Denagard 10% GF Premix (Canada)

Tiamulin Hydrogen Fumarate Medicated Premix, 10%

DIN: 02393301

Veterinary Use Only

For Use in Swine Feed Only

Description

Denagard 10% GF Premix is a free flowing white to cream-coloured medicated feed premix. Each kg of premix contains 100 g of tiamulin hydrogen fumarate (THF), equivalent to 80.91 g tiamulin base.

Therapeutic Classification: Antibiotic.

Denagard 10% GF Premix Indications

Denagard 10% GF Premix is indicated for:

1. The treatment of Swine Dysentery associated with Brachyspira hyodysenteriae;

2. The prevention of Swine Dysentery associated with Brachyspira hyodysenteriae;

3. The treatment of Porcine Colonic Spirochaetosis (colitis) associated with Brachyspira pilosicoli;

4. The treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis;

5. The treatment of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae.

Active Ingredient

Tiamulin hydrogen fumarate (Ph. Eur.) 100 g/kg of Premix.

Dosage:

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 and Feeding Directions: Thoroughly mix Denagard 10% GF Premix into complete non-medicated swine feed for each treatment as shown in the table below:

*mg/kg is equivalent to g/tonne and equivalent to ppm

Note: Use as the only source of tiamulin. During treatment, swine should be housed under conditions of adequate space and sanitation.

Contra-indications:

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

2. Do not feed to animals other than swine.

3. Do not use undiluted.

4. Swine being medicated with Denagard 10% GF Premix 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 swine feed only. This drug should not be administered to sows and gilts 4 weeks after service.

Warnings

Treated swine must not be slaughtered for use in food for at least 7 days after the latest treatment with this drug at the dose of up to 220 mg/kg tiamulin hydrogen fumarate (178.1 mg/kg tiamulin base) for treatment claims or at least 2 days after use at 38.6 mg/kg tiamulin hydrogen fumarate (31.2 mg/kg tiamulin base) for prevention claims.

When mixing, direct contact with the skin and eyes should be avoided by wearing impermeable rubber gloves and safety glasses. In case of accidental eye contact, irrigate the eyes thoroughly with clean running water immediately. Seek medical advice if irritation persists. When handling the product, inhalation of the dust must be avoided by wearing a disposable half-mask respirator. Contaminated clothing should be removed and any splashes on to the skin should be washed off immediately. Wash hands after use. In case of accidental ingestion, seek medical advice immediately and show the label to the physician.

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 Conditions:

Store below 25°C in a dry place.

Once opened, use content of bag within 12 weeks.

Presentation: Denagard 10% GF Premix is supplied in 25 kg bags.

Manufactured For:

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

Date: March 2022

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

© 2022 Elanco or its affiliates.

CPN: 1231107.6