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Denagard
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  • FDA PI

Denagard

Generic name: tiamulin liquid concentrate
Dosage form: FOR ANIMAL USE ONLY

Denagard®

(tiamulin)

Liquid Concentrate

12.3%Tiamulinhydrogenfumarate

NADA 140-916, Approved by FDA

One Quart

(32fl oz; 946mL)

Warning:

Keep out of reach of children. Avoid direct contact with the skin. Direct contact with skin or mucous membranes may cause irritation.

Withdraw medicated water 3 days before slaughter after use at 3.5 mg per pound and 7 days before slaughter after use at 10.5 mg per pound.

Active Ingredient:

This bottle contains 4.10 oz (116.4 g) tiamulin hydrogen fumarate in solution.

Caution:

For use in animals only – Not for human use.

Prepare fresh medicated water daily. Use as the only source of drinking water for 5 days. The effects of tiamulin on swine reproductive performance, pregnancy and lactation have not been determined.

Contraindication:

Swine being treated with Denagard (tiamulin) should not have access to feeds containing polyether ionophores (e.g., monensin, lasalocid, narasin, salinomycin and semduramicin) as adverse reactions may occur.

Indications:

Treatment of swine dysentery associated with Brachyspira(formerly SerpulinaorTreponema) hyodysenteriaeand swine pneumonia due to Actinobacilluspleuropneumoniae, susceptible to tiamulin.

Use Directions:

Do not use undiluted.

This bottle contains 116,400 mg tiamulin hydrogen fumarate for use in preparing medicated drinking water for swine. See package insert for complete directions, read completely.

Protect from direct sunlight. Store at controlled room temperature, 59°-86°F (15°-30°C).

Restricted Drug (California): Use only as directed

Denagard®is a registered trademark of Novartis AG

U.S. Patent No. 4,278,674

Product # 701

NAH/DEN-LC/BL/2

Marketed by:

Novartis Animal Health US, Inc.

Greensboro, NC 27408 U.S.A.

NADA 140-916, Approved by FDA

Denagard®

(tiamulin...