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Gentamicin containing products presented as solutions for injection to be administered to cattle and pigs – changes to the withdrawal periods

Notice type: Advisory

Date: 19/01/2018

  

Product name or type:
The following gentamicin containing veterinary medicine that has been authorised by the HPRA is concerned: Genta 50 mg/ml solution for injection

Reference:
The change to the withdrawal periods for the product concerned has arisen as a result of the outcome of a European Procedure undertaken by the European Medicines Agency.

Authorisation Number:
VPA10981/011/001

Active Substance:
Gentamicin     

Product Classification:
The product concerned is supplied in Ireland under the ‘Prescription only medicine’ (POM) category.

Authorisation Holder:
Kela n.v.

Prescription Required:
Yes

Target Audience:
Veterinary practitioners, pharmacists, farmers.

Problem Or Issue:
Following a European regulatory procedure to harmonise the withdrawal periods of certain veterinary medicinal products containing gentamicin presented as solutions for injection for cattle and pigs, the withdrawal periods of the products concerned have been changed.

The European Medicines Agency (EMA) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) of the concerned products containing gentamicin. Following the EMA review the European Commission issued a binding decision on 27 February 2017 directing that the withdrawal periods of the products be changed. The product labelling of the product concerned has been updated. However, there are likely to be existing stocks of the product concerned with the old withdrawal periods indicated.

Background Information Or Related Documents:

Withdrawal periods are established by the competent authorities for veterinary medicines in each Member State, based on the maximum residue limit established by the EMA for the relevant drug residues in meat and milk.

Such withdrawal periods are established in line with EU guidelines, which are updated periodically in line with scientific advances. The Belgian competent authority noted that there were different approved withdrawal periods for similar products across Member States and referred the matter to the EMA for harmonisation. 

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.

Further Information:
The changes above do not apply to gentamicin products intended for use in horses.

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