Description
Tiamfenikol Biowet Puławy, 250 mg/ml, solution for injection for cattle
Statement of the active substance(s) and other ingredient(s)
Active substance:
Thiamphenicol – 250 mg
Excipients:
Qualitative composition of excipients and other constituents
Propylene glycol
Dimethylacetamide
Clear solution opalescent in brown.
Target species
Cattle
Indications for use
Recommended in the treatment of:
– respiratory diseases caused by Bordetellabronchiseptica, Haemophilus spp., Klebsiella spp., Pasteurella spp.,
– gastrointestinal diseases caused by Escherichia coli, Salmonellaspp.,
– metritis caused by Staphylococcus spp., Streptococcus spp., Listeria monocytogenes, Brucella spp., Haemophilus spp., Escherichia coli,
– wounds infected by bacteria of the genus Staphylococcus spp., Streptococcus spp., Proteus spp.
Contraindications
Do not use in case of hypersensitivity to thiamphenicol.
Do not administer simultaneously with beta-lactam antibiotics.
Special warnings
Special warnings:
The product may be less effective when administered in inflammatory conditions of the reproductive and urinary systems, and peritonitis with severe hepatic and renal dysfunction.
Special caution should be taken when administering the product to animals with end-stage renal failure or with inflammatory and degenerative lesions of the liver.
Special precautions for safe use in the target species:
Administration of the product should be based on results of antimicrobial resistance testing on isolates from sick animals. If this is impossible, applied treatment should be based on the local epidemiological information concerning drug susceptibility of the isolated bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. In case of contact with skin or mucous membranes – flush the affected area with water immediately.
Pregnancy:
Do not use in pregnant animals.
Lactation:
When using the product during the laying period, observe the 48-hour withdrawal period for milk.
Interaction with other medicinal products and other forms of interaction:
The product acts synergistically with oxytetracycline and macrolides.
Do not administer the product simultaneously with beta-lactam antibiotics.
Overdose:
Laboratory studies in rats have shown evidence of toxicity, with a lethal dose of 10 g/kg body weight in case of per os administration. For ruminants, lethal dose has not been established. No toxic effect has been found in cattle after administration of doses higher than recommended doses (of up to 60 mg/kg body weight).
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
Target species: cattle
| Rare (1 to 10 animals/10 000 animals treated): | Skin rash, lowered red blood cell (erythrocyte) count and haemoglobin. These symptoms may occur during long-term use of high therapeutic doses of the product. |
| Frequency unknown, cannot be determined based on available data: | Minor pain at the injection site, subsiding spontaneously. |
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorization holder using the contact details found at the end of this leaflet, or via your national reporting system: Department for Documentation Assessment and Pharmacovigilance of Veterinary Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49-21-687, Fax: +48 22 49-21-605, https://smz.ezdrowie.gov.pl
Dosage for each target species, routes and method of administration
The product is intended for intramuscular injection in the following doses:
25-50 mg of thiamphenicol/kg body weight/24 hours.
Administer the product in two separate doses, every 12 hours in the amount of 1-2 ml/20 kg body weight.
Treatment should be administered for 3 to 7 days.
Advice on correct administration
None.
Withdrawal period(s)
Meat and offal: 8 days.
Milk: 48 hours.
Special storage precautions
Keep out of the sight and reach of children.
Store below 25°C. Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription.
Marketing authorisation numbers and pack sizes
MA number: 1550/04
Pack size: 100 ml
Date on which the package leaflet was last revised
29/09/2023
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Contact details
Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel./Fax: + 48 (81) 886 33 53, Tel.: + 48 (81) 888 91 00
e-mail: sekretariat@biowet.pl
Contact details to report suspected adverse events:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel: + 48 (81) 888 91 33, + 48 509 750 444
e-mail: biowet@biowet.pl
SPC 2023-09-29
2025-03-25
