Animal NDC 58198-0510-1 Monteban 45

Narasin

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-0510-1
Proprietary Name	Monteban 45 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	Narasin 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	Otc Type A Medicated Article Animal Drug
Usage Information	Type C Feeds - Amounts of Monteban 45 necessary to manufacture one ton of Type C medicated feed containing 54 to 90 g narasin are shown in the table. A preblend of Monteban in 15 - 20 lbs of feed should be made before incorporating into the total amount of finished Type C medicated feed. The drug concentration should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. Narasin Type C Concentration(Grams/Ton) Monteban(Lbs/Ton of Type C Feed) Lbs541.20591.31631.40681.51721.60811.80902.00Type B Feeds - Amounts of Monteban 45 necessary to manufacture one ton of Type B medicated feed containing up to 5,400 g narasin are shown in the table.Narasin Type B Concentration(Grams/Ton) Monteban(Lbs/Ton of Type B feed) 1 ,3502,7005,400 3060120
Active Ingredient(s)	Narasin
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	NADA118980 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.

Monteban 45 Images

Monteban 45 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.

Other
Mixing Directions:
Warnings
Elanco™ Monteban™45Tm
Instrucciones De Mezclado:
Principal Display Panel - Monteban 45 Label
Package Label.Principal Display Panel

Other

Net Weight 25 kg
(55.12 lb)

(narasin Type A medicated article)

For Use in Broiler Chicken Feeds Only

Do Not Feed Undiluted.

Active Drug Ingredient: narasin ........................................................... 45 g per lb

For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

Important: Must be thoroughly mixed in feeds before use.

Feeding Directions — Feed the resulting Type C medicated feed continuously as the sole ration.

CAUTION: Do not allow adult turkeys, horses or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal

NOT FOR HUMAN USE

Principio activo: narasina ........................................................... 100 g/kg (45 g/lb)

Para la prevención de la coccidiosis causada por Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati y E. maxima.

Importante: Debe mezclarse bien con el alimento antes de usar.

Instrucciones de administración: Administrar el alimento medicado tipo C resultante de manera continua como la única ración.

PRECAUCIÓN: No permita que pavos adultos, caballos u otros equinos tengan acceso a formulaciones con narasina. La ingestión de narasina por estas especies ha sido mortal.

NO USAR EN SERES HUMANOS

Mixing Directions:

Type C Feeds - Amounts of Monteban 45 necessary to manufacture one ton of Type C medicated feed containing 54 to 90 g narasin are shown in the table. A preblend of Monteban in 15 - 20 lbs of feed should be made before incorporating into the total amount of finished Type C medicated feed.

The drug concentration should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions.

Narasin Type C Concentration (Grams/Ton)	Monteban (Lbs/Ton of Type C Feed)
	Lbs
54	1.20
59	1.31
63	1.40
68	1.51
72	1.60
81	1.80
90	2.00

Type B Feeds - Amounts of Monteban 45 necessary to manufacture one ton of Type B medicated feed containing up to 5,400 g narasin are shown in the table.

Narasin Type B Concentration (Grams/Ton)	Monteban (Lbs/Ton of Type B feed)
1 ,350 2,700 5,400	30 60 120

Warnings

WARNING: When mixing and handling Monteban, use protective clothing, impervious gloves and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water.

Store at or below 25° C (77° F). Excursions permitted to 37° C (99° F).
Not to be used after the date printed at top of bag.

PRINTED WITH SOY INK™

TAKE TIME

OBSERVE LABEL
DIRECTIONS

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

Restricted Drug (California) - Use Only as Directed
Approved by FDA under NADA # 118-980
Elanco US Inc.
Greenfield, IN 46140, USA

To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

BG102243X

ADVERTENCIA: Cuando se mezcle o manipule Monteban use ropa protectora, guantes impermeables y mascarilla contra polvo. Los operarios deben lavarse bien con agua y jabón tras manipular el producto. Si ocurre contacto accidental con los ojos, se deberán enjuagar inmediatamente con agua abundante.

Conservar a una temperatura igual o menor a 25 ° C (77 ° F). Se permiten variaciones hasta 37 ° C (99 ° F). No se deberá usar después de la fecha impresa en la parte superior del saco.

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

Medicamento Restringido (California) - Usar solo según las indicaciones Aprobado por la FDA bajo NADA # 118-980
Elanco US Inc.
Greenfield, IN 46140,
Estados Unidos de América

Para notificar de efectos adversos, tener acceso a información médica u obtener información adicional sobre el producto, llame al 1-800-428-4441.

BG102243X

Elanco™ Monteban™45Tm

Peso Neto: 25 kg
(55.12 libras)

(narasina Artículo medicado tipo A)

Solo para uso en alimento para pollos de engorde
No administrar sin diluir

Instrucciones De Mezclado:

Alimentos tipo C: En la tabla se muestran las cantidades de Monteban 45 necesarias para elaborar una tonelada corta de alimento tipo C medicado que contenga de 54 a 90 g de narasina. Se recomienda hacer una premezcla de Monteban en 7 a 10 kg (15 a 20 lb) de alimento antes de incorporarla a la cantidad total del alimento medicado tipo C terminado. La concentración del fármaco debe ajustarse de acuerdo con la gravedad de la infestación coccidial, que varÍa con las condiciones medioambientales y de manejo.

Narasina en concentración para alimentos tipo C (g/ton corta)	Monteban (lb/ton corta de alimento tipo C)	Narasina (g/ton métrica)	Monteban (kg/ton métrica)
g 54 59 63 68 72 81 90	lb 1.20 1 .31 1 .40 1 .51 1.60 1.80 2.00	g 60 65 70 75 80 90 100	kg 0.600 0.650 0.700 0.750 0.800 0.900 1.000

Alimentos tipo B: En la tabla se muestran las cantidades de Monteban 45 necesarias para elaborar una tonelada corta de alimento medicado tipo B con un contenido de hasta 5,400 g de narasina.

Narasina en concentración para alimentos tipo B (g/ton corta)	Monteban (lb/ton corta de alimento tipo B)	Narasina (g/ton métrica)	Monteban (kg/ton métrica)
1 ,350 2,700 5,400	30 60 120	1 ,500 3,000 6,000	15.0 30.0 60.0

Principal Display Panel - Monteban 45 Label

Elanco™

Monteban^™45_™