Polisulfalent®

Solution of sulphonamides for injections in bacterial infections

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Product Description

Solution for injection for horses, cattle, swine, sheep and dogs, for use in bacterial infections

 

Polisulfalent (77 mg/ml + 30 mg/ml +18 mg/ml) solution for injection for horses, cattle, swine, sheep and dogs

 

Active substance and excipient content

1 ml contains:

 

Active substance:

Sulphamethoxine sodium – 77 mg/ml

Sulphadimidine sodium – 30 mg/ml

Sulfatiazole sodium pentahydrate -18 mg/ml

 

Excipient:

chlorocresol – 2 mg 

 

Therapeutic indications

Horses:

  • primary and secondary bacterial infections of the respiratory tract caused by Staphylococcus, Streptococcus spp., Rhodococcus equi, Actinobacillus equi, Pasteurella spp.,
  • infections of the gastrointestinal tract caused by Rhodococcus equi, Actinobacillus spp., Salmonella spp. excluding cases with symptoms of dehydration
  • infections of the urinary tract caused by Streptococcus spp., Actinobacillus spp., Salmonella spp., 
  • infections of the reproductive tract caused by Streptococcus , Escherichia coli, Klebsiella pneumoniae, Salmonella abortus equi, Taylorella equigenitalis,
  • infections of soft tissues caused by Staphylococcus spp., Streptococcus ,

 

Cattle, sheep:

  • primary and secondary bacterial infections of the respiratory tract caused by Haemophilus somnus, Mannheimia haemolitica, Pasteurella multocida,
  • enzootic bronchopneumonia of calves caused by Mannheimia haemolitica,Pasteurella multocida,
  • colibacteriosis in calves caused by Escherichia coli,
  • diphtheroid inflammations caused by sensitive strains Fusobacterium necrophorum,
  • mastitis caused by Staphylococcus spp., Streptococcus spp., Escherichia coli,
  • infections of the reproductive tract caused by Staphylococcus spp., Streptococcus spp., Escherichia coli,  Haemophilus somnus,

 

Swine:

  • primary and secondary bacterial infections of the respiratory tract caused by Streptococcus suis,Actinobacillus pleuropneumoniae, Actinobacillus suis, Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida,
  • infections of the gastrointestinal tract caused by Escherichia coli, Salmonella choleraesuis,
  • infections of the reproductive tract (incl. MMA syndrom) caused by Staphylococcus, Streptococcus spp., Escherichia coli,  Klebsiella spp.,

 

Dogs:

  • primary and secondary bacterial infections of the respiratory tract caused by Staphylococcusspp., Bordetella bronchiseptica, Klebsiella ,
  • intestinal infections caused by Escherichia  coli, Salmonella spp,
  • urogenital infections caused by Staphylococcus spp, Klebsiellaspp, Proteus spp,
  • infections of the reproductive tract caused byStaphylococcus spp, Klebsiella spp., Proteusspp.,
  • infections soft tissues caused by Staphylococcus , Streptococcus spp., Proteus 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 and 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 expressed 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  may occur. In general, highly soluble long-acting sulphonamides do not cause crystalluria.

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. Long-term administration of sulphonamides may also lead to bone marrow damage, and consequently, to aplastic anemia, granulocytopenia and thrombocytopenia. Long-term therapy with large drug doses may lead to the development of hepatitis, icterus, nerve inflammation, spinal cord and peripheral nerve degeneration, stomatitis and keratitis. In dogs, thymus hyperplasia or hypothyrodoism may occur as a result of drug administration. 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 http://www.urpl.gov.pl (Department of Veterinary Medicinal Products).

 

Posology and routes of administration

Polisulfalent may be administered intravenously, intramuscularly, intraperitoneally and subcutaneously.

Posology: horses, cattle, swine, sheep, dogs:

Initial dose (first day of treatment): 45-112 mg of sulphonamides/kg b.w., i.e. 0.4-1.0 ml of Polisulfalent/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.

 

Recommendations for proper administration

Administration of an insufficient dose or too short therapy leads to development of microbial resistance to sulphonamides. For that reason, purposefulness of sulphonamide use must be confirmed by antibiogram results. During treatment, animals should be given profuse amounts of water or provided with unlimited access to water, in order to prevent crystalluria development. Polisulfalent administered intramuscularly or subcutaneously should be injected in a number of different sites, and in case of intravenous administration, the product should be warmed up to body temperature. Intravenous injection should be made slowly.

 

Withdrawal period

Cattle:
Edible tissues – 10 days

Milk – 5 days

 

Sheep:
Edible tissues – 10 days

Milk – 5 days

 

Swine:
Edible tissues – 10 days
Dogs: not applicable.

 

Do not use in horses whose tissues are intended for human consumption.

Horses treated with Polisulfalent can never be intended for human consumption.

Only use in horses whose passport contains a declaration “not intended for slaughter for food preparation (human consumption) in accordance with the law”

 

Special precautions for storage

Keep out of the sight and reach of children

Store in a refrigerator (2°C – 8°C). Protects from light. Do not freeze

Do not use this veterinary medical product after the expiry date given on the label.

The durability period after the first opening of the immediate container: 28 days.

 

Special warnings

Special warnings per each target species:

Provide unlimited access to drinking water in order to prevent crystallisation of sulfonamides in urine.
Administration of an insufficient dose or too short therapy leads to development of microbial resistance to sulphonamides. For that reason, purposefulness of sulphonamide use must be confirmed 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.

During treatment, animals should be carefully observed for symptoms related to problems with urination, opaque urine or haematuria. 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.

Polisulfalent administered intramuscularly or subcutaneously 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 to be taken by the person administering the 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 during pregnancy.

Lactation:
The product may be used during lactation.

 

Interactions with other medicinal products and other forms of interaction:

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):

Overdose leads to emergence of symptoms related to the nervous system, e.g. motor ataxia, considerable dejection and in case of acute poisoning – coma. Overdose may lead to circulatory failure. In cattle, acute poisoning may evoke shock symptoms, characterized by tremor, myatonia and vision disorders. Long-term administration of sulphonamides may also lead to bone marrow damage, and consequently, to aplastic anemia, granulocytopenia and thrombocytopenia. Long-term therapy with large drug doses may lead to development of hepatitis, icterus, nerve inflammation, spinal cord and peripheral nerve degeneration, stomatitis and keratitis.

In dogs, thymus hyperplasia or hypothyrodoism may occur as a result of long-term drug administration. In 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

Glass bottle containing 250 ml of the product

 

Shelf life

3 years

 

Other information


For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.

 

For animals treatment only.

Subject to medical prescription – prescription drug

To be administered under veterinary supervision.

 

Marketing Authorization Holder and manufacturer responsible for batch release:

Biowet Puławy Sp. z o.o.

  1. Arciucha 2, 24-100 Puławy

tel/fax: (81) 886 33 53

 

2015-10-28  SPC

31.08.2017 r.

Additional Information

animal type

dogs, horses, cattle, pigs, other

type of medicine

antibiotics & sulfonamides