Ecoporc Shiga

Glavna informacija

  • Trgovački naziv:
  • Ecoporc Shiga
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ecoporc Shiga
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • svinje
  • Područje terapije:
  • Imunološke za suidae, inaktivirane bakterijske vakcine
  • Terapijske indikacije:
  • Aktivna imunizacija praščića od dobi od četiri dana, kako bi se smanjila smrtnost i klinički znakovi bolesti edema uzrokovanih Shiga toksinom 2e koji su proizveli Escherichia coli (STEC). Početak imuniteta: 21 dan nakon cijepljenja. Trajanje imuniteta: 105 dana nakon cijepljenja.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/002588
  • Datum autorizacije:
  • 10-04-2013
  • EMEA koda:
  • EMEA/V/C/002588
  • Zadnje ažuriranje:
  • 23-02-2018

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP

Ecoporc SHIGA

Suspenzija za injekcije za svinje

1.

NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I

NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE

PROIZVODNE SERIJE, AKO JE RAZLIČITO

Nositelj odobrenja za stavljanje u promet i nositelj odobrenja za proizvodnju za puštanje proizvodne

serije:

IDT Biologika GmbH

Am Pharmapark

06861 Dessau-Rosslau

Njemačka

2.

NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA

Ecoporc SHIGA suspenzija za injekcije za svinje

3.

NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA

Jedna doza od 1 ml sadrži:

Djelatne tvari:

Genetski modificirani antigen Stx2e:

≥ 3,2 x 10

ELISA jedinica

Adjuvans:

Aluminij (u obliku hidroksida)

maks. 3,5 mg

Pomoćna tvar:

Tiomersal

maks. 0,115 mg

Izgled nakon protresanja: žućkasta do smećkasta homogena suspenzija.

4.

INDIKACIJE

Aktivna imunizacija praščića u dobi od četiri dana radi smanjenja smrtnosti i kliničkih znakova

edemske bolesti uzrokovanih toksinom Stx2e koji proizvodi

E. coli

(STEC).

Nastup imuniteta:

21 dan nakon cijepljenja.

Trajanje imuniteta:

105 dana nakon cijepljenja.

5.

KONTRAINDIKACIJE

Ne koristiti u slučaju preosjetljivosti na djelatnu tvar, na adjuvans ili na bilo koju pomoćnu tvar.

6.

NUSPOJAVE

Obično se mogu primijetiti neznatne lokalne reakcije poput blagog otoka na mjestu injekcije

(maksimalne veličine 5 mm), ali te reakcije su prolazne i prolaze nakon kratkog vremena (do sedam

dana) bez liječenja. Obično se nakon injekcije može javiti blagi porast tjelesne temperature

(maksimalno od 1,7 °C). Ali te reakcije prolaze nakon kratkog vremena (najviše za dva dana) bez

liječenja. Klinički znakovi poput privremenih blagih poremećaja u ponašanju rijetko se primjećuju

nakon primjene cjepiva Ecoporc SHIGA.

Učestalost nuspojava je određena sukladno sljedećim pravilima:

vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)a)

česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja)

manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)

rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)

vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirana slučajeve).

Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da

veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.

7.

CILJNE VRSTE ŽIVOTINJA

Svinje.

8.

DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)

PRIMJENE

Prije primjene pažljivo protresite cjepivo.

Injicira se jednokratno (1 ml) svinjama u dobi od četiri dana nadalje. Preferirano mjesto primjene je

vratni mišić iza uha.

9.

SAVJETI ZA ISPRAVNU PRIMJENU

Preporučuje se primjena igle prikladne za dob praščića (preferirana veličina 21G, duljina 16 mm).

10.

KARENCIJA

Nula dana.

11.

POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE

Čuvati izvan dosega i pogleda djece.

Čuvati u hladnjaku (2

C – 8

Čuvati od zamrzavanja.

Zaštititi od svjetlosti.

Rok valjanosti nakon prvog otvaranja spremnika: 24 sata.

Između navlačenja cjepivo treba čuvati na temperaturi od 2 °C – 8 °C.

Ne koristiti poslije isteka roka valjanosti naznačenog na etiketi ili kutiji.

12.

POSEBNO UPOZORENJE

Posebne mjere opreza za primjenu na životinjama:

Cijepiti samo zdrave životinje.

Posebne mjere koje treba uzeti u obzir osoba koja primjenjuje veterinarsko medicinski proizvod na

životinjama:

U slučaju samoinjiciranja ili gutanja odmah potražite liječničku pomoć i pokažite mu uputu ili etiketu

VMP.

Graviditet i laktacija:

Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena tijekom graviditeta i laktacije.

Ne preporuča se primjena tijekom graviditeta ili laktacije.

Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:

Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kad se koristi s bilo kojim

drugim veterinarsko-medicinskim proizvodom.

Stoga se odluka o primjeni ovog cjepiva prije, odnosno poslije primjene bilo kojeg drugog

veterinarsko-medicinskog proizvoda mora donositi od slučaja do slučaja.

Glavne inkompatibilnosti:

Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.

Predoziranje (simptomi, hitna pomoć, antidoti):

Nakon primjene dvostruke doze cjepiva nisu primijećene nuspojave različite od onih opisanih u

odjeljku 6.

13.

POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENOG

PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA

Pitajte vašeg veterinara kako odlagati veterinarsko medicinske proizvode koji vam više nisu potrebni. Te

mjere pomažu zaštiti okoliša.

14.

DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA

{MM/GGGG}

Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske

agencije za lijekove (EMA) http://www.ema.europa.eu/.

15.

OSTALE INFORMACIJE

PET bočica od 50 ili 100 ml zatvorene čepom od bromobutil-gume i zapečaćene aluminijskom tear-off

kapicom.

Veličine pakovanja:

Kartonska kutija s jednom PET bočicom od 50 doza (50 ml) ili 100 doza (100 ml).

Ne moraju sve veličine pakovanja biti u prometu.

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