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Denagard premix (Elanco Animal Health)

42

Description
Feed premix which contains 10% Tiamulin Hydrogen Fumarate

Primary Package
Bag 5 kg

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SKU: 8 Categories: ,

Description

NAME OF THE VETERINARY MEDICINAL PRODUCT

DENAGARD

Premix for medicated feed for pigs, poultry and rabbits

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:
Tiamulin hydrogen fumarate – 100 mg/g

Excipients: For full list of excipients, see section 6.1

PHARMACEUTICAL FORM
Premix for medicated feeding stuff

CLINICAL PARTICULARS
-Target species
Pig

Poultry
– Chicken (broiler, replacement pullet, layer/breeder)

– Turkey (poult (grower) and breeder)

Rabbit

-Indications for use, specifying the target species
Pig
For the treatment and prevention of swine dysentery caused by Brachyspira hyodysenteriae

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)

-Contraindications
Animals should not receive products containing ionophores (monensin, narasin or salinomycin) during or for at least seven days before or after treatment with tiamulin. Severe growth depression or death may result.
Refer to section 4.8 for information regarding interaction between tiamulin and ionophores

-Special warning for each target species
In case of reduced feed intake, the inclusion levels in feed may need to be increased to achieve target dosage. Acute cases and severely diseased animals with reduced feed intake should be treated with a product of suitable formulation such as an injectable or water solution.

-Special precautions for use

Special precautions for use in animals
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.

Refer to section 4.8 for information regarding interaction between tiamulin and ionophores.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter to European Standard EN 143. Wash contaminated skin.

In case of accidental ingestion, seek medical advice immediately and show the package insert or label to the physician.
People with known hypersensitivity to tiamulin should administer the product with caution.

-Adverse reactions (frequency and seriousness)
On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin.

-Use during pregnancy, lactation or lay
Can be used in pigs during pregnancy and lactation.

Can be used in laying and breeding chickens and turkeys.
Can be used in rabbits during pregnancy and lactation.

-Interaction with other medicinal products and other forms of interaction
Tiamulin has been shown to interact with ionophores such as monensin, salinomycin and narasin and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive products containing monensin, salinomycin or narasin during or at least 7 days before or after treatment with tiamulin. Severe growth depression, ataxia, paralysis or death may result.

If signs of an interaction do occur, administration of contaminated feed should be stopped immediately. The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin.

-Amounts 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 body weight should be determined as accurately as possible to avoid underdosing.

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

Pigs
Treatment 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 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

1.0 – 2.0 kg

Prevention of Swine Dysentery caused by B.hyodysenteriae

Dosage: 2.0 mg tiamulin hydrogen fumarate/kg bodyweight daily. The dosage will normally be achieved by an inclusion level of 40ppm tiamulin hydrogen fumarate in the finished feed, providing feed intake is unaffected. Preventive medication with tiamulin should be given for 2-4 weeks.

Preventive treatment with tiamulin should only be initiated after confirmed infection with B. hyodysenteriae and then as part of a program including measures aiming to eradicate or control the infection in the herd.

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

100.0

0.4 kg

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

Dosage: 7.5mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 10-14 consecutive days. The dosage will normally be achieved by an inclusion level of 150ppm 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 providing 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

Chicken (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 M. synoviae.

Dosage – Treatment and prevention: 25mg tiamulin hydrogen fumarate/kg body weight daily administered for the period of 3 to 5 consecutive days. This is normally achieved by aninclusion level of 250 – 500 ppm tiamulin hydrogen fumarate in the 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

1.25 – 2.5 kg

Turkey (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: 40mg tiamulin hydrogen fumarate/kg body weight 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- 4 kg

Preventive treatment with tiamulin should only be initiated after confirmed infection withM. 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.

Rabbit

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 body weight 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.

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

100.0

0.4 kg

-Overdose (symptoms, emergency procedures, antidotes), if necessary
Pigs: Single oral doses of 100 mg/kg body weight in pigs caused hyperpnoea and abdominal discomfort. At 150 mg/kg no CNS effects were noted except for sedation. At 55 mg/kg given for 14 days a transient salivation and slight gastric irritation occurred. A minimum lethal dose has not been established in the pig.

Poultry: The LD5 for chickens is 1290mg/kg and turkeys 840 mg/kg bodyweight.

The clinical signs of acute toxicity in chickens are – vocalization, clonic cramps and lateral recumbency. In turkeys signs of acute toxicity include clonic cramps, lateral or dorsal recumbency, salivation and ptosis.

If signs of intoxication do occur promptly remove the medicated feed, replace with fresh unmedicated feed and apply supportive, symptomatic therapy.

-Withdrawal period(s)
Pigs

Prevention (at 2.0mg/kg bwt): 1 day

Treatment (at 5-10mg/kgbwt): 6 days

Chickens
Meat and offal: 1 day

Eggs: 0 days

Turkeys
Meat and offal: 4 days

Rabbits
Meat and offal: 0 days

 

pdf Instructions Leaflet