TIA- tiamulin hydrogen fumarate solution, concentrate

TIA by

Drug Labeling and Warnings

TIA by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc., Virbac Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

TIA 12.5% (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. TIA 12.5% 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

TIA 12.5% (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

Swine being treated with TIA 12.5% (tiamulin hydrogen fumarate) should not have access to feeds containing
polyether ionophores (e.g. monensin, lasalocid, narasin, salinomycin and semduramicin) as adverse reactions may occur.

WARNINGS AND PRECAUTIONS

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

Residue Warnings: Withdraw medicated water 3 days before slaughter after treatment at 3.5 mg per pound body weight and 7 days before slaughter after treatment at 10.5 mg per pound body weight.

Caution: For use in drinking water of swine only - Not for use in humans.
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.

Adverse Reactions

Overdoses of tiamulin hydrogen fumarate 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.

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

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.

Directions for preparing TIA 12.5% medicated solutions

Determine the amount of TIA 12.5% (tiamulin hydrogen fumarate) 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.

Directions for using TIA 12.5%

In medicated proportioners: One liter of TIA 12.5% 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 TIA 12.5% 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 TIA 12.5% (tiamulin hydrogen fumarate) Liquid Concentrate will medicate 550 gallons ofdrinking 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 TIA 12.5% 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 afer treatment. Drugs are not substitutes for proper sanitary measures or good management, but should be used in conjunction with such practices.

STORAGE AND HANDLING

Store at or below 25°C (77°F). Excursions permitted up to 40°C (104°F).
Observe expiration date.

92601 302295-02

SPL UNCLASSIFIED SECTION

Restricted Drug (California): Use only as directed
Approved by FDA under ANADA # 200-695
Manufactured by: Virbac AH, Inc
P.O. Box 162059 Fort Worth, TX 76161

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIA 
tiamulin hydrogen fumarate solution, concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51311-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TIAMULIN FUMARATE (UNII: ION1Q02ZCX) (TIAMULIN - UNII:E38WZ4U54R)	TIAMULIN	125 mg

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-131-01	125 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200695	01/19/2022

Labeler - Virbac AH, Inc. (131568396)

Registrant - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Business Operations
Virbac Corporation		829166276	manufacture, pack, analysis