FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac ischaemia and/or infarction
Danish: Hjerteiskæmi og/eller infarkt
English: QT prolongation
Danish: QTforlængelse
English: (drug induced hepatitis) - a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis) - serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis) - abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis) - damage of the kidney causing them to leak large amounts of protein (nephrotic syndrome) - inflammation of the vessels in the skin which may result in rash (leucocytoclastic vasculitis)
Danish: Johnsons syndrom) - unormal nedbrydning af musklerne, hvilket kan medføre nyreproblemer (rabdomyolyse) - nyreskade, der forårsager udsivning af en stor mængde protein (nefrotisk syndrom) - betændelse i blodårerne i huden, hvilket kan medføre udslæt (leukocytoklastisk vasculitis)
English: Grade
Danish: Grad
English: Sorafenib has been shown to prolong the QT/QTc interval (see section 5.1), which may lead to an increased risk for ventricular arrhythmias.
Danish: Sorafenib er vist at forlænge QT/QTc-intervallet (se pkt.
English: hypertension flushing hypertensive crisis*
Danish: gastrointestinal blødning *, luftvejsblødning* og cerebral blødning*) hypertension anfaldsvis ansigtsrødme hypertensiv krise*
English: encephalopathy°
Danish: Sårhelingskomplikationer
English: may affect up to 1 in 100 people - inflamed stomach lining (gastritis) - pain in the tummy (abdomen) caused by pancreatitis, inflammation of the gall bladder and/or bile ducts - yellow skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinaemia) - allergic like reactions (including skin reactions and hives) - dehydration - enlarged breasts (gynaecomastia) - breathing difficulty (lung disease) - eczema - overactive thyroid gland (hyperthyroidism) - multiple skin eruptions (erythema multiforme) - abnormally high blood pressure - holes in the gut wall (gastrointestinal perforation) - reversible swelling in the rear part of the brain that can be associated with headache, altered consciousness, fits and visual symptoms including visual loss (reversible posterior leukoencephalopathy) - a sudden, severe allergic reaction (anaphylactic reaction)
Danish: - allergi-lignende reaktioner (inklusive hudreaktioner og nældefeber) - væskemangel - forstørrede bryster hos mænd (gynækomasti) - åndedrætsbesvær (lungesygdom) - eksem - øget aktivitet i skjoldbruskkirtlen (hypertyreoidisme) - udbredt hududslæt (erythema multiforme) - unormalt højt blodtryk - huller i tarmvæggen (gastrointestinal perforation) - reversibel hævelse i hjernens bagerste del, som kan forbindes med hovedpine, påvirket bevidsthed,
English: No data is available on patients with Child Pugh C (severe) hepatic impairment (see sections 4.4 and 5.2).
Danish: Der findes ingen tilgængelig data for patienter med Child Pugh C (svært) nedsat leverfunktion (se pkt.
English: Bayer Austria Ges.
Danish: Bayer Austria Ges.m.b.H.
English: Haemorrhage in DTC
Danish: Blødning ved DTC
English: Neutropenia
Danish: Amning
English: Musculoskeletal and connective tissue disorders arthralgia myalgia muscle spasms rhabdomyolysis
Danish: Knogler, led, muskler og bindevæv artralgi myalgi muskelspasmer rabdomyolyse
English: Wound healing complications
Danish: Deres sår heler.
English: The effect of Nexavar may be decreased.
Danish: Andre lægemidler kan påvirke virkningen af Nexavar, og Nexavar kan påvirke virkningen af andre lægemidler.
English: This summary was last updated in 03-2007.
Danish: Dette sammendrag blev sidst ajourført i 03-2007.
English: The marketing authorisation was renewed on 18 March 2007.
Danish: Markedsføringstilladelsen blev fornyet den 18. marts 2007.
English: It is available in strengths from 2,000 IU/ml to 20,000 IU/ml.
Danish: Det findes i forskellige styrker fra 2 000 IU/ml til 20 000 IU/ml.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dynepo to Shire Pharmaceutical Contracts Ltd on 18 March 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dynepo til Shire Pharmaceutical Contracts Ltd. den 18. marts 2002.
English: The starting doses are 50 IU/kg three times a week if given intravenously, and twice a week if given subcutaneously.
Danish: Startdosis er 50 IU/kg tre gange ugentligt, hvis det indgives intravenøst, og 50 IU/kg to gange om ugen, hvis det indgives subkutant.
English: Allergic reactions have occasionally been seen, so it is recommended that the first dose of Dynepo be given under medical supervision.
Danish: Allergiske reaktioner kan til tider forekomme, og det anbefales derfor, at den første dosis af Dynepo gives under lægeligt opsyn.
English: Epoetin delta, the active ingredient of Dynepo, is a copy of the human hormone, produced by a method known as ‘genetic engineering': the enzyme is made by a cell in which the gene (the code) for the enzyme is activated so that the cell makes more of the enzyme and it can then be extracted and used in Dynepo.
Danish: Det aktive stof i Dynepo, epoetin delta, er en kopi af det humane hormon, og det produceres ved hjælp af en metode, der er kendt under navnet ”genteknologi”: enzymet fremstilles af en celle, i hvilken genet (koden) for enzymet aktiveres, så cellen producerer mere af enzymet, som dernæst kan ekstraheres og anvendes i Dynepo.
English: The most common side effects are hypertension (raised blood pressure), headache, and, for patients on dialysis, problems with the dialysis tubes.
Danish: De almindeligste bivirkninger er hypertension (forhøjet blodtryk) og hovedpine, og for dialysepatienters vedkommende problemer i forbindelse med dialyseslangerne.
English: What is the risk associated with Dynepo?
Danish: Hvilken risiko er der forbundet med Dynepo?
English: Dynepo contains the active ingredient epoetin delta.
Danish: Dynepo indeholder det aktive stof epoetin delta.
English: Doses are adjusted depending on the response.
Danish: Doseringen skal tilpasses alt efter, hvordan behandlingen virker.
English: The effectiveness of Dynepo to treat anaemia has been studied in a total of 1308 patients with chronic renal failure, including two main clinical studies.
Danish: Virkningen af Dynepo til behandling af anæmi er blevet undersøgt i forsøg med i alt 1 308 patienter med kronisk nyresvigt, herunder to kliniske hovedundersøgelser.
English: The main measure of effectiveness in the clinical studies was whether Dynepo increased haemoglobin levels (the protein found in red blood cells that carries oxygen around the body).
Danish: I de kliniske undersøgelser var det vigtigste mål for virkningen, om Dynepo øgede mængden af hæmoglobin (det protein, der findes i røde blodlegemer, som transporterer ilt rundt i kroppen).
English: In the other study, three different dosing schedules of subcutaneous Dynepo were compared.
Danish: I den anden undersøgelse blev tre forskellige doseringsprogrammer for subkutant indgivet Dynepo sammenlignet.
English: Dynepo works by stimulating production of red blood cells in the same way as erythropoietin.
Danish: Dynepo virker ved at stimulere produktionen af røde blodlegemer på samme måde som erythropoietin.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Dynepo's benefits are greater than its risks for the treatment of anaemia in patients with chronic renal failure.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Dynepo er større end risiciene ved behandling af patienter med kronisk nyresvigt.
English: In one of these, Dynepo given intravenously was compared with epoetin alfa (a similar type of drug).
Danish: I en af disse blev intravenøst indgivet Dynepo sammenlignet med epoetin alfa (et lignende lægemiddel).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DYNEPO EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) DYNEPO
English: Dynepo is used to treat anaemia (fewer than normal red blood cells in the blood) in adult patients with chronic renal failure (long-term kidney disease).
Danish: Dynepo anvendes til behandling af anæmi (færre røde blodlegemer i blodet end normalt) hos voksne patienter med kronisk nyresvigt (langvarig nyresygdom).
English: The effectiveness was the same if it was administered intravenously or subcutaneously.
Danish: Virkningen var den samme ved intravenøs og subkutan indgivelse.
English: Dynepo can be given intravenously (injection into a vein) or subcutaneously (injection under the skin).
Danish: Dynepo kan indgives intravenøst (i en vene) eller subkutant (under huden).
English: Dynepo should not be used in people who may be hypersensitive (allergic) to epoetin delta or any of the other ingredients, and in patients who have uncontrolled high blood pressure.
Danish: Dynepo må ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for epoetin delta eller andre af indholdsstofferne, eller af patienter med ukontrolleret hypertension.
English: Dynepo was as effective as epoetin alfa at increasing haemoglobin levels in patients.
Danish: Dynepo var lige så effektivt som epoetin alfa til at øge hæmoglobinmængden.
English: A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Danish: Hormonet erythropoietin stimulerer produktionen af røde blodlegemer i knoglemarven.
English: It may be used in patients on dialysis (a blood clearance technique) or not on dialysis.
Danish: Det kan anvendes både til patienter i dialyse (blodrensningsteknik) og til patienter, der ikke er i dialyse.
English: Dynepo is a solution for injection in pre-filled syringe.
Danish: Dynepo er en injektionsvæske, der leveres i en fyldt injektionssprøjte.
English: For the full description of the side effects reported with Dynepo, please see the Package Leaflet.
Danish: Den fuldstændige beskrivelse af de indberettede bivirkninger ved Dynepo fremgår af indlægssedlen.
English: In patients with long-term kidney failure, a cause of their anaemia can be a lack of erythropoietin.
Danish: Mangel på erythropoietin kan være årsagen til anæmi hos patienter med langvarig nyresvigt.
English: What benefit has Dynepo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dynepo?
English: A doctor who has experience in the care of renal failure patients should start any treatment with Dynepo.
Danish: Behandling med Dynepo bør kun påbegyndes af læger med erfaring i behandling af patienter med nyresvigt.
English: These medicinal products include, but are not limited, to the following:
Danish: Disse lægemidler omfatter, men er ikke begrænset til, følgende:
English: Do not take Pifeltro if the above applies to you.
Danish: Tag ikke Pifeltro, hvis ovenstående gælder for dig.
English: Consistent results were seen for the comparison at study Week 24 in each treatment group.
Danish: Der sås overensstemmende resultater for sammenligningen ved studiets uge 24 i hver behandlingsgruppe.
English: Approach to handle missing data: Observed Failure (OF) approach.
Danish: Metode til håndtering af manglende data: Observed Failure (OF)-metoden.
English: This can happen when you start taking any HIV medicine, including this medicine.
Danish: Dette kan opstå, når du begynder at tage en hvilken som helst hiv-medicin, herunder dette lægemiddel.
English: Effect of food on oral absorption
Danish: Fødevarers indvirkning på oral absorption
English: This is because it has not been studied in pregnancy and it is not known if it will harm your baby while you are pregnant.
Danish: Dette skyldes, at det ikke er undersøgt under graviditet, og det er ukendt, om det kan skade dit ufødte barn, mens du er gravid.
English: The interaction was evaluated with ritonavir only.
Danish: Interaktionen blev kun vurderet med ritonavir.
English: Treatment results are shown in Table 6.
Danish: Behandlingsresultaterne er vist i tabel 6.
English: There are some medicines you must not take with Pifeltro.
Danish: Der er visse lægemidler, som du ikke må tage sammen med Pifeltro.
English: This is because other medicines may affect how Pifeltro works, and Pifeltro might affect the way some other medicines work.
Danish: Årsagen er, at andre lægemidler kan påvirke, hvordan Pifeltro virker, og Pifeltro kan påvirke, hvordan andre lægemidler virker.
English: If you take certain medicines, your doctor may need to change the amount of doravirine you take.
Danish: Hvis du tager visse lægemidler, kan lægen blive nødt til at ændre den mængde doravirin, du tager.
English: The clinical relevance of a 5-10 fold reduction in susceptibility is unknown.
Danish: Den kliniske relevans af en 5-10 gange reduktion i følsomhed er ukendt.
English: There is no information on potential acute symptoms and signs of overdose with doravirine.
Danish: Der findes ingen information vedrørende potentielle akutte symptomer og tegn på overdosering med doravirin.
English: Use caution when driving or riding a bicycle, or operating machines if you feel dizzy, tired, or sleepy after taking this medicine.
Danish: Vær forsigtig, når du fører motorkøretøj, kører på cykel eller betjener maskiner, hvis du føler dig svimmel, træt eller søvnig, efter at du har taget dette lægemiddel.
English: It is preferable to avoid the use of this medicine during pregnancy.
Danish: Det bør undgås at anvende dette lægemiddel under graviditet.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Danish: Hyppighederne defineres som Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100) eller Sjælden (≥ 1/10.000 til < 1/1.000).
English: Rare dermatitis allergic, rosacea
Danish: Sjælden allergisk dermatitis, rosacea
English: • It is important that you do not miss or skip doses of this medicine.
Danish: • Det er vigtigt, at du ikke glemmer eller springer doser af dette lægemiddel over.
English: 30 months After first opening of the bottle use within 35 days.
Danish: 30 måneder Efter første åbning af flasken skal lægemidlet anvendes inden for 35 dage.
English: Effects on Medicinal Product Levels Geometric Mean Ratio (90 % CI)*
Danish: Indvirkning på lægemiddelniveauer Geometrisk gennemsnitsratio (90% CI)*
English: The use of Pifeltro in people aged less than 18 years has not yet been studied.
Danish: Anvendelse af Pifeltro til personer under 18 år er endnu ikke undersøgt.
English: The recommended dose is one 100 mg tablet taken orally once daily with or without food.
Danish: Den anbefalede dosis er en 100 mg tablet oralt en gang dagligt med eller uden mad.
English: Expected: ↔ rosuvastatin ↔ simvastatin
Danish: Forventet: ↔ rosuvastatin ↔ simvastatin
English: Keep the desiccant inside the bottle and do not throw away until you have finished taking all of the medicine.
Danish: Lad tørremidlet blive i flasken og lad være med at kassere det, før du er færdig med at tage al medicinen.
English: Table 3: Resistance development up to week 96 in protocol defined virologic failure population + early discontinuation population
Danish: Tabel 3: Udvikling af resistens op til uge 96 i populationen med protokol-defineret virologisk svigt + populationen med udtræden af studiet før tid
English: You can still pass on HIV when taking Pifeltro, although effective therapylowers the risk.
Danish: Du kan stadig overføre hiv, når du tager Pifeltro, selvom effektiv behandling sænker risikoen.
English: You should not take Pifeltro if your doctor has told you that the virus causing your infection is resistant to doravirine.
Danish: Du må ikke tage Pifeltro, hvis lægen har fortalt dig, at det virus, som forårsager din infektion, er resistent (modstandsdygtigt) over for doravirin.
English: A positive value favours doravirine over efavirenz.
Danish: En positiv værdi favoriserer doravirin i forhold til efavirenz.
English: Pifeltro is used to treat HIV infection in people 18 years of age and older.
Danish: Pifeltro anvendes til behandling af hiv-infektion hos personer i alderen 18 år og derover.
English: Blood tests may also show: • increased levels of liver enzymes (ALT)
Danish: Blodprøver kan også vise: • øget indhold af leverenzymer (ALAT).
English: Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AG06
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, ATC-kode: J05AG06
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Pifeltro.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds om risici og fordele ved at tage Pifeltro.
English: GM: Geometric mean, % CV: Geometric coefficient of variation
Danish: GM: Geometrisk gennemsnit, %CV: Geometrisk variationskoefficient.
English: Pifeltro may have a minor influence on the ability to drive or use machines.
Danish: Pifeltro kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Women with HIV should not breast-feed because HIV can be passed on to their babies through breast milk.
Danish: Kvinder med hiv frarådes at amme, da hiv-infektionen kan overføres til spædbarnet gennem brystmælken.
English: Table 1 shows the established and other potential medicinal product interactions with doravirine but is not all inclusive (increase is indicated as , decrease is indicated as ↓, and no change as ↔).
Danish: Tabel 1 viser de dokumenterede og andre potentielle lægemiddelinteraktioner med doravirin, men er ikke udtømmende (stigning angives med , fald angives med ↓ og ingen ændring med ↔).
English: If the patient misses a dose of Pifeltro within 12 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule.
Danish: Hvis patienten glemmer en dosis Pifeltro inden for 12 timer efter det tidspunkt, hvor den normalt tages, skal patienten tage den så hurtigt som muligt og genoptage den normale doseringsplan.
English: Because of the potential for HIV-1 transmission and the potential for serious adverse reactions in breast-feeding infants, mothers should be instructed not to breast-feed if they are receiving Pifeltro.
Danish: På grund af risikoen for overførsel af hiv-1 og risikoen for alvorlige bivirkninger hos ammede spædbørn skal mødre instrueres i, at de ikke må amme, hvis de får Pifeltro.
English: Pifeltro is used to treat HIV (‘human immunodeficiency virus') infection.
Danish: Pifeltro anvendes til behandling af infektion med hiv (‘humant immundefekt-virus').
English: Pregnancy There are no or limited amount of data from the use of doravirine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af doravirin til gravide kvinder.
English: For storage conditions after first opening of the bottle see section 6.3.
Danish: For opbevaringsforhold efter første åbning af flasken se pkt.
English: No clinically relevant pharmacokinetic differences have been identified between men and women for doravirine.
Danish: Ingen klinisk relevante farmakokinetiske forskelle mellem mænd og kvinder er identificeret for doravirin.
English: Method of administration Pifeltro must be taken orally, once daily with or without food and swallowed whole (see section 5.2).
Danish: Pifeltro skal tages oralt, en gang dagligt med eller uden mad og sluges hel (se pkt.
English: Doravirine demonstrated antiviral activity against a broad panel of primary HIV-1 isolates (A, A1, AE, AG, B, BF, C, D, G, H) with EC50 values ranging from 1.2 nM to 10.0 nM.
Danish: Doravirin udviste antiviral aktivitet mod et bredt panel af primære hiv-1-isolater (A, A1, AE, AG, B, BF, C, D, G, H) med EC50-værdier fra 1,2 nM til 10,0 nM.
English: Doravirine at a dose of 100 mg once daily is not likely to have a clinically relevant effect on the plasma concentrations of medicinal products that are dependent on transport proteins for absorption and/or elimination or that are metabolized by CYP enzymes.
Danish: Det er ikke sandsynligt, at doravirin ved en dosis på 100 mg en gang dagligt har en klinisk relevant indvirkning på plasmakoncentrationen af lægemidler, der er afhængige af transportproteiner for at blive absorberet og/eller elimineret, eller der metaboliseres via CYP-enzymer.
English: The administration of a single doravirine tablet with a high-fat meal to healthy subjects resulted in a 16 % and 36 % increase in doravirine AUC and C24, respectively, while Cmax was not significantly affected.
Danish: Administration af en enkelt doravirin-tablet sammen med et fedtholdigt måltid til raske forsøgspersoner gav en stigning på henholdsvis 16% og 36% i AUC og C24 for doravirin, mens Cmax ikke blev påvirket signifikant.
English: Pifeltro tablets contain lactose
Danish: Pifeltro indeholder lactose
English: Although a limited number of subjects aged 65 years and over has been included (n=36), no clinically relevant differences in the pharmacokinetics of doravirine have been identified in subjects at least 65 years of age compared to subjects less than 65 years of age in a Phase 1 trial or in a population pharmacokinetic analysis.
Danish: Selvom der er inkluderet et begrænset antal forsøgspersoner i alderen 65 år eller derover (n=36), er ingen klinisk relevante forskelle i doravirins farmakokinetik identificeret hos forsøgspersoner på mindst 65 år sammenlignet med forsøgspersoner under 65 år i et fase 1-studie eller i en farmakokinetisk populationsanalyse.
English: There were no effects on fertility, mating performance or early embryonic development when doravirine was administered to rats up to 7 times the exposure in humans at the RHD.
Danish: Der var ingen indvirkning på fertilitet, formeringsevne eller tidlig embryonal udvikling, når doravirin blev administreret til rotter ved op til 7 gange eksponeringen hos mennesker ved RHD.
English: Doravirine was excreted into the milk of lactating rats following oral administration, with milk concentrations approximately 1.5 times that of maternal plasma concentrations.
Danish: Doravirin blev udskilt i mælken fra diegivende rotter efter oral administration og gav mælkekoncentrationer, der var ca. 1,5 gange plasmakoncentrationerne hos moderdyrene.
English: In a population pharmacokinetic analysis, which included subjects with CrCl between 17 and 317 mL/min, renal function did not have a clinically relevant effect on doravirine pharmacokinetics.
Danish: I en farmakokinetisk populationsanalyse, der inkluderede forsøgspersoner med CrCl mellem 17 og 317 ml/min, havde nyrefunktion ingen klinisk relevant indvirkning på doravirins farmakokinetik.
English: DRV + r + 2 NRTIs (383)
Danish: DRV + r + 2 NRTIer (383)
English: EU/1/18/1332/001 EU/1/18/1332/002 90 (3 x 30) tablets
Danish: EU/1/18/1332/001 EU/1/18/1332/002 90 (3 x 30) tabletter
English: If a patient misses a dose by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time.
Danish: Hvis en patient glemmer en dosis i mere end 12 timer, skal patienten ikke tage den glemte dosis og i stedet tage den næste dosis på det sædvanlige planlagte tidspunkt.
English: Subsequently F227(L/C/V) or L234I emerged in addition to V106 substitution (double mutants yielding a fold change of > 100).
Danish: Efterfølgende opstod F227(L/C/V) eller L234I ud over V106-substitutionerne (dobbeltmutanter, der gav en > 100 gange ændring).
English: Rare musculoskeletal pain
Danish: Sjælden muskuloskeletale smerter
English: Studies in pregnant rats and rabbits showed that doravirine is transferred to the foetus through the placenta, with foetal plasma concentrations of up to 40 % (rabbits) and 52 % (rats) that of maternal concentrations observed on gestation Day 20.
Danish: Studier med drægtige rotter og kaniner viste, at doravirin overføres til fosteret via placenta og gav føtale plasmakoncentrationer på op til 40% (kaniner) og 52% (rotter) af de koncentrationer, der er observeret hos moderdyrene på dag 20 i drægtighedsperioden.