Vetmulin 125 mg/ml Oral Solution for use in drinking water for pigs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Tiamulin hydrogen fumarate
Available from:
Huvepharma NV
ATC code:
QJ01XQ01
INN (International Name):
Tiamulin hydrogen fumarate
Dosage:
125 milligram(s)/millilitre
Pharmaceutical form:
Oral solution
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Pigs
Therapeutic area:
tiamulin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10782/009/001
Authorization date:
2010-02-05

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Vetmulin 125 mg/ml Oral

Solution for use in drinking water for pigs

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.

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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.

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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 Amounts 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.

.....ml Vetmulin 125 mg/ml

oral solution for use in

drinking water per kg body

weight and day

Average body

weight (kg)

=....ml Vetmulin 125 mg/ml oral

solution for use in drinking water

per litre of drinking water

Average daily water intake (l/animal)

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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

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, Pleuromutilins.

ATC Vet Code QJ01XQ01

5.1 Pharmacodynamic properties

Tiamulin hydrogen fumarate is a semi-synthetic derivative of the diterpene antibiotic pleuromutilin, produced by

Pleurotus mutilis.

Tiamulin is bacteriostatic and inhibits protein synthesis. The product has a strong affinity for the ribosome, causing an

inhibition of peptidyltransferases. As a result protein synthesis is stopped.

In vitro research has shown that resistant bacterial mutants can be created through multi step resistance. In practice,

resistance in mycoplasmas has been reported rarely. Resistance against B. hyodysenteriae has been seen, however this

spirochete remains very sensitive to tiamulin.

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

Cross resistance between tiamulin and tylosin has been reported.

5.2 Pharmacokinetic properties

Following oral administration, tiamulin hydrogen fumarate is rapidly absorbed from the gastrointestinal tract of pigs

(85-90%) and appears in the blood within 30 minutes. 2-4 hours (t

) after the oral administration of 10 mg

tiamulin/kg BW in the form of an oral solution, a C

of 1 µg/ml was measured; an oral administration of 25 mg/kg

gave a C

of 1.82 µg/ml.

There is very good distribution in the tissues with accumulation in lungs and in the colon. 30-50% of tiamulin is bound

to serum proteins.

Tiamulin is rapidly 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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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methylparahydroxybenzoate (E218)

Propylparahydroxybenzoate

Disodium phosphate, anhydrous

Ethanol 96%

Purified water

6.2 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 30 months

Shelf-life after first opening the immediate packaging: 3 months

Shelf-life after dilution according to directions: 24 hours

6.4 Special precautions for storage

Do not store above

25 °C.

6.5 Nature and composition of immediate packaging

Vetmulin 125 mg/ml is presented in a 1 litre white high density polyethylene bottle with white polypropylene tamper-

evident closure sealed with white foamed disk and in high density polyethylene can of 5 L, closed with high density

polyethylene ribbed cap with a tamper-evident ring.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10782/009/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 5

February 2010

Date of last renewal: 14

November 2014

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10 DATE OF REVISION OF THE TEXT

April 2017

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