Rispoval RS + Pi3 IntraNasal

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

Tilgængelig fra:

Zoetis UK Limited

ATC-kode:

QI02AD07

INN (International Name):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle

Terapeutisk område:

Live Viral Vaccine

Autorisation status:

Authorized

Autorisation dato:

2005-10-11

Produktets egenskaber

Revised: January 2020
AN: 01190/2019
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval RS+PI3 IntraNasal
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml:
Powder
ACTIVE SUBSTANCE:
-
Modified live Bovine Parainfluenza type 3 virus (PI3V),
thermosensitive strain
RLB103, ≥10
5.0
and ≤10
8.6
CCID
50
*
-
Modified live Bovine Respiratory Syncytial virus (BRSV) strain 375,
≥10
5.0
and
≤10
7.2
CCID
50
*
*CCID
50
: Cell Culture Infective Dose 50%
Diluent:
- Sodium chloride
18 mg
-
Water for injection
2 ml
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and diluent for suspension for intranasal application. Slightly
coloured powder
and clear colourless diluent. The reconstituted, dissolved vaccine is
a pinkish
suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of maternally derived antibody positive or
negative calves
from 9 days of age against BRSV and PI3V, to reduce the mean titre and
duration of
excretion of both viruses.
Onset of protective immunity: 5 days for BRSV and 10 days for PI3V
after a single
vaccination.
Duration of protective immunity: 12 weeks following a single dose. The
duration of
protective immunity against the PI3V fraction may be reduced in MDA
positive calves
vaccinated before 3 weeks of age.
Revised: January 2020
AN: 01190/2019
Page 2 of 4
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR CATTLE
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
Vaccinal viruses can spread from vaccinated to non-vaccinated calves
and may cause
a serological response, but without causing clinical signs. In
laboratory experiments
based on the data using 3 week-old animals, shedding was observed for
BRSV and
PI3V up to 11 and 7 days respectively after vaccination with one dose
containing the
maximal virus content.
Animals should preferably be vaccinated at lea