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.

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

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.

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. 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 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.

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.

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.

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

Do not use in poultry (including eggs) due to the risk of spread of antimicrobial resistance to humans.

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.

Excenel Sterile Powder selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, Excenel Sterile Powder should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis) to first line treatment.

Official, national and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of such resistance. Whenever possible, Excenel Sterile Powder should only be used based on susceptibility testing.

Excenel Sterile Powder is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use.

Cattle: meat: 1 day.

Milk: zero hours.

Pigs: meat: 2 days.

Horses: 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.

Care should be taken to avoid accidental self-injection. In the event of accidental self-injection, seek medical advice immediately.

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.

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

After reconstitution, product may be stored for 7 days at +2°C to +8°C, or for 12 hours when stored below 25°C.

Protect from light. The colour of the powder may vary from off-white to tan. The colour of the powder does not affect potency.

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

For animal treatment only.

Keep out of reach and sight of children.

Excenel Sterile Powder is supplied as 1 g vials or 4 g vials. Not all pack sizes may be marketed.

After recommended dose, therapeutic levels of ceftiofur are achieved within a few minutes and are maintained for at least 24 hours.

Vm 42058/4066