Eravac

For active immunisation of rabbits against Rabbit haemorrhagic disease type 2 virus (RHDV2)

For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2)

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About

An overview of Eravac and why it is authorised in the EU

Eravac is a veterinary vaccine used in rabbits to reduce death due to the rabbit haemorrhagic disease (RHD), a usually fatal disease caused by a new variant of RHD virus, called RHD type 2 virus, resulting in blood clot formation. RHD type 2 virus differs from the classic form of RHD virus since the course of disease is more prolonged, death occurs later and over a longer period and there are more deaths in young rabbits than in adults.

Eravac contains inactivated rabbit haemorrhagic disease type 2 virus, strain (V-1037), as the active substance.

How is Eravac used?

Eravac is available as an injection and can only be obtained with a prescription. The vaccine is given to rabbits from 30 days of age as a single injection under the skin of the side of the chest. Protection starts one week after vaccination and lasts nine months.

For further information, see the package leaflet.

How does Eravac work?

Eravac is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Eravac contains rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 which has been inactivated so it cannot cause the disease. When it is given to rabbits the immune system recognises the virus as ‘foreign’ and makes antibodies against it. In the future if rabbits are exposed to rabbit haemorrhagic disease type 2 virus, the immune system will be able to produce antibodies more quickly. This will help protect them against the disease.

Eravac contains an adjuvant (mineral oil) to enhance the immune response.

What benefits of Eravac have been shown in studies?

The effectiveness of the vaccine was compared with that of a placebo (dummy) vaccine in three laboratory studies involving 301 rabbits. After vaccination the rabbits were artificially infected with rabbit haemorrhagic disease type 2 virus. The studies showed the vaccine to be effective in reducing death. In one study all Eravac vaccinated rabbits survived compared with a 37% survival rate in the group that received the placebo vaccine. In the second study survival of Eravac vaccinated rabbits was 93% compared with 50% for rabbits given placebo. In the third study all Eravac vaccinated rabbits survived compared with less than 70% of the rabbits in the control group, when rabbits were artificially infected with rabbit haemorrhagic disease type 2 virus nine months after vaccination.

What are the risks associated with Eravac?

The most common side effects with Eravac (which may affect more than 1 in 10 rabbits) are a short-lived increase in body temperature to slightly above 40 ºC which may occur between two or three days following vaccination and nodules or swellings (less than 2 cm in size) at the injection site. The slight temperature increase resolves spontaneously without treatment within 5 days and the local reactions resolve spontaneously within 24 hours.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – this could result in the loss of the finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from rabbits treated with Eravac for is ‘zero’ days, which means there is no mandatory waiting time.

Why is Eravac approved in the EU?

The European Medicines Agency decided that Eravac’s benefits are greater than its risks and that it can be authorised for use in the EU.

Other information about Eravac?

Eravac received a marketing authorisation valid throughout the EU for Eravac on 22 September 2016.

Further information on Eravac can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.

Name Language First published Last updated
Eravac : EPAR - Medicine overview BG = bălgarski 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview ES = español 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview CS = čeština 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview DA = dansk 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview DE = Deutsch 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview ET = eesti keel 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview EL = elliniká 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview EN = English 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview FR = français 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview IT = italiano 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview LV = latviešu valoda 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview LT = lietuvių kalba 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview HU = magyar 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview MT = Malti 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview NL = Nederlands 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview PL = polski 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview PT = português 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview RO = română 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview SK = slovenčina 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview SL = slovenščina 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview FI = suomi 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview SV = svenska 2016-10-20 2018-04-18
Eravac : EPAR - Medicine overview HR = Hrvatski 2016-10-20 2018-04-18

This EPAR was last updated on 18/04/2018 .

Authorisation details

Product details

Product details for Eravac
NameEravac
Agency product numberEMEA/V/C/004239
Active substance

For active immunisation of rabbits against Rabbit haemorrhagic disease type 2 virus (RHDV2)

For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2)

International non-proprietary name (INN) or common name

Rabbit haemorrhagic disease vaccine (inactivated)

Species Rabbits
Anatomical therapeutic chemical veterinary (ATCvet) codes QI08AA
QI08AA01


Publication details

Publication details for Eravac
Marketing-authorisation holder

Laboratorios Hipra, S.A.

Revision3
Date of issue of marketing authorisation valid throughout the European Union22/09/2016

Contact address:

Laboratorios Hipra, S.A.
Avda. La Selva, 135
17170 Amer (Girona)
Spain

Product information

Product information

22/03/2018  Eravac -EMEA/V/C/004239 -II/003/G

Name Language First published Last updated
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - Product Information HR = Hrvatski 2016-10-20 2018-04-18

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18
Eravac : EPAR - All Authorised presentations HR = Hrvatski 2016-10-20 2018-04-18

Pharmacotherapeutic group

Immunologicals for Leporidae, inactivated viral vaccines for rabbits

Therapeutic indication

For active immunisation of rabbits against Rabbit haemorrhagic disease type 2 virus (RHDV2).

For active immunisation of fattening rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Eravac : EPAR - Public assessment report HR = Hrvatski 2016-10-20  
CVMP summary of positive opinion for Eravac HR = Hrvatski 2016-07-15