FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharyngitis
Danish: Stomatitis/ pharyngitis
English: bottle (HDPE) with child-resistant closure bottle (HDPE) with screw cap blister (alu/alu)
Danish: EU/1/99/108/006 Ferriprox 1000 mg Filmovertrukket tablet Oral anvendelse Blisterpakke (alu/alu)
English: Content Package size bottle (HDPE)
Danish: EU/1/99/108/004 Ferriprox 1000 mg Filmovertrukket tablet Oral anvendelse Flaske (HDPE) med børnesikret lukning
English: Packaging
Danish: Indhold Paknings-størrelse
English: These events are often transitory.
Danish: Disse hændelser er ofte forbigående.
English: • It is very important to take all your HIV medicines as prescribed and at the right times of day.
Danish: • Det er meget vigtigt at tage al din hiv-medicin som foreskrevet og på det rigtige tidspunkt på dagen.
English: Physicians are encouraged to register patients in this registry.
Danish: Læger opfordres til at registrere patienterne i dette register.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Typisk observeres sådanne reaktioner inden for de første uger eller måneder efter initiering af CART.
English: Interaction (mechanism, if known)
Danish: Interaktion (mekanisme, hvis kendt)
English: No fatalities occurred, and the patients recovered.
Danish: Der var ingen dødsfald, og patienterne kom sig.
English: • This medicine can be taken with or without food or drink.
Danish: • Dette lægemiddel kan indtages med eller uden mad eller drikke.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Danish: Forholdsregler til forebyggelse af overførsel skal tages i overensstemmelse med de nationale retningslinjer.
English: Do not take DUTREBIS:
Danish: Tag ikke Dutrebis:
English: Patients at increased risk should be followed closely.
Danish: Patienter med øget risiko skal følges tæt.
English: Notes: The analysis is based on all available data.
Danish: Noter: Analysen er baseret på alle tilgængelige data.
English: However, it is not clear whether these cases were due to the ART or to the underlying HIV disease.
Danish: Det er dog ikke klart, om disse tilfælde skyldtes ART eller den underliggende hiv-sygdom.
English: If you do take too many tablets, contact your
Danish: Hvis du har taget for mange tabletter, skal du kontakte
English: The observed half-life of elimination is 5 to 7 hours.
Danish: Den observerede eliminationshalveringstid er 5 til 7 timer.
English: Final dose population N=96
Danish: Slutdosis population N=96
English: Similar findings were not observed in rabbits.
Danish: Der blev ikke observeret lignende fund hos kaniner.
English: The frequency of this is unknown (see
Danish: Hyppigheden heraf er ukendt (se pkt.
English: Recommendations are based on available data from the individual components.
Danish: Anbefalingerne er baseret på tilgængelige data fra de enkelte komponenter.
English: BENCHMRK 1 and 2 Pooled
Danish: BENCHMRK 1 og 2 - Poolet
English: Patients with HIV are at higher risk of developing cancer than patients without the disease.
Danish: Patienter med hiv har større risiko for at få cancer end patienter uden sygdommen.
English: After first opening of the medicinal product, the in-use shelf life is 30 days, below 30°C.
Danish: Efter første åbning af lægemidlet er holdbarheden 30 dage under 30 °C.
English: • reduce the amount of HIV in your blood (this is called your "viral load")
Danish: • nedsætte mængden af hiv i blodet (dette kaldes for din "virusbelastning")
English: This means your body may fight infection better.
Danish: Dette betyder, at kroppen bedre kan bekæmpe infektion.
English: The long-term consequences of these events are currently unknown.
Danish: Langtidskonsekvenserne heraf er i øjeblikket ukendte.
English: Some patients experienced viral rebound between Week 16 and Week 96.
Danish: Nogle patienter oplevede viral rebound mellem uge 16 og uge 96.
English: HIV infection is spread by contact with blood or sexual contact with a person with HIV.
Danish: Hiv-infektion spredes ved kontakt med blod eller ved seksuel kontakt med en person, der har hiv.
English: See section 4 for more information about side effects.
Danish: Se punkt 4 for yderligere oplysninger om bivirkninger.
English: Clinical examination should include evaluation for physical signs of fat redistribution.
Danish: Den kliniske undersøgelse bør inkludere evaluering af fysiske tegn på omfordeling af fedt.
English: Talk with your doctor about the best way to feed your baby.
Danish: Tal med din læge om, hvordan du bedst giver dit barn mad.
English: The types and rates of specific cancers were those expected in a highly immunodeficient population.
Danish: Type og hyppighed af de specifikke cancerformer var som forventet i en yderst immundefekt population.
English: This can help your medicines work better.
Danish: Dette hjælper medicinen til at virke bedre.
English: • Do not take this medicine after the expiry date which is stated on the bottle after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på flasken.
English: • This medicine has been prescribed for you or your child only.
Danish: • Lægen har ordineret dette lægemiddel til dig eller dit barn personligt.
English: • signs and symptoms of infection or inflammation
Danish: • Tegn og symptomer på infektion eller betændelse
English: Green, oval tablet, marked with "144" on one side.
Danish: Grøn, oval tablet præget med ”144” på den ene side.
English: These changes are not considered clinically meaningful; therefore, DUTREBIS may be administered with or without food.
Danish: Disse forandringer ansås ikke for klinisk betydningsfulde; DUTREBIS kan derfor administreres med eller uden mad.
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
Danish: Hyppighed er defineret 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
English: • you have had problems with your liver before, including hepatitis B or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take this medicine.
Danish: • hvis du har tidligere haft problemer med leveren, herunder hepatitis B eller C. Din læge kan vurdere, hvor alvorlig din leversygdom er, før han/hun beslutter, om du kan tage dette lægemiddel.
English: Recommendations concerning co-administration with DUTREBIS
Danish: Anbefalinger vedrørende samtidig administration med DUTREBIS
English: Raltegravir has a relatively low genetic barrier to resistance.
Danish: Raltegravir har en relativt lav genetisk barriere mod resistens.
English: It is not yet known what causes these changes, or whether they have any long-term effects.
Danish: Årsagen til disse ændringer kendes endnu ikke, eller om de påvirker helbredet på længere sigt.
English: The following drug interaction information is based on Geometric Mean values; the effect for an individual patient cannot be predicted precisely.
Danish: Følgende informationer om lægemiddelinteraktioner er baseret på geometriske middelværdier, så effekten for den enkelte patient kan ikke forudsiges præcist.
English: This may mean that the HIV virus will develop resistance to DUTREBIS and become harder to treat.
Danish: Dette kan betyde, at hiv-virus kan udvikle resistens over for Dutrebis og dermed blive vanskeligere at behandle.
English: Patients had prior exposure to a median of 12 anti-retrovirals for a median of 10 years.
Danish: Patienterne havde tidligere været eksponeret for gennemsnitligt 12 antiretrovirale lægemidler i gennemsnitligt 10 år.
English: Additional side effects in children and adolescents • hyperactivity
Danish: Yderligere bivirkninger hos børn og unge • Hyperaktivitet
English: During a short break in taking the medicine, the amount of virus in your blood may increase.
Danish: Under en kort afbrydelse af medicinen, kan mængden af virus i blodet stige.
English: (chelation of metal cations)
Danish: (chelation med metalkation)
English: Biotransformation and excretion
Danish: Biotransformation og udskillelse
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Danish: Hvis der er tegn på forværring af leversygdommen hos disse patienter, bør det overvejes at afbryde eller stoppe behandlingen.
English: • certain kinds of kidney problems, including conditions in which the kidneys lose the ability to remove waste and excess water from the bloodstream.
Danish: • Visse typer nyresygdomme, herunder tilstande hvor nyrerne mister evnen til at fjerne affaldsstoffer og overskydende vand fra blodbanen.
English: Tmax was not significantly affected by renal function.
Danish: Tmax blev ikke signifikant påvirket af nyrefunktionen.
English: In vitro susceptibility testing has not been standardised and results may vary according to methodological factors.
Danish: Test af følsomheden in vitro er ikke blevet standardiseret, og resultaterne kan variere afhængigt af de anvendte metoder.
English: • increase your CD4-cell count (a type of white blood cell that plays an important role in maintaining a healthy immune system to help fight infection).
Danish: • øge CD4-celletallet (en type hvide blodlegemer, der spiller en vigtig rolle i vedligeholdelsen af et sundt immunforsvar, der hjælper med at bekæmpe infektion).
English: Non-completer is failure imputation: patients who discontinued prematurely are imputed as failure thereafter.
Danish: Non-completer er lig med failure: Patienter, som stoppede før tid, beregnes derefter som failure.
English: It also lowers the chance that your medicines will stop being able to fight HIV (also called "drug resistance").
Danish: Det nedsætter også risikoen for, at medicinen ophører med at bekæmpe hiv (også kaldet medicinresistens).
English: • rash (more often when used in combination with darunavir)
Danish: • Udslæt (oftest ved anvendelse sammen med darunavir)
English: Therefore DUTREBIS should be used with caution in this population.
Danish: DUTREBIS bør derfor anvendes med forsigtighed til denne population.
English: The initial dose finding stage included intensive pharmacokinetic evaluation.
Danish: Den initiale dose finding-fase omfattede intensiv farmakokinetisk evaluering.
English: Your doctor may decide to change your dose by using the medicines in DUTREBIS separately, if you are taking rifampicin.
Danish: Lægen kan beslutte at ændre din dosis ved at anvende lægemidlerne i Dutrebis hver for sig, hvis du tager rifampicin.
English: > 200 cells/mm Sensitivity score (GSS)
Danish: > 200 celler/mm Sensitivitets-score (GSS)
English: Patients should be advised that current antiretroviral therapy does not cure HIV and has not been proven to prevent the risk of transmission of HIV to others through blood contact.
Danish: Patienterne bør oplyses om, at den nuværende antiretrovirale behandling ikke helbreder hiv, og at det ikke er påvist at behandlingen udelukker risikoen for overførsel af hiv til andre ved kontakt via blod.
English: Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Danish: Efter oral administration er gennemsnitstiden (tmax) for at opnå maksimal serumkoncentration (Cmax) omkring en time.
English: Effects at exposure levels sufficiently in excess of clinical exposure levels indicate no special hazard for humans.
Danish: Virkninger med eksponeringsniveauer, der ligger tilstrækkeligt over de kliniske eksponeringsniveauer, tyder ikke på særlig fare for mennesker.
English: The maximum dose is one tablet twice daily.
Danish: Maksimal dosis er en tablet to gange dagligt.
English: What you need to know before you take DUTREBIS
Danish: Det skal du vide, før du begynder at tage Dutrebis
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen er den sidste dag i
English: It is rare (may affect up to 1 in 1,000 people) and if it does happen, it usually happens after a few months of treatment.
Danish: Det sker sjældent (kan forekomme hos 1 ud af 1.000 personer), men hvis det sker, kommer det normalt efter nogle få måneders behandling.
English: 126 treatment experienced children and adolescents 2 to 18 years of age.
Danish: I dette studie deltog 126 behandlingserfarne børn og unge i alderen 2 til 18 år.
English: Pack size: 1 bottle containing 60 tablets.
Danish: Pakningsstørrelse: 1 flaske med 60 tabletter.
English: If you notice within 6 hours, you must take the tablet immediately.
Danish: Hvis du opdager det inden for 6 timer, skal du tage tabletten straks.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selvom det er påvist, at effektiv viral suppression med antiretroviral behandling reducerer risikoen for seksuel overførsel væsentligt, kan en residual risiko ikke udelukkes.
English: The recommended dose is 1 tablet twice a day.
Danish: Den anbefalede dosis er 1 tablet to gange dagligt.
English: Sources of variability within the BENCHMRK study may include differences in co-administration with food and concomitant medicines.
Danish: Årsager til variabiliteten i BENCHMRK studiet kan omfatte forskelle i samtidig administration af mad og medicin.
English: If you are the parent of a child taking DUTREBIS, please read this information carefully with your child.
Danish: Hvis du har et barn, der tager Dutrebis, skal du læse denne information grundigt sammen med barnet.
English: See a doctor immediately, if you notice any of the following: These are uncommon (may affect up to 1 in 100 people)
Danish: Søg straks læge, hvis du bemærker en eller flere af følgende bivirkninger: Disse er ikke almindelige (kan forekomme hos op til 1 ud af 100 personer)
English: This is slightly faster than the raltegravir poloxamer formulation, which has a Tmax of approximately 3 hours.
Danish: Dette er lidt hurtigere end raltegravir poloxamer-formuleringen, som har et Tmax på cirka 3 timer.
English: Patients with a prior history of virological failure were not excluded and the number of previous antiretroviral therapies was not limited.
Danish: Patienter med virologisk svigt i anamnesen blev ikke ekskluderet, og antallet af tidligere antiretrovirale behandlinger var ikke begrænset.
English: A median of 4 ARTs was used in OBT.
Danish: Der blev anvendt gennemsnitligt 4 ARTer i OBT.
English: No specific signs or symptoms have been identified following such overdose.
Danish: Der er ikke set særlige tegn eller symptomer i forbindelse med overdosering.
English: Patients were stratified by age, enrolling adolescents first and then successively younger children.
Danish: Patienterne blev stratificeret i forhold til alder, idet de unge blev inkluderet først og derefter de yngre børn.
English: Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
Danish: Lamivudin var ikke genotoksisk in vivo ved doser, der medførte plasmakoncentrationer omkring 40-50 gange højere end de forventede kliniske plasmakoncentrationer.
English: STARTMRK Study
Danish: STARTMRK-studiet
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig(e) for batchfrigivelse
English: Standard genotoxicity studies to evaluate mutagenicity and clastogenicity were negative.
Danish: Genotoksikologiske standardstudier til evaluering af mutagenicitet og klastogenicitet var negative.
English: Raltegravir is approximately 83 % bound to human plasma protein over the concentration range of 2 to 10 µM.
Danish: Raltegravir er bundet cirka 83% til humane plasmaproteiner i koncentrationsområdet 2-10 μM.
English: 240 Weeks
Danish: 240 uger
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer bør vurderes, og behandling initieres efter behov.
English: If this is noticed later than 6 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Danish: Hvis dette først bemærkes senere end 6 timer efter det tidspunkt, hvor det normalt tages, skal den glemte dosis ikke tages, og patienten skal genoptage den sædvanlige doseringsplan.
English: People taking anti-retroviral medicines may find that their body shape changes.
Danish: Personer, der er i behandling med antiretrovirale lægemidler, opdager måske hen ad vejen, at deres krop ændrer facon.
English: These studies were terminated after the primary efficacy analysis at Week 24 because they failed to demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir.
Danish: Disse studier blev afsluttet efter analysen af primær effekt i uge 24, fordi de ikke kunne påvise noninferioritet for raltegravir i forhold til lopinavir (+) ritonavir.
English: Reducing the amount of HIV in the blood may improve the functioning of your immune system.
Danish: Nedsættelse af hiv-mængden i blodet kan forbedre immunforsvarets funktion.
English: Cases of pancreatitis have occurred rarely with lamivudine.
Danish: Der er sjældent forekommet tilfælde af pankreatitis med lamivudin.
English: Lamivudine is eliminated mainly by active renal secretion via the organic cationic transport system.
Danish: Lamivudin elimineres hovedsageligt ved aktiv renal sekretion via det organiske kationiske transportsystem.
English: For observed C12 hr in BENCHMRK 1 and 2 the coefficient of variation (CV) for inter-subject variability = 212 % and the CV for intra-subject variability = 122 %.
Danish: For det observerede C12t i BENCHMRK 1 og 2 var variationskoefficienten (CV) for den inter-individuelle variabilitet = 212% og CV for den intra-individuelle variabilitet = 122%.
English: DUTREBIS also helps stop the production of an enzyme called “HIV integrase”.
Danish: Dutrebis hjælper også med at stoppe dannelsen af et enzym kaldet ”hiv-integrase”.
English: Medicinal products by therapeutic area
Danish: Lægemidler i henhold til terapeutisk område
English: See section 4.4 regarding the need to administer raltegravir with another active agent.
Danish: 4.4 om nødvendigheden af at administrere raltegravir sammen med et andet aktivt lægemiddel.
English: DUTREBIS must not be used with the following medicines.
Danish: Dutrebis må ikke tages sammen med følgende lægemidler.
English: No specific information is available on the treatment of overdose with raltegravir.
Danish: Der findes ingen specifik information om behandling af overdosering i forbindelse med raltegravir.
English: The impact of other strong inducers of drug metabolizing enzymes, such as phenytoin and phenobarbital, on UGT1A1 is unknown.
Danish: Indvirkningen af andre stærke inducere af lægemiddelmetaboliserende enzymer, såsom phenytoin og phenobarbital, på UGT1A1 er ukendt.
English: Raltegravir and efavirenz were administered with emtricitabine (+) tenofovir.
Danish: Raltegravir og efavirenz blev administreret sammen med emtricitabin (+) tenofovir.
English: Do not operate machines, drive or cycle if you feel dizzy after taking this medicine.
Danish: Du må ikke arbejde med maskiner, køre bil eller cykle, hvis du føler dig svimmel, efter du har taget dette
English: As a general rule, it is recommended that mothers infected by HIV do not breast-feed their babies in order to avoid transmission of HIV.
Danish: Generelt anbefales det, at mødre med hiv ikke ammer deres spædbørn, for at undgå overførsel af hiv.
English: Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated.
Danish: Klinisk status inklusive leveraminotransferaser skal monitoreres og hensigtsmæssig behandling initieres.
English: 96 Weeks
Danish: 96 uger
English: The tablets should be swallowed whole, without crushing or chewing.
Danish: Tabletterne skal synkes hele og må ikke knuses eller tygges.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective therapy.
Danish: Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral behandling.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes
English: DUTREBIS film-coated tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor
Danish: Dutrebis filmovertrukne tabletter indeholder lactose Hvis du af din læge har fået at vide, at der er visse sukkerarter, du ikke kan tåle, skal du tale med lægen,
English: Dose adjustment is not considered necessary in subjects with reduced UGT1A1 activity due to genetic polymorphism.
Danish: Dosisjustering anses ikke for at være nødvendig hos patienter med nedsat UGT1A1-aktivitet på grund af genetisk polymorfisme.
English: These median proportions are approximately 3- to 6-fold lower than the free fraction of raltegravir in plasma.
Danish: Disse mediane mængdeforhold er cirka 3-6 gange lavere end den frie fraktion af raltegravir i plasma.
English: Dose selection was based upon achieving similar raltegravir plasma exposure and trough concentration as seen in adults, and acceptable short term safety.
Danish: Valg af dosis var baseret på opnåelse af samme plasma-raltegravireksponering og koncentration som set hos voksne samt acceptabel sikkerhed på kort sigt.
English: With twice-daily dosing of raltegravir, pharmacokinetic steady state is achieved rapidly, within approximately the first 2 days of dosing.
Danish: Med dosering af raltegravir to gange dagligt opnåedes farmakokinetisk steady state hurtigt, cirka inden for de første 2 dage af doseringen.
English: The risk of developing cancer in these studies was similar in the groups receiving raltegravir and in the groups receiving comparators.
Danish: Risikoen for udvikling af cancer i disse studier var den samme i de grupper, der fik raltegravir og de grupper, der fik
English: Whether the neurological disorders are transient or permanent is currently unknown.
Danish: Det er ukendt, om disse neurologiske forstyrrelser er forbigående eller vedvarende.
English: DUTREBIS film-coated tablets contain lactose.
Danish: DUTREBIS filmovertrukne tabletter indeholder lactose.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: For opbevaring efter første åbning af lægemidlet se pkt.
English: It is not known whether raltegravir is secreted in human milk.
Danish: Det vides ikke, om raltegravir udskilles i human mælk.
English: Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23 % of the dose, respectively.
Danish: To komponenter, nemlig raltegravir og raltegravirglucuronid, påvistes i urinen og udgjorde henholdsvis cirka 9 % og 23 % af dosis.
English: It should be taken into account that raltegravir is presented for clinical use as the potassium salt.
Danish: Det bør tages med i overvejelserne, at raltegravir til klinisk anvendelse er præsenteret som kaliumsalt.
English: This means that you may keep getting infections or other illnesses associated with HIV, if you don't take DUTREBIS as your doctor has instructed you.
Danish: Dette betyder, at du måske bliver ved med at få infektioner eller andre sygdomme, der er forbundet med hiv, hvis du ikke tager Dutrebis efter lægens
English: Based on modelling and simulation using raltegravir pharmacokinetic data in adults, the pharmacokinetics of raltegravir in DUTREBIS in children was projected to result in exposures that have been previously shown to be safe and efficacious in adults.
Danish: På baggrund af modellering og simulering ved anvendelse af farmakokinetiske data for raltegravir hos voksne, blev farmakokinetikken for raltegravir i DUTREBIS hos børn fremskrevet og resulterede i eksponeringer, som tidligere er blevet påvist som sikre og effektive hos voksne.