Animal NDC 58198-1372-1 Maxiban 72

Narasin And Nicarbazin

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-1372-1
Proprietary Name Maxiban 72 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 And Nicarbazin 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
    Feed continuously as the sole ration. Caution: Nicarbazin medicated broilers may show reduced heat tolerance if exposed to high temperature and high humidity. Provide adequate drinking water and ventilation during these periods. Do not allow adult turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens.
Active Ingredient(s)
  • Narasin
  • Nicarbazin
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 NADA138952 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.

Maxiban 72 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™

AF1372

Maxiban™72

(narasin and nicarbazin Type A medicated article)

For Use In Broiler Chicken Feeds Only

Do not feed undiluted.

Withdrawal Period: No withdrawal period is required.

User Safety Warning: When mixing and handling Maxiban 72, 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. Not for human use.

Elanco™

AF1372

Maxiban™72

(narasina y nicarbanzina artículo medicado Tipo A)

Sólo para uso en alimento de Pollos de Engorde

Instrucciones de uso: Administre continuamente como ración única.

Período de retiro: no se requiere ningún período de retiro.

Advertencia de seguridad para el usuario: Deberá usarse ropa protectora, guantes impermeables y mascarilla antipolvo al mezclar o manipular el producto. Los operadores deberán lavarse cuidadosamente con agua y jabón después de manejar el producto.

Si se produce contacto accidental con los ojos, lavar inmediatamente con agua abundante. No usar en seres humanos.

Reacciones adversas al fármaco: Para reportar efectos adversos, obtener información medica o información adicional del producto, llame al 1-800-428-4441.

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 envase.

Medicamento Restringido (California) - úsese Sólo Como se Indica.

NADA# 138-952, Aprobado por FDA.

Elanco US Inc.

Greenfield, IN 46140, Estados Unidos de América

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

TAKE TIME

OBSERVE LABEL DIRECTIONS

Peso neto: 25 kg (55.12 lb)

BG100754X


Active Drug Ingredients:



narasin

36 g per lb

nicarbazin

36 g per lb

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

Important: Must be thoroughly mixed into feeds before use.


Dosage & Administration



Mixing Directions: (Broiler Chickens): Thoroughly mix the following amounts of Maxiban 72 in one ton of complete feed to provide from 27 to 45 grams per ton each of narasin and nicarbazin. The dosage should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. A preblend of the Maxiban 72 in 15-20 lbs of feed should be made before incorporating into the total amount of finished feed.

Narasin and Nicarbazin (Grams Per Ton)

Maxiban 72 (Pounds Per Ton of Type C Medicated Feed)

27 Narasin and 27 Nicarbazin

0.75

36 Narasin and 36 Nicarbazin

1.00

45 Narasin and 45 Nicarbazin

1.25

Example of Type B medicated feed – Amounts of Type A medicated article necessary to manufacture one ton of Type B medicated feed. The maximum permitted Type B medicated feed concentration is 11,350 g/ton each of narasin and nicarbazin.

Pounds of Maxiban 72 to Add Per Ton to Make
a Type B Medicated Feed

Resulting Narasin and Nicarbazin Concentration in the Type B Medicated Feed

g/ton (for each drug)

g/lb (for each drug)

27.56

992.2

0.50

55.12

1,984.3

0.99

110.24

3,968.6

1.98


Feeding Directions:



Feed continuously as the sole ration.

Caution: Nicarbazin medicated broilers may show reduced heat tolerance if exposed to high temperature and high humidity. Provide adequate drinking water and ventilation during these periods. Do not allow adult turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens.


Adverse Drug Reactions:



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


Storage And Handling



Store at or below 25°C (77°F). Excursions permitted to 37°C (99°F).

Not to be used after the date printed on bag.

Restricted Drug (California) - Use Only as Directed

NADA # 138-952, Approved by FDA

Elanco US Inc.

Greenfield, IN 46140, USA

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

TAKE TIME

OBSERVE LABEL DIRECTIONS

Net Weight 25 kg (55.12 lb)

BG100754X


Otc - Active Ingredient



Principios Activos: narasina - 36 g per lb (80 g per kg)

nicarbazina - 36 g per lb (80 g per kg)

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

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


Indications & Usage



Instrucciones para la mezcla: (Pollos de engorde): Mézclese completamente las siguientes cantidades de Maxiban 72 en una tonelada de alimento completo para proporcionar de 27 a 45 g/tonelada corta (30 a 50 g/Ton Métrica), tanto de narasina como de nicarbazina. La dosis debe ajustarse de acuerdo con la gravedad del desafío por coccidias, el cual varía según las condiciones ambientales y de manejo.

Se debe realizar una premezcla de Maxiban 72 en 15-20 lb de alimento antes de incorporar al total de alimento terminado.

Narasina + Nicarbazina (Gramos por Tonelada)

Maxiban 72 (Libras por tonelada en
el alimento medicado tipo C)

27 Narasina and 27 Nicarbazina

0.75

36 Narasina and 36 Nicarbazina

1.00

45 Narasina and 45 Nicarbazina

1.25

Ejemplo de alimento medicado tipo B: Cantidad de artículo medicado tipo A necesaria para fabricar una tonelada de alimento medicado tipo B. La concentración máxima permitida para el alimento medicado tipo B es de 11,350 g/ton cada una de narasina y nicarbazina.

Libras de Maxiban 72 a añadir por tonelada para preparer alimento medic ado de tipo B

Concentración resultante de narasina y nicarbazina en el alimento medicado tipo B

g/ton (para cada medicamento)

g/lb (para cada medicamento)

27.56

992.2

0.50

55.12

1,984.3

0.99

110.24

3,968.6

1.98


Precautions



Precaución: Los pollos tratados con nicarbazina pueden presentar menor tolerancia al calor si son expuestos a temperaturas y humedad elevadas. Proveer agua de bebida y ventilación adecuadas durante estos períodos. No permita que pavos adultos, caballos u otros equinos tengan acceso a raciones que contengan narasina ya que la ingestión de narasina por parte de estas especies es fatal. No administrar a gallinas de postura.


Warnings



Advertencia:


Principal Display Panel – 22.68 Bag Label



Elanco

AF1372

Maxiban™72

(narasin and nicarbazin Type A medicated article)

For Use In Broiler Chicken Feeds Only

Do Not Feed Undiluted


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