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Sulfatrim is indicated for the treatment of acute and subacute bacterial infections or in infections secondary to the viral diseases caused by trimethoprim-sulfamethoxazole susceptible bacteria.
Pigs:
Treatment of:
· bronchopneumonia (Bordetella bronchiseptica, Actinobacillus pleuropneumoniae)
· infectious polyserositis (Haemophilus suis)
· salmonellosis
· atrophic rhinitis (Pasteurella multocida and Bordetella spp.)
· pneumonia, polyarthritis, meningoencephalitis (Streptococcus suis)
· exudative epidermis of pigs (Staphylococcus hyicus)
Chickens (broilers)
Treatment of:
· Pulorosis (S. pullorum)
· Enteric paratyphosis (S. typhimurium)
· Avian cholera (Pasteurella multocida)
· Infectious coryza (Haemophilus gallinarum)
Trimethoprim 20 mg/ml
Sulfamethoxazole 80 mg/ml
Do not use in animals suffering from severe kidney disease and dehydration because kidney stones can appear.
Do not use in case of known hypersensitivity to the active substances or to any of the excipients.
Renal and urinary tract disorders may occur after administration of sulfonamides.
Crystalluria, hematuria and obstruction of the renal tubules are a common consequence.
Hypersensitivity reactions consist of: urticaria, angioedema, anaphylaxis, skin rash, drug fever, polyarthritis, hemolytic anemia and agranulocytosis.
Oral administration, via drinking water.
Pigs and chickens (broilers): 1-2 litres of product/1000 litres drinking water for 4 to 7 days.
Medicated drinking water should be freshly prepared every 24 hours.
During the treatment period animals should not have access to water sources other than the medicated water. Body weight should be determined as accurately as possible to ensure administration of the correct dose and avoid over- or under-dosing.
The uptake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of the veterinary medicinal products has to be adjusted accordingly.
Meat and offal:
Pigs: 1 day.
Chickens (broilers): 2 days.
Not authorised for use in birds producing eggs for human consumption.
Keep out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. 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 of the veterinary medicinal product as packaged for sale: 1 year.
Shelf life after first opening of the immediate packaging: 28 days.
Shelf life after reconstitution in drinking water: 24 hours.
Special precautions for use
Special precautions for use in animals
Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for trimethoprim / sulfamethoxazole bacteriological sampling and susceptibility testing are recommended. 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 the active substances and may decrease the effectiveness due to the potential for cross-resistance. Official and local antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to the active substances or to any of the excipients should avoid contact with the medicinal product.
Use adequate protective equipment. 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 while handling this product. Wash hands with water and soap after use.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the physician this warning.
Swelling of the face, lips or eyes or respiratory difficulties are the most serious signs which require urgent medical attention.
Use during pregnancy, lactation or lay
The product can be used during pregnancy and / or lactation.
Not authorised for use in birds producing eggs for human consumption.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Sulfamethoxazole has a high therapeutic index. The therapeutic dose for oral administration is 25 mg / kg body weight. The LD50 for the most sensitive species is 2300 mg / kg body weight after oral administration. Trimethoprim also has a high therapeutic index. The usual dose of trimethoprim is 5 mg / kg body weight. LD50 in the most sensitive species is 200 mg / kg body weight after oral administration.
The recommended doses will be followed.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
White HDPE vials of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml and HDPE canisters of 5 L, 10 L, 20 L.
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