| Dosage for each species, routes and method of administration
3 mg ceftiofur/kg bw/day for 3 days via intramuscular route, i.e. 1 ml/16 kg bw at each injection.
Respiratory disease: 1 mg ceftiofur/kg bw/day for 3 to 5 days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection.
Acute interdigital necrobacillosis: 1 mg/kg bw/day for 3 days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection.
Acute post-partum metritis within 10 days of calving: 1 mg/kg bw/day for 5 consecutive days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection.
Subsequent injections must be given at different sites. For the injections, the neck should be preferred in cattle.
In case of acute post-partum metritis, additional supportive therapy might be required in some cases.
Meat and offal: 6 days.
Meat and offal: 8 days.
Milk: zero hours.
| Special storage precautions
This veterinary medicinal product does not require any special storage conditions.
Keep the container in the outer carton.
Keep out of the reach and sight of children.
Shelf-life after first broaching the vial: 28 days.
Ceftiofur (as hydrochloride) 50.0 mg/ml
Slightly yellow to slightly pink, milky suspension.
Infections associated with bacteria sensitive to ceftiofur:
For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.
For the treatment of bacterial respiratory disease associated with Pasteurella haemolytica (Mannheimia spp.), Pasteurella multocida and Haemophilus somnus.
For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum 50 mg/ml
suspension for injection for cattle and pigs and Bacteroides melaninogenicus (Porphyromonas asaccharolytica).
For treatment of the bacterial component of acute postpartum (puerperal) metritis within 10 days after calving associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur.
Do not administer to an animal previously found to be hypersensitive to ceftiofur and other β-lactam antibiotics.
Do not use in case of known resistance to the active substance.
Hypersensitivity reactions unrelated to dose can occur.
Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.
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 and discoloration of the subcutaneous tissue and/or fascial surface of the muscle may be observed.
Clinical resolution is reached in most animals by 10 days after injection although slight tissue discoloration may persist for 28 days or more.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Cattle and pigs.
When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.
Do not use after the expiry date stated on the carton and vial after EXP.
Special warnings for each target species
Accidental injection is dangerous.
Special precautions for use in animals
Shake the bottle well before use to bring the product back into suspension.
In case of the occurrence of allergic reaction the treatment should be withdrawn.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Ceftiofur should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to ceftiofur and may decrease the effectiveness of treatment with other cephalosporins, due to the potential for cross resistance.
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.
1.Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2.Handle this product with great care to avoid exposure taking all recommended precautions.
3. In case of accidental injection or 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 in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Use during pregnancy and lactation
Even though studies in laboratory animals show no evidence of teratogenesis, abortion or influence on reproduction, the reproductive safety of ceftiofur has not been specifically investigated in pregnant sows or cows.
Use only according to a benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Erythromycins and tetracyclines may have an antagonistic effect on cephalosporins whereas aminoglycosides may have a potentiating effect.
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.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
| Special precautions for the disposal of unused product or waste materials
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation