Eravac (Inactivated rabbit haemorrhagic disease...) – Summary of product characteristics - QI08AA01
Updated on site: 09-Feb-2018
|Toimeaine:||Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2)|
|Tootja:||Laboratorios Hipra, S.A.|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
ERAVAC emulsion for injection for rabbits.
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.5 ml contains:
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2),
(*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
For the full list of excipients, see section 6.1.
Emulsion for injection.
4.2Indications for use, specifying the target species
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).
Onset of immunity: 7 days.
Duration of immunity: has not been established.
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
4.4Special warnings for each target species
The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Vaccinate only fattening rabbits.
No information is available on the safety and efficacy in other categories such as breeding or pet rabbits.
4.5Special precautions for use
Special precautions for use in animals
Vaccinate only healthy rabbits.
Vaccination is recommended where RHDV2 is epidemiologically relevant.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, prompt, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
4.6Adverse reactions (frequency and seriousness)
Very common: a transient temperature increase slightly above 40 ºC might occur between two or three days following vaccination. This slight temperature increase resolves spontaneously without treatment by day 5
The frequency of adverse reactions is defined using the following convention:
4.7Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use during pregnancy or lactation.
4.8Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9Amounts to be administered and administration route
Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits at the age of 30 days by subcutaneous injection in the lateral thoracic wall.
Before use allow the vaccine to reach room temperature.
Shake well before administration.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No available data.
4.11 Withdrawal period(s)
Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
ATCvet code: QI08AA
To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
On the basis of serological data, antibodies are present at 21 days post vaccination.
6.1List of excipients
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Water for injections
Do not mix with any other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: Use immediately.
6.4.Special precautions for storage
Store and transport refrigerated (2
Do not freeze.
Keep the bottle in the outer carton in order to protect from light.
6.5Nature and composition of immediate packaging
Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses). The vials are closed with a rubber stopper and aluminium cap.
Cardboard box of 10 glass vials of 1 dose (0.5 ml).Cardboard box of 1 glass vial of 10 doses (5 ml). Cardboard box of 1 glass vial of 40 doses (20 ml).
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
Laboratorios Hipra S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN
Tel. +34 972 430660 Fax +34 972 430661
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 22 September 2016
10 DATE OF REVISION OF THE TEXT
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE