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Denagard 12.5% Liquid Concentrate (Canada)

This page contains information on Denagard 12.5% Liquid Concentrate for veterinary use.
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  • Denagard 12.5% Liquid Concentrate Indications
  • Warnings and cautions for Denagard 12.5% Liquid Concentrate
  • Direction and dosage information for Denagard 12.5% Liquid Concentrate

Denagard 12.5% Liquid Concentrate

This treatment applies to the following species:
Manufacturer: Novartis

DIN 00818623

12.5% w/v tiamulin hydrogen fumarate solution

For Veterinary Use Only

For use in drinking water of swine only.

Description

Denagard® 12.5% (Tiamulin hydrogen fumarate Ph. Eur.) contains 14-desoxy-I 4-[(2-diethylaminoethyl) mercaptoacetoxy] mutilin hydrogen fumarate, a semi-synthetic derivative of the antibiotic, pleuromulin. 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

Administer product in the drinking water at 0.0049% continuously for 5 days.

Bottle Size:

1000 mL (1 L)

Tiamulin Content:

101.206 g

Tiamulin, mg/kg daily

6.2

Body weight bottle will treat for one day

16,337 kg

Required treatment duration

5 days

Amount of water per bottle*

2,067 litres

Tiamulin per litre of water

49 mg

* 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® 12.5% bottle in the amount of drinking water indicated in the following chart to obtain the desired concentration of tiamulin. Mix thoroughly.

Package size

Final Tiamulin Concentration Desired

Approximate Quantity of Drinking Water

Litres

Imp. Gal.

US Gal.

1000 mL

0.0049%

2067

454.7

546

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.

Contraindications

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 Novartis Animal Health, 1-800-387-6325.

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: January 2012

Manufactured and Distributed by: Novartis Animal Health Canada Inc., 2000 Argentia Road, Suite 400, Plaza 3, Mississauga, Ontario L5N 1V9

® Registered trademark of Novartis AG - Novartis Animal Health Canada Inc., authorized user

NAH/DEN-LC 12.5/CAN/BL/2

611322 CAN 910370

NAC No.: 12310842

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 12.5% Liquid Concentrate 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: 2016-08-21

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