Denagard 12.5% Liquid Concentrate (Canada)

Company: Elanco

Liquid Concentrate

DIN 00818623

12.5% w/v tiamulin hydrogen fumarate solution

For Veterinary Use Only

Antibiotic

For use in drinking water of swine only

Description

Denagard 12.5% (Tiamulin hydrogen fumarate Ph. Eur.) contains 14-desoxy-1 4-[(2-diethylaminoethyl) mercaptoacetoxy] mutilin hydrogen fumarate, a semi-synthetic derivative of the antibiotic, pleuromutilin. Each 1 litre bottle contains 101.206 g of Tiamulin (equivalent to 125 g of Tiamulin hydrogen fumarate).

Therapeutic Classification: Antibiotic.

Indication: Denagard 12.5% is indicated in the treatment of swine dysentery caused by Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin.

Dosage and Administration

To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently. Administer product in the drinking water at 0.0049% continuously for 5 days.

* Adjust dilution as needed to get required daily drug dose.

Preparation of Denagard 12.5% medicated drinking water: Do not use undiluted. Mix the entire contents of the Denagard Liquid Concentrate bottle in the amount of drinking water indicated in the following chart to obtain the desired concentration of tiamulin. Mix thoroughly.

Directions For Use

1. Prepare fresh medicated drinking water daily.

2. Water medicated with Denagard 12.5% should be the only source of drinking water during the treatment period.

3. During treatment, swine should be housed under conditions of adequate space and sanitation.

4. If no response to treatment is obtained within 5 days, re-establish the diagnosis. Failure of response may be related to the presence of nonsusceptible organisms or other complicating disease conditions.

Contra-indications: Swine being medicated with Denagard 12.5% should not have access to or be treated with tiamulin incompatible polyether ionophores (e.g., monensin, lasalocid, narasin, salinomycin and semduramicin).

Cautions: For use in the drinking water of swine only. This drug should not be administered to sows during 4 weeks after service.

Warnings

Treated swine must not be slaughtered for use in food for at least 3 days after the latest treatment with this drug. Avoid contact with the skin. Direct contact with the skin or mucous membranes during mixing may cause irritation. If contact occurs, wash with soap and water. KEEP OUT OF REACH OF CHILDREN.

Adverse Reactions

i. Overdoses of tiamulin have sometimes produced transitory salivation, vomiting and an apparent calming effect on the pig. In very rare cases, death has been reported.

ii. In rare cases, redness of the skin, primarily over the ham and underline, has been observed during medication.

iii. If signs of toxicity or redness of the skin occurs, promptly discontinue use of medicated water and provide fresh, clean water for drinking.

To report suspected adverse drug events, contact Elanco Canada Limited, 1-800-265-5475.

Clinical Pharmacology

Tiamulin is active against Brachyspira (formerly Serpulina or Treponema) hyodysenteriae. Denagard 12.5% is well absorbed from the gastrointestinal tract of swine and appears in the blood within 30 minutes. Peak concentrations occur at 2-4 hours after the oral administration of a single dose. An average of 85% of a single dose is absorbed, 98% of which is excreted in the urine and feces within 72 hours.

Safety and Efficacy: Extensive field and laboratory testing with tiamulin has shown that this preparation, as recommended, has a high degree of safety. Doses greater than five times the recommended dose produced transitory salivation, emesis, and an apparent calming effect on the pig.

Storage

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

Presentation: Denagard 12.5% is supplied in a 1 litre (1000 mL) bottle containing 101.21 g of tiamulin (equivalent to 125 g tiamulin hydrogen fumarate) dissolved in an inert carrier.

Date: March 2022

Manufactured and Distributed by: Elanco Canada Limited, 1919 Minnesota Court, Suite 401, Mississauga, Ontario L5N 0C9

Denagard, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2022 Elanco or its affiliates.

CPN: 1231084.6