Description
200 mg/ml + 40 mg/ml
Solution for injection for cattle, horses, and swine
Name and address of the Marketing Authorization Holder and manufacturer responsible for batch release
Marketing Authorization Holder and manufacturer responsible for batch release:
Biowet Puławy Ltd.,
ul. H. Arciucha 2, 24-100 Puławy, Poland
Tel/fax (81) 886 33 53
Qualitative and quantitative composition
Active substance:
Sulfadoxine 200 mg/ml
Trimethoprim 40 mg/ml
Therapeutic indications
Cattle:
bacterial pneumonia in calves caused by Pasteurella multocida, Mannheimia haemolitica, Corynebacterium pyogenes, Staphylococcus spp., Streptococcus spp.;
bacterial enteritis in calves caused by Salmonella spp., Proteus spp.;
colibacillosis in calves caused by Escherichia coli;
uterine infections in cattle caused by Staphylococcus spp., Streptococcus spp., Escherichia coli, Haemophilus somnus, Corynebacterium pyogenes, Pseudomonas spp.;
listeriosis caused by Listeria monocytogenes;
pododermatitis superinfected with Fusobacterium necrophorum, Bacteroides melaninogenicus, and Actinomyces pyogenes.
Horses:
respiratory tract infections caused by Staphylococcus spp., Streptococcus spp., Actinobacillus equi, Rhodococcus equi, Pasteurella spp.;
gastro-intestinal infections caused by Rhodococcus equi, Actinobacillus equi, Salmonella spp.
Swine:
bacterial pneumonia caused by Streptococcus suis, Actinobacillus pleuropneumoniae, Actinobacillus suis, Bordatella bronchiseptica, Haemophilus parasuis, Pasteurella multocida;
bacterial arthritis caused by Arcanobacterium pyogenes, Escherichia coli, Staphylococcus spp., Streptococcus spp.
colibacillosis in piglets caused by Escherichia coli;
bacterial enteritis in piglets caused by Salmonella choleraesuis;
uterine infections in sows, MMA syndrome caused by Staphylococcus spp., Streptococcus spp.,Escherichia coli, Klebsiella spp.
atrophic rhinitis caused by Bordetella bronchiseptica, Mannheimia haemolytica and Pasteurella multocida.
Contraindications
Do not use in the case of hypersensitivity to the active substances or to any excipient.
Do not use in animals with kidney and/or liver failure.
Do not use during pregnancy.
Do not use in animals with blood dyscrasia (blood components disorder).
Do not use in dehydrated animals.
Adverse reactions
After intramuscular or intravenous injection painful swelling might occur at the injection site, which will disappear spontaneously. Hypersensitivity to the drug has been reported, especially after rapid intravenous administration.
Kidney dysfunction has been reported, caused by sulphonamide precipitation in renal tubules, especially in dehydrated animals, in animals with acidemia, or after administration of high doses of the medicine.
Any adverse reactions which emerged after administration of this product or any observed symptoms not listed in the leaflet (including symptoms in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Posology and routes of administration
Horses, cattle, swine: 13.33 mg/kg b.w., i.e. 1 ml/15 kg b.w. intravenously, intramuscularly or subcutaneously, once per day for 4-6 days.
Recommendations for proper administration
In intravenous administration, the product should be injected very slowly and the animal’s breath and heart rate, as well as the colour of the conjunctiva, should be monitored.
Withdrawal time
Edible tissues:
Cattle, horses, swine:
intravenous administration – 6 days, intramuscular administration up to 4 ml –15 days
intramuscular or subcutaneous administration over 4 ml – 30 days
Milk:
Cattle: 4 days
Special precautions for storage and transportation
Keep out of the reach and sight of children.
Store below 25°C. Protect from light. Do not freeze. Store in a closed container.
Do not use this veterinary medicinal product after the expiry date indicated on the label and the package. Expiration date refers to the last day of the month.
The Period after Opening of the primary container: 28 days
Special warnings and precautions
Special warnings concerning each of the target animal species
In horses treated with detomidine administration of the drug may cause severe arrhythmia.
Special precautions for use in animals
Large doses of the drug should be administered intravenously.
In intravenous administration, the medicine should be injected slowly.
The maximum dose given in one injection site in intramuscular or subcutaneous administration should not exceed 20 ml.
The product usage should be based on susceptibility tests results and local regulations on sulphonamides application.
Administration of an insufficient dose or too short treatment may lead to the development of drug resistance.
Sulphonamides in combination with trimethoprim, especially after prolonged treatment, might cause a deficiency of folic acid and vitamins produced by gastrointestinal microbiota.
Special precautions for persons administering the veterinary medicinal product to animals
The medicine should be administered slowly to avoid accidental self-injection. Wash your hands after usage.
In case of contact with eyes or skin, the contact site should be flushed with plenty of water.
In case of accidental self-injection, professional assistance should be sought immediately and the leaflet or the package should be shown to the physician.
People with diagnosed hypersensitivity to sulfadoxine or trimethoprim should avoid contact with the veterinary medicinal product or use it with caution. The product should not be administered by pregnant women.
Pregnancy
Do not use during pregnancy.
Lactation
The product can be used during lactation.
Interaction with other medicinal products and other forms of interaction
Do not combine with detomidine.
Sulphonamides may compete for blood protein-binding sites with other drugs, such as methotrexate, phenylbutazone, thiazide diuretics, salicylates, probenecid, and phenytoin. Urinary acidifying agents, such as ascorbic acid and ammonium chloride, might increase the risk of sulphonamides precipitation in the urinary system.
Trimethoprim might increase the effectiveness of antithrombotic agents, such as warfarin, by inhibiting its metabolism.
Overdose (symptoms, immediate aid procedure, and antidotes)
Overdosing the medicine in newborn animals and individuals with decreased liver and/or kidney functions may result in the accumulation of the drug and its metabolites.
Pharmaceutical incompatibilities
None reported.
Special precautions for the disposal of the unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Ask a veterinarian to learn about ways of disposal of no longer required medicines. These measures will help to protect the environment.
Other information
Bottle volume: 100 ml
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Shelf life
Shelf life for a medicinal veterinary product as packed for sale: 2 years
The Period after Opening of the primary container: 28 days
For animal treatment only. Subject to a medical prescription – a prescription drug. To be administered under the supervision of a veterinarian.
2018-04-03 CHPL
