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

PACKAGE LEAFLET FOR:

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 SUBSTANCE(S) 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.INDICATION(S)

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.CONTRAINDICATIONS

Do not use in case 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 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 leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Cattle

8.DOSAGE FOR EACH SPECIES, ROUTE(S) 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 WARNING(S)

Special 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.

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 occurred.

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

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 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.

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 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.

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.

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 carboard box.

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.

België/Belgique/Belgien

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm. V

SCS Boehringer Ingelheim Comm. V

Avenue Ariane/Arianelaan 16

Avenue Ariane/Arianelaan 16

1200 Bruxelles

1200 Bruxelles

Tel. : +32 (0) 2 773 33 11

BELGIUM

 

Tel. : +32 2 773 33 11

Република България

Magyarország

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Magyarországi Fióktelepe

Dr. Boehringer-Gasse 5-11

Lechner Ödön fasor 6.

1121 Виена

1095 Budapest

AUSTRIA

Tel: +36 1 299 8900

Tel. +43 1 80 105 0

 

Česká republika

Malta

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim Animal Health GmbH

Animal Health

Binger Str. 173

Dr. Boehringer-Gasse 5-11

55216 Ingelheim/Rhein

1121 Vídeň

GERMANY

AUSTRIA

Tel. +49 6132 77 6720

Tel. +43 1 80 105 0

 

Danmark

Nederland

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2100 København Ø

1817 MS Alkmaar

Tlf: +45-39 15 88 88

Tel: +31 (0) 72 566 2411

Deutschland

Norge

Boehringer Ingelheim Vetmedica GmbH

Boehringer Ingelheim Vetmedica A/S

Binger Str. 173

Billingstadsletta 30

55216 Ingelheim/Rhein

Postboks 155

Tel. +49-(0) 6132 77 92 888

1376 Billingstad

 

Tlf: +47-66 85 05 70

Eesti

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Animal Health

Dr. Boehringer-Gasse 5-11

Dr. Boehringer-Gasse 5-11

1121 Viin

1121 Wien

AUSTRIA

Tel. +43- (0) 1 80 105 0

Tel. +43 1 80 105 0

 

Ελλάδα

Polska

Boehringer Ingelheim Animal Health GmbH

Boehringer Ingelheim Sp.z o.o.

Binger Str. 173,

ul.Franciszka Klimczaka 1,

55216 Ingelheim/Rhein

02-797 Warszawa

GERMANY

Tel: +48- (0) 22 – 699 0 699

Tel. +49 6132 77 6720

 

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Portugal

Boehringer Ingelheim España, S.A.

Vetlima - Sociedade Distribuidora de Produtos

Prat de la Riba, 50

Agro-Pecuários, S.A.

08174 Sant Cugat del Vallès (Barcelona)

Centro Empresarial da Rainha, Lote 27

Tel: +34 93 404 51 00

2050-501 Vila Nova da Rainha

 

Tel: +351 - 263 406 570

France

România

Boehringer Ingelheim France

Boehringer Ingelheim RCV GmbH & Co KG

Division Santé Animale

Animal Health

12, rue André Huet

Dr. Boehringer-Gasse 5-11

51100 Reims

1121 Viena

Tél. : +33 03 26 50 47 50

AUSTRIA

Télécopie : +33 03 26 50 47 43

Tel. +43 1 80 105 0

infoveto@rei.boehringer-ingelheim.com

 

Ireland

Slovenija

Boehringer Ingelheim Limited,

Boehringer Ingelheim RCV GmbH & Co KG

Ellesfield Avenue,

Animal Health

Bracknell, Berkshire, RG12 8YS,

Dr. Boehringer-Gasse 5-11

UNITED KINGDOM

1121 Dunaj

Tel: +44 1344 424 600

AUSTRIA

 

Tel. +43 1 80 105 0

Ísland

Slovenská republika

Vistor hf.

Boehringer Ingelheim RCV GmbH & Co KG

Sími: +354- 535 7000

Animal Health

 

Dr. Boehringer-Gasse 5-11

 

1121 Viedeň

 

AUSTRIA

 

Tel. +43 1 80 105 0

Italia

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Boehringer Ingelheim Italia S.p.A.

Vetcare Oy

Via Lorenzini 8

PL/PB 99

20139 Milano

FI-24101 Salo

Tel: +39 02 5355 1

Puh/Tel: +358- (0) 20 144 3360

Κύπρος

Sverige

Boehringer Ingelheim Animal Health GmbH

Boehringer Ingelheim Vetmedica

Binger Str. 173,

Box 467

55216 Ingelheim/Rhein

SE-201 24 Malmö

GERMANY

Tel: +46- (0) 40 23 34 00

Tel. +49 6132 77 6720

 

Latvija

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Animal Health

Dr. Boehringer-Gasse 5-11

Dr. Boehringer-Gasse 5-11

1121 Vīne

1121 Viena

AUSTRIA

AUSTRIA

Tel. +43 1 80 105 0

Tel. +43 1 80 105 0

United Kingdom

Republika Hrvatska

Boehringer Ingelheim Limited,

Boehringer Ingelheim RCV GmbH & Co KG

Ellesfield Avenue,

Animal Health

Bracknell, Berkshire, RG12 8YS,

Dr. Boehringer-Gasse 5-11

Tel: +44- (0) 1344 424 600

1121 Beč

 

AUSTRIA

 

Tel. +43 1 80 105 0

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