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Date: Thursday, May 30, 2024 2:40

Release 2.156
Naxcel 100 mg/ml suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Ceftiofur
Product:Naxcel® 100 mg/ml suspension for injection for pigs
Product index: Naxcel injection for pigs
Pig - meat: 71 days
Incorporating:
Presentation
One ml contains:
Active substance:
Ceftiofur (as crystalline free acid) 100 mg.
Suspension for injection.
Opaque white to light brown suspension.
Uses
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
Intramuscular use.
Dose of 5 mg ceftiofur/kg body weight (equivalent to 1 ml of the veterinary medicinal product per 20 kg body weight) 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, body weight should be determined as accurately as possible.
It is recommended to limit the injection volumes to a maximum of 4 ml.
Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance, to other beta-lactam antibiotics or to any of the excipients. 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. No studies have been conducted in pregnant or lactating sows, or in breeding pigs. Use only according to the benefit-risk assessment by the responsible veterinarian.
Pigs:
Very common
(>1 animal / 10 animals treated):
Injection site swelling1, Injection site skin discolouration2,3, Injection site blister2
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Anaphylactic-type reaction
1Transient; following intramuscular injection.
2Have been observed for up to 42 days after injection and resolution has been observed at 56 days post injection.
3Less than 6 cm2.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
For systemically-administered broad-spectrum cephalosporins (3rd and 4th generation, 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 less critical 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, the veterinary medicinal product should only be used based on susceptibility testing. When considering the treatment strategy, it is appropriate to consider the improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).
Withdrawal period
Meat and offal: 71 days.
User warnings
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 the 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.
Pharmaceutical precautions
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 of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with national requirements.
Keep out of the reach and sight of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Cardboard box with one type I glass vial of 50 ml or 100 ml with chlorobutyl-isoprene rubber stopper and an aluminium cap.
Not all pack sizes may be marketed.
Further information
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 above.
Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and Gram-negative pathogens. Ceftiofur inhibits 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 (<0.2 µg/ml) for the target bacteria isolated in clinical studies, for at least 158 hours.
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.
Marketing Authorisation Number
UK(GB): Vm 42058/5040
UK(NI): EU/2/05/053/001-002
Significant changes
GTIN
GTIN description:50 ml:
GTIN:05414736034638
GTIN description:100 ml:
GTIN:05414736035789