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R. Aparicio Hernández, et al. Durante el desarrollo clínico las reacciones adversas acae-cidas con Gardasil 9® han sido en general de intensidad leve-moderada, las más comunes las relativas al punto de inocula-ción; apareciendo en los primeros 5 días postvacunación: dolor (89,9%), inflamación (40%), eritema (34%) y prurito (5,5%). Además de eventos sistémicos (55%) con predominancia de la cefalea (14,6%), seguido con menor porcentaje de aparición: náuseas, fatiga y mareo. El 26 de marzo de 2015 el Comité de Medicamentos de Uso Humano de la Agencia Europea del Medicamento adoptó una opinión positiva respecto al medicamento. BIBLIOGRAFÍA 1. Agencia Española de Medicamentos y Productos Sanitarios . Informe mensual sobre Medicamentos de Uso Humano y Productos Sanitarios Mayo 2015. Disponible en: http://www.aemps.gob.es/informa/boletinMen-sual/ 2015/mayo/boletin-mayo.htm#nuevosMed 2. Committe for Medical Products for Human Use (CHMP). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion_-_Initial_authorisation/human/003904/WC500187112.pdf 3. REYATAZ® (ATAZANOVIR). FICHA TÉCNICA. Disponible en: http:// www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Infor-mation/ human/000494/WC500056380.pdf 4. Deeks ED. Cobicistat: a review of its use as a pharmacokinetic enhan-cer of atazanavir and darunavir in patients with HIV-1 infection. Drugs. 2014 Feb;74(2):195-206. Disponible en: http://www.ncbi.nlm.nih.gov/pub-med/ 24343782 5. Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJes-us E, Antunes F et al. Cobicistat Versus Ritonavir as a Pharmacoenhan-cer of Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-Naive HIV Type 1–Infected Patients: Week 48 Results.J Infect Dis 2013 Jul;208(1):32-9. Disponible en: http://jid.oxfordjournals.org/con-tent/ 208/1/32.long 6. Agencia Española de Medicamentos y Productos Sanitarios . Informe men-sual sobre Medicamentos de Uso Humano y Productos Sanitarios Abril 2015. Disponible en: Disponible en: http://www.aemps.gob.es/informa/bole-tinMensual/ 2015/abril/boletin-abril.htm#nuevosMed 7. Committe for Medical Products for Human Use (CHMP). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion_-_Initial_authorisation/human/002749/WC500186149.pdf 8. Kjaer A, Knigge U. Use of radioactive substances in diagnosis and treatment of neuroendocrine tumors. Scand J Gastroenterol. 2015 Jun;50(6):740-7. Dis-ponible en: http://www.ncbi.nlm.nih.gov/pubmed/25959100 9. Yousefnia H, Jalilian AR, Zolghadri S. Preparation and evaluation of Lu-177 phytate Complex for Radiosynovectomy. World J Nucl Med. 2014 Jan;13(1):22- 7. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4149764/ 10. García E, Alberti A, Cruz arencibia J and Morin zorrilla J. Radiophar-maceuticals in metastatic bone pain palliation. Nucleus online. 2012, n.52:50-53. Disponible en: http://scielo.sld.cu/scielo.php?pid=S0864- 084X2012000200010&script=sci_abstract 11. Chakraborty S, Vimalnath KV, Rajeswari A, Shinto A, Sarma HD, Kama-leshwaran K et al. Preparation, evaluation, and first clinical use of 177Lu-la-beled hydroxyapatite (HA) particles in the treatment of rheumatoid arthritis: utility of cold kits for convenient dose formulation at hospital radiopharma-cy. J Labelled Comp Radiopharm. 2014 Jun 15;57(7):453-62. Disponible en: http://www.ncbi.nlm.nih.gov/pubmed/24966157 12. Clinical trials. Study of Lutetium-177 Labeled cG250 in Patients With Ad-vanced Renal Cancer. Disponible en: https://clinicaltrials.gov/ct2/show/NCT 00142415?term=Lutetium+%28177Lu%29&rank=1 13. Food and Drug Administration. Approved Drugs. Disponible en : http:// www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf 14. Giugliano R, Ruff C, Braunwald E, Murphy S, Wiviott S, Halperin J, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369: 2093-2104. 194  Sanid. mil. 2015; 71 (3) 15. The Hokusai.VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013; 369: 1406-1415. 16. Agencia Española de Medicamentos y Productos Sanitarios. Informe men-sual sobre Medicamentos de Uso Humano y Productos Sanitarios Mar-zo 2015. Disponible en: http://www.aemps.gob.es/informa/boletinMen-sual/ 2015/marzo/boletin-marzo.htm 17. Häring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Broedl UC, et al. Empagliflozin as add-on to metformin in patients with type 2 dia-betes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabe-tes Care 2014; 37 (6): 1650-9. 18. Liakos A, Karagiannis T, Athanasiadou E, Sargianni M, Mainou M, Pa-pathedorou K, et al. Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab 2014; 16 (10): 984-93. 19. Neumiller JJ. Empagliflozin: a new sodium-glucose co-transporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes. Drugs Context 2014; 3: 212262. 20. Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Voole HJ, et al. Im-proved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrate multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care 2014; 37 (7): 1815-23. 21. Committe for Medical Products for Human Use (CHMP). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion_-_Initial_authorisation/human/003766/WC500187093.pdf 22. Zhang XL, Zhu QQ, Zhu L, Chen JZ, Chen QH, Li GN et al. Safety and efficacy of anti-PCSK9 antibodies: a meta-analysis of 25 randomized, con-trolled trials. BMC Med. 2015 Jun 23;13:123. Disponible en: http://www.ncbi. nlm.nih.gov/pubmed/26099511 23. Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Eng J Med 2015 Apr 16;372(16):1500-9. Disponible en: http://www. ncbi.nlm.nih.gov/pubmed/25773607 24. Koren MJ, Giugliano RP, Raal FJ, Sullivan D, Bolognese M, Langslet G et al. Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open- Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomi-zed trial. Circulation. 2014 Jan 14;129(2):234-43. Disponible en: http://www. ncbi.nlm.nih.gov/pubmed/24255061 25. Committe for Medical Products for Human Use (CHMP). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion_-_Initial_authorisation/human/003702/WC500187113.pdf 26. Lindstrom RL, Loden JC, Walters TR, Dunn SH, Whitaker JS, Kim T et al. Intracameral phenylephrine and ketorolac injection (OMS302) for mainte-nance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification. Clin Ophthalmol. 2014 Sep 5;8:1735-44. Disponible en : http://www.dovepress.com/intraca-meral- phenylephrine-and-ketorolac-injection-oms302-for-maintena-peer-reviewed- article-OPTH 27. Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med 2015; 372 (7): 621-30. 28. Alonso-Gordoa T, Díez JJ, Durán M, Grande E. Advances in thyroid cancer treatment: latest evidence and clinical potential. Ther Adv Med Oncol 2015; 7: 22-38. 29. Committe for Medical Products for Human Use (CHMP). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion/human/003728/WC500184907.pdf 30. Endo T, Ninanic M, Harofuyo M, Ogawa T, Akita K, Nemoto M et al. Neu-rochemistry and neuro- pharmacology of emesis the role of serotonin. Toxi-cology 2000;153(1-3):189-201. Disponible en : http://www.ncbi.nlm.nih.gov/ pubmed/?term=Endo+T%2C+Ninanic+M%2C+Harofuyo+M%2C+Ogaw a+T%2C+et+al.+Neurochemistry+and+neuro-+pharmacology+of+emesis +the+role+of+serotonin.+Toxicology+2000%3B153(1-3)%3A189-201. 31. Hesketh PJ, Rossi G, Rizzi G, Palmas M, Alyasova A, Bondarenko I et al. Efficacy and safety of NEPA, an oral combination of netupitant and pa-lonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pi-votal study. Ann Oncol. 2014 Jul;25(7):1340-6. Disponible en: http://annonc. oxfordjournals.org/content/25/7/1340.long


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