GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens – patient leaflet, side effects, dosage

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

Laboratorios Hipra, S.A.

Avda. la Selva, 135

Amer 17170 (Girona)

Spain

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

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 1052........... 10^1.48 - 10^2.63 PU*

* PU: Potency Units

Excipients:

IBDV-specific antibody solution....................................2.7x106 VNU** of IgY per vial

**VNU: Virus Neutralisation Units

Lyophilisate: brown reddish colour.

Solvent: clear colourless solution.

4. INDICATION(S)

For active immunisation of 1-day-old broiler chicks and embryonated broiler chicken eggs to reduce clinical signs and lesions of 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.

5. CONTRAINDICATIONS

Do not use in flocks without MDAs against IBDV.

6. ADVERSE REACTIONS

In laboratory studies, lymphocyte depletion was very common after vaccine take, which was 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:

• very common (more than 1 in 10 animals treated displaying adverse reaction(s))
• common (more than 1 but less than 10 animals in 100 animals treated)
• uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
• rare (more than 1 but less than 10 animals in 10,000 animals treated)
• very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Chickens and embryonated chicken eggs.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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)

Reconstitution of the vaccine:

1. 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.

1. 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.
2. 3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
3. 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)

Reconstitution of the vaccine:

1. 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.

1. 2. Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1 and transfer it back into the solvent bag.
2. 3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
3. 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.

9. ADVICE ON CORRECT ADMINISTRATION

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.

10. WITHDRAWAL PERIOD(S)

Zero days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Lyophilisate:

Store and transport refrigerated (2 °C - 8 °C).

Do not freeze.

Protect from light.

Solvent:

Do not store above 25 °C.

Shelf life after reconstitution according to directions: 2 hours.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.

12. SPECIAL WARNING(S)

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.

Vaccinate healthy animals only.

It is recommended to vaccinate all chickens on a site at the same time.

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.

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.

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.

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.

Overdose (symptoms, emergency procedures, antidotes):

After the administration of a 10-fold overdose mild exudate and slight congestion in the bursa of

Fabricius were very commonly observed.

Incompatibilities:

Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http: //www.ema.europa.eu/).

15. OTHER INFORMATION

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.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

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