Description
Injection solution for cattle for use in bacterial infections
250 mg/ml, injection solution for cattle
Active substance and excipient content
1 ml contains:
Active substance:
thiamphenicol 250 mg
Excipient:
propylene glycol 100 mg
Therapeutic indications
The product is intended for treatment of:
- diseases of the respiratory tract caused by caused by Bordetellabronchiseptica, Haemophilus spp., Klebsiella spp., Pasteurella spp.,
- diseases of the gastrointestinal tract caused by Escherichia coli, Salmonella spp.
- endometritis caused by Staphylococcus spp., Streptococcus spp., Listeria monocytogenes, Brucella spp., Haemophilus spp., Escherichia coli,
- injuries infected by Staphylococcus spp., Streptococcus spp., Proteus spp.
Contraindications
Do not use in the case of hypersensitivity to thiamphenicol.
Do not administer in combination with β -lactam antibiotics.
Adverse reactions
Rarely, in the long-lasting use of high doses of the drug, a skin rash and a decrease in the level of haemoglobin and erythrocytes might occur. Benign pain that disappears spontaneously may sporadically occur at the injection site.
Using the drug longer than the recommended time might be conducive to development of fungal infections.
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, route and method of administration
Administer the product intramuscularly in the following doses:
25 – 50 mg of thiamphenicol/kg b.w./day.
The drug should be sued in two divided doses every 12 hours using 1-2 ml/20 kg b.w. The duration of treatment ranges from 3 to 7 days.
Recommendations for proper administration
None.
Withdrawal period
Edible tissues – 8 days.
Milk – 48 hours.
Special precautions for storage
Keep out of the reach and sight of children.
Store below 25°C. 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:
Particular caution should be taken when using the product in animals with advanced renal insufficiency or in animals with inflammatory and degenerative lesions of the liver.
Special precautions for use in animals:
The product should be used on the basis of results of 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.
Special precautions for persons administering the medicinal veterinary product to animals:
In the case of an accidental self-injection, seek medical help and give the leaflet or the packaging to the doctor. After an accidental contact with skin or mucosa, immediately wash the sites with water.
Pregnancy:
Do not use in pregnancy.
Lactation:
Administering the product in lactation, observe the 48-hour waiting period for milk.
Interaction with other medicinal products and other forms of interaction
The product has a synergic effect in combination with oxytetracycline and macrolides.
The product should not be combined with β -lactam antibiotics.
Overdose (symptoms, procedures concerning immediate help and antidotes):
Toxicity tests were performed on rats in which the lethal dose is 10g/kg b.w. in oral administration. It was not determined for ruminants.
No toxic effect of the drug was observed in cattle after higher than the recommended doses (up to 60 mg/kg b.w.) had been applied.
Pharmaceutical incompatibilities:
Since no conformity studies of this veterinary medicinal product have been conducted, this product must not be combined with other medicinal veterinary 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
100 ml.
Shelf life
2 years
For animal treatment only.
Subject to medical prescription – prescription drug.
Tobe administered under veterinary supervision.
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Marketing authorisation holder:
Biowet Puławy Sp. z o.o.
- H. Arciucha 2, 24-100 Puławy
tel./fax (81) 886 36 11
(81) 888 91 01
2015-04-15 SmPC
31.08.2017 r.
