Summary of medicine characteristics - Gumbohatch
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2 ml for a subcutaneous dose) contains:
Active substance:
Live attenuated infectious bursal disease virus (IBDV), strain 105 2........ 101.48 – 102.63 PU*
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* PU: Potency Units
Excipients:
IBDV-specific antibody solution...................................2.7×106 VNU** of IgY per vial
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**VNU: Virus Neutralisation Units
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: brown reddish colour.
Solvent: clear colourless solution.
4. CLINICAL PARTICULARS4.1 Target species
Chickens and embryonated chicken eggs.
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4.2 Indications for use, specifying the target species
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 43 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.
4.3 Contraindications
Do not use in flocks without MDAs against IBDV.
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4.4 Special warnings for each target species
Vaccinate healthy animals only.
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4.5 Special precautions for use
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 vaccine take. During this time, contact between the vaccinated chickens and any immunosuppressed or unvaccinated 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.
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 adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
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4.6 Adverse reactions (frequency and seriousness)
In laboratory studies, lymphocyte depletion was very common, followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius. This depletion does not cause immunosuppression in chickens.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– 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).
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4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during lay.
Do not use in birds in lay or breeding birds, or within 4 weeks before the start of the laying period.
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.
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4.9 Amounts 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: | Solvent volume to be used: |
| 4 × 1,000 doses | 200 ml |
| 8 × 1,000 doses | 400 ml |
| 2 × 2,000 doses | 200 ml |
| 4 × 2,000 doses | 400 ml |
| 8 × 2,000 doses | 800 ml |
| 8 × 2,500 doses | 1,000 ml |
| 1 × 4,000 doses | 200 ml |
| 2 × 4,000 doses | 400 ml |
| 4 × 4,000 doses | 800 ml |
| 5 × 4,000 doses | 1,000 ml |
| 4 × 5,000 doses | 1,000 ml |
Reconstitution of the vaccine:
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1. Withdraw 2 ml of the 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.
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2. Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1, and inject it back into the solvent bag.
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3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
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4. 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: | Solvent volume to be used: |
| 1 × 1,000 doses | 200 ml |
| 2 × 1,000 doses | 400 ml |
| 4 × 1,000 doses | 800 ml |
| 5 × 1,000 doses | 1,000 ml |
| 1 × 2,000 doses | 400 ml |
| 2 × 2,000 doses | 800 ml |
| 2 × 2,500 doses | 1,000 ml |
| 1 × 4,000 doses | 800 ml |
| 1 × 5,000 doses | 1,000 ml |
Reconstitution of the vaccine:
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1. Withdraw 2 ml of the 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.
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2. Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1, and inject it back into the solvent bag.
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3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
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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 broiler chicks.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
After the administration of a 10-fold overdose, a mild exudate and slight congestion in the bursa of Fabricius were very commonly observed.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccines, avian infectious bursal disease virus (Gumboro disease).
ATCvet code: QI01AD09
To stimulate active immunity against very virulent bursal disease viruses (Gumboro disease) in broiler chickens.
The vaccine contains an intermediate-plus IBDV strain bound to specific IBDV immunoglobulins, forming an immune-complex which is administered through vaccination.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Lyophilisate:
Glycine
L-histidine
Sucrose
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Potassium chloride
Sodium chloride
Solvent:
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Potassium chloride
Sodium chloride
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product.
6.3 Shelf life
Shelf life of the lyophilisate as packaged for sale: 24 months.
Shelf life of the solvent as packaged for sale: 3 years.
Shelf life after reconstitution according to directions: 2 hours.
6.4 Special precautions for storage
Lyophilisate:
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Solvent:
Do not store above 25 °C.
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6.5 Nature and composition of immediate packaging
Lyophilisate:
Type I glass vials closed with Type I bromobutyl stoppers and sealed with aluminium caps containing
1,000 doses, 2,000 doses, 2,500 doses, 4,000 doses or 5,000 doses of the freeze-dried vaccine.
Solvent:
Polypropylene bags containing 200 ml, 400 ml, 800 ml or 1,000 ml.
Package sizes:
Cardboard box with 10 lyophilisate vials containing 1,000 doses.
Cardboard box with 10 lyophilisate vials containing 2,000 doses.
Cardboard box with 10 lyophilisate vials containing 2,500 doses.
Cardboard box with 10 lyophilisate vials containing 4,000 doses.
Cardboard box with 10 lyophilisate vials containing 5,000 doses.
Cardboard box with 10 bags containing 200 ml solvent.
Cardboard box with 10 bags containing 400 ml solvent.
Cardboard box with 10 bags containing 800 ml solvent.
Cardboard box with 10 bags containing 1,000 ml solvent.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
Tel.: +34 972 43 06 60
Fax: +34 972 43 06 61
E-mail:
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/19/245/001–005
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12/11/2019