Excenel Sterile Powder

Excenel Sterile Powder for Injection is a broad spectrum antibiotic for the treatment of bovine footrot and treatment of respiratory infections in cattle, pigs and horses.
Excenel Sterile Powder for Injection contains the sodium salt of ceftiofur which is a broad-spectrum cephalosporin antibiotic active against gram-positive and gram-negative bacteria including ß-lactamase producing strains.  Like other cephalosporins, ceftiofur is anti-bacterial in vitro with this action resulting from inhibition of cell wall synthesis.

Approved uses/Indications
Ceftiofur sodium has demonstrated excellent in vitro and in vivo activity against Fusobacterium necrophorum and Bacteroides melaninogenicus the two major pathogens associated with bovine foot rot.
Ceftiofur sodium has also demonstrated excellent in vitro and in vivo activity against Pasteurella hemolytica and P. multocida, two of the major pathogenic bacteria associated with bovine respiratory disease (BRD).
Ceftiofur has demonstrated excellent in vitro and in vivo activity against gram-negative pathogens such as Actinobacillus (Haemophilus) pleuropneumoniae, Salmonella choleraesuis, Pasteurella multocida and the gram-positive pathogen Streptococcus suis, all of which singly or in combination can be associated with swine bacterial respiratory disease (swine-bacterial pneumonia).
Ceftiofur has demonstrated excellent in vitro and in vivo activity against respiratory pathogens of horse.  The drug was very active in vitro against Streptococcus zooepidemicus, S equi, Streptococcus spp, Staphylococcus spp, and Pasteurella spp isolated from patients with infections.
Key Features
Nil milk withhold:  Excenel is a unique antibiotic that binds to large proteins in the cows’ blood as it is transported around the body.  These proteins are too large to pass into the udder so there’s no risk of milk contamination – which means there’s no need to withhold the treated cows’ milk.
Efficacious: 
• In a clinical trial determining the effectiveness of Excenel in the treatment of interdigital necrobacillosis (footrot) in cattle, 92% of cows were successfully cured1. 
• In the treatment of bovine respiratory disease (BRD) in calves, Excenel (100% cure rate) was better than oxytetracycline (80% cure rate) and amoxicillin (91.7% cure rate)2.
Well tolerated: 
• Results from a five-day tolerance study in normal calves of 182-316kg body weight indicated that formulated ceftiofur sodium was well tolerated at over 50 times (55mg/kg/day) the recommended dose of 1.0 mg/kg/day for five consecutive days3.
• Results from a five-day tolerance study in normal feeder pigs indicated that formulated ceftiofur was well tolerated when administered at 25mg/kg (more than 8 times the recommended daily dosage of 3.0mg/kg of body weight) for five consecutive days.  Ceftiofur sodium administered intramuscularly to pigs produced no overt adverse signs of toxicity3.

Dosage & Administration
Reconstitute by adding 80ml Bacteriostatic water or sterile water for injection.  Rapid addition of diluent maintained at room temperature will give the best results.  A sterile needle and syringe should be used for each injection.  Administer reconstituted powder by intramuscular injection in the anterior half of the neck.  Before injecting the solution, pull back gently on the plunger.  If blood appears in the syringe, a blood vessel has been entered; withdraw the needle and select a different site.  No more than 10ml solution should be injected per site.
Cattle:  1.0 mg ceftiofur/kg bodyweight (ie. 1mL/50kg). Treatment should be repeated every 24 hours for a total of 3 treatments.  Treatments may be given on days 4 and 5 for animals that do not show a satisfactory response (not recovered) after the initial 3 treatments.
Pigs:  3.0 mg ceftiofur/kg bodyweight (ie. 1mL/16kg). Treatment should be repeated every 24 hours for a total of 3 treatments.
Horses:  2.0 mg ceftiofur/kg bodyweight (ie. 1mL/25kg). Treatment should be repeated every 24 hours.  Treatments should continue for 48 hours after symptoms have disappeared.  If no response is observed in 3–5 days, the diagnosis should be re-evaluated.

Storage:

store un-reconstituted product under 25°C.  Store reconstituted product in a refrigerator at 2–8°C for up to 7 days, at room temperature (below 30°C) for up to 12 hours, or frozen for up to 8 weeks.  Do not thaw reconstituted product more than once.  Protect from light.

Precautions
Beta lactam antibiotics such as penicillins and cephalosporins may cause allergic responses in sensitive individuals.  All such individuals should avoid direct contact of Excenel with skin and mucous membranes.
No meat or milk withholding period is required when the product is used according to label directions.  Use of doses in excess of those recommended on the label may result in illegal drug residues in edible tissues.
Not for use in bobby calves.

Packaging
Excenel is a sterile powder containing 4g ceftiofur sodium. 
Excenel is available as a carton of 6 x 4g vials with sterile diluent.