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Nobilis Gumboro D78 Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens

Active ingredient: Infectious bursal disease virus

Form

Liquid

Species

Chickens

Manufacturer

Intervet International B.V.

VMD MA No.

06376/4121

What it's used for

Onset of immunity: ▪ ▪ ▪ Duration of immunity: ▪ ▪ Cross protection studies in the progeny showed a reduction in mortality and clinical signs of disease ca...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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Clinical information

Nobilis Gumboro D78 Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

Onset of immunity:
▪
▪
▪
Duration of immunity:
▪
▪
Cross protection studies in the progeny showed a reduction in mortality and clinical
signs of disease caused by IBDV antigenic variant strains (variant E and GLS).
For ARV genotypes cross protection studies in the progeny showed the following:
•
genotype 2
•
•
for ARV genotype 5
The volume used for application depends on the way of administration.
The vaccine may be delivered as a freeze-dried cake in a glass vial or as freeze-dried
spheres in cups. In case of the latter presentation the cups may contain 3 up to 100
spheres depending on the required dosages and production yields. In case of the
product presented in cups, do not use the product if the contents stick to the container
as this indicates that the integrity of the container has been breached. Each container
should be used immediately and completely after opening.
Reconstitution of vaccine
A. Drinking water
The vials should be opened under water or the content of the cup(s) should be poured
into the water. In both cases mix the water containing the vaccine well before use. After
reconstitution the suspension looks clear. The vaccine should be dissolved in cool,
clean water which is free of iron and chlorine. By adding 2 grams of skimmed milk
powder per litre of water the virus retains its activity much longer. Ensure uptake of all
the vaccine-medicated water in 2 hours.
Depending on the weather conditions, it may be advisable to deprive the birds of water
prior to vaccination. A sufficient number of water containers to provide adequate
drinking space is essential. These should be clean and free from traces of detergents
and disinfectants. Dissolve 1000 doses in as many litres of water as the age of the birds
in days, to a maximum of 40 litres.
The vaccine should be given in the early morning as this is the main period of drinking
or the cool period on a hot day. When vaccinating larger flocks, it is advisable to start by
dissolving only part of the vaccine. If vaccine is administered through a central water
supply or a proportioner, great care should be taken. For numbers of birds between
standard dosages, the next higher dosage should be chosen.
B. Spray method
Reconstitute the vaccine in cool, clean water, to which 2% skimmed milk may be added.
The vials should be opened under water or the content of the cup(s) should be poured
into water. Chlorinated water should not be used. In both cases mix the water
containing vaccine well before use. After reconstitution the suspension looks clear. The
water and spray apparatus should be free from sediments, corrosion and traces of
disinfectants or antiseptics. Ideally the apparatus should be used for vaccination
purposes only. The volume of diluent for reconstitution should be sufficient to ensure an
even distribution when sprayed onto the birds. This will vary according to the age of the
birds being vaccinated and the management system, but a quantity of 1000 doses per
litre of water is suggested. The vaccine suspension should be sprayed evenly over the
birds at a distance of 30-40 cm, preferably when the birds are sitting together in dim
light. If applicable, reduce or stop ventilation to prevent loss of spray.
C. Oculonasal use
The vaccine should be dissolved in physiological saline solution (usually 30 ml per 1000
doses) and administered by means of a standardised dropper (of which the droplet size
is known and consistent). The amount of diluent required for eye- or nose-drop
administration depends on the number of doses and the droplet size. One drop should
be applied from a height of a few centimetres onto one nostril or one eye. Ensure that
the nasal drop is inhaled before freeing the bird.
Wash and disinfect hands and equipment after vaccinating. Any surplus vaccine should
be destroyed by burning or by boiling.
Each container should be used immediately after opening.
Administration
Water should be withheld before vaccination. For recommendations see below under
Management. Ensure that all medicated water is consumed within 1 - 2 hours. Turn on
mains water when all the vaccine water has been consumed. Always make sure that
there is food available when vaccinating.
Birds will not drink if they have no food to eat.
Vaccination programmes
It is only necessary to apply the vaccine once to susceptible birds and this should be
done as early as possible. In the field, maternal antibodies will exist in the majority of
chicks, therefore, vaccination before 17 days for broiler-type birds and 21 days for
replacement layers is not normally recommended where parent birds have been
injected with an inactivated Gumboro vaccine.
Suggested vaccination programmes
This programme is intended only as a guide; local conditions must be allowed for.
Broilers Rearing pullets and breeding
stock
17 days old* 21 days old
21 - 24 days old 28 - 30 days old
28 - 30 days old
*This may be reduced to 14 days if MDA is known to be present at only very low levels.
Management
Great care should be taken to ensure that all birds receive a full dose of vaccine when
the product is administered. When used in chickens where maternal antibody still
exists, the way in which this vaccine is administered is critical. The following points
have been found to improve vaccine "take":
1. Water withholding should be kept to a minimum, especially in broiler birds.
Approximately half an hour is all that is required if the following management techniques
are used.
2. Try to vaccinate at a time when birds are likely to be drinking, e.g. morning time for
broilers, when food is in the food tracks.
3. Turn the lights down low when the water is turned off. For bell drinkers, go round
the house emptying and cleaning the drinkers during the half-hour lights low period.
Mix up the vaccine according to the recommendations, and towards the end of the half-
hour water withholding period, go round all the drinkers filling each with water containing
vaccine. Leave the house and turn the light up. The increased light intensity will
stimulate the birds to look for water and food. Therefore, it is important that food is
available or the birds will not be interested in drinking. In some cases, it helps to run
food tracks at the time the light intensity is increased.
4. For nipple lines a substantial volume of residual water may remain in the lines
after the half-hour water withholding/dark period. It is advisable to drain the lines and
prime with vaccine loaded water before allowing the birds to have access to the drinker
lines. Mix up the vaccine and apply to the header tank(s). Calculate the volume of
water that is left in the tank below the outlet valve and make sure you add extra vaccine
to this volume of water. For example, if 10 litres remain below the outlet pipe and you
are using 10 litres/1000 birds to vaccinate, add one extra vial of vaccine when mixing up
vaccine for that tank. The use of this extra vaccine is important.
5. Once the vaccine has been consumed, resume management practices as normal.
This approach to vaccination will ensure a more even vaccination of the crop and will be
less stressful to the birds. Performance should therefore be less adversely affected.
For further information on use of a vaccine in specific circumstances or in conjunction
with other MSD vaccines consult marketing authorisation holder’s technical staff.
None.
Chickens:
None known.
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 its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
Vaccinate healthy animals only.
A good immune response is reliant on the reaction of an immunogenic agent and a fully
competent immune system. Immunogenicity of the vaccine antigen will be reduced by
poor storage or inappropriate administration. Immunocompetence of the animal may be
compromised by a variety of factors including poor health, nutritional status, genetic
factors, concurrent drug therapy and stress.

Special precautions for safe use in the target species:
The properties of D78 are such that the vaccine virus will spread to in-contact birds and
vaccine virus may increase in virulence on bird to bird passage.
Care should be taken to ensure that the vaccine virus does not spread to unvaccinated
birds.
Under certain conditions, for example extreme disease pressure and variant challenge,
fully immune birds may succumb to disease. Therefore, successful vaccination may not
be synonymous with full protection in the face of a disease challenge.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Wash and disinfect hands after use.
Special precautions for the protection of the environment:
Not applicable.
Complete lack of immunosuppression has not been demonstrated.
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.
Store in a refrigerator (2 C – 8 C).
Do not freeze.
Protect from light.
This approach to vaccination will ensure a more even vaccination of the crop and will be
less stressful to the birds. Performance should therefore be less adversely affected.
For further information on use of a vaccine in specific circumstances or in conjunction
with other MSD vaccines consult marketing authorisation holder’s technical staff.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
No symptoms.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary medicinal
products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Zero days.
4. IMMUNOLOGICAL INFORMATION
4.1 ATCvet code: QI01AD09.
The vaccine contains live Infectious Bursal (Gumboro) Disease virus for administration
to chickens to stimulate active immunity against the disease.
5.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.

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