ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Nobilis IB 4-91, lyophilisate for suspension
2.
Each vial contains per dose:
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 a full list of excipients, see section 6.1
3.
Lyophilisate for suspension.
4.
Chickens
Active immunisation of chickens to reduce the respiratory signs of Infectious Bronchitis caused by the
variant strain IB 4-91.
Future layers and breeders should not be vaccinated before 3 weeks of age.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT)
vaccine given within 7 days; therefore this vaccination scheme is contraindicated.
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.
Only healthy animals should be vaccinated.
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
2/17
relevant in the area. Care should be taken to avoid the introduction of the variant strain into an area
where it is not present.
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
None.
Vaccination with Nobilis IB 4-91 may induce mild respiratory signs of disease which may persist for a
few days depending on the health and condition of the chickens.
Nobilis IB4-91 has been shown to be safe in layers and breeders during lay.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT)
vaccine given within 7 days.
At least 3.6 log
10
EID
50
(1 dose) per animal by either spray vaccination, drinking water or
intranasal/ocular administration. Where the number of chickens is between the standard dosages, the
next higher dosage should be used.
Guideline:
Broiler: The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by
intranasal/ocular administration. The vaccine can be administered to 7-day and older chickens by
drinking water. For prolonged immunity, chickens should be revaccinated every 6 weeks after the
initial administration.
Future layers and breeders: The vaccine can be administered to future layers and breeders from three
weeks of age onwards via intranasal/ocular route, coarse spray or drinking water.
Spray method:
The vaccine should preferably be dissolved in distilled water or alternatively in cool,
clean water. The appropriate number of vials should be opened under water. The volume of water for
reconstitution should be sufficient to ensure an even distribution when sprayed onto the chickens. This
will vary according to the age of the chickens being vaccinated and the management system, but 250
to 400 ml of water per 1 000 doses is suggested. The vaccine suspension should be spread evenly over
the correct number of chickens, at a distance of 30-40 cm using a coarse spray, preferably when the
chickens are sitting together in dim light. The spray apparatus should be free from sediments,
corrosion and traces of disinfectants and ideally should be used for vaccination purposes only.
Drinking water:
The vials should be opened under water. Use cool, clean water to dissolve the
vaccine. For administration of the vaccine, as a general rule, dissolve 1 000 doses in one litre per age
in days up to a maximum volume of 20 litres per 1 000 doses. For heavy breeds, or in hot weather, the
quantity of water may be increased up to 40 litres per 1 000 doses. By adding approximately 2 grams
of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its
activity longer.
Ensure that all the vaccine suspension is consumed within 1-2 hours. The vaccine should be given in
the early morning as this is the main period of water intake or during the cool period on a hot day.
Feed should be available when vaccinating. Water should be withheld before vaccination to make the
chickens thirsty. The length of time of water deprivation is strongly dependent on the climatological
3/17
circumstances. Water withholding should be kept as short as possible with a minimum of half an hour.
A sufficient number of water containers to provide adequate drinking space is essential. These should
be clean and free from traces of detergents and disinfectants.
Turn on mains water when all the vaccine water has been consumed.
Intranasal/ocular administration:
Dissolve the vaccine in physiological saline solution or sterile
distilled water (usually 30 ml per 1 000 doses, 75 ml per 2 500 doses) and administer by means of a
standardized dropper. One drop should be applied onto one nostril or one eye. Ensure that the nasal
drop is inhaled before freeing the bird.
Ocular/intranasal administration or coarse spray, give the best responses and these should be the
methods of choice, especially when vaccinating young chickens.
Vaccination programme:
The veterinarian should determine the optimum vaccination schedule according to the local situation.
Ten times the maximum dose was shown to be safe for the target species by all the recommended
routes and methods of administration.
4.11 Withdrawal period
Zero days.
5.
ATC vet code: QI01AD07.
Active immunisation against avian Infectious Bronchitis virus variant strain IB 4-91 which causes
infectious bronchitis in chickens.
6.
6.1 List of excipients
Sorbitol, gelatine, pancreatic digest of casein, disodium phosphate, water for injections
6.2 Incompatibilities
Do not mix with any other medicinal product..
6.3 Shelf life
In freeze-dried form: 9 months at 2°C to 8°C.
After reconstitution: The vaccine should be used within 2 hours.
6.4 Special precautions for storage
Store at 2-8°C. Protect from light. Do not freeze.
4/17
6.5 Nature and composition of immediate packaging
A 10 ml vial of Type II hydrolytic glass containing 500, 1 000, 2 500, 5 000 or 10 000 doses of freeze-
dried vaccine. The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium
cap. The product is presented as a single vial or in multipacks of 10 vials of the same dosage.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials, derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
approved for use by the competent authorities.
7.
Intervet International B.V.
Wim de Körverstraat 35
5831 AN BOXMEER
The Netherlands
EU/2/98/006/001-010
9.
9 June 1998
21.05.2008
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of Nobilis IB 4-91 is/or may be prohibited in certain Member
States on the whole or part of its territory pursuant to national animal health policy. Any person
intending to import, sell, supply and/or use Nobilis IB 4-91 has to consult the relevant Member State’s
competent authorities on the current vaccination policies prior to the import, sale, supply and/or use.
5/17
ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
6/17
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance(s)
Intervet International
Wim de Körverstraat 35,
5831 AN Boxmeer,
The Netherlands
Name and address of the manufacturer responsible for batch release
Intervet International
Wim de Körverstraat 35,
5831 AN Boxmeer,
The Netherlands
B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING
RESTRICTIONS REGARDING SUPPLY AND USE
Veterinary Medicinal product subject to medical prescription.
C. PROHIBITION OF SALE, SUPPLY AND/OR USE
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council,
Member States prohibit or may prohibit the import, sale, supply and/or use of Nobilis IB 4-91 on the
whole or part of their territory if it is established that:
a) the administration of the veterinary medicinal product to animals will interfere with the
implementation of national programmes for the diagnosis, control and eradication of animal
diseases, or will cause difficulties in certifying the absence of contamination in live animals or
in foodstuffs or other products obtained from treated animals.
b) the disease to which the veterinary medicinal product is intended to confer immunity is
D. STATEMENT OF THE MRLs
Not applicable
7/17
largely absent from the territory.
ANNEX III
LABELLING AND PACKAGE LEAFLET
8/17
A. LABELLING
9/17
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Nobilis IB 4-91, lyophilisate for suspension
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Live attenuated Infectious Bronchitis Virus strain 4-91
≥
3.6 log
10
EID
50
. *
* EID
50
= 50% Embryo infective dose
3.
Lyophilisate for suspension.
4.
PACKAGE SIZE
1 x 500/1000/2500/5000/10000 doses
10 x 500/1000/2500/5000/10000 doses
5.
Chickens.
6.
INDICATION
Vaccine against avian Infectious Bronchitis
7.
METHOD AND ROUTES OF ADMINISTRATION
For intranasal/ocular, spray or drinking water administration.
8.
Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
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.
Read package leaflet before use.
10/17
10. EXPIRY DATE
{month/year}
11. SPECIAL STORAGE CONDITIONS
Store at 2-8°C. Protect from light. Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS,
IF ANY
Read package leaflet before use.
13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
Keep out of reach and sight of children.
Intervet International B.V.
16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
EU/2/98/006/001-010
17. MANUFACTURER'S BATCH NUMBER
Lot
11/17
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Nobilis IB 4-91
2.
QUANTITY OF ACTIVE SUBSTANCE
>
3.6 log
10
EID
50
IBV per dose
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
500/1000/2500/5000/10000 doses
4.
ROUTES OF ADMINISTRATION
intranasal/ocular, spray or drinking water
5. WITHDRAWAL PERIOD
Withdrawal period: Zero days
6.
BATCH NUMBER
.
Lot
7.
EXPIRY DATE
EXP.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only
12/17
B. PACKAGE LEAFLET
13/17
PACKAGE LEAFLET FOR:
Nobilis IB4-91, lyophilisate for suspension
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder and manufacturer:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
Nobilis IB 4-91
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
. *
* EID
50
= 50% Embryo infective dose: the titre required to infect 50% of the embryos inoculated
with the virus.
4.
INDICATION(S)
Active immunisation of chickens to reduce the respiratory signs of Infectious Bronchitis caused by the
variant strain IB 4-91.
5.
Future layers and breeders should not be vaccinated before 3 weeks of age.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT)
vaccine given within 7 days; therefore this vaccination scheme is contraindicated.
6.
ADVERSE REACTIONS
Vaccination with Nobilis IB 4-91 may induce mild respiratory signs which may persist for a few days
depending on the health and condition of the chickens.
7. TARGET SPECIES
Chickens
14/17
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
At least 3.6 log
10
EID
50
(1 dose) per animal by either spray vaccination, drinking water or
intranasal/ocular administration. Where the number of chickens is between the standard dosages, the
next higher dosage should be used.
Broiler: The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by
intranasal/ocular administration. The vaccine can be administered to 7-day and older chickens by
drinking water. For prolonged immunity, chickens should be revaccinated every 6 weeks after the
initial administration.
Future layers and breeders: The vaccine can be administered to future layers and breeders from three
weeks of age onwards via intranasal/ocular route, coarse spray or drinking water.
Spray method:
The vaccine should preferably be dissolved in distilled water or alternatively in cool,
clean water. The appropriate number of vials should be opened under the water. The volume of water
for reconstitution should be sufficient to ensure an even distribution when sprayed onto the chickens.
This will vary according to the age of the chickens being vaccinated and the management system, but
250 to 400 ml of water per 1 000 doses is suggested. The vaccine suspension should be spread evenly
over the correct number of chickens, at a distance of 30-40 cm using a coarse spray, preferably when
the chickens are sitting together in dim light. The spray apparatus should be free from sediments,
corrosion and traces of disinfectants and ideally should be used for vaccination purposes only.
Drinking water:
The vials should be opened under water. Use cool, clean water to dissolve the
vaccine. For administration of the vaccine, as a general rule, dissolve 1 000 doses in one litre per age
in days up to a maximum volume of 20 litres per 1 000 doses. For heavy breeds, or in hot weather, the
quantity of water may be increased up to 40 litres per 1 000 doses. By adding approximately 2 grams
of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its
activity longer. Ensure that all the vaccine suspension is consumed within 1-2 hours. The vaccine
should be given in the early morning as this is the main period of water intake or during the cool
period on a hot day. Feed should be available when vaccinating. Water should be withheld before
vaccination to make the chickens thirsty. The length of time of water deprivation is strongly dependent
on the climatological circumstances. Water withholding should be kept as short as possible with a
minimum of half an hour. A sufficient number of water containers to provide adequate drinking space
is essential. These should be clean and free from traces of detergents and disinfectants.
Turn on mains water when all the vaccine water has been consumed.
Intranasal/ocular administration:
Dissolve the vaccine in physiological saline solution or sterile
distilled water (usually 30 ml per 1 000 doses, 75 ml per 2 500 doses) and administer by means of a
standardized dropper. One drop should be applied onto one nostril or one eye. Ensure that the nasal
drop is inhaled before freeing the bird.
Ocular/intranasal administration or coarse spray give the best responses and these should be the
methods of choice, especially when vaccinating young chickens.
Vaccination programme:
The veterinarian should determine the optimum vaccination schedule according to the local situation.
9.
ADVICE ON CORRECT ADMINISTRATION
Since the stability of IBV in suspension may be low due to sensitivity to high temperatures and
impurities, water used for dissolving the freeze-dried vaccine should be cool and of good quality. By
adding skimmed milk to the drinking water the vaccine virus retains its activity longer. Only skimmed
milk should be used, since fat in whole milk may block the automatic drinking systems as well as
reduce vaccine virus efficacy.
15/17
Only healthy chickens should be vaccinated.
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. Chickens
should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local
IB vaccination programme.
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.
Do not mix or administer with other products.
Wash and disinfect hands and equipment after vaccinating.
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Store at 2-8°C. Protect from light. Do not freeze.
The vaccine should be used within 2 hours after reconstitution and should not be stored.
12. SPECIAL WARNING(S)
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.
Nobilis IB4-91 has been shown to be safe in layers and breeders during lay.
Ten times the maximum dose was shown to be safe for the target species by all the recommended
routes and methods of administration.
The vaccine virus may spread from vaccinated to non-vaccinated chickens and appropriate care should
be taken to separate vaccinated from non-vaccinated. Care should be taken to avoid spread of a
vaccine virus from vaccinated chickens to pheasants.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS,
IF ANY
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
approved for use by the competent authorities.
16/17
14. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
21.05.2008
15. OTHER INFORMATION
Active immunisation against avian Infectious Bronchitis virus variant strain IB 4-91 which causes
infectious bronchitis in chickens.
For animal treatment only.
1/10 x 500/1000/2500/5000/10000 doses
Not all pack sizes my be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the Marketing Authorisation Holder.
17/17
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/nobilis_ib_491_veterinary.html
Copyright © 1995-2021 ITA all rights reserved.