Tyawalt

Main information

  • Trade name:
  • Tyawalt 450 mg/ g Granules for Use in Drinking Water for Pigs, Chicken and Turkeys
  • Pharmaceutical form:
  • Granules for use in drinking water
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tyawalt 450 mg/g Granules for Use in Drinking Water for Pigs, Chicken and Turkeys
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Chickens, Pigs, Turkeys
  • Therapeutic area:
  • Antimicrobial

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 35501/4000
  • Authorization date:
  • 16-01-2018
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Revised: February 2018

AN: 01672/2014 (amended pages)

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Tyawalt 450 mg/g granules for use in drinking water for pigs, chickens and

turkeys (DE, BE, DK, ES, NL, PL, PT, UK)

Tyawalt 364.28 mg/g granules for use in drinking water for pigs, chickens and

turkeys (FR)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains:

Active substance:

Tiamulin hydrogen fumarate

450 mg (corresponds to 364.28 mg of

tiamulin base)

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Granules for use in drinking water

White to almost white small granules.

4.

CLINICAL PARTICULARS

4.1

Target species

Pigs, chickens and turkeys.

4.2

Indications for use, specifying the target species

Pigs

Treatment of Swine Dysentery caused by Brachyspira hyodysenteriae

susceptible to tiamulin. The presence of the disease in the herd must be

established before the product is used.

Treatment of Porcine Colonic Spirochaetosis (colitis) caused by

Brachyspira pilosicoli susceptible to tiamulin. The presence of the disease

in the herd must be established before the product is used.

Treatment of Porcine Proliferative Enteropathy (ileitis) caused by

Lawsonia intracellularis susceptible to tiamulin. The presence of the

disease in the herd must be established before the product is used.

Treatment and metaphylaxis of Enzootic Pneumonia caused by

Mycoplasma hyopneumoniae, including infections complicated by

Pasteurella multocida susceptible to tiamulin. The presence of the disease

in the herd must be established before the product is used.

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Treatment of Pleuropneumonia caused by Actinobacillus

pleuropneumoniae susceptible to tiamulin. The presence of the disease in

the herd must be established before the product is used.

Chickens

Treatment and metaphylaxis of Chronic Respiratory Disease caused by

Mycoplasma gallisepticum and Airsacculitis and Infectious Synovitis caused

by Mycoplasma synoviae susceptible to tiamulin. The presence of the disease

in the flock must be established before the product is used.

Turkeys

Treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by

Mycoplasma gallisepticum, Mycoplasma synoviae and Mycoplasma

meleagridis susceptible to tiamulin. The presence of the disease in the flock

must be established before the product is used.

4.3

Contraindications

Do not use in animals with known hypersensitivity to the active ingredient or to

any of the excipients.

Do not use in pigs and birds that could receive products containing monensin,

narasin or salinomycin during or for at least seven days before or after

treatment with tiamulin. Severe growth depression or death may result.

See section 4.8 for information regarding interaction between tiamulin and

ionophores.

4.4

Special warnings for each target species

Animals with reduced water intake and/or in a debilitated condition should be

treated parenterally.

Water intake may be depressed during the administration of tiamulin in birds.

It appears to be concentration-dependent with 500 mg tiamulin hydrogen

fumarate (equivalent to 1.11 g of product) in 4 litres of water reducing intake

by approximately 10% and 500 mg tiamulin hydrogen fumarate (equivalent to

1.11 g of product) in 2 litres of water by 15% in chickens. It does not appear to

have any adverse effect on overall performance of the birds or efficacy of the

veterinary medicinal product but water intake should be monitored at frequent

intervals, especially in hot weather. In turkeys, it is more marked, with

approximately 20% reduction and therefore it is recommended not to exceed

a concentration of 500 mg tiamulin hydrogen fumarate in 2 litres of the

drinking water.

4.5

Special precautions for use

Special precautions for use in animals

Use of the product should be based 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.

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AN: 01672/2014 (amended pages)

Inappropriate use of the veterinary medicinal product may increase the

prevalence of bacteria resistant to tiamulin.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals

People with known hypersensitivity to tiamulin should avoid contact with the

veterinary medicinal product.

When mixing, direct contact with the skin and mucous membranes should be

avoided.

Wear safety glasses, and rubber or latex gloves when handling or mixing the

product. Wash hands with soap and water after use.

If accidental contact occurs, contaminated clothing should be removed and

any splashes to the skin or mucous membranes should be washed off

immediately.

In case of accidental eye contact, irrigate the eyes thoroughly with clean

running water immediately.

Seek medical advice if irritation persists, and show package insert or labelling

to the physician.

4.6

Adverse reactions (frequency and seriousness)

On very rare occasions erythema or mild oedema of the skin may occur in

pigs following the use of tiamulin.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse

reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated

reports).

4.7

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used in pigs during pregnancy and lactation.

Laying birds:

Can be used in laying chickens and in breeding chickens and turkeys.

4.8

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.

Page 3 of 9

Revised: February 2018

AN: 01672/2014 (amended pages)

If signs of an interaction do occur, stop both the administration of tiamulin-

medicated drinking water and also the administration of ionophore-

contaminated feed immediately. The feed should be removed and replaced

with fresh feed not containing the anticoccidials monensin, salinomycin or

narasin.

Concomitant use of tiamulin and the divalent ionophore anticoccidials

lasalocid and semduramicin do not appear to cause any interaction, however

the concomitant use of maduramicin may lead to a mild to moderate growth

depression in chickens. The situation is transient and recovery normally

occurs within 3-5 days following withdrawal of tiamulin treatment.

4.9

Amounts to be administered and administration route

For use in drinking water.

Guidance for preparing product solutions:

When medicating large volumes of water, prepare a concentrated solution first

and then dilute to the required final concentration. Alternatively, the

concentrated solution can be used in a proportional water medicator. The

solubility of the product has been confirmed at the maximal concentration of

100 g of product/L in soft and hard water and at 4°C and 20°C.

Medicated drinking water should be refreshed or replaced every 24 hours.

Make sure the animals do not have access to non-medicated water during the

period when the medicated water is given.

After the end of the medication period the water supply system should be

cleaned appropriately to avoid intake of sub-therapeutic amounts of the active

substance.

To ensure the correct dosage, body weight should be determined as

accurately as possible to avoid underdosing. The intake of medicated water

depends on the clinical condition of the animals. In order to obtain the correct

dosage the concentration of tiamulin has to be adjusted accordingly.

In order to avoid interactions between the ionophores and tiamulin, the

veterinarian and farmer should check that the feed label does not state that it

contains salinomycin, monensin and narasin.

For chickens and turkeys, in order to avoid interactions between the

incompatible ionophores monensin, narasin and salinomycin and tiamulin, the

feed mill supplying the birds feed should be notified that tiamulin will be used

and that these anticoccidials should not be included in the feed or

contaminate the feed.

The feed should be tested for the ionophores prior to use if there is any

suspicion that contamination of the feed might occur.

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AN: 01672/2014 (amended pages)

If an interaction does occur, stop tiamulin medication immediately and replace

with fresh drinking water. Remove contaminated feed as soon as possible and

replace with feed not containing the tiamulin-incompatible ionophores.

The dosage of the product to be incorporated should be established according

to the following formula:

x mg product per kg

bodyweight per day

mean body weight

(kg) of animals to be

treated

= x mg product per

litre of drinking water

mean daily water consumption (L) per animal

Pigs:

For the treatment of Swine Dysentery caused by Brachyspira

hyodysenteriae: 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg

of product)/kg body weight administered daily in the drinking water of pigs

for 3 to 5 consecutive days depending on the severity of the infection

and/or the duration of the disease.

For the treatment of Porcine Colonic Spirochaetosis (colitis) caused by

Brachyspira pilosicoli: 8.8 mg tiamulin hydrogen fumarate (equivalent to

19.6 mg of product)/kg body weight administered daily in the drinking

water of pigs for 3 to 5 consecutive days depending on the severity of the

infection and/or the duration of the disease.

For the treatment of Porcine Proliferative Enteropathy (ileitis) caused by

Lawsonia intracellularis: 8.8 mg tiamulin hydrogen fumarate (equivalent to

19.6 mg of product)/kg body weight administered daily in the drinking

water of pigs for 5 consecutive days.

For the treatment and metaphylaxis of Enzootic Pneumonia caused by

Mycoplasma hyopneumoniae, including infections complicated by

Pasteurella multocida: 20 mg tiamulin hydrogen fumarate (equivalent to

44.4 mg of product)/kg body weight administered daily for 5 consecutive

days.

For the treatment of Pleuropneumonia caused by Actinobacillus

pleuropneumoniae: 20 mg tiamulin hydrogen fumarate (equivalent to 44.4

mg of product)/kg body weight administered daily for 5 consecutive days.

Chickens:

25 mg tiamulin hydrogen fumarate (equivalent to 55.6 mg of product)/kg body

weight administered daily for the period of 3 to 5 consecutive days

Turkeys

40 mg tiamulin hydrogen fumarate (equivalent to 88.9 mg of product)/kg body

weight administered daily for the period of 3 to 5 consecutive days.

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Revised: February 2018

AN: 01672/2014 (amended pages)

4.10

Overdose (symptoms, emergency procedures, antidotes), if

necessary

Single oral doses of 100 mg tiamulin hydrogen fumarate/kg body weight in

pigs caused hyperpnoea and abdominal discomfort. At 150 mg tiamulin

hydrogen fumarate/kg body weight no central nervous system effects were

noted except for tranquillisation. At 55 mg tiamulin hydrogen fumarate/kg body

weight given daily for 14 days, a transient salivation and slight gastric irritation

occurred. Tiamulin hydrogen fumarate is considered to have an adequate

therapeutic index in the pig and a minimum lethal dose has not been

established.

Regarding poultry, there is a relatively high therapeutic index with tiamulin

hydrogen fumarate and the likelihood of an overdose is considered remote

especially as water intake and hence tiamulin hydrogen fumarate intake is

reduced if abnormally high concentrations are given. The LD

is 1090 mg/kg

body weight for chickens and 840 mg/kg body weight for turkeys.

The clinical signs of acute toxicity in chickens are – vocalisation, clonic

cramps and lying in a lateral position, and in turkeys – clonic cramps, lateral or

dorsal position, salivation and ptosis.

If signs of intoxication do occur promptly remove the medicated water and

replace with fresh water.

4.11

Withdrawal period(s)

Pigs

Meat and offal: 2 days (8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6

mg of product)/kg body weight).

Meat and offal: 4 days (20 mg tiamulin hydrogen fumarate (equivalent to 44.4

mg of product)/kg body weight).

Chickens:

Meat and offal: 2 days;

Eggs: zero days.

Turkeys:

Meat and offal: 6 days.

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antibacterial for systemic use,

pleuromutilins/tiamulin

ATCvet code: QJ01XQ01

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5.1

Pharmacodynamic properties

Tiamulin is a bacteriostatic semi-synthetic antibiotic belonging to the

pleuromutilin group of antibiotics and acts at the ribosomal level to inhibit

bacterial protein synthesis.

Tiamulin has shown a high level of in vitro activity against porcine and avian

Mycoplasma species as well as gram-positive aerobes (streptococci and

staphylococci), anaerobes (clostridia), gram-negative anaerobes

(Brachyspira hyodysenteriae, Brachyspira pilosicoli), and gram-negative

aerobes (Actinobacillus pleuropneumoniae and Pasteurella multocida).

Tiamulin has been shown to act at the 70S ribosome level and the primary

binding sites are on the 50S subunit. It appears to inhibit microbial protein

production by producing biochemically inactive initiation complexes, which

prevent elongation of the polypeptide chain.

Bactericidal concentrations can be reached but vary according to the

bacterium. It can be as little as two times the MIC for Brachyspira

hyodysenteriae and Actinobacillus pleuropneumoniae but as high as 50 -100

times the bacteriostatic level for Staphylococcus aureus. The MIC distribution

for tiamulin against Brachyspira hyodysenteriae is bimodal, suggesting

reduced susceptibility of some strains to tiamulin. Due to technical constraints

the susceptibility of Lawsonia intracellularis is difficult to test in vitro.

Resistance in Brachyspira spp. to pleuromutilins is due to mutations at the

ribosomal target site. A combination of mutations at the peptidyl transferase

centre are associated with reduced susceptibility and have been

characterised in Brachyspira spp.

5.2

Pharmacokinetic particulars

Pigs

Tiamulin hydrogen fumarate is well absorbed in the pig (over 90%) following

oral administration and widely distributed through the body. Following a single

oral dose of 10 mg and 25 mg tiamulin hydrogen fumarate/kg body weight the

was 1.03 μg/ml and 1.82 μg/ml in serum respectively by microbiological

assay and the T

was 2 hours for both. It has been shown to concentrate in

the lung, polymorphonuclear leucocytes and also in liver, where it is

metabolised and excreted (70-85%) in the bile, the remainder is excreted via

the kidney (15-30%). Serum protein binding is approximately 30%. Tiamulin,

which has not been absorbed or metabolised, passes down the intestines to

the colon. Colon contents concentrations of tiamulin have been estimated at

3.41 μg/ml following administration of tiamulin hydrogen fumarate at 8.8

mg/kg body weight.

Chickens

Tiamulin hydrogen fumarate is well absorbed in chickens (70-95%) after oral

administration and reaches peak concentrations in 2-4 hours (T

2.85

hours). Following a 50 mg tiamulin hydrogen fumarate/kg body weight single

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dose the C

was 4.02 μg/ml in serum by microbiological assay and after a

25 mg/kg dose it was 1.86 μg/ml. In drinking water the 250 ppm (0.025%)

tiamulin hydrogen fumarate concentration provided a rolling serum level over

a 48 hour medication period of 0.78 μg/ml (range 1.4-0.45 μg/ml) and at 125

ppm (0.0125%), 0.38 μg/ml (range 0.65-0.2 μg/ml) in eight-week old chickens.

Serum protein-binding was approximately 45%. It distributes widely through

the body and has been shown to concentrate in the liver and kidney (sites of

excretion) and in the lung (30 times serum level). Excretion is mainly via the

bile (55-65%) and kidney (15-30%) as mainly microbiologically inactive

metabolites and is quite rapid, 99% of the dose within 48 hours.

Turkeys

In turkeys serum levels of tiamulin hydrogen fumarate are lower with a 50 mg

tiamulin hydrogen fumarate/kg body weight single dose giving a C

of 3.02

μg/ml in serum, and 25 mg/kg giving 1.46 μg/ml. These were achieved at

about 2-4 hours after dosing. In breeders on 0.025% tiamulin hydrogen

fumarate the average serum level was 0.36 μg/ml (range 0.22-0.5 μg/ml).

Serum protein-binding was approximately 50%.

Environmental properties

A transformation product of tiamulin is very persistent in soil.

Tiamulin may be toxic to plants and algae.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate

6.2

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must

not be mixed with other veterinary medicinal products.

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 4 months.

Shelf life after dilution in water according to directions: 24 hours.

6.4

Special precautions for storage

This veterinary medicinal product does not require any special storage

conditions.

After first opening, do not store above 25ºC.

Keep the original bag tightly closed after first opening.

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The product after dilution in water should be stored at temperatures below

25°C.

6.5

Nature and composition of immediate packaging

Low-density polyethylene-aluminium- polyethylene terephtalate laminated

bags containing 1 kg or 5 kg granules.

Not all pack sizes may be marketed.

6.6

Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from

such veterinary medicinal product should be disposed of in accordance with

local requirements.

7.

MARKETING AUTHORISATION HOLDER

HCS bvba

H. Kennisstraat 53

B 2650 Edegem

Belgium

8.

MARKETING AUTHORISATION NUMBER

Vm 35501/4000

9.

DATE OF FIRST AUTHORISATION

16 January 2018

10.

DATE OF REVISION OF THE TEXT

February 2018

Approved: 20/02/2018

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