Evalon
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
26-02-2021
Karatteristiċi tal-prodott
(SPC)
26-02-2021
Rapport ta 'Valutazzjoni Pubblika
(PAR)
13-05-2016
Ingredjent attiv:
vaccine against coccidiosis in chickens
Disponibbli minn:
Laboratorios Hipra, S.A.
Kodiċi ATC:
QI01AN01
INN (Isem Internazzjonali):
eimeria acervulina, strain 003, eimeria brunetti, strain 034, eimeria maxima, strain 013, eimeria necatrix, strain 033, eimeria tenella, strain 004
Grupp terapewtiku:
Chicken
Żona terapewtika:
Live parasitic vaccines, Immunologicals for aves
Indikazzjonijiet terapewtiċi:
For active immunisation of chicks from 1 day of age to reduce clinical signs (diarrhoea), intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.,
Sommarju tal-prodott:
Revision: 2
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2016-04-18
Fuljett ta 'informazzjoni
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
EVALON SUSPENSION AND SOLVENT FOR ORAL SPRAY FOR CHICKENS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Evalon suspension and solvent for oral spray for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Evalon:
Each dose (0.007 ml) of undiluted vaccine contains:
ACTIVE SUBSTANCES:
_Eimeria acervulina, _
strain 003 ..................................... 332 – 450*
_Eimeria brunetti, _
strain 034 .......................................... 213 – 288*
_Eimeria maxima, _
strain 013 .......................................... 196 – 265*
_Eimeria necatrix, _
strain 033 ......................................... 340 – 460*
_Eimeria tenella, _
strain 004 ........................................... 276 – 374*
* Number of sporulated oocysts derived from precocious attenuated
lines of coccidia, according to
_in _
_vitro_
procedures of the manufacturer at the time of blending.
HIPRAMUNE T (solvent):
ADJUVANT:
Montanide IMS
EXCIPIENTS:
Brilliant Blue (E133)
Red AC (E129)
Vanillin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension and solvent for oral spray.
Suspension: White turbid suspension.
Solvent: Dark brownish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chicks from 1 day of age to reduce clinical
signs (diarrhoea), intestinal
lesions and oocysts output associated with coccidiosis caused by
_Eimeria acervulina_
,
_Eimeria brunetti,_
_Eimeria maxima,_
_Eimeria necatrix _
and
_Eimeria tenella_
.
Onset of immunity: 3 weeks post-vaccination.
Duration of immunity: 60 weeks post-vaccination in an environment that
permits oocysts recycling.
3
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
The vaccine will not protect species other than chickens against
coccidiosis and is only effective
against the
_Eimeria_
species indicated.
It is normal to find vaccinal oocysts in the intestine or litter of
vaccinated flocks. Generally the number
is higher
Aqra d-dokument sħiħ
