Naxcel 100 mg solution for injection for pigs 100 ml
Treatment of bacterial respiratory disease for pigs
NAXCEL 100 mg/ml suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
One ml contains:
Ceftiofur (as crystalline free acid) 100 mg. For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Suspension for injection.
Opaque white to light brown suspension.
4. CLINICAL PARTICULARS:
4.1 Target species:
4.2 Indications for use NAXCEL, specifying the target species :
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.
4.3 Contraindications NAXCEL:
Do not use in cases of hypersensitivity to ceftiofur or other -lactam antibiotics, or to any of the excipients.
4.4 Special warnings for each target species:
4.5 Special precautions for use Special precautions for use in animals:
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 summary of product characteristics (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). Special precautions to be taken by the person administering the veterinary medicinal product to animals 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 the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
4.6 Adverse reactions NAXCEL(frequency and seriousness):
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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
4.7 Use during pregnancy, lactation or lay:
Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Laboratory studies in rats revealed no teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed. No effects on the reproductive performance were observed in both species. No studies have been conducted in pregnant or lactating sows, or in breeding pigs. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction:
4.9 Amounts to be administered and administration route:
Dose of 5 mg ceftiofur/kg bodyweight (equivalent to 1 ml of NAXCEL per 20 kg bodyweight) administered once in the neck by intramuscular injection. Shake bottle vigorously for 30 seconds, or until all visual settlement has been resuspended. To ensure a correct dosage, bodyweight should be accurately determined to avoid under-dosing. It is recommended to limit injection volumes to a maximum of 4 ml.
4 4.10 Overdose NAXCEL(symptoms, emergency procedures, antidotes)if necessary:
Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section
4.6 (Adverse reactions).
4.11 Withdrawal period(s):
Meat and offal: 71 days.
5. PHARMACOLOGICAL PROPERTIES:
Pharmacotherapeutic group: Antibacterials for systemic use, third-generation cephalosporins. ATCvet code: QJ01DD90.
5.1 Pharmacodynamic properties:
Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and Gram-negative pathogens. Ceftiofur inhibits the bacterial cell wall synthesis, thereby exerting bactericidal properties. Ceftiofur is particularly active against the following target pathogens causing respiratory and other diseases in pigs: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis. Bordetella bronchiseptica is inherently insensitive to ceftiofur in vitro. Desfuroylceftiofur is the principal active metabolite. It has an antimicrobial activity similar to that of ceftiofur against the target pathogens. At the recommended therapeutic dose, concentrations in plasma were higher than the MIC90 values (
5.2 Pharmacokinetic particulars After administration, ceftiofur is quickly metabolised to desfuroylceftiofur, the principal active metabolite. Protein binding of ceftiofur and its major metabolite is approximately 70%. One hour after a single administration, plasma concentrations are above 1 µg/ml. Maximum concentrations in plasma (4.2±0.9 µg/ml) are reached at approximately 22 hours after administration. Plasma concentrations above 0.2 µg/ml of ceftiofur and its metabolite are maintained for an appropriate period of time. Approximately 60% and 15% of the dose are excreted in the urine and faeces, respectively, within 10 days after administration.
6. PHARMACEUTICAL PARTICULARS:
6.1 List of excipients.
Oily vehicle (vegetable origin):
Triglycerides, medium chain Cottonseed oil.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life:
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the container: 28 days.
6.4. Special precautions for storage:
Do not store above 25ºC.
6.5 Nature and composition of immediate packaging:
Cardboard box with one type I glass vial of 50 ml or 100 ml with a chlorobutyl-isoprene rubber stopper and aluminium cap.
Not all pack sizes may be marketed.
6.6. Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.