Summary of medicine characteristics - Nobilis Influenza H5N2
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H5N2 emulsion for injection for chickens.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5 ml 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 log2 as tested according to the potency test.
Adjuvant:
Liquid light paraffin 234.8 mg
Excipients:
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection.
White homogeneous emulsion.
4. CLINICAL PARTICULARS4.1 Target species
Chickens.
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4.2 Indications for use, specifying the target species
For active immunisation of chickens against avian influenza type A, subtype H5.
Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
4.3 Contraindications
Do not administer intramuscularly in chickens less than 2 weeks old.
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4.4 Special warnings for each target species
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.
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4.5 Special precautions for use
Special precautions for use in animals
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.
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4.6 Adverse reactions (frequency and seriousness)
A transient diffuse swelling may very commonly occur at the vaccination site, which persists for about 14 days.
The frequency of adverse reactions is defined using the following convention: – very common (more than 1 in 10 animals treated displaying adverse reaction(s)) – common (more than 1 but less than 10 animals in 100 animals treated) – uncommon (more than 1 but less than 10 animals in 1,000 animals treated) – rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during lay.
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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.
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4.9 Amounts to be administered and administration route
For subcutaneous or intramuscular use.
Allow the vaccine to reach a temperature of 15 °C – 25 °C.
Shake well before use.
Use sterile syringes and needles.
It is recommended to use a closed multiject vaccination system.
From 8 – 14 days old: administer 0.25 ml subcutaneously.
From 14 days to 6 weeks old: administer 0.25 or 0.5 ml subcutaneously or intramuscularly.
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6 weeks and older: administer 0.5 ml subcutaneously or intramuscularly.
Future laying hens and breeders: administer a second 0.5 ml dose 4–6 weeks after the 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a double dose, no adverse reactions other than those described in section 4.6 have been observed.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Aves ; Inactivated viral vaccines, avian influenza virus.
ATC-vet code: QI01AA23.
The vaccine stimulates active immunity against avian influenza virus 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.
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. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Liquid light paraffin
Polysorbate 80
Sorbitane mono-oleate
Glycine
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
PET vials: 2 years.
Glass vials: 1 year.
Shelf life after first opening the immediate packaging: use within 8 hours.
6.4 Special precautions for storage
Store and transport refrigerated (2°C to 8°C). Do not freeze.
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6.5 Nature and composition of immediate packaging
Cardboard box with 250 or 500 ml hydrolytical type II glass or polyethylene terephthalate (PET) bottles. The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 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
Date of first authorisation: 01/09/2006
Date of last renewal: 23/08/2011