Polisulfamid®

 Description

Solution for injections for horses, cattle, pigs, sheep and dogs, for use in bacterial infections

 

Qualitative and quantitative composition of active ingredients
Sulphadimedine sodium -50 mg/ml
Sulphacetamide sodium - 40 mg/ml
Sulfatiazole sodium -30 mg/ml

 

Properties
Microbes sensitive to sulphonamides contained in Polisulfamid:

- Gram-positive bacteria: sensitive Staphylococcus and Streptococcus strains, Bacillus anthracis, Clostridium tetani, Clostridium perfringens, Nocardia spp.

- Gram-negative bacteria: sensitive strains of Shigella spp., Salmonell spp., E. coli, Klebsiella spp., Enterobacter spp., Pasteurella spp, Proteus spp. - Sensitive strains of Rickettsia and some protozoa - Toxoplasma spp.

Dogs:
Primary and secondary respiratory tract infections, including laryngitis, bronchitis and pneumonia caused by microbes sensitive to Polisulfamid. Infections of soft tissues. Bowel inflammation evoked by Salmonella-based infections.

Pigs:
Bacterial infections of the respiratory tract, including atrophic rhinitis of swine. E. coli-based gastrointestinal tract infections. Urogenital system infections: urinary bladder and urinary tract inflammations, MMA syndrome, postpartum infections.

Horses:
Respiratory system infections caused by Streptococcus equi. Gastrointestinal tract infections, urogenital system and soft tissue infections caused by microbes sensitive to Polisulfamid.

Cattle (calves):

Bacterial inflammations of the respiratory system, bovine respiratory disease, enzootic pneumonia of calves. Colibacteriosis of calves, diphtheroid caused by sensitiveFusobacterium necrophorum strains, mastitis evoked by Staphylococcus-based infections.

Sheep:
Bacterial inflammations of the respiratory system and bowels.

 

Contrindications

Do not use in case of animal hypersensitivity to active ingredients or any excipient.

Do not use the product in animals with renal and hepatic failure, haematopoietic system disorders, in dehydrated animals or in case of limited water uptake by animals.

Do not use in pregnant females and very young animals.

 

Undesirable effects
Administration of the product may cause urination problems, cloudy urine, haematuria and in animals hypersensitive to sulphonamides, haematuria and apathy. The product administered intramuscularly or subcutaneously may cause topical oedema reactions.

Side effects of sulphonamide use may include hypersensitivity reactions or direct toxic effect. Hypersensitivity reactions may be manifested in urticaria, anaphilaxis, fever, arthritis, haemolytic anemia, agranulocytosis, as well as skin lesions. Sometimes hematuria and renal tabule obstruction may occur. Instant intravenous infusion evokes toxic effect manifested in clinical symptoms, such as muscle weakness, ataxia, blindness and collapse. Gastrointestinal disorders may appear at times, resulting from bacteriostatic effect of sulphonamides on microflora of the gastrointestinal tract. In particular, this refers to ruminants in which as a result of bacteriostasis of the microflora of proventriculus, disturbed synthesis of vitamin B may also be observed.

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 occuras a result of drug administration.

At times, sulphonamides may have a photosensibilizing effect.

In case of emergence of any adverse effects after administration of this product or upon observation of any alarming symptoms not listed in the product leaflet (including symptoms in humans as a result contacting the product), seek advice of a competent veterinarian, marketing authorization holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Report form should be downloaded from the website: http://www.urpl.gov.pl (Department of Veterinary Medicinal Products).

 

Application and dosage

Polisulfalent may be administered intravenously, intramuscularly, intraperitoneally or, should a need arise, also subcutaneously. Initial dose for all animal species is: 0.4-1.0 ml of Polisulfalent/kg b.w., i.e. 48-120 mg of sulphonamides/kg b.w. It is best to administer the initial dose intravenously, which allows to obtain high drug concentration levels in the blood. Length of effective Polisulfalent therapy confirmed using an antibiogram is 5-7 days. In the following days, 2/3 – 1/2 of the initial dose is administered.

 

Indications for proper administration

Administration of an insufficient dose or too short therapy lead 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.

 

Wihtdrawal period
Cattle, sheep:
Edible tissues – 10 days
Milk – 5 days

Pigs: 
Edible tissues – 10 days
Do not use in horses whose tissues are intended for human consumption.

 

Special precautions to be taken for storage and transport

Keep out of reach and sight of children.

Store +2 to +8°C. Protect from light.Do not freeze.

Do not use after the expiration date.

The shelf life after the first opening of the primary packaging is 28 days.

 

Special warnings and precautions

Sulphonamides are less effective in purulent secretion and necrotic tissues.

During treatment, animals should be carefully observed for symptoms related to problems with urination, cloudy urine or haematuria. In animals hypersensitive to sulphonamides, haematuria or apathy may be observed. In such a case, drug administration should be stopped. Dogs are particularly sensitive to sulphonamides, especially large dog breeds in which after drug administration, hypersensitivity reactions may occur. In case of accidental self-injection, immediately seek doctor’s advice and present him/her with the information leaflet or packaging. Do not use the product during pregnancy. The product may be used during lactation. Do not use the product with Hexamethylenetetramine and topical anaesthetics belonging to esters of para-aminobenzoic acid.

Do not use together with acetylsalicylic acid. Sulphonamides may displace drugs strongly bound to proteins, such as methotrexate, warfarin, phenylbutazone, thiazide diuretics, esters of salicylic acid, probenecid. For this reason, concentrations of these agents should be controlled. Parallel use of bone marrow suppression drugs increases severity of leucopenia and thrombocytopenia. Simultaneous use with hepatotoxic drugs intensifies their ill effects on the liver. Due to the fact that bacteriostatic effect of sulphonamides may interfere with bactericidal action of penicillin, it is not recommended to use them simultaneously. 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. As no conformity studies of this medicinal veterinary product have been conducted, it is forbidden to combine it with other medicinal products.

 

Special precautions concerning neutralising the not used medicinal veterinary product or wastes originating from this product
The drugs must not be removed into the sewage system or thrown away with litter. Ask a veterinary doctor about the methods of disposal of useless drugs. It is crucial for environmental protection

 

Shelf-life

3 years.

 

Packing

Bottles of 250ml

 

Other information

Exclusively for animals
Prescription-only- medicine(POM)

 More details

Name Description
Place of Origin: Poland

 Ad details

 Ad ID : 89
 24-100 Pulawy, Arciucha 2 NIP 716-11-26-796 Biowet Pulawy Ltd.,Poland, Europe
 4 years, 9 months ago
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