NOAH Compendium

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Date: Friday, March 29, 2024 0:30

Release 4.18
Rispoval IBR-Marker Inactivated suspension for injection for cattle
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Rispoval® IBR-Marker Inactivated suspension for injection for cattle
Product index: Rispoval IBR-Marker Inactivated
Cattle - milk: Zero days
Cattle - meat: Zero days
Incorporating:
Presentation
An inactivated Infectious Bovine Rhinotracheitis Marker (gE negative) vaccine.
One dose (2 ml) contains: Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE‑negative) to induce a geometric mean seroneutralising titre of at least 1:160 in cattle. Also contains the adjuvants aluminum hydroxide 14-24 mg and Quil A 0.25 mg, and the preservative thimerosal 0.2 mg.
Uses
For the active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR) to reduce the clinical signs and virus shedding and, in female cattle, to prevent abortions associated with BoHV-1 infection. The vaccination of pregnant cattle will prevent abortion associated with BoHV-1 infection as demonstrated during the second trimester of gestation following challenge 28 days after vaccination.
Duration of immunity: 6 months.
For booster immunisation after primary vaccination with Rispoval IBR Marker Live to reduce the virus shedding and the clinical signs associated with BoHV-1 infection in cattle and, in female cattle, to prevent abortions associated with BoHV-1 infection. This vaccination of cattle will prevent abortion associated with BoHV-1 infections as demonstrated during the third trimester of gestation upon challenge 86 days after booster vaccination.
Duration of immunity: 6 months after complete primary vaccination with Rispoval IBR Marker Live followed by 12 months after annual booster with Rispoval IBR Marker Inactivated.
In order to prevent abortion in female cattle that have received basic immunisation, a single dose revaccination with Rispoval IBR-Marker Inactivated is recommended to be applied no later than by the start of the second trimester of each further pregnancy.
Dosage and administration
Dose
Cattle over 3 months of age: 2 ml.
Route
Subcutaneous injection.
Shake the vaccine well before use.
Vaccination Scheme
The vaccination scheme consists of basic immunisation and booster vaccinations.
Basic Immunisation
Two doses, each of 2 ml, 3-5 weeks apart.
Booster vaccinations of cattle having been administered the primary vaccination scheme using Rispoval IBR Marker Inactivated
One dose of 2 ml at 6 monthly intervals.
Booster vaccinations of cattle having been administered the primary vaccination scheme using Rispoval IBR Marker Live
Cattle having been administered the primary vaccination scheme using Rispoval IBR-Marker Live (according to the product information for this product) may be given booster vaccinations with Rispoval IBR-Marker Inactivated. These animals should be given a single dose booster vaccination with Rispoval IBR-Marker Inactivated 6 months after their initial vaccination course with Rispoval IBR-Marker Live. Thereafter, single dose booster vaccinations with Rispoval IBR-Marker Inactivated should be administered every 12 months.
It is recommended that all cattle in the herd are vaccinated.
Use only sterile needles and syringes for administration.
Avoid the introduction of contamination during use.
Due to the presence of maternal antibodies, the development of immunity in calves under 3 months of age may be impaired. These animals should be re-vaccinated when they are over 3 months of age.
To prevent abortions associated with BoHV-1, female cattle require a primary course of two subcutaneous doses of vaccine 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 subcutaneous doses 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.
Method of administration
Shake the vaccine well before use. The liquid suspension is injected aseptically via the subcutaneous route.
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 later 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)
Contra-indications, warnings, etc
Do not use in unhealthy animals.
Transient subcutaneous swelling up to 5 cm in diameter, which subsides within 14 days, may occur at the injection site in very rare cases. 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.
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 immunity.
Can be used during pregnancy and lactation.
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.
Withdrawal periods
Zero days.
User warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pharmaceutical precautions
Store in a refrigerator (+2°C to +8°C). Protect from frost, heat and light. Do not use after the expiry date which is stated on the label. Shelf-life after first opening the immediate packaging: 8 hours.
Any unused product or waste material should be disposed of in accordance with national requirements.
For animal treatment only.
Keep out of sight and reach of children.
Legal category
Legal category: POM-V
Packaging quantities
Cartons containing 20 ml (10 dose) or 100 ml (50 dose) vials. Not all pack sizes may be marketed.
Further information
Glycoprotein gE is absent in virus particles of Rispoval IBR-Marker Inactivated. Therefore the vaccine virus, and the antibodies against it, can be clearly differentiated from field strains, or antibodies against the latter by serological methods. The product induces antibodies in vaccinated cattle, which are detectable in serum neutralizing tests and in conventional ELISA tests. With specific gE test kits these antibodies can be differentiated from those of field virus infected animals or animals infected with conventional IBR vaccines.
The vaccine induces immunity in cattle against clinical respiratory symptoms caused by the IBR virus. Following infection the intensity of clinical symptoms as well as the titre and duration of virus shedding are significantly reduced. As with other vaccines, vaccination may not completely prevent but does reduce the risk of infection.
Vaccination of the whole herd, including both infected and uninfected cattle, is recommended. Following use of Rispoval IBR-Marker Inactivated the risk of infection, titre and duration of virus shedding are all reduced. The duration of a programme to achieve the status of a BoHV-1 free herd is dependent on the initial level of BoHV-1 infection in the herd and the sale or culling of remaining BoHV-1 positive animals.
Marketing Authorisation Number
Vm 42058/4127
Significant changes
GTIN
GTIN description:10 dose:
GTIN:05013457079418
GTIN description:50 dose:
GTIN:05013457078480