SULFATRIM

COMPOSITION

Each mL of product contains Trimethoprim 20 mg and Sulfamethoxazole 80 mg.

TARGET SPECIES

Pigs and chicken (broilers)

INDICATIONS

Sulfatrim is indicated in pigs and poultry for the treatment of acute and subacute bacterial infections or secondary viral infections caused by microorganisms susceptible to the action of the active substances.

Pigs - For the treatment of bronchopneumonia caused by Bordetella bronchiseptica, Actinobacillus pleuropneumoniae; infectious polyserositis caused by Haemophilus suis; salmonellosis; atrophic rhinitis caused by Pasteurella multocida and Bordetella spp.; infections caused by Streptococcus suis: pneumonitis, polyarthritis, meningoencephalitis; swine exudative epidermitis caused by Staphylococcus hyicus

Chicken (broilers) In the treatment of: white diarrhoea caused by S. Pullorum; paratyphoid fever caused by S. Typhimurium; avian cholera caused by Pasteurella multocida; infectious coryza caused by Haemophilus gallinarum

CONTRAINDICATIONS

Sulphonamides should not be administered to animals with renal dysfunction and dehydration due to the fact that kidney stones can develop. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

Renal and urinary tract disorders may occur after sulphonamide administration. Crystalluria, hematuria and obstruction of renal ducts are frequent consequences. 

Hypersensitivity reactions include: urticaria, angioedema, anaphylaxis, rash, drug fever, polyarthritis, haemolytic anaemia and agranulocytosis. 

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Sulfatrim is orally administered in drinking water.

Pigs and chicken (broilers): 1-2L of product/1000L of drinking water for 4-7 days. Only medicated drinking water will be administered during treatment. Medicated drinking water should be freshly prepared every 24 hours.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure a proper dose, the body weight of animals shall be determined as accurately as possible to avoid underdosing or overdosing. The consumption of medicated water depends on the clinical condition of the animals. In order to obtain a correct dose, the concentration should be adjusted accordingly.

WITHDRAWAL PERIOD(S)

Pigs - meat and offal: 1 day

Chicken (broilers) - Meat and offal: 2 days

Do not use in poultry laying eggs for human consumption.

It can be used during gestation and/or lactation.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 1 year. 

Shelf-life after first opening the original packaging: 28 days. 

Shelf-life after reconstitution in drinking water: 24 hours.

SPECIAL WARNING(S)

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Because of the variability (time, geographical area) in the susceptibility of bacteria when using the product, bacteriological sampling and susceptibility testing for isolated microorganisms from sick animals is recommended. If this is not possible, the treatment should be based on local epidemiological information (region, farm) concerning the target bacteria’s susceptibility. Using the product in violation of the instructions in the SmPC may increase the prevalence of active substance resistance and may decrease the effectiveness of treatment because of their potential cross-resistance. When using the product, official and local policies regarding antimicrobial substances shall be observed.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Avoid contact with the product. Those with known sensitivity to active substances or excipients will avoid contact with the product. Adequate protective equipment shall be used. Avoid contact of the product with skin and eyes. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not eat, drink or smoke during product administration. After use of the veterinary medicinal product, wash hands with water and soap. In case of symptoms like rash, seek medical advice and show the package leaflet or the label to your doctor. Swelling of the face, eyelids, lips or difficulty breathing are severe symptoms and require urgent medical attention.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

It can be used during gestation and lactation.

Do not use the products in poultry laying eggs for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Sulfamethoxazole has a high therapeutic index. The therapeutic dose for oral administration is 25 mg/kg body weight. DL50 for the most sensitive species is 2300 mg/kg body weight after oral administration. Trimethoprim also has an increased therapeutic index. The usual dose of trimethoprim is 5 mg/kg body weight DL50 in the most sensitive species is 200 mg/kg body weight after oral administration. The recommended doses should be observed.

INCOMPATIBILITIES

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

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

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

PRESENTATION/PACKAGE

The product is packaged in while 50mL, 100mL, 250mL, 500mL, 1L HDPE vials and 5L, 10L, 20L HDPE cans.