Econor

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-09-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
03-09-2019
Public Assessment Report Public Assessment Report (PAR)
07-12-2018

Active ingredient:

valnemulin

Available from:

Elanco GmbH

ATC code:

QJ01XQ02

INN (International Name):

valnemulin

Therapeutic group:

Pigs; Rabbits

Therapeutic area:

Противоинфекционные za sistemsku primjenu

Therapeutic indications:

PigsThe liječenje i prevenciju dizenterija svinja. Liječenje kliničkih znakova svinjske proliferativne enteropatije (ileitis). Prevencija kliničkih znakova svinjske kolonije spirochaetosis (kolitis) kada je bolest dijagnosticirana u stadu. Liječenje i prevencija svinjske enzootske upale pluća. Po preporučenoj dozi od 10-12 mg / kg tjelesne težine plućnih lezija i gubitka težine smanjuju se, ali infekcija Mycoplasma hyopneumoniae nije eliminirana. RabbitsReduction smrtnosti tijekom epidemije эпизоотическая zec энтеропатия (ЭРД). Liječenje treba započeti rano u izbijanju, kada je klincu dijagnosticiran prvi zec.

Product summary:

Revision: 21

Authorization status:

odobren

Authorization date:

1999-03-12

Patient Information leaflet

                                20
OSNOVNI PODACI NA UNUTARNJEM PAKOVANJU – KOMBINIRANA ETIKETA I
UPUTA O VMP
PLASTIČNE VREĆE PODSTAVLJENE ALUMINIJEM
1.
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA
ODOBRENJA ZA
PROIZVODNJU ODGOVORNOG ZA PUŠTANJE SERIJE U PROMET, AKO JE RAZLIČITO
Nositelj odobrenja za stavljanje u promet:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
NJEMAČKA
Proizvođač odgovoran za puštanje serije u promet:
Elanco France S.A.S.
26, Rue de la Chapelle
68330 Huningue
FRANCUSKA
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Econor 10 % premiks za izradu ljekovite hrane za svinje i kuniće
Valnemulinklorid
3.
KOLIČINA DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
Econor 10 % premiks sadrži valnemulin u obliku valnemulinklorida.
Valnemulinklorid
106,5 mg/g
odgovara valnemulinu
100 mg/g
OSTALI SASTOJCI:
Hipromeloza
Talk
Silicijev dioksid, koloidni, bezvodni
Izopropilmiristat
Laktoza
4.
FARMACEUTSKI OBLIK
Premiks za izradu ljekovite hrane.
5.
VELIČINA PAKOVANJA
1 kg
25 kg
21
6.
INDIKACIJE
Svinje:
Liječenje i prevencija dizenterije svinja.
Liječenje kliničkih znakova proliferativne enteropatije svinja
(ileitis).
Prevencija
kliničkih
znakova
spirohetoze
kolona
svinja
(intestinalna
spirohetoza)
nakon
dijagnosticiranja bolesti u uzgoju.
Liječenje i prevencija enzootske pneumonije svinja. Pri preporučenoj
dozi od 10 do 12 mg/kg tjelesne
mase smanjuju se lezije pluća i gubitak na težini, ali infekcija s
Mycoplasma hyopneumoniae nije
eliminirana.
Kunići:
Smanjenje smrtnosti tijekom izbijanja epizootske enteropatije kunića
(ERE). Liječenje treba početi
odmah na početku izbijanja bolesti kad je prvom kuniću klinički
dijagnosticirana bolest.
7.
KONTRAINDIKACIJE
Ne primjenjivati proizvod na svinjama ili kunićima koje primaju
ionofore.
Nemojte predozirati kuniće – povećane doze mogu poremetiti
crijevnu floru što može uzrokovati
razvoj enterotoksemije.
8.
NUSPOJAVE
Kunići:
Vidi u odjeljku "Posebno(a) upozorenje(a)."
Svinje:
Nuspojave nakon primjene Econora uglavnom su povezane s pasminama i
mješ
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Econor 50 % premiks za izradu ljekovite hrane za svinje
Econor 10 % premiks za izradu ljekovite hrane za svinje i kuniće
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Econor sadrži valnemulin u obliku valnemulinklorida.
ECONOR 50 %
ECONOR 10 %
DJELATNA TVAR
valnemulinklorid
532,5 mg/g
106,5 mg/g
što odgovara bazi
valnemulina
500 mg/g
100 mg/g
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
3.
FARMACEUTSKI OBLIK
Premiks za izradu ljekovite hrane.
Bijeli do blijedožućkasti prašak.
4.
KLINIČKE POJEDINOSTI
4.1
CILJNE VRSTE ŽIVOTINJA
Svinje i kunići.
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
ECONOR 50 %
Liječenje i prevencija dizenterije svinja.
Liječenje kliničkih znakova proliferativne enteropatije svinja
(ileitis).
Prevencija
kliničkih
znakova
spirohetoze
kolona
svinja
(intestinalna
spirohetoza)
nakon
dijagnosticiranja bolesti u uzgoju.
Liječenje i prevencija enzootske pneumonije svinja. Pri preporučenoj
dozi od 10 do 12 mg/kg tjelesne
mase smanjuju se lezije pluća i gubitak na težini, ali infekcija s
_Mycoplasma hyopneumoniae_
nije
eliminirana.
ECONOR 10 %
Svinje:
Liječenje i prevencija dizenterije svinja.
Liječenje kliničkih znakova proliferativne enteropatije svinja
(ileitis).
Prevencija
kliničkih
znakova
spirohetoze
kolona
svinja
(intestinalna
spirohetoza)
nakon
dijagnosticiranja bolesti u uzgoju.
Liječenje i prevencija enzootske pneumonije svinja. Pri preporučenoj
dozi od 10 do 12 mg/kg tjelesne
mase smanjuju se lezije pluća i gubitak na težini, ali infekcija s
_Mycoplasma hyopneumoniae_
nije
eliminirana.
Kunići:
Smanjenje smrtnosti tijekom izbijanja epizootske enteropatije kunića
(ERE).
3
Liječenje treba početi odmah na početku izbijanja bolesti kad je
prvom kuniću klinički dijagnosticirana
bolest.
4.3
KONTRAINDIKACIJE
Ne primjenjivati veterinarsko-medicinski proizvod na svinjama ili
kunićima koje primaju ionofore.
Nemojte predozirati kuniće – povećane doze mogu poremetiti
crij
                                
                                Read the complete document

Similar products

Active ingredient valnemulin

valnemulin

ATC code QJ01XQ02

QJ01XQ02

Marketed by Elanco GmbH

Elanco GmbH

INN (International Name) valnemulin

valnemulin

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Patient Information leaflet Patient Information leaflet Bulgarian 03-09-2019
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-09-2019
Public Assessment Report Public Assessment Report Bulgarian 07-12-2018
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