FrancophonIA/ELRC3.0 huggingface dataset:
English: BEFORE YOU TAKE DIFLUCAN
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE DIFLUCAN
English: Detailed information on this medicine is available on the web site of {MA/Agency} [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt] Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside: www.laegemiddelstyrelsen.dk.
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 10 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 [Se bilag I - Udfyldes nationalt]
English: The 200 mg hard gelatin capsule has a white body and a purple cap overprinted with “Pfizer” and the code “FLU-200” with black ink.
Danish: 200 mg hårde gelatinekapsler har hvid bund og rødviolet top mærket med ”Pfizer” og koden ”FLU200” med sort blæk.
English: Excipient: 0.55 g sucrose per ml of reconstituted suspension
Danish: 1 ml rekonstitueret suspension indeholder 40 mg fluconazol Hjælpestoffer: 0,55 g saccharose pr. ml rekonstitueret suspension.
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 2 mg/ ml solution for infusion [See Annex I - To be completed nationally] Fluconazole
Danish: Diflucan og tilhørende navne (se bilag I) 2 mg/ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Coadministration of fluconazole and quinidine is contraindicated (see section 4.3).
Danish: Samtidig behandling med fluconazol og quinidin er kontraindiceret (se pkt.
English: To stop mucosal infections affecting the lining of the mouth, throat
Danish: Forebyggelse af infektion i slimhinderne på indersiden af munden eller halsen
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Diflucan-kapsler indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Dose reduction of zidovudine may be considered.
Danish: Dosisreduktion af zidovudin kan være nødvendig.
English: Cholestasis (see section 4.4), jaundice (see section 4.4), bilirubin increased (see section 4.4)
Danish: 4.4), forhøjet bilirubin (se pkt.
English: They have “FLU-200” and “Pfizer” with black ink printed on them.
Danish: De er mærket med koden ”FLU200”og ”Pfizer” med sort blæk.
English: Additionally, if any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Fortæl det til lægen eller på apoteket, hvis en af følgende bivirkninger bliver alvorlig, eller De får bivirkninger, som ikke er nævnt her.
English: They have “FLU-150” and “Pfizer” with black ink printed on them.
Danish: De er mærket med koden ”FLU-150” og ”Pfizer” med sort blæk.
English: What Diflucan looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Tell your doctor if you have liver or kidney problems suffer from heart disease, including heart rhythm problems have abnormal levels of potassium, calcium or magnesium in your blood.
Danish: • har unormale mængder af kalium, calcium eller magnesium i blodet
English: - If you have an intolerance to some sugars, please contact your doctor before taking this medicine.
Danish: - Kontakt lægen, inden De tager denne medicin, hvis De ikke kan tåle sukker.
English: They have “FLU-50” and “Pfizer” with black ink printed on them.
Danish: De er mærket med koden ”FLU-50”og ”Pfizer” med sort blæk.
English: Hepatic failure (see section 4.4), hepatocellular necrosis (see section 4.4), hepatitis (see section 4.4), hepatocellular damage (see section
Danish: 4.4), hepatocellulær nekrose (se pkt.
English: They have “FLU-100” and “Pfizer” with black ink printed on them.
Danish: De er mærket med koden ”FLU-100”og ”Pfizer” med sort blæk.
English: Penis thrush infection
Danish: Svampeinfektion i penis
English: Fertility
Danish: Gelatine
English: severe skin reactions, swelling of the lips or face - hair loss
Danish: • hævede øjenlåg, ansigt eller læber
English: Mucosal thrush and throat infections caused by Candida - dose and duration depends on the severity of the infection and on where the infection is located
Danish: Behandling af svampeinfektioner i hud og negle Dosis afhænger af, hvor De har infektionen.
English: Coadministration of fluconazole and pimozide is contraindicated (see section 4.3).
Danish: Samtidig behandling med fluconazol og pimozid er kontraindiceret (se pkt.
English: damage (see section
Danish: Leversvigt (se pkt.
English: - prednisone (steroid) - zidovudine, also known as AZT; saquinavir (used in HIV-infected patients) - medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide - theophylline (used to control asthma) - vitamin A (nutritional supplement)
Danish: • medicin mod diabetes (sukkersyge) som chlorpropamid, glibenclamid, glipizid eller tolbutamid
English: The child should remain upright during administration.
Danish: Opbevares utilgængeligt for børn.
English: (Powder for oral suspension (175 ml bottle): Store below 25°C.
Danish: Pulver til oral suspension (175 ml flaske): Opbevares ved temperaturer under 25 °C.
English: (Powder for oral suspension (60 ml bottle): Store below 25°C no special storage conditions.
Danish: Pulver til oral suspension (60 ml flaske): Opbevares ved temperaturer under 25 °C.
English: To treat cryptococcal meningitis
Danish: Til behandling af kryptokokmeningitis
English: Seizures, paraesthesia, dizziness, taste perversion
Danish: Ikke almindelig Kramper, paræstesier, svimmelhed, smagsforstyrrelse
English: What Diflucan looks like and contents of the pack Diflucan is a clear, colourless to slightly yellow solution with a viscosity greater than water and is supplied in an amber glass bottle with a screw cap containing 750 mg fluconazole.
Danish: Den findes i en brun glasflaske med skruelåg og indeholder 750 mg fluconazol.
English: Anaphylaxis
Danish: • træthed
English: Store below 25°C - Powder for oral suspension (175 ml bottle): - Store the powder below 25°C.
Danish: Pulver til oral suspension (175 ml flaske): Opbevar pulveret ved temperaturer under 25˚C.
English: Alanine aminotransferase increased (see section 4.4), aspartate aminotransferase
Danish: Forhøjet alanin-aminotransferase (ALAT) (se pkt.
English: 50 mg once daily 2 to 4 weeks
Danish: 50 mg én gang dagligt
English: - itching all over the body reddening of the skin or itchy red spots - skin rash - severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).
Danish: • alvorlige hudreaktioner som udslæt med blærer (eventuelt også i munden og på tungen).
English: - This medicine has been prescribed for you.
Danish: • Lægen har ordineret Diflucan til Dem personligt.
English: Adjustment of dose of NSAIDs may be needed.
Danish: Dosisjustering af NSAID kan være nødvendig.
English: Alanine aminotransferase increased (see section 4.4), aspartate aminotransferase increased (see section 4.4), blood
Danish: 4.4), forhøjet asparat aminotransferase (ASAT) (se pkt.
English: - sudden wheezing, difficulty in breathing or tightness in the chest - swelling of eyelids, face or lips - itching all over the body reddening of the skin or itchy red spots - skin rash - severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).
Danish: • kløe og rødme på hele kroppen eller røde, kløende områder på huden
English: Alanine aminotransferase increased (see section 4.4), aspartate aminotransferase increased (see section 4.4), blood alkaline phosphatase increased (see section 4.4)
Danish: 4.4), forhøjet alkalisk fosfatase (se pkt.
English: - Each hard capsule contains fluconazole 150 mg. - The other ingredients are:
Danish: • Hver hård kapsel indeholder 150 mg fluconazol.
English: To treat coccidioidomycosis
Danish: Til behandling af kokcidioidomykose
English: What Diflucan is and what it is used for Before you are given Diflucan How Diflucan is given Possible side effects How to store Diflucan Further information
Danish: Det skal De vide, før De begynder at få Diflucan Sådan får De Diflucan
English: (PVC bags) Store below 30˚C.
Danish: PVC poser: Opbevares ved temperaturer under 30 ˚C.
English: Common side effects which affect 1 to 10 users in 100 are listed below: - headache - stomach discomfort, diarrhoea, feeling sick, vomiting - increases in blood tests of liver function - rash
Danish: De hyppigst rapporterede bivirkninger (>1/10) er hovedpine, mavesmerter, diarré, kvalme, opkastning, alanintransferase forhøjet, aspartataminotransferase forhøjet, forhøjet alkalisk fosfatase og udslæt
English: Store below 30°C.
Danish: Opbevares ved temperturer under 30°C.
English: Hepatobiliary system
Danish: Kardiovaskulært system
English: Detailed information on this medicine is available on the web site of {MA/Agency}: [To be completed nationally]
Danish: Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside: www.laegemiddelstyrelsen.dk.
English: Invasive candidasis
Danish: - Candiduri
English: Toxic epidermal necrolysis, (see section 4.4), Stevens-Johnson syndrome (see section 4.4), acute generalised exanthematouspustulosis (see section 4.4), dermatitis exfoliative, angioedema, face oedema, alopecia
Danish: 4.4), eksfoliative kutanreaktioner, angioødem, ansigtsødem, alopeci
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (IV - 30 ml glass vial)
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Limited data are available in patients with hepatic impairment, therefore fluconazole should be administered with caution to patients with liver dysfunction (see sections 4.4 and 4.8).
Danish: Fluconazol skal derfor administreres med forsigtighed til patienter med nedsat leverfunktion (se pkt.
English: This summary was last updated in 05-2010.
Danish: Dette sammendrag blev sidst ajourført i 05-2010.
English: The marketing authorisation holder is Eli Lilly Netherlands B.V.
Danish: Indehaveren af markedsføringstilladelsen er Eli Lilly Netherlands B.V.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xeristar on 17 December 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xeristar den 17. december 2004.
English: Xeristar duloxetine
Danish: Xeristar duloxetin
English: This document is a summary of the European Public Assessment Report (EPAR) for Xeristar.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xeristar.
English: The main measure of effectiveness was the change in the severity of pain each week.
Danish: Det primære mål for effekt var ændringen i sværhedsgraden af smerterne hver uge.
English: Other information about Xeristar:
Danish: Andre oplysninger om Xeristar:
English: Xeristar is used to treat adults (aged 18 years or over) with the following diseases:
Danish: Xeristar anvendes til behandling af voksne (18 år eller derover) med følgende sygdomme:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeristar.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Xeristar.
English: This prevents the active substance from being destroyed by the acid in the stomach.
Danish: Dermed forhindres det, at det aktive stof ødelægges af mavesyren.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: • generaliseret angst (langvarig angst eller nervøsitet over hverdagsanliggender).
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Danish: • smerter som følge af diabetisk perifer neuropati (beskadigelse af nerverne i ekstremiteterne, som kan forekomme hos patienter med diabetes)
English: Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Danish: Der må ikke indledes behandling af patienter med ukontrolleret hypertension (forhøjet blodtryk) på grund af risikoen for hypertensive kriser (pludselig farlig blodtryksforhøjelse).
English: For more information about treatment with Xeristar, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xeristar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Most patients will need to take 60 mg per day.
Danish: De fleste patienter har behov for at tage 60 mg dagligt.
English: Xeristar is a medicine that contains the active substance duloxetine.
Danish: Xeristar er et lægemiddel, der indeholder det aktive stof duloxetin.
English: Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks.
Danish: I fire undersøgelser så man på behandlingen af sygdommen ved at måle reduktionen af symptomerne efter ni til 10 uger.
English: Six of the studies looked at the treatment of depression and measured the change in symptoms over up to six months.
Danish: Seks af undersøgelserne vedrørte behandling af depression og målte ændringer i symptomerne i op til seks måneder.
English: The full EPAR for Xeristar can be found here.
Danish: Den fuldstændige EPAR for Xeristar findes her.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Danish: Ved at blokere for genoptagelsen af disse øger duloxetin mængden af disse neurotransmittere i mellemrummene mellem disse nerveceller, hvorved kommunikationsniveauet mellem cellerne øges.
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks.
Danish: I begge undersøgelser blev der opnået smertelindring fra første behandlingsuge i indtil 12 uger.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre neurotransmitterne 5-hydroxytryptamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nerveceller i hjernen og rygmarven.
English: The CHMP decided that Xeristar's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP var af den opfattelse, at fordelene ved Xeristar opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The most common side effects with Xeristar (seen in more than 1 patient in 10) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Danish: De hyppigste bivirkninger ved Xeristar (som optræder hos flere end 1 ud af 10 patienter) er kvalme, hovedpine, mundtørhed, træthed og svimmelhed.
English: Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Danish: Da disse neurotransmittere også medvirker til at holde humøret oppe og nedsætte smertefornemmelsen, kan blokeringen af genoptagelsen i nervecellerne forbedre symptomerne på depression, angst og neuropatiske smerter.
English: Patients who also have major depression should start with 60 mg once a day.
Danish: Patienter, som også har en svær depression, bør starte med 60 mg en gang dagligt.
English: Xeristar must also not be used in patients with certain types of liver disease or patients with severe kidney disease.
Danish: Xeristar må heller ikke anvendes til patienter med visse former for leversygdom eller patienter med svær nyresygdom.
English: Xeristar must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Danish: Xeristar må ikke anvendes sammen med monoaminoxidasehæmmere (en anden gruppe lægemidler mod depression), fluvoxamin (et andet middel mod depression) eller ciprofloxacin eller enoxacin (to typer antibiotika).
English: In patients who respond to Xeristar, treatment should continue for several months, to prevent the disorder coming back.
Danish: Hos patienter, der reagerer på Xeristar, bør behandlingen fortsættes i flere måneder for at undgå, at sygdommen kommer tilbage.
English: A response is usually seen in two to four weeks.
Danish: Virkningen indtræder normalt efter to til fire ugers behandling.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Danish: Ved generaliseret angst er den anbefalede startdosis 30 mg, men dosis kan øges til 60, 90 og 120 mg afhængigt af patientens respons.
English: What is the risk associated with Xeristar?
Danish: Hvilken risiko er der forbundet med Xeristar?
English: It also took longer for symptoms to return in patients taking Xeristar than in those taking placebo.
Danish: Det tog også længere tid, før symptomerne vendte tilbage, hos patienter, som fik Xeristar end hos dem, der fik placebo.
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Xeristar.
Danish: I den femte undersøgelse så man på, hvor lang tid det tog, inden symptomerne vendte til bage hos 429 patienter, hos hvem Xeristar oprindeligt havde virket.
English: The active substance in Xeristar, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof i Xeristar, duloxetin, er en serotonin-noradrenalin genoptagelseshæmmer.
English: In the two studies where the approved dose of Xeristar was compared with placebo, Xeristar was more effective.
Danish: I de to undersøgelser, hvor den godkendte dosering af Xeristar blev sammenlignet med placebo, var Xeristar mere effektivt.
English: Why has Xeristar been approved?
Danish: Hvorfor blev Xeristar godkendt?
English: Xeristar should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Danish: Xeristar bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for duloxetin eller andre af indholdsstofferne.
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Xeristar, including 288 patients with a history of repeated episodes of depression for up to five years.
Danish: De andre to undersøgelser så på, hvor lang tid der gik, inden symptomerne vendte tilbage hos patienter, der oprindeligt havde reageret på Xeristar, heraf 288 patienter, som tidligere havde haft gentagne episoder med depression i op til fem år.
English: As with other antidepressants, isolated cases of suicidal thoughts and behaviour have been seen in patients taking Xeristar, particularly in the first few weeks of treatment for depression.
Danish: Som med andre midler mod depression har patienter i behandling med Xeristar i enkelte tilfælde haft selvmordstanker og udvist selvmordsadfærd, navnlig i de første uger af behandlingen for depression.
English: Although the results of the depression studies varied, Xeristar was more effective than placebo in four of the studies.
Danish: Selvom resultaterne af depressionsundersøgelserne varierede, var Xeristar mere effektivt end placebo i fire af undersøgelserne.
English: For neuropathic pain, Xeristar has been compared with placebo in two 12-week studies in 809 diabetic adults.
Danish: Til neuropatiske smerter blev Xeristar sammenlignet med placebo i to 12-ugers undersøgelser af 809 voksne med sukkersyge.
English: For major depression, the recommended dose of Xeristar is 60 mg once a day.
Danish: Ved svær depression er den anbefalede dosis Xeristar 60 mg en gang dagligt.
English: For the full list of all side effects reported with Xeristar, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Xeristar fremgår af indlægssedlen.
English: For the treatment of diabetic neuropathic pain, Xeristar was more effective at reducing pain than placebo.
Danish: Til behandling af diabetiske neuropatiske smerter var Xeristar bedre til at lindre smerterne end placebo.
English: For major depression, Xeristar has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Danish: Ved svær depression blev Xeristar sammenlignet med placebo (en virkningsløs behandling) i otte hovedundersøgelser af i alt 2 544 patienter.
English: For generalised anxiety disorder, Xeristar was also more effective than placebo at treating the disorder and preventing symptoms returning.
Danish: Ved generaliseret angst var Xeristar mere effektivt end placebo til behandling af sygdommen og til forebyggelse af tilbagefald af symptomerne.
English: For generalised anxiety disorder, Xeristar has been compared with placebo in five studies involving a total of 2,337 patients.
Danish: Til behandling af generaliseret angst blev Xeristar sammenlignet med placebo i fem undersøgelser med deltagelse af i alt 2 337 patienter.
English: What is Xeristar?
Danish: Hvad er Xeristar?
English: Any patients taking Xeristar who have distressing thoughts or experiences at any time should tell their doctor immediately.
Danish: Hvis en patient, der er i behandling med Xeristar, på noget tidspunkt føler sig nedtrykt, bør patienten straks fortælle det til lægen.
English: What benefit has Xeristar shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xeristar?
English: The dose of Xeristar should be reduced gradually when stopping treatment.
Danish: Når behandlingen ophører, bør det ske ved gradvis nedsættelse af dosis af Xeristar.
English: How has Xeristar been studied?
Danish: Hvordan blev Xeristar undersøgt?
English: What is Xeristar used for?
Danish: Hvad anvendes Xeristar til?
English: How is Xeristar used?
Danish: Hvordan anvendes Xeristar?
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Danish: bør behandlingen fortsættes i flere måneder for at forhindre tilbagefald eller endnu længere hos patienter, som tidligere har haft gentagne perioder med depression Den anbefalede dosis til behandling af diabetiske neuropatiske smerter er 60 mg en gang dagligt, men visse patienter kan have behov for en højere dosis på 120 mg dagligt.
English: How does Xeristar work?
Danish: Hvordan virker Xeristar?
English: London, 17 January 2008 EMEA/31266/2008
Danish: London, den 17. januar 2008 EMEA/31266/2008
English: If you are in a clinical trial and have any questions, contact your doctor.
Danish: Hvis du deltager i en klinisk undersøgelse og har nogen som helst spørgsmål, skal du kontakte din læge.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for ZOMETA
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM ÆNDRING AF MARKEDSFØRINGSTILLADELSEN for ZOMETA
English: What is Zometa?
Danish: Hvad er Zometa?
English: The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Danish: CHMP er normalt op til 90 dage om at vedtage en udtalelse, efter at det har modtaget en ansøgning om ændring af en markedsføringstilladelse.
English: International non-proprietary name (INN): zoledronic acid
Danish: Internationalt fællesnavn (INN): zoledronsyre