Rispoval RS+PI3 IntraNasal

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Bovine parainfluenza 3 virus (pi3v), rlb 103, attenuated; Bovine respiratory syncytial virus (brsv), strain 375 attenuated

Διαθέσιμο από:

Zoetis Belgium S.A.

Φαρμακολογική κατηγορία (ATC):

QI02AD07

INN (Διεθνής Όνομα):

Bovine parainfluenza 3 virus (pi3v), rlb 103, attenuated; Bovine respiratory syncytial virus (brsv), strain 375 attenuated

Δοσολογία:

10^5.0-10^8.6 / 10^5.0-10^7.2 cell culture infective dose 50

Φαρμακοτεχνική μορφή:

pdr and diluent for intra-nasal soln

Τρόπος διάθεσης:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle

Θεραπευτική περιοχή:

bovine respiratory syncytial virus + bovine parainfluenza virus

Θεραπευτικές ενδείξεις:

Immunological - Live Vaccine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-12-09

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
20 November 2017
CRN000V0D
Page 1 of 5
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.
Health Products Regulatory Authority
20 November 2017
CRN000V0D
Page 2 of 5
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 EACH TARGET SPECIES
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 prefer