Powder vials contains:
Ceftiofur (as sodium) 1 g
Ceftiofur (as sodium) 4 g
Excipients qs 1 vial
One ml solvent contains
Water for injections 1 ml
1 ml of reconstituted solution contains:
Ceftiofur (as sodium) 50 mg
Powder and solvent for solution for injection.
Powder: white to off white powder.
Solvent: clear and colourless liquid.
Reconstituted solution: clear brownish yellow to yellow coloured solution.
Cattle and pigs.
Indications for use
- For the treatment of bacterial respiratory disease associated with Pasteurella multocida andMannheimia haemolyticasensitive to ceftiofur.
- For the treatment of cattle with interdigital necrobacillosis (foot rot) in which Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica) sensitive to ceftiofurare involved.
For the treatment of bacterial respiratory disease in which Pasteurella multocida, Actinobacilluspleuropneumonia and Streptococcus suis sensitive to ceftiofur are involved.
Do not use in animals previously found to be hypersensitive to ceftiofur or other beta-lactamines. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
In case of repeated administrations, precautions must be taken, such as injections on both sides of the neck.
Cevaxel selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, Cevaxel 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, Cevaxel should only be used based on susceptibility testing.
Cevaxel 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity 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. People with known hypersensitivity should avoid contact with the veterinary medicinal product. In case of development of a skin rash following exposure, seek medical advice. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention. Wash hands after use.
Fleeting symptoms of pain may be observed at the injection site.
In local tolerance studies conducted in cattle and swine, mild and transient swelling were observed at the injection site in a few pigs six hours after injection. No signs of swelling at the palpation of the injection site were observed 24 hours after injection.
Hypersensitivity reactions can occasionally occur. In the case of an allergic reaction, treatment should be stopped.
Interaction with other medicinal products and other forms of interaction
The use of ceftiofur with other ß-lactam antibiotics or cephalosporins may induce in rare occasion a potential immunological cross-reaction.
Amounts to be administered and administration route
The solution for injection is to be reconstituted with 20 ml of water for injections for the 1 g presentation and with 80 ml of water for injections for the 4 g presentation.
Rapid addition of solvent will give best results.
- For respiratory disease
1 mg ceftiofur (as sodium) per kg bodyweight per day for 3 to 5 days, i.e. 1 ml of reconstituted solution per 50 kg bodyweight per day for 3 to 5 days.
- For interdigital necrobacillosis (foul in the foot rot)
1 mg ceftiofur (as sodium) per kg bodyweight per day for 3 days, i.e. 1 ml of reconstituted solution per 50 kg bodyweight per day for 3 days.
3 mg ceftiofur (as sodium) per kg bodyweight per day for 3 days, i.e. 1 ml of reconstituted solution per 16 kg bodyweight per day for 3 days.
The dose should be given once daily at 24 hour intervals.
Do not administer more than 10 ml per injection site.
- For respiratory disease
Overdose (symptoms, emergency procedures, antidotes), if necessary
In cattle, no signs of systemic toxicity are observed after important overdose by parenteral administrations.
In pigs, the lowest toxicity of ceftiofur was demonstrated at 8 times the therapeutic dose for 15 days by intramuscular use.
Meat and offal:
- Cattle: 2 days.
- Pigs: 2 days.
Milk: zero days.
Pharmacotherapeutic group: third generation cephalosporins.
ATCvet code: QJ01DD90.
Ceftiofur is a cephalosporin, resistant to beta-lactamase. Ceftiofur is active against Gram-positive and Gram-negative bacteria.
Ceftiofur has bactericidal properties, acting by inhibition of the bacteria cell wall synthesis.
Cell wall synthesis is dependent on enzymes that are called penicillin-binding proteins (PBP's). Bacteria develop resistance to cephalosporins by four basic mechanisms: 1) altering or acquiring penicillin binding proteins insensitive to an otherwise effective b-lactam; 2) altering the permeability of the cell to b-lactams; 3) producing b-lactamases that cleave the b-lactam ring of the molecule, or 4) active efflux.
Ceftiofur is active against the following pathogenic bacteria:
- Mannheimia haemolytica, Pasteurella multocida, Actinobacillus somnus responsible for bovine respiratory diseases
- Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica) responsible for bovine interdigital necrobacillosis
- Pasteurella multocida, Streptococcus suis and Actinobacilluspleuropneumonia responsible for porcine respiratory diseases
The following Minimum Inhibitory Concentrations (MIC) have been determined for ceftiofur in European isolates (France, United Kingdom, Netherlands, Denmark, Germany, Belgium, Italy, Czech Republic, Ireland, Poland and Spain) collected from diseased animals between 2000 to 2007:
The following ceftiofur breakpoints are used: ? 2 µg/mL (Susceptible), 4 µg/mL (Intermediate) and ?8 µg/mL (Resistant).
After administration by intramuscular route, biodisponibility of ceftiofur is total in cattle and in pigs. Ceftiofur is quickly metabolised into desfuroyl ceftiofur for which the maximal concentration is reached in 2.5 hours in cattle and in less than one hour in pigs. Half-life of desfuroyl ceftiofur is of 11.2 hours in cattle and of 15.2 hours in pigs.
Repeated administrations induce no accumulation in cattle and pigs.
List of excipients
Potassium dihydrogen phosphate.
Water for injections.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life of the product after reconstitution according to directions:
7 days, stored in a refrigerator (2 °C – 8 °C)
12 hours, stored below 25°C
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Keep the vial in the outer carton in order to protect from light.
Nature and composition of immediate packaging
Nature of container: Powder:
- Glass vial type I
- Bromobutyl rubber stopper.
- Glass vial type II
- Chlorobutyl rubber stopper.
Box containing 1 vial of Cevaxel 50 mg/ml 1 g and box containing a vial of 20 ml solvent
Box containing 1 vial of Cevaxel 50 mg/ml, 4 g and box containing a vial of 80 ml solvent
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
From one country to another, product lines are adapted to local demand and regulatory requirements. For further information, please take a look at the CEVA Santé Animale site for your country. Warning: the information provided on the products depends on national registrations. Access to technical information is restricted to authorised persons.