Denagard 200 mg/ml Solution for Injection

Composition

Each ml provides tiamulin base equivalent to 200 mg tiamulin hydrogen fumarate.

Tiamulin hydrogen fumarate 200 mg/ml

For full list of excipients, see section 6.1.

6.1 List of excipients

Ethanol

Sesame oil

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Pharmaceutical form

Solution for injection.

Clear yellow oily solution.

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Pharmacological properties

Pharmacotherapeutic group: Antibacterial for systemic use.

ATCVet Code: QJ01XQ01

5.1 Pharmacodynamic properties

The following organisms show sensitivity to tiamulin in vitro:

Brachyspira: Brachyspira hyodysenteriae, Brachyspira pilosicoli

Mycoplasmas: Mycoplasma hyopneumoniae, M. hyorhinis, M. hyosynoviae, M. dispar,Ureaplasma spp,Gram-positive: Staphylococcus spp., Streptococcus spp., Corynebacterium pyogenes.

Gram-negative: Pasteurella spp., Klebsiella pneumoniae, Actinobacillus (Haemophilus)spp., Fusobacterium necrophorum, Bacteroides spp., Campylobacter coli,Lawsonia intracellularis.

5.2 Pharmacokinetic particulars

Following oral administration the active ingredient, tiamulin, is rapidly absorbed, peak serum levels being achieved within two hours. Tiamulin distributes widely in tissues, including the colon. High tiamulin concentrations are found in the lung of up to approximately 20 times the value found in the serum. Two hours post-injection, tiamulin lung levels of 14.5 – 16.7 mg/g have been found.

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Target species

Pigs

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Indications

Swine dysentery: For the treatment of swine dysentery caused by Brachyspira hyodysenteriae and complicated by Bacteroides spp and Fusobacterium spp.

Enzootic pneumonia complex of pigs: For the treatment of enzootic pneumonia complex, caused by M. hyopneumoniae and where the secondary bacteria are sensitive to tiamulin.

Mycoplasmal arthritis: For the treatment of arthritis caused by Mycoplasma hyosynoviae, to reduce lameness and restore growth performance.

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Dosage

To be administered by intramuscular injection. Swab the rubber septum before removing each dose. Use a dry, sterile, needle and syringe. The maximum volume to be administered at any one intramuscular injection site should not exceed 10 ml.

Swine dysentery Treatment: The dose is 1 ml/20 kg bodyweight (equivalent to 10 mg tiamulin hydrogen fumarate/kg body weight) intramuscularly administered as a single treatment to pigs showing clinical signs of the disease.

Follow-up treatment should be provided when necessary with either Denagard 12.5% w/v Concentrate for Oral Solution or Denagard 2% Premix for Medicated Feedingstuff administered according to directions in the drinking water or in the feed, respectively.

Enzootic pneumonia complex of pigs Treatment: The dose is 1.5 ml/20 kg bodyweight (equivalent to 15 mg tiamulin hydrogen fumarate/kg body weight) administered intramuscularly for a period of 3 consecutive days to pigs showing clinical signs of the disease.

Mycoplasmal arthritis Treatment: The dose is 1.5 ml/20 kg bodyweight (equivalent to 15 mg tiamulin hydrogen fumarate/kg body weight) administered intramuscularly for a period of 3 consecutive days to pigs showing clinical signs of the disease.

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Contraindications

Animals should not receive products containing monensin, narasin or salinomycin during or for at least seven days before and after treatment with Denagard 200 Solution for Injection. Severe growth depression or death may result.

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Adverse reactions

On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of this product.

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Warnings

i. Special precautions for use in animals

As Denagard 200 Solution for Injection 200 mg/ml is formulated with sesame oil, it is important to ensure that the syringe used is dry. The admixture of oil and water may cause the plunger to stick.

ii. Special precautions for the person administering the veterinary medicinal product to animals

Avoid accidental self-injection.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.

In case of skin contact with the product, wash immediately with running water in order to minimise absorption through the skin.

In case of eye contact with the product, wash immediately with running water and seek medical advice.

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Use during pregnancy, lactation or lay

Can be use during pregnancy and lactation.

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Interactions

Animals should not receive products containing monensin, narasin or salinomycin during or for at least seven days before and after treatment with Denagard 200 Solution for Injection. Severe growth depression or death may result.

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Overdose

Pleuromutilins have a wide margin of safety. Do not exceed the specified dosage.

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Special warnings

For intramuscular use only in pigs.

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Withdrawal period

Meat and offal: 22 days

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Incompatibilities

None known.

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Immediate packaging

100 ml Type III glass vial, closed with a rubber stopper with aluminium seal.

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Storage

Do not store above 25°C. Do not refrigerate.

This product does not contain an antimicrobial preservative. Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years

Shelf life after first opening the immediate packaging: 28 days

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Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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Additional information

Vm 52127/5080

9 DATE OF FIRST AUTHORISATION

31 July 1985

10 DATE OF REVISION OF THE TEXT

April 2025

Approved 29 April 2025

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Registration holder

Elanco GmbH

Heinz-Lohmann Strasse 4

D-27472 Cuxhaven

Groden

Germany

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