Estrumat Vet.

Primær information

  • Handelsnavn:
  • Estrumat Vet. 0,25 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 0,25 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Estrumat Vet. 0,25 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Hest, Kvæg, Svin

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 09130
  • Sidste ændring:
  • 16-07-2018

Produktresumé

20. november 2017

PRODUKTRESUMÉ

for

Estrumat Vet., injektionsvæske, opløsning

0.

D.SP.NR

3612

1.

VETERINÆRLÆGEMIDLETS NAVN

Estrumat Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder:

Aktivt stof:

Cloprostenol (som cloprostenolnatrium) 0,25 mg

Hjælpestof:

Benzylalkohol (E1519) 20,00 mg

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

Klar, farveløs opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Kvæg.

Svin.

Hest.

4.2

Terapeutiske indikationer

Kvier og køer: Abortprovokation ved uønsket drægtighed: Kastning af dødt foster.

Kronisk endometritis. Luteincyster. Brunstsynkronisering, herunder brunstinduktion.

Forebyggelse og afbrydelse af forlænget drægtighed.

Svin: Forebyggelse og afbrydelse af forlænget drægtighed.

Hest: Brunstinduktion.

09130_spc.doc

Side 1 af 5

4.3

Kontraindikationer

Bør ikke administreres intravenøst.

Må ikke anvendes til drægtige dyr, undtagen når abort ønskes.

4.4

Særlige advarsler

Ved behandling af drægtige søer/gylte tidligere end 3 dage før forventet faring kan fødsel

af ikke-levedygtige, præmature grise forekomme.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Induktion af abort eller fødsel kan forårsage kompliceret fødsel, føtal død, tilbageholdt

efterbyrd og metritis.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Cloprostenol kan absorberes gennem huden og medføre bronkospasme og abort.

Forsigtighed bør udvises ved håndtering af præparatet. Dette gælder især gravide kvinder,

astmatikere og personer med andre respiratoriske lidelser. Disse personer bør undgå

kontakt eller bære engangshandsker ved administration af lægemidlet. Ved spild på huden

bør afvaskning straks foretages. Ved utilsigtet selvinjektion skal der straks søges

lægehjælp, og indlægssedlen eller etiketten bør vises til lægen. I tilfælde af respiratoriske

komplikationer behandles med et hurtigt virkende bronkodilaterende middel som f.eks.

isoprenalin eller salbutamol.

Andre forsigtighedsregler

Ingen.

4.6

Bivirkninger

Bivirkninger kan primært henføres til effekten på den glatte muskulatur.

Svedudbrud og nedsat rektaltemperatur (ofte hos hopper), herudover forøget hjerte- og

respirationsfrekvens, kolik og inkoordination. Symptomerne ses inden for 15 min. og

forsvinder efter 1 time.

I meget sjældne tilfælde ses anafylaktiske reaktioner, der kræver øjeblikkelig medicinsk

behandling.

Lokale bakterielle infektioner kan forekomme på injektionsstedet. Disse kan i nogle

tilfælde generaliseres.

Hyppigheden af bivirkninger er defineret som:

− meget almindelige (forekommer hos mere end 1 ud af 10 dyr i løbet af en behandling)

− almindelige (forekommer hos mere end 1, men færre end 10 ud af 100 dyr)

− ikke almindelige (forekommer hos mere end 1, men færre end 10 ud af 1.000 dyr)

− sjældne (forekommer hos mere end 1, men færre end 10 ud af 10.000 dyr)

− meget sjældne (forekommer hos færre end 1 ud af 10.000 dyr, herunder isolerede

rapporter).

4.7

Drægtighed og diegivning

Se pkt. 4.3 ”Kontraindikationer”.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen.

Side 2 af 5

4.9

Dosering og indgivelsesmåde

Kvæg:

2 ml (0,5 mg) intramuskulært.

Brunstsynkronisering:

Hos reproduktionsmæssigt normalt fungerende dyr kan synkronisering af brunst opnås ved

at injicere 2 ml Estrumat Vet. intramuskulært, 2 gange med 11 dages interval. Tidsfast

inseminering 72 og 96 timer efter 2. injektion.

Brunstmangel:

Ved aktivt corpus luteum injiceres 2 ml Estrumat Vet. intramuskulært. Inseminering

foretages i brunsten, der optræder 2-4 dage efter behandling.

Fødselsinduktion:

2 ml Estrumat Vet. intramuskulært. Fødsel kan induceres fra dag 270 i drægtigheden. Det

anbefales at behandle tidligst 10 dage før beregnet termin. Der må forventes stigende

frekvens af tilbageholdt efterbyrd.

Abortprovokation:

Mellem dag 7 og dag 150 i drægtigheden fremkalder injektion af 2 ml Estrumat Vet.

intramuskulært abort. Efter dag 200 er effekten usikker.

Ved abortering af dødt foster kan det være nødvendigt at fjerne fostret eller fosterdele

manuelt fra vagina.

Kronisk endometritis og pyometra:

Luteolyse fremkaldes ved injektion af 2 ml Estrumat Vet. intramuskulært. Behandlingen

kan om nødvendigt gentages efter 10-14 dage.

Luteincyste:

Induktion af luteolyse foretages med injektion af 2 ml Estrumat Vet. intramuskulært. Hos

visse dyr kan konception først ske efter flere østralcykli.

Svin:

0,7 ml (0,175 mg) intramuskulært eller intravulvært.

Hest:

Dosering: 50 mikrogram pr. 100 kg legemsvægt intramuskulært, svarende til 1 ml

injektionsvæske 0,25 mg/ml pr. 500 kg legemsvægt.

4.10

Overdosering

Se pkt. 4.6 ”Bivirkninger”.

4.11

Tilbageholdelsestid

Kvæg:

Slagtning:

1 døgn.

Mælk:

1. udmalkning (mindst 7 timer).

Svin og hest:

Slagtning:

3 døgn.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Prostaglandiner og analoger

ATCvet-kode: QG02AD90

Side 3 af 5

5.1

Farmakodynamiske egenskaber

Cloprostenol er et syntetisk prostaglandin-analog. Prostaglandiner er umættede fede syrer

med bred biologisk aktivitet, syntetiseret ud fra arachidonsyre. Primære effekter er aktivitet

på den glatte muskulatur (kontraktion) samt evnen til at forårsage lysis af corpus luteum.

5.2

Farmakokinetiske egenskaber

Metaboliseringen sker hurtigt i flere væv. Halveringstiden for naturligt PFG

2alfa

er 90 sek.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Benzylalkohol (E1519)

Citronsyre, vandfri

Natriumcitrat

Natriumchlorid

Vand til injektionsvæsker

6.2

Uforligeligheder

Stærkt basiske eller sure præparater.

6.3

Opbevaringstid

Opbevaringstid for veterinærlægemidlet i salgspakning: 24 måneder

Opbevaringstid efter første åbning af den indre emballage: 28 dage ved temperaturer under 30°C

6.4

Særlige opbevaringsforhold

Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.

Opbevar hætteglasset i den ydre karton for at beskytte mod lys.

6.5

Emballage

Hætteglas á 10 ml og 20 ml.

Pakninger á 1 x 10 ml, 1 x 20 ml og 5 x 20 ml.

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

retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Repræsentant

MSD Animal Health A/S

Havneholmen 25

1561 København V

Side 4 af 5

8.

MARKEDSFØRINGSTILLADELSESNUMMER

9130

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

1. februar 1978

10.

DATO FOR ÆNDRING AF TEKSTEN

20. november 2017

11.

UDLEVERINGSBESTEMMELSE

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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