Summary of medicine characteristics - Nobilis Influenza H5N6
1.
Nobilis Influenza H5N6 emulsion for injection for chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5ml contains:
n influenza type A, subtype H5.
ain H5N6, tency test.
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
3. PHARMACEUTICAL FORM
Emulsion for injection
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
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
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.
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.
6. PHARMACEUTICAL PARTICULARS6.1 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
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
8. MARKETING AUTHORISATION NUMBER
AUTHORISATION
EU/2/07/076/001–004