Category: R
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| Category | POM-V |
| Temperature | Refrigerated |
| MA/VM/EU No: | 42058/4126 |
| Species |
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| VMD Link | https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_161554.PDF |
| NOAH Link | |
| Dosage | Dose 2 ml reconstituted vaccine. Route of administration Intranasal and/or intramuscular inoculation. The vaccine must be administered aseptically via the intramuscular route (2 ml) or sprayed into the nostrils (1 ml per nostril during aspiration) with the intranasal applicator available from Zoetis. Shake the vaccine well before use. Vaccine reconstitution The freeze-dried product should be reconstituted aseptically just prior to use. The vaccine is prepared as follows: For 10 and 50 dose vials, approximately 4 ml of the diluent is transferred into the vial containing freeze-dried pellet and then mixed. The reconstituted virus fraction is then transferred back into the remaining diluent and mixed well. The product is then ready for use. The needles and syringes used for application of the vaccine must not be sterilised by chemical disinfectants as this may impair the efficacy of the vaccine. Vaccination scheme Calves of 2 weeks to 3 months of age at first vaccination: The first vaccination should be applied intranasally, followed by a second vaccination intramuscularly at 3 months of age. A proportion of young calves may have maternally derived antibodies to BoHV-1, which may affect the immune response to vaccination. Consequently, the protection afforded by the vaccine may not be complete until the revaccination at 3 months of age. As an extra precaution in situations of high challenge with BoHV-1, maternal antibody positive animals that have been initially vaccinated at around 2 weeks of age may be given an additional vaccination between the first vaccination and vaccination at 3 months of age. This additional vaccination may be given via either intranasal or intramuscular administration and may be given from 3 weeks after the first vaccination. Cattle at 3 months of age or older at first vaccination: Animals should be given one intramuscular vaccination. To prevent abortions associated with BoHV-1 female cattle require a primary course of two intramuscular doses of Rispoval IBR-Marker Live 3-5 weeks apart or alternatively a primary course of a single intramuscular dose of Rispoval IBR-Marker Live followed 6 months later by a single dose booster using Rispoval IBR-Marker Inactivated. In order to cover the main abortion risk period, it is recommended that the second dose of the primary course of two intramuscular doses of Rispoval IBR-Marker Live or the single dose booster using Rispoval IBR-Marker Inactivated is administered no later than by the start of the second trimester of each pregnancy. Cattle at immediate risk of IBR In the case of known high BoHV-1 infection pressure, the first dose in cattle (including pregnant females) should be administered intranasally in order to stimulate local immunity followed 3-5 weeks later by the second dose administered intramuscularly to complete the primary vaccination course. Booster vaccinations Animals should be given a single dose booster vaccination 6 months after their initial vaccination course. Animals initially vaccinated with Rispoval IBR-Marker Live may be given a single dose booster vaccination with either Rispoval IBR-Marker Live to provide 6 months of protection or Rispoval IBR-Marker Inactivated to provide a duration of protective immunity of 12 months. Thereafter, single dose booster vaccinations should be administered every 6 months (if using Rispoval IBR-Marker Live) or every 12 months (if using Rispoval IBR-Marker Inactivated). Advice on correct administration Beef cattle and fattening bulls are vaccinated preferably just prior to housing (crowding) or at transfer to new groups while taking into account the interval needed for the onset of protection following the basic vaccination scheme. It is recommended that all the cattle in the herd are vaccinated. Vaccination schemes summary From 2 weeks to 3 months of age Rispoval IBR-Marker Vaccine Used Primary vaccination Revaccination Intervals First dose, from 2 weeks of age (route of administration) Second dose at 3 months of age (route of administration) Interval to next booster vaccination (vaccine and route of administration) All subsequent booster vaccinations (vaccine and route of administration) Live (IN) Live (IM) 6 Months (Live IM) 6 Months (Live IM) Live (IN) Live (IM) 6 Months (Inactivated SQ) 12 months (Inactivated SQ) From 3 months of age Rispoval IBR-Marker Vaccine Used Revaccination Intervals Primary vaccination (number of doses and route of administration) Interval to first booster vaccination (vaccine and route of administration) All subsequent booster vaccinations (vaccine and route of administration) Live (one dose IM) 6 Months (Live IM) 6 Months (Live IM) Live (one dose IM) 6 Months (Inactivated SQ) 12 Months (Inactivated SQ) Inactivated (two doses with 3 - 5 Week Interval SQ) 6 Months (Inactivated SQ) 6 Months (Inactivated SQ) For female cattle for protection against abortion Rispoval IBR-Marker Vaccine Used Revaccination recommended to be applied no later than by the start of the second trimester of each pregnancy Vaccine schedule (number of doses and route of administration) recommended to be applied no pater than by the start of the second trimester of pregnancy Live (two doses with 3-5 week interval IM) Inactivated (one dose SQ) Live (one dose IM) followed by Inactivated (on edose SQ) with 6 months interval Inactivated (one dose SQ) Inactivated (two doses with 3-5 week interval SQ) Inactivated (one dose SQ) For vaccination in known high BoHV-1 infection pressure Rispoval IBR-Marker Vaccine Used Revaccination Intervals Primary vaccination (number of doses and route of administration) Interval to first booster vaccination (vaccine and route of administration) All subsequent booster vaccinations (vaccine and route of administration) Live (one dose IN) followed by Live (one dose IM) with 3-5 weeks interval 6 Months (Live IM, OR Inactivated SQ) 6 Months (Live IM) OR 12 months (Inactivated SQ) |
| Withdrawals | Do not use in unhealthy animals. When injected intramuscularly in very rare cases minor, transient swelling up to 3 cm in diameter, which generally subsides within 7 days, may occur at the injection site. Following intranasal inoculation slight, transient, serous nasal discharge may occur in very rare cases for up to 7 days. In very rare cases, allergic reactions may occur as with other vaccines, therefore vaccinates should be observed for approximately 30 minutes following immunisation. In those cases, anti-allergics should be administered. In some cases, the vaccine virus may be excreted after intranasal administration from vaccinated animals. After intranasal administration of a 10-fold overdose, the vaccine virus was detected for up to 9 days after vaccination. In very young calves and in rare cases, vaccine virus was excreted until day 18 post intramuscular vaccination with a 10-fold overdose. Exceptional transmission of the virus from intranasally-vaccinated animals to non-vaccinated in-contact animals may occur due to the nature of the vaccine even though no verified data available would indicate that spreading of the vaccine virus occurs in a group of animals. It is recommended to vaccinate all the cattle in the herd. The presence of maternal antibodies can influence the efficacy of the vaccination. Therefore it is recommended to ascertain the immune status of calves before vaccination is started. The vaccine can be used during pregnancy and lactation. Immunosuppressive substances e.g. corticosteroids or Bovine Viral Diarrhoea modified live vaccines, should be avoided for a period of 7 days prior to and after vaccination as this may impair the development of the immunity. Interferon sensitive products should not be applied intranasally following 5 days after intranasal vaccination. 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. Do not mix with any other veterinary medicinal product except diluent supplied for use with the product. After intranasal administration of a 10-fold overdose, a transient hyperthermia (> 39.5 |
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