ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC UNI L
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of one dose vaccine:
Active substance:
Newcastle disease virus, strain Hitchner B1
min 10 5.5 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 (broiler chicken).
4.2
Indications for use, specifying the target species
The vaccine is recommended for the active immunisation against Newcastle
disease and for the reduction of clinical signs and mortality. The vaccination is
recommended for healthy, day-old broiler chickens, the immunity develops within
21 days. After booster vaccination, at the age of 2-3 weeks, the duration of
immunity is expected to take till 6 weeks of age. If the birds are kept over 42 days
of age, they should be re-vaccinated.
4.3
Contraindications
None.
4.4
Special warnings for each target species
None.
4.5
Special precautions for use
Special precautions for use in animals
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Only well-developed, healthy chickens can be vaccinated.
The vaccine should be used up within 2 hours after opening and diluting it.
The immunised birds can shed the vaccine virus and the virus shed can spread
from animal to animal and to the flocks being in their surroundings. It
recommended to vaccinate all the birds in the farm.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Regulations on general labour-safety should be followed. Should the vaccine
contact with skin or eyes thorough water rinsing is needed.
In case of inhalation or contacting with eyes by accident, doctor should be visited
together with the direction for use of the preparation.
Should the vaccine virus contact with eyes, it may cause mild conjunctivitis,
which last 3-4 days.
4.6 Adverse reactions (frequency and seriousness)
In 4-6 days following the immunisation, mild respiratory signs can occur in some
bird, which disappear within a few days.
4.7 Use during pregnancy, lactation or lay
The vaccine is recommended for day-old broiler chickens.
4.8 Interaction with other medicinal products and other forms of
interaction
the administration of the vaccine together with other preparations, with the
exception of Cevac Mass L vaccine, has not been investigated, for this reason its
administration together with other preparations, except Cevac Mass L vaccine, is
not recommended.
4.9
Amounts to be administered and administration route
The vaccine is administerd by eye-drop method. The vaccine should be diluted in
sterile distilled water or in the joint diluent (the diluent can be ordered only for the
presentation of 1000 doses). 1000 doses of the vaccine should be diluted in 30
ml of diluent, in case of diluting other presentations this ratio should be
considered. The number of doses should be always rounded up in case of lower
number of birds (e.g. the number of 19,450 chickens should be rounded up to
20,00) and the vaccine should be diluted accordingly. Vaccinate the birds during
the coolest time of the day. After dissolution, the diluted vaccine should be used
up immediately. Improper usage and storage of the vaccine may negatively
influence on the efficacy of the vaccine. Sterile tools should be used for
dissoluting the vaccine.
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Hold the bird with the head tilted to one side. Hold the bottle with the dropper tip
down and drop one drop of vaccine onto the eye of the bird. Hold the head of the
bird tilted until the vaccine spreads over the eye.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Cevac Uni L is safe even in 10-fold doses.
4.11 Withdrawal period
None.
5.
IMMUNOLOGICAL PROPERTIES
ATCvet code: QI01AD06
Pharmacotherapeutic group: avian Newcastle disease virus (Newcastle disease).
Immunising the day old chicken by intraocular route, the vaccine virus dropped
onto the conjunctiva does not come into direct contact with the passive
antibodies of the circulation.
The vaccine virus proliferated in the epithelial cells comes into contact with the
lymphoid tissues, as a consequence of it local and circulating antibodies are
produced against them. The development of active immunity is influenced by the
health and quality of chickens, conditions of the farm and the hygienic
circumstances.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
2-hydroxy-propyl-B-cyclodextrin
Sucrose
Sodium glutamate
Potassium dihydrogen phosphate
Dipotassium hydrogen phosphate
Patent blue V (E131)
Gentamycin sulphate
Norfloxacin
Colistin
6.2 Incompatibilities
Not known.
6.3 Shelf life
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The unopened vaccine can be used up for 21 months counting from the
manufacturing date.
The dissolved vaccine should be used up within 2 hours and should be stored below
+25º C.
6.4. Special precautions for storage
The vaccine must be stored between 2oC and 8oC, protected from light and keep
out of children reach.
6.5 Nature and composition of immediate packaging
The vaccine is put into circulation of 3 or 10 ml vials of type I hydrolytic glass,
sealed with rubber stoppers and plastic-aluminium caps, the diluent of the
vaccine (30 ml for 1000 doses) is available in plastic bottles sealed with rubber
stoppers and plastic-aluminium caps and plastic applicator supplied with.
The vaccine is put into circulation in presentations of 1000, 2500 and 5000
doses, with filling volume of 1 ml, 2.5 ml or 4 ml.
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)
16951
9.
DATE
OF
AUTHORISATION
FIRST
AUTHORISATION/RENEWAL
First authorisation: 20/1/1997
Renewal: 18/1/2007
10.
DATE OF REVISION OF THE TEXT
20/2/2013
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OF
THE