Borgal Mite Vet.

Primær information

  • Handelsnavn:
  • Borgal Mite Vet. 62,5 + 12,5 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 62,5 + 12,5 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • 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:
  • Borgal Mite Vet. 62,5 + 12,5 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 06343
  • Sidste ændring:
  • 02-02-2018

Produktresumé

21. maj 2013

PRODUKTRESUMÉ

for

Borgal Mite Vet., injektionsvæske, opløsning

0.

D.SP.NR

3052

1.

VETERINÆRLÆGEMIDLETS NAVN

Borgal Mite Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder: Sulfadoxin 62,5 mg, Trimethoprim 12,5 mg.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund.

4.2

Terapeutiske indikationer

Infektioner forårsaget af sulfonamid/trimethoprimfølsomme mikroorganismer.

4.3

Kontraindikationer

Allergi mod indholdsstoffer.

4.4

Særlige advarsler

Særlige advarsler for hver dyreart

Må ikke anvendes til detomidinbehandlede dyr.

4.5

Særlige forsigtighedsregler vedrørende brugen

På nyfødte dyr, samt dyr med nedsat lever- og nyrefunktion kan dosering over længere tid

medføre akkkumulation af TMP/sulfadoxin og metabolitter.

Særlige forsigtighedsregler for dyret

Ingen

06343_spc.doc

Side 1 af 4

06343_spc.doc

Side 2 af 4

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Ingen.

Andre forsigtighedsregler

Ingen

4.6

Bivirkninger

Overfølsomhedsreaktioner kan forekomme.

4.7

Drægtighed og diegivning

Kan anvendes.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen.

4.9

Dosering og indgivelsesmåde

1 ml/5 kg legemsvægt 1 gang dagligt i 4-6 dage.

Applikation: intramuskulært, intravenøst eller subkutant.

4.10

Overdosering

Ingen.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Terapeutisk klassifikation

QJ 01 EW 13

5.1

Farmakodynamiske egenskaber

Borgal Vet. er et potentieret, bredspektret sulfonamidpræparat og indeholder trimethoprim

(TMP) og sulfadoxin i forholdet 1:5.

TMP og sulfadoxin er hver for sig bakteriostatiske, men har tilsammen synergistisk baktericid

virkning, idet de griber ind i to på hinanden følgende trin i bakteriernes folinsyresyntese.

Kombinationen TMP/sulfadoxins antibakterielle spektrum omfatter de fleste grampositive og

gramnegative bakterier med undtagelse af Pseudomonas, Mycobacterium spp. og visse

Proteusstammer.

Bakteriel resistens forekommer og er plasmidbåren eller mutagen.

5.2

Farmakokinetiske egenskaber

Efter intramuskulær og intravenøs administration opnås maksimale serumkoncentrationer

efter 1-3 timer.

TMP har et højt fordelingsvolumen (>1.2 l/kg), der medfører at vævskoncentrationer er større

end plasmakoncentrationen. Sulfadoxin har et lavt fordelingsvolumen (0.3 l/kg) og lavere

koncentrationer i væv end i plasma.

TMP metaboliseres i udstrakt grad og kun få procenter af dosis udskilles uomdannet i urin og

fæces. Plasmahalveringstiden varierer mellem 1 og 4 timer. Sulfadoxin metaboliseres delvis

og udskilles såvel uomdannet som metaboliseret i urin og fæces. Plasmahalveringstiden

varierer mellem 8 og 11 timer.

06343_spc.doc

Side 3 af 4

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Lidocainhydrochlorid, natriumhydroxid, diethalonamin, glycerolformal og vand til

injektionsvæsker

6.2

Uforligeligheder

Ingen.

6.3

Opbevaringstid

4 år.

6.4

Særlige opbevaringsforhold

Ingen.

6.5

Emballage

Hætteglas.

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

Ceva Santé Animale

10, Avenue de La Ballastiere

F-33500 Libourne

Frankrig

Repræsentant

Ceva Animal Health A/S

Andkærvej 19

7100 Vejle

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

6343

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

17. juli 1973

10.

DATO FOR ÆNDRING AF TEKSTEN

21. maj 2013

11.

UDLEVERINGSBESTEMMELSE

06343_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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