FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Altargo?
Danish: Hvilken risiko er der forbundet med Altargo?
English: The Committee recommended that Altargo be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Altargo.
English: It is used for short-term treatment of superficial skin infections.
Danish: Det anvendes til korttidsbehandling af overfladiske hudinfektioner.
English: It works by blocking the bacteria's ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Danish: Det virker ved at blokere bakteriernes ribosomer, dvs. de dele af cellen, der producerer nye proteiner.
English: In all five studies, the main measure of effectiveness was the proportion of patients whose infections had cleared up after the end of treatment.
Danish: I alle fem undersøgelser blev behandlingens virkning hovedsagelig bedømt på den andel af patienterne, hvor infektionen var svundet ved afslutningen af behandlingen.
English: The most common side effect with Altargo (seen in between 1 and 10 patients in 100) is irritation at the site of application.
Danish: Den hyppigste bivirkning af Altargo (som ses hos mellem 1 og 10 patienter ud af 100) er irritation på påføringsstedet.
English: Altargo can be used in patients from the age of nine months, but in patients under 18 years of age, the area to be treated should not be more than 2% of the body's surface.
Danish: Altargo kan anvendes til patienter fra ni måneders alderen, men til patienter under 18 år må det behandlede område højst udgøre 2 % af legemsoverfladen.
English: • infected small lacerations, abrasions or sutured wounds.
Danish: • inficerede smårifter, hudafskrabninger og sår, der er blevet syet.
English: Altargo has been studied in five main studies involving over 3,000 patients aged from 9 months upwards.
Danish: Altargo har været genstand for fem hovedundersøgelser med over 3 000 patienter i alderen fra 9 måneder og opefter.
English: It is derived from a compound produced by certain types of fungus.
Danish: Det fremstilles af et stof, der produceres af bestemte typer svampe.
English: The treated area can be covered with a sterile bandage or gauze dressing.
Danish: Det behandlede område kan dækkes med en steril forbinding eller gaze.
English: The full EPAR for Altargo can be found here.
Danish: Den fuldstændige EPAR om Altargo findes her.
English: However, it may be used to treat infections caused by other types of Staphylococcus aureus.
Danish: Det kan derimod godt anvendes mod infektioner, der skyldes andre typer Staphylococcus aureus.
English: Altargo is an ointment that contains the active substance retapamulin.
Danish: Altargo er en salve, der indeholder det aktive stof retapamulin.
English: Altargo should not be used to treat infections known or thought likely to be due to methicillin-resistant Staphylococcus aureus (MRSA), as it may not work against this type of infection.
Danish: Altargo bør ikke anvendes til behandling af infektioner, der skyldes methicillin-resistente Staphylococcus aureus (MRSA), da det ikke nødvendigvis virker mod infektioner af denne art.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ALTARGO EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ALTARGO
English: For the treatment of infected skin wounds, Altargo and cefalexin had similar response rates: when the results of both skin wound studies were taken together, around 90% of both groups of patients responded to treatment.
Danish: Til behandling af inficerede hudsår havde Altargo og cefalexin lige god virkning: Når resultaterne af de to undersøgelser vedrørende hudsår blev lagt sammen, virkede behandlingen hos omkring 90 % af patienterne i de to grupper.
English: Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 and 141 (94.0%) of 150 patients, respectively, responding to treatment.
Danish: Altargo var mindst lige så effektivt som fusidinsyre, idet behandlingen virkede hos henholdsvis 314 (99,1 %) ud af 317 og 141 (94,0 %) ud af 150 patienter.
English: The active substance in Altargo, retapamulin, is an antibiotic belonging to the ‘pleuromutilin' class.
Danish: Det aktive stof i Altargo, retapamulin, er et antibiotikum tilhørende gruppen af "pleuromutiliner".
English: In patients with impetigo, Altargo was more effective than placebo, with 119 (85.6%) of the 139 patients using Altargo and 37 (52.1%) of the 71 using placebo responding to treatment.
Danish: Til børnesår var Altargo mere effektivt end placebo, idet behandlingen virkede hos 119 (85,6 %) af de 139 patienter, der fik Altargo, og hos 37 (52,1 %) af de 71 patienter, der fik placebo.
English: Altargo should not be used in people who may be hypersensitive (allergic) to retapamulin or any of the
Danish: Altargo bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for retapamulin
English: The full list of bacteria against which Altargo is active can be found in the Summary of Product
Danish: Den fuldstændige liste over de bakterier, som Altargo virker mod, fremgår af produktresuméet.
English: The data presented were insufficient to support the use of Altargo in the treatment of infected
Danish: De forelagte oplysninger var utilstrækkelige som dokumentation for anvendelsen af Altargo til be
English: Two studies were carried out in patients with impetigo.
Danish: Der er udført to undersøgelser hos patienter med børnesår.
English: However, these two studies found that Altargo was not sufficiently effective in the treatment of abscesses (cavities containing pus) or of infections known or likely to be caused by MRSA.
Danish: I disse to undersøgelser blev Altargo imidlertid ikke fundet tilstrækkelig effektivt til behandling af bylder eller infektioner, der vi
English: What benefit has Altargo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Altargo?
English: For the full list of all side effects reported with Altargo, see the Package
Danish: Den fuldstændige liste over de indberettede bivirkninger for Altargo fremgår af ind
English: compared the effects of five days' treatment with Altargo to those of cefalexin (an oral antibiotic medicine): two studies were carried out in a total of 1,918 patients with infected skin wounds, and the final study was carried out in 545 patients with infected dermatitis (skin inflammation).
Danish: ført to undersøgelser hos i alt 1 918 patienter med inficerede hudsår, og den sidste undersøgelse blev udført hos 545 patienter med inficeret dermatitis (hudbetændelse).
English: It can be used to treat impetigo (a skin infection causing crusting scabs), and small infected lacerations (cuts), abrasions (grazes) and wounds that have been sutured (stitched).
Danish: Det kan anvendes til behandling af børnesår, små inficerede rifter, hudafskrabninger og sår, der er blevet syet.
English: The first compared the effects of five days' treatment with Altargo to those of placebo (a dummy treatment) in 213 patients, and the second compared Altargo to fusidic acid (another antibiotic ointment) in 519 patients.
Danish: I den første blev virkningen af fem dages behandling med Altargo sammenlignet med placebo (uvirksom behandling) hos 213 patienter.
English: Prescribers should consider official guidance on the
Danish: Når lægen ordinerer medicinen, bør officielle retningslinjer for hensigtsmæssig brug af antibiotika følges.
English: Immediate Packaging Pack size
Danish: Styrke Lægemiddelfo rm
English: Pharmaceutical Form
Danish: Paknings-størrelse
English: This summary was last updated in 06.2013.
Danish: Dette sammendrag blev sidst ajourført den 06.2013.
English: These reactions are usually mild to moderate and temporary.
Danish: Disse reaktioner er som oftest lette og midlertidige.
English: The tablets are given every other day, with or without food.
Danish: Tabletterne gives hver anden dag med eller uden et måltid.
English: It is available as tablets: 10 mg (blue), 15 mg (orange) and 50 mg (red).
Danish: Det fås som tabletter: 10 mg (blå), 15 mg (orange) og 50 mg (rød).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Palladia on 23.09.2009.
Danish: EU har givet markedsføringstilladelse for Palladia gældende i hele Den Europæiske Union den 23.09.2009.
English: The duration of treatment depends on the dog's response to treatment.
Danish: Behandlingens varighed afhænger af, hvordan hunden reagerer på behandlingen.
English: The main study was carried out in two phases in 151 dogs with mast cell tumours.
Danish: Hovedundersøgelsen blev udført i to faser på 151 hunde med mastcelletumorer.
English: The usual dose is 3.25 mg per kilogram bodyweight, and the number of tablets to use is carefully calculated for each dog.
Danish: Den sædvanlige dosis er 3,25 mg pr. kg legemsvægt, og antallet af tabletter, som skal gives, beregnes nøje for hver hund.
English: Other information about Palladia:
Danish: Andre oplysninger om Palladia:
English: This means that it blocks some specific enzymes known as tyrosine kinases.
Danish: Det betyder, at det blokerer nogle bestemte enzymer kaldet tyrosinkinaser.
English: The tablets must be given whole and should not be divided, broken or ground up.
Danish: Tabletterne skal gives hele, og må ikke deles, knækkes over eller knuses.
English: If the disease was getting worse, treatment with Palladia was stopped and the dog was taken out of the study.
Danish: Hvis sygdommen blev værre, blev behandlingen med Palladia stoppet, og hunden blev taget ud af undersøgelsen.
English: In case of side effects, the veterinarian might decide to lower the dose of Palladia or to stop treatment, either temporarily or permanently.
Danish: I tilfælde af bivirkninger kan dyrlægen beslutte at nedsætte dosen af Palladia eller stoppe behandlingen enten midlertidigt eller permanent.
English: If broken tablets, or the vomit, urine or faeces of a treated dog comes into contact with the skin or eyes, rinse immediately with plenty of water.
Danish: Hvis en knækket tablet, opkast, urin eller afføring fra en behandlet hund kommer i kontakt med hud eller øjne, skylles øjnene straks med rigeligt vand.
English: Dogs should be regularly monitored for side effects by the veterinarian (at the beginning of treatment, this should be at least once per week).
Danish: Hundene skal tilses regelmæssigt af dyrlægen med henblik på kontrol med eventuelle bivirkninger (i begyndelsen af behandlingen mindst en gang om ugen).
English: After six weeks (second phase), the study continued with all the remaining dogs receiving Palladia for an average of another four and a half months.
Danish: Efter seks uger (den anden fase) fortsatte undersøgelsen af alle resterende hunde, som fik Palladia i gennemsnitligt op til yderligere fire og en halv måned.
English: Treatment started with the recommended dose, but this dose was later reduced or treatment interrupted for a few days in some dogs.
Danish: Behandlingen begyndte med den anbefalede dosis, men hos visse hunde blev dosen senere reduceret eller behandlingen afbrudt i nogle dage.
English: In a first phase (up to six weeks), Palladia was compared with placebo (a dummy treatment).
Danish: I den første fase (op til seks uger) blev Palladia sammenlignet med placebo (en virkningsløs behandling).
English: The main measures of effectiveness were the ‘objective response' (an evaluation by the veterinarian of the way the tumour changed during treatment) and the time taken until the tumour started to get worse.
Danish: Virkningen blev hovedsagelig bedømt på den ‘objektive respons' (dyrlægens vurdering af, hvordan tumoren havde ændret sig under behandlingen), og den tid, der gik, indtil der begyndte at ske en forværring af tumoren.
English: By blocking these enzymes, Palladia can help to control abnormal cell growth and prevent further development of this type of tumour.
Danish: Ved at blokere disse receptorer kan Palladia være med til at kontrollere denne unormale cellevækst og forebygge yderligere udvikling af denne form for tumorer.
English: The most common side effects with Palladia are diarrhoea and vomiting, loss of appetite, lethargy (lack of energy), neutropenia (low white blood cell counts), difficulty moving (lameness) and weight loss.
Danish: De mest almindelige bivirkninger ved Palladia er diarré, opkastning, appetitløshed, apati (mangel på energi) neutropeni (for lavt antal hvide blodlegemer), nedsat bevægelsesevne (halten ) og vægttab.
English: These enzymes can be found in mastcell tumours, where they are involved in the growth and spread of cancer cells, and the growth of blood vessels.
Danish: Disse enzymer findes i mastcelletumorer, hvor de medvirker til kræftcellernes vækst og spredning og væksten i blodkarene.
English: A number of studies with Palladia were carried out either in laboratory dogs or in animal patients in veterinary practices or hospitals.
Danish: Der er foretaget en række undersøgelser med Palladia enten af laboratoriehunde eller af hunde, som er blevet behandlet på veterinærklinikker eller -dyrehospitaler.
English: It is used for tumours that are severe in character (grade 2 or 3), have come back, and cannot be removed with surgery.
Danish: Det anvendes mod alvorlige tumorer (grad 2 eller 3), som er vendt tilbage, og som ikke kan fjernes ved operation.
English: If Palladia is taken accidentally, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Danish: Hvis man utilsigtet kommer til at tage Palladia, skal man omgående søge lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: Dogs treated with Palladia had greater objective response rates (37%) than dogs treated with placebo (8%) after six weeks of treatment.
Danish: Hunde behandlet med Palladia havde større objektive responsrater (37 %) end hunde behandlet med placebo (8 %) efter seks ugers behandling.
English: A complete response (disappearance of the tumour) was seen in around 8% and a partial response (shrinkage of the tumour) was seen in around 29% of the dogs treated with Palladia.
Danish: En komplet respons (tumoren er helt væk) kunne ses hos ca. 8 % og en delvis respons (formindskelse af tumoren) hos ca. 29 af de hunde, der blev behandlet med Palladia.
English: Palladia must not be used in dogs less than two years of age or weighting less than 3 kg, in bitches that are pregnant or lactating, or in dogs intended for breeding.
Danish: Palladia må ikke anvendes til hunde, som er under to år gamle eller som vejer under 3 kg, hos drægtige eller diegivende tæver eller hos avlshunde.
English: What is the risk associated with Palladia?
Danish: Hvilken risiko er der forbundet med Palladia?
English: The active substance in Palladia, toceranib, is a receptor tyrosine kinase inhibitor.
Danish: Det aktive indholdsstof i Palladia, toceranib, er en receptor-tyrosinkinasehæmmer.
English: For Palladia-treated dogs, it also took longer for the tumour to get worse (nine to ten weeks on average) than in those receiving placebo (three weeks on average).
Danish: For hunde behandlet med Palladia tog det også længere tid, inden tumoren blev forværret (ni til ti uger i gennemsnit) end hos dem, der fik placebo (tre uger i gennemsnit).
English: It must not be used in dogs with bleeding in the stomach or gut.
Danish: Det må ikke anvendes til hunde, som har blødninger fra mave eller tarm.
English: Palladia is used to treat dogs with mast-cell tumours (a type of skin cancer).
Danish: Palladia anvendes til at behandle mast-celletumorer hos hunde (en form for hudkræft).
English: For a full list of all side effects or precautions, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger og forsigtighedsregler fremgår af indlægssedlen.
English: Why has Palladia been approved?
Danish: Hvorfor blev Palladia godkendt?
English: It should not be used in dogs that may be hypersensitive (allergic) to toceranib or any of the other ingredients.
Danish: Det må ikke anvendes til dyr, som er overfølsomme (allergiske) over for toceranib eller et eller flere af de øvrige indholdsstoffer.
English: Palladia contains toceranib, which belongs to a class of medicines with anticancer activity.
Danish: Palladia indeholder toceranib, som tilhører en gruppe af lægemidler, der anvendes mod kræft.
English: What is Palladia?
Danish: Hvad er Palladia?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Palladia exceed the risks for the treatment of non-resectable Patnaik grade II (intermediate grade) or III (high grade), recurrent, cutaneous mast cell tumours in dogs and recommended that Palladia be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Palladia opvejer risiciene ved behandling af af kutane mastcelletumorer Patnaik grad II (intermediær grad) eller III (høj grad), som er recidiverende og som ikke kan fjernes kirurgisk, hos hunde.
English: What is Palladia used for?
Danish: Hvad anvendes Palladia til?
English: How has Palladia been studied?
Danish: Hvordan blev Palladia undersøgt?
English: Children should not have close contact with the medicine, or with the faeces or vomit of treated dogs.
Danish: Lægemidlet opbevares utilgængeligt for børn, og børn må ikke komme i kontakt med afføring eller opkast fra hunde, der behandles.
English: What benefit has Palladia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Palladia?
English: How does Palladia work?
Danish: Hvordan virker Palladia?
English: - Your doctor will decide how many treatments you need.
Danish: - Lægen beslutter, hvor mange behandlinger du har brug for.
English: 30 minutes.
Danish: 30 minutter.
English: Date of first authorisation: 17 July 2015
Danish: Dato for første markedsføringstilladelse: 17. juli 2015
English: *p-Value is nominal.
Danish: *p-værdien er nominel.
English: It is important that you also read the package leaflets for these other medicines.
Danish: Det er vigtigt, at du også læser indlægssedlerne for disse andre lægemidler.
English: These complications can be severe and can lead to death.
Danish: Disse komplikationer kan være alvorlige og kan medføre døden.
English: These results should be interpreted in the context of the open-label study design and therefore taken cautiously.
Danish: Disse resultater skal fortolkes i konteksten af det åbne studiedesign og skal derfor fortolkes med forsigtighed.
English: BRAF wild type
Danish: BRAF vildtype
English: - It is important that you keep the Alert Card with you during treatment.
Danish: - Det er vigtigt, at du har informationskortet med dig under behandlingen.
English: NA = not available
Danish: NA = Foreligger ikke
English: Patients without disease progression could be treated for up to 24 months.
Danish: Patienter uden sygdomsprogression kunne behandles i op til 24 måneder.
English: The potential risk of gastrointestinal perforation should be taken into consideration.
Danish: Den potentielle risiko for gastrointestinal perforation skal tages i betragning.
English: Safety and efficacy in elderly patients
Danish: Sikkerhed og virkning hos ældre patienter
English: Data from these patients are too limited to draw any conclusion on safety or efficacy in this population.
Danish: Data fra disse patienter er for begrænsede til at kunne drage konklusioner om sikkerhed eller virkning for denne population.
English: Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2
Danish: Eastern Cooperative Oncology Group (ECOG)-performance-status ≥ 2
English: Time in Months
Danish: Tid i måneder
English: Stable Disease
Danish: Stabil sygdom
English: They may occur if you had this kind of transplant in the past or if you get it in the future.
Danish: De kan forekomme, hvis du tidligere har gennemgået denne form for transplantation, eller hvis du skal have en sådan transplantation engang i fremtiden.
English: You may experience more than one side effect at the same time.
Danish: Du kan få mere end en bivirkning på samme tid.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Danish: Det er vigtigt, at du gemmer dette patientinformationskort og viser det til din partner eller dine omsorgspersoner.
English: Your doctor may give you other medicines in order to prevent more severe complications and reduce your symptoms.
Danish: Din læge vil muligvis give dig anden medicin for at forebygge mere alvorlige komplikationer og mildne dine symptomer.
English: These reactions are presented by system organ class and by frequency.
Danish: Disse bivirkninger er anført ud fra systemorganklasse og hyppighed.
English: These side effects may happen anytime during treatment or even after your treatment has ended.
Danish: Disse bivirkninger kan forekomme når som helst under behandlingen, eller selv efter afslutning af din behandling.
English: The following terms represent a group of related events that describe a medical condition rather than a single event.
Danish: Følgende termer repræsenterer en gruppe beslægtede bivirkninger, som snarere beskriver en medicinsk tilstand end en enkelt bivirkning.
English: KEYTRUDA is used in adults to treat:
Danish: Keytruda anvendes til voksne til at behandle:
English: The KEYNOTE-426 trial was not powered to evaluate efficacy of individual subgroups.
Danish: KEYNOTE-426-studiet var ikke designet til at vurdere virkningen i individuelle subgrupper.
English: A total of 559 patients were randomised.
Danish: I alt 559 patienter blev randomiseret.
English: Immune-related adverse reactions affecting more than one body system can occur simultaneously.
Danish: Immunrelaterede bivirkninger, der påvirker mere end et organsystem i kroppen, kan forekomme på samme tid.
English: Otherwise treatment should be discontinued.
Danish: Ellers skal behandlingen seponeres.
English: Participants were enrolled across 28 tumour types by primary diagnosis.
Danish: Deltagerne blev inkluderet på tværs af 28 tumortyper ud fra primær diagnose.
English: Do not Freeze.
Danish: Må ikke nedfryses.
English: A total of 861 patients were randomised.
Danish: Der blev randomiseret i alt 861 patienter.
English: These side effects can sometimes become life-threatening and can lead to death.
Danish: Disse bivirkninger kan nogle gange blive livstruende og kan medføre døden.
English: Efficacy results based on an additional seven months of follow-up are summarized in Table 10 and Figure 4.
Danish: Effektresultater baseret på yderligere 7 måneders opfølgning er opsummeret i tabel 10 og i figur 4.
English: Examples of these may include corticosteroids, such as prednisone.
Danish: Eksempler herpå kan være kortikosteroider, som f.eks. prednison.
English: Children and adolescents KEYTRUDA should not be used in children and adolescents below 18 years of age.
Danish: Børn og unge Keytruda må ikke anvendes til børn og unge under 18 år.
English: The exposure multiple between the NOAEL and a human dose of 200 mg was 74.
Danish: Den multiple eksponering mellem NOAEL og en human dosis på 200 mg var 74.
English: Allow up to 5 minutes for the bubbles to clear.
Danish: Lad der gå 5 minutter, så eventuelle bobler forsvinder.
English: This can affect your ability to drive or to use machines.
Danish: Dette kan påvirke din evne til at køre bil eller betjene maskiner.
English: Number (%
Danish: Antal (%
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Danish: Hyppigheden er angivet som: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100); Sjælden (≥ 1/10.000 til < 1/1.000); Meget sjælden (< 1/10.000) og Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There were no Grade 5 hepatic events.
Danish: Der var ingen hepatiske hændelser af grad 5.
English: Discard the vial if visible particles are observed.
Danish: Hætteglasset skal kasseres, hvis der observeres synlige partikler.
English: The value of biomarkers to predict the efficacy of pembrolizumab should be further explored, specifically:
Danish: Værdien af biomarkører til at forudsige pembrolizumabs virkning skal undersøges yderligere, især: