POM-V Prescription Required Companion Animal

Denagard 10% w/w Premix for Medicated Feeding Stuff for Pigs, Chickens, Turkeys and Rabbits

Active ingredient: Tiamulin Hydrogen Fumarate

Form

Premix

Species

Chickens Pigs Rabbits Turkeys

Manufacturer

Elanco Europe Ltd

VMD MA No.

00879/5065

What it's used for

Pig For the treatment and metaphylaxis, when the disease is present in the group, of swine dysentery caused by Brachyspira hyodysenteriae susceptible to ti...

Full indications, dosage and side effects ↓

View official SPC (PDF)

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1

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2

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Clinical information

Denagard 10% w/w Premix for Medicated Feeding Stuff for Pigs, Chickens, Turkeys and Rabbits — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 18 Mar 2026.

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 .
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 meleagridis and
Mycoplasma synoviae.

Revised: December 2025
MA split from NI Expiry following AN: 02282/2025
Rabbit
For the treatment and prevention of epizootic rabbit enterocolitis (ERE) (see
section 4.9 for further information regarding indications).

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
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
100.01.0 – 2.0 kg

Revised: December 2025
MA split from NI Expiry following AN: 02282/2025
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
100.01.5 kg
Treatment of Enzootic Pneumonia caused by
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
100.01.0 – 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
100.02.5 – 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.

Revised: December 2025
MA split from NI Expiry following AN: 02282/2025
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
100.02.5 – 5.0 kg
Preventive treatment with tiamulin should only be initiated after confirmed
infection with M. gallisepticum, M. synoviae 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.
Amount of THF (mg/g) per premix
formulation
Amount of premix formulation per
one tonne of feed
100.00.4 kg

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

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

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 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.

Revised: December 2025
MA split from NI Expiry following AN: 02282/2025

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.

Do not store above 25ºC. Protect from direct sunlight.

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
100.01.0 – 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
100.02.5 – 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.

Revised: December 2025
MA split from NI Expiry following AN: 02282/2025
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
100.02.5 – 5.0 kg
Preventive treatment with tiamulin should only be initiated after confirmed
infection with M. gallisepticum, M. synoviae 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.
Amount of THF (mg/g) per premix
formulation
Amount of premix formulation per
one tonne of feed
100.00.4 kg
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Pigs: Single oral doses of 100 mg/kg bodyweight 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 1290 mg/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.
4.11 Withdrawal period(s)
Pigs
Meat and offal:
Treatment (at 5-10 mg/kg bwt): 6 days

Revised: December 2025
MA split from NI Expiry following AN: 02282/2025
Chickens
Meat and offal: 1 day
Eggs: 0 days
Turkeys
Meat and offal: 4 days
Rabbits
Meat and offal: 0 days
5.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.