TRIMADOX INJ – Solution for Injection
200 mg/ml + 40 mg/ml solution for injection for horses, cattle, sheep, and pigs.
Composition: Active ingredients – Sulfadoxine 200.0 mg/ml, Trimethoprim 40.0 mg/ml.
Indications:
For horses: For the treatment of respiratory tract infections caused by Streptococcus equi subsp. equi and Streptococcus equi subsp. zooepidemicus, as well as genital tract infections caused by Streptococcus equi subsp. zooepidemicus, Klebsiella spp, and beta-hemolytic Streptococcus.
For cattle: For the treatment of respiratory tract diseases caused by Pasteurella multocida, Mannheimia haemolytica, and/or Histophilus somni, as well as for the treatment of gastrointestinal or urogenital tract diseases caused by Escherichia coli.
For sheep: For the treatment of respiratory tract infections caused by Pasteurella multocida and/or Mannheimia haemolytica.
For pigs: For the treatment of respiratory tract infections caused by Pasteurella multocida, Mannheimia haemolytica, Actinobacillus pleuropneumoniae, and Bordetella bronchiseptica, as well as for the treatment of meningitis and arthritis caused by Streptococcus suis. For the treatment of infections caused by Haemophilus parasuis (meningitis, polyserositis, arthritis) and Escherichia coli (diarrhea).
Contraindications: Do not administer to animals with a known hypersensitivity to the active substances or to any of the excipients. Do not administer to animals with severe damage to the hepatic or renal parenchyma, or with blood dyscrasia.
Side effects: Transient local reactions may occur following intramuscular or subcutaneous administration. Anaphylactic and hypersensitivity reactions may also occur after administration of the drug. In horses, cardiac and respiratory shock have been observed, most commonly following intravenous injection. As with all trimethoprim-sulfonamide compounds, the possibility of potential damage to the kidneys (e.g, crystalluria), liver, or hematopoietic system should be considered. If any side effect worsens, or if the animal experiences a side effect not mentioned in the leaflet, you should consult a veterinarian. Side effects may be reported to the Ministry of Health by clicking the link "Reporting side effects due to drug treatment" located on the Ministry of Health's homepage.
Target species: Horses, cattle, sheep, and pigs.
Dosage and route of administration: The product is administered via slow intravenous or intramuscular injection in horses, cattle, and sheep, and via subcutaneous or intramuscular injection in pigs. The recommended dose is 3 ml of TRIMADOX INJ per 50 kg of body weight, equivalent to 12 mg of sulfadoxine and 3 mg of trimethoprim per kg of body weight. A single treatment is usually sufficient; however, if an adequate therapeutic effect is not achieved within 24 hours, the treatment may be repeated 48 hours after the initial dose. Instructions for correct administration: To ensure the correct dosage, the animal's body weight should be determined as accurately as possible, thereby avoiding underdosing. To prevent renal damage resulting from crystalluria during treatment, ensure that an adequate supply of drinking water is available at all times.
Withdrawal periods: Cattle (meat and offal): 9 days. Cattle (milk): 6 milkings. Sheep (meat and offal): 14 days. Sheep (milk): 9 milkings. Pigs (meat and offal): 8 days. Horses (meat and offal): 10 days. Do not use in mares intended for the production of milk for human consumption.
Special storage precautions: Keep out of the reach and sight of children. Do not store above 25°C. Do not refrigerate. Protect from frost. Do not use after the expiry date stated on the label. After first opening the primary packaging, the product remains valid for: 28 days.
Special warnings:
Special warnings for each target species: None.
Special precautions for use in animals:
The product should be used based on susceptibility testing of bacteria isolated from the animal. If this is not feasible, treatment should be based on local (regional, farm, or holding-level) epidemiological data regarding the susceptibility of the target bacteria. Official national and regional antimicrobial policies should be followed when using the product. Use of the product in a manner inconsistent with the instructions provided in the Summary of Product Characteristics may increase the prevalence of resistant bacteria and reduce the efficacy of other antimicrobial agents due to cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Avoid contact of the product with the eyes and skin. In case of accidental contact with the eyes, rinse immediately with plenty of water. In case of accidental contact with the skin, wash immediately with soap and water. In the event of accidental self-injection, seek medical attention immediately and show the package leaflet or the label to the physician. Individuals with a known hypersensitivity to the active substances should avoid contact with the veterinary medicinal product. Do not eat, drink, or smoke while using or administering the veterinary medicinal product to animals.
Use during pregnancy, lactation, or egg-laying: Due to its glycerin content, the use of Trimadox Inj. in pregnant animals is not recommended.
Interaction with other medicinal products and other forms of interaction: Trimadox Inj. may potentiate the effects of analgesics, antidiabetic agents, and anticoagulants.
Overdose (symptoms, emergency procedures, antidotes), where applicable: Overdoses of up to 3 times the recommended dose were well tolerated in cows, heifers, horses, and pigs, with no systemic signs observed.
Incompatibilities: 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 applicable: Do not dispose of medicines via wastewater or household waste. Consult your veterinarian regarding the disposal of medicines that are no longer required. These measures are intended to help protect the environment.
