POM-V Prescription Required

GUMBOHATCH Lyophilisate and Solvent for Suspension for Injection for Chickens

Active ingredient: Infectious bursal disease virus

Form

Injection

Species

Chickens

Manufacturer

Laboratorios Hipra SA

VMD MA No.

17533/5005

What it's used for

For active immunisation of 1-day-old chicks and embryonated chicken eggs to reduce clinical signs and lesions of the bursa of Fabricius caused by very viru...

Full indications, dosage and side effects ↓

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Clinical information

GUMBOHATCH Lyophilisate and Solvent for Suspension for Injection for Chickens — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.

For active immunisation of 1-day-old chicks and embryonated chicken eggs to
reduce clinical signs and lesions of the bursa of Fabricius caused by very virulent
avian infectious bursal disease virus infection.
The onset of immunity depends on the initial maternally derived antibodies (MDA)
level of the batch of chickens and even then, will be different for individual chickens.
In practice, studies in commercial chickens have shown an onset of immunity from
between 24 days of age and 29 days of age.
Onset of immunity: Broiler chickens: from 24 days of age.
Future layer chickens: from 29 days of age.
Duration of immunity:

Revised: August 2025
AN: 04283/2024
Broiler chickens: up to 45 days of age.
Future layer chickens: up to 71 days of age.
The efficacy of the vaccine has been demonstrated in chickens having an average
MDA level from 4,500 to 5,100 ELISA units at hatching.

Do not use in flocks without MDAs against IBDV.

Chickens and embryonated chicken eggs:
Very common
(>1 animal / 10 animals
treated):
Lymphocyte depletion followed by a lymphocyte
repopulation and regeneration of the bursa of
Fabricius. This depletion does not cause
immunosuppression in chickens.
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 the last section of the package leaflet for
respective contact details.

Vaccinate healthy animals only.

i). Special precautions for use in animals
This product should only be used after it has been demonstrated that very
virulent IBDV strains are epidemiologically relevant in the area of vaccination.
Vaccinated birds may excrete the vaccine strain up to 3 weeks following
vaccination. During this time, the contact of immunosuppressed and
unvaccinated birds with vaccinated birds should be avoided.
Appropriate veterinary and husbandry measures should be taken to avoid
spread of the vaccine strain to susceptible wild and domestic birds.
It is recommended to vaccinate all chickens on a site at the same time.
ii). Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Wash and disinfect hands and equipment after use.
Wash and disinfect hands after handling vaccinated birds or their litter
because the virus is excreted by vaccinated birds for up to 3 weeks.
In case of accidental self-injection, seek medical advice immediately and
show the package leaflet or the label to the physician.
Special precautions for the protection of the environment: Not applicable.

Revised: August 2025
AN: 04283/2024
iii). Other precautions
Not applicable.

Safety and efficacy data are available which demonstrate that this vaccine can be
mixed with EVANOVO prior to use and administered simultaneously in ovo. The
product information of EVANOVO should be consulted before administration of the
mixed products.
The mixed administration of GUMBOHATCH and EVANOVO should only be used
when vaccinating 18-day-old embryonated eggs.
For mixed use, the onset and duration of immunity of the IBD virus included in the
GUMBOHATCH vaccine have been demonstrated to be equivalent to those
determined for GUMBOHATCH when used alone.
No information is available on the safety and efficacy of this immunological veterinary
medicinal product when used with any other veterinary medicinal product except the
product mentioned above.
A decision to use this immunological veterinary medicinal product before or after any
other veterinary medicinal product therefore needs to be made on a case by case
basis.

Lyophilisate:
Store and transport refrigerated (2 ºC – 8 ºC).
Do not freeze.
Protect from light.
HIPRAHATCH solvent, for poultry vaccines:
Do not store above 25 ºC.

which should be used within 2 hours after reconstitution.
The vaccine (0.05 ml dose) must be injected into the amniotic sac of 18-day-old
embryonated chicken eggs.
For subcutaneous administration:
An automated syringe can be used. The instructions for the calibration and use of the
equipment should be strictly followed in order to deliver the appropriate dose.
For the reconstitution and administration of the vaccine, use sterile equipment free
from any residues of chemical disinfectants.
Calculate and prepare the required volume of the vaccine as per the table below:
Dilutions for subcutaneous administration (0.2 ml per dose):
Number and content of vaccine
vials:
HIPRAHATCH solvent
volume to be used:
1 x 1,000 doses 200 ml2 x 1,000 doses400 ml4 x 1,000 doses800 ml5 x 1,000 doses1,000 ml1 x 2,000 doses400 ml2 x 2,000 doses800 ml1 x 2,500 doses500 ml2 x 2,500 doses1,000 ml1 x 4,000 doses800 ml1 x 5,000 doses1,000 ml
Reconstitution of the vaccine:
1. Withdraw 2 ml of the HIPRAHATCH solvent and inject into the vial containing
the lyophilisate.
Mix the contents of the vial by gentle agitation until the contents are
completely resuspended, then withdraw the suspension obtained and inject it
into the solvent container.

Revised: August 2025
AN: 04283/2024
2. Rinse the vial with another 2 ml of the HIPRAHATCH solvent/lyophilisate
suspension obtained in step 1, and inject it back into the solvent container.
3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the
solvent container.
4. The reconstituted vaccine is a slightly reddish homogeneous suspension
which should be used within 2 hours after reconstitution.
The vaccine (0.2 ml dose) must be injected under the skin of the neck of the 1-day-
old chicks.
For simultaneous use with EVANOVO, the mixed administration of GUMBOHATCH
and EVANOVO should only be used when vaccinating in ovo 18-day-old embryonated
eggs.
The following instructions should be used:
1. Taking into account the HIPRAHATCH solvent container volume, prepare the
EVANOVO vaccine.
2. Once the EVANOVO vaccine has been prepared, consider the container volume
to prepare enough GUMBOHATCH doses for the container volume.
3. In each GUMBOHATCH vial to be used, insert 4 ml of the EVANOVO diluted
vaccinal suspension prepared.
4. Once the lyophilized tablet is properly resuspended, introduce the volumes of the
different GUMBOHATCH vials into the vaccinal container.
5. Homogenize by moving the container volume with the hands until having an even
homogenate solution.

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.