Perlutex Vet.

Primær information

  • Handelsnavn:
  • Perlutex Vet. 5 mg tabletter
  • Dosering:
  • 5 mg
  • Lægemiddelform:
  • tabletter
  • 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:
  • Perlutex Vet. 5 mg tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 60314
  • Sidste ændring:
  • 23-02-2018

Produktresumé

23. januar 2018

PRODUKTRESUMÉ

for

Perlutex Vet., tabletter, gestagent hormon (Orifarm)

0.

D.SP.NR

1968

1.

VETERINÆRLÆGEMIDLETS NAVN

Perlutex Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 tablet indeholder:

Medroxyprogesteronacetat 5 mg

3.

LÆGEMIDDELFORM

Tabletter (Orifarm).

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund og kat

4.2

Terapeutiske indikationer

Hund: Kortvarig udsættelse af løbetid.

Afbrydelse af løbetid.

Kat: Langvarig udsættelse af løbetid.

4.3

Kontraindikationer

Perlutex Vet. bør ikke anvendes i tilfælde af seksuelle umodne dyr, drægtige og diegivende

dyr eller dyr med tumors, sukkersyge, akromegali, sygelige tilstande i vagina, uterus, lever,

bugspytkirtlen, mælkekirtlerne og reproduktions systemet.

Længere tids udsættelse af løbetiden må ikke starte under løbetiden, da dette kan øge risikoen

for bivirkninger i livmoderen, dette gælder især hos ældre dyr.

4.4

Særlige advarsler for hver dyreart

Når brunsten hos hund har været afbrudt med Perlutex Vet vil den næste løbetid komme

tidligere end forventet.

Efter behandling med Perlutex Vet. hos kat kommer næste brust med varierende intervaller.

Længerevarende afbrydelse af brunst (afbrydelse af mere end en brunst) hos avlsdyr kan ikke

anbefales.

60314_spc.doc

Side 1 af 4

Hos nogle hunkatte kan det være svært at registrere, hvornår katten er tæt på brunst og

hvornår den er uden for brunst, tidspunktet kan blive forvekslet med drægtighed. Det kan

være nødvendigt at isolerer katten for at konstatere, hvornår den er i brunst.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Det er tilrådeligt at monitorere ældre dyr for udvikling af sukkersyge.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Ingen

Andre forsigtighedsregler

Ingen

4.6

Bivirkninger

Følgende uønskede bivirkninger kan forekomme, sædvanligvis kort tid efter påbegyndelse af

behandlingen:

Øget appetit og fedme. Det kan blive nødvendigt at kontrollere fødeindtagelsen.

Adfærdsændringer.

Forstørrelse af brystkirtlerne.

Symptomerne er sædvanligvis forbigående.

Sjældne bivirkninger:

Cystisk forøgelse af slimhinden i livmoderen.

Mælkekirteltumor.

Suppression af binyren.

Sukkersyge

Akromegali

Risikoen for bivirkninger eksisterer specielt, hvis produktet bruges over lang tid.

4.7

Drægtighed, diegivning eller æglægning

Drægtighed:

Må ikke anvendes under hele eller en del af drægtigheden.

Diegivning:

Må ikke anvendes under diegivning

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen.

4.9

Dosering og indgivelsesmåde

Hund:

Afbrydelse og kortvarig udsættelse af brunst: 2 tabletter dagligt i 4 dage, derefter 1 tablet

dagligt i 14 dage. Dobbelt dosis til hunde over 25 kg.

Kat:

60314_spc.doc

Side 2 af 4

Langvarig udsættelse af brunst: 1 tablet pr. uge så længe udsættelse ønskes. Behandlingen kan

indledes i anøstrus, diøstrus eller laktationsanøstrus.

4.10

Overdosering

Ingen.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE OG IMMUNOLOGISKE OPLYSNINGER

ATCvet kode: QG 03 DA 02

5.1

Farmakodynamiske egenskaber

Medroxyprogesteronacetat er syntetisk progesteron der undertrykker ovulation og corpus

luteum-dannelse gennem et feedback system, der hindrer frigørelse af de gonadotrope

hormoner fra hypothalamus.

5.2

Farmakokinetiske egenskaber

Absorberes hurtigt men ufuldstændigt fra mavetarmkanalen. Metaboliseres i leveren og

udskilles hovedsageligt via galden, en mindre del med urinen.

5.3

Miljømæssige forhold

Ingen.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Laktose monohydrat, majsstivelse, talk, gelatine, magnesiumsterat.

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

3 år

6.4

Særlige opbevaringsforhold

Må ikke opbevares over 25°C.

6.5

Emballage

Blisterpakning.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

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

modtageordning.

60314_spc.doc

Side 3 af 4

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Orifarm A/S

Energivej 15

5260 Odense S

8.

MARKEDSFØRINGSTILLADELSESNUMMER

60314

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

23. januar 2018

10.

DATO FOR ÆNDRING AF TEKSTEN

11.

UDLEVERINGSBESTEMMELSE

60314_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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