TRIMADOX INJ.

200 mg/ml + 40 mg/ml solution for injection for horses, cattle, sheep and 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-hemolytic 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 (diarrhea).

COMPOSITION

Sulfadoxine    200 mg/ml

Trimethoprim   40 mg/ml

 

CONTRAINDICATIONS

Do not administer in animals with known hypersensitivity to the active substances or to any of the excipients.

Do not administer in animals with severe liver or kidney parenchymal damage or blood dyscrasias.

 

ADVERSE REACTIONS

After intramuscular or subcutaneous administration transient local reactions may appear.

Anaphylactic and hypersensitivity reactions may also occur after administration. In horses, heart and respiratory shock were observed, most of which occurred after intravenous injection.

As with all trimethoprim-sulphonamide formulations the possibility of potential damage to the kidney (e.g. crystalluria), liver or haematopoietic system should be considered.

If you notice any side effects, even those not already listed in this package leaflet, please inform your veterinary surgeon.

 

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

The product is administered by slow intravenous and intramuscular injection in horses, cattle and sheep and by subcutaneous or intramuscular injection in pigs.

The recommended dose is 3 ml TRIMADOX INJ. per 50 kg body weight, equivalent to 12 mg sulfadoxine and 3 mg trimethoprim per kg body weight.

Usually, a single treatment is sufficient, but if a sufficient therapeutic effect is not obtained within 24 hours, the treatment may be repeated 48 hours after the first dose.

 

ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing.

In order to avoid impairment of the kidneys by crystalluria during the treatment adequate drinking water should be 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 whose milk is intended for human consumption.

 

SPECIAL STORAGE PRECAUTIONS

Do not store above 25oC. Do not refrigerate. Protect from frost.

 

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 WARNINGS

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official, national and regional antimicrobial policies will be considered when using the product.

Using the product outside the instructions provided in SPC may increase the prevalence of resistant bacteria and may decrease the efficacy of other antimicrobials 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 eyes and skin. In case of accidental contact with eyes, rinse immediately with plenty of water. In case of accidental skin contact, wash immediately with soap and water.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

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

Do not eat, drink or smoke during handling or while administering the veterinary medicinal product to animals.

The use during pregnancy, lactation or lay

Due to the glycerin formal content, the use of Trimadox Inj. in pregnant animals is not recommended.

Interactions with other medicinal products and other forms of interaction

Trimadox Inj. may increase the effects of analgesics, antidiabetics and anticoagulants.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Overdoses 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 veterinary medicinal product should not be mixed with any other veterinary medicinal product.

 

PRESENTATION/PACKAGE

Vials of 50 ml, 100 ml, 250 ml and 500 ml.


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