PULMOTIL AC- tilmicosin phosphate concentrate
Pulmotil AC by
Drug Labeling and Warnings
Pulmotil AC by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Evonik Corporation, TriRx Speke Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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SPL UNCLASSIFIED SECTION
Elanco™
AH0470
Pulmotil™
960 mltilmicosin phosphate
(250 mg/ml tilmicosin)Aqueous concentrate for oral use in drinking water.
For swine only.
Macrolide Antibiotic.
Do not inject this product. Injection of tilmicosin has been shown to be fatal in swine and non-human primates, and may be fatal in horses and goats.
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BOXED WARNING
(What is this?)
WARNING
Exposure to tilmicosin in humans has been associated with chest pain, increased heart rate, dizziness, headache, and nausea. Death has been reported following ingestion or injection of tilmicosin.
Avoid ingestion. Avoid direct skin and eye contact. In case of human exposure, call 1-800-722-0987 and consult a physician immediately.
NOTE TO THE PHYSICIAN:
The cardiovascular system is the target of toxicity and should be monitored closely. The primary cardiac effects are tachycardia and decreased contractility. Cardiovascular toxicity may be due to calcium channel blockade.
See User Safety Warnings for additional information.
- SPL UNCLASSIFIED SECTION
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Indications:
For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
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Dosage and Administration:
Must be diluted before administration to animals. Include in the drinking water to provide a concentration of 200 mg tilmicosin per liter (200 ppm). One 960 ml bottle is sufficient to medicate 1200 liters (320 gallons) of drinking water for pigs. The medicated water should be administered for (5) five consecutive days.
Use within 24 hours of mixing with water. Do not use rusty containers for medicated water as they may affect product integrity.
When using a water medicating pump with a 1:128 inclusion rate, add 1 bottle (960 ml) of Pulmotil AC per 2.5 gallons of stock solution.
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WARNINGS:
USER SAFETY WARNINGS: FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. SEE BOXED WARNING AND ENCLOSED PRODUCT INFORMATION (INCLUDING NOTE TO THE PHYSICIAN). Wear overalls, impervious gloves and eye protection when mixing and handling the product. Wash hands after handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. To report suspected adverse events, for technical assistance, or to obtain a Material Safety Data Sheet (MSDS), call 1-800-428-4441.
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SPL UNCLASSIFIED SECTION
Elanco™
AH0470
Pulmotil™
960 mltilmicosin phosphate
(250 mg/ml tilmicosin)
Aqueous concentrate for oral use in drinking water.
For swine only.
Macrolide Antibiotic.
Do not inject this product. Injection of tilmicosin has been shown to be fatal in swine and non-human primates, and may be fatal in horses and goats.
-
BOXED WARNING
(What is this?)
WARNING
Exposure to tilmicosin in humans has been associated with chest pain, increased heart rate, dizziness, headache, and nausea. Death has been reported following ingestion or injection of tilmicosin.
Avoid ingestion. Avoid direct skin and eye contact. In case of human exposure, call 1-800-722-0987 and consult a physician immediately.
NOTE TO THE PHYSICIAN:
The cardiovascular system is the target of toxicity and should be monitored closely. The primary cardiac effects are tachycardia and decreased contractility. Cardiovascular toxicity may be due to calcium channel blockade.
See User Safety Warnings for additional information.
- SPL UNCLASSIFIED SECTION
- Active Drug Ingredient:
- Description:
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Indications:
For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
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Dosage and Administration:
Must be diluted before administration to animals. Include in the drinking water to provide a concentration of 200 mg tilmicosin per liter (200 ppm). One 960 ml bottle is sufficient to medicate 1200 liters (320 gallons) of drinking water for pigs. The medicated water should be administered for (5) five consecutive days.
Use within 24 hours of mixing with water. Do not use rusty containers for medicated water as they may affect product integrity.
When using a water medicating pump with a 1:128 inclusion rate, add 1 bottle (960 ml) of Pulmotil AC per 2.5 gallons of stock solution.
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WARNINGS:
USER SAFETY WARNINGS: FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. SEE BOXED WARNING AND NOTE TO THE PHYSICIAN FOR ADDITIONAL INFORMATION. Wear overalls, impervious gloves and eye protection when mixing and handling the product. Wash hands after handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. To report suspected adverse events, for technical assistance, or to obtain a Material Safety Data Sheet (MSDS), call 1-800-428-4441.
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Note to the Physician:
The cardiovascular system is the target of toxicity and should be monitored closely. Cardiovascular toxicity may be due to calcium channel blockade. In dogs, administration of intravenous calcium offset tilmicosin-induced tachycardia and negative inotropy (decreased contractility). Dobutamine partially offset the negative inotropic effects induced by tilmicosin injection in dogs. ß-adrenergic antagonists, such as propranolol, exacerbated the negative inotropy of tilmicosin injection in dogs. Epinephrine potentiated lethality of tilmicosin injection in pigs. This antibiotic persists in tissues for several days.
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Precautions:
Do not allow horses or other equines access to water containing tilmicosin. The safety of tilmicosin has not been established in male swine intended for breeding purposes.
Always treat the fewest number of animals necessary to control a respiratory disease outbreak. Prescriptions shall not be refilled. Concurrent use of Pulmotil AC and another macrolide by any route is not advised. Use of another macrolide immediately following this use of Pulmotil AC is not advised.
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Adverse Reactions in Animals:
Decreased water consumption was observed in healthy pigs administered tilmicosin in target animal safety studies. Ensure that pigs have continuous access to medicated water during the treatment period. Monitor pigs for signs of water refusal and dehydration while being treated. If decreased water consumption occurs, replace the medicated drinking water with fresh non-medicated water and contact your veterinarian.
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Clinical Pharmacology:
Tilmicosin is a macrolide antibiotic with in vitro antibacterial activity primarily against Gram-positive bacteria, although certain Gram-negative bacteria are also susceptible. Macrolides interfere with bacterial protein synthesis by reversibly binding to the 50S subunit of the ribosome. They are typically regarded as being bacteriostatic, but at high concentrations can be bactericidal. When administered orally to pigs via the drinking water, tilmicosin is rapidly absorbed and slowly eliminated from the body. Tilmicosin distributes rapidly to the target tissues. Detectable levels are found in lung tissue as early as 6 hours and peak at about 5 days after the commencement of treatment. The relationship of serum tilmicosin concentration to lung tilmicosin concentration or the concentrations in bronchial secretion has not been determined. In addition, the extent to which total lung concentrations represent free (active) drug has not been defined. Therefore, no conclusions can be made with regard to the clinical relevance of elevated tilmicosin concentrations in the lung. Tilmicosin has been shown to concentrate within alveolar macrophages. It is also found at fairly high concentrations in liver and kidney tissue, as it is excreted both via the bile into the feces and also via the urine.
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Effectiveness:
The effectiveness of Pulmotil AC for the control of SRD associated with P. multocida and H. parasuis was confirmed in a natural infection field study across six U.S. sites. A total of 960 commercial-type grower pigs were enrolled and assigned to the tilmicosin-treated group (200 mg tilmicosin/L in drinking water for 5 consecutive days), or a nonmedicated control group. Pigs that 1) were found dead and were diagnosed with SRD, or 2) had a depression score and a respiratory score ≥ 2 (on a scale from 0 [normal] to 3 [severe]) and a rectal temperature of ≥ 104.5 °F were considered clinically affected. At each site, treatments were initiated when at least 15% of the pigs were classified as clinically affected. After the 5-day treatment period and a 4-day post-treatment period, pigs were evaluated for treatment success (respiration and depression scores of 1 or 0 and rectal temperature < 104.5 °F), and were euthanized and evaluated for lung lesions. A significantly higher (p = 0.0118) success rate (based on backtransformed least squares means) was detected for the tilmicosin-treated group (275/473, 58.64%) compared to the control group (230/475, 47.89%).
The effectiveness of Pulmotil AC for the control of SRD associated with M. hyopneumoniae in the presence of PRRSV was confirmed in an induced infection model study. A total of 340 commercial-type pigs were enrolled and challenged with M. hyopneumoniae (single infection) or M. hyopneumoniae and PRRSV (co-infection). When necropsied sentinel pigs had at least 5% lung lesion involvement, study pigs were treated with Pulmotil AC (200 mg tilmicosin/L in drinking water) or non-medicated water for 5 consecutive days. After the 5-day treatment period and a 4 day post-treatment period, pigs were euthanized and evaluated for lung lesions.
For both the single infection and co-infection groups, the lung lesion percentage was statistically significantly different (p = 0.005 and p = 0.0004, respectively) in favor of the tilmicosin phosphate-treated group (21.01% and 31.74%, respectively) compared with the control group (28.26% and 43.04%, respectively).
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Animal Safety:
A pharmacokinetic study was conducted to evaluate Pulmotil AC concentrate solution in pigs. The results were compared to pharmacokinetic data generated with Pulmotil 90 Type A medicated article (NADA 141-064). The data demonstrates that blood and tissue levels of tilmicosin when administered to pigs at 200 mg/L (ppm) in water were consistently lower than when tilmicosin was administered to pigs at 181 g/ton (200 ppm) in feed.
A target animal safety study was conducted to evaluate the tolerance of Pulmotil AC concentrate solution in pigs when administered in drinking water. Twenty pigs were administered medicated water at 0, 200, 400, or 600 mg/L (0, IX, 2X, or 3X the labeled dose) for 5 consecutive days or 200 mg/L for 10 consecutive days. No treatment-related lesions were observed in any animals at necropsy. Water consumption was decreased in all tilmicosin-treated groups compared to the non-medicated group. One pig in the 600 mg/L group was euthanized due to decreased water consumption, neurological signs attributed to severe dehydration, and subsequent refusal to drink non-medicated water. Two pigs in the 400 mg/L group had reduced water intake and displayed mild clinical signs attributed to dehydration. One pig recovered after being offered non-medicated water. The second pig completed the treatment regimen without intervention.
Hydration and water consumption were evaluated during the control of SRD effectiveness field study. Tilmicosin was administered to study pigs in drinking water at 200 mg/l for 5 consecutive days. There was no statistically significant difference in water consumption between tilmicosin-treated pigs and pigs receiving non-medicated water. A subset of study pigs (20 tilmicosin-treated pigs and 20 non-medicated pigs) were evaluated for hydration via a physical examination and analysis of blood samples for hematocrit, total protein, creatinine, and blood urea nitrogen. There were no abnormal physical examination findings or clinically relevant differences in clinical pathology variables between tilmicosin-treated pigs and pigs receiving non-medicated water.
- How Supplied:
- Storage Conditions:
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SPL UNCLASSIFIED SECTION
tilmicosina como fosfato (250 mg/ml tilmicosina)
Concentrado acuoso para uso oral en el agua de consumo.
Para ganado porcino únicamente. Antibiótico macrólido.
No inyecte este producto. Se demostró que la inyección de tilmicosina es fatal para el ganado porcino y en primates no humanos, y podría ser fatal para caballos y cabras.
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BOXED WARNING
(What is this?)
ADVERTENCIA
La exposición humana a la tilmicosina ha sido asociada con dolor en el pecho, aumento de la frecuencia cardíaca, mareo, dolor de cabeza y náuseas. Se ha informado de fallecimientos tras la ingestión o inyección de la tilmicosina.
Evite su ingestión. Evite el contacto directo con la piel y los ojos. En caso de que ocurra alguna exposición humana, llame al 1-800-722-0987 y consulte inmediatamente con el médico.
NOTA PARA EL MÉDICO:
El sistema cardiovascular es el objetivo de la toxicidad y debe controlarse atentamente. Los efectos cardíacos principales son taquicardia y una disminución de la contractilidad. La toxicidad cardiovascular puede deberse al bloqueo de los canales de calcio.
Examine las Advertencias de seguridad para el usuario para obtener información adicional.
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PRECAUTIONS
PRECAUCIÓN: las leyes federales establecen que el uso de este fármaco se restrinja a veterinarios con licencia o bajo la indicación de estos.
Lea cuidadosamente la información del producto que se adjunta para conocer los detalles completos. Indicacions: para el control de la enfermedad respiratoria porcina asociada con Pasteurella multocida y Haemophilus parasuis en grupos de cerdos de establecimientos en los que se diagnostica un brote de enfermedad respiratoria.
Para el control de la enfermedad respiratoria porcina asociada con Mycoplasma hyopneumoniae en la presencia del virus del síndrome reproductivo y respiratorio porcino (Porcine Reproductive and Respiratory Syndrome Virus, PRRSV) en grupos de cerdos en edificios donde se diagnostica un brote de enfermedad respiratoria.
Posología y administración: se debe diluir antes de administrarse a los animales. Incluir en el agua de consumo para proporcionar una concentración de 200 mg de tilmicosina por litro (200 ppm). Un frasco de 960 ml es suficiente para medicar 1200 litros (320 galones) de agua de consumo para cerdos. El agua medicada debería administrarse durante 5 (cinco) días consecutivos. Usar dentro de las 24 horas de mezclarlo con agua. No use recipientes oxidados para el agua medicada, ya que los mismos podrían afectar la integridad del producto.
Si se usa una bomba de medicación de agua con una tasa de inclusión de 1:128, agregar 1 frasco (960 ml) de Pulmotil AC por cada 2.5 galones de solución concentrada.
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WARNINGS
ADVERTENCIAS:
ADVERTENCIAS DE SEGURIDAD PARA EL USUARIO:
PARA SU USO EN ANIMALES ÚNICAMENTE. ESTE PRODUCTO NO DEBE UTILIZARSE EN SERES HUMANOS. MANTENGA
FUERA DEL ALCANCE DE LOS NIÑOS. EXAMINE LA ADVERTENCIA PRESENTE EN LA CAJA Y LA INFORMACIÓN DEL PRODUCTO QUE SE ADJUNTA (INCLUIDA LA NOTA PARA EL MÉDICO). Use monos de trabajo, guantes impermeables y protección ocular al mezclar y manipular el producto. Lávese las manos después de manipular el producto. Lave las partes afectadas en caso de producirse el contacto con la piel. Si se produce contacto accidental con los ojos, inmediatamente enjuague bien con agua.
Para informar de una sospecha de eventos adversos, obtener asistencia técnica o una hoja de datos de seguridad del material (Material Safety Data Sheet, MSDS), llame al 1-800-428-4441.
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SPL UNCLASSIFIED SECTION
Elanco™
AH0470
960mL
tilmicosina como fosfato (250 mg/ml tilmicosina)
(Tilmicosina como fosfato de tilmicosina 250 mg/ml).
Concentrado acuoso para uso oral en el agua de consumo.
Para ganado porcino únicamente. Antibiótico macrólido.
No inyecte este producto. Se demostró que la inyección de tilmicosina es fatal para el ganado porcino y en primates no humanos, y podría ser fatal para caballos y cabras.
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BOXED WARNING
(What is this?)
ADVERTENCIA
La exposición humana a la tilmicosina ha sido asociada con dolor en el pecho, aumento de la frecuencia cardíaca, mareo, dolor de cabeza y náuseas. Se ha informado de fallecimientos tras la ingestión o inyección de la tilmicosina. Evite su ingestión. Evite el contacto directo con la piel y los ojos. En caso de que ocurra alguna exposición humana, llame al 1-800-722-0987 y consulte inmediatamente con el médico.
NOTA PARA EL MÉDICO:
El sistema cardiovascular es el objetivo de la toxicidad y debe controlarse atentamente. Los efectos cardíacos principales son taquicardia y una disminución de la contractilidad. La toxicidad cardiovascular puede deberse al bloqueo de los canales de calcio.
Examine las Advertencias de seguridad para el usuario para obtener información adicional.
- PRECAUTIONS
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ACTIVE INGREDIENT
Ingrediente fármaco activo: tilmicosina (como fosfato de tilmicosina) 250 mg/ml Descripción: Pulmotil es una formulación del antibiótico tilmicosina. La tilmicosina se produce en forma semisintética y pertenece a la clase de antibióticos macrólidos. Cada mililitro (ml) de solución de concentrado acuoso Pulmotil contiene 250 mg de tilmicosina.
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INDICATIONS & USAGE
Indicacions: para el control de la enfermedad respiratoria porcina asociada con Pasteurella multocida y Haemophilus parasuis en grupos de cerdos de establecimientos en los que se diagnostica un brote de enfermedad respiratoria.
Para el control de la enfermedad respiratoria porcina asociada con Mycoplasma hyopneumoniae en la presencia del virus del síndrome reproductivo y respiratorio porcino (Porcine Reproductive and Respiratory Syndrome Virus, PRRSV) en grupos de cerdos en edificios donde se diagnostica un brote de enfermedad respiratoria.
Posología y administración: se debe diluir antes de administrarse a los animales. Incluir en el agua de consumo para proporcionar una concentración de 200 mg de tilmicosina por litro (200 ppm). Un frasco de 960 ml es suficiente para medicar 1200 litros (320 galones) de agua de consumo para cerdos. El agua medicada debería administrarse durante 5 (cinco) días consecutivos. Usar dentro de las 24 horas de mezclarlo con agua. No use recipientes oxidados para el agua medicada, ya que los mismos podrían afectar la integridad del producto.
Si se usa una bomba de medicación de agua con una tasa de inclusión de 1:128, agregar 1 frasco (960 ml) de Pulmotil AC por cada 2.5 galones de solución concentrada.
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WARNINGS
ADVERTENCIAS:
ADVERTENCIAS DE SEGURIDAD PARA EL USUARIO: PARA SU USO EN ANIMALES ÚNICAMENTE. ESTE PRODUCTO NO DEBE UTILIZARSE EN SERES HUMANOS. MANTENGA FUERA DEL ALCANCE DE LOS NIÑOS. EXAMINE LA ADVERTENCIA Y LA NOTA PARA EL MÉDICO PARA ADICIONAL INFORMACIóN. Use monos de trabajo, guantes impermeables y protección ocular al mezclar y manipular el producto. Lávese las manos después de manipular el producto. Lave las partes afectadas en caso de producirse el contacto con la piel. Si se produce contacto accidental con los ojos, inmediatamente enjuague bien con agua.
Para informar de una sospecha de eventos adversos, obtener asistencia técnica o una hoja de datos de seguridad del material (Material Safety Data Sheet, MSDS), llame al 1-800-428-4441.
ADVERTENCIA ACERCA DE RESIDUOS: los cerdos para consumo humano no se deberán faenar dentro de los 7 días posteriores al último tratamiento con este producto.
Nota para el médico:
El sistema cardiovascular es el objetivo de la toxicidad y debe controlarse atentamente. La toxicidad cardiovascular puede deberse al bloqueo de los canales de calcio. En los perros, la administración de calcio por vía intravenosa contrarresta la taquicardia inducida por la tilmicosina y el inotropismo negativo (disminución de la contractilidad). La dobutamina contrarresta parcialmente los efectos inotrópicos negativos inducidos por la tilmicosina en perros. Los antagonistas ß adrenérgicos, como el propranolol, exacerbaron el inotropismo negativo de la inyección de tilmicosina en perros. La epinefrina potenció la letalidad de la inyección de tilmicosina en cerdos. Este antibiótico persiste en los tejidos durante varios días.
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PRECAUTIONS
Precauciones:
No permita que caballos u otros equinos accedan al agua que contiene tilmicosina. No se ha establecido la seguridad de la tilmicosina en cerdos machos que se usan con fines de reproducción.
Trate siempre el menor número de animales necesario para controlar un brote de enfermedad respiratoria. Las recetas no deben renovarse.
No se recomienda el uso simultáneo de Pulmotil AC y otro macrólido por cualquier vía de administración. No se recomienda el uso de otro macrólido inmediatamente después de este uso de Pulmotil AC.
Reacciones adversas en animales: se observó una disminución en el consumo de agua en cerdos saludables a los que se administró tilmicosina en estudios de seguridad en animales objetivo. Asegúrese de que los cerdos tengan acceso constante al agua medicada durante el período de tratamiento. Controle que los cerdos no presenten signos de rechazo al agua y deshidratación mientras se los esté tratando. Si se produce una disminución en el consumo de agua, reemplace el agua de consumo medicada por agua potable sin medicar y comuníquese con su veterinario.
Presentación: Pulmotil AC se proporciona en botellas de plástico, color ámbar de 960 ml selladas con tapas plásticas con rosca.
- Principal Display Panel – 960 mL Bottle Label
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INGREDIENTS AND APPEARANCE
PULMOTIL AC
tilmicosin phosphate concentrateProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 58198-0470 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tilmicosin phosphate (UNII: SMH7U1S683) (tilmicosin - UNII:XL4103X2E3) tilmicosin phosphate 250 g in 1 mL Inactive Ingredients Ingredient Name Strength edetate disodium (UNII: 7FLD91C86K) propyl gallate (UNII: 8D4SNN7V92) phosphoric acid (UNII: E4GA8884NN) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58198-0470-1 960 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141361 02/13/2014 Labeler - Elanco US Inc. (966985624)
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