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                        <name>Tylan 50</name>
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                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>™</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylan™ 50 Injection</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(tylosin injection) 50 mg per mL</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For Use In Cattle and Swine Only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">An Antibiotic</content>
                  </paragraph>
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               <title>Indications: </title>
               <text>
                  <paragraph>In Beef Cattle and Non-lactating Dairy Cattle, Tylan 50 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with <content styleCode="italics">Pasteurella multocida</content> and <content styleCode="italics">Arcanobacterium pyogenes</content>; foot rot (necrotic pododermatitis) and calf diphtheria caused by <content styleCode="italics">Fusobacterium necrophorum</content> and metritis caused by <content styleCode="italics">Arcanobacterium pyogenes</content>. </paragraph>
                  <paragraph>In Swine, Tylan 50 Injection is indicated for use in the treatment of swine arthritis caused by <content styleCode="italics">Mycoplasma hyosynoviae</content>; swine pneumonia caused by <content styleCode="italics">Pasteurella</content> spp.; swine erysipelas caused by <content styleCode="italics">Erysipelothrix rhusiopathiae</content>; swine dysentery associated with <content styleCode="italics">Treponema hyodysenteriae</content> when followed by appropriate medication in the drinking water and/or feed. </paragraph>
                  <paragraph>Each mL contains 50 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.</paragraph>
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               <title>ADMINISTRATION AND DOSAGE: </title>
               <text>
                  <paragraph>Tylan 50 Injection is administered intramuscularly. </paragraph>
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                        <paragraph>
                           <content styleCode="bold">BEEF CATTLE AND NON-LACTATING DAIRY CATTLE—</content>Inject intramuscularly 8 mg per pound of body weight one time daily (1 mL per 6.25 pounds). Treatment should be continued 24 hours following remission of disease signs, not to exceed 5 days. Do not inject more than 10 mL per site. </paragraph>
                        <paragraph>This formulation is recommended for use in calves weighing less than 200 pounds. </paragraph>
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                        <paragraph>
                           <content styleCode="bold">SWINE—</content>Inject intramuscularly 4 mg per pound of body weight (1 mL per 12.5 pounds) twice daily. Treatment should be continued 24 hours following remission of disease signs, not to exceed 3 days. Do not inject more than 5 mL per site. </paragraph>
                        <paragraph>Read accompanying directions fully before use. </paragraph>
                        <paragraph>
                           <content styleCode="bold">CAUTION:</content>
                        </paragraph>
                        <paragraph>Do not mix Tylan 50 Injection with other injectable solutions as this may cause a precipitation of the active ingredients. </paragraph>
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               <title>WARNINGS: </title>
               <text>
                  <paragraph>NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Adverse reactions, including shock and death, may result from overdosage in baby pigs.</content>
                  </paragraph>
                  <paragraph>Do not attempt injection into pigs weighing less than 6.25 pounds (0.5 mL) unless the syringe is capable of accurately delivering 0.1 mL. </paragraph>
                  <paragraph>Do not administer to horses or other equines. Injection of tylosin in equines has been fatal. </paragraph>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">RESIDUE WARNING: Swine:</content>
                        </paragraph>
                        <paragraph>Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product. </paragraph>
                     </text>
                     <effectiveTime value="20230717"/>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">RESIDUE WARNING: Cattle:</content>
                        </paragraph>
                        <paragraph>Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. </paragraph>
                        <paragraph>If tylosin medicated drinking water is used as a follow-up treatment for swine dysentery, the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues. </paragraph>
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               <title>STORAGE CONDITIONS: </title>
               <text>
                  <paragraph>Store at or below 25°C (77°F). Use this product within 90 days of the first puncture. Puncture the 100 mL vial a maximum of 30 times. If more than 30 punctures are anticipated, the use of multi-dosing equipment is recommended. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use.</paragraph>
                  <paragraph>Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.</paragraph>
                  <paragraph>© 2025 Elanco or its affiliates</paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under NADA # 012-965</content>
                  </paragraph>
                  <paragraph>For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or <linkHtml href="http://www.fda.gov/reportanimalae">http://www.fda.gov/reportanimalae</linkHtml>.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content>
                     <br/>
                     <content styleCode="bold">Elanco US Inc.</content>
                     <br/>
                     <content styleCode="bold">Greenfield, IN  46140, US</content>
                  </paragraph>
                  <paragraph>Product of Ireland <br/>AH0205<br/>YL231481X</paragraph>
                  <paragraph>Product of Brazil<br/>AH0205<br/>YL301933C</paragraph>
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               <text>
                  <paragraph> </paragraph>
                  <paragraph> </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>™</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylan™ 50 Inyectable</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(tilosina inyectable) 50 mg por ml</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Para uso exclusivo en ganado vacuno y cerdos</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Un antibiótico:</content>
                  </paragraph>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Indicaciones: </title>
               <text>
                  <paragraph>En ganado vacuno y vacas lecheras no lactantes, Tylan 50 INYECTABLE se indica para el tratamiento del complejo respiratorio bovino (fiebre de embarque, neumonía), generalmente asociado con <content styleCode="italics">Pasteurella multicida</content> y <content styleCode="italics">Arcanobacterium pyogenes</content>, pietín (pododermatitis necrótica), difteria de los terneros provocada por <content styleCode="italics">Fusobacterium necrophorum</content> y metritis provocada por <content styleCode="italics">Arcanobacterium pyogenes</content>. </paragraph>
                  <paragraph>En cerdos, Tylan 50 INYECTABLE se indica para el tratamiento de artritis en cerdos provocada por <content styleCode="italics">Mycoplasma hyosynoviae</content>, neumonía porcina causada por <content styleCode="italics">Pasteurella</content> spp., erisipelas porcinas provocadas por <content styleCode="italics">Erysipelothrix rhusiopathiae</content>, disentería porcina asociada con <content styleCode="italics">Treponema hyodysenteriae</content> cuando es tratada con el medicamento apropiado a través del alimento y/o el agua para beber. </paragraph>
                  <paragraph>Cada ml contiene 50 mg de actividad de tilosina (como tilosina base) en propilenglicol al 50 por ciento, alcohol bencílico al 4 por ciento y agua para inyección. </paragraph>
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               <title>POSOLOGÍA Y ADMINISTRACIÓN: </title>
               <text>
                  <paragraph>Tylan 50 INYECTABLE se administra por vía intramuscular. </paragraph>
               </text>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">GANADO VACUNO Y VACAS LECHERAS NO LACTANTES—</content>Inyectar por vía intramuscular 8 mg por libra de peso corporal una vez al día (1 ml cada 6.25 libras). El tratamiento debe continuarse durante 24 horas luego de la remisión de los signos de la enfermedad sin extenderse más de 5 días. No aplicar más de 10 ml por lugar de inyección. </paragraph>
                        <paragraph>Se recomienda aplicar esta formulación en terneros que pesen menos de 200 libras. </paragraph>
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                        <paragraph>
                           <content styleCode="bold">CERDOS—</content>Inyectar por vía intramuscular 4 mg por libra de peso corporal (1 ml cada 12.5 libras) dos veces al día. El tratamiento debe continuarse durante 24 horas luego de la remisión de los signos de la enfermedad sin extenderse más de 3 días. No aplicar más de 5 ml por lugar de inyección. </paragraph>
                        <paragraph>Leer todas las instrucciones adjuntas antes de usar. </paragraph>
                        <paragraph>
                           <content styleCode="bold">PRECAUCIÓN:</content>
                        </paragraph>
                        <paragraph>No mezclar la inyección Tylan 50 con otras soluciones inyectables ya que esto puede ocasionar la precipitación de los principios activos. </paragraph>
                     </text>
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               <title>ADVERTENCIAS: </title>
               <text>
                  <paragraph>ESTE PRODUCTO NO DEBE UTILIZARSE EN SERES HUMANOS. MANTENER FUERA DEL ALCANCE DE LOS NIÑOS. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Pueden ocurrir reacciones adversas, incluidos shock y muerte, en caso de sobredosis en crías de cerdos.</content>
                  </paragraph>
                  <paragraph>No administrar la inyección a cerdos que pesen menos de 6.25 libras (0.5 ml) a menos que la jeringa pueda administrar 0.1 ml de forma precisa. </paragraph>
                  <paragraph>No administrar a caballos u otros equinos. La inyección de tilosina en equinos ha resultado mortal. </paragraph>
               </text>
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                     <title>ADVERTENCIA ACERCA DE RESIDUOS: </title>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Ganado porcino:</content> el ganado porcino previsto para consumo humano no se debe faenar durante los 14 días posteriores al último uso de este producto farmacológico.</paragraph>
                     </text>
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                     <title>ADVERTENCIA ACERCA DE RESIDUOS: </title>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Ganado bovino:</content> el ganado bovino previsto para consumo humano no se debe faenar durante los 21 días posteriores al último uso de este producto farmacológico. Este producto farmacológico no está aprobado para su uso en ganado bovino lechero hembra de 20 meses de edad o más, incluidas las vacas lecheras secas. El uso en este ganado bovino puede producir residuos farmacológicos en la leche y/o en los terneros nacidos de estas vacas. Este producto no está aprobado para el uso en terneros que se procesarán para carne de ternera. No se ha establecido un período de retiro del fármaco en terneros prerrumiantes. </paragraph>
                        <paragraph>Si se suministra agua para beber con tilosina como tratamiento de seguimiento para la disentería porcina, el animal debe recibir posteriormente alimento que contenga entre 40 y 100 gramos de tilosina por tonelada durante 2 semanas para garantizar la depleción de los residuos de tejidos. </paragraph>
                     </text>
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               <title>CONDICIONES DE ALMACENAMIENTO: </title>
               <text>
                  <paragraph>Almacenar a una temperatura de 25 °C (77 °F) o inferior. Utilice este producto dentro de los 90 días posteriores a la primera punción. Perfore el vial de 100 ml un máximo de 30 veces. Si se anticipan más de 30 punciones, se recomienda el uso de equipo de dosificación. Cuando utilice una punta o aguja desprendible con un diámetro interior mayor que el calibre 16, deseche cualquier producto restante en el vial inmediatamente después de usarlo. </paragraph>
                  <paragraph>Tylan, Elanco y el logo de la barra diagonal son marcas de Elanco o sus afiliadas. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Aprobado por la FDA bajo NADA #012-965</content>
                  </paragraph>
                  <paragraph>Para obtener información adicional sobre cómo informar experiencias adversas de medicamentos para medicamentos animales, comuníquese con la FDA al 1-888-FDA-VETS o <linkHtml href="http://www.fda.gov/reportanimalae">http://www.fda.gov/reportanimalae</linkHtml>.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Fabricado por: Elanco US Inc.</content>
                     <br/>
                     <content styleCode="bold">Greenfield, IN  46140, USA</content>
                  </paragraph>
                  <paragraph>Producto de Irlanda <br/>AH0205<br/>YL231481X</paragraph>
                  <paragraph>Producto de Brasil<br/>AH0205<br/>YL301933C</paragraph>
               </text>
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               <title>Principal Display Panel - Tylan 50 Injection Carton Label </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Elanco™</content>
                  </paragraph>
                  <paragraph>AH0205 </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylan™ 50</content>
                     <br/>
                     <content styleCode="bold">Injection</content>
                  </paragraph>
                  <paragraph>™ </paragraph>
                  <paragraph>
                     <content styleCode="bold">100 mL</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(tylosin injection)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">50 mg per mL</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For Use In Cattle</content>
                     <br/>
                     <content styleCode="bold">and Swine Only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Federal law restricts<br/>this drug to use by or on the order<br/>of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">The Original Tylan 50</content>
                     <br/>
                     <content styleCode="bold">An Antibiotic For</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Cattle</content>
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                        <caption>•</caption>
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                        <caption>•</caption>
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                        <caption>•</caption>
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                  <paragraph>™ </paragraph>
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                  <paragraph>™ </paragraph>
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                     <content styleCode="bold">PRECAUCIÓN: </content>Las leyes federales <br/>estabablecen que el uso de este <br/>fármaco se restrinja a veterinarios<br/>con licencia o bajo la indicación <br/>de estos.</paragraph>
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