Animal NDC 58198-0206-3 Tylan 200
Tylosin

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-0206-3
Proprietary Name Tylan 200 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Tylosin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Elanco Us Inc.
Product Type Prescription Animal Drug
Usage Information
    In Beef Cattle and Non-lactating Dairy Cattle, Tylan 200 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes.In Swine, Tylan 200 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.Each mL contains 200 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.
Active Ingredient(s)
  • Tylosin
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA012965 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Tylan 200 Images

Tylan 200 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Elanco™

Tylan™ 200 Injection

(tylosin injection) 200 mg per mL

For Use In Cattle and Swine Only

An Antibiotic

Use automatic syringe equipment only

BEEF CATTLE AND NON-LACTATING DAIRY CATTLE—Inject intramuscularly 8 mg per pound of body weight one time daily (1 mL per 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.

SWINE—Inject intramuscularly 4 mg per pound of body weight (1 mL per 50 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.

Read accompanying directions fully before use.

CAUTION:

Do not mix Tylan 200 Injection with other injectable solutions as this may cause a precipitation of the active ingredients.

 

 

Elanco™

Tylan™ 200 Inyectable

(tilosina inyectable) 200 mg por ml

Para uso exclusivo en ganado vacuno y cerdos

Un antibiótico

Utilizar sólo equipos automáticos de jeringas

GANADO VACUNO Y VACAS LECHERAS NO LACTANTES—Inyectar por vía intramuscular 8 mg por libra de peso corporal una vez al día (1 ml cada 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.

CERDOS—Inyectar por vía intramuscular 4 mg por libra de peso corporal (1 ml cada 50 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.

Leer todas las instrucciones adjuntas antes de usar.

PRECAUCIÓN:

No mezclar la inyección Tylan 200 con otras soluciones inyectables ya que esto puede ocasionar la precipitación de los principios activos.

Ganado porcino: el ganado porcino previsto para consumo humano no se debe faenar durante los 14 días posteriores al último uso de este producto farmacológico.

Ganado bovino: 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.

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.

Almacenar a 25 °C (77 °F) o menos.

Tylan, Elanco y el logo de la barra diagonal son marcas de Elanco o sus afiliadas.

Aprobado por la FDA bajo NADA # 012-965

Para obtener información adicional sobre cómo informar experiencias adversas de medicamentos para medicamentos animales, comuníquese con la FDA al 1-888-FDA-VETS o http://www.fda.gov/reportanimalae.

Fabricado por: Elanco US Inc.
Greenfield, IN 46140, USA

Producto de Irlanda

AH0206

YL231483X


Indications:



In Beef Cattle and Non-lactating Dairy Cattle, Tylan 200 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes.

In Swine, Tylan 200 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

Each mL contains 200 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.


Administration And Dosage:



Tylan 200 Injection is administered intramuscularly.


Warnings:



NOT FOR HUMAN USE.

KEEP OUT OF REACH OF CHILDREN.

Adverse reactions, including shock and death may result from overdosage in baby pigs.

Do not attempt injection into pigs weighing less than 25 pounds (0.5 mL) with the common syringe. It is recommended that Tylan 50 Injection be used in pigs weighing less than 25 pounds.

Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.


Residue Warning: Swine:



Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product.


Residue Warning: Cattle:



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.

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.

Store at or below 25°C (77°F).

Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2022 Elanco or its affiliates

Approved by FDA under NADA # 012-965

For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Manufactured for: Elanco US Inc.
Greenfield, IN 46140, USA

Product of Ireland

AH0206

YL231483X


Indicaciones:



En ganado vacuno y vacas lecheras no lactantes, Tylan 200 Inyectable se indica para el tratamiento del complejo respiratorio bovino (fiebre de embarque, neumonía), generalmente asociado con Pasteurella multocida y Arcanobacterium pyogenes, pietín (pododermatitis necrótica), difteria de los terneros provocada por Fusobacterium necrophorum y metritis provocada por Arcanobacterium pyogenes.

En cerdos, Tylan 200 Inyectable se indica para el tratamiento de artritis en cerdos provocada por Mycoplasma hyosynoviae, neumonía porcina causada por Pasteurella spp., erisipelas porcinas provocadas por Erysipelothrix rhusiopathiae, disentería porcina asociada con Treponema hyodysenteriae cuando es tratada con el medicamento apropiado a través del alimento y/o el agua para beber.

Cada ml contiene 200 mg de actividad de tilosina (como tilosina base) en propilenglicol al 50 por ciento, alcohol bencílico al 4 por ciento y agua para inyección.


Posología Y Administración:



Tylan 200 Inyectable se administra por vía intramuscular.


Advertencias:



ESTE PRODUCTO NO DEBE UTILIZARSE EN SERES HUMANOS.

MANTENER FUERA DEL ALCANCE DE LOS NIÑOS.

Pueden ocurrir reacciones adversas, incluidos shock y muerte, en caso de sobredosis en crías de cerdos.

No administrar la inyección a cerdos que pesen menos de 25 libras (0.5 ml) con la jeringa común. Se recomienda usar la inyección Tylan 50 en cerdos que pesen menos de 25 libras.

No administrar a caballos u otros equinos. La inyección de tilosina en equinos ha resultado mortal.


Principal Display Panel - Tylan 200 Injection 250 Ml Bottle Label



Elanco™

AH0206

Tylan™ 200
Injection

™

250 mL

(tylosin injection)

For Use In Cattle and Swine Only

200 mg per mL

An Antibiotic

Indications: In Beef Cattle and
Non-lactating Dairy Cattle,


Principal Display Panel - Tylan 200 Injection 250 Ml Spanish Bottle Label



Elanco™

AH0206

Tylan™ 200
Inyectable

™

250 mL

(tilosina inyectable)

Para uso exclusivo en ganado
vacuno y cerdos

PRECAUCIÓN: Las leyes federales
estabablecen que el uso de este
fármaco se restrinja a veterinarios con
licencia o bajo la indicación de estos.

200 mg por mL

Un antibiótico
Indicaciones: En ganado vacuno


Principal Display Panel - Tylan 200 Injection 250 Ml Carton Label



Elanco™

AH0206

Tylan™ 200
Injection

™

200 mg per mL

(tylosin injection)

For Use In Cattle and Swine Only

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

The Original Tylan 200 Injection

An Antibiotic
For Cattle Diseases

  • •Pneumonia
  • •Shipping Fever
  • •Metritis
  • •Diphtheria
  • •Foot Rot

    • For Swine Diseases

    • •Pneumonia
    • •Mycoplasmal Arthritis
    • •Dysentery
    • •Erysipelas

      • 250 mL


Principal Display Panel - Tylan 200 Injection 500 Ml Bottle Label



Elanco™

AH0206

Tylan™ 200
Injection

™

Professional Size
500 mL

(tylosin injection)

For Use In Cattle and Swine Only

200 mg per mL

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

An Antibiotic

Use automatic syringe equipment only
Indications: In Beef Cattle and
Non-lactating Dairy Cattle,
Tylan 200 Injection is indicated for use in


Principal Display Panel - Tylan 200 Injection 500 Ml Spanish Bottle Label



Elanco™

AH0206

Tylan™ 200
Inyectable

™

Tamaño professional
500 mL

(tilosina inyectable)

Para uso exclusivo en ganado
vacuno y cerdos

200 mg por ml

PRECAUCIÓN: Las leyes federales
estabablecen que el uso de este fármaco se
restrinja a veterinarios con licencia o bajo
la indicación de estos.

Un antibiótico


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.