TIAGEN WSP 800

800 mg/g, water-soluble powder for administration in drinking water to pigs

Indications

Treatment of Swine Dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin.

Treatment of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae susceptible to tiamulin.

COMPOSITION

Tiamulin hydrogen fumarate 800 mg/g

CONTRAINDICATIONS

Do not use in animals with known hypersensitivity to tiamulin or to any of the excipients.

Do not use in cases of known resistance to tiamulin.

Do not use together with products containing ionophores such as monensin, salinomycin or narasin, during or at least 7 days before or after treatment with tiamulin. It can result in reduced growth or death.

 

ADVERSE REACTIONS

In rare cases, excessive salivation, mild edema, acute dermatitis with skin erythema and severe pruritus may occur. Side effects are often mild and transient. If these typical side effects occur, stop the treatment immediately.      

 

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

TIAGEN WSP 800 will be administered orally in drinking water,  for 5 consecutive days.

For the mass treatment we recommend the correct calculation of the total body weight and the amount of product to be administered. When medicating large volumes of water, prepare a concentrated solution first and then dilute to the required final concentration

Pigs: 10 mg active substance/kg body weight/day, equivalent to 12.5 mg TIAGEN WSP 800/kg body weight /day.

 

P x G C = mg product/l of water

 

P = mg product / kg body weight / day

G = average body weight (kg) of the animals to be treated

C = average daily water consumption (liters) per animal

ADVICE ON CORRECT ADMINISTRATION

Ingestion of the medicated water depends on the clinical condition of the animals. In case of insufficient ingestion of medicated water, the treatment schedule will be reviewed. Medicated water must be renewed every 24 hours.

Medicated water should be the only source of drinking water for animals throughout the treatment period. After the end of the medication period, the water supply system should be properly cleaned to avoid overdose or underdose.

 

WITHDRAWAL PERIOD

Pigs (meat and offal): 2 days.   

 

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package. Store in a dry place. Protect from direct sunlight.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

 

SHELF-LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

Shelf life after reconstitution into drinking water: 24 hours.

        

SPECIAL WARNINGS

Special warnings for each target species

Throughout the treatment, the animals should consume only the medicated water.

The product must be well homogenized with water to ensure a uniform dispersion.

If the animals do not ingest enough water to provide the medication, they will need to be treated parenterally.

After drinking the medicated water, animals should be provided with fresh drinking water.

Special precautions for use in animals
Use of the product should be based on susceptibility testing of bacteria isolates from the animal. If not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tiamulin and may decrease the efficacy of the treatment due to cross-resistance. Repeated or prolonged use of the product should be avoided and good management practices should be applied, for example, good hygiene, adequate ventilation, avoid overcrowding, in order to improve the health of the herd.

Official, national and regional antimicrobial policies should be taken into account when the product is used.

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

Direct contact with the skin and mucous membranes should be avoided during the mixing operation.

When handling or preparing the product, it is recommended to use safety glasses, protection mask (a disposable half-mask respirator conforming to European Standard EN 149 or a nondisposable respirator to European Standard EN 140 with a filter to EN 143) and latex or impermeable rubber gloves.

In case of accidental contact with the skin or the mucous membranes, the affected areas should be washed immediately with plenty of water and the contaminated clothing, which is in direct contact with the skin, should be removed.

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

People with known hypersensitivity to tiamulin should handle the product with caution. After using the product, wash your hands with soap and water.          

Use during pregnancy, lactation or lay

The product can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

To avoid interactions between tiamulin and incompatible ionophore substances such as monensin, narasin and salinomycin, must be checked whether these substances have been included in the feed or have contaminated the feed.

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

Do not exceed the recommended dose.

In case of overdose the symptoms are: salivation, vomiting and lethargy.

Major incompatibilities

Do not use in combination with monensin, narasin or salinomycin.

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

 

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. Ask your veterinarian or pharmacist for information on how to dispose of medicines no longer required. These measures contribute to the protection of the environment.

 

PRESENTATION/PACKAGE

Bags of 100 g, 1 kg and 5 kg  made of low density polyethylene terephthalate / polyethylene laminated foil, closed by heat sealing.


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