Gumbohatch
ATC code
Species
Chickens and embryonated chicken eggs.
Indications
For active immunisation of 1-day-old broiler chicks and embryonated broiler 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 broiler chickens have shown an onset of immunity from between 24 days of age and 28 days of age.
Onset of immunity: from 24 days of age.
Duration of immunity: up to 45 days of age.
The efficacy of the vaccine has been demonstrated in broilers having an average MDA level from 4,500 to 5,100 ELISA units at hatching.
Dose to be administered and administration route
In ovo and subcutaneous use.
It is important to note that the volumes of solvent which must be used to reconstitute the vaccine are different depending on whether the vaccine will be administered in ovo to embryonated eggs, or by subcutaneous injection to 1-day-old chicks. The final concentrations of the vaccines will therefore also differ.
Posology:
By the in ovo route: Administer one single injection of 0.05 ml of the reconstituted vaccine into each chicken egg at 18 days of embryonation.
By the subcutaneous route: Administer one single injection of 0.2 ml of the reconstituted vaccine to each chick at 1 day of age.
Method of administration:
For in ovo administration:
An automated egg injection machine 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 in ovo administration (0.05 ml per dose):
|
Number and content of vaccine vials: |
HIPRAHATCH solvent volume to be used: |
|
4 x 1,000 doses |
200 ml |
|
8 x 1,000 doses |
400 ml |
|
2 x 2,000 doses |
200 ml |
|
4 x 2,000 doses |
400 ml |
|
8 x 2,000 doses |
800 ml |
|
8 x 2,500 doses |
1,000 ml |
|
1 x 4,000 doses |
200 ml |
|
2 x 4,000 doses |
400 ml |
|
4 x 4,000 doses |
800 ml |
|
5 x 4,000 doses |
1,000 ml |
|
2 x 5,000 doses |
500 ml |
|
4 x 5,000 doses |
1,000 ml |
|
1 x 8,000 doses |
400 ml |
|
2 x 8,000 doses |
800 ml |
|
1 x 10,000 doses |
500 ml |
|
2 x 10,000 doses |
1,000 ml |
Reconstitution of the vaccine:
1. Withdraw 2 ml of the HIPRAHATCH solvent and inject into the vial containing the lyophilisate.
2. Mix the contents of the vial by gentle agitation until the contents are completely re-suspended, then withdraw the suspension obtained and inject it into the solvent bag.
3. Rinse the vial with another 2 ml of the HIPRAHATCH solvent/lyophilisate suspension obtained in step 1 and inject it back into the solvent bag.
4. Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
5. The reconstituted vaccine is a slightly reddish homogeneous suspension 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 broiler 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 ml |
|
2 x 1,000 doses |
400 ml |
|
4 x 1,000 doses |
800 ml |
|
5 x 1,000 doses |
1,000 ml |
|
1 x 2,000 doses |
400 ml |
|
2 x 2,000 doses |
800 ml |
|
1 x 2,500 doses |
500 ml |
|
2 x 2,500 doses |
1,000 ml |
|
1 x 4,000 doses |
800 ml |
|
1 x 5,000 doses |
1,000 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 bag.
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 bag.
3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
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-dayold broiler 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 bag volume, prepare the EVANOVO vaccine.
2. Once the EVANOVO vaccine has been prepared, consider the bag volume to prepare enough GUMBOHATCH doses for the bag 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 bag.
5. Homogenize by moving the bag volume with the hands until having an even homogenate solution.
6. Vaccinate using the vaccinal bag with the mixed vaccines within a period of 2 hours via in ovo. Mix the bag by gentle agitation every 30 minutes during vaccination.
Prepare the required volume of each vaccine as per the examples provided in the table below, showing different mixing possibilities, according to different presentations for in ovo administration (0.05 ml per dose):
|
GUMBOHATCH (Number and content of vaccine vials) |
EVANOVO (Number and content of vaccine vials) |
HIPRAHATCH solvent volume to be used |
|
4 x 1,000 doses |
4 x 1,000 doses |
200 ml |
|
2 x 2,000 doses |
2 x 2,000 doses |
200 ml |
|
4 x 2,000 doses |
4 x 2,000 doses |
400 ml |
|
1 x 4,000 doses |
1 x 4,000 doses |
200 ml |
|
2 x 4,000 doses |
4 x 2,000 doses |
400 ml |
|
2 x 4,000 doses |
2 x 4,000 doses |
400 ml |
|
4 x 4,000 doses |
4 x 4,000 doses |
800 ml |
|
2 x 5,000 doses |
2 x 5,000 doses |
500 ml |
|
8 x 2,500 doses |
4 x 5,000 doses |
1,000 ml |
|
2 x 4,000 doses |
1 x 8,000 doses |
400 ml |
|
1 x 8,000 doses |
1 x 8,000 doses |
400 ml |
|
4 x 4,000 doses |
2 x 8,000 doses |
800 ml |
|
2 x 8,000 doses |
2 x 8,000 doses |
800 ml |
|
4 x 2,500 doses |
1 x 10,000 doses |
500 ml |
|
1 x 10,000 doses |
1 x 10,000 doses |
500 ml |
|
5 x 4,000 doses |
2 x 10,000 doses |
1,000 ml |
|
4 x 5,000 doses |
2 x 10,000 doses |
1,000 ml |
|
2 x 10,000 doses |
2 x 10,000 doses |
1,000 ml |
The vaccine should not be used in case its appearance is different from a white turbid suspension.
Adverse reactions
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.
