Tilmicosin

Cattle (Beef and Non-Lactating Dairy)

For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

Do not allow horses or other equines access to feeds containing tilmicosin. The safety of tilmicosin has not been established in cattle or male swine intended for breeding purposes. Use only in cattle fed in confinement for slaughter. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy. The expiration dale tor a tilmicosin Veterinarv Feed Directive (VFD) for cattle must not exceed 45 days from the time of issuance. VFDs for tilmicosin shall not be refilled.

Tilmovet® 90

Beef and non-lactating dairy cattle

For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug 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. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product.

Pulmotil™ 90

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica.

Micotil™ 300

Cattle Fed in Confinement for Slaughter

For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. For cattle fed in confinement for slaughter, feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Feed at a rate of 0.14 to 0.42 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day.

Pulmotil® 90 and Rumensin® 90

Cattle Fed in Confinement for Slaughter

For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

Pulmotil® 90 and Rumensin® 90

Cattle (beef fed in confinement for slaughter)

For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

The safety of tilmicosin has not been established in cattle intended for breeding purposes. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with tilmicosin. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin and monensin are not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves.

Tilmovet® 90 and Rumensin® 90

Cattle (beef fed in confinement for slaughter)

For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

The safety of tilmicosin has not been established in cattle intended for breeding purposes. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with tilmicosin. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin and monensin are not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves.

Tilmovet® 90 and Rumensin® 90

Cattle fed in confinement for slaughter

For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

Pulmotil™ and Monovet®

Cattle fed in confinement for slaughter

For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

Pulmotil™ and Monovet®

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 (SRD) 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.

For use in swine only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.

Pulmotil™ AC

For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Do not allow horses or other equines access to feeds containing tilmicosin. The safety of tilmicosin has not been established in cattle or male swine intended for breeding purposes. Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before re-initiating a further course of therapy with an appropriate antimicrobial. Veterinary Feed Directive (VFD) expiration date for swine must not exceed 90 days from the time of issuance. VFDs for tilmicosin shall not be refilled.

Tilmovet® 90

For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica.

Micotil™ 300

Mixing Directions: For Incorporation into Swine Feeds: Thoroughly mix Tilmovet Type A medicated article with feed to provide a Type B medicated feed containing up to 36,300 grams tilmicosin per ton or to provide a complete Type C medicated feed containing 181 to 363 g tilmicosin per ton. Do not use in any feeds containing bentonite. Bentonite in feeds may affect the efficacy of tilmicosin. For Incorporation into Cattle Feeds: Thoroughly mix Tilmovet 90 Type A medicated article with feed to provide a Type B medicated feed containing up to 36,300 grams tilmicosin per ton on a 100% dry matter basis or to provide a complete Type C medicated feed containing 568 to 757 g tilmicosin per ton on a 100% dry matter basis. Complete Type C medicated feeds should not be pelleted. Do not use in any feeds containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, cottonseed meal, or cottonseed hulls in feeds may affect the efficacy of tilmicosin. LOT EXP

FDA application 200-509

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

FDA application 200-707

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

FDA application 200-707

Indications: Swine: For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae and Pasteurella multocida. Cattle: For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in groups of beef and nonlactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

FDA application 200-509

Micotil is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and for the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica. Micotil is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica.

FDA application 140-929

Clinical Pharmacology: Oral dosing of tilmicosin phosphate to swine at 181 to 363 g/ton of feed results in serum tilmicosin levels, which do not correlate with efficacy. Lung concentrations of tilmicosin are significantly higher than serum. Following 7 consecutive days of administering tilmicosin-medicated feeds to swine, the concentration of tilmicosin in respiratory tissues, phagocytic cells, and nasal secretions was significantly higher than that of plasma or serum. Lung levels are achieved within 2 days after beginning feeding and plateau by 4 days. Using in-vitro incubation techniques, the ratio of intracellular to extracellular concentrations of tilmicosin for neutrophils, monocyte-macrophages and alveolar macrophages were 69, 19 and 17, respectively, after four hours of incubation. Although lower levels of accumulation were observed in-vivo, swine alveolar macrophages have been shown in-vitro and in-vivo to concentrate large amounts of tilmicosin; these cells may be important for in-vivo distribution of the drug and may serve as an important reservoir for tilmicosin in lung tissue. Oral dosing of tilmicosin phosphate to cattle to target a dose of 12.5 mg/kg body weight resulted in serum tilmicosin concentrations above the analytical limit of quantification (0.5 ng/mL) within 12 hours following treatment administration. The relationship of serum tilmicosin concentration to lung tilmicosin concentration has not been determined following oral administration of tilmicosin.

FDA application 200-509

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.

FDA application 200-707

A single subcutaneous injection of Micotil (tilmicosin injection) at 10 mg/kg of body weight dose in cattle resulted in peak tilmicosin levels within one hour and detectable levels (0.07 μg/mL) in serum beyond 3 days. However, lung concentrations of tilmicosin remained above the tilmicosin MIC 95% of 3.12 μg/mL for Mannheimia haemolytica for at least 3 days following the single injection. Serum tilmicosin levels are a poor indicator of total body tilmicosin. The lung/serum tilmicosin ratio in favor of lung tissue appeared to equilibrate by 3 days post-injection at approximately 60. In a study with radioactive tilmicosin, 24% and 68% of the dose was recovered from urine and feces respectively over 21 days. After a single subcutaneous injection of Micotil at 10 mg/kg of body weight, tilmicosin concentrations in excess of 4 μg/mL were maintained in the alveolar macrophages and neutrophils of most cattle for at least 10 days. The clinical relevance of these findings has not been determined.

FDA application 140-929

Do not use in automatically powered syringes, single-use syringes, or other delivery devices not specified in the labeling. Do not administer intravenously to cattle or sheep. Intravenous injection in cattle or sheep will be fatal. Do not use in lambs less than 15 kg body weight. Do not administer to animals other than cattle or sheep. Injection of tilmicosin has been shown to be fatal in swine and non-human primates. Death following exposure to tilmicosin injection has been reported to FDA/CVM in goats, rabbits, pheasants, pigs, dogs, deer, cats, alpacas and horses.

FDA application 140-929

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.

FDA application 141-361

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. QUESTIONS/COMMENTS? For technical assistance or to report side effects, contact Elanco US Inc. at 1-800-428-4441. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae. RESIDUE WARNING: Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product. 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.

FDA application 141-361

Residue Warnings: Animals intended for human consumption must not be slaughtered within 42 days of the last treatment. Not for use in lactating dairy cattle 20 months of age or older. Use of tilmicosin in this class of cattle may cause milk residues. Not for use in lactating ewes producing milk for human consumption. For Subcutaneous Use in Cattle and Sheep Only. Administer only with a tube-fed safety syringe. Do not use in automatically powered syringes, single-use syringes, or other delivery devices. Contact Elanco at 1-800-428-4441, or your distributor, for a tube-fed safety syringe for use with this product. Solo Para Uso Subcutáneo en Ganado Vacuno y Ovino. Administrar únicamente con una jeringa de seguridad con tubo. No administrar con jeringas accionadas automáticamente, jeringas de un solo uso u otros dispositivos de aplicación. Contactar a Elanco al 1-800-428-4441, o al distribuidor, para obtener una jeringa de seguridad con tubo para usar con este producto.

FDA application 140-929

User Safety Warnings: Avoid inhalation, oral exposure and direct contact with skin or eyes. Operators mixing and handling Tilmovet 90 should use protective clothing, impervious gloves, goggles and a NIOSH-approved dust mask. Wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists, seek medical attention. Not for human consumption. Keep out of reach of children. The Safety Data Sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information, or to obtain a Safety Data Sheet, call 1-877-426-7765.

FDA application 200-509

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.

FDA application 200-707

WARNINGS: RESIDUE WARNING: Swine: Swine intended for human consumption must not be slaughtered within 7 days of the last treatment of this drug product. RESIDUE WARNING: Cattle: Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug 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.

FDA application 200-509

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.

FDA application 200-707

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.

FDA application 200-707

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.

FDA application 200-707

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.

FDA application 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. Aprobado por la FDA bajo ANADA # 200-707

FDA application 200-707

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

FDA application 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.

FDA application 200-707

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

FDA application 200-707

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.

FDA application 200-707

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.

FDA application 200-707

The following adverse reactions have been reported post-approval: In cattle: injection site swelling and inflammation, lameness, collapse, anaphylaxis/anaphylactoid reactions, decreased food and water consumption, and death. In sheep: dyspnea and death. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

FDA application 140-929

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

FDA application 200-707

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

FDA application 200-707

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 200-509

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

FDA application 200-707

Cattle (Beef and Non-Lactating Dairy)

Tilmicosin is to be fed continuously for a single, 14 day period at 568 grams to 757 grams (626 ppm to 834 ppm) per ton on a 100% dry matter basis of Type C medicated feed as the sole ration to provide 12.5 mg tilmicosin/kg/head/day.

Oral

Do not allow horses or other equines access to feeds containing tilmicosin. The safety of tilmicosin has not been established in cattle or male swine intended for breeding purposes. Use only in cattle fed in confinement for slaughter. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy. The expiration dale tor a tilmicosin Veterinarv Feed Directive (VFD) for cattle must not exceed 45 days from the time of issuance. VFDs for tilmicosin shall not be refilled.

Tilmovet® 90

Beef and non-lactating dairy cattle

Tilmicosin (as tilmicosin phosphate): 568 to 757 grams per ton (100% dry matter basis) of Type C medicated feed.

Oral

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug 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. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product.

Pulmotil™ 90

Administer a single subcutaneous dose of 10 to 20 mg/kg body weight (1 to 2 mL/30 kg or 1.5 to 3 mL per 100 lbs.). Do not inject more than 10 mL per injection site.

Subcutaneous

Micotil™ 300

Cattle Fed in Confinement for Slaughter

Tilmicosin phosphate - 568 to 757 g/ton Monensin – 10 to 40 g/ton 100% dry matter basis 90% dry matter basis

Oral

The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. For cattle fed in confinement for slaughter, feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Feed at a rate of 0.14 to 0.42 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day.

Pulmotil® 90 and Rumensin® 90

Cattle (beef fed in confinement for slaughter)

Tilmicosin phosphate – 568 to 757 g/ton and monensin – 10 to 40 g/ton

Oral

The safety of tilmicosin has not been established in cattle intended for breeding purposes. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with tilmicosin. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin and monensin are not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves.

Tilmovet® 90 and Rumensin® 90

Cattle fed in confinement for slaughter

568 to 757 g/ton of Pulmotil™ and 10 to 40 g/ton of Monovet®. To be fed continuously as the sole ration for a single, 14 day period at 568 grams to 757 grams tilmicosin per ton on a 100% dry matter basis (511.2 to 681.3 g per ton on a 90% dry matter basis) to provide 12.5 mg tilmicosin/kg of body weight/day and 10 grams to 40 grams monensin per ton on a 90% dry matter basis (11.1 to 44.4 g per ton on a 100% dry matter basis) to provide 0.14 to 0.42 mg monensin/lb bodyweight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day.

Oral

Pulmotil™ and Monovet®

Cattle fed in confinement for slaughter

568 to 757 g/ton of Pulmotil™ and 5 to 40 g/ton of Monovet®. To be fed continuously as the sole ration for a single, 14 day period at 568 grams to 757 grams tilmicosin per ton on a 100% dry matter basis (511.2 to 681.3 g per ton on a 90% dry matter basis) to provide 12.5 mg tilmicosin/kg of body weight/day and 5 grams to 40 grams monensin per ton on a 90% dry matter basis (5.6 to 44.4 grams per ton on a 100% dry matter basis) to provide 50 to 480 mg monensin/head/day.

Oral

Pulmotil™ and Monovet®

Tilmicosin is to be fed continuously at 181 grams to 363 grams per ton (200 ppm to 400 ppm) of Type C medicated feed as the sole ration for a 21-day period, beginning approximately 7 days before an anticipated disease outbreak.

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Do not allow horses or other equines access to feeds containing tilmicosin. The safety of tilmicosin has not been established in cattle or male swine intended for breeding purposes. Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before re-initiating a further course of therapy with an appropriate antimicrobial. Veterinary Feed Directive (VFD) expiration date for swine must not exceed 90 days from the time of issuance. VFDs for tilmicosin shall not be refilled.

Tilmovet® 90

Administer in drinking water at a concentration of 200 mg tilmicosin per liter for 5 consecutive days.

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Tilmovet® AC

Tilmicosin (as tilmicosin phosphate): 181 to 363 grams per ton of Type C medicated feed.

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Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product.

Pulmotil™ 90

200 mg tilmicosin/L (200 ppm) for 5 consecutive days

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For use in swine only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.

Pulmotil™ AC

In sheep greater than 15 kg, administer a single subcutaneous dose of 10 mg/kg of body weight (1 mL/30 kg or 1.5 mL per 100 lbs.). Do not inject more than 10 mL per injection site.

Subcutaneous

Micotil™ 300

Follow instructions for activation of the shroud before first usage. Inject Subcutaneously in Cattle and Sheep Only. See Safe Handling Practices, Contraindications, and Warnings prior to use. In cattle, administer a single subcutaneous dose of 10 to 20 mg/kg of body weight (1 to 2 mL/30 kg or 1.5 to 3 mL per 100 lbs). In sheep greater than 15 kg, administer a single subcutaneous dose of 10 mg/kg of body weight (1 mL/30 kg or 1.5 mL per 100 lbs). Do not inject more than 10 mL per injection site. If no improvement is noted within 48-hours, the diagnosis should be reevaluated. For cattle and sheep, injection under the skin in the neck is suggested. If not accessible, inject under the skin behind the shoulders and over the ribs. Note: Swelling at the subcutaneous site of injection may be observed.

SUBCUTANEOUS

FDA application 140-929

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.

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FDA application 200-707

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.

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FDA application 200-707