Nobilis Influenza H5N2 Emulsion for Injection for Chickens

Onset of immunity: 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
Duration of immunity: Not established. Serum antibodies could be expected to
persist for at least 1 year after administration of two doses of vaccine.
4.3 Contraindications
Do not administer intramuscularly in chickens less than 2 weeks old.
4.4 Special warnings for each target species
Vaccinate healthy animals only.

Issued: July 2023
AN: 01873/2022
4.5 Special precautions for use
Special precautions for use in animals
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:
To the user:
This veterinary medicinal 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 veterinary medicinal product contains mineral oil. Even if small amounts have
been injected, accidental injection with this veterinary medicinal 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.
Special precautions for the protection of the environment:
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Chickens:
Very common
(>1 animal / 10 animals
treated):
Injection site swelling
1
A transient diffuse swelling which persists for about 14 days.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian,
to either the marketing authorisation holder or the national competent authority via
the national reporting system. See also section “Contact details” of the package
leaflet.

Issued: July 2023
AN: 01873/2022
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during lay.
4.8 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.
4.9 Amount(s) 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 ml or 0.5 ml subcutaneously or
intramuscularly.
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 events other than those
described in section 4.6 have been observed.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Aves; Inactivated viral vaccines,
avian influenza virus.
ATCvet code: QI01AA23
The vaccine stimulates active immunity against avian influenza virus type A, subtype
H5.

Issued: July 2023
AN: 01873/2022
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