Nobilis Influenza H5N6
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
15
authorised
no
Medicinal
Medicinal product no longer authorised
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 H5N6 Emulsion for injection
On dose of 0.5 ml contains:
Inactivated whole avian influenza virus 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.
Adjuvant: Liquid paraffin
For active immunisation of chickens against avian influenza type A, subtype H5.
Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two 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.
None.
Medicinal product no longer authorised
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.
Chickens.
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 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.
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.
Zero days
Keep out of the reach and sight of children. Store 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.
Medicinal product no longer authorised
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 safety in ducks are available. 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 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 the relevance of these antibodies to protection is not known.
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.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
18.08.2009
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) https://www.emea.europa.eu
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 test to detect neuraminidase antibodies.
Medicinal product no longer authorised
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.