SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovilis BVD (AT, BE, DK, EL, ES, FR, IR, IT, LU, NL, PL, PT, SI, SK, UK)

Bovilis BVD-MD (DE)

Suspension for Injection for Cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Per dose of 2 ml:

Active substance:

Inactivated antigen of cytopathogenic BVDV strain C-86,

containing 50 ELISA Units (EU) and inducing at least 4.6 log₂VN units*

*Mean virus neutralizing titre obtained in the potency test

Adjuvant:

Aluminium 3+ (as Al-phosphate and Al-hydroxide): 6-9 mg

Excipients:

Methyl parahydroxybenzoate: 3 mg (preservative)

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Suspension for injection

Red to pink-coloured turbid suspension

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (cows and heifers)

4.2 Indications for use, specifying the target species

For active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with BVDV.

4.3 Contra-indications

None

4.4 Special warnings for each target species

None

4.5 Special precaution for use

Vaccinate only healthy animals.

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

4.6 Adverse reactions (frequency and seriousness)

In very rare cases a slight swelling may be observed for 14 days at the site of injection. Also in very rare cases transient mild pyrexia may occur. In isolated cases, allergic reactions including anaphylactic shock may occur. In case of anaphylactical reactions, appropriate treatment such as with antihistamine, corticosteroid or adrenaline is recommended.

4.7 Use during pregnancy and lactation

Can be used during pregnancy.

4.8 Interaction with other vaccines and medicinal products when administered in combination with the product

Safety and efficacy data are available which demonstrate that for the 6-monthly re-vaccination -in cattle from 15 months of age onwards (i.e. those that have previously been vaccinated separately with Bovilis BVD and Bovilis IBR marker live) - this vaccine can be mixed and administered with Bovilis IBR marker live (in Member States where this veterinary medicinal product is authorised). The product literature of Bovilis IBR marker live should be consulted before administration of the mixed products. The adverse effects observed after administration of one dose or an overdose of the mixed vaccines are not different from those described for the vaccines administered separately.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.

4.9 Amounts to be administered and administration route

Before using the vaccine allow it to reach ambient temperature (15-25°C).

Shake well before use. Use sterile syringes and needles.

Intramuscular injection. 2 ml per animal.

All cattle can be vaccinated from an age of eight months onwards.

Foetal protection can be expected if the primary immunisation has been finalised 4 weeks before start of the gestation. Animals which are vaccinated later than 4 weeks before gestation or during the early gestation will not be protected against foetal infection.

Individual vaccination

Basic immunisation

Two vaccinations with an interval of 4 weeks. The second vaccination should be given not later then 4 weeks before the start of the gestation.

Revaccination

One vaccination 4 weeks before start of the next gestation.

Herd vaccination

Basic immunisation

Two vaccinations with an interval of 4 weeks. For use in cattle from eight months of age, all animals should be vaccinated.

Revaccination

One vaccination every 6 months.

For the 6-monthly revaccination, the vaccine may be used for reconstitution of Bovilis IBR marker live for use in cattle from 15 months of age (i.e. those that have previously been vaccinated separately with Bovilis BVD and Bovilis IBR marker live) and the following instructions should be used:

Bovilis IBR marker live Bovilis BVD

5 doses + 10 ml

10 doses + 20 ml

25 doses + 50 ml

50 doses + 100 ml

A single dose (2 ml) of Bovilis BVD mixed with Bovilis IBR marker live is given intramuscularly.

Visual appearance after reconstitution of Bovilis IBR marker live in Bovilis BVD:

As specified for Bovilis BVD alone.

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

Reactions after a double dose are not different from those after the single dose.

4.11 Withdrawal period

Zero days

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group:inactivated bovine viral diarrhea vaccine

ATC-vet code:QI02AA01

Bovilis BVD is an adjuvanted aqueous inactivated viral vaccine for active immunisation of cows and heifers against transplacental infection with Bovine Viral Diarrhoea virus.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aluminium phosphate

Aluminium hydroxide

Methylparahydroxybenzoate

Propylene glycol

Tromethamine

Tissue culture medium

Hydrochloric acid solution or tromethamine solution

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product, except with Bovilis IBR marker live (for 6-monthly revaccination only).

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months

Shelf life after first opening the immediate packaging: 10 hours

Shelf life after mixing with Bovilis IBR marker live: 3 hours (at room temperature)

6.4 Special precautions for storage

Store in a refrigerator (2 to 8°C). Do not freeze.

6.5 Nature and composition of immediate packaging

2 ml single dose or 10/20/50/100 or 250 ml multidose vial of glass, hydrolytical class Type I (Ph. Eur.) or polyethylene-terephthalate (PET) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such produts

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

Intervet International BV

Represented by:

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 06376/4025

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date:25 June 1999 / 26 November 2009

10. DATE OF REVISION OF THE TEXT

Date:March 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

The import, sale, supply and/or use of Bovilis BVD is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. Any person intending to import, sell, supply and/or use Bovilis BVD must consult the relevant Member State's competent authority on the current vaccination policies prior to import, sale, supply and/or use.

Approved: 09/05/2013