Naxcel 100 mg/ml Suspension for Injection for Pigs.
Naxcel is presented as a vegetable oil-based suspension for injection of ceftiofur crystalline free acid, corresponding to 100 mg ceftiofur per ml.
Naxcel is indicated for the following uses in pigs:
- Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
- Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Dosage and administration
5 mg ceftiofur per kg bodyweight (1 ml per 20 kg bodyweight) administered once in the neck by the intramuscular route.
Shake bottle vigorously for 30 seconds or until all visual settlement has been resuspended before use.
To ensure a correct dosage, bodyweight should be determined accurately to avoid under-dosing. It is recommended to limit the injection volumes to a maximum of 4 ml.
Contra-indications, warnings, etc
Do not use in pigs that are known to be hypersensitive to ceftiofur, other ß-lactam antibiotics or any of the excipients.
Occasionally, transient local swelling may occur following intramuscular injection. Mild tissue reactions at the injection site, such as small areas (less than 6 cm2) of discolouration and small cysts have been observed for up to 42 days after injection. Resolution has been observed at 56 days post-injection. In very rare cases, anaphylactic type reactions may occur following administration of the product.
For systemically administered broad spectrum cephalosporins (3rd and 4thgeneration, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into account when the product is used.
Whenever possible, cephalosporins should only be used based on susceptibility testing. When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).
Meat and offal: 71 days.
Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals 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.
People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.
Avoid contact with skin or eyes. In the event of contact, wash with clean water. If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice and show the package leaflet or label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Do not store above 25°C.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf-life after first opening the container: 28 days.
Any unused product or waste material should be disposed of in accordance with national requirements.
Keep out of the reach and sight of children.
For animal treatment only.
Multidose glass vials containing 50 ml or 100 ml Naxcel. Not all pack sizes may be marketed.
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