Actions To Be Taken:
In accordance with the applicable legislation, in order to change the withdrawal periods for the product concerned to be in line with the outcome of the EU referral procedure, the marketing authorisation holder for the product involved has submitted a variation to amend the terms of the marketing authorisation to the HPRA and this has been approved. The following revised withdrawal periods have been established for Genta 50 mg/ml solution for injection:
Due to accumulation of gentamicin in liver, kidneys and injection site, any repeated course of treatment during the withdrawal period must be avoided.
Meat and offal: 214 days.
Milk: 7 days.
Veterinary practitioner should advise farmers of the increased withdrawal periods and apply them forthwith (even where the product labelling indicates otherwise). Even if it is the case that this is NOT a consumer safety issue (but rather a harmonisation of withdrawal periods), the HPRA considers that users of veterinary medicinal products should follow the conditions of the marketing authorisation as set out on the HPRA website www.hpra.ie
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.