FrancophonIA/ELRC3.0 huggingface dataset:
English: A higher fluconazole plasma elimination half-life of approximately 24 hours was found after a single dose.
Danish: Efter indgift af en enkelt dosis fandtes en højere plasma-halveringstid på ca. 24 timer.
English: This leaflet was last approved in [To be completed nationally]
Danish: Denne indlægsseddel blev sidst godkendt { MM/ÅÅÅÅ } [Udfyldes nationalt]
English: • Relapse of crytopcoccal meningitis in patients with high risk of recurrence.
Danish: • Mod tilbagefald af kryptokokmeningitis hos patienter med høj risiko for recediv.
English: Hepatobiliary system Diflucan should be administered with caution to patients with liver dysfunction.
Danish: Lever og galdeveje Diflucan bør administreres med forsigtighed til patienter med nedsat leverfunktion.
English: 400 mg once daily for 6 to 8 weeks or longer if needed.
Danish: 400 mg den første dag og derefter 200-400 mg 1 gang dagligt i 6-8 uger eller længere hvis nødvendigt.
English: - Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with high risk of recurrence.
Danish: - Vedligeholdelsesdosis til forebyggelse af tilbagefald af kryptokokmeningitis hos patienter med høj risiko for recediv.
English: The capsule size is no. 4.
Danish: Kapselstørrelse nr. 4.
English: Marketing Authorisation Holderand Manufacturer
Danish: Indehaver af markedsføringstilladelsen
English: This medicine contains a small amount of lactose (milk sugar).
Danish: Diflucan hårde kapsler indeholder en lille mængde lactose (mælkesukker).
English: 3 mg to 12 mg per kg of body weight
Danish: 3-12 mg/kg legemsvægt
English: - Each ml contains 2 mg of fluconazole.
Danish: • Hver ml indeholder 2 mg fluconazol.
English: Diflucan and associated names 10 mg/ml powder for oral suspension:
Danish: Diflucan 10 mg/ml pulver til oral suspension:
English: Renal system Diflucan should be administered with caution to patients with renal dysfunction (see section 4.2).
Danish: Nyresystemet Diflucan bør anvendes med forsigtighed til patienter med nedsat nyrefunktion (se pkt.
English: Where there is no evidence of renal impairment, normal dose recommendations should be adopted.
Danish: Patienter uden nedsat nyrefunktion skal have normal dosering.
English: 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.
Danish: 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.
English: Fluconazole is predominantly excreted in the urine as unchanged active substance.
Danish: Fluconazol udskilles overvejende som uomdannet lægemiddel i urinen.
English: 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.
Danish: BIVIRKNINGER Diflucan kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 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.
Danish: Behandling kan startes, før identifikation og resultaterne af andre laboratorieundersøgelser foreligger.
English: - Diflucan 100 mg hard capsules have a white body and a blue cap.
Danish: Diflucan 100 mg hårde kapsler har en hvid bund og blå top.
English: Powder for oral suspension 10 mg/ml (175 ml bottle): Store below 25°C.
Danish: Pulver til oral suspension 10 mg/ml (175 ml flaske): Opbevares under 25°C.
English: Diflucan and associated names 40 mg/ml powder for oral suspension:
Danish: Diflucan 40 mg/ml pulver til oral suspension:
English: Hypersensitivity to the active substance, to related azole substances, or to any of the excipients (see section 6.1).
Danish: Overfølsomhed over for fluconazol, andre azolderivater eller over for et eller flere af hjælpestofferne (se pkt.
English: Shellac (glaze), black iron oxide, N-Butyl alcohol, dehydrated alcohol, purified water, propylene glycol, industrial methylated spirit, isopropyl alcohol, strong ammonia solution, potassium hydroxide
Danish: Shellac (glasur); sort jernoxid (E172); n-butylalkohol; vandfri ethanol; renset vand; propylenglycol; industriel denatureret alkohol; isopropylalkohol; stærk amoniakopløsning; kaliumhydroxid
English: It is recommended that your pharmacist makes up Diflucan powder for oral suspension before giving it to you.
Danish: Det anbefales, at apoteket laver Diflucan pulver til oral suspension klar til Dem. Der er vejledning til sundhedspersonalet i sidste afsnit af indlægssedlen.
English: 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
Danish: 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
English: - Oropharyngeal candidiasis
Danish: - Orofaryngeal candidiasis
English: In cases of fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of patient has been observed.
Danish: 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.
English: 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.
Danish: Samtidig oral administration af fluconazol 200 mg og midazolam 7,5 mg øgede midazolams AUC og halveringstid henholdsvis 3,7 og 2,2 gange.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of reconstituted suspension contains 40 mg fluconazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml rekonstitueret suspension indeholder 40 mg fluconazol
English: 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.
Danish: • 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.
English: 150 mg capsules Gelatin
Danish: 150 mg kapsler:
English: Dose: 3 to 12 mg/kg daily
Danish: Dosis: 3-12 mg/kg dagligt
English: Dose: 6 to 12 mg/kg daily
Danish: Dosis: 6-12 mg/kg dagligt
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of reconstituted suspension contains 10 mg fluconazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml rekonstitueret suspension indeholder 10 mg fluconazol
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL(5 mg/ml oral solution)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FLASKEETIKET (5 mg/ml oral opløsning)
English: 200 mg capsules Gelatin
Danish: 200 mg kapsler: Gelatine
English: The shelf life of the powder for oral suspension is 24 months.
Danish: Pulver til oral suspension: 24 måender.
English: HOW TO TAKE DIFLUCAN
Danish: SÅDAN SKAL DE TAGE DIFLUCAN
English: - Mucosal candidiasis
Danish: Mukøs candidiasis
English: - The shelf life of the reconstituted suspension is 28 days.
Danish: Rekonstitueret suspension: 28 dage.
English: LIST OF EXCIPIENTS Also contains sucrose, glycerol.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også saccharose og glycerol.
English: Subsequent dose: 100 mg to 200 mg daily
Danish: Efterfølgende dosis: 100-200 mg dagligt.
English: High skin concentration of fluconazole, above serum concentrations, are achieved in the stratum corneum, epidermis-dermis and eccrine sweat.
Danish: I stratum corneum, epidermis-dermis og i ekkrin sved opnås højere koncentrationer af fluconazol end i serum.
English: 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
Danish: Sort printblæk: shellac; sort jernoxid (E172); n-butylalkohol; vandfri ethanol; renset vand; propylenglycol; industriel denatureret alkohol; isopropylalkohol; stærk amoniakopløsning, kaliumhydroxid
English: 1, 5, 10 or 20 plasticised PVC bags (100 or 200 ml).
Danish: Pakningsstørrelse: 30, 50, 100 eller 250 ml hætteglas 1, 5, 10 eller 20 plastificerede PVC poser (100 eller 200 ml)
English: For the 175 ml bottle: - Diflucan 10 mg/ml powder for oral suspension is a dry white to off-white powder.
Danish: Diflucan 10 mg/ml pulver til oral suspension er et tørt hvidt til off-white pulver.
English: The capsule size is no. 1.
Danish: Kapselstørrelse nr. 1.
English: 150 mg as a single dose.
Danish: 150 mg som 1 énkeltdosis.
English: Fatigue, malaise, asthenia, fever
Danish: Ikke almindelig Træthed, utilpashed, asteni, feber
English: The capsule size is no. 2.
Danish: Kapselstørrelse nr. 2.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (10 mg/ml powder for oral suspension - 60 ml and 175 ml bottles)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (10 mg/ml pulver til oral suspension - 60 ml og 175 ml flasker)
English: Drug eruption (see section 4.4), urticaria (see section 4.4), pruritus, increased sweating
Danish: 4.4), pruritus, øget svedtendens
English: - are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Diflucan.
Danish: • er overfølsom (allergisk) over for fluconazol, andre svampemidler eller et eller flere af hjælpestofferne i Diflucan.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket, hvis De føler Dem usikker.
English: Coadministration of fluconazole and astemizole is contraindicated (see section 4.3).
Danish: Samtidig behandling med fluconazol og astemizol er kontraindiceret (se pkt 4.3).
English: 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).
Danish: Patienter i samtidig behandling med fluconazol i doser under 400 mg dagligt og terfenadin bør monitoreres omhyggeligt (se pkt.
English: Dose: 6 mg/kg daily
Danish: Dosis: 6 mg/kg dagligt
English: Always take your medicine exactly as your doctor has told you.
Danish: Følg altid lægens anvisning.
English: LIST OF EXCIPIENTS Also contains sucrose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også saccharose.
English: please tell your doctor or pharmacist.
Danish: Fortæl det til lægen, hvis De
English: HOW DIFLUCAN IS GIVEN
Danish: SÅDAN FÅR DE DIFLUCAN
English: Concomitant treatment with fluconazole and cisapride is contraindicated (see section 4.3).
Danish: Samtidig behandling med fluconazol og cisaprid er kontraindiceret (se pkt.
English: - Chronic mucocutaneous candidiasis
Danish: - Kronisk mukokutan candidiasis
English: What Diflucan solution for infusion looks like and contents of the pack - Diflucan is a clear, colourless solution with no visible particles.
Danish: LÆGEMIDDELFORM Infusionsvæske, opløsning Klar, farveløs opløsning uden synlige partikler.
English: 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
Danish: Det skal De vide, før De begynder at tage Diflucan Sådan skal De tage Diflucan Bivirkninger
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL (10 mg/ml powder for oral suspension - 60 ml and 175 ml bottles)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET (10 mg/ml pulver til oral suspension - 60 ml og 175 ml flasker)
English: The solution for infusion is for single use only.
Danish: Dette lægemiddel er kun til engangsbrug.
English: To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth
Danish: Behandling af infektioner i slimhinderne på indersiden af munden, halsen eller mundbetændelse på grund af tandprotese
English: Undesirable effects
Danish: BIVIRKNINGER
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of oral solution contains 5 mg of fluconazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml oral opløsning indeholder 5 mg fluconazol
English: 100 mg to 200 mg daily or 200 mg 3 times per week
Danish: - Øsofageal candidiasis 100-200 mg dagligt eller 200 mg 3 gange om ugen
English: 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
Danish: 800 mg den første dag og derefter 400 mg 1 gang dagligt indtil De får besked på at stoppe behandlingen
English: 100 mg capsules Gelatin
Danish: 100 mg kapsler:
English: Astemizole: Concomitant administration of fluconazole with astemizole may decrease the clearance of astemizole.
Danish: 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.
English: • Coccidioidomycosis (see section 4.4).
Danish: • Kokcidioidomykose (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 150 mg hard capsules [See Annex I - To be completed nationally]
Danish: Diflucan og tilhørende navne (se bilag I) 150 mg hårde kapsler [Se bilag I - Udfyldes nationalt]
English: Each 50 ml solution for infusion contains 100 mg fluconazole.
Danish: Hver 50 ml infusionsvæske, opløsning indeholder 100 mg fluconazol.
English: 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.
Danish: Samtidig oral administration af fluconazol 200 mg og triazolam 0,25 mg øgede triazolams AUC og halveringstid henholdsvis 4,4 og 2,3 gange.
English: LIST OF EXCIPIENTS Contains sucrose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder saccharose.
English: Coccidioidomycosis
Danish: CYP-isoenzymer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (40 mg/ml powder for oral suspension - 60 ml bottle)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (40 mg/ml pulver til oral suspension - 60 ml flaske)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE
English: - Diflucan 200 mg hard capsules have a white body and a purple cap.
Danish: Diflucan 200 mg hårde kapsler har en hvid bund og rødviolet top.
English: Daily dose
Danish: dagligt.
English: Each 100 ml solution for infusion contains 200 mg fluconazole.
Danish: Hver 100 ml infusionsvæske, opløsning indeholder 200 mg fluconazol.
English: Each 200 ml solution for infusion contains 400 mg fluconazole.
Danish: Hver 200 ml infusionsvæske, opløsning indeholder 400 mg fluconazol.
English: Fluconazole is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and a moderate inhibitor of CYP3A4.
Danish: Fluconazol er en potent hæmmer af CYP-isoenzym 2C9 og en moderat hæmmer af CYP3A4.
English: INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 150 mg [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 150 mg [Udfyldes nationalt]
English: - Diflucan 150 mg hard capsules have a turquoise blue body and a turquoise blue cap.
Danish: Diflucan 150 mg hårde kapsler har en turkis bund og turkis top.
English: 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]
Danish: 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]
English: - Chronic atrophic candidiasis
Danish: - Kronisk atrofisk candidiasis
English: To treat fungal skin and nail infections
Danish: Behandling af svampeinfektioner i skeden eller penis
English: 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
Danish: • nedsat antal røde blodlegemer, hvilket kan få huden til at se bleg ud og give følelsen af svaghed eller åndenød
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER Af MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL(40 mg/ml powder for oral suspension - 60 ml bottle)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET (40 mg/ml pulver til oral suspension - 60 ml flaske)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains fluconazole 150 mg.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 150 mg fluconazol
English: 200 mg to 400 mg daily
Danish: 200-400 mg dagligt
English: For younger children, the medicinal product may be given directly into the mouth from the syringe.
Danish: De eller Deres pårørende kan selv indberette bivirkninger direkte til Lægemiddelstyrelsen.
English: SPECIAL STORAGE CONDITIONS Store below 30°C
Danish: Opbevares ved temperturer under 30 °C
English: 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]
Danish: 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]
English: Coadministration of fluconazole and erythromycin is contraindicated (see section 4.3).
Danish: Samtidig behandling med fluconazol og erythromycin er kontraindiceret (se pkt.
English: If you are concerned that you may have been given too much Diflucan, tell your doctor or nurse immediately.
Danish: Hvis De har fået for meget Diflucan infusionsvæske Fortæl det til lægen eller sundhedspersonalet, hvis De tror, at De har fået for meget Diflucan.
English: If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.
Danish: Kontakt lægen inden De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Loading dose: 200 mg to 400 mg on Day 1
Danish: - Øsofageal candidiasis Støddosis: 200-400 mg på dag 1.
English: Reconstituted suspension: Store below 30°C, do not freeze.
Danish: Rekonstiturede suspension: Opbevares ved temperaturer under 30 °C.
English: 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
Danish: • nedsat antal hvide blodlegemer (forsvarer kroppen mod infektioner) og blodplader (er med til at stoppe blødning)
English: Constipation disorders vomiting, diarrhoea, nausea dyspepsia, flatulence, dry mouth
Danish: Ikke almindelig Obstipation, dyspepsi, flatulens, mundtørhed
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 5 mg/ml oral solution [See Annex I - To be completed nationally]
Danish: Diflucan og tilhørende navne (se bilag I) 5 mg/ml oral opløsning [Se bilag I - Udfyldes nationalt]
English: INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 40 mg/ml [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 40 mg/ml [Udfyldes nationalt]
English: The 150 mg hard gelatin capsule has a turquoise blue body and turquoise blue cap overprinted with “Pfizer” and the code “FLU-150” with black ink.
Danish: 150 mg hårde gelatinekapsler har turkis bund og turkis top mærket med ”Pfizer” og koden ”FLU-150” med sort blæk.
English: - Diflucan 50 mg hard capsules have a white body and a turquoise blue cap.
Danish: Diflucan 50 mg hårde kapsler har en hvid bund og turkis top.
English: - The other ingredients are: sucrose, silica colloidal anhydrous, titanium dioxide (E 171), xanthan gum, sodium citrate, citric acid anhydrous, sodium benzoate and natural orange flavour (containing orange oil and maltodextrin).
Danish: xanthangummi; natriumcitrat (E331); citronsyre (E330); natriumbenzoat (E211); naturlig orangesmag (indeholder appelsinolie og maltodextrin)
English: You might be given this medicine by your doctor to treat the following types of fungal infections: - Mucosal thrush - infection affecting the lining of the mouth, throat - Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract - Cryptococcal meningitis - a fungal infection in the brain
Danish: • Infektioner, der skyldes Candida i blodet, i organer (f.eks. hjerte, lunger) eller i urinvejene • Kryptokokmeningitis - en svampeinfektion i hjernen
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains fluconazole 50 mg Excipients: each hard capsule also contains 49.70 mg lactose monohydrate Each hard capsule contains fluconazole 100 mg Excipients: each hard capsule also contains 99.41 mg lactose monohydrate Each hard capsule contains fluconazole 150 mg Excipients: each hard capsule also contains 149.12 mg lactose monohydrate Each hard capsule contains fluconazole 200 mg Excipients: each hard capsule also contains 198.82 mg lactose monohydrate For a full list of excipients, see section 6.1.
Danish: Hver hård kapsel indeholder 100 mg fluconazol Hjælpestoffer: Hver hård kapse indeholder også 99,41 mg lactosemonohydrat Hver hård kapsel indeholder 150 mg fluconazol.
English: To stop children from getting an infection caused by Candida (if their immune system is not working properly)
Danish: • forebygge svampeinfektioner, som skyldes Candida (hvis De har nedsat immunforsvar, eller hvis det ikke fungerer ordentligt)
English: INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 5 mg/ml [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 5 mg/ml [Udfyldes nationalt]
English: The 100 mg hard gelatin capsule has a white body and blue cap overprinted with “Pfizer” and the code “FLU-100” with black ink.
Danish: 100 mg hårde gelatinekapsler har hvid bund og blå top mærket med ”Pfizer” og koden ”FLU-100” med sort blæk.
English: INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 10 mg/ml [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 10 mg/ml [Udfyldes nationalt]
English: Excipients
Danish: • udslæt
English: - Candiduria
Danish: Candida.
English: - sudden wheezing, difficulty in breathing or tightness in the chest - swelling of eyelids, face or lips
Danish: • allergiske reaktioner (kan være alvorlige) med udbredt blæredannelse og hudafskalning, alvorlig hudreaktion, hævede læber og ansigt
English: Diflucan and associated names (see Annex I) 50 mg hard capsules Diflucan and associated names (see Annex I) 100 mg hard capsules Diflucan and associated names (see Annex I) 150 mg hard capsules Diflucan and associated names (see Annex I) 200 mg hard capsules [See Annex I - To be completed nationally]
Danish: Diflucan og tilhørende navne (se bilag I) 50 mg hårde kapsler Diflucan og tilhørende navne (se bilag I) 100 mg hårde kapsler Diflucan og tilhørende navne (se bilag I) 150 mg hårde kapsler Diflucan og tilhørende navne (se bilag I) 200 mg hårde kapsler [Se bilag I - Udfyldes nationalt]
English: The 50 mg hard gelatin capsule has a white body and a turquoise blue cap overprinted with “Pfizer” and the code “FLU-50” with black ink.
Danish: 50 mg hårde gelatinekapsler har hvid bund og turkis top mærket med ”Pfizer” og koden ”FLU-50” med sort blæk.
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 40 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
Danish: Diflucan og tilhørende navne (se bilag I) 40 mg/ml pulver til oral suspension [Se bilag I - Udfyldes nationalt]