FrancophonIA/ELRC3.0 huggingface dataset:
English: Hands and exposed skin should be washed after using Fungitraxx.
Danish: Hænder og udsat hud skal vaskes efter anvendelse af Fungitraxx.
English: It is given by mouth at a dose of 5 to 10 mg itraconazole per kg bodyweight each day for 8 weeks for aspergillosis, and 10 mg per kg daily for 2 weeks for candidiasis.
Danish: Det indgives gennem munden i en dosis på 5-10 mg itraconazol/kg kropsvægt dagligt i 8 uger ved aspergillose, og 10 mg/kg dagligt i 2 uger ved candidiasis.
English: Fungitraxx must not be used in birds intended for human consumption.
Danish: Fungitraxx må ikke anvendes hos fugle, der er bestemt til menneskeligt konsum.
English: If suspected signs of disease (such as lumps or red pimples on the skin, or symptoms such as coughing or wheezing) appear in people a doctor should be consulted.
Danish: Hvis personer får tegn på sygdommen (såsom knopper eller filipenser på hovedet eller symptomer som hoste eller hvæsende vejrtrækning), bør der søges læge.
English: Some fungal infections of birds can also infect humans.
Danish: Visse svampeinfektioner hos fugle kan overføres fra dyr til mennesker.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Fungitraxx exceed the risks for the approved indications and recommended that Fungitraxx be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) besluttede, at fordelene ved Fungitraxx opvejer risiciene til de godkendte anvendelser, og anbefalede udstedelse af en markedsføringstilladelse for Fungitraxx.
English: In the case of accidental ingestion the mouth should be rinsed, medical advice sought immediately and the package leaflet or label shown to the doctor.
Danish: Ved utilsigtet indtagelse skal munden skylles, der skal straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: It is available as a solution to be given by mouth.
Danish: Det leveres som en opløsning til indgift gennem munden.
English: By blocking production of this compound, itraconazole leads to the breakdown of the fungal cells, killing the fungus or preventing it from spreading.
Danish: Ved at blokere for produktionen af dette stof bevirker itraconazol, at svampecellerne nedbrydes, så svampen dør eller er ude af stand til at spredes.
English: The field study showed that Fungitraxx is effective in treating aspergillosis (with 56 out of 62 birds successfully treated) and candidiasis (with all birds successfully treated).
Danish: Feltundersøgelsen viste, at Fungitraxx var effektivt til behandling af aspergillose (med vellykket behandling af 56 ud af 62 fugle) og candidiasis (med vellykket behandling af samtlige fugle).
English: When handling birds infected with aspergillosis, latex gloves and a mask should be worn to prevent the disease being transmitted to the handler.
Danish: Ved håndtering af fugle, der er smittet med aspergillose, bør der anvendes latexhandsker og maske for at undgå at blive smittet med sygdommen.
English: It works by blocking the production of a compound in the fungus called ergosterol which is an important part of fungal cell membranes.
Danish: Det virker ved at blokere for dannelsen af ergosterol, der er en vigtig komponent i svampecellernes cellemembran.
English: The measure of effectiveness was disappearance of sleepiness, reduced appetite and loss of bodyweight and disappearance of aspergillosis or candidiasis.
Danish: Virkningen blev bedømt på fravær af søvnighed, nedsat appetit og vægttab samt fravær af aspergillose eller candidiasis.
English: Fungitraxx is a veterinary medicine that contains the active substance itraconazole.
Danish: Fungitraxx er et lægemiddel til dyr indeholdende det aktive stof itraconazol.
English: A field study was performed with 62 birds with aspergillosis (cockatoos, parrots, parakeets, budgerigars, falcons, hawks, owls and swans) and 18 birds with candidiasis (cockatoos, parrots, parakeets and budgerigars).
Danish: Der er udført en feltundersøgelse med 62 fugle med aspergillose (nymfeparakitter, papegøjer, parakitter, undulater, falke, høge, ugler og svaner) samt 18 fugle med candidiasis (nymfeparakitter, papegøjer, parakitter og undulater).
English: For aspergillosis, birds were included if the presence of Aspergillus fungi in air sacs was confirmed and, for candidiasis, birds were included if clinical signs of candidiasis were present and infection was confirmed.
Danish: For aspergillose omfattede undersøgelsen fugle, hvor det var bekræftet, at der fandtes Aspergillus-svampe i lungeblæresækkene, og for candidiasis omfattede undersøgelsen fugle, som viste kliniske tegn på candidiasis, og hvor smitten var bekræftet.
English: It can be used to treat aspergillosis in cockatoos, parrots, parakeets, budgerigars, falcons, hawks, owls and swans, and also to treat candidiasis in cockatoos, parrots, parakeets and budgerigars.
Danish: Det kan anvendes til behandling af aspergillose hos nymfeparakitter, papegøjer, parakitter, undulater, falke, høge, ugler og svaner, og til behandling af candidiasis hos nymfeparakitter, papegøjer, parakitter og undulater.
English: Fungitraxx is used to treat ornamental birds with two types of fungal infections of the respiratory tract (aspergillosis and candidiasis).
Danish: Fungitraxx anvendes til behandling af prydfugle med to typer svampeinfektioner i luftvejene (aspergillose og candidiasis).
English: Other information about Fungitraxx:
Danish: Andre oplysninger om Fungitraxx:
English: What is the risk associated with Fungitraxx?
Danish: Hvilken risiko er der forbundet med Fungitraxx?
English: Itraconazole
Danish: Fungitraxx itraconazol
English: Why has Fungitraxx been approved?
Danish: Hvorfor blev Fungitraxx godkendt?
English: What is Fungitraxx?
Danish: Hvad er Fungitraxx?
English: How has Fungitraxx been studied?
Danish: Hvordan blev Fungitraxx undersøgt?
English: What is Fungitraxx used for?
Danish: Hvad anvendes Fungitraxx til?
English: How does Fungitraxx work?
Danish: Hvordan virker Fungitraxx?
English: What benefit has Fungitraxx shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fungitraxx?
English: Itraconazole is an antifungal medicine.
Danish: Fungitraxx er et svampemiddel.
English: It is also cleared from the body less quickly.
Danish: Det udskilles heller ikke så hurtigt af kroppen.
English: The effectiveness of the two treatment options was compared over 36 weeks.
Danish: Virkningen af de to behandlinger blev sammenlignet over 36 uger.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mircera on 20 July 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mircera den 20. juli 2007.
English: The full EPAR for Mircera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Mircera findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It must also not be used in patients who have high blood pressure that is not controlled.
Danish: Det bør heller ikke anvendes til patienter med forhøjet blodtryk, som ikke er reguleret.
English: This document is a summary of the European public assessment report (EPAR) for Mircera.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mircera.
English: Patients can inject themselves once they have been trained appropriately.
Danish: Patienterne kan selv kan give injektionerne, når først de er blevet behørigt instrueret heri.
English: Other information about Mircera:
Danish: Andre oplysninger om Mircera:
English: Haemoglobin levels should be monitored every two weeks until they are stable, and then periodically.
Danish: Hæmoglobinindholdet skal måles hver anden uge, indtil det er stabilt, og derefter med jævne mellemrum.
English: Two of these studies involved patients who were starting treatment for anaemia.
Danish: To af disse undersøgelser omfattede patienter, der var i færd med at indlede en behandling for anæmi.
English: Most patients also received iron to prevent deficiency (low iron levels) during the studies.
Danish: Størstedelen af patienterne fik desuden jerntilskud for at undgå jernmangel i løbet af undersøgelserne.
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 Mircera.
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 Mircera.
English: For more information about treatment with Mircera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mircera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: However, the way it interacts with the receptor is slightly different from natural erythropoietin, which gives it a longer effect.
Danish: Dets vekselvirkning med receptorerne er smule anderledes end det naturlige erytropoietins, og det virker derfor i længere tid.
English: Erythropoietin is produced by the kidneys.
Danish: Erytropoietin produceres af nyrerne.
English: Mircera is intended for long-term use.
Danish: Mircera er beregnet til langtidsbehandling.
English: It is available in vials and in pre-filled syringes at various strengths ranging from 50 to 1,000 micrograms per millilitre.
Danish: Det leveres i hætteglas og i fyldte sprøjter i forskellige styrker fra 50 til 1 000 mikrogram pr. milliliter.
English: The Committee decided that Mircera's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Mircera opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The most common side effect with Mircera (seen in between 1 and 10 patients in 100) is hypertension (high blood pressure).
Danish: Den hyppigste bivirkning ved Mircera (som ses hos mellem 1 og 10 patienter ud af 100) er forhøjet blodtryk.
English: The epoetin beta is produced by ‘recombinant DNA technology': it is made by a cell that has received a gene, which makes it able to produce epoetin beta.
Danish: Epoetin beta fremstilles ved "rekombinant DNA-teknologi": Det produceres af en celle, der har fået indsat et gen, som gør den i stand til at producere epoetin beta.
English: Treatment with Mircera must be started under the supervision of a doctor who has experience in the management of patients with kidney disease.
Danish: Behandling med Mircera skal indledes under opsyn af en læge med erfaring i behandling af patienter med nyresygdomme.
English: Doses should be adjusted according to the patient's response, to obtain haemoglobin levels within the recommended range (between 10 and 12 grams per decilitre).
Danish: Dosis bør justeres ud fra patientens respons på behandlingen for at opnå et hæmoglobinindhold, der ligger inden for det anbefalede interval (mellem 10 og 12 gram pr. deciliter).
English: Mircera methoxy polyethylene glycol-epoetin beta
Danish: Mircera methoxypolyethylenglycol-epoetin beta
English: Mircera can be injected under the skin or into a vein.
Danish: Mircera kan injiceres under huden (subkutant) eller i en vene (intravenøst).
English: Mircera has been studied in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease.
Danish: Mircera blev undersøgt i seks hovedundersøgelser med i alt 2 399 voksne patienter med anæmi, som er opstået i forbindelse med kronisk nyresygdom.
English: In these studies, patients either remained on the medicines they were already receiving, or changed to Mircera, injected into a vein or under the skin every two or four weeks.
Danish: I disse undersøgelser fortsatte patienterne enten med den medicin, de fik i forvejen, eller skiftede til Mircera, givet intravenøst eller subkutant hver anden eller hver fjerde uge.
English: In the studies of patients starting treatment for anaemia for the first time, 126 (93%) of the 135 patients on dialysis, and 158 (98%) of the 162 not on dialysis had a significant increase in haemoglobin levels with Mircera.
Danish: I de undersøgelser af Mircera, hvor patienterne blev behandlet for anæmi for første gang, sås en væsentlig stigning i hæmoglobinindholdet hos 126 (93 %) af de 135 patienter, der var i dialyse, og hos 158 (98 %) af de 162, der ikke var i dialyse.
English: In all six studies, the main measure of effectiveness was the change in haemoglobin levels.
Danish: I alle seks undersøgelser blev behandlingens virkning hovedsagelig bedømt på ændringen i hæmoglobinindholdet.
English: The other four studies (in 1,894 patients) were carried out in patients on dialysis who had already been receiving medicines to stimulate red blood cell production.
Danish: De øvrige fire undersøgelser omfattede 1 894 patienter, der var i dialyse og i forvejen fik lægemidler til stimulation af dannelsen af røde blodlegemer.
English: Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Danish: Hæmoglobin er det protein, der findes i røde blodlegemer, som transporterer ilt rundt i kroppen.
English: Mircera was compared with other medicines used to stimulate red blood cell production.
Danish: Mircera blev her sammenlignet med andre lægemidler, der anvendes til at stimulere dannelsen af røde blodlegemer.
English: For the full list of all side effects reported with Mircera, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Mircera fremgår af indlægssedlen.
English: In the studies of patients who had already been receiving medicines to stimulate red blood cell production, patients who changed to Mircera maintained their haemoglobin levels as effectively as the patients who remained on their existing medicines.
Danish: I undersøgelserne af patienter, der i forvejen fik lægemidler til stimulering af dannelsen af røde blodlegemer, holdt hæmoglobinindholdet sig lige så godt oppe hos de patienter, der skiftede til Mircera, som hos dem, der fortsatte med den samme medicin som før.
English: The active substance in Mircera, methoxy polyethylene glycol-epoetin beta, works like natural erythropoietin to stimulate red blood cell production, because it can attach itself to the same receptors as erythropoietin.
Danish: Det aktive stof i Mircera, methoxypolyethylenglycol-epoetin beta, virker ligesom det naturlige erythropoietin ved at stimulere dannelsen af røde blodlegemer, da det kan binde sig til de samme receptorer som erythropoietin.
English: What is the risk associated with Mircera?
Danish: Hvilken risiko er der forbundet med Mircera?
English: A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Danish: Et hormon kaldet erytropoietin stimulerer dannelsen af røde blodlegemer i rygmarven.
English: Why has Mircera been approved?
Danish: Hvorfor blev Mircera godkendt?
English: The CHMP concluded that Mircera corrected and maintained haemoglobin levels in patients with chronic kidney disease and that its effects are comparable with those of other epoetins.
Danish: CHMP konkluderede, at Mircera rettede hæmoglobinniveauet op hos patienter med kronisk nyresygdom og holdt det oppe, og at dets virkning svarer til andre epoetiners.
English: The dose and the frequency of dosing depend on whether or not Mircera is replacing another medicine used to stimulate the production of red blood cells.
Danish: Dosis og dosishyppighed afhænger af, om Mircera erstatter et andet lægemiddel til stimulation af dannelsen af røde blodlegemer.
English: Mircera is used to treat anaemia (low red blood cell counts) that is causing symptoms in adults with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
Danish: Mircera anvendes til behandling af anæmi (mangel på røde blodlegemer) hos voksne patienter med kronisk nyresygdom (langvarig, fremadskridende nedsættelse af nyrefunktionen).
English: Mircera must not be used in people who are hypersensitive (allergic) to methoxy polyethylene glycolepoetin beta or any of the other ingredients.
Danish: Mircera må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for methoxypolyethylenglycol-epoetin beta eller andre af indholdsstofferne.
English: There was no overall change in haemoglobin levels over the course of these studies with any of the treatments.
Danish: Behandlingerne medførte ikke nogen generel ændring i hæmoglobinindholdet i løbet af undersøgelserne.
English: What is Mircera?
Danish: Hvad er Mircera?
English: Mircera was as effective as the comparator medicines in correcting and maintaining haemoglobin levels.
Danish: Mircera var lige så effektivt som sammenligningspræparaterne til at rette op på hæmoglobinindholdet og holde det oppe.
English: As a result, Mircera can be given less often than natural erythropoietin.
Danish: Det skal derfor ikke gives så ofte som lægemidler med naturligt erytropoietin.
English: Mircera is a solution for injection that contains the active substance methoxy polyethylene glycolepoetin beta.
Danish: Mircera er en injektionsvæske, opløsning, der indeholder det aktive stof methoxypolyethylenglycolepoetin beta.
English: The active substance in Mircera is made up of epoetin beta attached to a chemical called methoxypolyethylene glycol.
Danish: Det aktive stof i Mircera består af epoetin beta, som er bundet til det kemiske stof methoxypolyethylenglycol.
English: What is Mircera used for?
Danish: Hvad anvendes Mircera til?
English: How has Mircera been studied?
Danish: Hvordan blev Mircera undersøgt?
English: In patients with chronic kidney disease, the main cause of their anaemia is a lack of natural erythropoietin.
Danish: Mangel på erythropoietin er hovedårsagen til anæmi hos patienter med kronisk nyresvigt.
English: What benefit has Mircera shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Mircera?
English: The second study showed that patients taking Mircera and those taking darbepoetin alfa had similar increases in haemoglobin levels (around 2 g/dl).
Danish: I den anden undersøgelse steg hæmoglobinindholdet lige meget (ca. 2 g/dl) hos de patienter, der fik Mircera, og hos dem, der fik darbepoetin alfa.
English: How is Mircera used?
Danish: Hvordan anvendes Mircera?
English: The second study, in 324 patients not on dialysis, looked at Mircera injected under the skin every two weeks over 28 weeks, comparing it with darbepoetin alfa.
Danish: Her blev Mircera givet subkutant hver anden uge i 28 uger og sammenlignet med darbepoetin alfa.
English: The first study, in 181 patients on dialysis (a blood clearance technique used in advanced kidney disease), looked at Mircera injected into a vein every two weeks over 24 weeks and compared it with epoetin alfa or beta.
Danish: Her blev Mircera injiceret intravenøst hver anden uge i 24 uger og sammenlignet med epoetin alfa eller beta.
English: Similar response rates were seen in the patients taking the comparator medicines.
Danish: Sammenligningspræparaterne gav en tilsvarende virkning.
English: It can be taken with or without food.
Danish: Den kan tages sammen med eller uden mad.
English: The risk may be increased due to an invasive procedure.
Danish: Risikoen kan være øget som følge af et invasivt indgreb.
English: Your treatment will start at least 8 days before your surgery or procedure.
Danish: Din behandling vil starte mindst 8 dage før din operation eller indgrebet.
English: You can take it with food or between meals.
Danish: Du kan tage den sammen med mad eller mellem måltiderne.
English: Patients with body weight <45 Kg
Danish: Patienter med en legemsvægt <45 kg
English: Mulpleo is for oral use.
Danish: Mulpleo er til oral anvendelse.
English: If you forget to take a tablet
Danish: Hvis du har glemt at tage en tablet
English: Invasive procedure was performed between Days 9 and 14.
Danish: Der blev udført invasive indgreb fra dag 9 til dag 14.
English: Mulpleo should not be taken for more than 7 days.
Danish: Mulpleo må ikke tages i længere end 7 dage.
English: Human plasma protein binding ratio is ≥ 99.9%.
Danish: Plasmaproteinbindingsforholdet hos mennesker er ≥ 99,9 %.
English: Study drug was administered orally for up to 7 days.
Danish: Studielægemidlet blev administreret oralt i op til 7 dage.
English: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK
Danish: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK Shionogi B.V.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1348
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1348
English: Comparison with placebo [b]: Difference of proportion (95% CI)
Danish: Sammenligning med placebo [b]: Forskel i andel (95 % CI)
English: Therefore, a risk to the breast-feeding child cannot be excluded.
Danish: En risiko for det ammede barn kan derfor ikke udelukkes.
English: Recommended dose: take one tablet once a day, at the same time each day, for seven days only.
Danish: Anbefalet dosis: tag en tablet en gang dagligt på samme tidspunkt hver dag i kun 7 dage.
English: No dosage adjustment is expected for these patients.
Danish: Dosisjustering forventes ikke hos disse patienter.
English: Do not give this medicine to children or adolescents under the age of 18 years, because the medicine has not been studied in children and adolescents.
Danish: Dette lægemiddel må ikke gives til børn eller unge under 18 år, da lægemidlet ikke er blevet undersøgt hos børn og unge.
English: In the analysis for pooled data, study was added as a stratum.
Danish: I analysen for puljede data blev studiet tilføjet som et stratum.
English: If a dose is missed it should be taken as soon as possible.
Danish: Hvis en dosis springes over, skal den tages snarest muligt.
English: If you miss a tablet of Mulpleo, take it as soon as you remember on the same day.
Danish: Hvis du har glemt en tablet med Mulpleo, skal du tage den, så snart du husker det, på den samme dag.
English: Higher risk of blood clots
Danish: Større risiko for blodpropper
English: The p value and confidence interval were calculated using the Wald method.
Danish: P-værdien og konfidensintervallet blev beregnet ved hjælp af Wald-metoden.
English: Certain people may have a higher risk of blood clots, including people with liver disease, and medicines like Mulpleo could make this problem worse.
Danish: Visse personer kan have en større risiko for blodpropper, herunder personer med leversygdom, og lægemidler som Mulpleo kan forværre dette problem.
English: Platelets are blood components that help the blood to clot and so prevent bleeding.
Danish: Blodplader er blodkomponenter, der hjælper blodet med at størkne og derved forhindre blødning.
English: The film-coated tablet is to be taken once daily with liquid, swallowed whole and should not be chewed, divided, or crushed.
Danish: Den filmovertrukne tablet skal tages en gang dagligt sammen med væske, skal sluges hel og må ikke tygges, deles eller knuses.
English: If possible, show them the pack, or this leaflet.
Danish: Hvis det er muligt, skal du vise dem pakningen eller denne indlægsseddel.
English: - Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Danish: - Tal med lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: If you stop taking Mulpleo
Danish: Hvis du holder op med at tage Mulpleo
English: Signs of a blood clot: look out for any of the signs below:
Danish: Tegn på en blodprop: vær opmærksom på følgende tegn:
English: The medicine helps to increase the number of platelets in your blood.
Danish: Lægemidlet hjælper med at øge antallet af blodplader i blodet.
English: ➤ Get medical help immediately if you notice any of these.
Danish: ➤ Søg øjeblikkelig lægehjælp, hvis du bemærker en eller flere af disse ting.