Vetmulin 100 mg/g Oral Granules for Pigs

Composition

Each gram contains:

Active substance:

81 mg tiamulin (equivalent to 100 mg tiamulin hydrogen fumarate).

Excipients:

Qualitative composition of excipients and other constituents

Pregelatinised starch

Wheat starch

A yellowish granular material.

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Pharmacological properties

4.1 ATCvet code:

QJ01XQ01

4.2 Pharmacodynamics

Tiamulin hydrogen fumarate is a semi-synthetic derivative of the diterpene antibiotic pleuromutilin, produced by Pleurotus mutilis, later renamed Clitopilus scyphoides.

Tiamulin is active against pathogenic mycoplasmas, against most Gram-positive microorganisms and anaerobes.

Tiamulin is bacteriostatic at therapeutic concentrations and has been shown to act at the ribosome level and the primary binding site is on the 50S subunit and possibly a secondary site where the 50S and 30S subunits join. It appears to inhibit microbial protein production by producing biochemical inactive initiation complexes, which prevent elongation of the polypeptide chain.

Research has shown that resistant bacterial mutants can be created through multi-step resistance. Horizontal transferable resistance has also been described (eg. vga genes & cfr gene). In practice, resistance in mycoplasmas has been reported rarely. Resistance against B. hyodysenteriae has been seen, and can vary geographically.

If response to treatment of dysentery with the veterinary medicinal product is poor, then the possibility of resistance must be considered.

Cross resistance between tiamulin and tylosin tartrate has been reported: micro-organisms that are resistant for tiamulin, are also resistant for tylosin tartrate, but not vice versa. Transferable resistance mechanism (cfr) can cause cross-resistance to lincosamides, streptogramines (A) and phenicols (florfenicol).

Resistance in Brachyspirae hyodysenteriae can be caused by a point mutation in the 23S rRNA gene and/or the ribosomal protein L3 gene.

4.3 Pharmacokinetics

Tiamulin hydrogen fumarate is well absorbed from the gastrointestinal tract of pigs (85-90%) within 30 minutes. 2-4 hours (tmax) after the oral administration of 10 mg tiamulin hydrogen fumarate/kg BW, a Cmax of 1 µg/ml was measured. An oral administration of 25 mg/kg gave a Cmax of 1.82 µg/ml. There is a very good distribution in the tissues. There is accumulation in lungs and in the colon. 30-50% of the tiamulin is bound to serum proteins.

Tiamulin hydrogen fumarate is rapidly and largely metabolised in the liver (hydroxylation, de-alkalysation, hydrolysis). At least 16, biologically inactive metabolites have been identified. The excretion of tiamulin and its metabolites is through the bile and faeces (70-85%). The remainder is excreted through the urine (15-30%).

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Target species

Pigs

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Indications

For the treatment of swine dysentery caused by Brachyspira hyodysenteriae.

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Dosage

In-feed use.

The normal dose is 8.8 mg tiamulin hydrogen fumarate (equivalent to 7.1mg tiamulin base) per kg bodyweight per day during 7-10 consecutive days. Considering a feed intake of 50 grams per kg BW, this dose can be achieved by mixing 1.75 g p veterinary medicinal product into 1 kg of feed (175 ppm).

Examples of g of veterinary medicinal product per animal

The veterinary medicinal product should be administered to small quantities of feed for immediate consumption by individual animals. Pigs to be treated should be separated and treated individually. For treatment of larger groups, it is recommended to use tiamulin medicated premix for feeding stuff.

To ensure a correct dosage, body weight should be determined as accurately as possible.

In case of an altered feed intake (weight class, age, environment) adjust the incorporation in order to guarantee an intake of 8.8 mg tiamulin hydrogen fumarate per kg per day.

In order to achieve a homogeneous intake it is recommended to use a premixture. The required amount of veterinary medicinal product can first be mixed with 10 % of the intended volume of feed. This premixture should then further be mixed homogeneously with the feed. Alternatively the veterinary medicinal product can be mixed thoroughly into a part of the daily feed ratio and this can be administered prior to the feeding. It has to be ensured, that the calculated dose is completely taken up by the animals. Consideration must be given to pigs whose daily feed intake is reduced or restricted

The use of suitably calibrated measuring equipment is recommended. The veterinary medicinal product should only be added to dry non-pelleted feed.

If animals don’t recover within 3 days after oral medication, diagnosis should be reconsidered and treatment should be changed, if necessary

The treated feed must be prepared daily just before administration to the animals.

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Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients

Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least seven days before or after treatment with the veterinary medicinal product.

Severe growth depression or death may result.

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Adverse reactions

Pigs

1 Acute

2 Intense

3 If these typical side effects occur, stop treatment immediately and clean animals and pens with water. Normally, affected animals recover quickly. Symptomatic treatment such as electrolyte therapy and an anti-inflammatory therapy may be useful.

4 mild

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Do not use the veterinary medicinal product in liquid feed.

Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for tiamulin, the use of the veterinary medicinal product should be based on bacteriological sampling and susceptibility testing and take into account official and local antimicrobial policies.

Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tiamulin and may decrease the effectiveness of treatment with other pleuromutilins due to the potential for cross-resistance.

If there is no response to treatment within 3 days, the diagnosis should be re-established.

Avoid concurrent administration of tiamulin and the ionophore products monensin, narasin and salinomycin (see section 4.8). Inform the feed supplier that tiamulin will be used, to avoid incorporating the above listed products in the feed and to avoid contamination of the feed. In case of a suspected contamination, test the feed for the presence of these ionophores before feeding. If adverse effects occur due to an interaction, stop administration of the feed immediately. Remove the contaminated feed as soon as possible and replace with uncontaminated feed.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Direct contact with the skin, eyes, mucous membranes and inhalation of dust should be avoided. Personal protective equipment consisting of overalls, impermeable rubber gloves, safety glasses and a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143 should be worn when handling the veterinary medicinal product.

Contaminated clothing should be removed and any splashes on to the skin should be washed off immediately.

In case of accidental eye contact, irrigate the eyes thoroughly with clean running water immediately. If irritation persists, seek medical advice immediately and show the package leaflet or the label to the physician.

Accidental ingestion should be avoided. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

People with known hypersensitivity to tiamulin should avoid contact with the veterinary medicinal product.

Special precautions for the protection of the environment Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

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Interactions

Tiamulin is known to produce clinically important (often lethal) interactions with ionophore antibiotics, including monensin, narasin, salinomycin. Therefore, pigs should not receive products containing such compounds during or for at least seven days before or after treatment with this veterinary medicinal product. Severe growth depression or death may result.

Tiamulin may lessen the antibacterial activity of beta-lactam antibiotics, whose action is dependent on bacterial growth.

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Overdose

A single oral dose of 100 mg/kg BW caused hyperpnoea and abdominal complaints in pigs. At a dose of 150 mg/kg the only effect on the central nerve system was lethargy. A dose of 55 mg/kg during 14 days caused increased salivation and a mild irritation of the stomach. Tiamulin hydrogen fumarate has a relatively high therapeutic index in pigs. The minimum lethal dose has not been established in pigs.

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Special warnings

The uptake of medication by animals can be altered as a consequence of illness. For animals with a reduced feed intake, treat parenterally using an appropriate injectable veterinary medicinal product.

Long term or repeated use should be avoided by improving management practice and thorough cleansing and disinfection.

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Withdrawal period

Meat and offal: 7 days

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products

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Immediate packaging

0.25 kg, 1 kg, low density polyethylene bag and three-ply paper secondary bag. Not all pack sizes may be marketed.

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Storage

Store below 25°C. Store in a dry place. Protect from direct sunlight.

Store in the original container.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 3 months.

Shelf-life after mixing into meal or pelleted feed: 24 hours.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 30282/4016

8 DATE OF FIRST AUTHORISATION

28 October 2009

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

March 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 17 June 2025

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Registration holder

Huvepharma NV

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