Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Naxcel is presented as a vegetable oil-based suspension for injection of ceftiofur crystalline free acid, corresponding to 100mg ceftiofur per ml.

Uses

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 body weight (1 ml per 20 kg body weight) 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.

Ensure that body weight is determined accurately to avoid under-dosing. It is recommended to limit the injection volumes to a maximum of 4 ml at any one site.

Contra-indications, warnings, etc

Do not use in pigs that are known to be hypersensitive to ceftiofur or other β-lactam antibiotics.

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.

Withdrawal period:

Meat and offal: 71 days.

User warnings:

Penicillins and cephalosporins may cause hypersensitivity 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.

Do not handle this product if you know you are hypersensitive. 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. 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.

Use the product within 28 days of withdrawal of the first dose from the bottle.

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.

Legal category

POM-V

Packaging Quantities

Multidose glass vials containing 50 ml or 100 ml Naxcel.

Further information

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

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 according to the benefit/risk assessment by the responsible veterinarian.

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.