ΠΑΡΑΡΤΗΜΑ 1: SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AviPro REO
Lyophilisate and solvent for suspension for injection for use in chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
1 dose contains: at least 104.0 TCID50* and at the most 105.5 TCID50* live attenuated Reo
virus, strain 1133
Host system: SPF chicken embryo fibroblasts
* TCID50 = tissue culture-infectious dose
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection for use in chickens
Appearance: yellow white
4.
CLINICAL PARTICULARS
4.1
Target species
Chicken
4.2
Indications for use, specifying the target species
For vaccination of chicken against viral arthritis/tenosynovitis.
Onset of immunity: 14 days
Duration of immunity: The presence of neutralizing antibodies lasts for at least 6 weeks.
This is why a follow-up vaccination with inactivate vaccines at an interval of 5 – 9 weeks
for breeding and laying birds is recommended in order to ensure immunity during the
whole breeding and laying period.
4.3
Contraindications
Do not use in clinically ill or weakened birds
4.4
Special warnings
None
1/5
4.5
Special precautions for use

Protect the finished vaccine suspension from direct sunlight and heating above
25°C!

Use the whole content of opened containers at once.

Only prepare the amount of vaccine which can be used within 2 hours.
Special precautions for use in animals
Vaccinate only healthy birds.
Note:
The vaccine is by nature, only effective against viral arthritis/tenosynovitis. It does not
provide protection against bacterial infection, e.g. due to staphylococci or mykoplasma.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Live virus vaccine: avoid any contamination by splashing or spilling.
Wash and disinfect hands after use.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
4.6
Adverse reactions (frequency and seriousness)
None known
4.7
Use during pregnancy, lactation or lay
Do not use in birds during the laying period.
4.8
Interaction with other medicinal products and other forms of interaction
None known.
No information is available on the mutual compatibility of this vaccine with other
vaccines. For this reason the safety and efficacy of the use of this vaccination with
another (administered either on the same day or at different times) is not verified.
4.9
Amounts to be administered and administration route
1 dose (= 0.2 ml) of the vaccine should be administered per animal
For intramuscular or subcutaneous injection after preparation from the lyophilisate and
solvent.
Directly before the start of vaccination, the lyophilisate is re-suspended in the supplied
solution AviPro DILUJECT (200 ml/1000 doses). The solvent should be at room
2/5
temperature (+20°C to +25°C). After being mixed well (avoid foaming) the vaccine is ready
for use and must be used within 2 hours.
During the vaccination it is recommended to maintain a regular distribution by repeated
missing of the vaccine suspension (e.g. with a magnet agitator).
Up to now, REO virus infections have mainly resulted in diseases of the parent birds as
well as the broilers in the fattening areas. In individual cases, a clinical condition of
laying birds was also observed.
A generalized vaccination scheme cannot be supplied because the moment of the initial
vaccination and the subsequent vaccination intervals depend on different factors, such
as the current epidemic situation, the type of husbandry, further vaccinations as well as
the birds’ state of health.
The basic immunization is achieved by the administration of AviPro REO within the first
week of life. Booster vaccinations should be carried out with the respective inactivates.
Each bird is injected with 0.2 ml of the ready-to-use vaccine, either subcutaneously or
intramuscularly.
Possible vaccination scheme for breeding and laying birds:
1st vaccination:
2nd vaccination:
3rd vaccination:
1st week of life with AviPro REO
5th – 9th week of life with inactivated vaccine
2-4 weeks prior to the beginning of the laying period with
inactivated vaccine
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
An overdose is safe. Under-dosage, however, may lead to insufficient vaccination.
.
4.11 Withdrawal periods
Zero days.
5.
IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: live virus vaccines for poultry, ATCvet code: QI01AD10
As its immunological component, AviPro REO contains the Reo virus strain 1133, which
is attenuated via embryo passages and additional cell culture passages (in chicken
embryo cells).
The immunological response, which is induced by the vaccine, reduces the appearance
of clinical symptoms as well as the fecal virus excretion after an infection.
3/5
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Vaccine: Dipotassium hydrogen phosphate, potassium dihydrogen phosphate,
saccharose, sodium L-glutamate, bovine albumin, medium 199, skimmed milk powder.
Solvent: Dipotassium hydrogen phosphate, potassium
saccharose, sodium L-glutamate, lactalbumine hydrolysate.
6.2
dihydrogen
phosphate,
Incompatibilities
Do not mix with any other vaccines, immunological products or veterinary products.
6.3
Shelf life
The shelf-life of the vaccine is stated on the pack: 24 months at 2°C to 8°C.
Shelf-life after dilution or reconstitution according to the instructions: 2 hours at room
temperature.
6.4. Special precautions for storage
Store in a refrigerator (2°C - 8°C). Protect from direct sunlight. Do not freeze.
The solvent AviPro DILUJECT has to be stored below 25 C and protected from frost.
6.5
Nature and composition of immediate packaging
Glass bottle type I (Ph.Eur.) with welt edge and chlorbutyl elastomer cap.
The vaccine is available in the following pack sizes:
Pack with 1,000 doses and solvent
Bundle packs:
Pack with 10 x 1,000 doses and solvent
The sterile solvent AviPro DILUJECT is supplied in 200 ml units in plastic bottles. The
bottles are closed with rubber caps and sealed with aluminum tear caps.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product
or waste materials derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate
disinfectant approved for use by the competent authorities.
4/5
7.
NAME OF MARKETING AUTHORIZATION HOLDER
LOHMANN ANIMAL HEALTH GmbH
Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Germany
8. NUMBER OF MARKETING AUTHORIZATION
16315
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8/11/1995, 14/3/2014
10.
DATE OF REVISION OF THE TEXT
14/3/2014
AVAILABLE ON PRESCRIPTION/IN PHARMACIES
The vaccine is available only on prescription.
5/5