ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Vaxxitek HVT+IBD
2.
Each dose of vaccine contains:
Suspension:
Live vHVT013-69 recombinant virus, at least......................................................... 3.6 log10 PFU
Excipient ...........................................................................................................................qs 1 dose
Diluent:
Diluent...............................................................................................................................qs 1 dose
For a full list of excipients, see section 6.1.
3.
Frozen suspension and diluent for injection.
4.
Day-old chickens and 18 days embryonated eggs.
For active immunisation of chickens:
•
To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
The onset of protection is from 2 weeks and the protection extends to 9 weeks.
•
To reduce mortality, clinical signs and lesions of Marek’s disease.
The onset of protection is from 4 days. A single vaccination is sufficient to provide protection
during the risk period.
None.
Apply the usual aseptic precautions to all administration procedures.
As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Safety and reversion to virulence trials have shown that the strain is safe for turkeys. However,
precautionary measures have to be followed in order to avoid direct or indirect contact between
vaccinated chickens and turkeys.
2
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Wear protective gloves and spectacles during the ampoule thawing and opening operations.
Open ampoules holding them at arm’s length in order to prevent any risk of injury should an ampoule
break.
None known.
Do not use in breeding birds and birds in lay.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial
attenuated vaccines against Marek’s disease Rispens strain.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the
same day but not mixed with Merial attenuated vaccines against Newcastle disease and Infectious
bronchitis.
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product except the products mentioned above. A decision to use this vaccine
before or after any other veterinary medicinal product therefore needs to be made on a case by case
basis.
In the absence of specific studies, no other veterinary medicinal product should be administered
concurrently with the product by the
in ovo
route.
4.9.1 Reconstitution of the vaccine
•
Wear protective gloves and spectacles during the ampoule thawing and opening operations.
•
Remove from the liquid nitrogen container only those ampoules which are to be used
immediately.
•
Thaw the contents of the ampoules rapidly by agitation in water at 25-30°C. Proceed
immediately to next step.
•
As soon as they are thawed, open ampoules holding them at arm’s length in order to prevent any
risk of injury should an ampoule break.
•
Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
•
Transfer the suspension into the diluent (Do not use if cloudy).
•
Draw up 2 ml of the contents of the diluent into the syringe.
•
Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent. Repeat
the rinsing operation once or twice.
•
Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of
ampoules to be reconstituted in the diluent; either 1 ampoule of 1,000 doses of vaccine per 200
ml of diluent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of diluent) for subcutaneous
administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of diluent (or 4 ampoules of
2,000 doses of vaccines per 400 ml of diluent) for
in ovo
administration.
•
The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
It should be used immediately after the preparation (all of the diluted vaccine should be used up
within one hour). This is why the vaccine suspension should only be prepared as and when
required.
3
4.9.2
Posology
One single injection of 0.2 ml per chicken at the age of one day, by subcutaneous route.
One single injection of 0.05 ml per chicken egg at 18 days of embryonation, by
in ovo
route.
4.9.3
Method of administration
The vaccine must be administered by subcutaneous route or by
in ovo route
.
For
in ovo
administration, an automated egg injection machine can be used. The device should be
proven to safely and effectively deliver the appropriate vaccinal dose. The instructions for use of this
device should be strictly followed.
None known.
Zero days.
5.
ATCvet code QI01AD15
Live recombinant vaccine against Infectious Bursal Disease and Marek’s Disease.
The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen
(VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70.
The vaccine induces an active immunity and a serological response against Infectious Bursal Disease
and Marek’s Disease in chickens.
6.
6.1 List of excipients
Frozen viral suspension:
Dimethyl sulfoxide
Dilution medium
Diluent:
Sucrose
Casein hydrolysate
Phenol red sodium salt
Salts
6.2 Incompatibilities
Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.
Do not mix with any other veterinary medicinal product except the diluent supplied for use with
the product.
6.3 Shelf life
Shelf-life of the non-reconstituted vaccine: 36 months at –196°C
Shelf-life of the reconstituted vaccine: up to 2 hours at a temperature lower than 25°C.
4
Shelf-life of the diluent in polypropylene bottles: 12 months at a temperature lower than 30°C.
Shelf-life of the diluent in polyvinylchloride bags: 36 months at a temperature lower than 30°C.
6.4. Specialprecautionsforstorage
Store the vaccine in liquid nitrogen.
Store the reconstituted vaccine at a temperature lower than 25°C.
Store the diluent at a temperature lower than 30°C, protected from light. Avoid freezing and excessive
temperatures.
6.5 Nature and composition of immediate packaging
-
(glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
-
(glass) ampoule of 2,000 doses of vaccine, 4-ampoule carrier.
Ampoule carriers are stored in canister, and in liquid nitrogen containers.
-
(polypropylene) bottle of 200 ml of diluent.
-
(polyvinylchloride) bag of 200 ml of diluent
-
(polyvinylchloride) bag of 400 ml of diluent
-
(polyvinylchloride) bag of 600 ml of diluent
-
(polyvinylchloride) bag of 800 ml of diluent
-
(polyvinylchloride) bag of 1000 ml of diluent
-
(polyvinylchloride) bag of 1200 ml of diluent
-
(polyvinylchloride) bag of 1400 ml of diluent
-
(polyvinylchloride) bag of 1600 ml of diluent
-
(polyvinylchloride) bag of 1800 ml of diluent
-
(polyvinylchloride) bag of 2400 ml of diluent
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances.
Do not re-use opened containers of diluted vaccine.
Destroy unused vaccine contents.
Empty containers or contaminated equipment should be disposed of safely by boiling, incineration or
by immersion in an appropriate disinfectant approved by competent authorities.
7.
MERIAL
29 Avenue Tony Garnier
69007 LYON,
FRANCE
8.
EU/2/02/032/001-002
9.
09/08/2002
5
27.04.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER(S) 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
7
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance(s)
Merial Laboratoire Lyon Gerland,
254 rue Marcel Merieux
69007 Lyon
France
Merial Laboratoire Porte des Alpes
Rue de l'Aviation
69800 Saint Priest
France
Name and address of the manufacturer responsible for batch release
Merial Laboratoire Porte des Alpes
Rue de l'Aviation
69800 Saint Priest
France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE 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 the veterinary medicinal
product 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
largely absent from the territory.
D. STATEMENT OF THE MRLs
Pharmacologically active
substance
Animal Species
Other provisions
Dimethyl sulfoxide
Annex II: All food producing
species
Sodium hydrogen carbonate
Annex II (E500ii)
Hydrochloric acid
Annex II: All food producing
species (For use as excipient)
8
Casein hydrolysate
Peptides and proteins naturally
occurring - not within the scope
of Council Regulation 2377/90.
Dipotassium phosphate
Annex II (E340ii)
Potassium dihydrogen
phosphate (momopotassium
phosphate)
Annex II (E340i)
Sodium hydroxide
Annex II(E 524)
Water for injections
Not within the scope of Council
Regulation 2377/90
For the following substances, the data provided by the Applicant were assessed and the substances
considered not to be pharmacologically active at the doses used;
F10 HAM Medium
Phenol red
Gentamicin
9
199 medium
ANNEX III
LABELLING AND PACKAGE INSERT
10
A. LABELLING
11
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{
AMPOULE 1000 and 2000 doses
}
1.
Vaxxitek HVT+IBD
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1000 doses
2000 doses
4.
ROUTE(S) OF ADMINISTRATION
SC or
in ovo
route
5.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
12
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
STERILE DILUENT
1.
STERILE DILUENT
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3.
4.
PACKAGE SIZE
1 bottle of 200 ml
1 bag of 200 ml
1 bag of 400 ml
1 bag of 600 ml.
1 bag of 800 ml.
1 bag of 1000 ml.
1 bag of 1200 ml.
1 bag of 1400 ml.
1 bag of 1600 ml.
1 bag of 1800 ml.
1 bag of 2400 ml
5.
Chickens
6.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet supplied with the vaccine vial before use.
8.
Zero days
13
9.
SPECIAL WARNING(S), IF NECESSARY
Use immediately after preparation.
Do not use if cloudy.
10. EXPIRY DATE
EXP
11. SPECIAL STORAGE CONDITIONS
Store at a temperature lower than 30°C. Avoid freezing or excessive temperatures.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet supplied with the vaccine vial 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 the reach and sight of children.
MERIAL
29 Avenue Tony Garnier
69007 Lyon
France
EU/2/02/032/001
EU/2/02/032/002
17. MANUFACTURER’S BATCH NUMBER
Lot
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
(VACCINE SUSPENSION)
Vaxxitek HVT+IBD
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
MERIAL
29 Avenue Tony Garnier
69007 Lyon, France
Manufacturer for batch release
MERIAL
Laboratory of Lyon Porte des Alpes
Rue de l’Aviation,
F-69800 Saint-Priest
France
2.
Vaxxitek HVT+IBD
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of vaccine contains:
Suspension:
Live vHVT013-69 recombinant virus, at least......................................................... 3.6 log10 PFU
Excipient ...........................................................................................................................qs 1 dose
Diluent:
Diluent...............................................................................................................................qs 1 dose
4.
For active immunisation of chickens:
•
To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
The onset of protection is from 2 weeks and the protection extends to 9 weeks.
•
To reduce mortality, clinical signs and lesions of Marek’s disease.
The onset of protection is from 4 days. A single vaccination is sufficient to provide protection
during the risk period.
5.
Vaccinate only healthy birds.
Do not use in birds in lay and breeding birds.
6.
None known.
16
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Day-old chickens and 18 days embryonated eggs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous or
in ovo
route.
For
in ovo
administration, an automated egg injection machine can be used. The device should be
proven to safely and effectively deliver the appropriate vaccinal dose. The instructions for use of this
device should be strictly followed.
Subcutaneous route: one single injection of 0.2 ml per chicken at the age of one day.
In ovo
route: one single injection of 0.05 ml per egg at 18 days of embryonation.
9.
ADVICE ON CORRECT ADMINISTRATION
•
Wear protective gloves and spectacles during the ampoule thawing and opening operations.
•
Remove from the liquid nitrogen container only those ampoules which are to be used
immediately.
•
Thaw rapidly the contents of the ampoules by agitation in water at 25-30°C. Proceed
immediately to next step.
•
As soon as they are thawed, open ampoules holding them at arm’s length in order to prevent any
risk of injury should an ampoule break.
•
Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
•
Transfer the suspension into the diluent (Do not use if cloudy).
•
Draw up 2 ml of the contents of the diluent into the syringe.
•
Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
Repeat the rinsing operation once or twice.
Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of
ampoules to be reconstituted in the diluent; either 1 ampoule of 1,000 doses of vaccine per 200
ml of diluent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of diluent) for subcutaneous
administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of diluent (or 4 ampoules of
2,000 doses of vaccine per 400 ml of diluent) for
in ovo
administration.
•
The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
It should be used immediately after the preparation (all of the diluted vaccine should be used up
within one hour). This is why the vaccine suspension should only be prepared as and when
required
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store the vaccine in liquid nitrogen.
Do not use after the expiry date stated on the ampoule.
17
12. SPECIAL WARNING(S)
Apply the usual aseptic precautions to all administration procedures.
As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Safety and reversion to virulence trials have shown that the strain is safe for turkeys. However,
precautionary measures have to be followed in order to avoid direct or indirect contact between
vaccinated chickens and turkeys.
Wear protective gloves and spectacles during the ampoule thawing and opening operations.
Open ampoules holding them at arm’s length in order to prevent any risk of injury should an ampoule
break.
Do not use in breeding birds and birds in lay.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial
attenuated vaccines against Marek’s disease Rispens strain.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the
same day but not mixed with Merial attenuated vaccines against Newcastle disease and Infectious
bronchitis.
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product except the products mentioned above. A decision to use this vaccine
before or after any other veterinary medicinal product therefore needs to be made on a case by case
basis.
In the absence of specific studies, no other veterinary medicinal product should be administered
concurrently with the product by the
in ovo
route.
Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.
Do not mix with any other veterinary medicinal product except the diluent supplied for use with the
product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances.
Do not re-use opened containers of diluted vaccine.
Destroy unused vaccine contents.
Empty containers or contaminated equipment should be disposed of safely, by boiling, incineration or
immersion in an appropriate disinfectant approved for use by the competent authorities.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
27.04.2010
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/
15. OTHER INFORMATION
Live recombinant vaccine against Infectious Bursal Disease and Marek’s Disease.
The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen
(VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70.
The vaccine induces an active immunity and a serological response against Infectious Bursal Disease
and Marek’s Disease in chickens.
18
-
(glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
-
(glass) ampoule of 2,000 doses of vaccine, 4-ampoule carrier.
Ampoule carriers are stored in canister, and in liquid nitrogen containers.
-
(polypropylene) bottle of 200 ml of diluent.
-
(polyvinylchloride) bag of 200 ml of diluent
-
(polyvinylchloride) bag of 400 ml of diluent
-
(polyvinylchloride) bag of 600 ml of diluent
-
(polyvinylchloride) bag of 800 ml of diluent
-
(polyvinylchloride) bag of 1000 ml of diluent
-
(polyvinylchloride) bag of 1200 ml of diluent
-
(polyvinylchloride) bag of 1400 ml of diluent
-
(polyvinylchloride) bag of 1600 ml of diluent
-
(polyvinylchloride) bag of 1800 ml of diluent
-
(polyvinylchloride) bag of 2400 ml of diluent
Not all pack sizes may be marketed.
Veterinary medicinal product subject to prescription.
19
PACKAGE LEAFLET
STERILE DILUENT
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
MERIAL
29 avenue Tony Garnier
69007 Lyon, France
Manufacturer for the batch release
:
MERIAL
Laboratory of Lyon Porte des Alpes
Rue de l’Aviation,
F-69800 Saint-Priest
France
2.
STERILE DILUENT
3.
None known.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
4.
Chickens.
5.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Read the package leaflet supplied with the vaccine vial.
6.
ADVICE ON CORRECT ADMINISTRATION
Frozen vaccines:
•
Wear protective gloves and spectacles during the ampoule thawing and opening operations.
•
Remove from the liquid nitrogen container only those ampoules which are to be used
immediately.
•
Thaw rapidly the contents of the ampoules by agitation in water at 25-30°C. Proceed
immediately to next step.
•
As soon as they are thawed, open ampoules holding them at arm’s length in order to prevent any
risk of injury should an ampoule break.
•
Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
•
Transfer the suspension into the diluent.
20
•
Draw up 2 ml of the contents of the diluent into the syringe.
•
Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent. Repeat
the rinsing operation once or twice.
•
Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of
ampoules to be reconstituted in the diluent; either 1 ampoule of 1,000 doses of vaccine per 200
ml of diluent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of diluent) for subcutaneous
administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of diluent (or 4 ampoules of
2,000 doses of vaccine per 400 ml of diluent) for
in ovo
administration.
•
The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
It should be used immediately after the preparation (all of the diluted vaccine should be used up
within one hour). This is why the vaccine suspension should only be prepared as and when
required.
7.
Zero days.
8.
SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store at a temperature lower than 30°C. Avoid freezing or excessive temperatures
9.
SPECIAL WARNING(S)
Use immediately after preparation.
Do not use if cloudy.
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused container or waste materials should be disposed of in accordance with the local
requirements.
11. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
27.04.2010
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/.
12. OTHER INFORMATION
This diluent may be used with the following products:
Vaxxitek HVT+IBD (EU/2/02/032/001-002)
21
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/vaxxitek_hvtibd_veterinary.html
Copyright © 1995-2021 ITA all rights reserved.