Bluevac BTV (previously known as Bluevac BTV8) - summary of medicine characteristics

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of vaccine contains:

Active substances:

Inactivated bluetongue virus (BTV)

One of the following inactivated bluetongue virus serotypes:

Adjuvants:

Excipients:

For the full list of excipients, see section 6.1.

The type of strain included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the label.

3. PHARMACEUTICAL FORM

Suspension for injection.

White or pinkish-white suspension.

4. CLINICAL PARTICULARS4.1 Target species

Sheep and cattle.

• 4.2 Indications for use, specifying the target species

Sheep

For active immunisation of sheep to prevent the viraemia* caused by bluetongue virus serotype 1 or 4 or 8) and to reduce clinical signs caused by bluetongue virus serotype 8

• * Below the level of detection by the validated RT-PCR method at 1 log10 TCID50/ml for serotypes 8 and 4, and 1.3 log10 TCID50/ml for serotype 1.

Onset of immunity:     21 days after completion of the primary vaccination scheme.

Duration of immunity: 1 year after completion of the primary vaccination scheme.

Cattle

For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotype 1 or 4 or 8.

• * Below the level of detection by the validated RT-PCR method at 1 log10 TCID50/ml for serotypes 8 and 4, and 1.3 log10 TCID50/ml for serotype 1.

Onset of immunity:    BTV, serotype 1: 28 days after completion of the primary vaccination scheme

BTV, serotype 4: 21 days after completion of the primary vaccination scheme BTV, serotype 8: 31 days after completion of the primary vaccination scheme

Duration of immunity: 1 year after completion of the primary vaccination scheme.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

Occasionally, the presence of maternally-derived antibodies in sheep of minimum recommended age might interfere with the protection induced by the vaccine.

No information is available on the use of the vaccine in cattle with maternally-derived antibodies.

If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in sheep and cattle.

• 4.5 Special precautions for use

Special precautions for use in animals

Not applicable.

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.

• 4.6 Adverse reactions (frequency and seriousness)

Sheep :

A transient increase in rectal temperature not exceeding 1°C is common. It lasts not longer than 24 to 72 hours.

Temporary local reactions at the injection site in the format of a normally painless nodule of 0.5 to 3 cm which decreases progressively over time occur very common.

Most local reactions disappear before 14 days, although some can persist after that time.

In very rare cases, loss of appetite can occur. Hypersensitivity reactions are very rarely observed.

Cattle :

A transient increase in rectal temperature is rare.

Temporary local reactions at the injection site in the format of a normally painless nodule of 0.5 to 5 cm which decreases progressively over time occur very common.

Most local reactions disappear before 21 days, although some can persist after that time.

In very rare cases, loss of appetite can occur. Hypersensitivity reactions are very rarely observed.

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

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – 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).

• 4.7 Use during pregnancy, lactation or lay

Pregnancy:

Can be used during pregnancy in ewes and cows.

Lactation:

There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.

Fertility:

The safety and efficacy of the vaccines has not been established in breeding males (sheep and cattle). In this category of animals, the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National Competent Authorities on the current vaccination policies against bluetongue virus (BTV).

4.8 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.

• 4.9 Amounts to be administered and administration route

Subcutaneous use.

Shake well before use. Avoid multiple vial broaching. Avoid introduction of contamination.

Primary vaccination

Sheep:

Sheep from 2.5 months of age :

For monovalent vaccine containing bluetongue virus serotype 1 or serotype 4 administer one dose of 2 ml subcutaneously.

For monovalent vaccine containing bluetongue virus serotype 8 administer two doses of 2 ml subcutaneously 3 weeks apart.

Cattle:

Cattle from 2 months of age :

Administer two doses of 4 ml subcutaneously 3–4 weeks apart.

Revaccination

An annual revaccination is recommended.

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

After the administration of a double dose, no adverse reactions other than those described in section 4.6 were observed.

• 4.11 Withdrawal period

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated bluetongue virus vaccines for sheep.

ATC vet code: QI04AA02.

BLUEVAC BTV stimulates active immunity of sheep and cattle against bluetongue virus serotype(s) related to those contained in the vaccine.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Aluminium hydroxide

Purified saponin (Quil A)

Thiomersal

Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal products.

6.3 Shelf life

Shelf life formulation with Bluetongue virus serotype 1: 18 months

Shelf life formulation with Bluetongue virus serotype 4 or 8: 2 years

Shelf life after first opening the immediate packaging: 10 hours

6.4. Special precautions for storage

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

Do not freeze.

Protect from light.

• 6.5 Nature and composition of immediate packaging

High density polyethylene (HDPE) bottles of 52 ml, 100 ml or 252 ml with bromobutyl stoppers and aluminium seals.

Package sizes:

Cardboard box with 1 bottle containing 52 ml.

Cardboard box with 1 bottle containing 100 ml

Cardboard box with 1 bottle containing 252 ml

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 products

7. MARKETING AUTHORISATION HOLDER

CZ Veterinaria, S.A.

La Relva s/n – Torneiros

36410 Porriño (Spain)

Tel.: + 34 986 33 04 00

Fax: + 34 986 33 65 77

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/11/122/001

EU/2/11/122/002

EU/2/11/122/003

EU/2/11/122/004

EU/2/11/122/005

EU/2/11/122/006

EU/2/11/122/007

EU/2/11/122/008

EU/2/11/122/009

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14/04/2011

Date of last renewal: 15/03/2016