Evalon

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
26-02-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
26-02-2021
Public Assessment Report Public Assessment Report (PAR)
13-05-2016

Active ingredient:

vaccine against coccidiosis in chickens

Available from:

Laboratorios Hipra, S.A.

ATC code:

QI01AN01

INN (International Name):

eimeria acervulina, strain 003, eimeria brunetti, strain 034, eimeria maxima, strain 013, eimeria necatrix, strain 033, eimeria tenella, strain 004

Therapeutic group:

Chicken

Therapeutic area:

Live parasitic vaccines, Immunologicals for aves

Therapeutic indications:

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.,

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2016-04-18

Patient Information leaflet

                                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 
                                
                                Read the complete document

Summary of Product characteristics

                                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 
                                
                                Read the complete document

Similar products

Active ingredient vaccine against coccidiosis in chickens

vaccine against coccidiosis in chickens

ATC code QI01AN01

QI01AN01

Marketed by Laboratorios Hipra, S.A.

Laboratorios Hipra, S.A.

INN (International Name) eimeria acervulina, strain 003, eimeria brunetti, strain 034, eimeria maxima, strain 013, eimeria necatrix, strain 033, eimeria tenella, strain 004

eimeria acervulina, strain 003, eimeria brunetti, strain 034, eimeria maxima, strain 013, eimeria necatrix, strain 033, eimeria tenella, strain 004

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 26-02-2021
Public Assessment Report Public Assessment Report Bulgarian 13-05-2016
Patient Information leaflet Patient Information leaflet Spanish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Spanish 26-02-2021
Public Assessment Report Public Assessment Report Spanish 13-05-2016
Patient Information leaflet Patient Information leaflet Czech 26-02-2021
Summary of Product characteristics Summary of Product characteristics Czech 26-02-2021
Public Assessment Report Public Assessment Report Czech 13-05-2016
Patient Information leaflet Patient Information leaflet Danish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Danish 26-02-2021
Public Assessment Report Public Assessment Report Danish 13-05-2016
Patient Information leaflet Patient Information leaflet German 26-02-2021
Summary of Product characteristics Summary of Product characteristics German 26-02-2021
Public Assessment Report Public Assessment Report German 13-05-2016
Patient Information leaflet Patient Information leaflet Estonian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Estonian 26-02-2021
Public Assessment Report Public Assessment Report Estonian 13-05-2016
Patient Information leaflet Patient Information leaflet Greek 26-02-2021
Summary of Product characteristics Summary of Product characteristics Greek 26-02-2021
Public Assessment Report Public Assessment Report Greek 13-05-2016
Patient Information leaflet Patient Information leaflet French 26-02-2021
Summary of Product characteristics Summary of Product characteristics French 26-02-2021
Public Assessment Report Public Assessment Report French 13-05-2016
Patient Information leaflet Patient Information leaflet Italian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Italian 26-02-2021
Public Assessment Report Public Assessment Report Italian 13-05-2016
Patient Information leaflet Patient Information leaflet Latvian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Latvian 26-02-2021
Public Assessment Report Public Assessment Report Latvian 13-05-2016
Patient Information leaflet Patient Information leaflet Lithuanian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 26-02-2021
Public Assessment Report Public Assessment Report Lithuanian 13-05-2016
Patient Information leaflet Patient Information leaflet Hungarian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Hungarian 26-02-2021
Public Assessment Report Public Assessment Report Hungarian 13-05-2016
Patient Information leaflet Patient Information leaflet Maltese 26-02-2021
Summary of Product characteristics Summary of Product characteristics Maltese 26-02-2021
Public Assessment Report Public Assessment Report Maltese 13-05-2016
Patient Information leaflet Patient Information leaflet Dutch 26-02-2021
Summary of Product characteristics Summary of Product characteristics Dutch 26-02-2021
Public Assessment Report Public Assessment Report Dutch 13-05-2016
Patient Information leaflet Patient Information leaflet Polish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Polish 26-02-2021
Public Assessment Report Public Assessment Report Polish 13-05-2016
Patient Information leaflet Patient Information leaflet Portuguese 26-02-2021
Summary of Product characteristics Summary of Product characteristics Portuguese 26-02-2021
Public Assessment Report Public Assessment Report Portuguese 13-05-2016
Patient Information leaflet Patient Information leaflet Romanian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Romanian 26-02-2021
Public Assessment Report Public Assessment Report Romanian 13-05-2016
Patient Information leaflet Patient Information leaflet Slovak 26-02-2021
Summary of Product characteristics Summary of Product characteristics Slovak 26-02-2021
Public Assessment Report Public Assessment Report Slovak 13-05-2016
Patient Information leaflet Patient Information leaflet Slovenian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Slovenian 26-02-2021
Public Assessment Report Public Assessment Report Slovenian 13-05-2016
Patient Information leaflet Patient Information leaflet Finnish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Finnish 26-02-2021
Public Assessment Report Public Assessment Report Finnish 13-05-2016
Patient Information leaflet Patient Information leaflet Swedish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Swedish 26-02-2021
Public Assessment Report Public Assessment Report Swedish 13-05-2016
Patient Information leaflet Patient Information leaflet Norwegian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Norwegian 26-02-2021
Patient Information leaflet Patient Information leaflet Icelandic 26-02-2021
Summary of Product characteristics Summary of Product characteristics Icelandic 26-02-2021
Patient Information leaflet Patient Information leaflet Croatian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Croatian 26-02-2021
Public Assessment Report Public Assessment Report Croatian 13-05-2016

Search alerts related to this product

Alerts Evalon vaccine against coccidiosis chickens eimeria acervulina, strain 003,

Evalon vaccine against coccidiosis chickens eimeria acervulina, strain 003,

View documents history

Documents history Documents history

Evalon