Patient leaflet - Bluevac BTV (previously known as Bluevac BTV8)
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:
CZ Veterinaria, S.A.
La Relva s/n - Torneiros
36410 Porriño (Spain)
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
BLUEVAC BTV Suspension for injection for cattle and sheep
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml of vaccine contains:
Active substances:
Inactivated bluetongue virus (BTV)
One of the following inactivated bluetongue virus serotypes:
| Inactivated bluetongue virus, serotype 1 (BTV-1), strain BTV-1/ALG/2006/01 | > 22.60 ^g/ml |
| Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 | > 2.55 ^g/ml |
| Inactivated bluetongue virus, serotype 8 (BTV-8), strain BTV8/BEL/2006/01 | > 55.80 Lig/ml |
Adjuvants:
Aluminium hydroxide 6
Purified saponin (Quil A) 0.05
Excipient:
Thiomersal 0.1
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.
White or pinkish-white suspension.
4. INDICATION(S)
Sheep
For active immunisation of sheep to prevent the viraemia1 caused by bluetongue virus serotype 1 or 4 or 8) and to reduce clinical signs caused by bluetongue virus serotype 8.
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 4or 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 log10TCID50/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.
5. CONTRAINDICATIONS
None.
6. ADVERSE REACTIONS
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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
7. TARGET SPECIES
Sheep and cattle.
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use.
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 with a 3 - 4 weeks apart.
Revaccination
An annual revaccination is recommended.
9. ADVICE ON CORRECT ADMINISTRATION
Shake well before use. Avoid multiple vial broaching. Avoid introduction of contamination.
10. WITHDRAWAL PERIOD(S)
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.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Shelf life after first opening the container: 10 hours.
12. SPECIAL WARNING(S)
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.
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:
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 vaccine 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).
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.
Overdose (symptoms, emergency procedures, antidotes):
After the administration of a double dose, no adverse reactions other than those described in section 6 were observed.
Incompatibilities:
Do not mix with any other veterinary medicinal products.
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 is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
15. OTHER INFORMATION
Pharmacotherapeutic group: Bluetongue virus vaccines, inactivated. 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.
Pack sizes:
Cardboard box of 1 bottle containing 52 ml
Cardboard box of 1 bottle containing 100 ml
Cardboard box of 1 bottle containing 252ml
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.
United Kingdom
Intervet UK Ltd.
Walton Manor
Walton
Milton Keynes
MK7 7AJ
UK
Tel: +44 (0)1908 685685
CZ Veterinaria, S.A.
La Relva s/n - Torneiros 36410 Porriño
Spain
Tel: +34 986330400
Ireland and Northern Ireland
Intervet Ireland Ltd.
Magna Drive
Magna Business Park
Citywest Road
Dublin 24
Ireland
Tel: +353 (0)1 2970220
CZ Veterinaria, S.A.
La Relva s/n - Torneiros
36410 Porriño
Spain
Tel: +34 986330400
Deutschland
Intervet Deutschland GmbH
Feldstraße 1a
D-85716 Unterschleißheim
Tel: +49(0)89 456 14 499
CZ Veterinaria, S.A.
La Relva s/n - Torneiros 36410 Porriño
Spanien
Tel: +34 986330400
Nederland
Intervet Nederland B.V.
Wim de Körverstraat 35 5831 AN Boxmeer
Tel: +31.485.587652
CZ Veterinaria, S.A.
La Relva s/n - Torneiros
36410 Porriño
Spanje
Tel: +34 986330400
España
Vetia Animal Health, S.A.
Calle Teide n° 4
28703 San Sebastián de los Reyes,
Madrid
España
Tel: +34 619292771
CZ Veterinaria, S.A.
La Relva s/n - Torneiros
36410 Porriño
España
Tel: +34 986330400
Belgie/Belgique/Belgien, Luxembourg/Luxemburg, PenyS^uKa Et.nrapun, Magyarország, Česká republika, Malta, Danmark, Norge, Eesti, Österreich, EXXáSa, Polska, Portugal, France, Romania, Slovenija, island, Slovenská republika, Italia, Suomi/Finland, Kúnpog, Sverige, Latvija, Lietuva, Hrvatska
CZ Veterinaria, S.A.
La Relva s/n - Torneiros
36410 Porriño
Spain
Tel: +34 986330400
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1
Below the level of detection by the validated RT-PCR method at 1 log10 TCID50/ml for serotypes 8 and 4, and 1.3 log10TCID50/ml for serotype 1