Patient leaflet - Poulvac E. coli
B. PACKAGE LEAFLET
PACKAGE LEAFLET
Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release :
Zoetis Manufacturing & Research Spain, S.L.
Ctra. de Camprodon, s/n°
Finca La Riba
Vall de Bianya
Gerona, 17813
SPAIN
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose contains:
Live aroA gene deleted Escherichia coli , 5.2 × 106 – 9.1 × 108 CFU*
type O78, strain EC34195
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* Colony forming units when grown on trypticase soy agar plates.
Cream coloured lyophilisate.
Upon reconstitution, transparent to white-yellowish and opaque suspension (depending on the volume of diluent used).
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4. INDICATION(S)
For active immunisation of broiler chickens, future layer/breeders and turkeys in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with Escherichia coli serotype O78.
Onset of immunity:
Chickens: 2 weeks after vaccination for the reduction of lesions. The onset of immunity has not been established for the mortality claim.
Turkeys: 3 weeks after second vaccination for the reduction of lesions and mortality.
Duration of immunity:
Chickens: 8 weeks for the reduction of lesions and 12 weeks for the reduction of mortality (spray).
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12 weeks for the reduction of lesions and mortality (drinking water).
Turkeys: duration of immunity has not been established.
A cross protection study showed reduction of incidence and severity of airsacculitis caused by E. coli serotypes O1, O2 and O18 for spray application for chickens. For these serotypes no onset of immunity or duration of immunity was established.
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5. CONTRAINDICATIONS
Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.
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6. ADVERSE REACTIONS
None.
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.
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7. TARGET SPECIES
Chickens (broilers, future layers/breeders) and turkeys.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Chickens: One dose of vaccine from 1 day of age by coarse spray or from 5 days of age by drinking water administration.
Turkeys: One dose of vaccine from 1 day of age followed by a second dose of vaccine 3 weeks later by coarse spray administration.
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9. ADVICE ON CORRECT ADMINISTRATION
Coarse spray administration for chickens and turkeys or in drinking water use for chickens.
Spray application :
Use clean vaccination materials and turn off ventilation until 15 minutes after vaccination.
Remove seal and stopper. Half-fill the vial with chlorine-free water at room temperature. Replace the stopper and shake well until dissolved. Pour the reconstituted vaccine into a clean container and add chlorine-free water to further dilute the vaccine in order to obtain an even distribution when sprayed onto the birds.
No disinfectants or other substances impairing the performance of the live vaccine should be used in the sprayer.
Dilute and administer the reconstituted vaccine at a rate of one dose of reconstituted vaccine per bird, according to the directions of your specific coarse spray vaccination equipment. The recommended volume for 1 dose is between 0.1 and 0.5 ml. The spraying distance should be between 30 and 80 cm above the animals in order to ensure an even distribution and the recommended droplet size is greater than 100 ^m.
In drinking water use :
Make sure that all conduit pipes, tubing, troughs, drinkers etc. are thoroughly clean and free of any trace of disinfectants, detergents, soap, etc. and antibiotics. Contact with disinfectants makes the vaccine ineffective.
Allow water to be consumed so that levels of drinkers are minimal before vaccine is applied. All tubing should be emptied of plain water, so that the drinkers contain only vaccine water.
It may be necessary to withhold water prior to vaccination in order to ensure that all birds drink during the vaccination period.
Open the vaccine vial under water and dissolve thoroughly in a container. Care should be taken to empty the vial and its top completely by rinsing them in water. Do not split large vials to vaccinate more than 1 house or drinking system, as this may lead to mixing errors.
Use cold and fresh non-chlorinated water that is free from metal-ions. Low-fat skimmed milk powder (i.e. < 1% fat) may be added to the water (2–4 grams per litre) or skimmed milk (20–40 ml per litre of water) to improve the water quality and to increase the stability of the bacteria.
Ideally, vaccine should be administered in the volume of water consumed by the birds in up to 3 hours. The aim is to give every bird one dose of vaccine. As a general rule, apply reconstituted vaccine to chlorine-free and fresh water at the rate of 1,000 doses of the vaccine to 1 litre of water per day of age for 1,000 chickens, e.g. 10 litres would be needed for 1,000 10-day old chickens. If in doubt, measure the water intake the day before administering vaccine.
Administer the dissolved vaccine to birds immediately after reconstitution.
Avoid exposure of the vaccine suspension to sunlight.
10.
WITHDRAWAL PERIOD(S)
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Shelf life after reconstitution according to directions: 2 hours.
SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
Do not use antibiotic treatment within 1 week before and after vaccination because antibiotic treatment might impair the efficacy of the vaccine.
No information is available on the influence of high levels of maternally derived antibodies on the efficacy.
Special precautions for use in animals :
The vaccine strain can be detected in tissues (liver, heart) until 6 days (chickens) or in tissues (thoracic air sacs) 4 days (turkeys) post vaccination. Vaccinated birds may excrete the vaccine strain by faecal route for up to 5 weeks (chickens) or 7 days (turkeys) post vaccination and the vaccine may remain present in the environment until the end of the finishing or rearing period (chickens) or for 7 days (turkeys). Therefore, it is recommended to clean and disinfect bird houses where the vaccine was applied after completion of the finishing or rearing period.
The vaccine strain may spread to in-contact birds. The vaccine strain can be identified by its growth properties on biological growth media: it shows normal growth on MacConkey and trypticase soy agar, while no colonies are observed when plated without aromatic amino acids (minimum agar).
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Apply the usual aseptic precautions to all administration procedures.
The use of eye-protection, gloves and a nose-mouth mask by the operator is advised during administration. Immunosuppressed people should not be present during administration of the vaccine. Disinfect hands and equipment after use.
Personnel involved in attending vaccinated animals should follow general hygiene principals and take particular care in handling litter from recently vaccinated animals.
Other precautions:
Immunisation has to be considered as one component in a complex control program that addresses all important hygienic and health factors for poultry.
Lay :
The safety of Poulvac E. coli has been demonstrated when administered to chickens during lay at one dose by both coarse spray and drinking water administration. However, the efficacy of Poulvac E. coli has not been demonstrated when administered to chickens during lay. A decision to use this vaccine in chickens during lay should be made on a case by case basis.
The safety of Poulvac E. coli has not been investigated in turkeys during lay. Do not use in turkeys in lay and within 6 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) :
No adverse reactions have been observed after the administration of a 10-fold overdose of the vaccine.
Incompatibilities :
Do not mix with any other veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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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.
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15. OTHER INFORMATION