Vetidex 20% Vet.

Primær information

  • Handelsnavn:
  • Vetidex 20% Vet. 200 mg/ml injektionsvæske, opløsning, i.v.
  • Dosering:
  • 200 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning, i.v.
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
  • 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.

Lokation

  • Fås i:
  • Vetidex 20% Vet. 200 mg/ml injektionsvæske, opløsning, i.v.
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 12998
  • Sidste ændring:
  • 22-02-2018

Produktresumé

28. januar 2014

PRODUKTRESUMÉ

for

Vetidex Vet., injektionsvæske, opløsning 20%

0.

D.SP.NR

8037

1.

VETERINÆRLÆGEMIDLETS NAVN

Vetidex Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder:

Ferridextrankompleks sv.t. 200 mg Fe (III).

Hjælpestof:

Phenol.

En fuld fortegnelse over hjælpestoffer: Se pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Svin og kvæg.

4.2

Terapeutiske indikationer

Profylaktisk og kurativ behandling af anæmi som følge af jernmangel.

4.3

Kontraindikationer

Bør ikke anvendes til heste.

4.4

Særlige advarsler for hver dyreart

Ved mistanke om vitamin E og selenmangel skal man ikke give jerntilskud.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Ingen.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

12998_spc.doc

Side 1 af 3

Ikke relevant.

Andre forsigtighedsregler

4.6

Bivirkninger

Jerndextran kan i sjældne tilfælde fremkalde fatale reaktioner ved injektion hos pattegrise.

Genetiske faktorer, mangel på vitamin E eller selen er angivet som årsager.

4.7

Drægtighed, diegivning eller æglægning

Kan anvendes.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Pattegris:

1 ml.

Applikation:

subkutant eller intramuskulært.

Søer:

3 ml

Kalve:

2-3 ml.

Applikation:

intramuskulært.

4.10

Overdosering

Ikke relevant.

4.11

Tilbageholdelsestid

0 dage.

5.

FARMAKOLOGISKE OG IMMUNOLOGISKE OPLYSNINGER

5.0

Terapeutisk klassifiktion

Farmakoterapeutisk gruppe: Jern, parenterale midler. QB 03 AC.

5.1

Farmakodynamiske egenskaber

Jerndextran

absorberes

efter

intramuskulær

eller

subkutan

injektion

ferrihydroxiddextrankompleks og aflejres i det reticuloendoteliale system, hvorfra jern

mobiliseres til brug i syntesen af hæmoglobin.

5.2

Farmakokinetiske egenskaber

Ikke relevant.

5.3

Miljømæssige forhold

Ikke relevant.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

12998_spc.doc

Side 2 af 3

Phenol

Saltsyre (pH justering)

Natriumhydroxid (pH justering)

Vand til injektionsvæske.

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

3 år.

6.4

Særlige opbevaringsforhold

Ingen.

6.5

Emballage

Hætteglas type II.

50, 100 and 250 ml.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Beholder og eventuelt restindhold tilbageleveres til apotek/leverandør eller til kommunal

modtageordning.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

Holland

Repræsentant

ChemVet dk A/S

A.C. Illums Vej 6

8600 Silkeborg

8.

MARKEDSFØRINGSTILLADELSESNUMMER

12998

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

31. januar 1991

10.

DATO FOR ÆNDRING AF TEKSTEN

28. januar 2014

11.

UDLEVERINGSBESTEMMELSE

12998_spc.doc

Side 3 af 3

  • 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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