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 Ireland Limited

Φαρμακολογική κατηγορία (ATC):

QI02AD07

INN (Διεθνής Όνομα):

BOVINE PARAINFLUENZA 3 VIRUS (PI3V), RLB 103, ATTENUATED, BOVINE RESPIRATORY SYNCYTIAL VIRUS (BRSV), STRAIN 375 ATTENUATED

Δοσολογία:

Unknown

Φαρμακοτεχνική μορφή:

pdr and diluent for intra-nasal soln

Τρόπος διάθεσης:

POM(E)

Θεραπευτική ομάδα:

Bovine

Θεραπευτική περιοχή:

Bovine respiratory syncytial virus vaccine + Bovine parainfluenza virus vaccine

Θεραπευτικές ενδείξεις:

Immunological - Live Vaccine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-12-09

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval RS+PI3 IntraNasal
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 EACH TARGET SPECIES
None.
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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_4_
_/_
_1_
_1_
_/