Do not use in cases of hypersensitivity to the active substance, to other beta-lactam antibiotics or to any of the excipients. Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Laboratory studies in rats revealed no teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed. No effects on the reproductive performance were observed. No studies have been conducted in pregnant or lactating sows, or in breeding pigs. Use only according to the benefit-risk assessment by the responsible veterinarian.
Pigs:
Very common (>1 animal / 10 animals treated): | Injection site swelling1, Injection site skin discolouration2,3, Injection site blister2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactic-type reaction |
1Transient; following intramuscular injection.
2Have been observed for up to 42 days after injection and resolution has been observed at 56 days post injection.
3Less than 6 cm2.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
For systemically-administered broad-spectrum cephalosporins (3rd and 4th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to less critical antimicrobials. Increased use, including use of the product deviating from the instructions given in the Summary of Product Characteristics (SPC), may increase the prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into account when the product is used.
Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing. When considering the treatment strategy, it is appropriate to consider the improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).
Withdrawal period
Meat and offal: 71 days.
User warnings
Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
People with known hypersensitivity to penicillins and cephalosporins should avoid contact with the veterinary medicinal product.
Avoid contact with skin or eyes. In the event of contact, wash with clean water.
If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice and show the package leaflet or label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.