SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Vetmulin 125 mg/ml Oral Solution for use in drinking water for pigs (BE, BG, CZ, EL, HU, IE, NL, PL, RO, UK, ES, IT, AT, DE, PT)

Vetmulin Vet, Oral Solution for use in drinking water for pigs (DK)

Vetmulin 101.2 mg/g Oral Solution for use in drinking water for pigs (FR)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance

Tiamulin hydrogen fumarate 125 mg (equivalent to 101.2 mg tiamulin

Excipients

Methyl parahydroxybenzoate (E218) 0.90 mg
Propyl parahydroxybenzoate 0.10 mg

For the full list of excipients: see section 6.1

3.

PHARMACEUTICAL FORM

Oral solution for use in drinking water

Clear colourless to slightly yellow liquid.

4.

CLINICAL PARTICULARS

4.1

Target species

Pigs

4.2

Indications for use (specifying the target species)

In pigs

For the treatment of swine dysentery caused by or further complicated by tiamulin-susceptible Brachyspira hyodysenteriae.

For the treatment of enzootic pneumonia and the reduction of lesions caused by tiamulin-susceptible Mycoplasma hyopneumoniae

The presence of the disease in the herd should be established before use

4.3

Contraindications

Do not use in animals with known hypersensitivity to the active substance or to any of the excipient.

Do not use in the case of resistance to tiamulin.

Do not administer products containing monensin, salinomycin, narasin, maduramicin or other ionophores during or for at least seven days before or after treatment with the product. See also section 5.1. and 4.8.

4.4

Special warnings (for each target species)

The uptake of medication by animals can be altered as a consequence of illness.

In case of insufficient uptake of water, animals should be treated parenterally.

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

4.5

Special precautions for use

4.5.1

Special precautions for use in animals

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Severe growth depression or death may result if animals receive products containing monensin, salinomycin, narasin, maduramycin or other ionophores during or for at least seven days before or after treatment with the product. See also section 4.3 and 4.8.

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

4.5.2

Special precautions for the person administering the veterinary medicinal product to animals

People with known hypersensitivity to the active substance must not administer the veterinary medicinal product .

When mixing, direct contact with the skin and mucous membranes should be avoided. Accidental ingestion should be avoided. Wear overalls, safety glasses, mask and impervious gloves when handling or mixing the product. Contaminated clothing should be removed and any splashes on to the skin should be washed off immediately. If accidental eye contact occurs, immediately rinse thoroughly with water. Seek medical advice if irritation persists.

Wash hands after use.

4.6

Adverse reactions (frequency and seriousness)

In rare cases, hypersensitivity to tiamulin following oral administration is reported in terms of cutaneous and genital erythema and pruritus. The adverse reactions are often mild and transient but in very rare cases may be serious. If these typical side effects occur, stop treatment immediately and clean animals and pens with water. Normally, the animals recover fast thereafter. Symptomatic treatment such as electrolyte therapy and an anti-inflammatory therapy may be useful.

4.7

Use during pregnancy, lactation or lay

The product can be used during pregnancy and lactation.

4.8

Interaction with other medicinal products and other forms of interaction

Animals should not receive products containing monensin, salinomycin, narasin, maduramicin or other ionophores during or for at least seven days before or after treatment with the product. Severe growth depression, paralysis or death may result.

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

Cross resistance may occur between other members of macrolides or lincosamide antibiotics. Resistance to the active substance and cross resistance should be considered before the product is used.

See also section 4.3 and 4.5.1.

4.9

Amount(s) to be administered and administration route

For oral administration through the drinking water

Swine dysentery

8.8 mg tiamulin hydrogen fumarate per kg bodyweight per day (equivalent to 7ml product per 100 kg bodyweight per day) for 5 consecutive days.

Enzootic pneumonia

15-20 mg tiamulin hydrogen fumarate per kg bodyweight per day (equivalent to 12 – 16 ml product per 100 kg bodyweight per day) for 5 days.

Administration:

The uptake of medicated water depends on the actual body weight, the water consumption, the clinical condition of the animals, the environment, the age and the kind of feed provided. In order to obtain the correct dosage, the concentration of tiamulin should be calculated, as follows:

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

The required doses should be measured by suitably calibrated measuring equipment. Medicated water should be refreshed every 24 hours. The uptake of consistent amounts of drinking water should be ensured by sufficient drinking facilities.

To avoid formation of resistance by consumption of tiamulin in sub therapeutic doses, the watering equipment has to be cleaned adequately at the end of treatment.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

A single oral dose of 100 mg of tiamulin/kg BW caused hyperpnoea and abdominal complaints in pigs. At a dose of 150 mg of tiamulin/kg the only effects on the central nervous system was lethargy. A dose of 55 mg of tiamulin/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.

If signs of poisoning are observed, withdraw rapidly the medicated water and replace it with fresh water. Appropriate symptomatic treatment should be initiated.

4.11

Withdrawal period(s)

Meat and offal

5 days