Hiprabovis IBR marker live vaccine – Changes to precautions for use
25/07/2022
Medicines for animal use
Caution-in-use notification (CIUN)
Following an increase in the incidence of anaphylactic-type reactions in cattle after the use of the vaccine Hiprabovis IBR Marker Live in Italy and Spain, the precautions for use of the product are being strengthened to alert veterinarians and product users.
Problem or issue
Since early 2022, an increase in the incidence of anaphylactic-type reactions in cattle has been observed after the use of the vaccine Hiprabovis IBR Marker Live.
Within the period from 1 March 2022 to 31 May 2022, a total of 27 cases involving 175 animals that had an anaphylactic-type reaction, and 8 animals that have died, have been reported. In at least 5 of the animals that have died, the animals had anaphylactic-type reactions with a fatal outcome.
Most of the cases have been reported in specific geographic regions of Spain (19/27) and Italy (7/27). Within this period, more than 641,075 doses have been administered in 14 EU countries. This situation has not been observed in Ireland or in other EU countries where the vaccine is currently used.
A clear root cause has not been identified yet and investigations are ongoing. The product information is being updated on the frequency and severity of hypersensitivity / anaphylactic-type reactions.
Product information
- Active substance
- Live gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL
- Authorisation holder
- Laboratorios HIPRA, S.A Avda. La Selva 135 17170 Amer (Girona) Spain
- Authorisation number
- EU/2/10/114/001-003, Hiprabovis IBR Marker Live lyophilisate and solvent for suspension for injection for cattle
- Human or veterinary medicine
- Veterinary medicine
- Target audience
- Veterinary practitioners, pharmacists
Actions to be taken
The HPRA advises veterinary practitioners to follow the updated conditions of the relevant marketing authorisations, as set out above) pending the availability of new stock with updated labelling and package leaflet reflecting the changes outlined above.
In case an anaphylactic-type reaction occurs, an appropriate symptomatic treatment should be administered.
As with all veterinary medicines, any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.
Further Information:
The product information will be updated on the frequency of hypersensitivity reactions from ‘very rare’ to ‘rare’ and on their severity with the addition of anaphylaxis (sometimes fatal). As this is a centrally authorised veterinary medicinal product, further details will be made available on the EMA website; Hiprabovis IBR Marker Live | European Medicines Agency (europa.eu).