Rofenaid 40

Dosage Form: FOR ANIMAL USE ONLY
RofenAid®

40

Sulfadimethoxine & Ormetoprim

Type A Medicated Article

(medicated premix)

Antibacterial

Anticoccidial

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

Active drug ingredients

Sulfadimethoxine 113.5 grams per pound (25%), and ormetoprim 68.1 grams per pound (15%) in a carrier suitable for incorporation in feed.

For use in manufacturing medicated feeds only

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% (0.0125% sulfadimethoxine and 0.0075% ormetoprim) concentration in feed.

Limitations

Feed continuously as the sole ration.

Warning

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

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% (0.00625% sulfadimethoxine and 0.00375% ormetoprim) concentration in feed.

Limitations

Feed continuously as the sole ration.

Ducks

Indications

As an aid in the control of 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% (0.025% sulfadimethoxine and 0.015% ormetoprim) concentration in feed.

Indications

As an aid in the control of 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% (0.050% sulfadimethoxine and 0.030% ormetoprim) concentration in feed.

Limitations

Feed for 7 days as the sole ration.

Caution

For control of duck disease, medication should be started at the first signs of infection. The safety of feeding Rofenaid 40 at levels higher than 0.04% in breeding ducks has not been established.

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% (0.0125% sulfadimethoxine and 0.0075% ormetoprim) concentration in feed.

Limitations

Feed continuously as the sole ration to young birds up to 8 weeks of age.

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

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.

Note: Manufacture of Type B or C feeds from this product requires a Medicated Feed License Application approved by the FDA.

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

Restricted Drug (California) - Use only as directed. Not for human use. NADA 40-209, Approved by FDA

Marketed by

Alpharma, LLC

Bridgewater, New Jersey 08807

Net wt 50 LB (22.68 kg)

Made in USA

Trademarks

registered by

Alpharma, LLC

770302 1007

PRINCIPAL DISPLAY PANEL - 50 LB BAG

RofenAid®

40

ALPHARMA

Sulfadimethoxine & Ormetoprim

Type A Medicated Article

(medicated premix)

Antibacterial

Anticoccidial

Important: See back panel for

warnings and use directions

Net wt 50 LB (22.68 kg)

ALPHARMA®

RofenAid®

40

Rofenaid 40  sulfadimethoxine and ormetoprim  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 46573-446 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfadimethoxine (Sulfadimethoxine) Sulfadimethoxine 113.5 g  in 0.45 kg Ormetoprim (Ormetoprim) Ormetoprim 68.1 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN (beige to light tan) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46573-446-00 22.68 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA040209	01/01/2009

Labeler - Alpharma, LLC. (070954094)

Revised: 12/2010Alpharma, LLC.