Bovela (modified live bovine viral diarrhoea...) – Package leaflet - QI02AD02

Updated on site: 08-Feb-2018

Medication name: Bovela
ATC: QI02AD02
Substance: modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93
Manufacturer: Boehringer Ingelheim Vetmedica GmbH

PACKAGE LEAFLET:

Bovela lyophilisate and solvent for suspension for injection for cattle

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: Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein GERMANY

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovela lyophilisate and solvent for suspension for injection for cattle

3.STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Each dose (2 ml) contains:

Lyophilisate:

Modified live BVDV*-1, non-cytopathic parent strain KE-9: 104.0–106.0 TCID50**, Modified live BVDV*-2, non-cytopathic parent strain NY-93: 104.0–106.0 TCID50**.

*Bovine viral diarrhoea virus

**Tissue culture infectious dose 50%

Lyophilisate: Off-white colour without foreign matter.

Solvent: Clear, colourless solution.

4.INDICATIONS

For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2.

For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection.

Onset of immunity:

3 weeks after immunisation.

Duration of immunity:

1 year.

5.CONTRAINDICATION

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

6.ADVERSE REACTIONS

Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination.

An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours.

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

-very common (more than 1 in 10 animals treated displaying adverse reactions)

-common (more than 1 but less than 10 animals in 100 animals treated)

-uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

-rare (more than 1 but less than 10 animals in 10,000 animals treated)

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

If you notice any side effects, even those not already listed in this package leaflet or think that the medicine has not worked, please inform your veterinary surgeon.

7.TARGET SPECIES

Cattle

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

Intramuscular use.

Primary vaccination:

After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection.

It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception. Animals which are vaccinated later than 3 weeks before gestation or during the early gestation may not be protected against foetal infection. This should be considered in case of herd vaccination.

Recommended re-vaccination programme: Revaccination is recommended after 1 year.

12 months after primary vaccination most studied animals still had antibody titres at plateau while some animals had lower titres.

9.ADVICE ON CORRECT ADMINISTRATION

Preparation of vaccine for use (reconstitution):

Reconstitute the lyophilisate by adding the full content of the solvent at room temperature. Ensure that the lyophilisate is completely reconstituted before use.

The reconstituted vaccine is transparent and colourless. Avoid multiple broaching.

10.WITHDRAWAL PERIOD

Withdrawal period: 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.

Keep the vials in the outer carton.

Shelf life after reconstitution: 8 hours.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after the abbreviation EXP.

12.SPECIAL WARNINGS

Special warnings for each target species: Vaccinate healthy animals only.

To ensure the protection of animals introduced to the herd where BVDV is circulating, vaccination has to be completed 3 weeks before introduction.

The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals. A definitive diagnosis of persistent infection can only be established upon re-testing in blood after an interval of at least 3 weeks. In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests. Additional laboratory tests to differentiate vaccine strain virus from field strain are available.

The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed.

Special precautions for use in animals:

Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study). This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy was observed in studies.

Shedding of the vaccine virus by body fluids cannot be excluded.

The vaccine strains are able to infect sheep and swine when administered intranasally, but no adverse reactions or spreading to in-contact animals occurred.

The vaccine has not been tested in breeding bulls and should therefore not be used in breeding bulls.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Pregnancy and lactation:

It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus. While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur.. Therefore, use during pregnancy should only be on a case-by-case basis decided by the responsible veterinarian, taking into consideration e.g. the BVD immunological status of the animal, the time-span between vaccination and mating/insemination, the stage of pregnancy and the risk of infection.

Can be used during lactation.

Studies have shown that vaccine virus may be excreted in milk up to 23 days after vaccination at low amounts (~ 10 TCID50/ml), although when such milk was fed to calves, no seroconversion occurred in those calves.

Interactions with other medical 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):

Mild swellings or nodules up to 3 cm diameter were observed at the injection site after administration of a 10-fold overdose and disappeared within 4 days post vaccination.

Furthermore, a increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section “Adverse reactions”).

Incompatibilities:

Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.

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

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

The vaccine is designed to stimulate the development of an active immune response against BVDV-1 and BVDV-2 in cattle.

Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.

Package sizes:

1, 4, 6 or 10 lyophilisate vials 5 doses, 10 doses, 25 doses or 50 doses and 1, 4, 6 or 10 solvent bottles containing 10 ml, 20 ml, 50 ml or 100 ml respectively in cardboard box.

Not all pack sizes may be marketed.

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