Fucidin

Primær information

  • Handelsnavn:
  • Fucidin 2% salve
  • Dosering:
  • 2%
  • Lægemiddelform:
  • salve
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Fucidin 2% salve
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 04742
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Scale:

12/07/04

19/01/04

Ref. No.:

Size:

Material:

Type:

100%

145 x 280 mm

Insert, 2 columns

Packaging Component Specification

Revision Date:

Sign:

Creation Date:

Sign:

LEO Pharma

Internal Market Access

Industriparken 55

2750 Ballerup

Denmark

INS006-00

Space for text: 2 X 60 x 260 mm.

Itemnumber and pharmacode must be printed on both sides,

font: OCR-B, 8 pt., kerning +10., rotate 90%

Approval:

Date:

057589

Indlægsseddel: Information til brugeren

Fucidin

2 % salve

natriumfusidat

Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel,

da den indeholder vigtige oplysninger.

• Gem indlægssedlen. Du kan få brug for at læse den igen.

• Spørg lægen eller apoteketspersonalet, hvis der er mere, du vil vide.

• Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med

at give medicinen til andre. Det kan være skadeligt for andre, selvom de har de

samme symptomer, som du har.

• Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får

bivirkninger, som ikke er nævnt her. Se afsnit 4.

Se den nyeste indlægsseddel på

www.indlaegsseddel.dk

Oversigt over indlægssedlen

1. Virkning og anvendelse

2. Det skal du vide, før du begynder at

bruge Fucidin

3. Sådan skal du bruge Fucidin

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere

oplysninger

1. Virkning og anvendelse

Fucidin indeholder et antibiotikum,

der virker på bakterier, der kan give

betændelse i huden.

Du kan bruge Fucidin mod betændelse,

der skyldes bakterier, som Fucidin virker

på.

Lægen kan have foreskrevet anden

anvendelse. Følg altid lægens anvisning.

Kontakt lægen, hvis du får det værre,

eller hvis du ikke får det bedre.

2. Det skal du vide, før du begynder

at bruge Fucidin

Lægen kan have foreskrevet anden

anvendelse eller dosering end angivet

i denne information. Følg altid lægens

anvisning og oplysningerne på

doseringsetiketten.

Brug ikke Fucidin:

• hvis du er allergisk over for

natriumfusidat eller et eller flere af de

øvrige indholdsstoffer i Fucidin

(angivet i afsnit 6).

Advarsler og forsigtighedsregler

Brug ikke salven omkring øjnene, da det

kan irritere øjet.

Graviditet og amning

Hvis du er gravid eller ammer, har

mistanke om, at du er gravid, eller

planlægger at blive gravid, skal du spørge

din læge eller apotekspersonalet til råds,

før du bruger dette lægemiddel.

Graviditet

Du må kun bruge Fucidin efter lægens

anvisning.

Amning

Du kan amme, selv om du bruger

Fucidin, men du bør dog ikke smøre det

på brystet.

Trafik- og arbejdssikkerhed

Fucidin påvirker ikke arbejdssikkerheden

og evnen til at færdes sikkert i trafikken.

Brug af anden medicin sammen med

Fucidin

Fortæl altid lægen eller apoteket, hvis du

bruger anden medicin eller har gjort det

for nylig.

Du kan bruge Fucidin sammen med

anden medicin.

Fucidin indeholder butylhydroxytoluen,

cetylalkohol og lanolin

Indeholdet af cetylalkohol og

butylhydroxytoluen E321 kan give lokalt

hududslæt (fx kontakteksem) Lanolin kan

give lokalt hududslæt hos personer med

allergi over for lanolin.

Butylhydroxytoluen E321 kan desuden

give irritation af øjne og slimhinder.

3. Sådan skal du bruge Fucidin

Brug altid lægemidlet nøjagtigt efter

lægens eller apotekspersonalets

anvisning. Er du i tvivl, så spørg lægen

eller på apotekspersonalet.

Den sædvanlige dosis er:

Børn og voksne:

Påsmør salven 2-3 gange dagligt.

Hvis du har brugt for meget Fucidin

Kontakt lægen, skadestuen eller

apotekspersonalet, hvis du har brugt

mere Fucidin end der står i denne

information, eller mere end lægen har

foreskrevet (og du føler dig utilpas).

Der er ikke kendskab til forgiftninger efter

brug af Fucidin.

Hvis du har glemt at bruge Fucidin

Du må ikke bruge en dobbeltdosis, som

erstatning for den glemte dosis. Fortsæt

blot med den sædvænlige dosis.

4. Bivirkninger

Dette lægemiddel kan som al anden

medicin give bivirkninger, men ikke alle

får bivirkninger.

Ikke almindelige (kan forekomme hos op

til 1 ud af 100 personer):

• Eksem

• Udslæt

• Kløe

• Rødmen af huden

• Smerter på påføringsstedet

(herunder brændende eller stikkende

fornemmelse på huden)

• Irritation på påføringsstedet

Ireland

Scale Get-up

Matrial No

Sent by e-mail

Subject

Date

Colour

Sign.

Date

Sign.

Preparation

Place of production

Strength

Packsize

Comments:

Scale:

12/07/04

19/01/04

Ref. No.:

Size:

Material:

Type:

100%

145 x 280 mm

Insert, 2 columns

Packaging Component Specification

Revision Date:

Sign:

Creation Date:

Sign:

LEO Pharma

Internal Market Access

Industriparken 55

2750 Ballerup

Denmark

INS006-00

Space for text: 2 X 60 x 260 mm.

Itemnumber and pharmacode must be printed on both sides,

font: OCR-B, 8 pt., kerning +10., rotate 90%

Approval:

Date:

057589

Sjælden (kan forekomme hos op til 1 ud

af 1.000 personer):

• Overfølsomhed

• Øjenbetændelse med røde øjne og

tåreflåd

• Udslæt (nældefeber) og hævelse:

Kan være alvorligt. Tal med lægen.

Hvis der er hævelse af ansigt, læber og

tunge, kan det være livsfarligt. Ring 112

• Nældefeber

• Blærer

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du

tale med din læge, sygeplejerske eller

apoteket. Dette gælder også mulige

bivirkninger, som ikke er medtaget i

denne indlægsseddel.

Du eller dine pårørende kan også

indberette bivirkninger direkte til

Lægemiddelstyrelsen via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan

du hjælpe med at fremskaffe mere

information om sikkerheden af dette

lægemiddel.

5. Opbevaring

Opbevar lægemidlet utilgængeligt for

børn.

Brug ikke lægemidlet efter den

udløbsdato, der står på pakningen eller

tuben efter EXP. Udløbsdatoen er den

sidste dag i den nævnte måned.

6. Pakningsstørrelser og yderligere

oplysninger

Spørg på apoteket, hvordan du skal

bortskaffe medicinrester. Af hensyn til

miljøet må du ikke smide medicinrester i

afløbet, toilettet eller skraldespanden.

Fucidin indeholder:

Aktivt stof: Natriumfusidat.

Øvrige indholdsstoffer: Cetylalkohol,

vandfrit lanolin, paraffinolie, hvid blød

paraffin, butylhydroxytoluen E321 og

all-rac-

-tocopherol..

Udseeende og pakningsstørrelser

Fucidin er en hvid til gullig hvid,

gennemskinnelig salve.

Pakningsstørrelser:15 g og 30 g

Indehaver af markedsføringstilladelsen

LEO Pharma A/S, Industriparken 55,

2750 Ballerup

Fremstiller

LEO Laboratories Ltd., 285 Cashel Road,

Dublin 12, Irland

Denne indlægsseddel blev senest ændret

i januar 2018.

LEO

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7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

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SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

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31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

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29-8-2018

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15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

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AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

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Sodium glucose co-transporter 2 inhibitors

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25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

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Kexxtone (Elanco GmbH)

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Inhixa (Techdow Europe AB)

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EU/3/18/2043 (Dr Ulrich Granzer)

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5-7-2018

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19-6-2018

Xyrem (UCB Pharma S.A.)

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Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

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Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

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

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

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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

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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