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Denagard 10% GF Premix (Canada)

This page contains information on Denagard 10% GF Premix for veterinary use.
The information provided typically includes the following:
  • Denagard 10% GF Premix Indications
  • Warnings and cautions for Denagard 10% GF Premix
  • Direction and dosage information for Denagard 10% GF Premix

Denagard 10% GF Premix

This treatment applies to the following species:
Manufacturer: Elanco (Novartis)

(Tiamulin hydrogen fumarate, 100 g/kg)

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 and Administration

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:

Denagard 10% GF Premix Indications

THF Use Level*
(Tiamulin Base)

Amt of Denagard 10% GF Premix per tonne of Feed

1. Treatment of Swine Dysentery associated with Brachyspira hyodysenteriae

220 mg/kg
(178.1 mg/kg)

2.2 kg/tonne of feed for 14 days.

2. Prevention of Swine Dysentery associated with Brachyspira hyodysenteriae

38.6 mg/kg
(31.2 mg/kg)

0.39 kg/tonne of feed on premises with a history of swine dysentery but where signs of the disease have not yet occurred, or following treatment at 220 mg/kg tiamulin hydrogen fumarate (178.1 mg/kg tiamulin base) to prevent reinfection during the risk period of 6 to 8 weeks.

3. Treatment of Porcine Colonic Spirochaetosis (colitis) associated with Brachyspira pilosicoli

220 mg/kg
(178.1 mg/kg)

2.2 kg/tonne of feed for 14 days.

4. Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis

150 mg/kg
(121.4 mg/kg)

1.5 kg/tonne of feed for 14 days.

5. Treatment of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae

165 mg/kg
(133.5 mg/kg)

1.65 kg/tonne of feed for 14 days.

*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 5 kg and 25 kg bags.

Date: July 2016

Manufactured and Distributed by: Elanco Canada Limited, 150 Research Lane, Suite 120, Guelph, Ontario N1G 4T2

Net Weight:

 

5 kg

08Jul2016

25 kg

08Jul2016

CPN: 1231107.2

ELANCO CANADA LIMITED
Distributed by ELANCO, Division Eli Lilly Canada Inc. & ELANCO CANADA LIMITED (successor to Novartis Animal Health Canada Inc.)
RESEARCH PARK CENTRE, 150 RESEARCH LANE, SUITE 120, GUELPH, ON, N1G 4T2
Telephone:   519-821-0277
Order Desk:   800-773-7603
Fax:   519-821-7831
Elanco Canada Limited Customer Service Telephone:   800-387-6325
Elanco Canada Limited Customer Service Fax:   800-827-5782
Website:   www.Elanco.ca
Every effort has been made to ensure the accuracy of the Denagard 10% GF Premix information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-10-31

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