Target species
Cattle, pigs, and horses.
Indications for use for each target species
The veterinary medicinal product is indicated for treatment of bovine bacterial respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, and Actinobacillus (Haemophilus) somnus and other sensitive bacterial pathogens.
For the treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which Fuosbacterium necrophorum and Bacteroides melaninogenicus are involved.
The treatment of pigs with bacterial respiratory disease in which Actinobacillus (Haemophilus) pleuropneumonia, Pasteurella multocida and Streptococcus suis are involved.
For the treatment of horses with bacterial respiratory disease associated with Streptococcus spp. (including Streptococcus zooepidemicus), Staphylococcus spp.
and/or Pasteurella spp.
Contraindications
Do not use in cases of hypersensitivity to the active substance.
Do not use in poultry (including eggs) due to the risk of spread of antimicrobial resistance to humans.
Special warnings
Use of the veterinary medicinal product may constitute a risk to public health due to the spread of antimicrobial resistance.
Special precautions for use
Special precautions for safe use in the target species:
The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhoea, which could be fatal. If acute diarrhoea is observed, discontinue use of this antimicrobial and initiate appropriate therapy.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure taking all recommended precautions.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cattle, pigs, and horses:
Very common (>1 animal / 10 animals treated): | Injection site pain1 |
1 Temporary; this reaction was associated with a transient increase in muscle enzymes
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
The safety of the veterinary medicinal product has not been established during pregnancy.
Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Interaction with other medicinal products and other forms of interaction
None known.
Administration routes and dosage
Intramuscular use in cattle, pigs, and horses.
Reconstitution:
Dissolve the 1 g sterile powder in 20 ml of water for injections.
Dissolve the 4 g sterile powder in 80 ml of water for injections.
Rapid addition of diluent will give best results.
The resulting solution contains 50 mg ceftiofur free acid equivalents per ml. For ease of reconstitution use an 18-gauge needle.
Dosage
Cattle:
1 mg/kg bodyweight. This is equivalent to 1 ml of the reconstituted solution per 50 kg bodyweight.
For respiratory disease, the dose should be given once daily at 24-hour intervals for 3 to 5 days in total.
For interdigital necrobacillosis (foul in the foot), the dose should be given once daily at
24-hour intervals for 3 days. As with all antibiotic therapy, treatment of this condition with the veterinary medicinal product should be instituted as early as possible in order to provide maximum clinical benefit.
Pigs:
3 mg/kg bodyweight: This is equivalent to 1 ml of the reconstituted solution per 16 kg bodyweight. The dose should be given once daily at 24-hour intervals for 3 days.
If no response is seen within these periods, the diagnosis should be redetermined.
Horses:
2 mg/kg bodyweight: This is equivalent to 2 ml of the solution per 50 kg bodyweight. The dose should be given once daily at 24-hour intervals and continued for 48 hours after clinical signs have disappeared. A 10-day treatment period is usually adequate. A maximum of 10 ml solution should be administered per injection site.
If no response is seen within 4-5 days, the diagnosis should be re-determined.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
None known.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
The veterinary medicinal product selects for resistant strains such as bacteria carrying extended spectrum beta-lactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, the veterinary medicinal product should be reserved for the treatment of clinical conditions which have responded poorly or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis) to first line treatment.
Official, national, and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of such resistance. Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
The veterinary medicinal product is intended for treatment of individual animals. Do not use for disease prevention or as a part of heard health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use.
Withdrawal periods
Meat and offal:
Cattle: 1 day.
Pigs: 2 days.
Milk:
Cattle: Zero hours.
Not authorised for use in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.