Description
(50 mg + 40 mg + 30 mg)/ml solution for injection for horses, cattle, swine, sheep and dogs for use in bacterial infections
Active substance and excipient content
1 ml contains:
Active substance:
sodium sulfadimidine – 50 mg
sodium sulfacetamide – 40 mg
sodium sulfathiazole – 30 mg
Excipient:
chlorocresol – 2 mg
Therapeutic indications
Horses:
- respiratory infections caused by Staphylococcus spp., Streptococcus equi, Pasteurella multocida,
- gastrointestinal infections caused by Salmonella spp.
- urinary infections caused by Streptococcus spp., Salmonella spp.,
- infections of the reproductive tract caused by Streptococcus spp., Escherichia coli, Klebsiella pneumoniae, Salmonella equi,
- soft tissue infections caused by Staphylococcus spp., Streptococcus spp.,,
Cattle:
- primary and secondary respiratory infections caused by Haemophilus somnus, Mannheimia haemolytica and Pasteurella multocida,
- enzootic bronchopneumonia in calves caused by Mannheimia haemolitica, Pasteurella multocida,
- colibacillosis in calves caused by Escherichia coli,
- diphtheroid inflammations in calves caused by sensitive strains of Fusobacterium necrophorum,
- mastitis caused by Staphylococcus spp., Streptococcus spp., Escherichia coli,
Sheep:
- respiratory infections caused by Haemophilus somnus, Mannheimia haemolytica and Pasteurella multocida,
- intestinal infections caused by Escherichia coli,
Swine:
- respiratory infections, including atrophic rhinitis caused by Streptococcus suis, Actinobacillus pleuropneumoniae, Actinobacillus suis, Bordatella bronchiseptica, Haemophilus parasuis, Pasteurella multocida,
- gastrointestinal infections caused by Escherichia coli, Salmonella choleraesuis,
- urogenital infections: cystitis, urinary tract infection, MMA syndrome, postpartum infections caused by Staphylococcus spp., Streptococcus spp., Escherichia coli, Klebsiella spp.,
Dogs:
- laryngitis, bronchitis and pneumonia caused by Staphylococcus spp., Streptococcus spp., Bordatella bronchiseptica, Klebsiella spp.,
- intestinal infections caused by Escherichia coli, Salmonella spp.,
- soft tissue infections caused by Staphylococcus spp., Streptococcus spp., Proteus spp., Nocardia spp.
Contraindications
Do not use in the case of sensitivity to the active substances or to any excipient. Do not use in animals with renal and hepatic insufficiency, diseases of the haematopoietic system, in dehydrated animals or in the case of limited water intake by the animal. Do not use in pregnant females or very young animals.
Adverse reactions
The product may cause impaired urination, opaque urine, haematuria and in animals hypersensitive to sulphonamides – haematuria and apathy.
When administered intramuscularly or subcutaneously, the product may cause local reactions in the form of swelling.
Side effects of sulphonamides may be manifested by hypersensitivity reactions or a direct toxic effect. Hypersensitivity reactions may be manifested by the occurrence of urticaria, anaphylaxis, fever, arthritis, haemolytic anaemia, agranulocytosis and cutaneous lesions. Sometimes haematuria and obstruction of renal tubules or crystalluria may occur.
Rapid intravenous infusion exerts a toxic effect, manifested by such clinical symptoms as muscle weakness, ataxia, blindness and collapse.
Sometimes gastrointestinal disorders may occur as a consequence of the bacteriostatic impact of sulphonamides on the microflora of the gastrointestinal tract. This situation particularly refers to ruminants, in which, as a result of bacteriostasis of the microflora of forestomachs, vitamin B synthesis may also be disrupted. At times, sulphonamides may have a photosensibilizing effect.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported 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 for each species, routes and methods of administration
Polisulfamid is administered intravenously, intramuscularly, intraperitoneally and subcutaneously.
Posology: horses, cattle, swine, sheep, dogs:
The therapeutic dose of each substance:
sodium sulfadimidine 20 – 50 mg/kg b.w.
sodium sulfacetamide 16 – 40 mg/kg b.w.
sodium sulfathiazole 12 – 30 mg/kg b.w.
i.e. 48 – 120 mg of the combination of sulfonamides/kg b.w.
Doses in ml/kg b.w.:
horses, cattle, swine, sheep, dogs: 0.4-1.0 ml of Polisulfamid/kg b.w.
It is best to administer the first dose intravenously in order to obtain a high blood concentration of the drug.
In the successive days of treatment, 2/3 – 1/2 of the initial dose is administered. The duration of treatment with Polisulfamid, whose efficacy has been confirmed with an antibiogram, is 5-7 days.
Rapid intravenous infusion exerts a toxic effect, manifested by such clinical symptoms as muscle weakness, ataxia, blindness and collapse.
Recommendations for proper administration
During the treatment, animals ought to receive a lot of water and have easy access to water in order to prevent crystalluria.
Polisulfamid administered intramuscularly or subcutaneously should be injected at various sites, and when administered intravenously, it should be warmed up to the body temperature. Intravenous injection should be made slowly.
Withdrawal period
Cattle:
Edible tissues – 10 days
Milk – 5 days
Sheep:
Edible tissues – 10 days
Do not use in sheep whose milk is intended for human consumption.
Swine:
Edible tissues – 10 days
Dogs: Not applicable
Do not use in horses whose tissues are intended for human consumption.
Horses treated with Polisulfamid can never be intended for human consumption.
Only use in horses whose passports contain a declaration “not intended for slaughter for food preparation (human consumption) in accordance with the law”
Special precautions for storage
Keep out of the reach and sight of children.
Store at a temp. of 2şC – 8şC. Protect from light. Do not freeze.
Do not use the veterinary medicinal product after the expiry date stated on the label.
The durability period after the first opening of the immediate container: 28 days.
Special warnings
Special warnings concerning each of the target animal species:
Administration of too low doses or too short therapy cause occurrence of bacterial resistance to sulphonamides. Therefore, use of sulphonamides must be justified by antibiogram results.
Sulphonamides are less effective in purulent secretion and necrotic tissues.
Special precautions for use in animals:
The product should be used on the basis of results of the resistance tests for bacteria isolated from sick animals. If this is impossible, treatment should be performed on the basis of local epidemiological information concerning sensitivity of isolated bacteria.
Administration of sulphonamides may be followed by impaired urination, opaque urine or haematuria. Therefore, animals should be monitored attentively during the treatment.
In animals hypersensitive to sulphonamides, haematuria or apathy may occur. In such cases, administration of the drug should be discontinued.
Especially sensitive to the activity of sulphonamides are dogs, particularly of large breeds, which can experience hypersensitivity reactions.
In intramuscular or subcutaneous use, the drug should be administered into various sites. In the case of intravenous administration, the preparation should be warmed to body temperature and injected slowly.
Special precautions for persons administering veterinary medicinal product to animals:
In the case of accidental self-injection, immediately seek medical advice and show the package leaflet or the label to the physician.
Pregnancy:
Do not use in pregnancy.
Lactation:
The product may be used in lactation.
Interactions with other medicinal products or other forms of interactions:
Do not use with urotropine and local anaesthetics from the group of 4-aminobenzoic acid esters.
Do not combine with acetylsalicylic acid.
Sulphonamides may transport drugs strongly binding with proteins, such as methotrexate, warfarin, phenylbutazone, thiazide diuretics, salicylates or probenecid. Therefore, concentrations of the listed drugs should be monitored. Simultaneous use of myelosuppressive drugs intensifies leucopoenia and thrombocytopenia. Combining them with hepatotoxic drugs enhances their negative effect on the liver. Since the bacteriostatic effect of sulphonamides may interfere with the bactericidal effect of penicillins, their simultaneous application is not recommended.
Overdose (symptoms, procedures concerning immediate help and antidotes):
Overdosing the drug causes circulatory insufficiency and the occurrence of nervous system symptoms such as motor ataxia or significant apathy. A coma occurs in acute poisonings. In cattle, acute poisoning may be indicated by shock symptoms, characterised by muscle tremor, muscle paralysis and vision impairment.
Overdosing sulphonamides may lead to bone marrow damage, aplastic anaemia, granulocytopenia and thrombocytopenia. It may cause hepatitis, icterus, neuritis, degeneration of the spinal cord and peripheral nerves, stomatitis and keratitis.
In dogs, overdosing the drug may result in thymus hyperplasia or hypothyroidism.
In the case of overdose, symptomatic treatment should be applied.
Pharmaceutical incompatibilities:
Since no conformity tests of this veterinary medicinal product have been conducted, this product must not be combined with other medicinal products.
Special precautions for the disposal of 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 your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Available containers
250 ml
Shelf life
3 years
For animal treatment only.
Subject to medical prescription – prescription drug.
Tobe administered under veterinary supervision.
Other information
Not applicable
2015-02-15 SPC
31.08.2017
