Eravac (Inactivated rabbit haemorrhagic disease...) – Summary of product characteristics - QI08AA01

Updated on site: 09-Feb-2018

Ravimi nimetus: Eravac
ATC: QI08AA01
Toimeaine: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2)
Tootja: Laboratorios Hipra, S.A.

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:

Active substance:

Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037……≥70% cELISA40*

Adjuvant:

 

Mineral oil

104.125 mg

Excipients:

 

Thiomersal

0.05 mg

(*) ≥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.

3.PHARMACEUTICAL FORM

Emulsion for injection.

Whitish emulsion.

4.CLINICAL PARTICULARS

4.1Target species

Rabbits

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.

4.3Contraindications

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 injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

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 post-vaccination.

The frequency of adverse reactions is defined using the following convention:

-very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

-common (more than 1 but less than 10 animals in 100 animals) -uncommon (more than 1 but less than 10 animals in 1,000 animals) -rare (more than 1 but less than 10 animals in 10,000 animals)

-very rare (less than 1 animal in 10,000 animals, including isolated reports).

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

Subcutaneous use.

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)

Zero days.

5.IMMUNOLOGICAL PROPERTIES

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.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Mineral oil

Thiomersal

Sorbitan mono-oleate

Polysorbate 80

Sodium chloride

Potassium chloride

Disodium phosphate dodecahydrate

Potassium dihydrogen phosphate

Water for injections

6.2Major incompatibilities

Do not mix with any other veterinary medicinal products.

6.3Shelf life

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 ºC–8 ºC).

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.

Pack sizes:

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 E-mail: hipra@hipra.com

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/199/001-003

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

Not applicable.

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