FrancophonIA/ELRC3.0 huggingface dataset:
English: When used with other medicines, Isentress may reduce the amount of HIV in your blood (this is called your "viral load") and increase your CD4-cell count (a type of white blood cells that plays an important role in maintaining a healthy immune system to help fight infection).
Danish: Når Isentress tages sammen med anden medicin, kan det nedsætte mængden af hiv i blodet (dette kaldes "virusbelastning") og øge CD4celletallet (en type hvide blodlegemer, der spiller en vigtig rolle i vedligeholdelsen af et sundt immunforsvar, der hjælper med at bekæmpe infektion).
English: The safety and efficacy of raltegravir in preterm (<37 weeks of gestation) and low birth weight (<2000 g) newborns have not been established.
Danish: Raltegravirs sikkerhed og virkning hos for tidligt fødte børn (gestationsalder <37 uger) og nyfødte med lav fødselsvægt (<2.000 g) er ikke klarlagt.
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 raltegravireksponering i plasma og dalkoncentration som set hos voksne samt acceptabel sikkerhed på kort sigt.
English: Birth to 1 Week - Once daily dosing
Danish: Fødsel til 1 uge - dosering en gang dagligt
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 pga. genetisk polymorfisme.
English: Following reconstitution the oral suspension has a concentration of 10 mg per mL.
Danish: Efter rekonstitution har den orale suspension en koncentration på 10 mg pr. ml.
English: Table 9 displays pharmacokinetic parameters for neonates in Cohort 2 at birth and at 2 weeks of age.
Danish: Tabel 9 viser de farmakokinetiske parametre for nyfødte i kohorte 2 ved fødslen og i 2 ugers alderen.
English: Be sure to go to all of your doctor's appointments so your child gets the right dose!
Danish: Sørg for at møde op til alle besøg hos lægen, så dit barn får den korrekte dosis!
English: • Women with HIV should not breast-feed their infants because babies can be infected with HIV through their breast milk.
Danish: • Kvinder med hiv må ikke amme, da spædbørn kan blive smittet med hiv gennem modermælken.
English: • You can ask your doctor or pharmacist for a list of medicines that interact with Isentress.
Danish: • Du kan spørge lægen eller apotekspersonalet, om du kan få en liste over de lægemidler, der påvirker eller påvirkes af Isentress.
English: Throw away any leftover Isentress after you have given the dose to your child.
Danish: Kasser eventuelt resterende Isentress, efter at du har givet dosis til dit barn.
English: This dose must not exceed 300 mg twice a day.
Danish: Denne dosis må ikke overstige 300 mg to gange dagligt.
English: This neoplasia could result from local deposition and/or aspiration of drug on the mucosa of the nose/nasopharynx during oral gavage dosing and subsequent chronic irritation and inflammation; it is likely that it is of limited relevance for the intended clinical use.
Danish: Denne neoplasi kan være opstået ud fra lokal aflejring og/eller aspiration af lægemiddelstoffet i næsens/nasopharynx slimhinder under dosering via oral sonde og efterfølgende kronisk irritation og inflammation; dette er sandsynligvis af begrænset relevans for den tilsigtede kliniske anvendelse.
English: Driving and using machines 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 lægemiddel.
English: • buzzing, hissing, whistling, ringing or other persistent noise in the ears
Danish: • Summende, hvislende, fløjtende, ringende eller anden vedvarende støj i ørerne
English: • allergic reaction
Danish: • Allergisk reaktion
English: DO NOT SHAKE the mixture
Danish: Blandingen MÅ IKKE RYSTES
English: Factors associated with failure include high baseline viral load and OBT that did not include at least one potent active agent.
Danish: Faktorer, der er forbundet med failure, omfatter høj viral belastning ved baseline og OBT, som ikke omfattede mindst ét potent aktivt middel.
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Tegn på osteonekrose er ledstivhed, ledsmerter (især i hofte, knæ og skulder) samt besvær med at bevæge sig.
English: In vitro, raltegravir is a weak inhibitor of organic anion transporter (OAT) 1 (IC50 of 109 µM) and OAT3 (IC50 of 18.8 µM).
Danish: In vitro er raltegravir en svag hæmmer af organisk anion-transportør (OAT) 1 (IC50-værdi på 109 µM) og OAT3 (IC50-værdi på 18,8 µM).
English: Move this part of the plunger to the correct mark on the syringe
Danish: Skub denne del af stemplet hen til det korrekte mærke på sprøjten
English: Factors that reduced the likelihood of developing resistance included lower baseline viral load and use of other active anti-retroviral agents.
Danish: Faktorer, som reducerede sandsynligheden for udvikling af resistens, omfattede et lavt viralt load ved baseline samt brug af andre aktive antiretrovirale lægemidler.
English: If you are the parent of a child taking Isentress, please read this information carefully with your child.
Danish: Hvis du har et barn, der tager Isentress, skal du læse denne information grundigt sammen med barnet.
English: UGT1A1 Polymorphism
Danish: UGT1A1-polymorfisme
English: Patients can remain on the granules for oral suspension as long as their weight is below 20 kg.
Danish: Patienterne kan anvende granulatet til oral suspension så længe deres vægt ligger under 20 kg.
English: There were no clinically important pharmacokinetic differences due to gender, race or body mass index (BMI) in adults.
Danish: Der var ingen klinisk betydningsfulde farmakokinetiske forskelle på grund af køn, race eller BMI (Body Mass Index) hos voksne.
English: Do not take Isentress:
Danish: Tag ikke Isentress:
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Der har været rapporteret om tilfælde af osteonekrose hos især patienter med generelt kendte risikofaktorer, fremskreden hiv-sygdom eller langvarig eksponering for antiretroviral kombinationsbehandling (CART).
English: Your doctor has prescribed Isentress to help control your HIV infection.
Danish: Din læge har ordineret Isentress som middel til at hjælpe med at holde din hiv-infektion under kontrol.
English: Therefore, no dose adjustment is required with use of proton pump inhibitors or H2 antagonists.
Danish: Dosisjustering er derfor ikke nødvendig ved anvendelse sammen med protonpumpehæmmere eller H2-antagonist.
English: Dizziness has been reported in some patients during treatment with regimens containing raltegravir.
Danish: Der er blevet rapporteret om svimmelhed hos nogle patienter under behandling med regimer, der indeholdt raltegravir.
English: Raltegravir may be administered with or without food.
Danish: Raltegravir kan administreres med eller uden mad.
English: 1.5 mg/kg once daily 25 38.2 (38.4%)
Danish: 1,5 mg/kg en gang dagligt 25 38,2 (38,4%)
English: What Isentress is
Danish: Hvad Isentress er
English: Do not open the Isentress sachets until you are ready to prepare a dose.
Danish: Folieposerne med Isentress må ikke åbnes, før du er parat til at klargøre en dosis.
English: (increased solubility)
Danish: (øget opløselighed)
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: Hypersensitivity reactions have also been reported and were characterised by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure.
Danish: Der er også rapporteret om overfølsomhedsreaktioner, som var karakteriseret ved udslæt, konstitutionelle fund og nogle gange organdysfunktion inklusive leversvigt.
English: Raltegravir inhibits the catalytic activity of integrase, an HIV-encoded enzyme that is required for viral replication.
Danish: Raltegravir hæmmer den katalytiske aktivitet af integrase, som er et hiv-kodet enzym, der er nødvendig for viral replikation.
English: Pull back the plunger.
Danish: Træk stemplet tilbage.
English: *Number of patients with intensive pharmacokinetic (PK) results at the final recommended dose.
Danish: *Antal patienter med intensive farmakokinetiske (PK) resultater ved den anbefalede slutdosis.
English: Re-check the amount of water in the syringe.
Danish: Kontroller mængden af vand i sprøjten igen.
English: Their doctor may also want to prescribe the 400 mg tablet when they are able to swallow a tablet.
Danish: Det kan også være, at lægen vil ordinere 400 mg tabletten, når de er i stand til at sluge en tablet.
English: The doctor will tell you how many chewable tablets the child must take.
Danish: Lægen vil fortælle dig, hvor mange Isentress tyggetabletter, barnet skal tage.
English: Most viruses isolated from patients failing raltegravir had high-level raltegravir resistance resulting from the appearance of two or more mutations in integrase.
Danish: De fleste af de isolerede vira fra patienter, som ikke havde effekt af raltegravir, havde høj resistens over for raltegravir, hvilket var et resultat af forekomsten af to eller flere mutationer i hiv-integrase.
English: The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter α-phase half-life (~1 hour) accounting for much of the AUC.
Danish: Den tilsyneladende terminale halveringstid for raltegravir er ca. 9 timer med en kortere α-fase halveringstid (1 time), der udgør det meste af AUC.
English: Then find the mL mark on the syringe barrel that matches your child's dose.
Danish: Find derefter ml-mærket på sprøjtecylinderen, der svarer til dit barns dosis.
English: Adverse reactions considered by investigators to be causally related to raltegravir (alone or in combination with other ART), as well as adverse reactions established in post-marketing experience, are listed below by System Organ Class.
Danish: De kliniske bivirkninger, som investigatorerne anså for at være relateret til raltegravir (alene eller i kombination med anden ART), samt bivirkninger opstået i forbindelse med brug efter markedsføring, er nævnt nedenfor i henhold til systemorganklasse.
English: The most frequently reported adverse reactions during treatment were headache, nausea and abdominal pain.
Danish: De hyppigst rapporterede bivirkninger under behandlingen var hovedpine, kvalme og abdominalsmerter.
English: Complete details on preparation and administration of the suspension can be found in the instructions for use booklet that is included in the carton.
Danish: Alle oplysninger vedrørende klargøring og administration af suspensionen kan findes i hæftet med brugsvejledning i kartonen.
English: • Isentress 1,200 mg (two 600 mg tablets once daily) is not recommended in pregnancy because it has not been studied in pregnant women.
Danish: • Isentress 1.200 mg (to 600 mg tabletter en gang dagligt) må ikke bruges under graviditet, da det ikke er undersøgt hos gravide.
English: The rates of discontinuation of raltegravir due to adverse reactions were 5% or less in clinical trials.
Danish: Hyppigheden for seponering af raltegravir på grund af bivirkninger var 5% eller mindre i kliniske studier.
English: Delay in stopping raltegravir treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.
Danish: Forhalet seponering af raltegravir eller andre mistænkte lægemidler efter optræden af alvorligt udslæt kan resultere i en livstruende reaktion.
English: Recommended Dose for ISENTRESS For Oral Suspension in Full-Term Neonates (Birth to 4 weeks [28 days] of age*
Danish: Anbefalet dosis for ISENTRESS granulat til oral suspension til fuldbårne nyfødte (fødsel til 4 uger gamle [28 dage]*
English: The safety and efficacy of raltegravir have not been established in patients with severe underlying liver disorders.
Danish: Raltegravirs sikkerhed og virkning er ikke klarlagt hos patienter med svær tilgrundliggende leversygdom.
English: Mental health problems
Danish: Psykiske helbredsproblemer
English: Once absorbed, both formulations of raltegravir exhibit similar systemic pharmacokinetics.
Danish: Efter absorption udviser begge formuleringer sammenlignelig systemisk farmakokinetik.
English: Pharmacotherapeutic group: antivirals for systemic use, other antivirals, ATC code: J05AX08.
Danish: Farmakoterapeutisk klassifikation: antivirale lægemidler til systemisk anvendelse, andre antivirale lægemidler, ATC-kode: J05AX08.
English: If it is less than 10 mL, put the tip back into the water and pull back on the plunger until you get to the 10 mL mark.
Danish: Hvis der er mindre end 10 ml, skal du sætte sprøjten ned i vandet igen og trække stemplet tilbage, indtil du når til 10 mlmærket.
English: Adults and paediatric population
Danish: Voksne og pædiatrisk population
English: If you forget to take Isentress
Danish: Hvis du har glemt at tage Isentress
English: • Outer carton
Danish: • Ydre karton
English: Isentress chewable tablets contain aspartame Isentress contains aspartame, a source of phenylalanine, which may be harmful to people with phenylketonuria.
Danish: Isentress tyggetabletter indeholder aspartam Isentress indeholder aspartam, en phenylalaninkilde, som kan være skadelig for personer med fenylketonuri (Føllings sygdom).
English: • accumulation of fat in the liver
Danish: • Ophobning af fedt i leveren
English: This study enrolled 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: The effect of food on the granules for oral suspension formulation was not studied.
Danish: Madens indvirkning på granulatet til oral suspension er ikke undersøgt.
English: Remember that Isentress is not a cure for HIV infection.
Danish: Husk, at Isentress ikke helbreder hiv-infektion.
English: Keep a list of all your medicines to show your doctor and pharmacist.
Danish: Før en liste over alle de lægemidler, du tager, så du kan vise den til lægen eller apotekspersonalet.
English: Age (hours/days) at PK Sampling
Danish: Alder (timer/dage) ved PKprøvetagning
English: Raltegravir was administered as granules for oral suspension formulation without regard to food in combination with an optimised background regimen that included lopinavir plus ritonavir in two-thirds of patients.
Danish: Raltegravir blev administreret som granulat til oral suspension uden hensyntagen til mad i kombination med et optimeret baggrundsregime, som inkluderede lopinavir og ritonavir hos to tredjedele af patienterne.
English: Put the tip of the syringe into the glass of water.
Danish: Sæt sprøjtespidsen ned i glasset med vand.
English: • atazanavir (an antiretroviral medication)
Danish: • atazanavir (et antiretroviralt lægemiddel)
English: • tiredness, unusual tiredness or weakness; fever
Danish: • Træthed, usædvanlig træthed eller svaghed, feber
English: Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination anti-retroviral therapy and should be monitored according to standard practice.
Danish: Patienter med leverdysfunktion, herunder kronisk hepatitis, har øget hyppighed af unormal leverfunktion under den antiretrovirale kombinationsbehandling og bør monitoreres i henhold til gældende praksis.
English: The absolute bioavailability of raltegravir has not been established.
Danish: Raltegravirs absolutte biotilgængelighed er ikke fastslået.
English: Food appears to increase pharmacokinetic variability relative to fasting.
Danish: Mad synes at øge den farmakokinetiske variabilitet i forhold til faste.
English: While the magnitudes of change on raltegravir exposure from raltegravir 400 mg twice daily by ritonavir, boceprevir or etravirine were small, the impact from tipranavir/ritonavir was greater (GMR Ctrough=0.45, GMR AUC=0.76).
Danish: Mens ændringen i eksponering for raltegravir ved raltegravir 400 mg to gange dagligt frembragt af ritonavir, boceprevir eller etravirin var lille, var indvirkningen af tipranavir/ritonavir større (GMR Cdal=0,45, GMR AUC=0,76).
English: However, the effect of raltegravir on darunavir plasma concentrations does not appear to be clinically meaningful.
Danish: Raltegravirs virkning på darunavirs plasmakoncentration synes dog ikke at være klinisk relevant.
English: Isentress is used to treat those who are infected by HIV.
Danish: Isentress bruges til behandling af personer, som er smittet med hiv.
English: Geometric coefficient of variation.
Danish: Geometrisk variationskoefficient.
English: Because the extent to which raltegravir may be dialysable is unknown, dosing before a dialysis session should be avoided.
Danish: Da det ikke vides, i hvor høj grad raltegravir er dialyserbart, bør dosering undgås før en dialysesession.
English: Based on a formulation comparison study in healthy adult volunteers, the chewable tablet and granules for oral suspension have higher oral bioavailability compared to the 400 mg tablet.
Danish: Baseret på et sammenlignende formuleringsstudie hos raske voksne frivillige har tyggetabletten og granulatet til oral suspension en højere oral biotilgængelighed sammenlignet med 400 mg tabletten.
English: Inhibition of integrase prevents the covalent insertion, or integration, of the HIV genome into the host cell genome.
Danish: Hæmning af integrase hindrer den kovalente insertion, eller integration, af hiv-genomet i værtscellegenomet.
English: Some patients taking combination anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, som får antiretroviral kombinationsbehandling, kan udvikle en knoglesygdom, som hedder osteonekrose (hvor knoglevævet dør pga. manglende blodforsyning til knoglen).
English: You must give to your child within 30 minutes of mixing.
Danish: Du skal give medicinen til dit barn inden for 30 minutter efter blanding.
English: Based on these data, raltegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of these enzymes or P-glycoprotein.
Danish: Baseret på disse data forventes raltegravir ikke at påvirke farmakokinetikken af lægemidler, der er substrater for disse enzymer eller P-glykoprotein.
English: This is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Danish: Det er dette virus, som forårsager erhvervet immundefekt-syndrom (aids).
English: ‡ AUC0-24hr (N = 24); C24hr §AUC0-12hr; C12hr
Danish: ‡AUC0-24t (N = 24); C24t §AUC0-12t; C12t
English: Dizziness may influence some patients' ability to drive and use machines (see section 4.8).
Danish: Svimmelhed kan påvirke patientens evne til at føre motorkøretøj og betjene maskiner (se pkt.
English: Mutations at amino acid 143 confer greater resistance to raltegravir than to elvitegravir, and the E92Q mutation confers greater resistance to elvitegravir than to raltegravir.
Danish: Mutationer ved aminosyre 143 fører til større resistens over for raltegravir end elvitegravir, og E92Q-mutationer fører til større resistens over for elvitegravir end raltegravir.
English: When Isentress should be used
Danish: Hvornår Isentress skal anvendes
English: In both studies at Week 24, suppression of HIV RNA to less than 50 copies/mL was maintained in 84.4 % of the raltegravir group versus 90.6 % of the lopinavir (+) ritonavir group, (Non-completers = Failure).
Danish: I begge studier i uge 24 blev hæmning af hiv-RNA til under 50 kopier/ml opretholdt hos 84,4% af raltegravirgruppen versus 90,6% af lopinavir (+) ritonavir-gruppen (non-completers = failure).
English: for 1 mL or less for 1.5 mL to 3 mL
Danish: til 1 ml eller derunder til 1,5 ml til 3 ml til 3,5 ml til 10 ml
English: Stop when you get to the line that matches your child's prescribed dose.
Danish: Stop, når du kommer til dosismarkeringen, der svarer til dit barns ordinerede dosis.
English: In a comparison of 30 subjects with *28/*28 genotype to 27 subjects with wild-type genotype, the geometric mean ratio (90 % CI) of AUC was 1.41 (0.96, 2.09) and the geometric mean ratio of C12 hr was 1.91 (1.43, 2.55).
Danish: I en sammenligning af 30 forsøgspersoner med *28/*28 genotype med 27 forsøgspersoner med vildtype genotype var den geometriske middelratio (90% CI) af AUC 1,41 (0,96; 2,09) og den geometriske middelratio af C12t var 1,91 (1,43; 2,55).
English: Note before adding Isentress:
Danish: Bemærk, før du tilsætter Isentress:
English: There are no data for the use of raltegravir 1,200 mg once daily in pregnant women.
Danish: Der er ingen data for anvendelse af raltegravir 1.200 mg en gang dagligt til gravide kvinder.
English: Switch to raltegravir
Danish: Skift til raltegravir
English: †Geometric coefficient of variation.
Danish: †Geometrisk variationskoefficient.
English: No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies.
Danish: Der blev ikke observeret tegn på mutagenicitet eller genotoksicitet i in vitro-mikrobielle mutagentest (Ames' test), in vitro-alkaliske elueringsbestemmelser for DNA-beskadigelse og in vitro- og in vivokromosomafvigelsesstudier.
English: The dose should be administered orally within 30 minutes of mixing.
Danish: Dosis skal administreres oralt inden for 30 minutter efter blanding
English: Raltegravir C12 hr was 66 % higher and Cmax was 5 % higher following a moderate-fat meal compared to fasting.
Danish: Raltegravirs C12t var 66% højere, og Cmax var 5% højere efter et måltid med moderat fedtindhold i forhold til faste.
English: • If you are allergic to raltegravir or to any of the other ingredients in this medicine (listed in section 6.
Danish: • hvis du er allergisk over for raltegravir eller et af de øvrige indholdsstoffer i Isentress (angivet i punkt 6).
English: Re-check the amount of Isentress in the syringe.
Danish: Kontroller mængden af Isentress i sprøjten igen.
English: The doctor will work out the right dose of the chewable tablet based on the age and weight of the child.
Danish: Lægen vil udregne den rigtige dosis af tyggetabletten på basis af barnets alder og vægt.
English: There are no data for the use of raltegravir granules for oral suspension in pregnant women.
Danish: Der er ingen data for anvendelse af raltegravir granulat til oral suspension til gravide kvinder.
English: Similarly, darunavir use in OBT in darunavir-naïve patients was counted as one active drug in OBT.
Danish: På samme måde blev anvendelse af darunavir i OBT til darunavir-naive patienter beregnet som et aktivt lægemiddel i OBT.
English: The safety profile observed in patients who used atazanavir and / or tenofovir disoproxil fumarate was generally similar to the safety profile of patients who did not use these agents.
Danish: Den sikkerhedsprofil, der blev observeret hos patienter, som fik atazanavir og/eller tenofovirdisoproxilfumarat, var sædvanligvis den samme som sikkerhedsprofilen hos patienter, der ikke fik disse lægemidler.
English: For raltegravir 1,200 mg (2 x 600 mg) once daily, population PK analysis also demonstrated that the impacts of gender, race, ethnicity and body weight are not clinically meaningful.
Danish: For raltegravir 1.200 mg (2 x 600 mg) en gang dagligt viste den farmakokinetiske populationsanalyse også, at indvirkningen af køn, race, etnicitet og kropsvægt ikke er klinisk relevant.
English: Week 48 and Week 96 outcomes from ONCEMRK are shown in Table 4.
Danish: Uge 48- og 96-resultaterne fra ONCEMRK fremgår af tabel 4.
English: ISENTRESS 600 mg tablet formulation has not been studied in paediatric patients (see section 4.2).
Danish: ISENTRESS 600 mg tabletformuleringen er ikke blevet undersøgt hos pædiatriske patienter (se pkt.