ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Nobilis Influenza H5N2 emulsion for injection for chickens
One dose of 0.5ml contains:
Active substance:
Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
Adjuvant:
Liquid light paraffin 234.8 mg/0,5 ml
For a full list of excipients see section 6.1
Emulsion for injection
Chickens
For active immunisation of chickens against avian influenza type A, subtype H5.
Efficacy has been evaluated on the basis of preliminary results in chickens. Reduction of clinical signs,
mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Serum antibodies could be expected to persist for at least 12 months after administration of two doses
of vaccine.
Do not administer intramuscularly in chickens less than 2 weeks old.
This vaccine has been tested for safety in chickens. If used in other avian species that are considered at
risk of infection, its use in these species should be undertaken with care and it is advisable to test the
vaccine on a small number of birds prior to mass vaccination. The level of efficacy for other species
may differ from that observed in chickens.
The level of efficacy attained may vary depending on the degree of antigenic homology between the
vaccine strain and circulating field strains.
2
None
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the
affected finger if prompt medical attention is not given. If you are accidentally injected with this
product, seek prompt medical advice even if only a very small amount is injected and take the package
leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical
advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with
this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even
the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision
and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
4.6 Adverse Reactions (frequency and seriousness)
Safety has been assessed on the basis of results in chickens.
A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for
about 14 days.
No information is available on the safety of this vaccine for birds in lay.
4.8 Interactions with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product. 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.
For subcutaneous or intramuscular use.
Allow the vaccine to reach a temperature of 15°C - 25°C and shake well before use.
Use sterile syringes and needles.
It is recommended to use a closed multiject vaccination system.
From 8-14 days old: 0.25 ml subcutaneously
From 14 days to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly
6 weeks and older: 0.5 ml subcutaneously or intramuscularly
Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
No information is available on vaccination in the presence of maternally derived antibodies.
Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have
declined.
3
Following the administration of a double dose no adverse reactions other than those described in
section 4.6 have been observed.
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: inactivated vaccine, ATC-vet code: QI01AA23
The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H5.
If the circulating avian influenza field virus has a different N component to the N2 included in the
vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic
test to detect Neuraminidase antibodies.
6.1 List of excipients
Liquid light paraffin
Polysorbate 80
Sorbitane mono-oleate
Glycine
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
PET vials: 2 years
Glass vials: 1 year
After broaching, use within 8 hours, provided the product is not subject to extreme temperatures or
contaminated.
6.4 Special precautions for storage
Store and transport refrigerated (2C to 8C). Do not freeze.
6.5 Nature and composition of immediate packaging
250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Not all pack sizes may be marketed.
4
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products, if appropriate
Any unused product or waste material should be disposed of in accordance with national requirements.
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
8. MARKETING AUTHORISATION NUMBER
EU/2/06/061/001-004
9. DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
01.09.2006
05.10.2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of Nobilis Influenza H5N2 is or may be prohibited in certain
Member States on the whole or part of their territory pursuant to national animal health policy. Any
person intending to import, sell, supply and/or use Nobilis Influenza H5N2 must consult the relevant
Member State’s competent authority on the current vaccination policies prior to the import, sale,
supply and/or use.
Detailed information on this product is available on the website of the European Medicines Agency
5
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE 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
E.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
6
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
Intervet International BV
Wim de Korverstraat 35
NL-5831 AN Boxmeer
The Netherlands
Laboratorios Intervet SA
Poligono El Montalvo
Apartado 3006
Salamanca 37080
Spain
Intervet International BV, site De Bilt
Ambachtstraat 4
3732 CN De Bilt
The Netherlands
Name and address of the manufacturer responsible for batch release
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as
amended, 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.
The use of this veterinary medicinal product is only allowed under the particular conditions
established by European Community legislation on the control of Avian Influenza.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable
7
D. STATEMENT OF THE MRLS
The active substance being a principle of biological origin intended to produce active immunity is not
within the scope of Regulation (EC) No 470/2009.
The following constituents of Nobilis Influenza H5N2 are included in Table 1 (Allowed substances) of
the annex to Commission Regulation (EU) No 37/2010 as follows:
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRLs Target
tissues
Other
provisions
Therapeutic
classification
Polysorbate 80 Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Glycine
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Light liquid paraffin is a mineral hydrocarbon while sorbitan mono oleate (E 494) is a substance with
an E number. These constituents of Nobilis Influenza H5N2 are included in Table 1 (Allowed
substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRLs Target
tissues
Other
provisions
Therapeutic
classification
Mineral
hydrocarbons,
low to high
viscosity
including
microcrystalline
waxes,
approximately
C10-C60,
aliphatic,
branched
aliphatic and
alicyclic
compounds
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
Excludes
aromatic and
unsaturated
compounds
No entry
Food additives
(substances
with a valid E
number
approved as
additives in
foodstuffs for
human
consumption)
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
Only
substances
approved as
additives in
foodstuffs for
human
consumption,
with the
exception of
preservatives
listed in part C
of Annex III to
European
Parliament and
Council
Directive
95/2/EC
No entry
8
E.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
The Marketing Authorisation Holder shall complete the following programme of studies within the
specified time frame, the results of which shall form the basis of the annual reassessment of the
benefit/risk profile.
QUALITY ASPECTS
1. Test for identification: A final product batch test should be introduced to identify the
neuraminidase component and confirm that the vaccine has the correct composition. A proposal
is required.
2. The antigen should be stored for no longer than 12 months at 2-8ºC pending the provision of
data supporting a longer period of storage
9
ANNEX III
LABELLING AND PACKAGE LEAFLET
10
A. LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON
{250ml Bottle / 500ml Bottle}
Nobilis Influenza H5N2
Emulsion for injection
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
One dose of 0.5 ml contains:
Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
Adjuvant:
Liquid light paraffin 234.8 mg/0.5 ml
Emulsion for injection
4. PACKAGE SIZE
250 ml
500 ml
5. TARGET SPECIES
Chickens
6. INDICATION(S)
Active immunisation against avian influenza type A, subtype H5.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular or subcutaneous injection of 0.25 to 0.5 ml, depending on the age.
Read the package leaflet before use.
12
8. WITHDRAWAL PERIOD
Withdrawal period - Zero days
9. SPECIAL WARNING(S), IF NECESSARY
Accidental self-injection is dangerous
10. EXPIRY DATE
<EXP {month/year}>
Once broached, use within 8 hours.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C to +8°C). Do not freeze.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
For disposal read the package leaflet.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
The use of this veterinary medicinal product is only allowed under the particular conditions
established by European Community legislation on the control of Avian Influenza.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
13
EU/2/06/061/001-004
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
14
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
BOTTLE LABEL
{250ml/500ml}
Nobilis Influenza H5N2
Emulsion for injection
2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
One dose of 0.5 ml contains:
Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
Adjuvant:
Liquid light paraffin 234.8 mg/0.5 ml
3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
250 ml
500 ml
4. ROUTE(S) OF ADMINISTRATION
Intramuscular or Subcutaneous injection
Read the package leaflet before use.
5. WITHDRAWAL PERIOD
Withdrawal period: Zero days
6. BATCH NUMBER
<Lot> {number}
7. EXPIRY DATE
<EXP {month/year}>
Once broached, use within 8 hours.
15
8. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET FOR
Nobilis Influenza H5N2
emulsion for injection
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer for the batch release:
Intervet International BV
Wim de Körverstraat 35
NL-5831 AN Boxmeer
The Netherlands
Nobilis Influenza H5N2
Emulsion of injection
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
On dose of 0.5 ml contains:
Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
Adjuvant: Liquid paraffin
4. INDICATION
For active immunisation of chickens against avian influenza type A, subtype H5.
Efficacy has been evaluated on the basis of preliminary results in chickens. Reduction of clinical signs,
mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Serum antibodies could be expected to persist for at least 12 months after administration of two doses
of vaccine.
5. CONTRAINDICATIONS
Do not administer intramuscularly in chickens less than 2 weeks old.
18
Safety has been assessed on the basis of results in chickens.
A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for
about 14 days.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7. TARGET SPECIES
Chickens
8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
For subcutaneous or intramuscular use.
From 8-14 days old: 0.25 ml subcutaneously
From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly
6 weeks and older: 0.5ml subcutaneously or intramuscularly
Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination
No information is available on vaccination in the presence of maternally derived antibodies.
Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have
declined.
9. ADVICE ON CORRECT ADMINISTRATION
Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Use sterile syringes and needles. It is recommended to use a closed multiject vaccination system.
10. WITHDRAWAL PERIOD
Zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport at +2°C to +8°C. Do not freeze.
After broaching, use within 8 hours, provided the product is not subject to extreme temperatures or
contaminated.
Do not use after the expiry date which is stated on the label.
12. SPECIAL WARNINGS
This vaccine has been tested for safety in chickens. If used in other avian species that are considered at
risk of infection, its use in these species should be undertaken with care and it is advisable to test the
vaccine on a small number of birds prior to mass vaccination. The level of efficacy for other species
may differ from that observed in chickens.
The level of efficacy attained may vary depending on the degree of antigenic homology between the
vaccine strain and circulating field strains.
19
No information is available on the safety of this vaccine for birds in lay.
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product. 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.
Do not mix with any other veterinary medicinal product.
Special warning for the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the
affected finger if prompt medical attention is not given. If you are accidentally injected with this product,
seek prompt medical advice even if only a very small amount is injected and take the package leaflet
with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with
this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even
the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and
irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
05.10.2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
If the circulating avian influenza field virus has a different N component to the N2 included in the
vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic
test to detect Neuraminidase antibodies.
The use of this veterinary medicinal product is only allowed under the particular conditions
established by European Community legislation on the control of Avian Influenza.
Pack sizes:
250 or 500 ml multidose glass bottle
250 or 500 ml multidose PET bottle
The bottles are closed with a rubber stopper and an aluminium cap.
Not all pack sizes may be marketed.
20
Source: European Medicines Agency
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