Nobilis IB Primo QX
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
26-04-2021
Produktets egenskaber
(SPC)
26-04-2021
Offentlige vurderingsrapport
(PAR)
28-01-2021
Aktiv bestanddel:
live avian infectious bronchitis virus, strain D388
Tilgængelig fra:
Intervet International B.V.
ATC-kode:
QI01AD07
INN (International Name):
avian infectious bronchitis virus strain D388
Terapeutisk gruppe:
Chicken
Terapeutisk område:
Live viral vaccines, Domestic fowl
Terapeutiske indikationer:
For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus.
Produkt oversigt:
Revision: 5
Autorisation status:
Authorised
Autorisation dato:
2014-09-04
Indlægsseddel
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL - LYOPHILISATE CUPS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB Primo QX
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Live IBV, D388
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1,000 doses (3-100 spheres)
2,500 doses (3-100 spheres)
5,000 doses (3-100 spheres)
10,000 doses (3-400 spheres)
4.
ROUTE(S) OF ADMINISTRATION
See package leaflet.
5.
WITHDRAWAL PERIOD(S)
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
17
PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
LABEL - SOLVENT VIALS
1.
NAME OF THE VETERINARY PRODUCT
Solvent Oculo/Nasal
2.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
35 ml
3.
ROUTE OF ADMINISTRATION
Read the vaccine package before use.
4.
STORAGE CONDITIONS
Store below 25 °C.
Do not freeze.
5.
BATCH NUMBER
Lot
6.
EXPIRY DATE
EXP
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
NOBILIS IB PRIMO QX LYOPHILISATE AND SOLVENT FOR OCULONASAL SUSPENSION
FOR CHICKENS
NOBILIS IB PRIMO QX LYOPHILISATE FOR OCULONASAL SUSPENSION FOR
CHICKENS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension
for chickens
Nobilis IB Primo QX lyophilisate for oculonasal suspension for
chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of reconstituted vaccine contains:
Live attenuated avian infectious bronchitis virus, strain D388: 10
4.0
– 10
5.5
EID
50
1
1
50% egg infective dose.
Lyophilisate: Off white, predominantly sphere shaped.
Solvent (Solvent Oculo/Nasal): blue-coloured solution.
4.
INDICATION(S)
For
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension
for chickens
Nobilis IB Primo QX lyophilisate for oculonasal suspension for
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live attenuated avian infectious bronchitis virus, strain D388: 10
4.0
– 10
5.5
EID
50
1
1
50% egg infective dose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for oculonasal suspension
Lyophilisate for oculonasal suspension.
Lyophilisate: Off white, predominantly sphere shaped.
Solvent (Solvent Oculo/Nasal): blue-coloured solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens in order to reduce respiratory
signs of avian infectious bronchitis
caused by QX-like variants of infectious bronchitis virus (IBV).
Onset of immunity: 3 weeks.
Duration of immunity: 8 weeks.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
The vaccine virus is capable of spreading to in contact birds for a
minimum of 20 days after
vaccination and appropriate care should be taken to separate
vaccinated from non-vaccinated chickens.
Precautionary measures should be taken to prevent spreading to
wildlife. The premises must be
cleaned and disinfected after each production round.
This vaccine should only be used after it has been established that
the QX-like IBV variant strain is
epidemiologically relevant. It is important to avoid introduction of
the IB D388 vaccine virus into
premises in which the wild type strain is not present. The IB D388
vaccine should only be applied in
3
hatcheries to chickens from 1 day of age or older if adequate controls
are in place to avoid the spread
of the vaccine virus to birds that will be transported to non-IB QX
exposed flocks.
The vaccine has been demonstr
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