Antisedan Vet.

Primær information

  • Handelsnavn:
  • Antisedan Vet. 5 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 5 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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    Anmode informationsbrochure for offentligheden.

Lokation

  • Fås i:
  • Antisedan Vet. 5 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 13327
  • Sidste ændring:
  • 22-02-2018

Produktresumé

6. juni 2018

PRODUKTRESUMÉ

for

Antisedan Vet., injektionsvæske, opløsning

0.

D.SP.NR

6785

1.

VETERINÆRLÆGEMIDLETS NAVN

Antisedan Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Aktivt stof:

Atipamezol hydrochlorid

5,0 mg/ml

Hjælpestoffer:

Methylparahydroxybenzoat

1,0 mg/ml

Natriumchlorid

8,5 mg/ml

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, klar farveløs opløsning

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund og kat.

4.2

Terapeutiske indikationer

Ophævelse af den sederende og analgetiske virkning af medetomidin eller dexmedetomidin

hos hund og kat.

4.3

Kontraindikationer

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

flere af hjælpestofferne.

4.4

Særlige advarsler

Efter indgivelse af dette veterinærlægemiddel skal dyret hvile et stille sted.

13327_spc.doc

Side 1 af 5

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Hvis dyret er bedøvet med en kombination af medetomidin eller dexmedetomidin og ketamin,

bør Antisedan tidligst injiceres 30-40 min. efter ketamin injektionen. Hvis virkningen af

medetomidin elimineres tidligere, kan residualeffekten af ketamin forårsage kramper.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Kontakt med hud og slimhinder bør undgås. Hvis det sker, skal det berørte område renses

med vand.

Andre forsigtighedsregler

Ingen.

4.6

Bivirkninger

Opkastning eller overdreven savlen, halsen, defækering og muskel tremor er blevet

rapporteret, men disse symptomer er meget sjældne

Forbigående hyperaktivitet og tachykardi kan ses hos enkelte dyr.

Hyppigheden af bivirkninger er defineret som:

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

behandling)

- Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr)

- Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)

- Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr)

- Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede

rapporter)

4.7

Drægtighed, diegivning eller æglægning

Lægemidlets sikkerhed under drægtighed og diegivning er ikke fastlagt.

Anvendelse frarådes under drægtighed og diegivning.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Uspecifikke CNS stimulerende midler (såsom 4-aminopyridin) potentierer opvågningen inkl.

effekten af atipamezol.

4.9

Dosering og indgivelsesmåde

Antisedan skal injiceres intramuskulært. Indgives 15-60 min. efter medetomidin eller

dexmedetomidin. Dyret genvinder normal bevidsthedstilstand i løbet af 5-10 min. Det

anbefales, at dyret får lov at hvile et roligt sted efter administration af Antisedan.

Hos hund

svarer Antisedan-dosis i milliliter til det antal milliliter der er brugt af

medetomidineller dexmedetomidin 0,5 mg/ml. Derimod er Antisedan-dosis i milliliter kun en

femtedel (1/5) af det anvendte volumen dexmedetomidin 0,1 mg/ml.

Beregnes dosis i mikrogram, er dosis af Antisedan 5 gange dosis af medetomidin og 10 gange

dosis af dexmedetomidin 0,5 mg/ml og dexmedetomidin 0,1 mg/ml.

Hos kat svarer Antisedan-dosis i milliliter til det halve antal milliliter der er brugt af

medetomidin eller dexmedetomidin 0,5 mg/ml. Derimod er Antisedan-dosis i milliliter kun en

tiendedel (1/10) af det anvendte volumen dexmedetomidin 0,1 mg/ml.

Beregnes dosis i mikrogram, er dosis af Antisedan 2,5 gange dosis af medetomidin og 5

gange dosis af dexmedetomidin 0,5 mg/ml og dexmedetomidin 0,1 mg/ml.

13327_spc.doc

Side 2 af 5

Doseringseksempler:

Hund:

Lægemiddel

Medetomidin

Dexmedetomidin

Dexmedetomidin

Antisedan

Styrke

1mg/ml

= 1000 μg/ml

0,5mg/ml

=500 μg/ml

0,1 mg/ml

=100 μg/ml

5mg/ml

= 5000 μg/ml

Dosis

40 μg/kg

20 μg/kg

20 μg/kg

200 μg/kg

Dosis

volumen

0,4 ml/10 kg

0,4 ml /10kg

2,0 ml/10kg

0,4 ml/10kg

Kat:

Lægemiddel

Medetomidin

Dexmedetomidin

Dexmedetomidin

Antisedan

Styrke

1mg/ml

= 1000 μg/ml

0,5mg/ml

=500 μg/ml

0,1 mg/ml

=100 μg/ml

5mg/ml

= 5000 μg/ml

Dosis

80 μg/kg

40 μg/kg

40 μg/kg

200 μg/kg

Dosis

volumen

0,4 ml/5kg

0,4 ml /5kg

1,0 ml/3kg*

0,2 ml/5kg

0,1 ml/3kg*

* For katte der vejer mere end 3 kg anbefales dexmedetomidin 0,5 mg/ml.

Desuden kan Antisedan bruges til at reversere sedering med en kombination af ketamin og

medetomidin eller dexmedetomidin. Antisedan-dosis er i dette tilfælde den samme som

angivet ovenfor ved sedering med medetomidin eller dexmedetomidin alene, men Antisedan

bør ikke administreres før 30 til 40 minutter efter indgift af ketamin. Dette skyldes risiko for

ataxi og muskulær inkoordination under opvågning som følge af carry-over effekt fra ketamin

efter ophør af medetomidin/dexmedetomidins sedative effekt.

4.10

Overdosering

Se pkt. 4.6 ”Bivirkninger”.

Overdosering manifesteres som forbigående hyperaktivitet og tachykardi. Disse reaktioner

er sædvanligvis milde og begrænset til et par timer og kræver derfor normalt ikke

behandling.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Terapeutisk klassifikation: QV 03 AB 90

5.1

Farmakodynamiske egenskaber

Atipamezol er en potent og selektiv

2-receptor antagonist. Den kan hermed eliminere

virkningerne af

2-receptor agonister som f.eks. medetomidin eller dexmedetomidin. Dette

bevirker, at dyr sederede med medetomidin eller dexmedetomidin hurtigt genvinder

bevidstheden samt genvinder normal hjerte- og åndedrætsfunktion.

5.2

Farmakokinetiske egenskaber

Atipamezol absorberes hurtigt efter intramuskulær injektion. Maksimum koncentrationen i

CNS opnås efter 10-15 min. Distributionsvolumen (V

) er 1-2,5 1/kg efter i.v. eller i.m.

injektion.

13327_spc.doc

Side 3 af 5

Atipamezols halveringstid er ca. 3 timer. Atipamezol oxideres primært i leveren, men en lille

del metaboliseres i nyrerne. Dets metabolitter udskilles hovedsageligt med urinen.

5.3

Miljømæssige forhold

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

modtageordning.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Methylparahydroxybenzoat

1,0 mg

Natriumchlorid

8,5 mg

Vand til injektion

6.2

Uforligeligheder

Antisedan bør ikke anvendes til at eliminere virkningen af andre typer af sedative midler

(såsom acepromazin, diazepam eller opiater).

6.3

Opbevaringstid

3 år.

Efter at pakningen er åbnet, kan Antisedan anvendes i 28 dage. Bakteriel kontaminering kan

ødelægge produktet tidligere.

6.4

Særlige opbevaringsforhold

Opbevares i originalbeholder.

6.5

Emballage

Hætteglas 10 ml.

Klar glas type II med rød gummiprop og aluminiumseglring.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

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

retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Repræsentant

Orion Pharma Animal Health A/S

Ørestads Boulevard 73

2300 København S

Danmark

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

13327

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

30. juni 1989

13327_spc.doc

Side 4 af 5

10.

DATO FOR ÆNDRING AF TEKSTEN

6. juni 2018

11.

UDLEVERINGSBESTEMMELSE

13327_spc.doc

Side 5 af 5

  • 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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