Denagard Medicated Premix (Canada)

Company: Elanco

(tiamulin hydrogen fumarate)

Medicated Premix

DIN 00860735

Veterinary Use Only

For Use in Swine and Rabbit Feeds Only

Active Ingredient

Tiamulin Base: 17.8 g/kg (equivalent to 22 g tiamulin hydrogen fumarate/kg)

Description

Denagard premix contains 14-desoxy-I 4-[(2- diethylaminoethyl) mercaptoacetoxy] mutilin hydrogen fumarate, a semi-synthetic derivative of the antibiotic, pleuromutilin. Each kg contains 17.8 g of tiamulin base equivalent to 22 g of tiamulin hydrogen fumarate.

Therapeutic Classification: Antibiotic

Denagard Medicated Premix Indications

Swine: For the treatment and for the prevention of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin. Rabbits: For the prevention of mortality associated with Epizootic Rabbit Enterocolitis (ERE).

Note: The use of Denagard for the prevention of ERE in growing rabbits should be implemented alongside proper feeding and hygiene strategies to optimize the maintenance of animal health.

Dosage and Administration

To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently and for the shortest duration required to achieve the desired clinical outcome.

Mixing Directions:

Swine: Thoroughly mix Denagard into complete nonmedicated swine feed for the treatment or for the prevention of swine dysentery at the rates per metric tonne (1,000 kg) of feed as shown in the table below.

Rabbits: Thoroughly mix Denagard into complete nonmedicated rabbit feed for the prevention of mortality associated with Epizootic Rabbit Enterocolitis (ERE) at the rate per metric tonne (1,000 kg) of feed as shown in the table below.

Feeding Directions:

For treatment of swine dysentery, feed at 178.1 g/tonne for 14 days.

For prevention of swine dysentery, feed continuously at 31.2 g/tonne as the sole ration to swine on premises with a history of swine dysentery but where signs of the disease have not yet occurred. Feed continuously at 31.2 g/tonne to prevent reinfection following use of tiamulin at 178.1 g/tonne for 14 days or following use of tiamulin medicated water for treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin.

For prevention of mortality associated with Epizootic Rabbit Enterocolitis (ERE), feed at 32 g/tonne for 21 days starting the first week after weaning.

Note: Use as the only source of tiamulin. During treatment pigs should be housed under conditions of adequate space and sanitation. To reduce occurrence of ERE in growing rabbits, proper feeding and hygiene strategies should be put in place to optimize the maintenance of animal health.

Cautions:

1. Swine and rabbits being medicated with Denagard should not have access to or be treated with tiamulin incompatible polyether ionophores (e.g., monensin, lasalocid, narasin, salinomycin and semduramicin).

2. Do not use in feed containing pellet binding agents.

3. Do not feed to animals other than swine and rabbit.

4. Not to be administered to sows and gilts 4 weeks after service.

5. Do not use undiluted.

Warnings

Treated swine must not be slaughtered for use in food for at least 7 days after the latest treatment with this drug at 178.1 g/tonne or for at least 2 days after the latest treatment with this drug at 31.2 g/tonne. Treated rabbits must not be slaughtered for use in food for at least 2 days after the latest treatment with this drug.

When handling the product, avoid inhalation, oral exposure and direct contact with skin or eyes.

KEEP OUT OF REACH OF CHILDREN.

Adverse Reactions

1. 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.

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

3. If signs of toxicity or redness of the skin occurs, promptly discontinue use of the therapeutic level of medicated feed.

Storage

Store at less than 25 °C in a dry place.

Presentation: Denagard is supplied in a 15 kg bag containing 17.8 g of tiamulin per kg (equivalent to 22 g of tiamulin hydrogen fumarate/kg).

Date: October 2022

Manufactured For:

Elanco Canada Limited, 1919 Minnesota Court, Suite 401, Mississauga, Ontario L5N 0C9

1-800-265-5475

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

© 2022 Elanco or its affiliates.

CPN: 1231085.5