Ketaminol Vet.

Primær information

  • Handelsnavn:
  • Ketaminol Vet. 50 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 50 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Ketaminol Vet. 50 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 13646
  • Sidste ændring:
  • 22-02-2018

Produktresumé

20. november 2017

PRODUKTRESUMÉ

for

Ketaminol Vet., injektionsvæske, opløsning

0.

D.SP.NR.

8350

1.

VETERINÆRLÆGEMIDLETS NAVN

Ketaminol Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

50 mg/ml:

1 ml indeholder: Ketamin 50 mg (som hydrochlorid)

100 mg/ml:

1 ml indeholder: Ketamin 100 mg (som hydrochlorid)

Se pkt. 6.1 for en fuldstændig fortegnelse over hjælpestoffer.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Kat.

4.2

Terapeutiske indikationer

Beroligelse, immobilisering og anæstesi.

4.3

Kontraindikationer

Lever- og nyreinsufficiens. Cerebrale traumer og øget intrakranielt tryk. Glaukom.

4.4

Særlige advarsler for hver dyreart

Da øjnene er åbne under anæstesien, anbefales applikation af neutral øjensalve.

4.5

Særlige forsigtighedsregler vedrørende brugen

Ingen.

13646_spc.doc

Side 1 af 4

Særlige forsigtighedsregler for dyret

Ingen.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Ingen.

Andre forsigtighedsregler

Ingen.

4.6

Bivirkninger

Salivation og vomitus. Respirationsdepression. Øget muskeltonus. Postoperativ forvirring.

Spontan motorisk ekscitation kan forekomme, især i begyndelsen af anæstesi og under

opvågning.

4.7

Drægtighed, diegivning eller æglægning

Kan anvendes

4.8

Interaktion med andre lægemidler og andre former for interaktion

Kloramfenikol forlænger opvågningstiden. Ketaminol forstærker virkningen af halothan og

forlænger virkningen af suxamethonium.

4.9

Dosering og indgivelsesmåde

Dosering med ketamin alene:

Beroligelse:

5-10 mg/kg i.m.

Immobilisering:

10-20 mg/kg i.m.

Anæstesi:

20-40 mg/kg i.m eller

5-10 mg/kg i.v (kortere anæstesi).

Ved kombination med xylazin:

Beroligelse:

5-10 mg/kg + 0,5 mg xylazin /kg i.m.

Anæstesi:

10-15 mg/kg + 0,5-1 mg xylazin /kg i.m.

Patienten bør være fastende før operationen (min. 6 timer)

4.10

Overdosering

Overdosering kan forårsage respirationsstop.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE OG IMMUNOLOGISKE OPLYSNINGER

Terapeutisk klassifikation

QN 01 AX 03

5.1

Farmakodynamiske egenskaber

Ketamin er et hurtigt virkende universelt anæstetikum. Ketamin fremkalder, hvad der kan

betegnes som en "dissociativ anæstesi". Anæstesien er karakteriseret ved dyb analgesi og øget

muskeltonus, som bringer patienten i en kataleptisk tilstand. Pharynx og larynxreflekserne er

13646_spc.doc

Side 2 af 4

bevaret, øjnene er åbne og pupillerne dilaterede. Der er forbigående stimulering af det

kardiovaskulære system, og der er en let depressiv virkning på respirationen (afhængig af

dosis). Til modvirkning af den øgede muskeltonus kan der anvendes en passende præmedika-

tion f.eks. med xylazin.

5.2

Farmakokinetiske egenskaber

Metaboliseringen foregår primært i lever ved demethylering og hydroxylering, en mindre del

udskilles uomdannet i urinen.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Benzethoniumchlorid.

Vand til injektionsvæske.

6.2

Uforligeligheder

Må ikke blandes med alkaliske vandige væsker eller olie-opløsninger.

6.3

Opbevaringstid

3 år

6.4

Særlige opbevaringsforhold

Holdbarhed efter anbrud: Må opbevares 4 uger i køleskab (2

C til 8

6.5

Emballage

Brune hætteglas, type I glas (evt. type II)

Tropeprop, butyl-gummi PH 4002/45

Metalkapsel uden gummi (ringformet).

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Repræsentant

MSD Animal Health A/S

Havneholmen 25

1561 København V

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

13646:

50 mg

13647:

100 mg

13646_spc.doc

Side 3 af 4

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

13. august 1991

10.

DATO FOR ÆNDRING AF TEKSTEN

20.november 2017

11.

UDLEVERINGSBESTEMMELSE

13646_spc.doc

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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