Introduction

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

Vials containing 50 or 100 ml of a sterile suspension. Each ml contains ceftiofur hydrochloride equivalent to 50 mg ceftiofur.

Uses

Excenel contains ceftiofur which is a β-lactamase resistant, broad spectrum, bactericidal cephalosporin antibiotic and is effective in the treatment of infections associated with bacteria sensitive to ceftiofur. The product is indicated for:-

Cattle

For the treatment of bacterial respiratory disease associated with Mannheimia spp. (Pasteurella haemolytica), Pasteurella multocida and Histophilus somni.

For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica).

For treatment of acute post-partum (puerperal) metritis within 10 days of calving, associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur.

Pigs

For the treatment of bacterial respiratory disease associated with micro-organisms sensitive to ceftiofur: Actinobacillus pleuropneumoniae, Pasteurella multocida and Streptococcus suis.

Dosage and administration

Cattle

For the treatment of respiratory disease: 1 mg/kg bwt/day subcutaneously for 3 to 5 days, i.e. 1 ml/50 kg bwt at each injection.

For the treatment of acute interdigital necrobacillosis: 1 mg/kg bwt/day subcutaneously for 3 days, i.e. 1 ml/50 kg bwt at each injection.

For the treatment of acute post-partum metritis: 1 mg/kg bwt/day subcutaneously for 5 consecutive days, i.e. 1 ml/50 kg bwt at each injection.

Subsequent injections must be given at different sites.

Pigs

3 mg ceftiofur/kg bwt (i.e. 1ml/16kg bwt) intramuscularly once daily at 24 hour intervals for 3 days in total.

Contra-indications, warnings, etc

Do not administer to an animal previously found to be hypersensitive to ceftiofur and other β-lactam antibiotics. Do not inject intravenously.

Even though studies in laboratory animals show no evidence of teratogenesis, abortion or influence on reproduction, the reproductive safety of ceftiofur has not been specifically investigated in pregnant sows or cows. Use only according to a benefit/risk assessment by the attending veterinary surgeon.

Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.

In the case of an allergic reaction the treatment should be withdrawn.

Inappropriate use of the product may increase the prevalence of bacteria resistant to cephalosporins.

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

Cattle

In cattle, mild inflammatory reactions at the injection site, such as tissue oedema and discolouration of the subcutaneous tissue and/or fascial surface of the muscle may be observed. Clinical resolution is reached in most animals by 10 days after injection although slight tissue discolouration may persist for 28 days or more. In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.

Pigs

In pigs, mild reactions at the injection site such as discolouration of the fascia or fat have been observed in some animals for up to 20 days after injection.

The low toxicity of ceftiofur has been demonstrated in swine using ceftiofur sodium at doses in excess of 8 times the recommended daily dose of ceftiofur administered intramuscularly for 15 consecutive days.

Withdrawal Periods

Animals must not be slaughtered for human consumption during treatment.

Milk

Zero days.

Milk for human consumption may be taken during and after last treatment.

Meat

Cattle may be slaughtered for human consumption only after 8 days from last treatment.

Pigs may be slaughtered for human consumption only after 5 days from last treatment.

Operator Warnings

Penicillins and cephalosporins may cause hypersensitivity (allergy) 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:

1.Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

2.Handle this product with great care to avoid exposure taking all recommended precautions.

3.If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Pharmaceutical precautions

Keep out of reach of children.

For animal treatment only.

Shake the bottle well before use to bring the product back into suspension. Do not store above 25°C. Following withdrawal of the first dose, use the product within 30 days. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Excenel RTU is supplied in 50 or 100 ml vials. Not all pack sizes may be marketed.

Further information

In case of acute post-partum metritis, additional supportive therapy might be required in some cases.

Marketing authorisation number

Vm 00057/4238.