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Date: Monday, November 30, 2020 11:41

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.28
AviPro IBD Xtreme Lyophilisate for suspension
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:AviPro IBD Xtreme Lyophilisate for suspension
Product index: AviPro IBD Xtreme Lyophilisate for suspension
Poultry - meat: Zero days
Qualitative and quantitative composition
Active substance:
1 dose contains 101.5 - 103.0 ELD50* live intermediate plus IBD (Infectious Bursal Disease)-virus, strain V217.
*ELD50 = 50 % egg-lethal dose: the virus titre required to cause death in 50 % of the inoculated embryos
Host system: embryonated SPF-hen’s eggs
Pharmaceutical form
Lyophilisate for suspension.
Appearance: rose to red brown lyophilisate
Clinical particulars
Target species
Chickens (from 7 days old)
Indications for use
For active immunisation of chickens 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 protection: 2 weeks.
Duration of immunity: 12 weeks based on serology
Contra-indications
Do not use in unhealthy birds.
Special warnings for each target species
See Adverse reactions
Special precautions for use
Special precautions for use in animals
The vaccine may spread to unvaccinated chickens, since it is excreted via the faeces for at least 9 days. Avoid spreading to laying hens, birds approaching lay and young birds below 7 days of age.
The vaccine should not be used in birds without maternally derived antibodies. Spread of the vaccine strain to such birds should be prevented.
This vaccine induces serious and prolonged lesions in the bursa of Fabricius. It should therefore only be used to compete with very virulent (vv) IBD virus infection or to induce immunity in the face of still high maternally derived antibody (MDA) levels (breakthrough ELISA titre 636), where vaccines containing mild and intermediate strains have appeared to be insufficient.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash and disinfect hands and equipment after vaccinating.
Adverse reactions
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.
Use during pregnancy, lactation or lay
Do not use in birds in lay or close to the onset of lay.
Interactions
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.
Amounts to be administered and administration route
One dose should be administered per chicken in the drinking water after resuspension.
Vaccination programme
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.
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 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 antibody 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.
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.
-The vaccine is ready for use.
Drinking water application:
Determine the number of vaccine doses and amount of water (see below) required. Do not split large vials to vaccinate more than 1 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 vaccine is applied. All tubing should be emptied of plain water, so that the drinkers contain only vaccine water. If water is still present, drain lines before applying vaccine.
Apply 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 vaccine should be administered in the volume of water consumed by the birds in up to 2 hours. As a general rule, apply 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 vaccine.
– Administer the reconstituted vaccine to birds immediately.
– Make sure that birds do not have access to unmedicated water during vaccination.
Overdose
See adverse reactions
Withdrawal periods
Zero days.
Pharmacological particulars
Pharmacotherapeutic group: avian infectious bursal disease virus (Gumboro disease),
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 strain causes an average score of bursal lesion of 2.9 (out of 5 according to Ph. Eur.) at 21 days post vaccination.
Pharmaceutical particulars
Excipients
Potassium dihydrogen phosphate,
Disodium phosphate dihydrate,
Lactose monohydrate,
Skim milk powder.
Major incompatibilities
Do not mix with any substances other than water or skimmed milk.
Shelf life
Lyophilisate: 21 months.
Reconstituted vaccine should be used within 2 hours.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Protect from direct sunlight. Do not freeze.
Avoid exposure of the reconstituted vaccine suspension to sunlight and temperatures above 25oC.
.
Immediate packaging
Nature of primary packaging elements:
Vaccine:
-type I glass vial
-type I rubber closure
The vaccine is available in the following packaging sizes:
Box with vial with 500 doses
Box with ten vials with 500 Doses
Box with vial with 1,000 doses
Box with ten vials with 1,000 Doses
Box with vial with 2,500 doses
Box with ten vials with 2,500 Doses
Box with vial with 5,000 doses
Box with ten vials with 5,000 Doses
Box with vial with 10,000 doses
Box with ten vials with 10,000 Doses
Potentially not all packaging sizes are placed into the market.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Lohmann Animal Health GmbH,
Heinz-Lohmann-Str. 4,
27472 Cuxhaven,
Niedersachsen
Germany
Marketing Authorisation Number
Vm 16894/4006
Significant changes
Date of the first authorisation or date of renewal
29 May 2008
Date of revision of the text
March 2015
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Vial with 2,500 doses: 04029989446452; Ten vials with 2,500 Doses: 04029989428847
GTIN:Vial with 5,000 doses: 04029989458363; Ten vials with 5,000 Doses: 04029989428861