Category: B
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| Category | POM-V |
| Temperature | Refrigerated |
| MA/VM/EU No: | 04491/5004 |
| Species |
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| VMD Link | https://www.vmd.defra.gov.uk/ProductInformationDatabase/product/A008858 |
| NOAH Link | |
| Dosage | Dosage and administration Intramuscular use. Preparation of vaccine for use (reconstitution): Reconstitute the lyophilisate by adding the full content of the solvent at room temperature. Ensure that the lyophilisate is completely reconstituted before use. The reconstituted vaccine is transparent and colourless. Avoid multiple broaching. Primary vaccination: After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection. It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception. Animals which are vaccinated later than 3 weeks before gestation or during the early gestation may not be protected against foetal infection. This should be considered in case of herd vaccination. Recommended re-vaccination programme: Revaccination is recommended after 1 year. 12 months after primary vaccination most studied animals still had antibody titres at plateau while some animals had lower titres. Contra-indications, warnings, etc Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Special precautions for each target species Vaccinate healthy animals only. To ensure the protection of animals introduced to the herd where BVDV is circulating, vaccination has to be completed 3 weeks before introduction. The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals. A definitive diagnosis of persistent infection can only be established upon re-testing in blood after an interval of at least 3 weeks. In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests. Additional laboratory tests to differentiate vaccine strain virus from field strain are available upon request from the marketing authorization holder. The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed. Special precautions for use in animals Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study). This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy were observed in studies. Shedding of the vaccine virus by body fluids can not be excluded. The vaccine strains are able to infect sheep and swine when administered intranasally, but no adverse reactions or spreading to in-contact animals has been demonstrated. The vaccine has not been tested in breeding bulls and should therefore not be used in breeding bulls. 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. Adverse reactions (frequency and seriousness) An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours (clinical studies). Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination (clinical studies). Hypersensitivity reactions, including anaphylactic-type reactions, have been reported very rarely (post-marketing safety experience). The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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). Pregnancy and Lactation It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus. While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur. Therefore, use during pregnancy should only be on a case-by-case basis decided by the responsible veterinarian, taking into consideration e.g. the BVD immunological status of the animal, the time-span between vaccination and mating/insemination, the stage of pregnancy and the risk of infection. Can be used during lactation. Studies have shown that vaccine virus may be excreted in milk up to 23 days after vaccination at low amounts (~ 10 TCID50/ml), although when such milk was fed to calves, no seroconversion occurred in those calves. Interactions 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 Mild swellings or nodules up to 3 cm diameter were observed at the injection site after administration of a 10-fold overdose and disappeared within 4 days post vaccination. Furthermore, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours. |
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