Target species
Cattle and pigs.
Indications for use, specifying the target species
Infections associated with bacteria sensitive to ceftiofur.
In cattle:
For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Mannheimia haemolytica and Histophilus somni.
For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica).
For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum: this indication is restricted to cases where treatment with another antimicrobial has failed.
In pigs:
For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.
Contraindications
Do not administer to an animal previously found to be hypersensitive to ceftiofur and other β-lactam antibiotics.
Do not inject intravenously.
Do not use where resistance to other cephalosporins or beta-lactam antibiotics has occured.
Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.
Special warnings for each target species
None known.
Special precautions for use
Special precautions for use in animals
Do not use as prophylaxis in case of retained placenta.
This 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, this 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, this product should only be used based on susceptibility testing.
This product is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) 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.
- 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. Wash hands after use.
- 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 or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Adverse reactions (frequency and seriousness)
Hypersensitivity reactions (e.g. skin reactions, anaphylaxia) have been reported in very rare cases. In case of the occurrence of hypersensitivity reaction the treatment should be withdrawn.
In pigs, mild reactions at the injection site, such as discoloration of the fascia or fat, have been observed in some animals for up to 20 days after injection.
In cattle, mild inflammatory reactions at the injection site, such as tissue oedema, thickening of connective tissue and discoloration of the subcutaneous tissue and/or fascial surface of the muscle may be observed in rare cases. Clinical resolution is reached in most animals by 10 days after injection although slight tissue discoloration may persist for 28 days or more.
Use during pregnancy, lactation or lay
Studies in laboratory animals have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the product has not been established in sows or cows during pregnancy and lactation.
Use only according to a benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
The bactericidal properties of cephalosporins are antagonized by simultaneous use of bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines).
Amounts to be administered and administration route
Cattle: Subcutaneous use
- Respiratory disease: 1 mg ceftiofur (as hydrochloride)/kg /day for 3 to 5 days, i.e. 1 ml/50 kg at each injection.
- Acute interdigital necrobacillosis: 1 mg ceftiofur (as hydrochloride)/kg /day for 3 days, i.e. 1 ml/50 kg at each injection.
- Acute post-partum metritis within 10 days after calving: 1 mg ceftiofur (as hydrochloride)/kg /day for 5 consecutive days, i.e. 1 ml/50 kg at each injection.
In case of acute post-partum metritis, additional supportive therapy might be required in some cases.
Pigs: Intramuscular use
3 mg ceftiofur (as hydrochloride)/kg /day for 3 days, i.e. 1 ml/16 kg at each injection.
Shake the bottle well before use to bring the product back into suspension.
To ensure a correct dosage, body weight should be determined as accurately as possible in order to avoid under-dosing. Subsequent injections must be given at different sites.
As the vial cannot be broached more than 50 times, the user should choose the more appropriate vial size.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The low toxicity of ceftiofur has been demonstrated in pigs using ceftiofur sodium at doses in excess of 8 times the recommended daily dose of ceftiofur intramuscularly administered for 15 consecutive days.
In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.
Withdrawal periods
Cattle:
Meat and offal: 8 days.
Milk: zero hours.
Pigs:
Meat and offal: 5 days.