Fucidin

Primær information

  • Handelsnavn:
  • Fucidin imprægneret gaze
  • Lægemiddelform:
  • imprægneret gaze
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Fucidin imprægneret gaze
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 05344
  • Sidste ændring:
  • 22-02-2018

Produktresumé

22. juli 2014

PRODUKTRESUMÉ

for

Fucidin, imprægneret gaze

0.

D.SP.NR.

2212

1.

LÆGEMIDLETS NAVN

Fucidin

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Fucidin salve 1,5 g/100 cm

sv.t. natriumfusidat 30 mg/100 cm

Hjælpestoffer, som behandleren skal være opmærksom på:

Butylhydroxytoluene (E321), cetylalkohol og lanolin.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Imprægneret gaze.

10 x 10 cm gazestykker imprægneret med salve.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Hudinfektioner forårsaget af bakterier følsomme over for natriumfusidat.

4.2

Dosering og indgivelsesmåde

Voksne og børn: Appliceres 1 gang daglig.

4.3

Kontraindikationer

Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført

i pkt. 6.1.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Bakteriel resistens af Staphylococcus aureus er rapporteret ved topikal behandling med

Fucidin. Som det gælder for alle antibiotika kan forlænget eller gentagen anvendelse af

fusidinsyre øge risikoen for udvikling af antibiotikaresistens.

05344_spc.doc

Side 1 af 5

Når Fucidin imprægneret gaze anvendes i ansigtet, skal der udvises forsigtighed for at

undgå kontakt med øjnene, da hjælpestoffet i salven kan medføre irritation af conjunctiva.

Fucidin imprægneret gaze må ikke bruges på alvorligt læderet hud.

Fucidin imprægneret gaze indeholder cetylalkohol og lanolin Disse hjælpestoffer kan give

lokalt hududslæt (f.eks. kontakteksem). Fucidin imprægneret gaze indeholder desuden

Butylhydroxytoluen (E321). Som kan give lokalt hududslæt (f.eks. kontakteksem) og

irritation af øjne og slimhinder.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Der er ikke udført interaktionsstudier. Risikoen for interaktioner med systemisk

administrerede lægemidler anses at være minimal da den systemiske absorption af topikal

påført Fucidin er ubetydelig.

4.6

Graviditet og amning

Graviditet:

Bør kun anvendes med forsigtighed til gravide.

Der foreligger ingen kliniske data vedrørende anvendelsen af natriumfusidat i forbindelse

med graviditet. Dyreforsøg indikerer ikke nogle direkte eller indirekte skadelige virkninger

på graviditet, den embryonale/føtale udvikling, fødsel eller den postnatale udvikling.

Amning:

Der forventes ingen påvirkning af nyfødte/spædbørn, ammet af mødre i behandling med

topikal fusidinsyre / natriumfusidate, idet den systemiske eksponering er ubetydelig.

Fucidin imprægneret gaze kan anvendes under amning, men ammende kvinder bør undgå

at påføre Fucidin på brystet.

Fertilitet:

Der er ingen kliniske fertilitets studier for topikalt Fucidin. Der forventes ingen virkning på

fertilitet hos kvinder i den fødedygtige alder, da den systemiske eksponering efter topikalt

anvendt fusidinsyre / natriumfusidate er ubetydelig.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Fucidin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene

maskiner.

4.8

Bivirkninger

Hyppigheden af bivirkninger er baseret på en samlet analyse af data fra kliniske studier og

spontane rapporter.

De hyppigst rapporterede bivirkninger ved behandling er forskellige hudreaktioner såsom

kløe og udslæt, efterfulgt af forskellige reaktioner på applikationsstedet såsom smerter og

irritation, som optrådte hos færre end 1% af patienterne.

Overfølsomhed og angioødem er blevet rapporteret.

Bivirkninger er anført efter MedDRA-systemorganklasser (SOC) og de enkelte

bivirkninger er listet med den hyppigst rapporterede først. Inden for hver frekvensgruppe

er bivirkningerne opstillet i rækkefølge efter faldende alvorlighed.

Meget almindelig ≥ 1/10

05344_spc.doc

Side 2 af 5

Almindelig ≥ 1/100 til <1/10

Ikke almindelig ≥ 1/1.000 til <1/100

Sjælden ≥ 1/10.000 til <1 /1.000

Meget sjælden <1/10.000

Immunsystemet

Sjælden:

(≥ 1/10.000 til <1/1.000)

Overfølsomhed

Øjne

Sjælden:

(≥ 1/10.000 til <1/1.000)

Konjunktivit

Hud og subkutane væv

Ikke almindelig:

(≥1/1.000 til <1/100)

Dermatitis (inkl. kontaktdermatit, eksem)

Udslæt *

Pruritus

Erytem

* Der er rapporteret forskellige former for

udslæt, bl.a. erytematøst, pustuløst,

vesikuløst, makulo-papuløst og papuløst.

Generaliseret udslæt er også rapporteret.

Sjælden:

(≥ 1/10.000 til <1/1.000)

Angioødem

Urticaria

Blærer

Almene symptomer og reaktioner på administrationsstedet

Ikke almindelig:

(≥1/1.000 til <1/100)

Smerter på påføringsstedet (inkl.

brændende fornemmelse i huden)

Irritation på påføringsstedet

Pædiatrisk population

Frekvens, type og sværhedsgrad af bivirkninger hos børn forventes at være den samme

som hos voksne.

Indberetning af mistænkte bivirkninger

Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger til

Sundhedsstyrelsen

Axel Heides Gade 1, DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: sst@sst.dk

4.9

Overdosering

Overdosering er ikke sandsynlig.

4.10

Udlevering

05344_spc.doc

Side 3 af 5

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

D 09 AA 02 – Salvekompresser med antiinfektiva.

5.1

Farmakodynamiske egenskaber

Fucidin udøver antibakteriel effekt ved hæmning af proteinsyntesen i bakterier. Resistens

overfor natriumfusidat er efter 30 år anvendelse sjælden (1-2%). Bakterier med resistens over

for penicillin og andre antibiotika er oftest følsomme overfor natriumfusidat.

5.2

Farmakokinetiske egenskaber

Ubetydelig systemisk absorption.

5.3

Prækliniske sikkerhedsdata

Der er ingen prækliniske data, der er relevante for den ordinerende læge, udover hvad der

allerede er nævnt i andre afsnit af produktresuméet.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

1 stk. imprægneret gaze 10 x 10 cm indeholder 1,5 g salve med følgende indhold:

Cetylalkohol

Lanolin, vandfrit

Paraffinolie

Paraffin, hvid blød

α-Tocopherol, all-rac

Butylhydroxytoluen (BHT) (E321)

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

3 år.

6.4

Særlige opbevaringsforhold

Må ikke opbevares ved temperaturer over 25 °C

6.5

Emballagetyper og pakningsstørrelser

Brev (folie).

6.6

Regler for destruktion og anden håndtering

Ingen særlige forholdsregler.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

LEO Pharma A/S

Industriparken 55

05344_spc.doc

Side 4 af 5

2750 Ballerup

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

5344

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

Dato for første markedsføringstilladelse: 4. maj 1962

10.

DATO FOR ÆNDRING AF TEKSTEN

22. juli 2014

05344_spc.doc

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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EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety