Each gram contains : Active substances:

Trimethoprim 66.7 mg

Sulfadiazine 333.3 mg

Excipient(s): Chlorocresol 2.0 mg

Oral paste. White to almost white suspension.

Horses

Treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly:

Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus;

Gastrointestinal infections associated with E. coli;

Urogenital infections associated with beta-hemolytic streptococci;

Wound infections and open or drained abscesses associated with Streptococcus spp. and Staphylococcus aureus.

Do not use in horses known to be hypersensitive to sulfonamides, with serious hepatic or renal insufficiency nor with blood dyscrasias,

Do not use this product to treat abscesses without proper drainage.

Do not use in case resistance to sulphonamides occurs.

During treatment with the product animals must have free and easy access to drinking water.

Do not use the same syringe in more than one animal.

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

Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacteria resistant to the combination of Sulfadiazine and Trimethoprim, and may decrease the effectiveness of treatment with sulphonamides and/or trimethoprim due to the potential for cross-resistance.

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

In case of reaction of hypersensitivity after exposure (such as skin rash), seek medical advice and show the package leaflet or the label to the physician. In case of severe reactions (swelling of the face, lips or eyes), seek prompt medical attention and take the package leaflet with you.

Decrease or loss of appetite can occur in treated animals.

Hematuria, crystalluria, tubular obstruction have been observed.

Loose faeces and diarrhoea may develop during treatment with the product. If such effects appear, discontinue treatment immediately and institute appropriate symptomatic measures.

Laboratory studies in rats and mice have shown evidence of teratogenic effects. The safety of the product has not been established during pregnancy. Use only according to the benefit/risk assessment by the responsible veterinarian.

Potentiated sulfonamides used in conjunction with detomidine are known to be able to cause fatal arrhythmias in the horse.

Administration route: Oral use.

Posology:

5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.

One syringe is intended for 600 kg body weight and each syringe is subdivided into 12 markings. The equivalent of one marking is sufficient to treat 50 kg of body weight and the minimum body weight for treatment is 50 kg.

Directions for use

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. The calculated dose is provided by adjusting the ring on the plunger according to the body weight of the horse.

The paste is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of paste on the back of the tongue. The animal's mouth should be free of any food. Immediately after administration, elevate the head of the horse for a few seconds to ensure the dose is swallowed.

Meat and offal: 14 days

Not permitted for use in mares producing milk for human consumption.

Pharmacotherapeutic group: Antibacterials for systemic use, Sulfonamides and Trimethoprim.

ATCvet code: QJ01EW10

Both active substances produce a sequential double blockade of bacterial synthesis of folic acid. This results in a synergistic and bactericidal action inhibiting sequential steps in the synthesis of purines, which are required for DNA synthesis. The combination has a broad action against many Gram-positive and Gram-negative bacteria such as staphylococci, streptococci and E.coli.

MIC-breakpoints mg/l for susceptible organisms (EUCAST v. 3.1, February 2013):

(breakpoints are expressed as the trimethoprim concentration, when used in cominbation with sulfamethoxazole)

After a single oral administration of 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight to horses, the following parameters (mean ± sd) were observed:

Food intake appeared to affect the pharmacokinetic profile as both trimethoprim and sulfadiazine have been absorbed more rapidly in fasted horses.

Excretion of both actives is chiefly by the kidneys, by both glomerular filtration, and tubular secretion.

Urine concentrations of both trimethoprim and sulfadiazine are several fold higher than blood

concentrations. Neither trimethoprim nor sulfadiazine interferes with the excretion pattern of the other.

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

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

Shelf-life after first opening the immediate packaging: 8 weeks.

Do not refrigerate or freeze.

1 or 5 pre-filled multi-dose (Low Density) polyethylene syringes with adjustable screw ring closed with a (Low Density) polyethylene cap, packed in a cardboard box.

Each syringe contains 45 g paste.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Le Vet Beheer BV, Wilgenweg 7, 3421 TV Oudewater, The Netherlands.

Vm 19994/4004

7 July 2008

October 2015

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.