Target species
Pigs.
Indications for use, specifying the target species
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.
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.
Special warnings for each target species
For intramuscular use only in pigs.
Special precautions for use
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.
Adverse reactions (frequency and seriousness)
On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of this product.
Use during pregnancy, lactation or lay
Can be use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
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.
Amounts to be administered and administration route
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.
Overdose (symptoms, emergency procedures, antidotes) if necessary
Pleuromutilins have a wide margin of safety. Do not exceed the specified dosage.
Withdrawal period(s)
Meat and offal: 22 days