Nobilis IB 4-91
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-02-2019
Produktets egenskaber
(SPC)
11-02-2019
Offentlige vurderingsrapport
(PAR)
08-07-2015
Aktiv bestanddel:
live attenuated avian infectious bronchitis virus variant strain 4-91
Tilgængelig fra:
Intervet International BV
ATC-kode:
QI01AD07
INN (International Name):
live attenuated vaccine against avian infectious bronchitis
Terapeutisk gruppe:
Chicken
Terapeutisk område:
IMMUNOLOGICALS FOR AVES
Terapeutiske indikationer:
Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.
Produkt oversigt:
Revision: 13
Autorisation status:
Authorised
Autorisation dato:
1998-06-08
Indlægsseddel
15
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL – LYOPHILISATE CUPS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB 4-91
2.
QUANTITY OF ACTIVE SUBSTANCE
Live IBV, 4-91
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
1,000 doses (3-100 spheres)
2,500 doses (3-100 spheres)
5,000 doses (3-100 spheres)
10,000 doses (3-100 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.
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
NOBILIS IB4-91 LYOPHILISATE FOR SUSPENSION FOR CHICKENS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, 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 4-91 lyophilisate for suspension for chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Live attenuated infectious bronchitis virus variant strain 4-91:
3.6 log
10
EID
50
* per dose
* EID
50
: 50% embryo infective dose - the titre required to infect 50% of the
embryos inoculated with the virus.
Lyophilisate
Vials: off-white/cream-coloured pellet.
Cups: off-white, predominantly sphere shaped.
4.
INDICATION(S)
Active immunisation of chickens to reduce the respiratory signs of
infectious bronchitis caused by the
variant strain IB 4-91.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
In laboratory studies and field trails:
Vaccination with Nobilis IB 4-91 may very commonly induce mild
respiratory signs of disease which
may persist for a few days depending on the health and condition of
the chickens.
In post marketing experience:
In very rare cases mild respiratory signs of disease are reported.
The frequency of adverse reactions is defined using the following
convention:
- very commo
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB 4-91 lyophilisate for suspension for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE
Live attenuated avian infectious bronchitis virus (IBV), variant
strain 4-91:
3.6 log
10
EID
50
*
* EID
50
: 50% embryo infective dose - the virus titre required to produce
infection in 50% of the
embryos inoculated.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension
Vials: off-white/cream-coloured pellet
Cups: off-white, predominantly sphere shaped
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens to reduce the respiratory signs of
infectious bronchitis caused by the
variant strain IB 4-91.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
The vaccine virus may spread from vaccinated to non-vaccinated
chickens and appropriate care should
be taken to separate vaccinated from non-vaccinated.
Wash and disinfect hands and equipment after vaccinating to avoid
spread of the virus.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Nobilis IB 4-91 is intended to protect chickens against respiratory
signs of disease caused by IBV
variant strain 4-91 only and should not be used as a replacement for
other IBV vaccines. The product
should only be used after it has been established that IBV variant
strain 4-91 is epidemiologically
relevant in the area. Care should be taken to avoid the introduction
of the variant strain into an area
where it is not present.
3
Care should be taken to avoid spread of the vaccine virus from
vaccinated chickens to pheasants.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of spray administration, personal protective equipment
consisting of masks with eye protection
sh
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