Label: ROFENAID 40- sulfadimethoxine and ormetoprim powder

  • Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated March 20, 2019

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    RofenAid
    40

    Sulfadimethoxine & Ormetoprim

    Type A Medicated Article

    Antibacterial

    Anticoccidial

    For use in broiler, replacement (breeder and layer) chickens, turkeys, ducks and chukar partridges only.

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  • Active Drug Ingredients

    Sulfadimethoxine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.5 grams per pound (25%),

    Ormetoprim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.1 grams per pound (15%)

    in a carrier suitable for incorporation in feed.

    For use in manufacturing medicated feeds only

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  • Chickens

    Broiler and replacement (breeder and layer) chickens

     

    Indications:

    As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and Pasteurella multocida (fowl cholera).

    Use directions:

    Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration.

    Warning:

    Do not feed to chickens over 16 weeks (112 days) of age.

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  • Turkeys

    Indications:

    As an aid in the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis; for the prevention of bacterial infections caused by Pasteurella multocida (fowl cholera).

    Use directions:

    Add 1/2 lb of RofenAid 40 to one ton of feed to provide 0.01% (56.75 g/ton [0.00625%] sulfadimethoxine and 34.05 g/ton [0.00375%] ormetoprim) concentration in feed. Feed continuously as the sole ration.

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  • Ducks

    Ducks, including breeding ducks

     Indications:

    As an aid in the control of bacterial infections due to Pasteurella multocida (fowl cholera) in ducks including breeding ducks.

    Use directions:

    Add 2 lbs of RofenAid 40 to one ton of feed to provide 0.04% (227 g/ton [0.025%] sulfadimethoxine and 136.2 g/ton [0.015%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.

     

    Ducks

    Indications:

    As an aid in the control of bacterial infections due to Escherichia coli, Riemerella anatipestifer (strains 2, 3 & 4) and severe challenge of P. multocida (fowl cholera).

    Use directions:

    Add 4 lbs of RofenAid 40 to one ton of feed to provide 0.08% (454 g/ton [0.050%] sulfadimethoxine and 272.4 g/ton [0.030%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.

    Caution:

    Not for breeding ducks. The safety of feeding sulfadimethoxine and ormetoprim at levels higher than 0.025% and 0.015%, respectively, in breeding ducks has not been established.

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  • Partridges

    Chukar Partridges

     

    Indications:

    For the prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.

    Use directions:

    Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration to young birds up to 8 weeks of age.

    Caution:

    The safety of feeding RofenAid 40 to breeding stock has not been established.

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  • Warning

    Do not feed to turkeys and ducks producing eggs for food. Withdraw 5 days prior to slaughter of broiler and replacement chickens, turkeys and ducks.

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  • Note

    Manufacture of Type B or C feeds from this product requires a Medicated Feed Mill License.

    Labels for feeds containing RofenAid 40 must contain appropriate indications, limitations and warnings as well as required feed ingredient information.

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  • SPL UNCLASSIFIED SECTION

    Restricted Drug (California) - Use only as directed. Not for human use.

    NADA 40-209, Approved by FDA

    Store below 25°C (77°F), excursions permitted to 37°C (99°F).

    Zoetis

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Net wt 50 LB (22.68 kg)

    Made in USA

    10010601

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  • PRINCIPAL DISPLAY PANEL

    RofenAid 40

    Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

    Sulfadimethoxine & Ormetoprim Type A Medicated Article

    Antibacterial

    Anticoccidial

    Net wt 50 LB (22.68 kg)

    Zoetis

    Principal Display Label
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  • INGREDIENTS AND APPEARANCE
    ROFENAID 40 
    sulfadimethoxine and ormetoprim powder
    Product Information
    Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:54771-1446
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFADIMETHOXINE (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) SULFADIMETHOXINE 113.5 g  in 0.45 kg
    ORMETOPRIM (UNII: M3EFS94984) (ORMETOPRIM - UNII:M3EFS94984) ORMETOPRIM 68.1 g  in 0.45 kg
    Product Characteristics
    Color BROWN (beige to light tan) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54771-1446-0 22.68 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA040209 12/01/2018
    Labeler - Zoetis Inc. (828851555)
    Establishment
    Name Address ID/FEI Business Operations
    SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO., LTD. 544646342 API MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Zoetis LLC 069370112 MANUFACTURE
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