Other products
AviPro IBD Xtreme
ATC code
Species
Chickens
Indications
For active immunisation of chickens from 7 days of age with maternally derived antibodies (breakthrough titre: 636) to reduce clinical disease, weight loss and acute lesions of the bursa of Fabricius associated with infection caused by very virulent avian infectious bursal disease (IBD) viruses.
Onset of immunity: 2 weeks.
Duration of immunity: 12 weeks after vaccination based on serology.
Dose to be administered and administration route
One dose per chicken should be administered in the drinking water after resuspension.
Vaccination schedule:
The determination of the vaccination date depends on a number of factors including status of maternal antibodies, type of bird, infection pressure, housing and management conditions.
In the case of a vv (very virulent)-IBDV field challenge, the field virus is extraordinarily virulent and requires the use of a vaccine able to break through relatively high levels of maternally derived antibodies (MDAs). AviPro IBD Xtreme can break through a maternal ELISA-antibody level of 636.
Homogenous levels of MDA levels facilitate a more accurate timing of the vaccination. To predict the age, when MDA have sufficiently decreased to allow effective vaccination, it is advised to test serum samples of at least 20 chicks by serology and apply the “Deventer Formula” for intermediate plus vaccines.
According to this formula the optimum age of vaccination is as follows:
1. Decide what percentage of the flock shall be representing and remove the highest titres that are excluded (e.g. 75 % of the flock; remove the highest 25 % of the titres).
2. Calculate the mean ELISA antibody titre of these birds.
3. Vaccination age = {(log2 titre bird % - log2 breakthrough) x t_} + age at sampling + correction 0-4 (bird % = ELISA titre of the bird representing a certain percentage of the flock
t_ = half-life time (ELISA) of the antibodies in the type of chickens being sampled age at sampling = age of the birds at sampling correction 0-4 = extra days when the sampling was done at 0 to 4 days of age)
Birds should be at least 7 days of age at vaccination. The optimum age for vaccination may be calculated using the level of maternal antibodies in the chicks at day old (“Deventer Formula”) but normally lies in the range 12-21 days. Additional information on application and disease control is available from Elanco Animal Health.
Avoid stress before, during and after vaccination.
Use the whole contents of the opened bottles at once.
To reduce infection pressure before the onset of immunity, litter should be removed and chicken houses should be cleaned between rearing cycles.
Drinking water application:
Ensure that the drinking water is cold, clean, non-chlorinated and free from detergents, disinfectants and metal ions.
• Remove sealing cap and stopper from vaccine container.
• Suspend the vaccine in the corresponding amount of water and mix carefully.
• Prepare only the amount of vaccine that can be consumed within 2 hours.
• Determine the number of vaccine doses and amount of water (see below) required. Do not split large vials to vaccinate more than one house or drinking system, as this may lead to mixing errors.
• Make sure that all conduit pipes, tubing, troughs, drinkers etc. are thoroughly clean and free of any trace of disinfectants, detergents etc.
• Use only cold and fresh water preferably non-chlorinated and 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 virus. This, however, has to be done at least 10 minutes prior to reconstitution of the vaccine.
• Open the vaccine ampoule under water and reconstitute contents thoroughly. Care should be taken to empty the ampoule and its top completely by rinsing them in water.
• Allow water to be consumed so that levels in drinkers are minimal before the vaccine is applied. All tubing should be emptied of plain water, so that the drinkers contain only the vaccine suspension. If water is still present, drain lines before applying the vaccine. • Apply the vaccine over (up to) 2 hours, ensuring that all birds drink during this time. Birds drinking behaviour varies, it may be necessary to withhold water on some sites prior to vaccination in order to ensure that all birds drink during the vaccination period.
• Ideally, the vaccine should be administered in the volume of water consumed by the birds in up to 2 hours. As a general rule, apply the reconstituted vaccine to cold and fresh water at the rate of 1 000 doses of 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. Under hot climates or with heavy breeds this amount may have to be increased up to a maximum of 40 litres per 1 000 birds. If in doubt, measure water intake the day before administering the vaccine.
– Administer the reconstituted vaccine to birds immediately.
– Make sure that birds do not have access to unmedicated water during vaccination.
Adverse reactions
Chickens:
|
Very common (>1 animal / 10 animals treated): |
Bursa of Fabricius lymphocyte depletion1 |
1On day 7 post vaccination severe lymphocyte depletion is seen in the bursae of the majority of birds. Lymphocyte repopulation commences after day 7 post vaccination but by day 28 post vaccination notable lesions still remain in the bursae of the birds.
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 the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
AviPro IBD Xtreme
Lyophilisate for use in drinking water for chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
Active substances:
Infectious bursal disease virus, strain V217 (intermediate plus), Live: 101.5 - 103.0 EID50* *EID50 = 50 % embryo infective dose: the virus titre required to infect 50 % of the inoculated embryos Excipients:
|
Qualitative composition of excipients and other constituents |
|
Disodium phosphate dihydrate |
|
Lactose monohydrate |
|
Potassium dihydrogen phosphate |
|
Skim milk powder |
Rose to red brown lyophilisate
3. CLINICAL INFORMATION
3.1 Target species
Chickens
3.2 Indications for use for each target species
For active immunisation of chickens from 7 days of age with maternally derived antibodies (breakthrough titre: 636) to reduce clinical disease, weight loss and acute lesions of the bursa of Fabricius associated with infection caused by very virulent avian infectious bursal disease (IBD) viruses.
Onset of immunity: 2 weeks.
Duration of immunity: 12 weeks after vaccination based on serology.
3.3 Contraindications
Do not use in flocks without maternally derived antibodies (MDAs) against IBD viruses.
3.4 Special warnings
Vaccinate healthy animals only.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The vaccine strain can spread to unvaccinated chickens, since it is excreted via the faeces for at least 9 days. Special precautions should be taken to avoid spreading of the vaccine strain to laying hens, birds approaching lay, birds without MDAs and young birds below 7 days of age.
This vaccine induces serious and prolonged lesions in the bursa of Fabricius. Therefore, this product should only be used after it has been demonstrated that very virulent IBD virus strains are epidemiologically relevant in the area of vaccination.
MDA levels may differ throughout a given population. Therefore, depending on age and genetic factors of the birds IBD-like symptoms or mortality may occur in animals with low MDA level or without MDAs.
Whenever the field situation allows this, try to switch back from an intermediate plus vaccine to an intermediate.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash and disinfect hands and equipment after vaccinating.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events Chickens:
|
Very common (>1 animal / 10 animals treated): |
Bursa of Fabricius lymphocyte depletion[1] |
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during lay.
Laying birds:
Do not use in birds in lay or breeding birds, and within 4 weeks before the start of the laying period.
3.8 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.
3.9 Administration routes and dosage
One dose per chicken should be administered in the drinking water after resuspension.
Vaccination schedule:
The determination of the vaccination date depends on a number of factors including status of maternal antibodies, type of bird, infection pressure, housing and management conditions.
In the case of a vv (very virulent)-IBDV field challenge, the field virus is extraordinarily virulent and requires the use of a vaccine able to break through relatively high levels of maternally derived antibodies (MDAs). AviPro IBD Xtreme can break through a maternal ELISA-antibody level of 636.
Homogenous levels of MDA levels facilitate a more accurate timing of the vaccination. To predict the age, when MDA have sufficiently decreased to allow effective vaccination, it is advised to test serum samples of at least 20 chicks by serology and apply the “Deventer Formula” for intermediate plus vaccines.
According to this formula the optimum age of vaccination is as follows:
1. Decide what percentage of the flock shall be representing and remove the highest titres that are excluded (e.g. 75 % of the flock; remove the highest 25 % of the titres).
2. Calculate the mean ELISA antibody titre of these birds.
3. Vaccination age = {(log2 titre bird % - log2 breakthrough) x t_} + age at sampling + correction 0-4 (bird % = ELISA titre of the bird representing a certain percentage of the flock
t_ = half-life time (ELISA) of the antibodies in the type of chickens being sampled age at sampling = age of the birds at sampling correction 0-4 = extra days when the sampling was done at 0 to 4 days of age)
Birds should be at least 7 days of age at vaccination. The optimum age for vaccination may be calculated using the level of maternal antibodies in the chicks at day old (“Deventer Formula”) but normally lies in the range 12-21 days. Additional information on application and disease control is available from Elanco Animal Health.
Avoid stress before, during and after vaccination.
Use the whole contents of the opened bottles at once.
To reduce infection pressure before the onset of immunity, litter should be removed and chicken houses should be cleaned between rearing cycles.
Drinking water application:
Ensure that the drinking water is cold, clean, non-chlorinated and free from detergents, disinfectants and metal ions.
• Remove sealing cap and stopper from vaccine container.
• Suspend the vaccine in the corresponding amount of water and mix carefully.
• Prepare only the amount of vaccine that can be consumed within 2 hours.
• Determine the number of vaccine doses and amount of water (see below) required. Do not split large vials to vaccinate more than one house or drinking system, as this may lead to mixing errors.
• Make sure that all conduit pipes, tubing, troughs, drinkers etc. are thoroughly clean and free of any trace of disinfectants, detergents etc.
• Use only cold and fresh water preferably non-chlorinated and 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 virus. This, however, has to be done at least 10 minutes prior to reconstitution of the vaccine.
• Open the vaccine ampoule under water and reconstitute contents thoroughly. Care should be taken to empty the ampoule and its top completely by rinsing them in water.
• Allow water to be consumed so that levels in drinkers are minimal before the vaccine is applied. All tubing should be emptied of plain water, so that the drinkers contain only the vaccine suspension. If water is still present, drain lines before applying the vaccine. • Apply the vaccine over (up to) 2 hours, ensuring that all birds drink during this time. Birds drinking behaviour varies, it may be necessary to withhold water on some sites prior to vaccination in order to ensure that all birds drink during the vaccination period.
• Ideally, the vaccine should be administered in the volume of water consumed by the birds in up to 2 hours. As a general rule, apply the reconstituted vaccine to cold and fresh water at the rate of 1 000 doses of 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. Under hot climates or with heavy breeds this amount may have to be increased up to a maximum of 40 litres per 1 000 birds. If in doubt, measure water intake the day before administering the vaccine.
– Administer the reconstituted vaccine to birds immediately.
– Make sure that birds do not have access to unmedicated water during vaccination.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No other signs have been observed as described under “Adverse events” following administration of a ten-fold dose.
+
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Zero days.
4. IMMUNOLOGICAL INFORMATION
4.1 ATCvet code: QI01AD09
The active ingredient of the lyophilisate is a live intermediate plus infectious bursal disease virus strain V217 which stimulates active immunity against IBD virus. The vaccine strain causes an average score of bursal lesions of 2.9 (out of 5 according to Ph. Eur.) at 21 days post vaccination.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
Do not mix with any other veterinary medicinal product.
No information is available on potential interactions or incompatibilities of this veterinary medicinal product administered orally by mixing into drinking water containing other substances used in drinking water.
5.2 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 21 months. Shelf life after reconstitution according to directions: 2 hours.
5.3 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Protect from direct sunlight. Protect the reconstituted vaccine from direct sunlight and temperatures of above 25 °C. Do not freeze.
5.4 Nature and composition of immediate packaging
Nature of immediate packaging elements:
• type I glass vial
• type I rubber closure
• aluminium cap
• cardboard box
Pack sizes:
1 x 500 / 1 000 / 2 500 / 5 000 / 10 000 doses 10 x 500 / 1 000 / 2 500 / 5 000 / 10 000 doses
Not all pack sizes may be marketed.
5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
Elanco GmbH
7. MARKETING AUTHORISATION NUMBERS
Vm 52127/5147
Vm 52127/3072
8. DATE OF FIRST AUTHORISATION
29 May 2008
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
February 2026
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription
Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.
Gavin Hall
Approved: 17 April 2026
[1] On day 7 post vaccination severe lymphocyte depletion is seen in the bursae of the majority of birds. Lymphocyte repopulation commences after day 7 post vaccination but by day 28 post vaccination notable lesions still remain in the bursae of the birds.
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 the package leaflet for respective contact details.
| Art. Nr. | 00879/5036 |
|---|---|
| GTIN | • • • • • • • • • 6452 |
