Description
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Buy Bovela Online, Bovela is a veterinary vaccine that contains two types of a modified live bovine viral diarrhea (BVD) virus (BVDV-1 and BVDV-2). It is available as a lyophilizate (freeze dried powder) and solvent for injection.
Vaccine against BVD – Bovine Virus Diarrhea
Thanks to L2D (live double deleted) technology, the new BVD vaccine Bovela ® offers effective and safe protection against BVDV type 1 and also BVDV type 2. With just one vaccination (one shot), Bovela® offers year-round protection – for all cattle from 3 months; If possible, vaccinate 3 weeks before the insemination in order to ensure protection over the entire duration of pregnancy. This means that the birth of PI calves due to transplacental infection can be effectively prevented if vaccination takes place 3 weeks before insemination. Vaccination of entire herds, regardless of the reproductive status, is possible on a case-by-case basis at the discretion of the doctor.
SUMMARY OF THE CHARACTERISTICS OF THE VETERINARY MEDICINAL PRODUCT
Bovela
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovela
Bovela lyophilisate and solvent for suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bovela
Each dose (2 ml) contains:
Lyophilisate:
active ingredients
BVDV * -1, live, modified, non-cytopathogenic, initial strain KE-9: 10 4.0 – 10 6.0 GKID 50 **
BVDV * -2, live, modified, non-cytopathogenic, initial strain NY-93: 10 4.0 – 10 6.0 GKID 50 **
* Bovine
Viral Diarrhea Virus ** Tissue Culture Infectious Dose 50%
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
Lyophilisate: Cream-colored without foreign substances
Solvent: Clear, colorless solution
4. CLINICAL PARTICULARS
4.1 Target species
Bovine
4.2 Areas of application, specifying the target species
Active immunization of cattle from the age of 3 months to reduce hyperthermia and to minimize the decrease in the number of leukocytes caused by BVD viruses (BVDV-1 and BVDV-2) and to reduce virus excretion and viraemia caused by BVDV-2.
Active immunization of cattle against BVDV-1 and BVDV-2 to prevent the birth of persistently infected calves caused by transplacental infection.
Onset of immunity: 3 weeks after immunization.
Duration of immunity: 1 year
4.3 Contraindications
Do not use in case of hypersensitivity to the active substances or any of the other ingredients.
4.4 Special warnings for each target species Bovela
Vaccinate only healthy animals.
In order to ensure the protection of animals that are introduced into a herd in which BVDV circulates, vaccination must be completed 3 weeks before introduction.
The most important measures in the eradication of bovine viral diarrhea (BVD) are the identification and eradication of persistently infected animals. A reliable diagnosis of persistent infection can only be made after another blood test at least three weeks apart. In molecular diagnostic tests, BVDV vaccine strain positive ear punches have been indicated in a limited number of newborn calves. Additional laboratory tests are available to differentiate vaccine virus strain from field virus.
The field studies to test the effectiveness of the vaccine were carried out in herds from which persistently infected animals had been removed.
4.5 Special precautions for use Bovela
Special precautions for use in animals:
Long-term viraemia after vaccination (10 days in one study) was observed, particularly in pregnant, seronegative heifers. This can lead to transplacental transmission of the vaccine virus, but no harmful effects on the fetus or on pregnancy were observed in the studies.
The excretion of vaccine viruses through body fluids cannot be ruled out.
The vaccine viruses can infect sheep and pigs when administered intranasally, but no harmful effects or spread to contact animals have occurred.
The vaccine has not been tested on breeding bulls and should therefore not be used on breeding bulls.
Special precautions for the user:
In the event of accidental self-injection, seek medical advice immediately and show the package insert or the label.
4.6 Adverse reactions (frequency and severity) Bovela
Slight swellings or nodules up to 3 cm in diameter may be seen at the injection site and will disappear within 4 days of vaccination.
An increase in body temperature in the physiological range is often observed within 4 hours of vaccination and decreases within 24 hours.
The information on the frequency of side effects is defined as follows:
– Very common (more than 1 in 10 animals treated show side effects)
– Common (more than 1 but less than 10 in 100 animals treated)
– Uncommon (more than 1 but less than 10 in 1000 animals treated)
– Rare (more than 1 but less than 10 animals in 10,000 animals)
– Very rare (less than 1 in 10,000 animals treated, including individual reports).
4.7 Use during pregnancy, lactation or lay Bovela
It is recommended to vaccinate before pregnancy to ensure protection from persistent infection of the fetus. Although persistent infection of the fetus caused by the vaccine has not been observed, transmission of the vaccine virus to the fetus may occur.
The attending veterinarian should therefore decide on the application of the vaccine during pregnancy on a case-by-case basis, taking into account, for example, the immunological BVD status of the animal, the period between vaccination and mating / insemination, the gestation stage and the risk of infection.
Can be used during lactation.
Studies have shown that the vaccine viruses can be excreted with the milk in small quantities (~ 10 GKID 50 ) up to 23 days after vaccination . Seroconversion did not occur in calves that were given this milk.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the harmlessness and efficacy of the vaccine when used at the same time as another veterinary product. Whether the vaccine should be used before or after administration of another veterinary product must therefore be decided on a case-by-case basis.
4.9 Dosage and method of administration Bovela
For intramuscular use.
Preparation of the vaccine for use (reconstitution): Reconstitute the
lyophilisate by adding the entire contents of the solvent bottle at room temperature.
Ensure that the lyophilisate is completely reconstituted before use.
The reconstituted vaccine is transparent and colorless.
Avoid piercing the bottle multiple times.
Primary vaccination:
After reconstitution, inject one dose (2 ml) of the vaccine intramuscularly (im).
It is recommended to vaccinate cattle at least 3 weeks prior to insemination / mating to ensure fetal protection from day one of conception.
The following should be taken into account
when vaccinating the herd for the first time: Animals vaccinated less than 3 weeks before insemination or which are vaccinated in early pregnancy may not be protected against fetal infection.
Recommended Revaccination Scheme:
Revaccination is recommended after one year.
Most of the animals examined had consistently high antibody titers for 12 months after the first vaccination, while some animals had lower titers.
4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary
After administration of 10 times the vaccine dose, slight swellings or nodules up to 3 cm in diameter were observed at the injection site, which disappeared within 4 days after vaccination.
In addition, rectal body temperature increases often occurred within 4 hours of administration and then resolved by itself within 24 hours (see section 4.6).
4.11 Waiting times
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for cattle, live vaccines,
ATCvet code: QI02AD02
The vaccine is intended to stimulate the development of an active immune response against BVDV 1 and BVDV 2 in cattle.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lyophilisate:
sucrose
gelatin
potassium hydroxide
L-glutamic acid
potassium dihydrogen
phosphate dipotassium phosphate
sodium chloride
water for injections
Solvent:
Sodium
chloride
Potassium chloride Potassium dihydrogen
phosphate Disodium hydrogen phosphate
Water for injections
6.2 Significant incompatibilities
Do not mix with other veterinary medicinal products with the exception of the solvent supplied for the application of the animal vaccine.
6.3 Shelf life
Shelf life of the lyophilisate according to the sales packaging: 2 years.
Shelf life of the solvent: 3 years.
Shelf life after reconstitution according to instructions: 8 hours
6.4 Special storage instructions
Store and transport cool (2 ° C – 8 ° C).
Do not freeze.
Keep the lyophilisate and solvent vials in the outer carton.
6.5 Nature and composition of the container
Lyophilisate:
1, 4, 6 or 10 amber glass type I vials contain 5 doses (10 ml), 10 doses (20 ml), 25 doses (50 ml) and 50 doses (100 ml) of the lyophilisate, sealed with a siliconized bromobutyl rubber stopper and painted aluminum cap.
Solvent:
1, 4, 6 or 10 high-density polyethylene (HDPE) bottles with 10 ml, 20 ml, 50 ml and 100 ml solvent each, closed with a siliconized chlorobutyl rubber stopper and a lacquered aluminum cap.
The vials of the lyophilizate and the solvent are packed in the cardboard boxes with the same number of doses.
Not all pack sizes may be marketed.
6.6 Special precautionary measures for the disposal of unused veterinary medicinal products or waste generated during use
Unused veterinary medicinal products or waste materials derived from them must be disposed of in accordance with national regulations.
7. MARKETING AUTHORIZATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim / Rhein
GERMANY
8. APPROVAL NUMBER (S)
EU / 2/14/176 / 001-016
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION
Date of first admission: 22.12.2014
10. STATE OF INFORMATION
December 2017
Detailed information on this veterinary medicinal product can be found on the European Medicines Agency website
PROHIBITION OF SALE, DELIVERY AND / OR USE Bovela
Anyone who intends to manufacture, import, own, sell, supply and / or use this veterinary medicinal product must first obtain information from the competent authority of the Member State concerned about the current vaccination policy, as these activities are in accordance with the applicable national legislation may be prohibited in the entire territory of the member state or in parts thereof.
