Viloferron

Primær information

  • Handelsnavn:
  • Viloferron 200 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 200 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

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Lokation

  • Fås i:
  • Viloferron 200 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 52519
  • Sidste ændring:
  • 18-07-2018

Produktresumé

11. maj 2017

PRODUKTRESUMÉ

for

Viloferron, injektionsvæske, opløsning

0.

D.SP.NR

28809

1.

VETERINÆRLÆGEMIDLETS NAVN

Viloferron

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver ml indeholder:

Aktivt stof:

Jern(III)-ioner

200,0 mg

som gleptoferron

532,6 mg

Hjælpestoffer:

Phenol

5,0 mg

Vand til injektionsvæske

ad 1 ml

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

Mørkebrun, let viskøs, steril, kolloid, vandig opløsning

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Svin (pattegrise).

4.2

Terapeutiske indikationer

Til profylakse og behandling af anæmi som følge af jernmangel hos pattegrise.

4.3

Kontraindikationer

Bør ikke anvendes til pattegrise ved mistanke om mangel på vitamin E og/eller selen.

Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller

flere af hjælpestofferne.

52519_spc.docx

Side 1 af 4

Bør ikke anvendes til klinisk syge dyr, især i tilfælde af diarré.

4.4

Særlige advarsler

Ingen.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Ikke relevant.

Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr

Der skal udvises forsigtighed for at undgå selvinjektion ved hændeligt uheld samt kontakt

med slimhinder, især af personer med kendt overfølsomhed over for jerndextran.

I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og

indlægssedlen eller etiketten bør vises til lægen.

Vask hænder efter brug.

Andre forsigtighedsregler

4.6

Bivirkninger

Misfarvning af vævet og/eller let, blød hævelse ved injektionsstedet kan undertiden

observeres. Den bør forsvinde inden et par dage. Der kan også opstå overfølsomheds-

reaktioner. I sjældne tilfælde er der forekommet dødsfald blandt svin efter indgivelse af

parentale jerndextranpræparater. Disse dødsfald tilskrives genetiske faktorer eller mangel

på vitamin E og/eller selen. I meget sjældne tilfælde er der rapporteret dødsfald blandt

pattegrise, som tilskrives øget modtagelighed over for infektion som følge af midlertidig

blokering af det retikuloendoteliale system.

Hyppigheden af bivirkninger er defineret som:

Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en

behandling)

Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr)

Ikke almindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)

Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr)

Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).

4.7

Drægtighed, diegivning eller æglægning

Ikke relevant.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Absorptionen af samtidigt administreret oralt jern kan reduceres.

Se også pkt. 6.2.

4.9

Dosering og indgivelsesmåde

Udelukkende til intramuskulær injektion.

Pattegrise:

200 mg Fe

per dyr svarende til: 1 ml lægemiddel per dyr.

Injiceres én gang mellem 1. og 3. levedag.

52519_spc.docx

Side 2 af 4

4.10

Overdosering

Transferrin-jern mætningsniveauer førende til øget tilbøjelighed til (systemisk) bakteriel

sygdom, smerter, inflammationsreaktioner såvel som absces ved injektionsstedet kan

forekomme.

Der kan forekomme vedvarende misfarvning af muskelvæv ved injektionsstedet.

Iatrogen forgiftning med følgende symptomer: blege slimhinder, blødende gastroenteritis,

opkastning, takykardi, hypotension, dyspnø, ødemer på lemmer, halthed, shock, dødsfald,

leverskade.

Overdosering kan behandles med f.eks. et chelerende præparat.

4.11

Tilbageholdelsestid

Slagtning: 0 dage

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Jern(III), parenterale præparater, gleptoferron

ATCvet-kode: QB03AC91

5.1

Farmakodynamiske egenskaber

Jern er et væsentligt mikronæringsmiddel. Jern spiller en vigtig rolle for hæmoglobins og

myoglobins ilttransport samt for enzymer, f.eks. cytokromer, katalaser og peroxidaser.

Jern genoprettes hurtigt fra stofstiftet og den indtagne næring. Derfor forekommer

jernmangel kun meget sjældent hos voksne dyr.

5.2

Farmakokinetiske egenskaber

Efter intramuskulær injektion absorberes jernkomplekset i det lymfatiske væv inden for 3

dage. Her deles komplekset og frigiver Fe

, der lagres som ferritin i de vigtigste

lagringsorganer (f.eks. lever, milt og det retikuloendoteliale system). I blodet bindes det

frie Fe

til transferrin (transportformen) og bruges hovedsagelig i syntesen af

hæemoglobin.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Phenol (konserveringsmiddel)

Vand til injektionsvæsker

6.2

Uforligeligheder

Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette

lægemiddel ikke blandes med andre lægemidler.

6.3

Opbevaringstid

I salgspakning: 24 måneder.

Efter første åbning af den indre emballage: 28 dage.

52519_spc.docx

Side 3 af 4

6.4

Særlige opbevaringsforhold

Må ikke fryses.

6.5

Emballage

100 ml klart hætteglas (type II), 100 ml LDPE-flaske eller 200 ml LDPE-flaske med

chlorbutylgummilukning (type I) og aluminium/polypropylenlåg

Kartonæske med 1 hætteglas med 100 ml

Kartonæske med 10 hætteglas med 100 ml

Kartonæske med 10 LDPE-flasker med 100 ml

1 LDPE-flaske med 100 ml indpakket i plastik

Kartonæske med 10 LDPE-flasker med 200 ml

1 LDPE-flaske med 200 ml indpakket i plastik

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale

retningslinier.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

iron4u

Næsseslottet

Dronninggårds Allé 136

2840 Holte

Repræsentant

Vilofarm A/S

Søagervej 9

9500 Hobro

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

52519

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

19. august 2013

10.

DATO FOR ÆNDRING AF TEKSTEN

11. maj 2017

11.

UDLEVERINGSBESTEMMELSE

52519_spc.docx

Side 4 af 4

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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