BTVPUR (bluetongue-virus serotype-1 antigen...) – Summary of product characteristics - QI04AA02
Updated on site: 08-Feb-2018
|Stoff:||bluetongue-virus serotype-1 antigen /bluetongue-virus serotype-8 antigen|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR suspension for injection for sheep and cattle.
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
Active substances *:
Inactivated Bluetongue Virus .........................................≥ strain specific pass level (log10 pixels) **
(*) maximum of two different inactivated bluetongue virus serotypes
(**) Antigen content (VP2
1.9 log10 pixels/mL
1.86 log10 pixels/mL
2.12 log10 pixels/mL
A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released
Al3+ (as hydroxide)
(**) Haemolytic units
For the full list of excipients, see section 6.1.
The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the package and in the package leaflet
Homogeneous milky white suspension for injection.
Sheep and cattle
4.2Indications for use, specifying the target species
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of maximum 2 serotypes)
*(below the level of detection by the validated
Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. The duration of immunity for cattle and sheep is 1 year after primary vaccination course.
4.4Special warnings for each target species
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.
4.5Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
4.6Adverse reactions (frequency and seriousness)
In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm2 in sheep) which becomes residual 35 days later (≤ 1 cm2).
In very rare cases it has been observed a transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
The frequency of adverse reactions is defined using the following convention:
-Very common (more than 1 in 10 animals displaying adverse reaction(s) 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
Can be used during pregnancy and lactation
The safety and the efficacy of the vaccine have not been established in breeding males. 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).
4.8Interaction 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
Apply usual aseptic procedures.
Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of injection. The entire content of the bottle should be used immediately after broaching and during the same procedure. Avoid multiple vial broaching.
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
• Primary vaccination
-First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
-Second injection: after
For a monovalent vaccine containing an inactivated Bluetongue Virus serotype 4, one injection is sufficient.
-First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune cattle).
-Second injection: after
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Very rare and transient apathy can be observed after the administration of a
4.11 Withdrawal period
Pharmacotherapeutic group: bluetongue virus vaccine, ATC vet code QI04AA02 (sheep) and QI02AA08 (cattle).
The vaccine contains inactivated Bluetongue Virus with aluminium hydroxide and saponin adjuvants. It induces an active and specific immunity against bluetongue virus in the vaccinated animal.
6.1List of excipients
Do not mix with any other veterinary medicinal product.
Shelf life of monovalent or bivalent formulation with Bluetongue Virus serotypes 1 and/or 8 (100 ml, 50 ml and 10 ml bottles): 2 years
Shelf life of monovalent or bivalent formulation with Bluetongue Virus serotype 4 (100 ml, 50ml and 10 ml bottles): 18 months
Shelf life after first opening the immediate packaging: use immediately.
6.4Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C)
Do not freeze
Protect from light
6.5Nature and composition of immediate packaging
Polypropylene bottle of 50 or 100 ml with butyl elastomer closure.
Box of 1 bottle of 100 doses (1 x 100 ml)
Box of 10 bottles of 100 doses (10 x 100 ml)
Box of 1 bottle of 50 doses (1 x 50 ml)
Box of 10 bottles of 50 doses (10 x 50 ml)
Type I glass bottle of 10 ml with butyl elastomer closure.
Box of 1 bottle of 10 doses (1 x 10 ml)
6.6 Special 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
29, avenue Tony Garnier 69007 Lyon
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17/12/2010
Date of latest renewal: 08/09/2015
10.DATE OF REVISION OF THE TEXT
Detailed information of this 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 BTVPUR containing serotypes 1,
4 and 8 may be prohibited in a certain Member State on the whole or part of their territory pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply and/or use BTVPUR 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.