natgillin/translations-raw huggingface dataset:
Fluconazol er også en hæmmer af CYP2C19.
Fluconazole is also an inhibitor of CYP2C19.
Barnet må højst få en dosis på 12 mg pr. kg legemsvægt hver 48. time.
The maximum dose is 12 mg per kg of body weight every 48 hours.
Fra 11 måneder og op til 24 måneder eller længere afhængig af patienten.
11 months for up to 24 months or longer if needed.
Selvom Diflucan er beregnet til voksne, kan det også anvendes til unge (fra 12-17 år), hvis behandling er strengt nødvendigt, og der ikke findes andre mulige behandlinger.
Although this medicine is for adults it can be used in adolescents (from 12 to 17 years old) if treatment is essential and no suitable alternative exists, and should be taken in the same way as for adults.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (5 mg/ml oral opløsning)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACKAGING CARTON (5 mg/ml oral solution)
Samtidig behandling med fluconazol i doser på 400 mg eller mere dagligt og terfenadin er kontraindiceret (se pkt.
The combined use of fluconazole at doses of 400 mg or greater with terfenadine is contraindicated (see section 4.3).
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET (IV 50, 100 eller 250 ml hætteglas, 100 og 200 ml PVC poser)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL (IV- 50, 100 or 250 ml glass vials, 100 and 200 ml PVC bags)
Forebyggelse af infektioner, som skyldes Candida (hvis Deres immunforsvar er svækket eller ikke fungerer ordentligt)
To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)
100-200 mg dagligt eller 200 mg 3 gange om ugen.
100 to 200 mg daily or 200 mg 3 times per week.
Distributionsvolumen var 1.183 ml/kg (1.070-1.470 ml/kg) på dag 1 og steg over tid til gennemsnitligt 1.184 ml/kg (510-2.130 ml/kg) på dag 7 og 1.328 ml/kg (1.0401.680 ml/kg) på dag 13.
The volume of distribution (ml/kg) was 1183 (range 1070-1470) on day 1 and increased, with time, to a mean of 1184 (range 510-2130) on day 7 and 1328 (range 1040-1680) on day 13.
Diflucan er indiceret til nedenstående svampeinfektioner (se pkt.
Diflucan is indicated in the following fungal infections (see section 5.1).
Nedsat nyrefunktion:
Reconstitution instructions:
• Kryptokokmeningitis (se pkt.
• Cryptococcal meningitis (see section 4.4).
Kapsel indhold: lactosemonohydrat; majsstivelse; silica, kolloid vandfri; magnesiumstearat; natriumlaurilsulfat.
Capsule content: lactose monohydrate, maize starch, colloidal silica anhydrous, magnesium stearate and sodium laurilsulfate.
Fluconazol har god fordeling i hele legemets vandfase.
Fluconazole achieves good penetration in all body fluids studied.
Det er vist, at fluconazol 50 mg dagligt i op til 28 dage hverken påvirker plasma-testosteron hos mænd eller steroidkoncentrationen hos kvinder i den fertile alder. Fluconazol 200-400 mg dagligt har ingen klinisk signifikant effekt på endogene steroidniveauer eller på ACTH-stimuleret respons hos raske, mandlige, frivillige forsøgspersoner.
Fluconazole 200 mg to 400 mg daily has no clinically significant effect on endogenous steroid levels or on ACTH stimulated response in healthy male volunteers.
• får alvorlige hudlidelser (kløe, rødme af huden eller vejtrækningsproblemer)
develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Hårde kapsler
PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Fluconazol er vist at være mere selektiv for CYP-enzymer hos svampe end for forskellige CYP-enzymsystemer hos pattedyr.
Fluconazole has been shown to be more selective for fungal cytochrome P-450 enzymes than for various mammalian cytochrome P-450 enzyme systems.
Kapselstørrelse nr. 0.
The capsule size is no. 0.
Lægen kan have ordineret en anden dosis.
Doctors sometimes prescribe different doses to these.
LISTE OVER HJÆLPESTOFFER Indeholder saccharose og glycerol.
LIST OF EXCIPIENTS Contains sucrose, and glycerol.
Plastificeret PVC poser: Opbevares ved temperaturer under 30˚C.
Plasticised PVC bags: Store below 30˚C.
Der er begrænset bevis for fluconazols virkning ved behandling af kryptokokkose andre steder (f.eks. pulmonal eller kutan kryptokokkose).
The evidence for efficacy of fluconazole in the treatment of cryptococcosis of other sites (e.g. pulmonary and cutaneous cryptococcosis) is limited, which prevents dosing recommendations.
--------------------------------------------------------------------------------------------------------------------Følgende oplysninger er kun til læger og sundhedspersonale
The following information is intended for medical or healthcare professionals only:
• Mod tilbagefald af orofaryngeal eller øsofageal candidiasis hos patienter med hiv, som har høj risiko for recediv.
• Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
Hver kapsel indeholder 50 mg fluconazol Hver kapsel indeholder 100 mg fluconazol Hver kapsel indeholder 150 mg fluconazol Hver kapsel indeholder 200 mg fluconazol
Each hard capsule contains fluconazole 50 mg Each hard capsule contains fluconazole 100 mg Each hard capsule contains fluconazole 150 mg Each hard capsule contains fluconazole 200 mg
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver 25 ml infusionsvæske, opløsning indeholder 50 mg fluconazol.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 ml solution for infusion contains 50 mg fluconazole.
Hvis De er gravid eller ammer, vil lægen beslutte, om De skal behandles med Diflucan.
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding and your doctor will decide whether you should be given Diflucan.
Efterfølgende dosis:
Loading dose:
Diflucan oral opløsning indeholder saccharose.
Diflucan oral solution contains sucrose.
Til børn med nedsat nyrefunktion, se dosering under ”Nedsat nyrefunktion”.
For paediatric patients with impaired renal function, see dosing in “Renal impairment”.
• A-vitamin (kosttilskud)
- theophylline (used to control asthma) - vitamin A (nutritional supplement)
Barnet må højst få en dosis på 12 mg pr. kg legemsvægt hver 72. time.
The maximum dose is 12 mg per kg of body weight every 72 hours.
Protrombintiden skal monitoreres nøje hos patienter, der får antikoagulantia af coumarin-typen samtidig med fluconazol.
In patients receiving coumarin-type anticoagulants concurrently with fluconazole the prothrombin time should be carefully monitored.
Fluconazol er også en hæmmer af isoenzymet CYP2C19.
Fluconazole is also an inhibitor of the isozyme CYP2C19.
50 mg dagligt
50 mg daily
Titandioxid (E171) Erythrosin (E127) Patent blue V (E131)
Titanium dioxide (E171) Erythrosin (E127) Patent blue V (E131)
6-12 mg/kg legemsvægt
6 mg to 12 mg per kg of body weight
Efter indgift af en enkelt dosis fandtes en højere plasma-halveringstid på ca. 24 timer.
A higher fluconazole plasma elimination half-life of approximately 24 hours was found after a single dose.
Denne indlægsseddel blev sidst godkendt { MM/ÅÅÅÅ } [Udfyldes nationalt]
This leaflet was last approved in [To be completed nationally]
• Mod tilbagefald af kryptokokmeningitis hos patienter med høj risiko for recediv.
• Relapse of crytopcoccal meningitis in patients with high risk of recurrence.
Lever og galdeveje Diflucan bør administreres med forsigtighed til patienter med nedsat leverfunktion.
Hepatobiliary system Diflucan should be administered with caution to patients with liver dysfunction.
400 mg den første dag og derefter 200-400 mg 1 gang dagligt i 6-8 uger eller længere hvis nødvendigt.
400 mg once daily for 6 to 8 weeks or longer if needed.
- Vedligeholdelsesdosis til forebyggelse af tilbagefald af kryptokokmeningitis hos patienter med høj risiko for recediv.
- Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with high risk of recurrence.
Kapselstørrelse nr. 4.
The capsule size is no. 4.
Indehaver af markedsføringstilladelsen
Marketing Authorisation Holderand Manufacturer
Diflucan hårde kapsler indeholder en lille mængde lactose (mælkesukker).
This medicine contains a small amount of lactose (milk sugar).
3-12 mg/kg legemsvægt
3 mg to 12 mg per kg of body weight
• Hver ml indeholder 2 mg fluconazol.
- Each ml contains 2 mg of fluconazole.
Diflucan 10 mg/ml pulver til oral suspension:
Diflucan and associated names 10 mg/ml powder for oral suspension:
Nyresystemet Diflucan bør anvendes med forsigtighed til patienter med nedsat nyrefunktion (se pkt.
Renal system Diflucan should be administered with caution to patients with renal dysfunction (see section 4.2).
Patienter uden nedsat nyrefunktion skal have normal dosering.
Where there is no evidence of renal impairment, normal dose recommendations should be adopted.
Saquinavir: Fluconazol øger AUC og Cmax for saquinavir med henholdsvis ca. 50% og ca. 55% pga. hæmning af saquinavirs hepatiske metabolisering via CYP3A4 og hæmning af P-glykoprotein.
Saquinavir: Fluconazole increases the AUC and Cmax of saquinavir with approximately 50% and 55% respectively, due to inhibition of saquinavir's hepatic metabolism by CYP3A4 and inhibition of P-glycoprotein.
Fluconazol udskilles overvejende som uomdannet lægemiddel i urinen.
Fluconazole is predominantly excreted in the urine as unchanged active substance.
BIVIRKNINGER Diflucan kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Diflucan can cause side effects, although not everybody gets them A few people develop allergic reactions although serious allergic reactions are rare.
Behandling kan startes, før identifikation og resultaterne af andre laboratorieundersøgelser foreligger.
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Diflucan 100 mg hårde kapsler har en hvid bund og blå top.
- Diflucan 100 mg hard capsules have a white body and a blue cap.
Pulver til oral suspension 10 mg/ml (175 ml flaske): Opbevares under 25°C.
Powder for oral suspension 10 mg/ml (175 ml bottle): Store below 25°C.
Diflucan 40 mg/ml pulver til oral suspension:
Diflucan and associated names 40 mg/ml powder for oral suspension:
Overfølsomhed over for fluconazol, andre azolderivater eller over for et eller flere af hjælpestofferne (se pkt.
Hypersensitivity to the active substance, to related azole substances, or to any of the excipients (see section 6.1).
Shellac (glasur); sort jernoxid (E172); n-butylalkohol; vandfri ethanol; renset vand; propylenglycol; industriel denatureret alkohol; isopropylalkohol; stærk amoniakopløsning; kaliumhydroxid
Shellac (glaze), black iron oxide, N-Butyl alcohol, dehydrated alcohol, purified water, propylene glycol, industrial methylated spirit, isopropyl alcohol, strong ammonia solution, potassium hydroxide
Det anbefales, at apoteket laver Diflucan pulver til oral suspension klar til Dem. Der er vejledning til sundhedspersonalet i sidste afsnit af indlægssedlen.
It is recommended that your pharmacist makes up Diflucan powder for oral suspension before giving it to you.
Diflucan og tilhørende navne (Se bilag I) 10 mg/ml pulver til oral suspension Diflucan og tilhørende navne (Se bilag I) 40 mg/ml pulver til oral suspension
Diflucan and associated names (see Annex I) 10 mg/ml powder for oral suspension Diflucan and associated names (see Annex I) 40 mg/ml powder for oral suspension
- Orofaryngeal candidiasis
- Oropharyngeal candidiasis
Der er ikke påvist nogen sammenhæng mellem hepatotoksicitet og den totale døgndosis af fluconazol, behandlingsvarigheden eller patientens køn eller alder. I de fleste tilfælde var hepatotoksiciteten reversibel efter seponering.
In cases of fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of patient has been observed.
Samtidig oral administration af fluconazol 200 mg og midazolam 7,5 mg øgede midazolams AUC og halveringstid henholdsvis 3,7 og 2,2 gange.
Concomitant intake of fluconazole 200 mg and midazolam 7.5 mg orally increased the midazolam AUC and half life 3.7 fold and 2.2 fold, respectively.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml rekonstitueret suspension indeholder 40 mg fluconazol
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of reconstituted suspension contains 40 mg fluconazole.
• gulfarvning af huden eller det hvide i øjnene (gulsot) Hvis De får nogle af disse bivirkninger, skal De stoppe med at tage Diflucan og straks kontakte en læge.
The signs of liver problems include: tiredness loss of appetite vomiting yellowing of your skin or the whites of your eyes (jaundice) If any of these happen, stop taking Diflucan and tell your doctor immediately.
150 mg kapsler:
150 mg capsules Gelatin
Dosis: 3-12 mg/kg dagligt
Dose: 3 to 12 mg/kg daily
Dosis: 6-12 mg/kg dagligt
Dose: 6 to 12 mg/kg daily
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml rekonstitueret suspension indeholder 10 mg fluconazol
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of reconstituted suspension contains 10 mg fluconazole.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FLASKEETIKET (5 mg/ml oral opløsning)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL(5 mg/ml oral solution)
200 mg kapsler: Gelatine
200 mg capsules Gelatin
Pulver til oral suspension: 24 måender.
The shelf life of the powder for oral suspension is 24 months.
SÅDAN SKAL DE TAGE DIFLUCAN
HOW TO TAKE DIFLUCAN
Mukøs candidiasis
- Mucosal candidiasis
Rekonstitueret suspension: 28 dage.
- The shelf life of the reconstituted suspension is 28 days.
LISTE OVER HJÆLPESTOFFER Indeholder også saccharose og glycerol.
LIST OF EXCIPIENTS Also contains sucrose, glycerol.
Efterfølgende dosis: 100-200 mg dagligt.
Subsequent dose: 100 mg to 200 mg daily
I stratum corneum, epidermis-dermis og i ekkrin sved opnås højere koncentrationer af fluconazol end i serum.
High skin concentration of fluconazole, above serum concentrations, are achieved in the stratum corneum, epidermis-dermis and eccrine sweat.
Sort printblæk: shellac; sort jernoxid (E172); n-butylalkohol; vandfri ethanol; renset vand; propylenglycol; industriel denatureret alkohol; isopropylalkohol; stærk amoniakopløsning, kaliumhydroxid
Printing ink: shellac (glaze), black iron oxide, N-Butyl alcohol, dehydrated alcohol, purified water, propylene glycol, industrial methylated spirit, isopropyl alcohol, strong ammonia solution, potassium hydroxide
Pakningsstørrelse: 30, 50, 100 eller 250 ml hætteglas 1, 5, 10 eller 20 plastificerede PVC poser (100 eller 200 ml)
1, 5, 10 or 20 plasticised PVC bags (100 or 200 ml).
Diflucan 10 mg/ml pulver til oral suspension er et tørt hvidt til off-white pulver.
For the 175 ml bottle: - Diflucan 10 mg/ml powder for oral suspension is a dry white to off-white powder.
Kapselstørrelse nr. 1.
The capsule size is no. 1.
150 mg som 1 énkeltdosis.
150 mg as a single dose.
Ikke almindelig Træthed, utilpashed, asteni, feber
Fatigue, malaise, asthenia, fever
Kapselstørrelse nr. 2.
The capsule size is no. 2.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (10 mg/ml pulver til oral suspension - 60 ml og 175 ml flasker)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (10 mg/ml powder for oral suspension - 60 ml and 175 ml bottles)
4.4), pruritus, øget svedtendens
Drug eruption (see section 4.4), urticaria (see section 4.4), pruritus, increased sweating
• er overfølsom (allergisk) over for fluconazol, andre svampemidler eller et eller flere af hjælpestofferne i Diflucan.
- are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Diflucan.
Spørg lægen eller på apoteket, hvis De føler Dem usikker.
You should check with your doctor or pharmacist if you are not sure.
Samtidig behandling med fluconazol og astemizol er kontraindiceret (se pkt 4.3).
Coadministration of fluconazole and astemizole is contraindicated (see section 4.3).
Patienter i samtidig behandling med fluconazol i doser under 400 mg dagligt og terfenadin bør monitoreres omhyggeligt (se pkt.
The coadministration of fluconazole at doses lower than 400 mg per day with terfenadine should be carefully monitored (see sections 4.3 and 4.5).
Dosis: 6 mg/kg dagligt
Dose: 6 mg/kg daily
Følg altid lægens anvisning.
Always take your medicine exactly as your doctor has told you.
LISTE OVER HJÆLPESTOFFER Indeholder også saccharose.
LIST OF EXCIPIENTS Also contains sucrose.
Fortæl det til lægen, hvis De
please tell your doctor or pharmacist.
SÅDAN FÅR DE DIFLUCAN
HOW DIFLUCAN IS GIVEN
Samtidig behandling med fluconazol og cisaprid er kontraindiceret (se pkt.
Concomitant treatment with fluconazole and cisapride is contraindicated (see section 4.3).
- Kronisk mukokutan candidiasis
- Chronic mucocutaneous candidiasis
LÆGEMIDDELFORM Infusionsvæske, opløsning Klar, farveløs opløsning uden synlige partikler.
What Diflucan solution for infusion looks like and contents of the pack - Diflucan is a clear, colourless solution with no visible particles.
Det skal De vide, før De begynder at tage Diflucan Sådan skal De tage Diflucan Bivirkninger
What Diflucan is and what it is used for Before you take Diflucan How to take Diflucan Possible side effects How to store Diflucan Further information
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET (10 mg/ml pulver til oral suspension - 60 ml og 175 ml flasker)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL (10 mg/ml powder for oral suspension - 60 ml and 175 ml bottles)
Dette lægemiddel er kun til engangsbrug.
The solution for infusion is for single use only.
Behandling af infektioner i slimhinderne på indersiden af munden, halsen eller mundbetændelse på grund af tandprotese
To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth
BIVIRKNINGER
Undesirable effects
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml oral opløsning indeholder 5 mg fluconazol
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of oral solution contains 5 mg of fluconazole.
- Øsofageal candidiasis 100-200 mg dagligt eller 200 mg 3 gange om ugen
100 mg to 200 mg daily or 200 mg 3 times per week
800 mg den første dag og derefter 400 mg 1 gang dagligt indtil De får besked på at stoppe behandlingen
To treat internal fungal infections caused by Candida 800 mg on the first day then 400 mg once daily until you are told to stop
100 mg kapsler:
100 mg capsules Gelatin
Astemizol: Samtidig behandling med fluconazol og astemizol kan nedsætte astemizols clearance, resulterende i en stigning i astemizols plasmakoncentration, som kan føre til QT-forlængelse og i sjældne tilfælde torsades de pointes.
Astemizole: Concomitant administration of fluconazole with astemizole may decrease the clearance of astemizole.
• Kokcidioidomykose (se pkt.
• Coccidioidomycosis (see section 4.4).
Diflucan og tilhørende navne (se bilag I) 150 mg hårde kapsler [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 150 mg hard capsules [See Annex I - To be completed nationally]
Hver 50 ml infusionsvæske, opløsning indeholder 100 mg fluconazol.
Each 50 ml solution for infusion contains 100 mg fluconazole.
Samtidig oral administration af fluconazol 200 mg og triazolam 0,25 mg øgede triazolams AUC og halveringstid henholdsvis 4,4 og 2,3 gange.
Fluconazole 200 mg daily given concurrently with triazolam 0.25 mg orally increased the triazolam AUC and half-life 4.4-fold and 2.3-fold, respectively.
LISTE OVER HJÆLPESTOFFER Indeholder saccharose.
LIST OF EXCIPIENTS Contains sucrose.
CYP-isoenzymer
Coccidioidomycosis
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (40 mg/ml pulver til oral suspension - 60 ml flaske)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (40 mg/ml powder for oral suspension - 60 ml bottle)
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Diflucan 200 mg hårde kapsler har en hvid bund og rødviolet top.
- Diflucan 200 mg hard capsules have a white body and a purple cap.
dagligt.
Daily dose
Hver 100 ml infusionsvæske, opløsning indeholder 200 mg fluconazol.
Each 100 ml solution for infusion contains 200 mg fluconazole.
Hver 200 ml infusionsvæske, opløsning indeholder 400 mg fluconazol.
Each 200 ml solution for infusion contains 400 mg fluconazole.
Fluconazol er en potent hæmmer af CYP-isoenzym 2C9 og en moderat hæmmer af CYP3A4.
Fluconazole is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and a moderate inhibitor of CYP3A4.
INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 150 mg [Udfyldes nationalt]
INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 150 mg [To be completed nationally]
Diflucan 150 mg hårde kapsler har en turkis bund og turkis top.
- Diflucan 150 mg hard capsules have a turquoise blue body and a turquoise blue cap.
Diflucan og tilhørende navne (se bilag I) 50 mg Diflucan og tilhørende navne (se bilag I) 100 mg Diflucan og tilhørende navne (se bilag I) 150 mg Diflucan og tilhørende navne (se bilag I) 200 mg [Udfyldes nationalt]
Diflucan and associated names (see Annex I) 50 mg Diflucan and associated names (see Annex I) 100 mg Diflucan and associated names (see Annex I) 150 mg Diflucan and associated names (see Annex I) 200 mg [To be completed nationally]
- Kronisk atrofisk candidiasis
- Chronic atrophic candidiasis
Behandling af svampeinfektioner i skeden eller penis
To treat fungal skin and nail infections
• nedsat antal røde blodlegemer, hvilket kan få huden til at se bleg ud og give følelsen af svaghed eller åndenød
Uncommon side effects which affect 1 to 10 users in 1,000 are listed below: - reduction in red blood cells which can make skin pale and cause weakness or breathlessness
INDEHAVER Af MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET (40 mg/ml pulver til oral suspension - 60 ml flaske)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL(40 mg/ml powder for oral suspension - 60 ml bottle)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 150 mg fluconazol
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains fluconazole 150 mg.
200-400 mg dagligt
200 mg to 400 mg daily
De eller Deres pårørende kan selv indberette bivirkninger direkte til Lægemiddelstyrelsen.
For younger children, the medicinal product may be given directly into the mouth from the syringe.
Opbevares ved temperturer under 30 °C
SPECIAL STORAGE CONDITIONS Store below 30°C
Diflucan og tilhørende navne (se bilag I) 10 mg/ml pulver til oral suspension Diflucan og tilhørende navne (se bilag I) 40 mg/ml pulver til oral suspension [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 10 mg/ml powder for oral suspension Diflucan and associated names (see Annex I) 40 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
Samtidig behandling med fluconazol og erythromycin er kontraindiceret (se pkt.
Coadministration of fluconazole and erythromycin is contraindicated (see section 4.3).
Hvis De har fået for meget Diflucan infusionsvæske Fortæl det til lægen eller sundhedspersonalet, hvis De tror, at De har fået for meget Diflucan.
If you are concerned that you may have been given too much Diflucan, tell your doctor or nurse immediately.
Kontakt lægen inden De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.
- Øsofageal candidiasis Støddosis: 200-400 mg på dag 1.
Loading dose: 200 mg to 400 mg on Day 1
Rekonstiturede suspension: Opbevares ved temperaturer under 30 °C.
Reconstituted suspension: Store below 30°C, do not freeze.
• nedsat antal hvide blodlegemer (forsvarer kroppen mod infektioner) og blodplader (er med til at stoppe blødning)
Rare side effects which affect 1 to 10 users in 10,000 are listed below: - lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding
Ikke almindelig Obstipation, dyspepsi, flatulens, mundtørhed
Constipation disorders vomiting, diarrhoea, nausea dyspepsia, flatulence, dry mouth