Eravac (Inactivated rabbit haemorrhagic disease...) – Package leaflet - QI08AA01

Updated on site: 21-Sep-2017

Nafn lyfs: Eravac
ATC: QI08AA01
Efni: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2)
Framleiðandi: Laboratorios Hipra, S.A.

PACKAGE LEAFLET:

ERAVAC emulsion for injection for rabbits

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135 17170 Amer (Girona) SPAIN

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

ERAVAC

Emulsion for injection for rabbits

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of 0.5 ml contains:

Active substance:

Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-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.

Whitish emulsion.

4.INDICATION(S)

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.

5.CONTRAINDICATIONS

Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

6.ADVERSE REACTIONS

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).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Rabbits

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Subcutaneous use.

Administer 1 dose (0.5 ml) to rabbits at the age of 30 days by subcutaneous injection in the lateral thoracic wall.

9.ADVICE ON CORRECT ADMINISTRATION

Before use allow the vaccine to reach room temperature.

Shake well before administration.

10.WITHDRAWAL PERIOD(S)

Zero days.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C – 8 °C).

Do not freeze.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Shelf life of the veterinary medicinal product as packaged for sale: 1 year

Shelf life after first opening the immediate packaging: Use immediately

12.SPECIAL WARNING(S)

Special 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 breeds or pet rabbits.

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 12hours 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.

Pregnancy and lactation:

Do not use during pregnancy and lactation

Interaction 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.

Overdose (symptoms, emergency procedures, antidotes):

No available data.

Incompatibilities:

Do not mix with any other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

15.OTHER INFORMATION

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.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

Österreich

België/Belgique/Belgien

HIPRA DEUTSCHLAND GmbH

HIPRA BENELUX NV

Münsterstraße 306

Adequat Business Center

40470 Düsseldorf

Brusselsesteenweg 159

DEUTSCHLAND

9090 Melle

e-mail: deutschland@hipra.com

e-mail: benelux@hipra.com

Deutschland

Ελλάδα

HIPRA DEUTSCHLAND GmbH

HIPRA EΛΛAΣ A.E.

Münsterstraße 306

Ψuχάρη 3 / 184 53 Níκαια

40470 Düsseldorf

Tηλ: 210 4978660 - Fax: 210 4978661

e-mail: deutschland@hipra.com

e-mail: greece@hipra.com

España

France

LABORATORIOS HIPRA, S.A.

HIPRA FRANCE

Avda. la Selva, 135

7 rue Roland Garros, Batiment H

17170 Amer (Girona)

44700 - Orvault

 

Tél. - 02 51 80 77 91 Fax - 02 51 8082 20

 

e-mail: france@hipra.com

Ireland

Italia

HIPRA UK AND IRELAND, Ltd.

Hipra Italia S.r.l.

Innovation Center

Via Rovato, 29

BioCity Nottingham

25030 Erbusco (BS)

Pennyfoot Street

e-mail: italia@hipra.com

Nottingham

 

NG1 1GF - UNITED KINGDOM

 

e-mail: ukandireland@hipra.com

 

Luxembourg

Netherland

HIPRA BENELUX NV

HIPRA BENELUX NV

Adequat Business Center

Adequat Business Center

Brusselsesteenweg 159

Brusselsesteenweg 159

9090 Melle

9090 Melle

BELGIUM

BELGIUM

e-mail: benelux@hipra.com

e-mail: benelux@hipra.com

Polska

Portugal

HIPRA POLSKA Sp.z.o.o.

ARBUSET, Produtos Farmacêuticos e Sanitários

Ul. Królowej Marysieńki, 9 - 1

De Uso Animal, Lda

02-954 – WARSZAWA

Portela de Mafra e Fontaínha - Abrunheira

e-mail: admin.polska@hipra.com

2665 – 191 Malveira

 

e-mail: portugal@hipra.com

United Kingdom

 

HIPRA UK AND IRELAND, Ltd.

 

Innovation Center

 

BioCity Nottingham

 

Pennyfoot Street

 

Nottingham

 

NG1 1GF

 

e-mail: ukandireland@hipra.com

 

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