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

Vials containing a powder for solution for injection. Vials contain either 1 g or 4 g ceftiofur as the sterile, freeze-dried sodium salt. Ceftiofur sodium is a white to beige, amorphous powder requiring reconstitution with Water for Injection. Each ml of reconstituted solution contains ceftiofur sodium equivalent to 50 mg ceftiofur.

Uses

Excenel contains ceftiofur which is a beta-lactamase resistant, broad spectrum, bactericidal cephalosporin antibiotic. The product is indicated for:

1.the treatment of cattle with acute respiratory disease in which Pasteurella haemolytica, Pasteurella multocida, Actinobacillus (Haemophilus) somnus or other sensitive bacterial pathogens of the respiratory tract are involved,

2.the treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which Fusobacterium necrophorum and Bacteroides melaninogenicus are involved. As with all antibiotic therapy, treatment of this condition with Excenel should be instituted as early as possible in order to provide maximum clinical effect.

3.the treatment of pigs with bacterial respiratory disease in which Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida and/or Streptococcus suis are involved,

4.the treatment of horses with bacterial respiratory disease in which Streptococcus spp. (including Streptococcus zooepidemicus and Streptococcus equi), Staphylococcus spp. and/or Pasteurella spp are involved.

Dosage and administration

Reconstitution

1 g vial. Reconstitute by adding 20 ml Water for Injection.

4 g vial. Reconstitute by adding 80 ml Water for Injection.

For ease of reconstitution use an 18 gauge needle. Rapid addition of diluent will give best results.

Dosage: Cattle

1 mg/kg bodyweight. This is equivalent to 1 ml of the reconstituted solution per 50 kg bodyweight. For respiratory disease, the dose should be given once daily at 24 hour intervals for 3 to 5 days in total. For foul in the foot, the dose should be given once daily at 24 hour intervals for 3 days in total.

Pigs

3 mg/kg bodyweight. This is equivalent to 1 ml of the reconstituted solution per 16 kg bodyweight. The dose should be given once daily at 24 hour intervals for 3 days in total.

If no response is seen within these periods, the diagnosis should be redetermined.

Horses

2 mg/kg bodyweight. This is equivalent to 2 ml of the reconstituted solution per 50 kg bodyweight. The dose should be given once daily at 24 hour intervals and continued for 48 hours after clinical signs have disappeared. A 10 day treatment period is usually adequate. A maximum of 10 ml solution should be administered per injection site. If no response is seen within 4–5 days, the diagnosis should be redetermined.

Administration

The intramuscular route only should be used in cattle, pigs and horses. In the pig, particular care must be taken to avoid injection into fat tissue. Normal aseptic injection techniques should be practiced.

Contra-indications, warnings, etc

The use of Excenel Sterile Powder is contra-indicated in animals previously found to be hypersensitive to ceftiofur.

The use of the product may cause occasional local discomfort upon injection but this is a transient effect.

The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhoea which could be fatal. If acute diarrhoea is observed, discontinue use of this antimicrobial and initiate appropriate therapy.

Milk withdrawal time

Zero hours.

Meat withdrawal time

Animals must not be slaughtered for human consumption during treatment. Cattle and pigs may be slaughtered for human consumption only after the following times from last treatment:

Cattle:	1 day
Pigs:	2 days

Not for use in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

Operator warnings

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

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

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

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 or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

Pharmaceutical precautions

Store unreconstituted product in a refrigerator (2°–8°C).

Store reconstituted product in a refrigerator (2°–8°C); any reconstituted product remaining 24 hours after preparation should be discarded.

Protect from light.

Any unused product or waste materials should be disposed with in accordance with national requirements.

For animal treatment only.

Keep out of reach of children.