Animal NDC 23243-7287-1 Tilmovet Ac Oral Solution

Table of Contents

• Warnings And Precautions
• Boxed Warning
• General Precautions
• Indications & Usage
• Dosage & Administration
• Warnings
• Adverse Reactions
• Residue Warning
• Other
• Spl Patient Package Insert
• Description
• Veterinary Indications
• User Safety Warnings
• Animal Pharmacology & Or Toxicology
• Precautions
• Clinical Pharmacology
• Summary Of Safety And Effectiveness
• How Supplied
• Storage And Handling
• Package Label.Principal Display Panel

Warnings And Precautions

960 ml

Tilmovet^® AC
(tilmicosin 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

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 1-877-994-4883 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.

                                                                                          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 1-877-994-4883 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.

ADVERTENCIA
La exposición humana a la tilmicosina ha sido asociada con dolor en el pecho, aumenta 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 1-877-994-4883 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 informacin adicional.

ADVERTENCIA
La exposición humana a la tilmicosina ha sido asociada con dolor en el pecho, aumenta 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 1-877-994-4883 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 informacin adicional.

General Precautions

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Read enclosed product information carefully for complete details.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

PRECAUClÓN: 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.

PRECAUClÓN: las leyes federales establecen que el uso de este fármaco se restrinja a veterinarios con
licencia o bajo la indicación de estos.

Ingrediente fármaco activo: tilmicosina (como fosfato de tilmicosina) 250 mg/ml

Indications & Usage

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.

Lot No.

Exp. Date

lndicacions: para el control de la enfermedad respiratoria porcina asociada con Pasteurella multocida y Haemophilus parasuis en grupos de cerdos de establecimientos en las que se diagnostica un brote de enfermedad respiratoria.
Para el control de la enfermedad respiratoria porcina asociada con Mycoplosma hyopneumoniae en la presencia del virus del sindrome 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.

Lot No. 

Exp. Date

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.

Dosage & Administration

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 Tilmovet AC
(tilmicosin phosphate) per 2.5 gallons of stock solution.

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 Tilmovet AC (tilmicosin phosphate) per 2.5 gallons of stock solution.

Posologia y administración: se debe diluir antes de administrarse a los animales. lncluir 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 Tilmovet AC (tilmicosina coma fosfato) por cada 2.5 galones de solucion concentrada.

Posología y administración: se debe diluir antes de administrarse a los animales. lncluir 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 horasde 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 Tilmovet AC (tilmicosina coma fosfato) par cada 2.5 galones de solucin concentrada.

Warnings

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. 

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 INFORMAClÓN 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.

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 INFORMATIÓN. 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.

Adverse Reactions

QUESTIONS/COMMENTS? For technical assistance or to report side effects, contact Huvepharma, Inc. at 1-877-994-4883. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

QUESTIONS/COMMENTS? For technical assistance or to report side effects, contact Huvepharma, Inc. at 1-877-994-4883. For additional information about reporting side effects for for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

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.

INFORMACIÓN DE CONTACTO: para reportar una sospecha de experiencias adversas téchnica o un ejemplar de la Hoja de Datos Seguridad, comuníquese con Huvepharma, Inc. al 1-877-994-4883. Para obtener información adicional sobre cómo reportar experiencias adversas con las fármacos para animales, comuniquese con la FDA al 1-888-FDA o visite www.fda.gov/reportanimalae

INFORMACIÓN DE CONTACTO: para reportar una sospecha de experiencias adversas con fármacos, obtener asistencia técnica o un ejemplar de la Hoja de Datos de Seguridad, comuniquese con Huvepharma, Inc. al 1-877-994-4883. Para obtener información adicional sobre cómo reportar experiencias adversas con los farmacos para animales, comuniquese con la FDA al 1-888-FDA-VETS o visite www.fda.gov/reportanimalae

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 las 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.

Residue Warning

RESIDUE WARNING: Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product.

Approved by FDA under ANADA # 200-707

RESIDUE WARNING: Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product.

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.

Aprobado por la FDA bajo ANADA # 200-707

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.

Other

960 ml

Tilmovet® AC
(tilmicosin 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.

960 ml
Tilmovet® AC
(tilmicosina como fosfato)
250 mg/ml tilmicosina

Concentrado acuoso para uso oral en el agua de consumo.
Para ganado porcine 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.

960 ml
Tilmovet® AC
(tilmicosina como fosfato)
250 mg/ml tilmicosina

Concentrado acuoso para uso oral en el agua de consumo.
Para ganado porcine 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.

Spl Patient Package Insert

Active Drug Ingredient: tilmicosin (as tilmicosin phosphate) 250 mg/ml.

Description

Description: Tilmovet AC is a formulation of the antibiotic tilmicosin. Tilmicosin is produced semi-synthetically and is in the macrolide class of antibiotics. Each milliliter (mL) of Tilmovet aqueous concentrate solution contains 250 mg of tilmicosin.

Descripción: Tilmovet AC 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 Tilmovet contiene 250 mg de tilmicosina.

Veterinary Indications

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.

User Safety Warnings

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. 

Animal Pharmacology & Or Toxicology

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. β-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.

Animal Safety: A pharmacokinetic study was conducted to evaluate tilmicosin phosphate solution in pigs. The results were compared to pharmacokinetic data generated with tilmicosin phosphate 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 tilmicosin phosphate solution in pigs when administered in drinking water.

Twenty pigs were administered medicated water at 0, 200, 400, or 600 mg/L (0, 1X, 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.

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 las 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 dobutamine contrarresta parcialmente los efectos inotrópicos negatives inducidos por la tilmicosina en perros. Los antagonistas β adrenérgicos, como el propranolol, exacerbaron el inotropismo negative 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.

Precautions

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 Tilmovet AC (tilmicosin phosphate) and another macrolide by any route is not advised.
Use of another macrolide immediately following this use of Tilmovet AC is not advised.

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 Tilmovet AC (tilmicosina coma fosfato) y otro macrólido por cualquier vía de administración. No se recomienda el uso de otro macrólido inmediatamente después de este uso de Tilmovet AC.

Clinical Pharmacology

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.

Summary Of Safety And Effectiveness

Effectiveness: The effectiveness of tilmicosin phosphate 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 non-medicated 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 back-transformed 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 tilmicosin phosphate 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 tilmicosin phosphate (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).

How Supplied

How Supplied: Tilmovet AC (tilmicosin phosphate) is provided in a 960 ml white-colored plastic bottle sealed with a plastic screw cap.

Presentación: Tilmovet AC se proporciana en botellas de plástico, color blanco de 960 ml selladas con tapas plásticas con rosca.

Storage And Handling

Storage Conditions:
Store at or below 25° C (77° F). Excursions permitted to 40° C (104° F). Protect from direct sunlight.

Restricted Drug (California) - Use Only as Directed
Approved by FDA under ANADA # 200-707

Manufactured For:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

Huvepharma and Tilmovet are registered trademarks of
Huvepharma EOOD.

Condiciones de almacenamiento: Almacenar a o menos 25° C (77° F). Excursiones permitidas a 40° C (104° F). Proteger de la luz solar directa.

Fármaco restringido (California). Usar únicamente según las indicaciones.
Aprobado por la FDA bajo ANADA # 200-707

Fabricado por:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269, EE. UU.

Huvepharma y Tilmovet son marcas registradas propiedad a Huvepharma EOOD.

Package Label.Principal Display Panel