Solution for injection for pigs and cattle.
STATEMENT OF ACTIVE SUBSTANCE AND OTHER INGREDIENTS
One ml of suspension contains:
Ceftiofur (as hydrochloride) 50.0 mg.
Beige, white to off-white suspension.
INDICATIONS
Infections associated with bacteria susceptible to ceftiofur.
Pigs:
For the treatment of respiratory diseases associated with Pasteurella multocida, Actinobacillus pleuropneumonia and Streptococcus suis.
Cattle:
For the treatment of bacterial respiratory diseases associated with Mannheimia haemolytica (formerly Haemophilus somnus).
For the treatment of acute interdigital necrobacillosis (panaritium, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharoiytica).
For the treatment of the bacterial component of acute postpartum (puerperal) metritis occurring within 10 days of calving, associated with Escherichia coli, Arcanobacterium pylogenes and Fusobacterium necrophorum, susceptible to ceftiofur.
The indication is limited to cases where treatment with another antimicrobial agent has failed.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to ceftiofur or other beta-lactams.
Do not inject intravenously.
Do not administer in case of resistance to other cephalosporins or beta-lactam antibiotics.
Do not use in poultry (including eggs) due to the risk of spreading antimicrobial resistance to humans.
ADVERSE REACTIONS
Hypersensitivity reactions may occur without any relation to the dose. Allergic reactions (e.g. skin reactions, anaphylaxis) may occasionally occur. In case of an allergic reaction, treatment should be stopped.
In pigs, mild reactions at the injection site, such as discoloration of the fascia or fat layer, have been observed up to 20 days after injection.
In cattle, mild inflammatory reactions at the injection site, such as tissue edema and discoloration of the subcutaneous tissue and/or muscle fascia, may be observed. Clinical remission is achieved in most animals 10 days after injection, although mild tissue discoloration may persist for 28 days or more. If you notice any serious reactions or defects not mentioned in the package leaflet, please inform your veterinarian!
Target species:
Pigs and cattle.
DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Swine:
3 mg certiofur/kg body weight/day, for 3 days, intramuscularly, i.e. 1 ml/16 kg body weight for each injection.
Cattle:
Respiratory diseases: 1 mg certiofur/kg body weight/day, for 3-5 days, subcutaneously, i.e. 1 ml/50 kg body weight for each injection;
Acute interdigital necrobacillosis: 1 mg/kg body weight/day, for 3 days subcutaneously, i.e. 1 ml/50 kg body weight, for each injection;
Acute postpartum metritis within 10 days of calving: 1 mg/kg body weight/day for 5 consecutive days subcutaneously, i.e. 1 ml/50 kg body weight for each injection.
Before use, shake the bottle well for at least 30 seconds until the product is resuspended. The absence of sediment can be confirmed by inverting the bottle and examining the contents through the base of the bottle.
The maximum volume to be administered in a single injection is 4 ml in pigs and 6 ml in cattle. Subsequent administrations should be applied at different sites.
The bottle can be opened a maximum of 66 times.
In case of acute post-partum metritis, additional supportive therapy may be necessary in some cases.
Withdrawal period:
Swine: meat and offal: 5 days;
Cattle: meat and offal: 8 days;
Milk: zero hours.
Special precautions for storage:
Keep out of the sight and reach of children;
Do not refrigerate or freeze.
Keep the bottle in the outer carton in order to protect from light.
Special warnings:
The use of the product may constitute a risk to public health due to the spread of antimicrobial resistance. The product should be reserved for the treatment of clinical conditions that have responded inadequately, or are expected to respond inadequately, to first-line treatment. When using this product, official, national and regional antimicrobial policies should be taken into account. Increased use, including use of the product deviating from the instructions provided, may increase the prevalence of resistance. Whenever possible, the product should only be used based on susceptibility testing.
Special precautions for use in animals:
This veterinary medicinal product does not contain any antimicrobial preservative.
The product is intended for the treatment of individual animals. Do not use for disease prophylaxis or as part of herd health programmes. Treatment of groups of animals should be strictly limited to current disease outbreaks in accordance with
the conditions of use current. Do not use for prophylactic purposes in the case of incompletely detached placenta.
Warnings for the user:
Handle the product with great care to avoid exposure. After use, hand washing is recommended.
Use during pregnancy and lactation
Although studies conducted in laboratory species have not shown teratogenic effects, abortion or influence on reproductive function, the safety of certifur at the reproductive system level has not been specifically investigated in pregnant sows or cows.
Use only according to the benefit/risk assessment carried out by the responsible veterinarian.
Interactions with other medicinal products and other forms of interaction:
The bactericidal properties of beta-lactam antibiotics are neutralized by the simultaneous use of bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines).
Overdose:
The low toxicity of certiofur has been demonstrated in pigs using ceftiofur sodium at doses 8 times the recommended daily dose, administered intramuscularly for 15 consecutive days. In cattle, no signs of systemic toxicity have been observed after parenteral administration of substantial overdoses.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Presentation:
100 ml bottles.


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