Patient leaflet - Nobilis Influenza H5N6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H5N6 emulsion for injection for chickens
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5ml contains:
n influenza type A, subtype H5.
ain H5N6, tency test.
Active substance:
Inactivated whole avian influenza virus antigen of H5 sub
A/duck/Potsdam/2243/84), inducing an HI titre of >6.0 log2 as tested according
Adjuvant:
Liquid light paraffin 234.8 mg/0.5 ml
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Emulsion for injection
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4. CLINICAL PARTICULARS
4.1 Target species
Chickens
4.2 Indications for use, specifying the target
For active immunisation of chickens agai
Reduction of clinical signs, mortali strain, were shown by two weeks
Serum antibodies have been sh with other vaccine strains sho least 12 months after administra
and excretion of virus after challenge with a virulent H5N1 ingle dose vaccination.
ersist in chickens for at least 7 months and studies performed serum antibodies would be expected to persist in chickens for at of two doses of vaccine.
None
4.3 Contraindicatio
4.4 Special w
for each target species
This availa shoul to
cy attained may vary depending on the degree of antigenic homology between the circulating field strains.
s been tested for safety in chickens. and some supportive data for safety in ducks are sed in other avian species that are considered at risk of infection, its use in these species dertaken with care and it is advisable to test the vaccine on a small number of birds prior
The level of vaccine str
accination. The level of efficacy for other species may differ from that observed in chickens. ine has been shown to induce antibodies in ducks to the homologous virus by four weeks wo doses and these persist for at least six months but the relevance of these antibodies to ction is not known.
4.5 Special precautions for use
uct to
Special precautions for use in animals
None
Special precautions to be taken by the person administering the veterinary medicin 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 medica nation, seek medical advice again.
To the physician:
ted, accidental injection with ischaemic necrosis and even
may necessitate early incision of finger pulp or tendon.
This product contains mineral oil. Even if small amounts have bee this product can cause intense swelling, which may, for example, the loss of a digit. Expert, PROMPT, surgical attention is require and irrigation of the injected area, especially where there is i
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4.6 Adverse Reactions (frequency and seriousness)
A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
4.7 Use during pregnancy, lactation or la
No information is available on the safety of this vaccine for birds in lay.
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4.8 Interactions with other medicinal products and other forms of interaction
No information is available on veterinary medicinal product. A medicinal product therefore nee
4.9 Amounts to be administ
and administration route
and efficacy of this vaccine when used with any other ion to use this vaccine before or after any other veterinary 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 multidose vaccination system.
Chickens
From 8–14
From
ld: 0.25 ml subcutaneously
to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly nd older: 0.5 ml subcutaneously or intramuscularly 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.
H5.
ent to the N6 included in the ted birds by using a diagnostic
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a double dose no adverse reactions other than those section 4.6 have been observed.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: inactivated vaccine, ATC-vet code: QI01
The vaccine stimulates active immunity against Avian Influenza vi
If the circulating avian influenza field virus has a different N co vaccine, it may be possible to differentiate between vaccinate test to detect neuraminidase antibodies.
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6. PHARMACEUTICAL PARTICULARS
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 refrigerated (2°C to 8°C). Do not freeze.
6.5 Nature and composition of immediate packaging
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, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
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8. MARKETING AUTHORISATION NUMBER
AUTHORISATION
EU/2/07/076/001–004
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9. DATE OF FIRST AUTHORISATION/ RENEWA 31.01.2008
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10. DATE OF REVISION OF THE TEXT 18.08.2009
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use o Member States on the whole or part o person intending to import, sell, suppl
Member State’s competent supply and/or use.
authority
lis Influenza H5N6 is or may be prohibited in certain neir territory pursuant to national animal health policy. Any d/or use Nobilis Influenza H5N6 must consult the relevant the current vaccination policies prior to the import, sale,
The use of this veterinary by the European Communi
.europa.eu
product is only allowed under the particular conditions established islation on the control of Avian Influenza.
Detailed information on thi
(EMEA) http://www.
oduct is available on the website of the European Medicines Agency
A.
ANNEX II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
B.
C.
STATEMENT
D.
E.
CONDITIONS OR RE AUTHORISATION
RLs
IONS OF THE MARKETING
EGARD TO SAFE AND EFFECTIVE USE
SPECIFIC O AUTHORIS
IONS TO BE FULFILLED BY THE MARKETING HOLDER
HE MARKETING AUTHORISATION
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A. MANUFACTURERS 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 bate
Intervet International BV Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
a) the administration implementation o diseases, or will
To be supplied only on veterinary pres
According to Article 71 of Direct amended, Member States prohibit medicinal product on the whole
2/EC of the European Parliament and of the Council as prohibit the import, sale, supply and/or use of the veterinary of their territory if it is established that:
in foodstuffs or oth
terinary medicinal product to animals will interfere with the al programmes for the diagnosis, control and eradication of animal use difficulties in certifying the absence of contamination in live animals or
oducts obtained from treated animals.
b) the diseas absent
medicinal product is intended to confer immunity is largely
The use of established
pla
The holde
terinary medicinal product is only allowed under the particular conditions ropean Community legislation on the control of Avian Influenza.
f this marketing authorisation must inform the European Commission about the marketing e medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION W REGARD TO SAFE AND EFFECTIVE USE
Not applicable.
D. STATEMENT OF THE MRLs
The following substances contained in the final product are included in Annex II of Counci Regulation (EEC) No 2377/90:
| Pharmacologically active substance | Animal Species | Other provisions |
| Light liquid paraffin Polysorbate 80 Sorbitan mono oleate (E494) Glycine | All food producing species All food producing species All food producing species All food producing species |
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. The specified timeframe for all specific obligations is that a first update on the progress of the fulfilment of the specific obligations is expected to be received by the CVMP by 1 October 2007.
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II. ANALYTICAL ASPECTS
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1. Tryptose: The Applicant should provide a list of suitable source countries for the pigs used as a source of the porcine starting material in tryptose.
Specific Measures concerning the prevention of the transmission of animal spongiform encephalopathies
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2. Tryptose and NZ-Amines: The use of unspecified countries of origin of the cows providing the milk and unspecified suppliers of the tryptose and NZ-Amine is not considered acceptable. Up-to-date information should be provided on the source countries of origin of the animals supplying the milk for preparation of the Tryptose from BD Biosciences and for the preparation of the casein, and lactose where appropriate, for manufacture of the NZ-Amines purchased from Quest/Kerry. The Applicant should agree to specify the NZ-Amine(s) used in production and only to source Tryptose and these specified NZ-Amine(s) from specified companies from whom suitable ‘milk statements’ have been submitted in the dossier, together with details of the countries of origin of the source animals.
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II.E. C ONTROL TESTS ON THE FINISHED PRODUCT
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II.E.2 Identification and assay of active ingredients
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3. 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 should be provided.
II.E.9 Batch to batch consistency
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4. Results should be provided for final product tests on three batches of Nobilis Influenza H5N6, to demonstrate batch consistency.
II. F.
Stability
II.F.1 Stability of the bulk antigen
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5. The antigen should be stored for no longer than 12 months at 2–8°C pending the provision supporting a longer period of storage.
PHARMACOVIGILANCE ASPECTS
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6. The Applicant is required to submit 3-montly Periodic Update Safety repo following the initial use in the field and is additionally required to presen ensure adequate recording and reporting of field data in relation to susp including suspected lack of efficacy.
first 2 years tocol that would verse reactions
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON
{250ml Bottle / 500ml Bottle}
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H5N6 Emulsion for injection
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
One dose of 0.5 ml contains:
Inactivated whole avian influenza virus antigen of
A/duck/Potsdam/2243/84), inducing an HI titre of >6.0 log2 as tester
subtype (strain H5N6, ding to the potency test.
Adjuvant:
Liquid light paraffin 234.8 mg/0.5 ml
3. PHARMACEUTICAL FORM
Emulsion for injection
7. METHOD A ND ROUTE(S) OF ADMINISTRATION
Intramuscular or subcutaneous injection of 0.25 or 0.5 ml, depending on the age. Read the package leaflet before use.
8.
wal 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 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
For animal treatment only.
The use of this veterinary medicinal produ established by European Community legislati
ly
allowed under the particular conditions
n 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 childre
15. NAME AND ADDRE
16. MARK
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
EU/2/07/07
17.
THE MARKETING AUTHORISATION HOLDER
AUTHORISATION NUMBER(S)
FACTURER’S BATCH NUMBER
(strain H5N6, to the potency test.
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
BOTTLE LABEL
{250ml/500ml}
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H5N6 Emulsion for injection
2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
Withdrawal period: Zero days
<Lot> {number}
250 ml
500 ml
Intramuscular or subcutaneous injection Read the package leaflet before use.
Adjuvant:
Liquid light paraffin 234.8 mg/0.5 ml
<EXP
Once b
5. WITHDRAWAL PERIO
6. BATCH NUMB
4. ROUTE(S) OF ADMINISTRATION
7. EXPIR
3. CONTENTS BY WEIGHT, BY VOLUME OR
One dose of 0.5 ml contains:
Inactivated whole avian influenza virus antigen of H
A/duck/Potsdam/2243/84), inducing an HI titre of >6.0 log2 as tested ac
8.
BER OF DOSES
se within 8 hours.
WORDS “FOR ANIMAL TREATMENT ONLY
imal treatment only.
PACKAGE LEAFLET FOR:
Nobilis Influenza H5N6 emulsion for injection
ODUCT
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLD THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE 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
2. NAME OF THE VETERINARY MEDICIN
Nobilis Influenza H5N6 Emulsion for injection
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
D OF
ATCH
On dose of 0.5 ml contains:
Inactivated whole avian influenz s antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of >6.0 log2 as tested according to the potency test.
4. INDICATION
Adjuvant: Liquid paraffin
For active immunisation of chickens against avian influenza type A, subtype H5.
Reduction of clinica strain, were show
s, mortality and excretion of virus after challenge with a virulent H5N1 weeks after a single dose vaccination.
Serum antibodies have been shown to persist in chickens for at least 7 months. Studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
5.
RAINDICATIONS
6. ADVERSE REACTIONS
our
ISTRATION
cularly
Safety has been assessed on the basis of results in chickens. A transient diffuse swelling may o 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 i veterinary surgeon.
7. TARGET SPECIES
Chickens.
8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF
For subcutaneous or intramuscular use.
Chickens
From 8–14 days old: 0.25 ml subcutaneously
From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or i
6 weeks and older: 0.5ml subcutaneously or intramuscula
Future laying hens and breeders should get a second va
n 4–6 weeks after first vaccination
TION
No information is available on vaccination i Immunisation of progeny from vaccinated birds declined.
the presence of maternally derived antibodies. erefore be delayed until such antibodies have
9. ADVICE ON CORRECT ADMI
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 multidose vaccination system.
10.
Zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the re Store at +2°C to + After broaching, contaminated.
Do not u
sight of children.
. Do not freeze.
within 8 hours, provided the product is not subject to extreme temperatures or
e expiry date which is stated on the label.
12. SPECIAL WARNINGS
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
This vaccine has been tested for safety in chickens and only some supportive data for safet cks
are available. If used in other avian species that are considered at risk of infection, its u ese
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 vaccine has been shown to induce antibodies in ducks to the homologous virus by
four weeks after two doses and these persist for at least six months but antibodies to protection is not known.
No information is available on the safety of this vaccine for birds in lay.
nce of these
No information is available on the safety and efficacy of this vaccine veterinary medicinal product. A decision to use this vaccine before or medicinal product therefore needs to be made on a case by case basis.
used with any other any other veterinary
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 seek prompt medical advice even if only a very sma with you. If pain persists for more than 12 hours after medi
e accidentally injected with this product, is injected and take the package leaflet 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.
Ask your veterinary surgeon help to protect the environme
13. SPECIAL PRECAUTIO MATERIALS, IF ANY
R THE DISPOSAL OF UNUSED PRODUCT OR WASTE
ispose of medicines no longer required. These measures should
14. DATE ON WHI
E PACKAGE LEAFLET WAS LAST APPROVED
18.08.2009
Detailed information on this product is available on the website of the European Medicines Agency (EMEA)
15.
NFORMATION
If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic tect 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.
Not all pack sizes may be marketed.
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.
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