ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC BRON 120 L
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of one dose vaccine:
Active substance:
Avian infectious bronchitis virus, Massachusets H-120 strain min 10 3.5 EID50
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Live, freeze-dried vaccine.
4.
CLINICAL PARTICULARS
4.1
Target species
Chicken.
4.2
Indications for use, specifying the target species
For the active immunisation of healthy chickens against infectious bronchitis.
The vaccine may be used for initial or re-vaccination of broilers, pullets and hens.
4.3
Contraindications
No contraindications are known.
4.4
Special warnings for each target species
None.
4.5
Special precautions for use
Special precautions for use in animals
Satisfactory protection can be achieved only in healthy birds.
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Always round the number of doses up (e.g. 20,000 doses for 19,450 birds), do
not stretch dosage.
All the birds in the flock must be vaccinated at the same time.
Administer the vaccine during the coolest time of the day.
Improper storage or handling of the vaccine may result in loss of potency.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
None.
4.6 Adverse reactions (frequency and seriousness)
Rarely, catarrhal respiratory symptoms appear 4 to 6 days following vaccination
but disappear in a few days.
4.7 Use during pregnancy, lactation or lay
Not reported.
4.8 Interaction with other medicinal products and other forms of
interaction
Unknown.
4.9
Amounts to be administered and administration route
Primary vaccination should be carried-out with Cevac Bron 120 L by eye-drop or
spray method, as from 1 day of age.
Booster vaccination is recommended three to four weeks later by spray or
drinking water.
For pullets, a second booster vaccination is recommended at 10 to 12 weeks of
age.
Eye-drop method
Fill the vaccine vial with diluent till ¾ of the total volume to dissolve the
lyophilised vaccine (sterile distilled water). Pour and dilute the vaccine
suspension into the remaining diluent contained in the plastic bottle with the
dropper. Sterile needle and syringe should be used for this preparation.
30 ml of diluent should be used to administer 1,000 doses.
Hold the bird to be vaccinated with the head tilted to one side.
Hold the plastic bottle with the dropper tip down, gently press the sides, dropping
one drop of vaccine onto the eye of the bird. Be sure the vaccine spreads over
the eye before releasing the bird.
Spray method
Use sterile distilled water and reconstitute the vaccine as explained in the eyedrop method.
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It is preferable to use a sprayer working under constant pressure. Use the right
nozzle size (as prescribed by the sprayer manufacturer) and tune the pressure to
produce a coarse spray.
Delivery rate varies from 0.2 to 0.3 litres/1000 day old chicks in a box, from 0.5 to
1 litre/1000 birds on litter. The volume may change according to the weather
conditions. The birds should be slightly wet after vaccination.
Vaccinate during the coolest time of the day. Switch off the heaters and shut
down the ventilation. Gather the birds on the ground or in boxes. Dim the lighting
and spray 20-30 cm above the birds. Return to spray a second time. Leave the
birds quiet for at least 15 minutes after vaccination. Switch on heaters and
ventilation.
Drinking water method
Do not use a disinfectant in the drinking water for a period of 48 hours prior to
and 24 hours after vaccination.
When a chlorine pump is used, switch it off for the same period of time.
The waterers should be thoroughly cleaned before vaccination. No disinfectant
shall be used.
Close the water distribution system, raise and empty the nipple lines or empty the
waterers.
Water withholding period varies according to age of birds and climatic conditions
(average 1h30 min.).
Prepare only the amount of vaccine to be used immediately.
Use only plastic material and tools to prepare and administer vaccine.
Prepare the required volume of water that will be consumed by the birds in 2
hours. This volume may change according to the climatic and environmental
conditions.
Age
3-4 weeks From
10
minimal amount of water for 1000
weeks
vaccine doses
25-30 litres 40 litres
(for treatment of 1000 birds)
As an aid in preserving the virus activity, neutralise the chlorine with 2.5 g of
skimmed milk powder per litre of water or 15 mg of sodium thiosulfate per litre of
water. Do not use water conatining high concentrations of metal ions.
Mix the vaccine with clean, cool, non-chlorinated water by opening the vials
under the water and let stand for 10 minutes.
Open the water system when the colour of the water changes (blue dye), lower
the lines and check distribution throughout the house. When the tank is empty: fill
it with a solution of skimmed milk powder, let it stand for 10 min., then open the
water system to flush out the remaining vaccine solution in the pipeworks.
Vaccine solution can be distributed also manually by workers using plastic
watering cans.
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4.10Overdose (symptoms, emergency procedures, antidotes), if necessary
Unknown.
4.11 Withdrawal period
0 days
5.
IMMUNOLOGICAL PROPERTIES
ATCvet code: QI01AD07
Pharmacotherapeutic group: avian infectious Bronchitis virus (Bronchitis
disease).
The vaccine is recommended to be used for active immunisation of chickens
against infectious bronchitis.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cyclodextrin
Sucrose
Patent Blue V (E131)
6.2 Incompatibilities
Chlorine, fluorine or any elements present in the water affect adversely the virus
content of the vaccine. Thus for the reduction of this disadvantageous activity is
recommended to dissolve in the drinking water 2.5 g skimmed milk powder per
litre water or 15 mg of sodium thiosulfate per litre of water prior to the addition of
the vaccine.
6.3 Shelf life
18 months.
6.4. Special precautions for storage
At temperature 2oC and 8oC, protected from light.
6.5 Nature and composition of immediate packaging
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The vaccine is put into circulation in glass vials which 20x1000, 20x2000,
20x2500 and 20x5000 doses of vaccine. The vials are sealed with rubber
stoppers and plastic (tear flip up) aluminium 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
The unused product or waste materials have to be handled according to the national
rules concerning medicinal waste products.
7.
MARKETING AUTHORISATION HOLDER
CEVA SANTE ANIMALE
10, avenue de la Ballastiere
33500 Libourne
France
8.
MARKETING AUTHORISATION NUMBER(S)
19045
9.
DATE
OF
AUTHORISATION
FIRST
AUTHORISATION/RENEWAL
First authorisation: 7/12/2000
Renewal: 19/4/2013
10.
DATE OF REVISION OF THE TEXT
19/4/2013
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OF
THE