BioBos IBR marker live, lyophilisate and solvent for suspension

Homepage Products Veterinary products BioBos IBR marker live, lyophilisate and solvent for suspension

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (2 ml) contains:

Active substance:

Lyophilisate:

Live attenuated Bovine herpesvirus type 1 (BHV-1), strain Bio-27: IBR gE -    

10^5.7- 10^7.5 TCID₅₀

TCID₅₀ - tissue culture infectious dose – 50%

Excipients:

Qualitative composition of excipients and other constituents

Lyophilisate:

Trometamol (TRIS)

Edetic acid (Chelaton II)

Sucrose

Dextran 70

Water for injection

Solvent:

Sodium chloride

Potassium chloride

Disodium phosphate dodecahydrate

Potassium dihydrogen phosphate

Water for injection

The lyophilisate has a spongy consistency, a cream, yellowish to pinkish colour.

The solvent is clear, colourless solution.

CLINICAL INFORMATION

Target species

Cattle

Indications for use for each target species

For active immunisation of cattle to reduce the severity and duration of clinical signs of viral infection caused by BHV-1 (IBR - infectious bovine rhinotracheitis) and to reduce the excretion of the field virus.

Onset of immunity: The onset of immunity was demonstrated 7 days after intranasal vaccination and 14 days after intramuscular vaccination of  animals without maternally derived antibodies.

Duration of immunity: 6 months after primary vaccination.

The duration of immunity after intranasal administration from 2 weeks of age was demonstrated by challenge only in animals without maternally derived antibodies to be 10 weeks until the intramuscular administration of the second dose from 3 months of age.

Contraindications

None.

Special warnings

Vaccinate healthy animals only.

Maternal antibodies may have a negative impact on the efficacy of vaccination. Therefore, it is recommended to verify the immune status of calves prior to vaccination.

Special precautions for use

Special precautions for safe use in the target species:

Due to the nature of the vaccine (live vaccine) the possibility of transmission of the virus from animals vaccinated intranasally to unvaccinated animals (for max. 5 days after vaccination) that are in contact with them cannot be ruled out completely. For this reason, it is recommended to either vaccinate all animals in the herd or isolate the cattle to be absolutely free of antibodies to BHV-1 from the animals vaccinated intranasally.

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.

Special precautions for the protection of the environment:

Not applicable.

Adverse events

None.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Fertility:

No information is available on the use of this vaccine in breeding bulls.

Interaction with other medicinal products and other forms of interaction

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.

Administration routes and dosage

Reconstitute vaccine immediately before use by aseptically mixing lyophilisate with the solvent in 2 steps:

1. Inject suitable volume of solvent on the lyophilised plug in the lyophilisate vial.

2. Shake well and extract the resuspended lyophilisate from the lyophilisate vial and mix with the rest of solvent in the solvent vial.

Shake well before use.

After reconstitution, a slightly opalescent liquid of pinkish-red or yellowish colour is formed.

In case of intranasal administration suck the required volume of reconstituted vaccine (1 ml of the reconstituted vaccine for each nostril) with a syringe needle from the vial, then replace the needle with an applicator and administer the vaccine. The applicator is used to apply the desired amount of the vaccine in aerosol form from the syringe into the nostrils of a vaccinated calf. The applicator used should spray the vaccine in the form of 30 µm to 100 µm droplets.

Dosage:

2 ml of reconstituted vaccine per animal.

Method of administration:

• Intranasal:                from 2 weeks up to 3 months of age
• Intramuscular:          from 3 months of age

Administer one dose (2 ml) of the reconstituted vaccine intranasally to calves from 14 days of age using an intranasal applicator. It is recommended to use a new applicator for each animal to prevent the transmission of infection.

Vaccination schedule:

Primary vaccination:

Calves from 2 weeks of age without maternal antibodies up to 3 months of age

The first administration (intranasal) from 2 weeks of age, the second administration (intramuscular) from the age of 3 months.

Cattle from 3 months of age

One intramuscular administration of one dose per animal from 3 months of age.

Revaccination:

Revaccination is always intramuscular with one dose every 6 months after completion of primary vaccination.

Sterile equipment free of disinfectants should be used for vaccination as disinfectants could reduce the efficacy of vaccination.

Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Administration of a 10-fold recommended dose of the vaccine did not cause any adverse effects.

Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

Withdrawal periods

Zero days.

IMMUNOLOGICAL INFORMATION

ATCvet code: QI02AD01

To stimulate active immunity against bovine herpesvirus type 1 (BHV-1)/ infectious bovine rhinotracheitis (IBR).

The vaccine does not induce production of antibodies against BHV-1 virus glycoprotein E (a marker vaccine). This allows the differentiation between the cattle vaccinated with this vaccine and the cattle infected with field BHV-1 virus or vaccinated with conventional non-marker vaccines against IBR virus.

PHARMACEUTICAL PARTICULARS

Major incompatibilities

Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.

Shelf life

Shelf life of the veterinary medicinal product (lyohilisate) as packaged for sale: 2 years.

Shelf life of the veterinary medicinal product (solvent) as packaged for sale: 4 years.

Shelf life after reconstitution according to directions: 8 hours.

Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Protect from light.

Store the reconstituted vaccine below 25°C (for 8 hours).

Nature and composition of immediate packaging

Colourless glass vials 3 ml of hydrolytic class I (Ph.Eur.) containing five doses of the lyophilised vaccine. The vial is closed with a rubber lyophilisation stopper (brombutyl) (Ph.Eur.) and an aluminium cap.

The solvent is filled in colourless glass vials of hydrolytic class I (Ph.Eur.) containing 10 ml of sterile buffered saline. The vial is closed with a rubber injection stopper (chlorbutyl) (Ph.Eur.) and an aluminium cap.

Colourless glass vials 10 ml of hydrolytic class I (Ph.Eur.) containing twentyfive doses of the lyophilised vaccine. The vial is closed with a rubber lyophilisation stopper (brombutyl) (Ph.Eur.) and an aluminium cap.

The solvent is filled in colourless glass vials of hydrolytic class II (Ph.Eur.) containing 50 ml of sterile buffered saline. The vial is closed with a rubber injection stopper (chlorbutyl) (Ph.Eur.) and an aluminium cap.

Package size:

a/ Plastic box with a lid, with 10 wells

5 x 5 doses - (5 x 5 doses of lyophilised vaccine + 5 x 10 ml of solvent)

b/ Carton:

1 x 25 doses - (1 x 25 doses of lyophilised vaccine + 1 x 50 ml of solvent)

Applicators are distributed together with the vaccine and packaged separately.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.