Hylartil Vet.

Primær information

  • Handelsnavn:
  • Hylartil Vet. 10 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 10 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Hylartil Vet. 10 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Hest

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 11259
  • Sidste ændring:
  • 16-07-2018

Produktresumé

14. marts 2016

PRODUKTRESUMÉ

for

Hylartil Vet., injektionsvæske, opløsning

0.

D.SP.NR

6107

1.

VETERINÆRLÆGEMIDLETS NAVN

Hylartil Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Aktivt stof:

1 ml indeholder:

Natriumhyaluronat 10 mg

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hest

4.2

Terapeutiske indikationer

Noninfektiøse artriter og tenditis hos hest.

4.3

Kontraindikationer

Ingen kendte.

4.4

Særlige advarsler

Ingen.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Ingen kendte.

11259_spc.doc

Side 1 af 4

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Ingen.

Andre forsigtighedsregler

Intravasal injektion skal undgås.

4.6

Bivirkninger

I enkelte tilfælde er set let hævelse i første døgn efter behandlingen.

4.7

Drægtighed, diegivning eller æglægning

Kan anvendes.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Ledinflammation: 2 ml intraartikulært i mindre og mellemstore led pr. led pr. behandling. Ved

behandling af hestens største led kan øget dosis være nødvendig.

Seneinflammation: 2 ml i centrum af seneskaden. Ved skader, hvis længde overstiger 10 cm,

deles dosis på 2 injektionssteder. Er skaden både lang i udstrækning og kraftigt inflammeret,

kan dosis fordobles. Injektion i senevæv bør ikke foretages med en kanyle grovere end 0,8

mm. For at undgå udsivning af væsken bør kanylen først fjernes 1 minut efter endt injektion.

Opnås ikke tilstrækkelig effekt, kan doseringen gentages.

Streng aseptik skal iagttages i forbindelse med injektion.

4.10

Overdosering

Da overdosering er en praktisk umulighed kendes ingen konsekvenser af overdosering.

4.11

Tilbageholdelsestid

Slagtning: 0 døgn.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk klassifikation: Andre midler mod forstyrrelser i det muskulo-skeletale

system, ATCvet-kode: QM 09 AX 01

5.1

Farmakodynamiske egenskaber

Ved ledinflammation:

Hylartil Vet. har antiflammatoriske egenskaber og hæmmer proteoglykannedbrydningen

hvorved skader på ledbrusken modvirkes. Højmolekylær hyaluronsyre danner en

permeabilitetsbarriere mod indtrængning af leukocytter, er et transportmedium for

stofskifteprodukter til og fra ledbrusken samt stimulerer den endogene syntese af

højmolekylært hyaluronat.

Hylartil Vet. er en stærkt viskoelastisk væske, som fysisk smører og støddæmper leddene.

Ved intraartikulær injektion af Hylartil Vet. opnås som regel hurtig smertelindring og bortfald

eller mindskning af halthed.

Ved seneinflammation:

Hylartil Vet. stimulerer de reparative processer ved at stimulere makrofagaktiviteten og

revaskulariseringen samt aktivere fibrinocytterne til øget syntese af kollagen.

11259_spc.doc

Side 2 af 4

5.2

Farmakokinetiske egenskaber

Efter lokal injektion er hele dosis umiddelbart tilgængelig på virkningsstedet. Lokal injektion

giver ikke målelige plasmakoncentrationer. Radioaktivt mærket hyaluronsyre har i raske led

en halveringstid på 9-16 timer. Variationen synes at være forårsaget af varierende belastning,

bevægelighed og blodforsyning i de forskellige led. Langtidseffekten af en enkelt injektion

med Hylartil Vet. beror formentlig på stimuleringen af endogen syntese.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Natriumchlorid

Dinatriumhydrogenfosfatdihydrat

Natriumdihydrogenfosfatdihydrat

Vand til injektionsvæsker

Kan indeholde små mængder natriumhydroxid og saltsyre anvendt til pH-justering.

6.2

Uforligeligheder

Må ikke blandes med andre injektionsvæsker, da inkompatibiliteten ikke kan udelukkes og en

ændring af viskositeten kan reducere effekten af Hylartil.

6.3

Opbevaringstid

3 år.

6.4

Særlige opbevaringsforhold

Opbevares ved 2

C til 8

Må ikke fryses. Opbevares i ydre karton.

Kan opbevares 4 uger ved højst 25°C.

6.5

Emballage

Fyldt injektionssprøjte à 2 ml.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Ikke anvendte veterinære lægemidler, samt affald heraf bør destrueres i henhold til lokale

retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Zoetis Finland Oy

Tietokuja 4

00330 Helsinki

Finland

Repræsentant

Orion Pharma Animal Health A/S

Ørestads Boulevard 73

2300 København S

11259_spc.doc

Side 3 af 4

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

11259

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

1. februar 1984

10.

DATO FOR ÆNDRING AF TEKSTEN

14. marts 2016

11.

UDLEVERINGSBESTEMMELSE

11259_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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