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Removal of the indication for treatment of infections caused by E. coli in chickens and/or turkeys for veterinary medicinal products (VMPs) containing enrofloxacin that are administered via the drinking water.

Notice type: Advisory

Date: 04/07/2018

Following the opinion of the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA), the Health Products Regulatory Authority (HPRA) wishes to advise veterinary practitioners that the indication to treat infections caused by E. coli susceptible to enrofloxacin in chickens and/or turkeys is being removed from the Summary of Product Characteristics (SPCs) and product literature of VMPs that are administered via the drinking water and that have had the indication authorised up until now.

The following enrofloxacin-containing veterinary medicines that have been authorised by the HPRA are concerned:

Table 1: List of concerned VMPs including the name, veterinary product authorisation (VPA) number and marketing authorisation holder (MAH):

Name of VMP	VPA number	MAH
Baytril 10% oral solution	10021/022/001	Bayer Limited
Enrofloxacin Krka 100 mg/ml oral solution for chickens and turkeys	10774/024/001	KRKA, d.d., Novo mesto
ENRO-K 100 mg/ml Solution for use in drinking water	10786/001/001	Laboratorios Karizoo S.A.,
Enro-Sleecol 100 mg/ml oral solution for chickens and turkeys	10774/025/001	KRKA, d.d., Novo mesto
Enrotron 100 mg/ml solution for use in drinking water for chicken, turkeys and rabbits	10826/018/001	aniMedica GmbH
ENROX 100 MG/ML ORAL SOLUTION	10774/003/001	KRKA, d.d., Novo mesto
Floxamax 100 mg/ml concentrate for oral solution for chickens and turkeys	10790/002/001	SP Veterinaria, S.A.
KARIFLOX 100 mg/ml Oral Solution for Chickens and Turkeys	10786/002/001	Laboratorios Karizoo S.A.,
LANFLOX 100 mg/ml Solution for use in drinking water for chickens and turkeys	10516/004/001	Vetpharma Animal Health, S.L.
Solu-Flox 100 mg/ml Solution for use in drinking water	10990/047/001	Univet Limited
SPECTRON 100 mg/ml solution for use in drinking water for chickens and turkeys	10846/011/001	Laboratorios Hipra S.A.
Unisol 100 mg/ml Oral Solution for use in drinking water for chickens and turkeys	10516/003/001	Vetpharma Animal Health, S.L.

Product name or type:
Enrofloxacin-containing VMPs administered via the drinking water for use in chickens and/or turkeys

Reference:
n/a

Authorisation Number:
See Table 1 above.

Active Substance:
Enrofloxacin

Product Classification:
n/a

Manufacturer Or Supplier:
n/a

Serial Or Batch Number And Expiry Date:
n/a

Authorisation Holder:
See Table 1 above.

Prescription Required:
Yes

Recall Classification:
n/a

Target Audience:
Veterinary practitioners

Problem Or Issue:
The previous dosage of enrofloxacin for the treatment of E. coli infections when given in drinking water was deemed not sufficient to limit the emergence of resistant sub-populations. This is a concern because of the potential threat to animal health and possibly public health due to antimicrobial resistance. The CVMP considered that the indication for treatment of infections caused by E. coli susceptible to enrofloxacin in chickens and/or turkeys cannot remain in the product information with the currently-approved dose.

Background Information Or Related Documents:
The background to the decision is the opinion of the CVMP, which resulted from a follow-up assessment procedure of the dosage regimen aimed at limiting the development of resistance for the target pathogens. Having reviewed all relevant information the CVMP considered that the outstanding concern over optimisation of the dosage regimen for the treatment of E. coli infections was not resolved, and that the previously approved dosage regimen was not adequate and could accelerate the development of resistance to enrofloxacin.

Actions To Be Taken:

Veterinary practitioners should note that the indication for the treatment of infections caused by E. coli in chickens and/or turkeys is being removed from the SPCs and product literature of VMPs that contain enrofloxacin and that are administered via the drinking water to these target species. This action is being taken in order to limit the development of antimicrobial resistance.

Note that the indication for the treatment of mycoplasma in poultry for the relevant products remains.

Veterinary practitioners who consider it essential to treat infections caused by E. coli in chickens and/or turkeys with enrofloxacin that is administered via the drinking water must consider the requirements of the ‘cascade’ provision of the legislation before prescribing or using the products concerned.

Further Information:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicines_containing_enrofloxacin_to_be_administered_via_the_drinking_water_to_chickens_and/or_turkeys/vet_referral_000079.jsp&mid=WC0b01ac05805c5170

Commission decision (2014)1484 of 28/02/2014

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