The Health Products Regulatory Authority (HPRA) wishes to advise that the withdrawal periods for meat and offal derived from cattle, pigs and sheep as well as milk produced from cows treated with the products identified below have been increased; the maximum injection volumes at each administration site have been restricted and the route of administration has been restricted to intramuscular use only in cattle, sheep and pigs.
These changes have been made following a review of the available residue data by the European Medicines Agency, in order to implement a harmonised withdrawal period for the products concerned throughout the EU.
Authorisation Holder:
The following products are concerned:
| Name of VMP | VPA number | MAH |
| Betamox LA 150 mg/ml Suspension for Injection | 22664/010/001 | Norbrook Laboratories (Ireland) Limited |
| Trymox LA 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs and Cats | 10990/051/001 | Univet Limited |
Problem Or Issue:
The German veterinary regulatory authority observed that the withdrawal periods for injectable formulations of the antibiotic amoxicillin differed amongst EU Member States and initiated a referral procedure to the European Medicines Agency on 16/07/2020.
Following the outcome of the EMA referral and the subsequent implementing decision by the European Commission on 12/10/2020, the withdrawal periods for Betamox LA 150 mg/ml Suspension for Injection and associated names, and generic products thereof, which contain the active substance amoxicillin trihydrate, have been harmonised throughout the European Union for cattle, sheep and pigs.
The injection volume per injection site has been restricted for cattle, sheep and pigs.
The route of administration for cattle, pigs and sheep is restricted to the intramuscular route.
Actions To Be Taken:
In accordance with the applicable legislation, in order to change the withdrawal periods for the products concerned to be in line with the outcome of the EU referral procedure, the marketing authorisation holders for the products involved have submitted a variation application to amend the terms of their marketing authorisations to the HPRA and this has now been approved.
The following revised withdrawal periods and method of administration have been established for both products:
Cattle
Meat and offal: 39 days
Milk: 108 hours (4.5 days)
Pigs
Meat and offal: 42 days
Sheep
Meat and offal: 29 days
Milk: Not authorised for use in sheep producing milk for human consumption.
In addition, the maximum injection volume has been restricted to 15 ml per injection site in cattle and 4 ml in sheep and pigs.
The route of administration for cattle, pigs and sheep is restricted to the intramuscular route.
The HPRA advises veterinary practitioners and users of these veterinary medicinal products to follow the updated conditions of the relevant marketing authorisations, as set out on the HPRA website (www.hpra.ie). New stock with updated labelling reflecting the revised withdrawal periods and method of administration for the products concerned will become available with the manufacture of new batches of the products concerned As with all veterinary medicines, any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form available at https://www.hpra.ie/homepage/about-us/report-an-issue/veterinary-medicines-adverse-reaction or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.