Continuing to deliver new innovations, Pfizer Animal Health recently received FDA approval for the use of EXCEDE®
(ceftiofur crystalline free acid) Sterile Suspension in lactating dairy cattle for the treatment of Bovine Respiratory
Disease (BRD) and also for a new location of subcutaneous injection, the posterior aspect of the ear where it attached
to the head (base of ear/ BOE) in beef and non-lactating cattle.
Click the links below to view printable charts of the new withdrawal times:
Dairy Anti-Infective Product Pre-Slaughter Withdrawal Periods and Milk
Discards - In English - jpeg file
Dairy Anti-Infective Product Pre-Slaughter Withdrawal Periods and Milk
Discards - In Spanish - jpeg file
Beef Anti-Infective Pre-Slaughter Withdrawal Periods - In
English - jpeg file
Beef Anti-Infective Pre-Slaughter Withdrawal Periods - In
Spanish - jpeg file
New Pre-Slaughter Withdrawal Periods for NAXCEL, EXCENEL RTU, EXCEDE, SPECTRAMAST DC & SPECTRAMAST LC
With the introduction of the base of ear site of administration for EXCEDE, it is important to note that the
pre-slaughter withdrawal periods for brands containing ceftiofur have been changed because a new kidney tolerance was
established by the FDA.
New Pre-Slaughter Withdrawal Periods
|
| EXCEDE® (ceftiofur crystalline free acid) Sterile Suspension |
13 days |
| EXCENEL® RTU (ceftiofur hydrochloride) Sterile Suspension |
3 days |
| NAXCEL® (ceftiofur sodium) Sterile Powder |
4 days |
| SPECTRAMAST® DC (ceftiofur hydrochloride) Sterile Suspension |
16 days |
| SPECTRAMAST® LC (ceftiofur hydrochloride) Sterile Suspension |
2 days |
As always, your veterinarian is your most valuable resource for information and advice about prescription products. Your
veterinarian is aware of the new pre-slaughter withdrawal periods and if necessary, can help you update treatment
protocols to incorporate the new withdrawal periods into your health management programs.
Why the Pre-Slaughter Withdrawal Periods are Changing
Injection site concentrations of ceftiofur and ceftiofur-related residues determine the pre-slaughter withdrawal time. By
law, injection sites cannot be monitored for residue because they cannot easily be identified at slaughter. The kidney is
the tissue that is monitored for ceftiofur and ceftiofur-related residues at slaughter. Therefore, the concentration in
the kidneys of injected animals was correlated to the concentration at the injection site at the time when the
concentration at the injection sites was safe. Ceftiofur residues at the injection site were below the research tolerance
by 13 days after administration of one 6.6 mg/kg body weight dose and the corresponding kidney tolerance was set at 0.4
ppm. Therefore, the pre-slaughter withdrawal for EXCEDE is 13 days. The new kidney tolerance of 0.4 ppm applies to all
ceftiofur brands, including NAXCEL, EXCENEL RTU, SPECTRAMAST DC and SPECTRAMAST LC. The net impact is an increase in the
withdrawal times for each of these brands.
The change in pre-slaughter withdrawal periods is not a result of residue or food safety concerns with previously approved
ceftiofur brands. The safety of ceftiofur is well established. The pre-slaughter withdrawal periods have changed to
accommodate the new base of ear site of administration for EXCEDE. The new pre-slaughter withdrawal periods are effective
immediately.
Advantages for Dairy Producers
EXCEDE provides dairy producers with a progressive approach to treating pneumonia in lactating dairy cows, offering
extended therapy in a single dose, ensured compliance for anti-infective treatment protocol and zero-day milk discard.
EXCEDE ensures proper dose and duration for optimum therapeutic effect, enhances the ability to manage resources including
labor and cow movement, with no risk of bulk tank residues, thus increasing the overall herd health and profitability.
Administration of EXCEDE at base of ear is well-tolerated by cattle, is easily accommodated in dairy routines, and
contributes to better Beef Quality Assurance
Advantages for Beef Producers
Beef producers will now have the added flexibility of administering EXCEDE at the new base of ear site of administration,
as well as subcutaneously at the middle one-third of the posterior aspect of the ear.
These unique injection sites promote better beef quality. Base of ear administration provides a safe and convenient
alternative injection site and accommodates a larger volume of injection. Middle one-third of ear administration is a
management practice that contributes to the highest standard of Beef Quality Assurance.
Despite which injection site beef producers choose – base of the ear or middle-one third of the ear – EXCEDE provides seven
days of therapeutic blood concentrations with a single injection. This extended therapy creates a wider range of management
options for control and treatment of bovine respiratory disease in high-risk cattle.
IMPORTANT NOTE: Pfizer Animal Health pioneered the research and development that led to the first and only no milk discard
antibiotic for use in dairy cattle, and recognizes the significance of this key characteristic when using an anti-infective.
As such, the 0 milk discard feature will not change for NAXCEL and EXCENEL RTU, and in fact EXCEDE now carries the same
zero-day milk discard time. The milk discard periods for SPECTRAMAST LC and SPECTRAMAST DC are NOT changing.
|
|
|