Engemycin Vet.

Primær information

  • Handelsnavn:
  • Engemycin Vet. 100 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 100 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Engemycin Vet. 100 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Får, Kvæg, Svin

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 09743
  • Sidste ændring:
  • 16-07-2018

Produktresumé

20. november 2017

PRODUKTRESUMÉ

for

Engemycin Vet., injektionsvæske, opløsning

0.

D.SP.NR.

6007

1.

VETERINÆRLÆGEMIDLETS NAVN

Engemycin Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder: Oxytetracyclin 100 mg som oxytetracyclinhydrochlorid.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Kvæg. Svin. Får.

4.2

Terapeutiske indikationer

Infektioner forårsaget af tetracyclinfølsomme bakterier.

4.3

Kontraindikationer

Overfølsomhed over for indholdsstoffer.

Nedsat nyre- eller leverfunktion.

4.4

Særlige advarsler for hver dyreart

Hurtig intravenøs administration kan forårsage kredsløbskollaps (hypotension). Dette kan

forhindres ved langsom infusion af oxytetracyclin (>5. min.) eller forbehandling med

intravenøs calciumgluconat.

Da tetracycliner interferer med proteinsyntese i både bakterier og værtsceller kan en forøgelse

af blodurin-kvælstof (BUN) forventes.

Vægttab, især i anoretiske dyr, kan forekomme ved samtidig behandling med tetracyclin og

glukocortikoid.

Se endvidere pkt. 4.3.

09743_spc.doc

Side 1 af 4

4.5

Særlige forsigtighedsregler vedrørende brugen

Tetracycliner bør kun med forsigtighed anvendes til dyr med nedsat nyre- eller leverfunktion.

Ved anvendelse af bredspektret antibiotika - som tetracycliner - er der altid en risiko for

superinfektion.

Særlige forsigtighedsregler for dyret

Ingen.

Særlige forsigtighedsregler for den person, der administrerer lægemidlet

Ingen.

Andre forsigtighedsregler

Ingen.

4.6

Bivirkninger

Gastrointestinale forstyrrelser kan forekomme.

Kan give anledning til emaljehypoplasi og -misfarvning hos dyr, hvor mineraliseringen af

tandanlægget ikke er afsluttet.

Kredsløbskollaps kan forekomme ved hurtig intravenøs applikation.

4.7

Drægtighed, diegivning.

Kan anvendes.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Tetracycliner udviser antagonisme over for antibiotika/kemoterapeutika med overvejende

bactericid effekt, f.eks. penicilliner, cefalosporiner og aminoglykosider.

Samtidig optagelse af fødeemner, herunder mælk og mælkeprodukter, eller behandling med

præparater indeholdende store mængder calcium, magnesium, aluminium eller jernsulfat kan

hæmme absorptionen af oralt indgivet tetracyclin pga. kompleksbinding.

4.9

Dosering og indgivelsesmåde

Engemycin vet. kan gives i lave doser til kvæg, svin og får uanset legemsvægt. Effekten varer i

24 timer.

Til dyr med en legemsvægt op til 100 kg kan Engemycin vet. gives i en høj dosis for at opnå

forlænget effekt.

Lav dosering:

5 til 10 mg oxytetracyclin pr. kg legemsvægt i.v. eller i.m. (se tabel). Behandling bør gentages

med 24 timers interval i 3 til 5 dage.

Høj dosering:

20 mg oxytetracyclin pr. kg legemsvægt i.m. (se tabel). Ved behov kan dosis gentages 48 timer

efter første behandling. Det maksimale injektionsvolumen er 10 ml pr. injektion og maksimalt

2 injektioner pr. behandling.

09743_spc.doc

Side 2 af 4

dyreart

Vægt

Dosering og indgivelsesmåde

Lav dosering:

24 timers interval i 3 til 5 dage

Høj dosering:

Engangsdosering. Kan gentages efter 48 timer

Administrations-

Dosering

Administrations-

Dosering

Antal inj. steder x

Volumen

Kvæg

alle

IV, IM

5-10 mg/kg

Kalve

< 100 kg

IV, IM

5-10 mg/kg

20 mg/kg

Max 2x10ml

Svin

alle

5-10 mg/kg

-

-

-

Svin

< 100 kg

5-10 mg/kg

IM

20 mg/kg

Max 2x10ml

Får

Alle

IV, IM

5-10 mg/kg

Får

< 100 kg

IV, IM

5-10 mg/kg

20 mg/kg

Max 2x10ml

4.10

Overdosering

Ingen.

4.11

Tilbageholdelsestid

Slagtning:

6 døgn efter intravenøs injektion.

30 døgn efter intramuskulær injektion.

Mælk:

4 døgn.

5.

FARMAKOLOGISKE OPLYSNINGER

Terapeutisk klassifikation: ATC-vetkode: QJ 01 AA 06

5.1

Farmakodynamiske egenskaber

Oxytetracyclin er et bredspektret antibiotikum med bakteriostatisk virkning på både aerobe og

anaerobe, grampositive og gramnegative bakterier, Rikketsia, Mycoplasma og Chlamydia. Der

er krydsresistens mellem samtlige tetracycliner.

5.2

Farmakokinetiske egenskaber

Ved normaldosering opnås terapeutiske serumkoncentrationer efter 1-2 timer. Terapeutiske

plasmakoncentrationer (>1µg) opretholdes i et døgn. Oxytetracyclin udskilles i galde, urin

(glomerulær filtration) samt i mælk.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Natriumformaldehydsulfoxylat

Magnesiumoxid, let

Polyvinylpyrrolidon

Monoethanolamin

Vand til injektionsvæsker

6.2

Uforligeligheder

Se punkt 4.8.

09743_spc.doc

Side 3 af 4

6.3

Opbevaringstid

Type II brune hætteglas (Ph.Eur) af glas:

3 år.

Type II brune hætteglas (Ph. Eur) af PET (polyethylenterphthalat): 2 år

6.4

Særlige opbevaringsforhold

Ingen.

6.5

Emballage

Type II brune hætteglas (Ph.Eur) af glas eller PET (polyethylenterphthalat) lukket med

gummiprop af halogenobutyl med aluminiumsforsegling.

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 B.V.

Wim de Körverstraat 35

NL-5831 AN Boxmeer

Holland

Repræsentant

MSD Animal Health A/S

Havneholmen 25

1561 København V

8.

MARKEDSFØRINGSTILLADELSESNUMMER.

9743

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

7. februar 1983

10.

DATO FOR ÆNDRING AF TEKSTEN

20. november 2017

11.

UDLEVERINGSBESTEMMELSE

09743_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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