Bovela (modified live bovine viral diarrhoea...) – Summary of product characteristics - QI02AD02

Updated on site: 21-Sep-2017

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

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovela lyophilisate and solvent for suspension for injection for cattle

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (2 ml) contains:

Lyophilisate:

Active substances:

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%

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection

Lyophilisate: Off-white colour without foreign matter.

Solvent: Clear, colourless solution.

4.CLINICAL PARTICULARS

4.1Target species

Cattle

4.2Indications for use, specifying the target species

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.

4.3Contraindications

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

4.4Special warnings for each target species

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

4.5Special precautions for use

Special precautions for use in animals: Vaccinate healthy animals only.

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 can not 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 has been demonstrated.

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.

4.6Adverse reactions (frequency and seriousness)

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 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

It is recommended to vaccinate before pregnancy to ensure protection againt 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 cannot be ruled out. 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.

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

Intramuscular use.

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.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section 4.6).

4.11 Withdrawal period(s)

Zero days.

5.IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for bovidae, live viral vaccines. ATCvet code: QI02AD02.

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

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Lyophilisate:

Sucrose

Gelatine

Potassium hydroxide

L-Glutamine acid

Potassium dihydrogen phosphate

Dipotassium phosphate

Sodium chloride

Water for injections

Solvent:

Sodium chloride

Potassium chloride

Potassium dihydrogen phosphate

Disodium hydrogen phosphate

Water for injections

6.2Incompatibilities

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

6.3Shelf life

Lyophilisate:

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Solvent:

Shelf life of the solvent:3 years. Shelf life after reconstitution according to directions: 8 hours.

6.4Special precautions for storage

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

Do not freeze.

Keep the lyophilisate and the solvent vials in the outer carton.

6.5Nature and composition of immediate packaging

Lyophilisate:

1, 4, 6 or 10 type I amber glass vials containing 5 doses (10 ml), 10 doses (20 ml), 25 doses (50 ml) and 50 doses (100 ml) of lyophilisate, closed with siliconised bromobutyl rubber stopper with lacquered aluminium seal.

Solvent:

1, 4, 6 or 10 high density polyethylene (HDPE) bottles containing 10 ml, 20 ml, 50 ml and 100 ml of solvent, closed with a siliconised chlorobutyl rubber stopper with lacquered aluminium seal.

Corresponding vials of vaccine and bottles of solvent are packed in cardboard boxes together.

Not all pack sizes may be marketed.

6.6Special 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 products should be disposed of in accordance with local requirements.

7.MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/14/176/001-016

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 22.12.2014

10.DATE OF REVISION OF THE TEXT

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

PROHIBITION OF SALE, SUPPLY AND/OR USE

The manufacture, import, possession, sale, supply and/or use of Bovela may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply and use Bovela must consult the relevant

Member State’s competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.

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