Denagard 10%

1 x 1 kg

Premix for medicated feeding

Active substance

Tiamulin (Tiamulin hydrogenfumarate) : 100 mg/g

ATC code

QJ01XQ01 Tiamulin

QJ01XQ Pleuromutilins

QJ01X Other antibacterials

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Pig

Chicken (broiler, replacement pullet, layer/breeder)

Turkey (poult (grower) and breeder)

Rabbit

Indications

Pig

For the treatment and metaphylaxis, when the disease is present in the group, of swine dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin. The presence of the disease in the group must be established before the product is used.

For the treatment of colitis caused by Brachyspira pilosicoli.

For the treatment of ileitis caused by Lawsonia intracellularis.

For the treatment of enzootic pneumonia caused by Mycoplasma hyopneumoniae.

Chicken

For the treatment and prevention of chronic respiratory disease (CRD) and air sacculitis caused by Mycoplasma gallisepticum and Mycoplasma synoviae.

Turkey

For the treatment and prevention of infectious sinusitis and air sacculitis caused by Mycoplasma gallisepticum, Mycoplasma meleagridis and Mycoplasma synoviae.

Rabbit

For the treatment and prevention of epizootic rabbit enterocolitis (ERE) (see section 4.9 for further information regarding indications).

Dose to be administered and administration route

Calculations to achieve the correct dose rate and achieve the correct inclusion rate should be based on: - Inclusion rate (ppm) = dose rate (mg/kg bwt) x bodyweight (kg) / daily feed intake (kg).

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of tiamulin hydrogen fumarate has to be adjusted accordingly.

Pigs

Treatment and metaphylaxis of Swine Dysentery caused by

B. hyodysenteriae, treatment of Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli

Dosage: 5 - 10 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 7 to 10 consecutive days. The dosage will normally be achieved by an inclusion level of 100 – 200 ppm tiamulin hydrogen fumarate in the finished feed provided that feed intake is unaffected.

Amount of THF (mg/g) per premix formulation	Amount of premix formulation per one tonne of feed
100.0	1.0 – 2.0 kg

Treatment of Porcine Proliferative Enteropathy (ileitis) caused by

L. intracellularis

Dosage: 7.5 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 10 to 14 consecutive days. The dosage will normally be achieved by an inclusion level of 150 ppm tiamulin hydrogen fumarate in the finished feed providing that feed intake is unaffected.

Amount of THF (mg/g) per premix formulation	Amount of premix formulation per one tonne of feed
100.0	1.5 kg

Treatment of Enzootic Pneumonia caused by M. hyopneumoniae

Dosage: 5.0 – 10.0 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 7 to 10 consecutive days. The dosage will normally be achieved by an inclusion level of 100 -200 ppm tiamulin hydrogen fumarate in the finished feed provided that feed intake is unaffected.

Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.

Amount of THF (mg/g) per premix formulation	Amount of premix formulation per one tonne of feed
100.0	1.0 – 2.0 kg

Chickens (broiler, replacement pullet, laying and breeding hens)

Treatment and prevention of Chronic Respiratory Disease (CRD) caused by M. gallisepticum and air sacculitis and infectious synovitis caused by and M. synoviae.

Dosage – Treatment and prevention: 25 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for the period of 3 to 5 consecutive days. This is normally achieved by an inclusion level of 250 - 500 ppm tiamulin hydrogen fumarate in finished feed provided that feed intake is unaffected. Inclusion levels in the higher range will in most cases be needed to avoid underdosing. In fast growing birds, e.g. broiler chickens during the first 2-4 weeks of life, inclusion levels in the lower range may be sufficient.

Amount of THF (mg/g) per premix formulation	Amount of premix formulation per one tonne of feed
100.0	2.5 – 5.0 kg

Turkeys (young poults, breeding turkeys)

Treatment and prevention of infectious sinusitis and air sacculitis caused by M. gallisepticum, M. synoviae and M. meleagridis.

Dosage – Treatment and prevention: 40 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for the period of 3 to 5 consecutive days. This is normally achieved by an inclusion level of 250 – 500 ppm tiamulin hydrogen fumarate in finished feed provided that feed intake is unaffected. Inclusion levels in the higher range will in most cases be needed to avoid underdosing. In fast growing birds, e.g. poults during the first 2-4 weeks of life, inclusion levels in the lower range may be sufficient.

Amount of THF (mg/g) per premix formulation	Amount of premix formulation per one tonne of feed
100.0	2.5 – 5.0 kg

Preventive treatment with tiamulin should only be initiated after confirmed infection with M. gallisepticum, M. synoviae or M. meleagridis and then as an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease in flocks where infection in ovum is likely because the disease is known to exist in the parent generation. The prevention strategy should include efforts to eliminate the infection from the parent generation.

Rabbits

Treatment of Epizootic Rabbit Enterocolitis (ERE) and prevention of ERE in farms with clinical signs of ERE in the previous fattening cycle as part of a programme including measures aiming to eradicate or control the infection in the farm.

Dosage: 3 mg tiamulin hydrogen fumarate /kg bodyweight daily. The dosage will normally be achieved by an inclusion level of 40 ppm tiamulin hydrogen fumarate in the finished feed provided that feed intake is unaffected. Treatment should be administered until 2 – 3 days after clinical signs has resolved. Prevention should be administered during 3 – 4 weeks from the first week after weaning.