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Date: Tuesday, April 16, 2024 11:54

Release 3.87
Bovilis® IBR Marker Inac suspension for injection for cattle
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Bovilis® IBR Marker Inac suspension for injection for cattle
Product index: Bovilis IBR Marker Inac
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of 2 ml contains:
Active substance:
Inactivated bovine herpesvirus type 1 (BHV-1) strain GK/D (gE¯)*: 60 ELISA units**.
* gE¯: glycoprotein E negative
** inducing 6.1 - 11.1 log2 virus neutralising units in mouse potency test
Adjuvant:
Aluminium-phosphate and -hydroxide (Al3+) 6.0 - 8.8 mg
Excipient:
Formaldehyde 0.6 - 1.0 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Suspension for injection. Pink turbid suspension.
Clinical particulars
Target Species
Cattle.
Indications for use
For active immunisation of cattle to reduce the intensity and duration of clinical signs (pyrexia) induced by an infection with bovine herpesvirus type 1 (BHV-1) as well as to reduce the replication and nasal excretion of the field virus.
Onset of immunity:- 3 weeks
Duration of immunity:- 6 months
The schedule using Bovilis IBR Marker Live for primary vaccination and revaccination after 6 months with Bovilis IBR Marker Inac, will result in protective immunity that lasts for 12 months.
Contraindications
None.
Special warnings for each target species
Efficacy has not been demonstrated in the face of maternally derived antibodies.
Special precautions for use
Vaccinate only healthy animals.
Operator warnings
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Adverse Reactions
A local reaction at the injection site may occur in very rare cases.
Hypersensitivity reactions can occur in very rare cases. In such cases an appropriate symptomatic treatment should be administered.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy or lactation
Can be used during pregnancy and lactation.
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.
Amounts to be administered and administration route
Use sterile vaccination equipment.
Before use, allow the vaccine to reach ambient temperature (15°C - 25°C).
Shake well before use.
Intramuscular injection, 2 ml per animal.
All cattle can be vaccinated from an age of three months onwards.
Primary vaccination:
Two vaccinations with an interval of 4 weeks.
Re-vaccination:
One vaccination every 6 months.
Bovilis IBR Marker Inac can be used for re-vaccination in a schedule where Bovilis IBR Marker Live has been used for primary vaccination:
Primary vaccination:
Consult the product literature for Bovilis IBR Marker Live for advice.
First re-vaccination:
A single vaccination should be given 6 months after primary vaccination.
Subsequent re-vaccinations:
Single vaccinations given at intervals no greater than 12 months.
Overdose
Administration of a double dose does not cause other effects than after a single dose.
Withdrawal period
Zero days.
Pharmacological particulars
ATC Vet code: QI02AA03
This product is an inactivated adjuvanted vaccine for active immunisation of cattle against bovine herpesvirus type 1 (BHV-1). The vaccine does not elicit antibodies to glycoprotein E of BHV-1 (marker vaccine). This enables discrimination between cattle vaccinated with the product and cattle infected with BHV-1 field virus.
Pharmacotherapeutic group
Inactivated viral vaccine, vaccine against bovine rhinotracheitis virus (IBR).
Pharmaceutical particulars
Excipients
Aluminium phosphate, Aluminium hydroxide, Formaldehyde, Trometamol, Sodium chloride, Veggie medium, Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 8 - 10 hours.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Immediate packaging
Vials of glass (hydrolytic type I) or plastic (polyethylene-terephthalate) closed with a rubber stopper and an aluminium cap.
Pack sizes:
Cardboard box with 1 glass or plastic vial (5 doses).
Cardboard box with 1 glass or plastic vial (10 doses)
Cardboard box with 1 glass or plastic vial (25 doses)
Cardboard box with 1 glass or plastic vial (50 doses)
Cardboard box with 1 glass or plastic vial (100 doses)
Cardboard box with 10 glass or plastic vials (5 doses)
Cardboard box with 10 glass or plastic vials (10 doses)
Cardboard box with 10 glass or plastic vials (25 doses)
Cardboard box with 10 glass or plastic vials (50 doses)
Cardboard box with 10 glass or plastic vials (100 doses)
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB): Vm 01708/5109
UK(NI): Vm 01708/3039
Significant changes
Date of the first authorisation or date of renewal
19 July 2006.
Date of revision of the text
October 2023
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Bovilis IBR Marker inac 1x10ds:
GTIN:8713184075833,
GTIN description:Bovilis IBR Marker inac 1x50ds:
GTIN:8713184121493