FrancophonIA/ELRC3.0 huggingface dataset:
English: After 14 days of treatment, both medicines had been successful in curing or improving about 92% of patients.
Danish: Efter 14 dages behandling opnåedes helbredelse eller bedring hos ca. 92 % af patienterne.
English: The oral suspension must be shaken
Danish: Den orale suspension skal omrystes grundigt inden brug.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Posaconazole SP to SP Europe on 25 October 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Posaconazole SP til SP Europe den 25. oktober 2005.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
English: The duration of treatment depends on the severity of the disease and the patient's response.
Danish: Behandlingens varighed afhænger af sygdommens sværhedsgrad og patientens reaktion på behandlingen.
English: In all studies, the main measure of effectiveness was the number of patients with a complete or partial response to treatment.
Danish: I alle undersøgelserne blev behandlingens virkning hovedsagelig bedømt på, hvor mange patienter der reagerede helt eller delvis positivt på behandlingen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Danish: Formålet er at forklare, hvordan Udvalget for Humanmedicinske Lægemidlers (CHMP) vurdering af de gennemførte undersøgelser førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
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 fra torne eller splinter),
English: Other common side effects (seen in between 1 and 10 patients in 100) are neutropenia (low white blood cell count), electrolyte imbalance, anorexia (lack of appetite), dizziness, paresthesia (pins and needles), somnolence (sleepiness), vomiting, abdominal (tummy) pain, diarrhoea, dyspepsia (indigestion), dry mouth, flatulence (gas), signs of liver damage in the blood, rash, asthenia (weakness), fatigue (tiredness) and pyrexia (fever).
Danish: Andre almindelige bivirkninger (ses hos mellem 1 og 10 patienter ud af 100) er et for lavt antal hvide blodlegemer (neutropeni), forstyrrelser i elektrolytbalancen, appetitløshed (anoreksi), svimmelhed, prikken og stikken (paræstesi), søvnighed, opkast, mavesmerter, diarré, dyspepsi (fordøjelsesbesvær), mundtørhed, luft i maven (flatulens), tegn på leverskader i blodet, udslæt, kraftesløshed, træthed og feber (pyreksi).
English: Posaconazole SP is an oral suspension that contains the active substance posaconazole (40 mg/ml).
Danish: Posaconazole SP er en oral suspension, der indeholder det aktive stof posaconazol (40 mg/ml).
English: • Pimozide (used for treating mental illness),
Danish: • pimozid (til behandling af psykiske sygdomme),
English: The effectiveness was measured by looking at how many patients developed an invasive fungal infection, either proven or probable, during the studies.
Danish: Virkningen blev bedømt på, hvor mange patienter, der fik en invasiv svampeinfektion i løbet af undersøgelserne, uanset om infektionen var påvist eller formodet.
English: • Cisapride (used for stomach problems),
Danish: • cisaprid (mod maveproblemer),
English: It is used to treat patients with the following diseases, when they cannot tolerate other antifungal medicines (amphotericin B, itraconazole or fluconazole) or have not improved after at least 7 days of treatment with other antifungal medicines:
Danish: Det anvendes til behandling af patienter med følgende sygdomme, når andre svampemidler (amfotericin B, itraconazol eller fluconazol) ikke tåles eller ikke har fremkaldt bedring efter mindst 7 dages behandling:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) POSACONAZOLE SP EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) POSACONAZOLE SP EPAR - sammendrag for offentligheden
English: Caution is also needed when Posaconazole SP is taken at the same time as other medicines.
Danish: Der bør også udvises forsigtighed, når Posaconazole SP anvendes sammen med andre lægemidler.
English: • fusariosis (another type of fungal infection due to Fusarium),
Danish: • fusariose (en anden type svampeinfektion forårsaget af Fusarium),
English: The study included 107 patients with aspergillosis, 18 patients with fusariosis, 11 with chromoblastomycosis or mycotema, 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: • Halofantrine (used to treat malaria),
Danish: • halofantrin (mod malaria),
English: Posaconazole SP is given with a meal or nutritional supplement.
Danish: Posaconazole SP gives sammen med et måltid eller med kosttilskud.
English: • Simvastatin, lovastatin or atorvastatin (used to lower cholesterol).
Danish: • simvastatin, lovastatin og atorvastatin (kolesterolsænkende midler).
English: Posaconazole SP should not be used in patients who are taking any of the following drugs:
Danish: Posaconazole SP bør ikke anvendes hos patienter, der får nogen af nedenstående lægemidler:
English: The Committee decided that Posaconazole SP's benefits are greater than its risks for treatment of invasive aspergillosis, fusariosis, coccidioidomycosis, chromoblastomycosis and mycetoma in patients who cannot tolerate other antifungal drugs or have not improved after at least 7 days of treatment.
Danish: Udvalget fandt, at fordelene ved Posaconazole SP er større end risiciene ved behandling af invasiv aspergillose, fusariose, coccidioidomykose, chromoblastermykose og mycetom hos patienter, der ikke tåler andre svampemidler, eller hos hvem der ikke er indtrådt bedring efter 7 dages behandling.
English: • Ergotamine or dihydroergotamine (used to treat migraine),
Danish: • ergotamin eller dihydroergotamin (midler mod migræne),
English: Posaconazole SP should not be used in people who may be hypersensitive (allergic) to posaconazole or any of the other ingredients.
Danish: Posaconazole SP bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for posaconazol eller andre af indholdsstofferne.
English: Other information about Posaconazole SP:
Danish: Andre oplysninger om Posaconazole SP:
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Danish: • coccidioidomykose (svampeinfektion i lungerne, opstået ved indånding af sporer).
English: • Quinidine (used for irregular heart beat),
Danish: • kinidin (mod uregelmæssig hjerterytme),
English: The results obtained with Posaconazole SP were compared with the records of 218 patients who were treated with other antifungal medicines.
Danish: Resultaterne af behandlingen med Posaconazole SP blev sammenholdt med journalerne for 218 patienter, der var blevet behandlet med andre svampemidler.
English: Posaconazole SP treatment should be started by a doctor who has experience in the management of fungal infections or of treating patients at high risk of invasive fungal infections.
Danish: Behandlingen med Posaconazole SP bør indledes af en læge med erfaring i behandling af svampeinfektioner eller i behandling af patienter med høj risiko for invasive svampeinfektioner.
English: In invasive aspergillosis, a successful response at the end of treatment was seen in 42% of the patients taking Posaconazole SP, compared with 26% of the comparison group.
Danish: Ved invasiv aspergillose var der ved behandlingens afslutning positiv reaktion hos 42 % af de patienter, der fik Posaconazole SP, mod 26 % i sammenligningsgruppen.
English: • invasive aspergillosis (a type of fungal infection due to Aspergillus),
Danish: • invasiv aspergillose (en type svampeinfektion forårsaget af Aspergillus),
English: This can be either because they have cancer in the blood or bone marrow and have received chemotherapy, or because they have had a haematopoietic stem cell transplant (a transplant of cells that make blood cells) and are receiving high doses of immunosuppressant medicines.
Danish: Det nedsatte immunforsvar kan enten skyldes, at patienten har blodkræft eller knoglemarvskræft og har fået kemoterapi, eller at patienten har fået en transplantation af bloddannende stamceller (hæmatopoietisk stamcelletransplantation) og får høje doser af immundæmpende medicin.
English: The Committee for Medicinal products for Human Use (CHMP) concluded that, although the main study lacked a control group, the effectiveness of Posaconazole SP in fungal infections refractory to other antifungal medicines had been shown.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Posaconazole SP − selv om der ikke var nogen kontrolgruppe i hovedundersøgelsen − er påvist at være effektivt til behandling af svampeinfektioner, hvor andre svampemidler ikke virker.
English: Posaconazole SP also successfully treated 11 of 24 patients who had proven or probable fusariosis, 9 of 11 patients with chromoblastomycosis or mycetoma, and 11 of 16 patients with coccidioidomycosis.
Danish: Behandlingen med Posaconazole SP var desuden vellykket hos 11 ud af 24 patienter med påvist eller formodet fusariose, 9 ud af 11 patienter med chromoblastermykose eller mycetom, og 11 ud af 16 patienter med coccidioidomykose.
English: For candidiasis, Posaconazole SP is given 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 Posaconazole SP i en dosis på 200 mg (5 ml) den første dag, efterfulgt af 100 mg (2,5 ml) en gang dagligt de følgende 13 dage.
English: • Terfenadine, astemizole (used for allergy),
Danish: • terfenadin eller astemizol (midler mod allergi),
English: In the treatment of fungal infections except candidiasis, Posaconazole SP is given 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 bortset fra trøske gives Posaconazole SP 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: Posaconazole SP is also used to treat patients with oropharyngeal candidiasis or ‘thrush', a fungal infection of the mouth and throat due to Candida.
Danish: Posaconazole SP anvendes desuden til behandling af patienter med "trøske" (oropharyngeal candidiasis), som er en svampeinfektion i munden og svælget forårsaget af Candida.
English: In oropharyngeal candidiasis, Posaconazole SP was as effective as fluconazole.
Danish: Ved trøske var Posaconazole SP lige så effektivt som fluconazol.
English: The active substance in Posaconazole SP, posaconazole, is an antifungal medicine that belongs to the triazoles group.
Danish: Det aktive stof i Posaconazole SP, posaconazol, er et svampemiddel i triazolgruppen.
English: In the prevention of invasive fungal infections, Posaconazole SP is given as 200 mg (5 ml) three times a day.
Danish: Til forebyggelse af invasive svampeinfektioner gives Posaconazole SP i en dosis på 200 mg (5 ml) tre gange dagligt.
English: Posaconazole SP can be used to prevent invasive fungal infections in patients whose immune system is weakened.
Danish: Posaconazole SP kan anvendes til forebyggelse af invasive svampeinfektioner hos patienter med svækket immunsystem.
English: It also decided that Posaconazole SP's effectiveness had been shown as first-line therapy in oropharyngeal candidiasis and in the prophylaxis of invasive fungal infections in patients receiving chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS), and haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease.
Danish: Virkningen af Posaconazole SP som førstevalgsbehandling til trøske og til forebyggelse af invasive svampeinfektioner blev desuden fundet at være bevist hos patienter, der får kemoterapi for akut myelogen leukæmi (AML) eller myelodysplastisk syndrom (MDS) samt til modtagere af hæmatopoietisk stamcelletransplantation (HSCT), der får høje doser af immundæmpende medicin for at modvirke transplantat-mod-vært-reaktion.
English: In the prevention of invasive fungal infections, the effectiveness of Posaconazole SP has been studied in 600 stem cell transplant patients with fluconazole as a comparator and 602 patients with blood or bone marrow cancer, comparing it to fluconazole or itraconazole.
Danish: Til forebyggelse af invasive svampeinfektioner blev virkningen af Posaconazole SP undersøgt hos 600 patienter, der havde fået stamcelletransplantation, hvor sammenligningsstoffet var fluconazol, og hos 602 patienter med blod- eller knoglemarvskræft, hvor sammenligningsstoffet var fluconazol eller itraconazol.
English: In the prevention studies, Posaconazole SP was as effective as fluconazole in stem cell transplant patients, with 5% of patients developing an infection in the Posaconazole SP group, and 9% in the comparator group.
Danish: I undersøgelserne af forebyggende anvendelse var Posaconazole SP lige så effektivt som fluconazol hos stamcelletransplanterede patienter, hvor infektion opstod hos 5 % af patienterne i Posaconazole SP-gruppen og 9 % i sammenligningsgruppen.
English: Posaconazole SP has also been studied in 350 HIV-infected patients with oropharyngeal candidiasis, where its effectiveness was compared with that of fluconazole.
Danish: Posaconazole SP blev desuden undersøgt hos 350 hiv-smittede patienter med trøske, og virkningen blev sammenlignet med virkningen af fluconazol.
English: Posaconazole SP is an antifungal medicine.
Danish: Posaconazole SP er et middel mod svamp.
English: What is the risk associated with Posaconazole SP?
Danish: Hvilken risiko er der forbundet med Posaconazole SP?
English: Posaconazole SP was studied in 238 patients with invasive fungal infections that did not respond to standard antifungal treatment.
Danish: Posaconazole SP blev undersøgt hos 238 patienter med invasiv svampeinfektion, hvor sædvanlige svampemidler ikke virkede.
English: The list of fungi against which Posaconazole SP is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Danish: En liste over de svampearter, som Posaconazole SP virker mod, fremgår af produktresuméet, der også er en del af denne EPAR.
English: They recommended that Posaconazole SP be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Posaconazole SP.
English: For the full list of all side effects reported with Posaconazole SP, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Posaconazole SP fremgår af indlægssedlen.
English: Why has Posaconazole SP been approved?
Danish: Hvorfor er Posaconazole SP blevet godkendt?
English: The medicine was more effective than fluconazole or itraconazole in cancer patients, with 2% of patients developing an infection in the Posaconazole SP group, and 8% in the comparator group.
Danish: Hos kræftpatienter var Posaconazole SP mere effektivt end fluconazol og itraconazol, idet infektion opstod hos 2 % af patienterne i Posaconazole SP-gruppen og 8 % i sammenligningsgruppen.
English: The full EPAR for Posaconazole SP is available here.
Danish: Den Europæiske Offentlige Vurderingsrapport (EPAR) for Posaconazole SP kan ses i sin helhed her.
English: What is Posaconazole SP?
Danish: Hvad er Posaconazole SP?
English: Posaconazole SP is used if the disease is severe, or if the patient is immunocompromised (with a weakened immune system).
Danish: Posaconazole SP anvendes ved svær sygdom og hos patienter med nedsat immunforsvar.
English: How has Posaconazole SP been studied?
Danish: Hvordan blev Posaconazole SP undersøgt?
English: What is Posaconazole SP used for?
Danish: Hvad anvendes Posaconazole SP til?
English: How does Posaconazole SP work?
Danish: Hvordan virker Posaconazole SP?
English: What benefit has Posaconazole SP shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Posaconazole SP?
English: How is Posaconazole SP used?
Danish: Hvordan anvendes Posaconazole SP?
English: Page 2/2©EMEA 2007
Danish: Side 2/2©EMEA 2007
English: The marketing authorisation was renewed on 25 September 2007.
Danish: Markedsføringstilladelsen blev fornyet den 25. september 2007.
English: This makes it suitable for use in a vaccine.
Danish: Dette gør den egnet til brug i en vaccine.
English: This summary was last updated on 25 September 2007.
Danish: Dette sammendrag blev sidst opdateret den 25. september 2007.
English: Immunity against infection is usually established after around three days and lasts for up to a year.
Danish: Immuniteten imod infektion indtræder normalt efter cirka tre dage og varer i op til et år.
English: The vaccine may be administered by veterinarians only.
Danish: Vaccinen må kun gives af dyrlæger.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner virker ved, at de ‘lærer' immunsystemet (kroppens naturlige forsvarssystem), hvordan det skal forsvare sig selv imod sygdomme.
English: In animals that show more severe signs, treatment with an antibiotic may be necessary.
Danish: Hvis et dyr udviser mere alvorlige symptomer, kan det være nødvendigt at give antibiotisk behandling.
English: Occasional side effects include sneezing, coughing and a mild and temporary discharge from the eyes or nose.
Danish: Lejlighedsvise bivirkninger omfatter nysen, hoste samt let og forbigående flåd fra øjne eller næse.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelserne for lægemidlet findes på etiketten/den ydre emballage.
English: Cats are vaccinated by giving a 0.2-ml dose into one nostril.
Danish: Kattene vaccineres med en 0,2 ml dosis ind i det ene næsebor.
English: Nobivac Bb is a vaccine.
Danish: Nobivac Bb er en vaccine.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBIVAC BB EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NOBIVAC BB EPAR - sammendrag for offentligheden
English: In case of accidental administration to people seek medical advice immediately and show the Package Leaflet or label to the doctor.
Danish: I tilfælde af, at vaccinen ved et hændeligt uheld indgives til mennesker, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidler (CVMP) vurderede den forelagte dokumentation og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Bb exceed the risks of its use.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Nobivac Bb er større end risiciene.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Bb to Intervet International B.V. on 10 September 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobivac Bb til Intervet International B.V.
English: Vaccines against B. bronchiseptica that are administered through the nose are also used in dogs.
Danish: Vacciner imod B. bronchiseptica, der gives gennem næsen, anvendes også til hunde.
English: The live bacterium strain included in Nobivac Bb differs from other types of B. bronchiseptica because it is missing certain molecules and is therefore less likely to cause disease.
Danish: Den levende bakteriestamme i Nobivac Bb er forskellig fra andre typer B. bronchiseptica, fordi den mangler visse molekyler og derfor mindre sandsynligt vil forårsage sygdommen.
English: Other information about Nobivac Bb:
Danish: Andre oplysninger om Nobivac Bb:
English: The main studies showed that Nobivac Bb was effective in reducing the symptoms caused by B. bronchiseptica.
Danish: Hovedundersøgelserne viste, at Nobivac Bb var effektivt til at reducere symptomer, der var forårsaget af B. bronchiseptica.
English: Although the risk for people with weak immune systems becoming infected with B. bronchiseptica is extremely low, it is advised that cats which are in close contact with such people are not vaccinated with Nobivac Bb, since they can shed the bacteria intermittently for up to a year after vaccination.
Danish: Selv om der kun er en meget lille risiko for, at mennesker med dårligt immunsystem bliver smittet med B. bronchiseptica, frarådes det, at katte, der er i kontakt med sådanne mennesker, vaccineres med Nobivac Bb, da de med mellemrum kan sprede bakterierne i op til et år efter vaccinationen.
English: The effectiveness of Nobivac Bb was investigated in three main studies involving cats of various breeds.
Danish: Virkningerne af Nobivac Bb blev afprøvet i tre hovedundersøgelser med katte af forskellige racer.
English: Nobivac Bb is a dry substance and solvent that are made up into a suspension, which is given via the nose.
Danish: Nobivac Bb er en frysetørret vaccine og solvens, der opblandes til en suspension og gives gennem næsen.
English: Nobivac Bb was the first live B. bronchiseptica vaccine licensed for use in cats.
Danish: Nobivac Bb var den første levende B. bronchiseptica vaccine, der blev godkendt til brug til katte.
English: Nobivac Bb is used to vaccinate cats aged one month or older against the disease (a flu-like illness) caused by the bacterium B. bronchiseptica.
Danish: Nobivac Bb anvendes til vaccination af katte i alderen én måned eller ældre mod den sygdom (en influenzalignende sygdom), der forårsages af bakterien Bordetella bronchiseptica.
English: When a cat is given the vaccine, the immune system recognises the bacteria as ‘foreign' and makes a special type of antibodies against them.
Danish: Når en kat får vaccinen, genkender immunsystemet bakterierne som ‘fremmede' og danner en særlig type anstistoffer imod dem. I fremtiden vil immunsystemet være i stand til at producere disse antistoffer hurtigere, når det igen udsættes for bakterierne.
English: The cats were vaccinated with Nobivac Bb before being challenged by being exposed to wild-type B. bronchiseptica.
Danish: Kattene blev vaccineret med Nobivac Bb, inden de med vilje blev udsat for en ”vildtype” B. bronchiseptica.
English: Nobivac Bb contains a type of live B. bronchiseptica called strain B-C2.
Danish: Nobivac Bb indeholder en type levende B. bronchiseptica, der kaldes stamme B-C2.
English: What is the risk associated with Nobivac Bb?
Danish: Hvilken risiko er der forbundet med Nobivac Bb?
English: Nobivac Bb is a vaccine that contains a live bacterium Bordetella bronchiseptica strain B-C2.
Danish: Nobivac Bb er en vaccine, der indeholder en levende Bordetella bronchiseptica bakteriestamme B-C2.
English: Why has Nobivac Bb been approved?
Danish: Hvorfor blev Nobivac Bb godkendt?
English: What is Nobivac Bb?
Danish: Hvad er Nobivac Bb?
English: How has Nobivac Bb been studied?
Danish: Hvordan blev Nobivac Bb undersøgt?
English: What is Nobivac Bb used for?
Danish: Hvad anvendes Nobivac Bb til?
English: How does Nobivac Bb work?
Danish: Hvordan virker Nobivac Bb?
English: What benefit has Nobivac Bb shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobivac Bb?
English: This summary was last updated in December 2006.
Danish: Dette sammendrag blev sidst ajourført i december 2006.