Description of Reassessment: Registered veterinary medicines containing aminoglycosides, in combination with β lactam antibiotics or oral formulations, will be reassessed to ensure their registrations are in line with the following recommendations:
a) Evidence of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside.
b) Oral aminoglycosides, alone or in combinations, should not be used to treat non-specific enteric infections in groups of food producing animals. If used to treat gut infections, their selection should be confirmed by bacteriology and susceptibility testing.
New Information Prompting Reassessment Consideration:
In response to the recommendations from the report of the Antimicrobial Resistance Expert Panel, 30 August 2005 and the advice of the Antimicrobial Resistance Steering Group, NZFSA has agreed with the recommendations and is commencing a reassessment of veterinary medicines containing antimicrobials in the aminoglycoside class to ensure the registrations meet the recommendations of the expert panel.
Potential Outcome of Reassessment:
1. Potential Changes in conditions:
a. Use could be restricted to cases where aminoglycosides are confirmed to be the appropriate choice of antibiotic.
b. A requirement to report use to the ACVM Group could be imposed.
2. Potential Changes to Label Content:
a. Information to convey a condition such as in 1. may be required.
3. Potential Changes to Formulation:
a. For some products there may be a requirement to remove the aminoglycoside component of the formulation
4. Other Potential Changes:
a. It may be necessary for registration of some products to be discontinued.
Timeframe: The initial step of reassessment is gazetting of these products, which occurred on Thursday 7th May 2009. The notification period is for 40 working days and will allow any person to make a submission on the intended reassessments. The formal reassessment will commence on the first of July and will take the standard timeframe of 40 working days.
For further information on the reassessment, contact Lucy Johnston, Advisor (ACVM Standards-Animals). Email: firstname.lastname@example.org
Last updated 7th May 2009