Patient leaflet - Nobilis Influenza H5N2
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Nobilis Influenza H5N2 emulsion for injection for chickens
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release:
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H5N2 emulsion of injection for chickens.
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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.
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4. INDICATION(S)
For active immunisation of chickens against avian influenza 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.
Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
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5. CONTRAINDICATIONS
Do not administer intramuscularly in chickens less than 2 weeks old.
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6. ADVERSE REACTIONS
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)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– 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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Chickens.
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8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
For subcutaneous or intramuscular use.
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: 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.
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9. ADVICE ON CORRECT ADMINISTRATION
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.
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10. WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C). Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life after first opening the container: 8 hours.
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12. SPECIAL WARNINGS
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
Lay
The safety of the veterinary medicinal product has not been established during lay.
Interaction 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.
Incompatibilities
Do not mix with any other veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency
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15. OTHER INFORMATION