Carofertin

Primær information

  • Handelsnavn:
  • Carofertin 10 mg/ml injektionsvæske, emulsion
  • Dosering:
  • 10 mg/ml
  • Lægemiddelform:
  • injektionsvæske, emulsion
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Carofertin 10 mg/ml injektionsvæske, emulsion
    Danmark
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Kvæg, Svin

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 56571
  • Sidste ændring:
  • 18-07-2018

Produktresumé

22. september 2016

PRODUKTRESUMÉ

for

Carofertin, injektionsvæske, emulsion

0.

D.SP.NR.

29950

1.

VETERINÆRLÆGEMIDLETS NAVN

Carofertin

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder:

Aktivt stof:

Betacaroten

10,00 mg

Hjælpestoffer:

Benzylalkohol (E1519)

10,00 mg

Ascorbylpalmitat (E304)

0,12 mg

All-rac-α-tocopherol

0,10 mg

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, emulsion

Klar, mørkerød emulsion.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Kvæg (køer/kvier), svin (søer).

4.2

Terapeutiske indikationer

For at forhindre og behandle betacarotenmangel og fertilitetsproblemer forbundet med

betacarotenmangel, hvilket kan opstå under faser med utilstrækkelig ernæring.

56571_spc.docx

Side 1 af 5

4.3

Kontraindikationer

Bør ikke anvendes til nyfødte dyr på grund af tilstedeværelsen af benzylalkohol. Bør ikke

anvendes i tilfælde af overfølsomhed over for macrogolstearat, eller i tilfælde af

overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.

4.4

Særlige advarsler

Ingen.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Ikke relevant.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Der bør udvises forsigtighed for at undgå selvinjektion.

I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og

indlægssedlen eller etiketten bør vises til lægen.

Personer med kendt overfølsomhed over for betacaroten eller over for et eller flere af

hjælpestofferne bør administrere veterinærlægemidlet med forsigtighed.

Vask hænder efter brug.

Andre forsigtighedsregler

4.6

Bivirkninger

I meget sjældne tilfælde forekommer hævelse på injektionsstedet. Dette forsvinder normalt

uden behov for behandling.

På grund af indholdet af macrogol-15-hydroxystearat er der en sjælden mulighed for

allergirelaterede eller pseudoallergiske overfølsomhedsreaktioner, især hos dyr, som

tidligere har fået sådan medicin enten via injektion eller infusion. Disse reaktioner kan

variere betydeligt med hensyn til varighed og sværhedsgrad (f.eks. markante lokale

reaktioner, svære generelle reaktioner), og kan i meget sjældne tilfælde føre til livstruende

tilstande.

Alvorlige reaktioner og fataliteter er blevet observeret, især hos kvæg.

I tilfælde af bivirkninger skal præparatet straks afbrydes, og der skal iværksættes

symptomatisk behandling.

Hyppigheden af bivirkninger er defineret som:

Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en

behandling)

Almindelige (mere end 1, men mindre en 10 dyr i 100 dyr)

Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)

Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr)

Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)

4.7

Drægtighed, diegivning eller æglægning

Kan anvendes under drægtighed og diegivning.

56571_spc.docx

Side 2 af 5

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Til intramuskulær eller subkutan injektion.

Køer/kvier:

Dosis: 20 – 25 ml

Doseringen skal deles og administreres som flere injektioner.

Maksimalt volumen pr. injektionssted: 10 ml.

Drægtige køer/kvier:

giv 1 dosis 1-2 uger ante partum.

Ikke drægtige køer/kvier:

giv op til 3 doser med mindst 14 dages mellemrum.

Søer:

Dosis:7 ml

Drægtige søer/gylte:

giv 1 dosis 1-2 uger ante partum.

Ikke drægtige søer/gylte:

giv op til 3 doser med mindst 14 dages mellemrum.

Præparatet bør kun bruges i en runde til flere dyr. Alt resterende præparat i beholderen

efter et indgreb skal bortskaffes umiddelbart efter administration. Anvendelsen af en

kanyle til optrækning foretrækkes.

4.10

Overdosering

Ikke relevant.

4.11

Tilbageholdelsestid

Kvæg:

Slagtning:

0 dage

Mælk:

0 dage

Svin:

Slagtning:

0 dage

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: A-vitamin, usammensatte, betacaroten.

ATCvet-kode: QA 11 CA 02

5.1

Farmakodynamiske egenskaber

Den biologiske vigtighed af betacaroten beror på A-provitaminfunktionen. Ud over at være

vigtigt for synet spiller A-vitamin en vital rolle for reproduktion, mønsterdannelse under

embryogenese, epiteldifferentiering, vækst, knogleudvikling, hæmatopoiese og hjernens

udvikling. Det er også vigtigt for at opretholde en korrekt funktion af immunsystemet.

Konverteringshastigheden fra betacaroten til retinol falder med en øget forsyning.

Betacaroten aflejres i fedtvævet og leveren, og virker dermed som et reservoir for A-

vitamin, som kan aktiveres i henhold til individuelle behov.

56571_spc.docx

Side 3 af 5

5.2

Farmakokinetiske egenskaber

Intramuskulær eller subkutan injektion af betacaroten fører til en vedvarende forhøjelse af

plasmaniveauet og genopfyldning af den normale pool.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Benzylalkohol (E1519)

Ascorbylpalmitat (E304)

All-rac-

-tocopherol

Macrogol-15-hydroxystearat

Isopropylmyristat

Vand til injektionsvæsker.

6.2

Uforligeligheder

Må ikke blandes med andre lægemidler til dyr.

6.3

Opbevaringstid

I salgspakning: 3 år

Efter første åbning af den indre emballage: Anvendes straks.

Efter første åbning skal præparatet anvendes straks. Præparatet bør kun bruges i en runde

til flere dyr. Alt resterende præparat i beholderen efter et indgreb skal bortskaffes

umiddelbart efter administration.

6.4

Særlige opbevaringsforhold

Må ikke opbevares over 25°C. Må ikke nedfryses.

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

6.5

Emballage

Brune hætteglas type II, brombutyl-gummipropper, aluminiumslåg

Pakning med 1 hætteglas med 100 ml injektionsvæske, emulsion.

Pakning med 10 hætteglas med 100 ml injektionsvæske, emulsion.

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

retningslinier.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

ALVETRA u. WERFFT GmbH

Boltzmanngasse 11

1090 Wien

Østrig

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

56571

56571_spc.docx

Side 4 af 5

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

22. september 2016

10.

DATO FOR ÆNDRING AF TEKSTEN

11.

UDLEVERINGSBESTEMMELSE

56571_spc.docx

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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