Bovilis IntraNasal RSP Live

5 x 1 dose
Lyofilisate and solvent for suspension for nasal administration
IN

Species

Cattle.

Indications

For active immunisation of calves from the day of birth onwards to reduce clinical signs of respiratory disease and viral shedding from infection with BRSV and PI3.

Onset of immunity:   

BRSV:

 

 

 

 

6 days (for calves vaccinated from the day of birth onwards)

 

5 days (for calves vaccinated from the age of 1 week onwards)

 

PI3:

1 week.

Duration of immunity:

12 weeks.

 

Dose to be administered and administration route

Nasal use.

Calves can be vaccinated from the day of birth onwards.

Reconstitute lyophilisate with solvent as described below. Ensure that the lyophilisate is completely reconstituted before use. The reconstituted vaccine is an orange/brown to off-pink or pink coloured suspension.

Administer a single dose of 2 ml reconstituted vaccine per animal in one nostril.

Instructions for reconstitution:

1 and 5 dose presentations

For proper reconstitution of the lyophilisate, transfer the solvent to the vial with the lyophilisate (2 ml for the 1 dose, 10 ml for the 5 dose; also see the table below) using a needle and syringe. The vacuum in the vaccine vial will allow quick emptying of the syringe. Then resuspend by shaking. The vaccine suspension can be drawn up in a syringe with a clean tip. The vaccine in the syringe is now ready for administration, directly from the tip of the syringe. A spraying device is not required.

10 and 20 dose presentations

For proper reconstitution of the lyophilisate, transfer 10 ml of the solvent to the vial with the lyophilisate using a needle and syringe. The vacuum in the vaccine vial will allow quick emptying of the syringe. Then resuspend by shaking. Completely draw up the vaccine suspension and transfer it back to the solvent vial in order to get the correct dose/volume ratio for the respective presentation (20 ml for the 10 dose, 40 ml for the 20 dose; also see the table below). The vaccine suspension can be drawn up in a syringe with a clean tip. The vaccine in the syringe is now ready for administration, directly from the tip of the syringe. A spraying device is not required.

When vaccinating animals, it is recommended to change syringes or tips of a multidose syringe between animals to avoid transmission of pathogens.

Doses per

vial

Solvent volume required

dose volume

1

2 ml

2 ml

5

10 ml

2 ml

10

20 ml

2 ml

20

40 ml

2 ml

Adverse reactions

Cattle:

Very common

(>1 animal / 10 animals treated):

Nasal discharge1.

Elevated temperature2.

Common

(1 to 10 animals / 100 animals treated):

Cough3, increased respiratory rate4. Ocular discharge5.

1 Mild and transient. Occurs during two days following vaccination.

2 Minor and transient (very rarely up to 41.1 °C); normally resolves within four days.

3 Mild and transient. Normally resolves in three days.

4 Transient. Normally resolves within four days.

5 Mild and transient. Normally resolves in two days.

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 the package leaflet for respective contact details.

Dispensing

POM-V - Prescription Only Medicine – Veterinarian
Cattle
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Art. Nr. 01708/5104
PACKAGES
Bovilis IntraNasal RSP Live
MSD
5 x 1 dose
01708/5104
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