ΠΑΡΑΡΤΗΜΑ 1:SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NOBILIS REO 1133, 103.1 TCID50, freeze-dried pellet with accompanying
suspending liquid, chicken.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.2 ml:
Active substance: Live attenuated reovirus, strain S1133, 235 chicken
embryo-100 chicken embryo-fibroblast passage: at least 103.1 TCID50.
Excipients:see list of excipients at 6.1
3.
4.
PHARMACEUTICAL FORM
Freeze-dried pellet with accompanying suspending liquid.
CLINICAL PARTICULARS
4.1. Target species
Chicken.
4.2.
Indications use, specifying the target species
- Active immunization of chicks from the age of 5 days against Tenosynovitis
(viral artrhritis) caused by avian reovirus (serotype 1133);
- Active basic immunization of primary and multiplier breeding chickens at the
age of 6-10 weeks, as a preliminary to re-vaccination with NOBILIS REO INAC,
REG NL 2371 for the passive immunization of offspring against Tenosynovitis (viral
arthritis) cause by avian reovirus (serotype 1133).
After vaccination with this medicine according to the instructions an immunity of
three weeks has been substantiated.
4.3. Contraindications
None.
4.4.
Special warnings for each target species
Maternal antibodies may have a negative effect on the result of the
vaccination.
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4.5.
Special precautions for use
Special precautions for use in animals
•
Vaccinate healthy chickens only. Although disease may not be
evident, coccidiosis, Mycoplasm infections, Marek’s disease, and other
disease conditions may cause complications or reduce development of
immunity.
• Efforts should be taken to reduce stress during the vaccination and the post
vaccination period.
• Once dissolved, the vaccine is very vulnerable and can loose its activity
depending on environmental conditions.
• Use entire contents when first opened.
• Do not vaccinate within 12 weeks prior to the onset and during egg
production in breeders.
• Burn containers and all unused contents.
• Do not use this vaccine in combination with Marek Disease vaccine or live
Gumboro vaccine.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None.
4.6.
Adverse reaction(frequency and seriousness)
None known.
4.7.
4.8.
Use during pregnancy, lactation and egg lay
Not applicable.
Interaction with other medicinal and other forms of interaction
None known.
4.9.
Posology and method of administration
Dosage:One dose(0.2 ml) per bird.
Route of administration:Subcutaneous.
Vaccination programm:
In areas of high exposure, chicks can become susceptible during the first weeks of
life. Therefore early vaccination becomes mandatory. In these areas, vaccination
with this vaccine could be accomplished beginning at day five. Revaccination
should occur at 5 to 7 weeks of age and again at 9 to 11 weeks of age.In areas of
lesser exposure, vaccination should occur at 5 to 7 weeks of age and again at 9 to
11 weeks of age. To complete this program for breeding birds, the administration
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of an inactivated Reovirus vaccine is recommended between 18 to 22 weeks of
age.
Preparation of vaccine
-The Diluent Poultry Freeze Dried, is recommended for the reconstitution of this
vaccine.Use 200 ml diluent for 1000 doses of vaccine.
-Vaccination equipment should be sterile and free from traces of disinfectant or
spirit.
-Add some diluent into the vial of vaccine and shake.
-Withdraw the rehydrated vaccine into the syringe and add to the rest of the
diluent.
Gently shake to mix. Withdraw a portion of the diluent with the syringe to flush
the vial.
Inject the liquid back into the diluent bottle.
-Remove the syringe.
-Fill the previously sterilized automatic syringe according to the manufacturer’s
recommendations and set the dose for 0,2 ml.
-The vaccine is now ready for use.
4.10.
Overdose (symptoms, emergency procedures, antidotes)if
necessary
None known.
4.11. Withdrawal periods
Slaughter: 0 days
Eggs:
0 days
5.
IMMUNOLOGICAL PROPERTIES
Live viral vaccine.
ATC vet. Code: QI01AD10.
Stimulation of active immunity against Tenosynovitis (viral arthritis).
6.
PHARMACOKINETIC PARTICULARS
6.1.
List of excipients
TC medium
Pancreatic digest of casein
Dextran 70
Sorbitol
Sucrose
Gelatin
Dibasic potassium phosphate
Monobasic potassium phosphate
Water for injection
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6.2.
Incompatibilities
Do not mix with any other veterinary products
6.3.
Shelf-life
3 years.
Re-suspended vaccine: use immediately.
6.4.
.
Special precautions for storage
Store at 2-8oC.
Protect against light
6.5. Nature and composition of immediate packaging
Vaccine: Glass (Type II, Ph.Eur.) vial with rubber stopper and metal seal cap.
Suspending liquid: Glass (Type II, Ph. Eur.) vial or plastic bag (polyethylene)
with a rubber stopper.
6.6.
Special precautions for the disposal of unused veterinary
medicinal product or waste derived from the use of such
products
Dispose of residues by boiling, burning or submersion in a suitable disinfectant
in accordance with national requirements.
7.
MARKETING AUTHORISATION HOLDER
Intervet International B.V,Wim de Korverstraat 35 NL-5831 AA Boxmeer,The
Netherlends.
8.
MARKETING AUTHORISATION NUMBER
14164
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
4/5/1993
10. DATE OF REVISION OF THE TEXT
23/3/2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
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