports Postmarketing ® 14. Relja M, Poole AC, AC, Poole M, Relja 2007;8(6):478-485. Med Pain migraine. episodic of prevention the in doses and sites injection A type toxin botulinum of comparison 13. Saper JR, Mathew NT, Loder EW, DeGryse R, VanDenburgh AM; for the BoNTA-009 Study Group. A double-blind, randomized, placebo-controlled placebo-controlled randomized, double-blind, A Group. Study BoNTA-009 the for AM; VanDenburgh R, DeGryse EW, Loder NT, Mathew JR, Saper WARNING: DISTANT SPREAD OF TOXIN EFFECT TOXIN OF SPREAD DISTANT WARNING: . 2006;7(10):688-696. 2006;7(10):688-696. Pain J prophylaxis. migraine for A type toxin botulinum with treatments repeated of studies controlled randomized, sequential, three 12. Elkind AH, O’Carroll P, Blumenfeld A, DeGryse R, Dimitrova R; for the BoNTA-024-026-036 Study Group. A series of of series A Group. Study BoNTA-024-026-036 the for R; Dimitrova R, DeGryse A, Blumenfeld P, O’Carroll AH, Elkind 2000;123(6):669-676. Surg Neck Otolaryngol Head Head Otolaryngol study. open-label an headaches: migraine of treatment for ) Brin MF, Blitzer A, Schoenrock LD, Pogoda JM. Botulinum toxin type A (BOTOX A type toxin Botulinum JM. Pogoda LD, Schoenrock A, Blitzer MF, Brin ® IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING BOXED INCLUDING INFORMATION, SAFETY IMPORTANT 11. Binder WJ, WJ, Binder 2010;50(9):1406-1418. Headache program. clinical PREEMPT the on based paradigm treatment effective and well-tolerated, safe, a migraine: 10. Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic chronic for onabotulinumtoxinA of injection of Method WJ. Binder CC, Turkel SK, Aurora DW, Dodick SD, Silberstein A, Blumenfeld 2010;50(6):921-936. Headache program. clinical PREEMPT the of phases placebo-controlled randomized, double-blind, the from results pooled migraine: chronic of treatment (14 headache days or fewer per month) in 7 placebo-controlled studies. placebo-controlled 7 in month) per fewer or days headache (14 9. Dodick DW, Turkel CC, DeGryse RE, et al; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for for OnabotulinumtoxinA Group. Study Migraine Chronic PREEMPT al; et RE, DeGryse CC, Turkel DW, Dodick 2003;43(4):336-342. Headache migraine. Safety and effectiveness have not been established for the prophylaxis of episodic migraine migraine episodic of prophylaxis the for established been not have effectiveness
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