TRIMADOX inj

COMPOSITION

Each mL of product contains Sulphadoxine 200 mg and Trimethoprim 40 mg.

TARGET SPECIES

Horses, cattle, sheep, pigs

INDICATIONS

Horses - For the treatment of respiratory tract infections caused by Streptococcus equi subs. equi and subs. zooepidemicus, as well as genital tract infections caused by Streptococcus equi subsp. zooepidemicus, Klebsiella spp. and ß-haemolytic streptococcus.

Cattle - For the treatment of respiratory diseases caused by Pasteurella multocida, Mannheimia haemolytica and/or Histophilus somni, as well as for the treatment of gastrointestinal or urogenital diseases caused by Escherichia coli.

Sheep - For the treatment of respiratory infections caused by Pasteurella multocida, and/or Mannheimia haemolytica.

Pigs - For the treatment of respiratory 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. (diarrhoea)

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Do not use in animals with severe liver disease, renal parenchymal injuries or blood dyscrasia.

ADVERSE REACTIONS

Transient local reactions may occur after intramuscular or subcutaneous administration. Anaphylactic reactions and hypersensitivity may also occur after administration. Cardiac and respiratory shock was observed in horses, most of which occurring after intravenous injection. For all trimethoprim and sulphamide formulations, the possibility of affecting the kidneys (e.g., crystalluria), the liver or the hematopoietic system should be considered.

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

The product is administered by slow intravenous and intramuscular injection to horses, cattle and sheep and by subcutaneous or intramuscular injection to pigs. The recommended dose is 3 mL TRIMADOX INJ per 50 kg body weight equivalent to 12 mg Sulphadoxine and 3 mg Trimethoprim per kg body weight. Only one treatment is sufficient, but if a sufficient therapeutic effect is not achieved within 24 hours, the treatment can be repeated 48 hours after the first dose. 

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To avoid renal crystalluria during treatment, plenty of drinking water should be provided. To ensure correct dosing, accurately measure the body weight of the animals whenever possible to avoid underdosing.

WITHDRAWAL PERIOD(S)

Cattle - meat and offal: 9 days. Milk: 6 milks

Sheep (meat and offal): 14 days. Milk: 9 milks

Pigs (meat and offal): 8 days

Horses (meat and offal): 10 days

Do not use in mares whose milk is intended for human consumption.

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.

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25 °C. Do not refrigerate. Do not freeze. 

SPECIAL WARNING(S)

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on antimicrobial susceptibility testing of bacteria isolated from animals. If this is not possible, therapy should be based locally on epidemiological information (regional, farm) on the target bacteria’s susceptibility. When using the product, official, national and regional antimicrobial policies shall be observed.

Using the product in violation of the instructions provided in the SmPC may increase the prevalence of resistant bacteria and may decrease treatment effectiveness with antimicrobial medicines, due to their cross-resistance.

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

Avoid contact of the product with eyes or skin. In case of accidental contact with eyes, rinse immediately with plenty of water. In case of accidental contact with skin, wash immediately with water and soap. In case of accidental self-injection, seek medical advice immediately and show the package leaflet and the product label to the physician. Those with known hypersensitivity to the active substances should avoid contact with the veterinary medicinal product. Do not eat, drink or smoke while handling or administering the veterinary medicinal product to animals.

USE DURING PREGNANCY AND LACTATION

Due to the content of Glycerol formal, the use of TRIMADOX INJ during gestation is not recommended.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

TRIMADOX INJ may increase the effect of painkillers, antidiabetics and anticoagulants.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Overdoses of 3 times the recommended dose in cows, heifers, horses and pigs were well tolerated and no systemic signs were observed.

INCOMPATIBILITIES

In the absence of compatibility studies, this product shall not be 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. Medicines should not be disposed of via waste water or household waste.

PRESENTATION/PACKAGE

100 mL and 250 mL polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.