Alamycin Vet.

Primær information

  • Handelsnavn:
  • Alamycin 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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    Anmode informationsbrochure for offentligheden.

Lokation

  • Fås i:
  • Alamycin 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:
  • 12304
  • Sidste ændring:
  • 22-02-2018

Produktresumé

2. april 2007

PRODUKTRESUMÉ

for

Alamycin Vet., injektionsvæske, opløsning 100 mg/ml

0.

D.SP.NR.

6382

1.

VETERINÆRLÆGEMIDLETS NAVN

Alamycin Vet., injektionsvæske, opløsning 100 mg/ml

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder:

Oxytetracyclin HCL 100 mg, svarende til 92,75 mg oxytetracyclin (base).

Natriumformaldehydsulfoxylat 5 mg.

Benzylalcohol 5 mg.

Komplet liste over hjælpestoffer se punkt 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

4

KLINISKE OPLYSNINGER

4.1

Dyrearter

Kvæg. Svin. Får.

4.2

Terapeutiske indikationer

Infektioner forårsaget af tetracyklinfølsomme bakterier.

4.3

Kontraindikationer

Allergi over for indholdsstoffer.

Nedsat nyrefunktion.

4.4

Særlige advarsler for hver dyreart

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

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

intravenøs calciumgluconat.

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

af blodurin-kvælstof (BUN) forventes.

12304_spc.doc

Side 1 af 4

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

glukokortikoid.

Se endvidere punkt 4.6.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

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

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

superinfektion.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Ingen.

4.6

Bivirkninger

Lokalirriterende ved store volumina intramuskulært.

Kredsløbskollaps kan forekomme ved hurtig intravenøs administration.

Der kan forekomme gastrointestinale forstyrrelser, ataxi, rystelser, perifere ødemer, dyspnø,

fråde, kollaps og eventuelt mors.

Heste bør ikke injiceres intramuskulært.

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

tandanlægget ikke er afsluttet.

4.7

Drægtighed, diegivning eller æglægning

Kan anvendes.

4.8

Interaktioner med andre lægemidler og andre former for interaktion

Tetracycliner udviser antagonisme over for antibiotika/kemoterapeutika med overvejende

bactericid effekt, e.g. 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 tetracyklin pga. kompleksbinding.

4.9

Dosering og indgivelsesmåde

5-10 mg/kg legemsvægt intravenøst eller intramuskulært.

4.10

Overdosering

Ingen.

4.11

Tilbageholdelsestider

Slagtning:

Intravenøst:

6 døgn.

Intramuskulært:

30 døgn.

Mælk:

3 døgn.

5.

FARMAKOLOGISKE EGENSKABER

Terapeutisk klassifikation

QJ 01 AA 06

12304_spc.doc

Side 2 af 4

5.1

Farmakodynamiske egenskaber

Oxytetracyklin 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 tetracykliner.

5.2

Farmakokinetiske egenskaber

Maksimum serumkoncentration på 1,6-4

g/ml opnås efter 1 time efter intramuskulær

injektion af 5-10 mg/kg og vil ligge over 0,8

g/ml i ca. 1 døgn. Maksimum koncentration i

mælk er på 1,3

g/ml. Plasmaproteinbinding ca. 50 %. Passerer placentamembranen.

Udskilles i aktiv form i mælk, urin og fæces, 25-30 % genfindes uændret i urinen, ca. 10 % i

fæces.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer:

Magnesiumchloridhexahydrat

Povidon (PVC) K12

Benzylalcohol

Monoethanolamin

Natriumformaldehydsulfoxylat

Vand til injektionsvæsker

6.2

Uforligeligheder

Se pkt. 4.8.

6.3

Opbevaringstid

2 år.

Efter anbrud: 28 dage.

6.4

Særlige opbevaringsforhold

Ingen.

6.5

Emballage

Hætteglas.

6.6

Særlige forsigtighedsregler vedrørende bortskaffelse af affald

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

modtageordning.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

ScanVet Animal Health A/S

Kongevejen 66

3480 Fredensborg

8.

MARKEDSFØRINGSTILLADELSESNUMMER

12304_spc.doc

Side 3 af 4

12304.

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

28. maj 1986.

10.

DATO FOR ÆNDRING AF TEKSTEN

2. april 2007

11.

UDLEVERINGSBESTEMMELSE

12304_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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