Updated product information for Gentaject 10% Solution for Injection for Horses

Notice type: Advisory

Date: 09/07/2015

On 14 February 2014, Denmark presented to the European Medicines Agency (EMA) a referral notification under Article 35 of Directive 2001/82/EC, concerning veterinary medicinal products containing the antibiotic gentamicin presented as solutions for injection to be administered to horses.The issue was that the indications and dosages for the drug differed between Member States.The EMA was requested to harmonise the indications and dosing regimens of the concerned products, taking into account the available data, with particular attention to target animal safety.

Following the outcome of this referral procedure, the marketing authorisation of Gentaject 10% Solution for Injection for Horses was amended. Further scientific detail on the EMA assessment is available on the EMA website (link here).

Important changes: A number of amendments have been made to the marketing authorisation of the product in Ireland. In particular, the following important changes should be noted:

• the product is no longer authorised for administration using the intramuscular route
• the posology has been revised to a single dose of 6.6 mg/kg bodyweight given intravenously once daily for 3-5 consecutive days
• use of the product is no longer recommended in foals and neonates.

The marketing authorisation holder (Franklin Pharmaceuticals Ltd.) will be introducing updated product labelling and package insert in due course. However, in the meantime, veterinary practitioners and pharmacists should ensure that the updated Summary of Product Characteristics (available here) on the HPRA website) is referred to when prescribing or dispensing the product. All antibiotics are subject to prescription control. Users should take note of the contents of the amended marketing authorisation for the product.