Patient leaflet - BTVPUR
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
BTVPUR suspension for injection for sheep and cattle
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release :
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
69800 Saint-Priest
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR suspension for injection for sheep and cattle
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
Active substance*:
Inactivated Bluetongue Virus.........................................> strain specific pass level (logio pixels)
* maximum of two different inactivated bluetongue virus serotypes
| ()Strain-specific pass levels | () Antigen content (VP2 protein) by immuno-assay |
| BTV1 | 1.9 log10 pixels/mL |
| BTV2 | 1.82 log10 pixels/mL |
| BTV4 | 1.86 log10 pixels/mL |
| BTV8 | 2.12 log10 pixels/mL |
A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released.
Adjuvants:
Al3+ (as hydroxide).................................................................................................................. 2.7 mg
Saponin...................................................................................................................................30 HU (**)Haemolytic units
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 label.
Appearance: homogeneous milky white.
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4. INDICATION(S)
Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by Bluetongue Virus Serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1, 2, 4 and/or 8, 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 RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
Onset of immunity has been demonstrated 3 weeks (or 5 weeks in sheep for BTV2) after the primary vaccination course for BTV1, BTV2 (cattle), BTV-4 and BTV-8 serotypes.
The duration of immunity for cattle and sheep is 1 year after primary vaccination course.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
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 a transient increase in body temperature, normally not exceeding an average of
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1.1 °C, may occur within 24 hours after vaccination.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– 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.
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7. TARGET SPECIES
Sheep and cattle.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
- Primary vaccination
In sheep
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– 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
born to immune sheep).
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– 2nd injection: after 3–4 weeks
For a monovalent vaccine containing an inactivated Bluetongue Virus serotypes 2 or 4, or for a bivalent vaccine containing both serotypes 2 and 4 together, one injection is sufficient.
In cattle
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– 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
born to immune cattle).
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– 2nd injection: after 3–4 weeks.
- Revaccination
Annual.
9.
ADVICE ON CORRECT ADMINISTRATION
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.
10.
WITHDRAWAL PERIOD(S)
Zero days.
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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.
Shelf life after first opening the immediate packaging: use immediately.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
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 for use in animals:
Not applicable.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Fertility:
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).
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 decided on a case by case basis.
Overdose (symptoms, emergency procedures, antidotes):
Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine. No other adverse reactions except those mentioned in section ‘Adverse Reactions’ were observed.
Incompatibilities:
Do not mix with any other veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency
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15. OTHER INFORMATION