Rispoval RS + PI3 IntraNasal

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

Available from:

Kernfarm B.V.

ATC code:

QI02AD07

INN (International Name):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Live Viral Vaccine

Authorization status:

Expired

Authorization date:

2015-03-27

Summary of Product characteristics

Revised: May 2020
AN: 02154/2019
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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR CATTLE
None.
Revised: May 2020
AN: 02154/2019
Page 2 of 4
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 least 10 da