Following a European regulatory procedure to harmonise the withdrawal periods of certain veterinary medicinal products containing oxyclozanide, which is used mainly as a flukicide worm drench but is also indicated against certain tapeworms in ruminant animals, the withdrawal periods of the products concerned have been changed.
The following oxyclozanide containing veterinary medicines that have been authorised by the HPRA are concerned:
Zanil Fluke Drench (VPA 10996/262/001)
Rumenil 34 mg/ml oral suspension for cattle (VPA 10987/113/001)
Chanil 34 mg/ml oral suspension for cattle (VPA 10987/114/001)
Distocur 34 mg/ml oral suspension for cattle (VPA 10857/085/001)
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 variations to the terms of the marketing authorisations to the HPRA and these have been approved. Where cattle and/or sheep have been authorised as target species, the following revised withdrawal periods have been established for the products concerned:
Meat and offal: 13 days.
Milk: 108 hours (4.5 days).
Meat and offal: 14 days.
Milk: 7 days. Veterinary practitioners, pharmacists, licensed merchants and farmers should follow the amended withdrawal periods, in particular the increase in the milk withdrawal period to 108 hours (4.5 days), and apply them forthwith (even where the product labelling indicates otherwise). While 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 for the products concerned on the HPRA website (www.hpra.ie ), pending the availability of new stock with updated labelling reflecting the revised withdrawal periods for the products concerned.
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.