Bovilis IBR Marker inac, Suspension for injection

Bovilis IBR Marker inac, Suspension for injection
Qualitative and quantitative composition

Per dose of 2 ml.

For a list of excipients, see section Pharmaceutical Particulars.

Pharmaceutical form

Suspension for injection

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 BHV-1 as well as to reduce the replication and nasal excretion of the field virus.

Onset of immunity: 3 weeks after basic vaccination.

Duration of immunity: 6 months after basic vaccination.

Contra-indications

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 warning:

In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.

Adverse reactions

Occasionally a hypersensitivity reaction may occur. In such cases an appropriate symptomatic treatment should be administered. At the injection site a local reaction may occur.

Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

Interactions

No information is available on the safety and efficacy 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.

Basic vaccination: Two inoculations with an interval of 4 weeks.

Re-vaccination (after basic vaccination with Bovilis IBR marker inac or with Bovilis IBR marker live): One inoculation every 6 months.

Overdose

Administration of a double dose does not cause other effects than after a single dose.

Withdrawal periods

Zero days.

Pharmacological particulars

Immunological properties

Bovilis IBR marker inac 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 BHV-1 field virus.

Pharmacotherapeutic group: inactivated viral vaccine, ATCvet code: QI02AA03.

Pharmaceutical particulars

Excipients

Formaldehyde, Culture medium, Trometamol, Sodium chloride and 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 to 8°C). Do not freeze.

Immediate packaging

Hydrolytical glass type I (PhEur) or polyethylene-terephthalate (PET) vials with 5, 10, 25, 50 or 100 doses closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.

Presentations: Cardboard boxes with 1 or 10 vials. 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.