Bovalto Respi Intranasal, Nasal Spray, Lyophilisate and Solvent for Suspension

Ország: Egyesült Királyság

Nyelv: angol

Forrás: VMD (Veterinary Medicines Directorate)

Aktív összetevők:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

Beszerezhető a:

Boehringer Ingelheim Animal Health UK Ltd

ATC-kód:

QI02AD07

INN (nemzetközi neve):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

Gyógyszerészeti forma:

Nasal spray, suspension

Recept típusa:

POM-V - Prescription Only Medicine – Veterinarian

Terápiás csoport:

Cattle

Terápiás terület:

Live Viral Vaccine

Engedélyezési státusz:

Authorized

Engedély dátuma:

2018-04-16

Termékjellemzők

Revised: September 2021
AN: 00564/2021 & 00567/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovalto Respi Intranasal, Nasal Spray, Lyophilisate and Solvent for
Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
LYOPHILISATE:
ACTIVE SUBSTANCES:
Bovine parainfluenza 3 virus (PI3V), modified live virus, strain Bio
23/A 10
5.0
– 10
7.5
TCID
50
Bovine respiratory syncytial virus (BRSV), modified live virus, strain
Bio 24/A 10
4.0
–
10
6.0
TCID
50
TCID
50
– a 50% infectious dose for tissue cultures
SOLVENT:
Phosphate buffered saline 2 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, lyophilisate and solvent for suspension
Appearance before reconstitution:
The lyophilisate has a porous structure, off-white or yellowish
colour.
The solvent is clear, colourless.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of calves from the age of 10 days against
bovine
respiratory syncytial virus (BRSV) and bovine parainfluenza 3 virus
(PI3V), to reduce
the quantity and duration of nasal excretion of both viruses.
Onset of immunity: 10 days after vaccination
Duration of immunity: 12 weeks after vaccination.
Revised: September 2021
AN: 00564/2021 & 00567/2021
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The laboratory efficacy studies have demonstrated that the presence of
maternally
derived antibodies at the time of vaccination had no impact on vaccine
efficacy in
young animals.
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinated calves can excrete the vaccine strains BRSV and PI3V for up
to 6 days
after vaccination. Therefore, the spread of the vaccine virus from
vaccinated to
unvaccinated calves cannot be excluded. Animals should be vaccinated
at least 10
days before the critical period of stress or high risk of infection,