EXCEDE Sterile Suspension

Transcription

1 VIAL LABEL MAIN PANEL PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS FOR ANIMAL TREATMENT ONLY EXCEDE Sterile Suspension 200 mg/ml CEFTIOFUR as Ceftiofur Crystalline Free Acid For the treatment of bovine bacterial respiratory diseases caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni 100 ml VIAL LABEL SIDE PANEL Pfizer [logo] READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: Restraints ADMINISTER ONLY by injection in base of ear. DO NOT re-treat animals less than 28 days after the last injection. DO NOT USE for mass medication: for individual animal treatment only. DO NOT USE for the treatment of mastitis in dairy cattle. SHAKE WELL BEFORE USING Dose: 6.6mg/kg BW (3.3mL/100kg BW) as a single dose. WITHHOLDING PERIODS: MEAT: DO NOT USE less than 14 days before slaughter for human consumption. MILK: NIL DO NOT SLAUGHTER for export less than 14 days after treatment. Disposal: Refer leaflet APVMA 65092/50131 Store below 25 C (Air conditioning). Use within 28 days of initial broaching. Batch: Expiry: Pfizer Animal Health A division of Pfizer Australia Pty Ltd Pfizer trademark EXCEDE Sterile Suspension Text Label Version 1.0 Page 1 of 9

2 LEAFLET/INSERT PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS FOR ANIMAL TREATMENT ONLY EXCEDE Sterile Suspension For the treatment of bovine bacterial respiratory diseases caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. DESCRIPTION: EXCEDE Sterile Suspension is a ready-to-use formulation that contains the crystalline free acid form of ceftiofur, a broad spectrum cephalosporin antibiotic. Each ml of this ready-to-use sterile suspension contains ceftiofur crystalline free acid equivalent to 200mg ceftiofur. Pharmacology & Microbiology EXCEDE Sterile Suspension is a ready-to-use formulation that contains the crystalline free acid form of ceftiofur, which is a broad spectrum cephalosporin antibiotic active against grampositive and gram-negative bacteria including -lactamase-producing strains. Like other cephalosporins, ceftiofur is bacteriocidal, in vitro, resulting in inhibition of cell wall synthesis. Studies with ceftiofur have demonstrated in vitro and in vivo activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the three major pathogenic bacteria associated with bovine respiratory disease (BRD). DIRECTIONS FOR USE: Restraints ADMINISTER ONLY by injection in base of ear. DO NOT re-treat animals less than 28 days after the last injection DO NOT USE for mass medication: for individual animal treatment only. DO NOT USE for the treatment of mastitis in dairy cattle. Discard contents within 28 days of initial vial broaching. Prudent Use: Indiscriminate use of ceftiofur can contribute to the development of antibiotic resistance. Culture and sensitivity tests should be performed when appropriate to determine susceptibility of the causative organism(s). Empirical therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. Dosage SHAKE WELL BEFORE USING Administer one dose as a single subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) to cattle at a dosage of 6.6mg/kg body weight (3.3mL per 100 kg body weight). EXCEDE Sterile Suspension Text Label Version 1.0 Page 2 of 9

3 Most animals will respond to treatment within three to five days. If no improvement is observed, the diagnosis should be re-evaluated. Administration Technique Base of the Ear Hold the syringe and needle behind the ear so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the animal s opposite eye. See Figures 1 and 2. Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head (base of the ear) while maintaining this angle. See Figure 1. Deliver the entire contents of the syringe. Figure 1: Subcutaneous administration of EXCEDE Sterile Suspension at the posterior aspect of the ear where it attached to the head (base of the ear). Figure 2: Injection location for the subcutaneous administration of EXCEDE Sterile Suspension at the posterior aspect of the ear where it attaches to the head (base of the ear). GENERAL INSTRUCTIONS: Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route or disease may result in the need to extend the approved withholding period. Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions in sensitised individuals. To minimise the possibility of such a reaction, users of such antimicrobial products, including EXCEDE Sterile Suspension, are advised to avoid direct contact of the product with the skin and mucous membranes. EXCEDE Sterile Suspension Text Label Version 1.0 Page 3 of 9

4 As with all drugs, the use of EXCEDE Sterile Suspension is contra-indicated in animals previously found to be hypersensitive to the drug. WITHHOLDING PERIODS MEAT: DO NOT USE less than 14 days before slaughter for human consumption. Calves born to cows that were treated during pregnancy must not be slaughtered for human consumption for 14 days after treatment of the dam. MILK: Milk may be collected or processed for human consumption at any time after treatment. DO NOT SLAUGHTER for export less than 14 days after treatment. Calves born to cows that were treated during pregnancy must not be slaughtered for export for 14 days after treatment of the dam. CLINICAL PHARMACOLOGY Ceftiofur administered as ceftiofur crystalline free acid (EXCEDE Sterile Suspension) is metabolised rapidly to desfuroylceftiofur, the primary metabolite. Pharmacokinetic studies in lactating dairy cattle and beef cattle demonstrate that subcutaneous administration at the base of the ear of ceftiofur as ceftiofur crystalline free acid, provides therapeutic concentrations of ceftiofur and desfuroylceftiofur-related metabolites in plasma above the MIC 90 for the bovine respiratory disease (BRD) label pathogens, Pasteurella multocida, Mannheimia (Pasteurellla) haemolytica and Histophilus somni (Haemophilus somnus), for generally not less than 150 hours after a single administration (See Table 1 and Figure 3). Table 1: Pharmacokinetic parameters measured after a single SC administration of 6.6mg/kg bodyweight (BW) of EXCEDE Sterile Suspension in the base of the ear. Pharmacokinetic Parameter Beef- Base of the Ear Mean Value ± Standard Deviation Dairy - Base of the Ear Mean Value C max ( g/ml) 6.39 ± t max (h) 19.8 ± 5.81 AUC 0-LOQ ( g h/ml) 412 ± t 1/2 (h) 40.7 ± 11.2 C max ( g/ml) = maximum plasma concentration (in g/ml) AUC 0-LOQ ( g h/ml) = the area under the plasma concentration vs. time curve from the time of injection to the limit of quantification of the assay (0.15 g/ml) t 1/2 (h) = terminal phase biologic half life (in hours) Figure 3: Average plasma concentrations of ceftiofur and desfuroylceftiofur-related metabolites after administration of EXCEDE Sterile Suspension at 6.6mg/kg via subcutaneous injection of the ear base in beef and lactating dairy cattle. EXCEDE Sterile Suspension Text Label Version 1.0 Page 4 of 9

5 Note: MOE graph and key to be deleted. CLINICAL EFFECTIVENESS A field dose confirmation study for the treatment of BRD evaluated the effectiveness of a negative control, 4.4 mg/kg and 6.6 mg/kg EXCEDE Sterile Suspension, for the treatment of the bacterial component of BRD under field conditions. The 6.6 mg/kg EXCEDE Sterile Suspension dose significantly (p 0.05) increased day 14 treatment success rate (70.4%), defined as animals that did not require any ancillary treatment and had a rectal temperature of < 40 o C, normal respiration index, and had no or mild depression on that day. ANIMAL SAFETY The local tolerance of the ear to a single injection at the base of the ear of EXCEDE Sterile Suspension was evaluated in a large multi-location field study in both dairy and beef cattle. It was concluded that administration of EXCEDE Sterile Suspension at this site was acceptable in dairy and beef cattle. A transient injection site swelling and tissue irritation can be expected, with the majority (>95%) of swellings resolved by 4 weeks post-injection. SAFETY DIRECTIONS Repeated exposure may cause allergic disorders. Avoid contact with eyes and skin. Wash hands after use. General Safety Precautions May cause allergy. While this product is well tolerated by cattle, there is a risk of severe injury to humans associated with accidental self-injection. Care should therefore be taken to avoid accidental self-injection and needle stick injury when administering the product. In the event of accidental self-injection, seek medical advice immediately. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre Phone Additional information is in the Material Safety Data Sheet. DISPOSAL Dispose of empty containers by wrapping with paper and putting in garbage. STORAGE Store below 25 C (Air conditioning). Discard unused contents within 28 days of initial vial broaching. EXCEDE Sterile Suspension Text Label Version 1.0 Page 5 of 9

6 Made in USA Pfizer Animal Health A division of Pfizer Australia Pty Ltd Wharf Road West Ryde. NSW 2114 Pfizer trademark. APVMA Approval Number 65092/50131 EXCEDE Sterile Suspension Text Label Version 1.0 Page 6 of 9

7 MAIN PANEL PRESCRIPTION ANIMAL REMEDY READ SAFETY DIRECTIONS KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY EXCEDE Sterile Suspension 200 mg/ml CEFTIOFUR as Ceftiofur Crystalline Free Acid For the treatment of bovine bacterial respiratory diseases caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. 1 x 100 ml vial RIGHT SIDE PANEL READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: Restraints: ADMINISTER ONLY by injection in base of ear. DO NOT re-treat animals less than 28 days after the last injection DO NOT USE for mass medication: for individual animal treatment only. DO NOT USE for the treatment of mastitis in dairy cattle. SHAKE WELL BEFORE USE Pfizer [logo] Administer one dose as a single subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) to cattle at a dosage of 6.6mg/kg body weight (3.3mL per 100 kg body weight). Most animals will respond to treatment within three to five days. If no improvement is observed, the diagnosis should be re-evaluated. WITHHOLDING PERIODS: MEAT: DO NOT USE less than 14 days before slaughter for human consumption. Calves born to cows that were treated during pregnancy must not be slaughtered for human consumption or export for 14 days after treatment of the dam. MILK: Milk may be collected or processed for human consumption at any time after treatment. DO NOT SLAUGHTER for export less than 14 days after treatment. EXCEDE Sterile Suspension Text Label Version 1.0 Page 7 of 9

8 BACK PANEL GENERAL INSTRUCTIONS: Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route or disease may result in the need to extend the approved withholding period. Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions in sensitised individuals. To minimise the possibility of such a reaction, users of such antimicrobial products, including EXCEDE Sterile Suspension, are advised to avoid direct contact of the product with the skin and mucous membranes. As with all drugs, the use of EXCEDE Sterile Suspension is contra-indicated in animals previously found to be hypersensitive to the drug. General Safety Precautions May cause allergy. While this product is well tolerated by cattle, there is a risk of severe injury to humans associated with accidental self-injection. Care should therefore be taken to avoid accidental self-injection and needle stick injury when administering the product. In the event of accidental self-injection, seek medical advice immediately. Pfizer [logo] EXCEDE Sterile Suspension Text Label Version 1.0 Page 8 of 9

9 LEFT SIDE PANEL SAFETY DIRECTIONS Repeated exposure may cause allergic disorders. Avoid contact with eyes and skin. Wash hands after use FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre Phone DISPOSAL Dispose of empty container by wrapping with paper and putting in garbage. APVMA Approval No /50131 EAN: Made in USA Pfizer Animal Health A division of Pfizer Australia Pty Ltd Wharf Road, West Ryde NSW Pfizer trademark TOP FLAP (LID) 1 x 100 ml vial EXCEDE Sterile Suspension Store below 25 C (Air conditioning). Use within 28 days of initial broaching. Batch: Expiry: EXCEDE Sterile Suspension Text Label Version 1.0 Page 9 of 9