Novartis (Farm Animal) (tiamulin) 12.3% Tiamulin hydrogen fumarate NADA 140-916, Approved by FDA Description: Denagard (tiamulin) Liquid Concentrate is a solution containing 12.3% tiamulin hydrogen fumarate (w/v) in an aqueous solution. The active ingredient, tiamulin, chemically is 14-desoxy-14-[(2-diethylaminoethyl) mercaptoacetoxy] mutilin hydrogen fumarate, a semi-synthetic diterpene antibiotic. Denagard Liquid Concentrate is for use only in preparing medicated drinking water for swine. Actions: Tiamulin is active against Brachyspira (formerly Serpulina or Treponema) hyodysenteriae and Actinobacillus pleuropneumoniae. It is readily absorbed from the gut and can be found in the blood within 30 minutes after dosing. Indications: Denagard (tiamulin), when administered in the drinking water for five consecutive days, is an effective antibiotic for the treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin at a dose level of 3.5 mg tiamulin hydrogen fumarate per pound of body weight daily and for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin when given at 10.5 mg tiamulin hydrogen fumarate per pound body weight daily. Use Directions: Do not use undiluted. The concentration of tiamulin in the drinking water must be adjusted to compensate for variation in water consumption due to weight or size of the pig, environmental temperature and other factors. It is important that pigs receive the proper drug dose, 3.5 mg tiamulin hydrogen fumarate per pound for swine dysentery or 10.5 mg tiamulin hydrogen fumarate per pound for swine pneumonia, each day for 5 consecutive days. Table 1 Approximate daily water consumption per pig. Pig Weight, lb Water Intake, gal. 20 0.3 - 0.5 45 0.4 - 1.1 75 0.7 - 1.5 125 1.0 - 2.0 180 1.2 - 3.0 Note: 1. Prepare fresh medicated drinking water every day for the 5 day treatment period. 2. Water medicated with Denagard should be the only source of drinking water during the treatment period. Directions for preparing Denagard medicated solutions Determine the amount of Denagard Liquid Concentrate needed to medicate the desired volume of drinking water at the proper concentration. Carefully measure out this amount, add it to the water and stir to thoroughly mix. Table 2 Denagard Liquid Concentrate One Quart Net Tiamulin hydrogen fumarate content: 116,400 mg Disease to be treated: Swine Dysentery Swine Pneumonia Daily tiamulin hydrogen fumarate required per pound body weight: 3.5 mg 10.5 mg Required treatment duration: 5 days 5 days Pig body weight this bottle will treat for ONE day: 33,257 lb 11,086 lb Number of pigs this bottle will treat for ONE day: Pig Wt, lb 20 1,663 554 45 739 246 75 443 148 125 266 88 180 185 62 Suggested final dilution of: 1 bottle 512 gal - 3 bottles - 512 gal 1/2 pint (8 oz) 128 gal 43 gal 1 1/2 pints (24 oz) - 128 gal Tiamulin hydrogen fumarate concentration per gallon at suggested final dilution* 227 mg (60 ppm) 681 mg (180 ppm) *Note: Increase or decrease dilution rate as required to obtain proper daily drug dose. Directions for using Denagard In medicated proportioners: One quart of Denagard Liquid Concentrate mixed with water to make four gallons of stock solution and this stock solution metered at one fluid ounce per gallon will provide 227 mg of tiamulin hydrogen fumarate per gallon to 512 gallons of drinking water for treatment of swine dysentery. Three quarts of Denagard Liquid Concentrate mixed with water to make four gallons of stock solution and this stock solution metered at one fluid ounce per gallon will provide 681 mg tiamulin hydrogen fumarate per gallon to a total of 512 gallons of drinking water for treatment of swine pneumonia. One pint of Denagard Liquid Concentrate mixed with water to make two gallons of stock solution and this stock solution metered at one fluid ounce per gallon will provide 227 mg of tiamulin hydrogen fumarate per gallon to 256 gallons of drinking water for treatment of swine dysentery. Use three pints of Denagard Liquid Concentrate in two gallons of stock solution to be metered at one fluid ounce per gallon to deliver 681 mg per gallon to a total of 256 gallons of drinking water for treatment of swine pneumonia. One-half pint (8 fluid ounces) of Denagard Liquid Concentrate diluted with water to make one gallon of stock solution and this stock solution metered at one fluid ounce of drinking water with a medication proportioner will provide 227 mg of tiamulin hydrogen fumarate per gallon to 128 gallons of drinking water for treatment of swine dysentery. Use one and one-half pints of Denagard Liquid Concentrate per gallon of stock solution to be metered at one fluid ounce per gallon to provide 681 mg per gallon to 128 gallons of drinking water for treatment of swine pneumonia. In barrels or tanks: Three fluid ounces of Denagard Liquid Concentrate will medicate 48 gallons of drinking water at 227 mg per gallon for treatment of swine dysentery or 16 gallons at 681 mg per gallon for treatment of swine pneumonia. Measure Denagard Liquid Concentrate carefully, pour into the proper amount of water and thoroughly mix. The concentration of tiamulin hydrogen fumarate in the stock solution and in the drinking water delivered must be adjusted to compensate for variation in water consumption by pigs due to body weight, environmental and other factors. It is important that the pigs receive the proper drug dose of 3.5 mg of tiamulin hydrogen fumarate per pound of body weight daily for 5 consecutive days for treatment of swine dysentery or a dose of 10.5 mg per pound body weight daily for 5 consecutive days for treatment of swine pneumonia.