natgillin/translations-raw huggingface dataset:
Diflucan og tilhørende navne (se bilag I) 5 mg/ml oral opløsning [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 5 mg/ml oral solution [See Annex I - To be completed nationally]
INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 40 mg/ml [Udfyldes nationalt]
INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 40 mg/ml [To be completed nationally]
150 mg hårde gelatinekapsler har turkis bund og turkis top mærket med ”Pfizer” og koden ”FLU-150” med sort blæk.
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.
Diflucan 50 mg hårde kapsler har en hvid bund og turkis top.
- Diflucan 50 mg hard capsules have a white body and a turquoise blue cap.
xanthangummi; natriumcitrat (E331); citronsyre (E330); natriumbenzoat (E211); naturlig orangesmag (indeholder appelsinolie og maltodextrin)
- 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).
• Infektioner, der skyldes Candida i blodet, i organer (f.eks. hjerte, lunger) eller i urinvejene • Kryptokokmeningitis - en svampeinfektion i hjernen
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
Hver hård kapsel indeholder 100 mg fluconazol Hjælpestoffer: Hver hård kapse indeholder også 99,41 mg lactosemonohydrat Hver hård kapsel indeholder 150 mg fluconazol.
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.
• forebygge svampeinfektioner, som skyldes Candida (hvis De har nedsat immunforsvar, eller hvis det ikke fungerer ordentligt)
To stop children from getting an infection caused by Candida (if their immune system is not working properly)
INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 5 mg/ml [Udfyldes nationalt]
INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 5 mg/ml [To be completed nationally]
100 mg hårde gelatinekapsler har hvid bund og blå top mærket med ”Pfizer” og koden ”FLU-100” med sort blæk.
The 100 mg hard gelatin capsule has a white body and blue cap overprinted with “Pfizer” and the code “FLU-100” with black ink.
INFORMATION I BRAILLE-SKRIFT Diflucan og tilhørende navne (se bilag I) 10 mg/ml [Udfyldes nationalt]
INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 10 mg/ml [To be completed nationally]
• udslæt
Excipients
Candida.
- Candiduria
• allergiske reaktioner (kan være alvorlige) med udbredt blæredannelse og hudafskalning, alvorlig hudreaktion, hævede læber og ansigt
- sudden wheezing, difficulty in breathing or tightness in the chest - swelling of eyelids, face or lips
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]
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]
50 mg hårde gelatinekapsler har hvid bund og turkis top mærket med ”Pfizer” og koden ”FLU-50” med sort blæk.
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.
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) 40 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE DIFLUCAN
BEFORE YOU TAKE DIFLUCAN
DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt] Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside: www.laegemiddelstyrelsen.dk.
Detailed information on this medicine is available on the web site of {MA/Agency} [To be completed nationally]
Diflucan og tilhørende navne (se bilag I) 10 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 [See Annex I - To be completed nationally]
200 mg hårde gelatinekapsler har hvid bund og rødviolet top mærket med ”Pfizer” og koden ”FLU200” med sort blæk.
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.
1 ml rekonstitueret suspension indeholder 40 mg fluconazol Hjælpestoffer: 0,55 g saccharose pr. ml rekonstitueret suspension.
Excipient: 0.55 g sucrose per ml of reconstituted suspension
Diflucan og tilhørende navne (se bilag I) 2 mg/ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
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
Samtidig behandling med fluconazol og quinidin er kontraindiceret (se pkt.
Coadministration of fluconazole and quinidine is contraindicated (see section 4.3).
Forebyggelse af infektion i slimhinderne på indersiden af munden eller halsen
To stop mucosal infections affecting the lining of the mouth, throat
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Dosisreduktion af zidovudin kan være nødvendig.
Dose reduction of zidovudine may be considered.
4.4), forhøjet bilirubin (se pkt.
Cholestasis (see section 4.4), jaundice (see section 4.4), bilirubin increased (see section 4.4)
De er mærket med koden ”FLU200”og ”Pfizer” med sort blæk.
They have “FLU-200” and “Pfizer” with black ink printed on them.
Fortæl det til lægen eller på apoteket, hvis en af følgende bivirkninger bliver alvorlig, eller De får bivirkninger, som ikke er nævnt her.
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.
De er mærket med koden ”FLU-150” og ”Pfizer” med sort blæk.
They have “FLU-150” and “Pfizer” with black ink printed on them.
Udseende og pakningsstørrelser
What Diflucan looks like and contents of the pack
• har unormale mængder af kalium, calcium eller magnesium i blodet
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.
- Kontakt lægen, inden De tager denne medicin, hvis De ikke kan tåle sukker.
- If you have an intolerance to some sugars, please contact your doctor before taking this medicine.
De er mærket med koden ”FLU-50”og ”Pfizer” med sort blæk.
They have “FLU-50” and “Pfizer” with black ink printed on them.
4.4), hepatocellulær nekrose (se pkt.
Hepatic failure (see section 4.4), hepatocellular necrosis (see section 4.4), hepatitis (see section 4.4), hepatocellular damage (see section
De er mærket med koden ”FLU-100”og ”Pfizer” med sort blæk.
They have “FLU-100” and “Pfizer” with black ink printed on them.
Svampeinfektion i penis
Penis thrush infection
Gelatine
Fertility
• hævede øjenlåg, ansigt eller læber
severe skin reactions, swelling of the lips or face - hair loss
Behandling af svampeinfektioner i hud og negle Dosis afhænger af, hvor De har infektionen.
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
Samtidig behandling med fluconazol og pimozid er kontraindiceret (se pkt.
Coadministration of fluconazole and pimozide is contraindicated (see section 4.3).
Leversvigt (se pkt.
damage (see section
• medicin mod diabetes (sukkersyge) som chlorpropamid, glibenclamid, glipizid eller tolbutamid
- 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)
Opbevares utilgængeligt for børn.
The child should remain upright during administration.
Pulver til oral suspension (175 ml flaske): Opbevares ved temperaturer under 25 °C.
(Powder for oral suspension (175 ml bottle): Store below 25°C.
Pulver til oral suspension (60 ml flaske): Opbevares ved temperaturer under 25 °C.
(Powder for oral suspension (60 ml bottle): Store below 25°C no special storage conditions.
Til behandling af kryptokokmeningitis
To treat cryptococcal meningitis
Ikke almindelig Kramper, paræstesier, svimmelhed, smagsforstyrrelse
Seizures, paraesthesia, dizziness, taste perversion
Den findes i en brun glasflaske med skruelåg og indeholder 750 mg fluconazol.
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.
• træthed
Anaphylaxis
Pulver til oral suspension (175 ml flaske): Opbevar pulveret ved temperaturer under 25˚C.
Store below 25°C - Powder for oral suspension (175 ml bottle): - Store the powder below 25°C.
Forhøjet alanin-aminotransferase (ALAT) (se pkt.
Alanine aminotransferase increased (see section 4.4), aspartate aminotransferase
50 mg én gang dagligt
50 mg once daily 2 to 4 weeks
• alvorlige hudreaktioner som udslæt med blærer (eventuelt også i munden og på tungen).
- 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).
• Lægen har ordineret Diflucan til Dem personligt.
- This medicine has been prescribed for you.
Dosisjustering af NSAID kan være nødvendig.
Adjustment of dose of NSAIDs may be needed.
4.4), forhøjet asparat aminotransferase (ASAT) (se pkt.
Alanine aminotransferase increased (see section 4.4), aspartate aminotransferase increased (see section 4.4), blood
• kløe og rødme på hele kroppen eller røde, kløende områder på huden
- 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).
4.4), forhøjet alkalisk fosfatase (se pkt.
Alanine aminotransferase increased (see section 4.4), aspartate aminotransferase increased (see section 4.4), blood alkaline phosphatase increased (see section 4.4)
• Hver hård kapsel indeholder 150 mg fluconazol.
- Each hard capsule contains fluconazole 150 mg. - The other ingredients are:
Til behandling af kokcidioidomykose
To treat coccidioidomycosis
Det skal De vide, før De begynder at få Diflucan Sådan får De Diflucan
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
PVC poser: Opbevares ved temperaturer under 30 ˚C.
(PVC bags) Store below 30˚C.
De hyppigst rapporterede bivirkninger (>1/10) er hovedpine, mavesmerter, diarré, kvalme, opkastning, alanintransferase forhøjet, aspartataminotransferase forhøjet, forhøjet alkalisk fosfatase og udslæt
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
Opbevares ved temperturer under 30°C.
Store below 30°C.
Kardiovaskulært system
Hepatobiliary system
Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside: www.laegemiddelstyrelsen.dk.
Detailed information on this medicine is available on the web site of {MA/Agency}: [To be completed nationally]
- Candiduri
Invasive candidasis
4.4), eksfoliative kutanreaktioner, angioødem, ansigtsødem, alopeci
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
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (IV - 30 ml glass vial)
Fluconazol skal derfor administreres med forsigtighed til patienter med nedsat leverfunktion (se pkt.
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).
Dette sammendrag blev sidst ajourført i 05-2010.
This summary was last updated in 05-2010.
Indehaveren af markedsføringstilladelsen er Eli Lilly Netherlands B.V.
The marketing authorisation holder is Eli Lilly Netherlands B.V.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xeristar den 17. december 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Xeristar on 17 December 2004.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xeristar.
This document is a summary of the European Public Assessment Report (EPAR) for Xeristar.
Det primære mål for effekt var ændringen i sværhedsgraden af smerterne hver uge.
The main measure of effectiveness was the change in the severity of pain each week.
Andre oplysninger om Xeristar:
Other information about Xeristar:
Xeristar anvendes til behandling af voksne (18 år eller derover) med følgende sygdomme:
Xeristar is used to treat adults (aged 18 years or over) with the following diseases:
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.
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.
Dermed forhindres det, at det aktive stof ødelægges af mavesyren.
This prevents the active substance from being destroyed by the acid in the stomach.
• generaliseret angst (langvarig angst eller nervøsitet over hverdagsanliggender).
• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
• smerter som følge af diabetisk perifer neuropati (beskadigelse af nerverne i ekstremiteterne, som kan forekomme hos patienter med diabetes)
• pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Der må ikke indledes behandling af patienter med ukontrolleret hypertension (forhøjet blodtryk) på grund af risikoen for hypertensive kriser (pludselig farlig blodtryksforhøjelse).
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).
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.
For more information about treatment with Xeristar, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De fleste patienter har behov for at tage 60 mg dagligt.
Most patients will need to take 60 mg per day.
Xeristar er et lægemiddel, der indeholder det aktive stof duloxetin.
Xeristar is a medicine that contains the active substance duloxetine.
I fire undersøgelser så man på behandlingen af sygdommen ved at måle reduktionen af symptomerne efter ni til 10 uger.
Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks.
Seks af undersøgelserne vedrørte behandling af depression og målte ændringer i symptomerne i op til seks måneder.
Six of the studies looked at the treatment of depression and measured the change in symptoms over up to six months.
Den fuldstændige EPAR for Xeristar findes her.
The full EPAR for Xeristar can be found here.
Ved at blokere for genoptagelsen af disse øger duloxetin mængden af disse neurotransmittere i mellemrummene mellem disse nerveceller, hvorved kommunikationsniveauet mellem cellerne øges.
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.
I begge undersøgelser blev der opnået smertelindring fra første behandlingsuge i indtil 12 uger.
In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks.
Det virker ved at forhindre neurotransmitterne 5-hydroxytryptamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nerveceller i hjernen og rygmarven.
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.
CHMP var af den opfattelse, at fordelene ved Xeristar opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Xeristar's benefits are greater than its risks and recommended that it be given marketing authorisation.
De hyppigste bivirkninger ved Xeristar (som optræder hos flere end 1 ud af 10 patienter) er kvalme, hovedpine, mundtørhed, træthed og svimmelhed.
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.
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.
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.
Patienter, som også har en svær depression, bør starte med 60 mg en gang dagligt.
Patients who also have major depression should start with 60 mg once a day.
Xeristar må heller ikke anvendes til patienter med visse former for leversygdom eller patienter med svær nyresygdom.
Xeristar must also not be used in patients with certain types of liver disease or patients with severe kidney disease.
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).
Xeristar must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Hos patienter, der reagerer på Xeristar, bør behandlingen fortsættes i flere måneder for at undgå, at sygdommen kommer tilbage.
In patients who respond to Xeristar, treatment should continue for several months, to prevent the disorder coming back.
Virkningen indtræder normalt efter to til fire ugers behandling.
A response is usually seen in two to four weeks.
Ved generaliseret angst er den anbefalede startdosis 30 mg, men dosis kan øges til 60, 90 og 120 mg afhængigt af patientens respons.
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.
Hvilken risiko er der forbundet med Xeristar?
What is the risk associated with Xeristar?
Det tog også længere tid, før symptomerne vendte tilbage, hos patienter, som fik Xeristar end hos dem, der fik placebo.
It also took longer for symptoms to return in patients taking Xeristar than in those taking placebo.
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.
The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Xeristar.
Det aktive stof i Xeristar, duloxetin, er en serotonin-noradrenalin genoptagelseshæmmer.
The active substance in Xeristar, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
I de to undersøgelser, hvor den godkendte dosering af Xeristar blev sammenlignet med placebo, var Xeristar mere effektivt.
In the two studies where the approved dose of Xeristar was compared with placebo, Xeristar was more effective.
Hvorfor blev Xeristar godkendt?
Why has Xeristar been approved?
Xeristar bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for duloxetin eller andre af indholdsstofferne.
Xeristar should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
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.
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.
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.
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.
Selvom resultaterne af depressionsundersøgelserne varierede, var Xeristar mere effektivt end placebo i fire af undersøgelserne.
Although the results of the depression studies varied, Xeristar was more effective than placebo in four of the studies.
Til neuropatiske smerter blev Xeristar sammenlignet med placebo i to 12-ugers undersøgelser af 809 voksne med sukkersyge.
For neuropathic pain, Xeristar has been compared with placebo in two 12-week studies in 809 diabetic adults.
Ved svær depression er den anbefalede dosis Xeristar 60 mg en gang dagligt.
For major depression, the recommended dose of Xeristar is 60 mg once a day.
Den fuldstændige liste over alle de indberettede bivirkninger ved Xeristar fremgår af indlægssedlen.
For the full list of all side effects reported with Xeristar, see the Package Leaflet.
Til behandling af diabetiske neuropatiske smerter var Xeristar bedre til at lindre smerterne end placebo.
For the treatment of diabetic neuropathic pain, Xeristar was more effective at reducing pain than placebo.
Ved svær depression blev Xeristar sammenlignet med placebo (en virkningsløs behandling) i otte hovedundersøgelser af i alt 2 544 patienter.
For major depression, Xeristar has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.