Eravac (Inactivated rabbit haemorrhagic disease...) – Package leaflet - QI08AA01
Updated on site: 09-Feb-2018
|Efni:||Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2)|
|Framleiðandi:||Laboratorios Hipra, S.A.|
- 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
- 2. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
- 4. INDICATION(S)
- 5. CONTRAINDICATIONS
- 6. ADVERSE REACTIONS
- 7. TARGET SPECIES
- 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
- 9. ADVICE ON CORRECT ADMINISTRATION
- 10. WITHDRAWAL PERIOD(S)
- 11. SPECIAL STORAGE PRECAUTIONS
- 12. SPECIAL WARNING(S)
- 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
- 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
- 15. OTHER INFORMATION
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
Emulsion for injection for rabbits
3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 0.5 ml contains:
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain
Mineral oil: 104.125 mg
Thiomersal: 0.05 mg
(*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
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.
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:
-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.
8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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.
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: 2 years
Shelf life after first opening the immediate packaging: Use immediately
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
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.
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)
Cardboard box of 10 glass vial 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.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
HIPRA DEUTSCHLAND GmbH
HIPRA EΛΛAΣ A.E.
Ψuχάρη 3 / 184 53 Níκαια
Tηλ: 210 4978660 - Fax: 210 4978661
LABORATORIOS HIPRA, S.A.
HIPRA POLSKA Sp.z.o.o.
Avda. la Selva, 135
Ul. Królowej Marysieńki, 9 - 1
17170 Amer (Girona)
ARBUSET, ProdutosFarmacêuticos e
7 rue Roland Garros, Batiment H
Sanitários De Uso Animal, Lda
44700 - Orvault
Portela de Mafra e Fontaínha - Abrunheira
Tél. - 02 51 80 77 91 Fax - 02 51 80 82 20
2665 – 191 Malveira
HIPRA UK AND IRELAND, Ltd.
HIPRA ITALIA, S.R.L.
Via Franciacorta, 74
25038, ROVATO (BS)
NG1 1GF - UNITED KINGDOM
HIPRA BENELUX NV
HIPRA UK AND IRELAND, Ltd.
Adequat Business Center
NG1 1GF - UNITED KINGDOM