Label: DENAGARD- tiamulin fumarate concentrate
- NDC Code(s): 58198-7425-1, 58198-7425-2
- Packager: Elanco US Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated October 18, 2024
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Description:
Denagard (tiamulin hydrogen fumarate) Liquid Concentrate is a solution containing 12.5 % tiamulin hydrogen fumarate (w/v) in an aqueous solution.
The active ingredient, tiamulin hydrogen fumarate, 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:
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Indications:
Denagard (tiamulin hydrogen fumarate), 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 of body weight daily.
- Contraindications:
- Warning:
- Residue Warnings:
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Adverse Reactions:
Overdoses of Denagard have sometimes produced transitory salivation, vomiting and an apparent calming effect on the pig. If signs of toxicity occur, discontinue use of medicated water and replace with clean, fresh water. In rare cases, redness of the skin primarily over the ham and underline has been observed during medication. If these signs appear, discontinue use of this drug. Provide ample clean drinking water. Thoroughly rinse (hose down) the housing to remove urine and feces from animal contact surfaces or move the animals to clean pens. If the condition persists, consult your veterinarian.
Studies to evaluate the safety of the water soluble form of tiamulin in breeding swine have not been done.
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Use Directions:
The concentration of tiamulin hydrogen fumarate 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.
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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.
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. *3. Increase or decrease dilution rate as required to obtain proper daily drug dose. Number of pigs this bottle will treat for ONE day based on water consumption per pig
One Liter
Net tiamulin hydrogen fumarate content:
125,000 mg
Diseases 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 Wt, lb
Water Intake, gal
# of Pigs
# of Pigs
20
0.3 - 0.5
1,786
595
45
0.4 - 1.1
794
265
75
0.7 - 1.5
476
159
125
1.0 - 2.0
286
95
180
1.2 - 3.0
198
66
Suggested final dilution of:
1 bottle (1 Liter)
550 gal
183 gal
3 bottles (3 Liters)
1650 gal
550 gal
1/2 bottle (0.5 Liters)
275 gal
92 gal
Tiamulin hydrogen fumarate concentration per gallon at suggested final dilution*
227 mg
681 mg
(60 ppm)
(180 ppm)
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Directions for using Denagard
In medicated proportioners: One liter of Denagard Liquid Concentrate mixed with water to make 4.3 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 550 gallons of drinking water for treatment of swine dysentery. Three liters of Denagard Liquid Concentrate mixed with water to make 4.3 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 550 gallons of drinking water for treatment of swine pneumonia.
In barrels or tanks: One liter (1000 mL) of Denagard Liquid Concentrate will medicate 550 gallons of drinking water at 227 mg per gallon for treatment of swine dysentery or 183 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.
Attention: If no response to treatment is obtained within 5 days re-establish the diagnosis. Failure of response may be related to the presence of non-susceptible organisms of other complicating disease conditions. Because of the tendency for the disease to recur on premises with a history of swine dysentery or with swine pneumonia, a control program should be implemented after treatment. Drugs are not substitutes for proper sanitary measures or good management, but should be used in conjunction with such practices.
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How supplied:
Container Size
Active Ingredients
1 Liter bottle
12.5% (125.0 g)
(33.8 fl oz; 1000 mL)
Tiamulin hydrogen fumarate
5 Liter bottle
12.5% (625.0 g)
(169 fl oz; 5000 mL)
Tiamulin hydrogen fumarate
Protect from direct sunlight. Store at controlled room temperature, 59 °–77 °F (15 °–25 °C).
Observe expiration date.
Restricted Drug (California): Use only as directedApproved by FDA under NADA # 140-916
Denagard, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2024 Elanco or its affiliates
Product of Italy
Manufactured for: Elanco US Inc.
Greenfield, IN 46140, USAElanco™
- Principal Display Panel - Denagard 1000 mL Bottle Label
- Principal Display Panel - Denagard 5000 mL Bottle Label
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INGREDIENTS AND APPEARANCE
DENAGARD
tiamulin fumarate concentrateProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-7425 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tiamulin fumarate (UNII: ION1Q02ZCX) (TIAMULIN - UNII:E38WZ4U54R) tiamulin fumarate 0.125 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-7425-1 1000 mL in 1 BOTTLE 2 NDC:58198-7425-2 5000 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140916 06/14/2010 Labeler - Elanco US Inc. (966985624)
