Patient leaflet - Nobilis Influenza H7N1
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
Name and address of the manufacturer responsible for batch release
Intervet International BV Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands
B. CONDITIONS OR RESTRICTIONS OF TH REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
a) the administration of the veterin
implementation of nation diseases, or will cause difficu in foodstuffs or other p
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 o territory if it is established that: ary medicinal product to animals will interfere with the rammes for the diagnosis, control and eradication of animal s in certifying the absence of contamination in live animals or
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.
cable.
ITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH RD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
Other provisions
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/90:
| Pharmacologically active substance | Animal Species |
| 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 MA 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.
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II. ANALYTICAL ASPECTS
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II. C. S TARTING MATERIALS
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II. C.2 Not listed in a Pharmacopoeia
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1. Tryptose: The Applicant should provide a list of any changes to the 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. A revised supporting TSE compliance table should be provided with deletion of the words ‘or equivalent’ after the source companies for the tryptose and NZ-Amines and ‘e.g.’ before the corresponding lists of source countries.
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3. An up-to-date certificate of suitability should be provided for Rousselot Acid hide gelatin (European origin)
II.E. C ONTROL TESTS ON THE FINISHED PRODUCT
II.E.2 Identification and assay of active ingredients
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4. Batch potency test:
A clear justification should be given in support of the proposed pass level of an HI serum titre of 6.0 log2.
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II. F. S TABILITY
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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 of data supporting a longer period of storage.
SAFETY ASPECTS
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6. The report of the overdose safety studies in ducks with Nobilis Influenza H7N1 administered by both s.c. and i.m. routes should be provided as soon as it is available
PHARMACOVIGILANCE ASPECTS
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7. The applicant is required to submit 3-montly Periodic Update Safety reports for the first following the initial use in the field and is additionally required to present a protocol that ensure adequate recording and reporting of field data in relation to suspected adverse including suspected lack of efficacy.
EFFICACY ASPECTS
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8. Batch release data for all batches of H7N1 vaccine used in the efficacy tri
dossier and justification for the potency release criteria should be pr between what might be protective titres of antibodies and the level of a the conditions of the batch potency test should be taken into account an the time of batch release should be sufficient to provide the claimed d
s presented in the
The distinction s generated under nimum potency at
of immunity.
ROUTE(S) OF ADMINISTRATION
7. METH
I.M. or S.C. injection of 0.25, 0.5 ml or 1 ml, depending on the age and species. Read the package leaflet before use.
8. WITHDRAWAL PERIOD
wal period – Zero days
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9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
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10. EXPIRY DATE <EXP {month/year}>
Once broached, use within 8 hours.
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11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C to +8°C). Do not freeze.
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12. SPECIFIC PRECAUTIONS FOR THE WASTE MATERIALS, IF ANY
NUSED PRODUCTS OR
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATM RESTRICTIONS REGARDING SUPPLY
For animal treatment only.
ly
The use of this veterinary medicinal produ established by European Community legislati
NLY” AND CONDITIONS OR
SE, if applicable allowed under the particular conditions
n the control of Avian Influenza.
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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
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
BOTTLE LABEL
{250ml/500ml}
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H7N1 Emulsion for injection
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2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
One dose of 0.5 ml contains:
Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of >6.0 log2 as tested according to the potency test.
Withdrawal period: Zero days
<Lot> {number}
250 ml
500 ml
Adjuvant:
Liquid light paraffin 234.8 mg/0.5 ml
I.M. or S.C. injection
Read the package leaflet before use.
<EXP
Once b
5. WITHDRAWAL PERIO
6. BATCH NUMB
4. ROUTE(S) OF ADMINISTRATION
7. EXPIR
3. CONTENTS BY WEIGHT, BY VOLUME OR
8.
BER OF DOSES
se within 8 hours.
WORDS “FOR ANIMAL TREATMENT ONLY
imal treatment only.
PACKAGE LEAFLET FOR:
Nobilis Influenza H7N1 emulsion for injection
ND OF ATCH
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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
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2. NAME OF THE VETERINARY MEDICIN
Nobilis Influenza H7N1 Emulsion of injection
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
On dose of 0.5 ml contains: Inactivated whole avian influenza vi tigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of >6.0 log2 as tested according to the potency test.
Adjuvant: Liquid paraffin
4. INDICATION
For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.
Efficacy has been ev
-In chickens, reductio
were shown by -In ducks, redu after a sing
ted on the basis of preliminary results in chickens and ringed teals.
f clinical signs, mortality, excretion and transmission of virus after challenge s after a single dose vaccination.
ion of excretion and transmission of virus after challenge were shown by two weeks ccination.
Althou other chick im
not been investigated with this particular AI vaccine strain, studies performed with how that protective levels of serum antibody titres would be expected to persist in at least 12 months after administration of two doses of vaccine. The duration of ducks is unknown.
5. CONTRAINDICATIONS
None.
6. ADVERSE REACTIONS
Safety has been assessed on the basis of results in chickens. A transient diffuse swelli the vaccination site in 50% of the animals, which persists for about 14 days.
Supportive data in ducks suggest that minor local swellings may occur at the inj disappear within 3 weeks.
occur at
ase inform your
ion sites but
If you notice any serious effects or other effects not mentioned in this le veterinary surgeon.
7. TARGET SPECIES
Chickens and ducks
8. DOSAGE FOR EACH SPECIES, ROUTES AND
Chickens
From 8 to 14 days old: 0.25 ml subcutaneously
F ADMINISTRATION
From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly
6 weeks and older: 0.5ml subcutaneously or intr
arly
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.
Ducks
From 2 to 6 weeks: 0.5 ml subcutaneously or intramuscularly.
Laying and breeder stock should get a second vaccination 6–10 weeks after the first vaccination. A dose of 1 ml is advised.
9. ADVICE ON CORRECT ADMINISTRATION
10.
Zero
Allow the vaccin Use sterile
WAL PERIOD
ch a temperature of 15°C-25°C and shake well before use.
needles. It is recommended to use a closed multidose vaccination system.
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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 temp contaminated.
Do not use after the expiry date which is stated on the label.
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12. SPECIAL WARNINGS