FrancophonIA/ELRC3.0 huggingface dataset:
English: Other common side effects include vomiting, diarrhoea, pyrexia (fever) and increased bilirubin (a sign of liver problems) in the blood.
Danish: Andre almindelige bivirkninger er opkastning, diarré, feber og forhøjet bilirubin (et tegn på leverproblemer) i blodet.
English: Caution is also needed when Noxafil is taken at the same time as other medicines.
Danish: Der bør også udvises forsigtighed, når Noxafil anvendes sammen med andre lægemidler.
English: In both studies, the main measure of effectiveness was the number of patients with a complete or partial response to treatment.
Danish: I begge undersøgelser blev behandlingens virkning hovedsagelig bedømt på, hvor mange patienter der reagerede helt eller delvis positivt på behandlingen.
English: Noxafil treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Danish: Behandlingen med Noxafil bør indledes af en læge med erfaring i behandling af svampeinfektioner eller i behandling af patienter med høj risiko for invasive svampeinfektioner.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Noxafil, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Noxafil, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Danish: • chromoblastermykose og mycetom (langvarige svampeinfektioner i huden eller i vævet lige under huden, sædvanligvis forårsaget af svampesporer, der inficerer sår efter torne eller splinter)
English: The active substance in Noxafil, posaconazole, is an antifungal medicine that belongs to the triazole group.
Danish: Det aktive stof i Noxafil, posaconazol, er et svampemiddel, der tilhører triazolgruppen.
English: Gastroresistant means that the tablets pass through the stomach without being broken down until they reach the intestine.
Danish: Entero betyder, at tabletterne passerer gennem maven og først nedbrydes, når de når ned i tarmen.
English: Noxafil is used to treat adults (aged 18 years or over) with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Danish: Noxafil anvendes til behandling af voksne (18 år eller derover) med nedenstående svampesygdomme, når andre svampemidler (amfotericin B, itraconazol eller fluconazol) ikke tåles eller ikke har virket:
English: It is used in patients whose infection is severe or patients with weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.
Danish: Det anvendes til patienter med svær infektion og til patienter med svækket immunsystem, når der ikke er sandsynlighed for, at lokalt anvendte lægemidler (direkte på trøsken) vil virke.
English: • cisapride (used for stomach problems),
Danish: • cisaprid (mod maveproblemer)
English: Patients given the solution for infusion should be switched to Noxafil tablets or oral suspension as soon as the patient's condition allows it.
Danish: Patienter, der behandles med infusionsvæske, opløsning, bør skifte til Noxafil-tabletter eller oral suspension, så snart patientens tilstand tillader det.
English: • pimozide (used for treating mental illness),
Danish: • pimozid (til behandling af psykiske sygdomme)
English: What is the risk associated with Noxafil?
Danish: Hvilken risiko er der forbundet med Noxafil?
English: The duration of treatment depends on the severity of the disease and the patient's response.
Danish: Behandlingens varighed afhænger af sygdommens sværhedsgrad samt patientens reaktion.
English: The Committee decided that Noxafil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Noxafil opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Noxafil.
English: The study included 107 patients with aspergillosis, 18 patients with fusariosis, 11 with chromoblastomycosis or mycetoma, and 16 with coccidioidomycosis.
Danish: Undersøgelsen omfattede 107 patienter med aspergillose, 18 patienter med fusariose, 11 med chromoblastermykose eller mycetom og 16 med coccidioidomykose.
English: The results obtained with Noxafil were compared with the records of 218 patients who were treated with other antifungal medicines.
Danish: Resultaterne af behandlingen med Noxafil blev sammenholdt med journalerne for 218 patienter, der var blevet behandlet med andre svampemidler.
English: The most common side effect with Noxafil, seen in more than one patient in 10, is nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Noxafil (som optræder hos flere end 1 ud af 10 patienter) er kvalme.
English: In oropharyngeal candidiasis, Noxafil oral suspension was as effective as fluconazole.
Danish: Ved trøske var Noxafil som oral suspension lige så effektivt som fluconazol.
English: Noxafil oral suspension is also used as a first-line treatment for ‘thrush', a fungal infection of the mouth and throat due to Candida.
Danish: Noxafil som oral suspension anvendes desuden til førstevalgsbehandling af »trøske«, som er en svampeinfektion i munden og svælget forårsaget af Candida.
English: Noxafil oral suspension and tablets have different dosages and should not be used interchangeably.
Danish: Noxafil som oral suspension og tabletter har forskellige doseringer og bør ikke anvendes i flæng.
English: In invasive aspergillosis, a successful response at the end of treatment was seen in 42% of the patients taking Noxafil oral suspension, compared with 26% of the patients in the comparator group.
Danish: Ved invasiv aspergillose var der ved behandlingens afslutning positiv reaktion hos 42 % af de patienter, der fik Noxafil som oral suspension, mod 26 % af patienterne i sammenligningsgruppen.
English: Why has Noxafil been approved?
Danish: Hvorfor blev Noxafil godkendt?
English: • halofantrine (used to treat malaria),
Danish: • halofantrin (mod malaria)
English: Noxafil tablets and solution for infusion must not be used for the treatment of thrush.
Danish: Noxafil-tabletter og infusionsvæske, opløsning, må ikke anvendes til behandling af trøske.
English: The ability to prevent infections was investigated in two additional main studies, where Noxafil oral suspension was compared with fluconazole in 600 stem cell transplant patients and with fluconazole or itraconazole in 602 patients with blood or bone marrow cancer.
Danish: Noxafils evne til at forebygge infektioner blev undersøgt i to yderligere hovedundersøgelser, hvor Noxafil som oral suspension blev sammenlignet med fluconazol hos 600 patienter, der havde fået stamcelletransplantation, og med fluconazol eller itraconazol hos 602 patienter med blod- eller knoglemarvskræft.
English: • simvastatin, lovastatin or atorvastatin (used to lower cholesterol).
Danish: • simvastatin, lovastatin og atorvastatin (kolesterolsænkende midler).
English: • ergotamine or dihydroergotamine (used to treat migraine),
Danish: • ergotamin eller dihydroergotamin (midler mod migræne)
English: • quinidine (used for irregular heart beat),
Danish: • kinidin (mod uregelmæssig hjerterytme)
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Danish: • coccidioidomykose (svampeinfektion i lungerne opstået ved indånding af sporer).
English: • fusariosis (fungal infection caused by Fusarium),
Danish: • fusariose (en svampeinfektion forårsaget af Fusarium)
English: Noxafil also successfully treated 11 of the 18 patients who had proven or probable fusariosis, 9 of the 11 patients with chromoblastomycosis or mycetoma, and 11 of the 16 patients with coccidioidomycosis.
Danish: Behandlingen med Noxafil var desuden vellykket hos 11 ud af 18 patienter med påvist eller formodet fusariose, hos 9 ud af 11 patienter med chromoblastermykose eller mycetom og hos 11 ud af 16 patienter med coccidioidomykose.
English: Noxafil oral suspension, solution for infusion and gastro-resistant tablets are also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a transplant of cells that make blood cells).
Danish: Noxafil som oral suspension, infusionsvæske, opløsning, og enterotabletter kan anvendes til forebyggelse af invasive svampeinfektioner hos patienter med svækket immunsystem, som skyldes en behandling af blodkræft eller knoglemarvskræft eller lægemidler, der anvendes ved hæmatopoietisk stamcelletransplantation (en transplantation af bloddannende stamceller).
English: • invasive aspergillosis (fungal infection caused by Aspergillus),
Danish: • invasiv aspergillose (en svampeinfektion forårsaget af Aspergillus)
English: • Noxafil tablets can be taken with or without food and should be swallowed whole with water; the tablets should not be crushed, chewed, broken or dissolved.
Danish: • Noxafil-tabletterne kan tages med eller uden mad og bør synkes hele sammen med vand.
English: For the full list of all side effects reported with Noxafil, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Noxafil fremgår af indlægssedlen.
English: In the prevention studies, Noxafil oral suspension was as effective as fluconazole in stem cell transplant patients, with 5% of patients developing an infection in the Noxafil group, and 9% in the comparator group.
Danish: I undersøgelserne af forebyggende anvendelse var Noxafil som oral suspension lige så effektivt som fluconazol hos stamcelletransplanterede patienter, hvor der opstod infektion hos 5 % af patienterne i Noxafil-gruppen og 9 % i sammenligningsgruppen.
English: What is Noxafil?
Danish: Hvad er Noxafil?
English: The list of fungi against which Noxafil is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: En liste over de svampearter, som Noxafil virker mod, fremgår af produktresuméet, der også er en del af denne EPAR.
English: • terfenadine, astemizole (used for allergy),
Danish: • terfenadin eller astemizol (midler mod allergi)
English: The CHMP concluded that, although the first study compared Noxafil with records of patients who were actually enrolled in that study, the effectiveness of Noxafil was shown.
Danish: CHMP konkluderede, at virkningen af Noxafil var påvist, selv om lægemidlet i den første undersøgelse blev sammenlignet med journaler for patienter, som allerede deltog i undersøgelsen.
English: For the treatment of fungal infections, with the exception of oral candidiasis, Noxafil oral suspension is taken at a dose of 400 mg (10 ml) twice a day, or 200 mg (5 ml) four times a day in patients who cannot tolerate a meal.
Danish: Til behandling af svampeinfektioner, med undtagelse af trøske, tages Noxafil som oral suspension i en dosis på 400 mg (10 ml) to gange dagligt eller 200 mg (5 ml) fire gange dagligt til patienter, der ikke kan indtage mad.
English: For the prevention of invasive fungal infections, Noxafil oral suspension is given at a dose of 200 mg (5 ml) three times a day.
Danish: Til forebyggelse af invasive svampeinfektioner gives Noxafil som oral suspension i en dosis på 200 mg (5 ml) tre gange dagligt.
English: In one main study, Noxafil oral suspension was studied in 238 patients with invasive fungal infections that did not respond to standard antifungal treatment.
Danish: Noxafil som oral suspension blev undersøgt i en hovedundersøgelse med 238 patienter med invasiv svampeinfektion, hvor sædvanlige svampemidler ikke virkede.
English: The medicine was more effective than fluconazole or itraconazole in cancer patients, with 2% of patients developing an infection in the Noxafil group, and 8% in the comparator groups.
Danish: Hos kræftpatienter var Noxafil mere effektivt end fluconazol eller itraconazol, idet der opstod infektion hos 2 % af patienterne i Noxafil-gruppen og 8 % i sammenligningsgruppen.
English: For oral candidiasis, Noxafil oral suspension is taken as 200 mg (5 ml) on the first day followed by 100 mg (2.5 ml) once a day for the following 13 days.
Danish: Til behandling af trøske gives Noxafil som oral suspension i en dosis på 200 mg (5 ml) den første dag, efterfulgt af 100 mg (2,5 ml) én gang dagligt de efterfølgende 13 dage.
English: For the treatment and prevention of fungal infections, the recommended dose of Noxafil tablets or Noxafil solution for infusion is 300 mg twice a day on the first day followed by 300 mg once a day thereafter; the duration of treatment depends on the severity of the disease and the patient's response.
Danish: Til behandling og forebyggelse af svampeinfektioner er den anbefalede dosis af Noxafil-tabletterne eller Noxafil-infusionsvæsken, opløsning, 300 mg to gange dagligt den første dag, efterfulgt af 300 mg én gang dagligt derefter.
English: In another main study involving 350 HIV-infected patients with oropharyngeal candidiasis, Noxafil oral suspension was compared with fluconazole.
Danish: 350 hivsmittede patienter med trøske blev Noxafil som oral suspension sammenlignet med fluconazol.
English: What is Noxafil used for?
Danish: Hvad anvendes Noxafil til?
English: How has Noxafil been studied?
Danish: Hvordan blev Noxafil undersøgt?
English: What benefit has Noxafil shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Noxafil?
English: • Noxafil oral suspension is taken with a meal or nutritional supplement; the suspension must be shaken well before use.
Danish: • Noxafil som oral suspension tages sammen med et måltid eller et kosttilskud.
English: Noxafil is an antifungal medicine that contains the active substance posaconazole; it is available as an oral suspension (40 mg/ml), a concentrate (300 mg) for solution for infusion (drip) into a vein and as gastroresistant tablets (100 mg).
Danish: Det fås som en oral suspension (40 mg/ml), et koncentrat (300 mg) til infusionsvæske, opløsning, (drop i en vene) og som enterotabletter (100 mg).
English: How is Noxafil used?
Danish: Hvordan anvendes Noxafil?
English: For additional information, see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: How does Noxafil work?
Danish: Hvordan virker Noxafil?
English: This summary was last updated in November 2011.
Danish: Dette sammendrag blev sidst ajourført i november 2011.
English: Presentations of Flexicam oral suspension were subsequently not renewed.
Danish: Markedsføringstilladelsen for Flexicam oral suspension blev efterfølgende ikke fornyet.
English: These side effects occur usually within the first week of treatment and are generally temporary.
Danish: Disse bivirkninger opstår som regel inden for den første uge af behandlingen og er generelt forbigående og forsvinder ved behandlingens ophør.
English: Flexicam has been investigated in comparison with Metacam which is already authorised in the EU.
Danish: Flexicam er blevet undersøgt og sammenlignet med Metacam, som allerede er tilladt i EU.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Danish: Benefit/riskforholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: Why has Flexicam been approved?
Danish: Hvorfor blev Flexicam godkendt?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Flexicam on 10 April 2006 and an extension to Flexicam 5mg/ml solution for injection on 9 December 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Flexicam den 10. april 2006 og bevilligede en udvidelse af tilladelsen til Flexicam injektionsvæske, opløsning, 5mg/ml den 9. december 2008.
English: What are the precautions for the person who gives the medicine or comes
Danish: Hvilke forholdsregler skal der træffes af den, der indgiver lægemidlet eller
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den videnskabelige
English: What is Flexicam used for?
Danish: Hvad anvendes Flexicam til?
English: Flexicam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Flexicam indeholder meloxicam, der tilhører en klasse af lægemidler, som kaldes non-steroide antiinflammatoriske lægemidler (NSAID).
English: An oral follow-up therapy using meloxicam or other NSAIDs should not be used in cats, as no safe dosage for repeated oral administration has been established.
Danish: Der må ikke anvendes en oral opfølgningsbehandling med meloxicam eller andre NSAID'er til katte, da der ikke er fastsat nogen dosis, som er sikker til brug ved gentagen indgivelse.
English: A study looked at how Flexicam was absorbed and its effects in the body, in comparison with Metacam
Danish: En undersøgelse så på, hvordan Flexicam blev optaget i kroppen og på dets virkninger i kroppen i forhold
English: Flexicam should not be administered to pregnant or lactating animals as the safety of the product has not been established in these cases.
Danish: Flexicam må ikke gives til drægtige eller lakterende dyr, da det ikke er fastslået, at lægemidlet er sikkert i disse tilfælde.
English: Flexicam was presented as a pale green oral suspension (1.5mg/ml) for dogs (to be given mixed with food) and a yellow solution for injection (5mg/ml) for dogs and cats.
Danish: Flexicam leveredes som en lysegrøn oral suspension (1,5 mg/ml) til hunde (gives opblandet i foder) og som en gul injektionsvæske, opløsning (5mg/ml) til hunde eller katte.
English: Occasional side effects of Flexicam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Danish: De bivirkninger, der undertiden ses ved Flexicam, er dem der normalt ses ved NSAID'er, såsom appetitløshed, opkastning, diarré, blod i afføringen og apati (mangel på vitalitet).
English: As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam
Danish: Da prostaglandinerne er de stoffer, der udløser inflammation, smerte, væskeudskillelse og feber, mindsker
English: Flexicam should also not be used in animals suffering from gastrointestinal or hemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than 6 weeks of age or in cats of less than 2 kg.
Danish: Flexicam må ikke gives til dyr, som lider af gastrointestinale eller blødningsmæssige forstyrrelser, eller som har nedsat nyre- eller leverfunktion, dyr med kendt overfølsomhed over for NSAID'er eller dyr, som er under 6 uger gamle, eller katte på under 2 kg.
English: Flexicam contains meloxicam which belongs to a class of medicines having anti-inflammatory action.
Danish: Flexicam indeholder meloxicam, som tilhører gruppen af lægemidler med antiinflammatorisk virkning.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Flexicam has been shown to be bioequivalent to Metacam 1.5 mg/ml oral suspension.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at Flexicam i henhold til EU-kravene er påvist at være bioækvivalent med Metacam, oral suspension, 1,5 mg/ml.
English: Studies have been carried out to prove that Flexicam is ‘bioequivalent' to the reference veterinary medicine: this means that Flexicam is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.
Danish: De udførte undersøgelser viser, at Flexicam er "bioækvivalent" med det veterinære referencelægemiddel: Det vil sige at Flexicam svarer til Metacam, suspension, 1,5 mg/ml, med hensyn til den måde, det optages og udnyttes på i kroppen.
English: Flexicam is a ‘generic': this means that Flexicam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam 1.5 mg/ml oral suspension).
Danish: Flexicam er et "generisk" lægemiddel, dvs. det svarer til et "veterinært referencelægemiddel", der i forvejen er godkendt i EU (Metacam, oral suspension, 1,5 mg/ml).
English: What benefit has Flexicam shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Flexicam?
English: Cats: Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Danish: Katte: Begrænsning af postoperative smerter efter ovariehysterektomi og mindre bløddelskirurgi hos katte.
English: The CVMP concluded that the benefits of Flexicam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders, reduction of postoperative pain and inflammation following orthopaedic and soft tissue surgery in dogs and reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats and recommended that Flexicam be given a marketing authorisation.
Danish: CVMP fandt derfor, at fordelene ved Flexicam opvejer risiciene ved lindring af inflammation og smerter ved både akutte og kroniske lidelser i bevægeapparatet og ved begrænsning af postoperative smerter og inflammation efter ortopædiske operationer og bløddelskirurgi hos hunde og ved begrænsning af postoperative smerter efter ovariehysterektomi og mindre bløddelskirurgi hos katte.
English: Dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders and reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Danish: Hunde: Lindring af inflammation og smerter ved både akutte og kroniske lidelser i bevægeapparatet og ved begrænsning af postoperative smerter og inflammation efter ortopædiske operationer og bløddelskirurgi.
English: Flexicam is efficacious in alleviating the inflammation and pain in both acute and chronic musculoskeletal disorders and reducing the post operative pain following orthopaedic and soft tissue surgery in dogs and in reducing the post-operative pain after ovariohysterectomy and minor soft tissue surgery in
Danish: Flexicam er effektivt til lindring af inflammation og smerter ved både akutte og kroniske lidelser i bevægeapparatet og til begrænsning af postoperative smerter efter ortopædiske operationer og bløddelskirurgi hos hunde og til begrænsning af postoperative smerter efter ovariehysterektomi og
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Danish: Heri forklares, hvordan agenturet vurderede lægemidlet for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks.
Danish: Dette reducerer normalt blodets indhold af urinsyre inden for to uger, men dosen kan øges til 120 mg én gang dagligt, hvis blodets indhold af urinsyre forbliver højt (over 6 mg pr. deciliter) efter to til fire uger.
English: This is a summary of the European public assessment report (EPAR) for Febuxostat Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Febuxostat Mylan.
English: The Committee recommended that Febuxostat Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Febuxostat Mylan godkendes til anvendelse i EU.
English: As for every medicine, the company provided studies on the quality of Febuxostat Mylan.
Danish: Som for alle lægemidler, fremlagde virksomheden undersøgelser af kvaliteten af Febuxostat Mylan.