FrancophonIA/ELRC3.0 huggingface dataset:
English: Add the 10 mL of water to the mixing cup
Danish: Tilsæt de 10 ml vand i blandebægeret
English: If at least 4 weeks of age and weighing at least 3 kg to less than 25 kg: Weight based dosing, as specified in Table 2.
Danish: Børn, som er mindst 4 uger gamle og vejer mindst 3 kg til under 25 kg: Vægtbaseret dosering som specificeret i tabel 2.
English: A further 531 treatment-naïve adults have received raltegravir 1,200 mg once daily with emtricitabine and tenofovir disoproxil fumarate for up to 96 weeks.
Danish: Yderligere 531 behandlingsnaive voksne havde fået raltegravir 1.200 mg en gang dagligt sammen med emtricitabin og tenofovirdisoproxilfumarat i op til 96 uger.
English: Keep the booklet and follow it each time you prepare the medicine.
Danish: Gem hæftet og følg brugsvejledningen hver gang, du skal klargøre medicinen.
English: The tablet may also contain trace amount of carnauba wax.
Danish: Tabletten kan også indeholde en spormængde af carnaubavoks.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination anti-retroviral therapy.
Danish: Selvom ætiologien anses for at være multifaktoriel (inklusive kortikosteroid anvendelse, alkoholforbrug, svær immunsuppression, højere BMI), er tilfælde af osteonekrose blevet observeret især blandt patienter med fremskreden hiv-sygdom og/eller langvarig eksponering for antiretroviral kombinationsbehandling.
English: 1 to 4 Weeks - Twice daily dosing
Danish: 1 til 4 uger - dosering to gange dagligt
English: Raltegravir and efavirenz were administered with emtricitabine (+) tenofovir disoproxil fumarate.
Danish: Raltegravir og efavirenz blev administreret sammen med emtricitabin (+) tenofovirdisoproxilfumarat.
English: Talk to your doctor, pharmacist or nurse before taking Isentress.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Isentress.
English: • tipranavir/ritonavir (antiretroviral medicines)
Danish: • tipranavir/ritonavir (antiretrovirale lægemidler)
English: Uncommon accidental overdose
Danish: Ikke almindelig Uforsætlig overdosering
English: The extent to which raltegravir may be dialysable is unknown.
Danish: Det vides ikke, i hvilken grad raltegravir er dialyserbart.
English: • NEW Amount of water for mixing the product
Danish: • NY vandmængde til blanding af præparatet
English: Take 1 sachet of ISENTRESS and shake the granules to the bottom of the sachet.
Danish: Tag 1 foliepose med Isentress og ryst granulatet ned i bunden af folieposen.
English: Raltegravir readily crossed the placenta in rats, but did not penetrate the brain to any appreciable extent.
Danish: Raltegravir passerede uden besvær placenta hos rotter, men penetrerede ikke blod-hjernebarrieren i væsentlig grad.
English: The doctor will tell you how much of the oral suspension the infant or toddler must take.
Danish: Lægen vil fortælle dig, hvor meget oral suspension, spædbarnet eller småbarnet skal tage.
English: IMPAACT P1066 is a Phase I/II open label multicenter trial to evaluate the pharmacokinetic profile, safety, tolerability, and efficacy of raltegravir in HIV infected children.
Danish: IMPAACT P1066 er et fase-I/II åbent, multicenterstudie til evaluering af raltegravirs farmakokinetiske profil, sikkerhed, tolerabilitet samt effektivitet hos hiv-inficerede børn.
English: If you notice any of these symptoms please inform your doctor.
Danish: Hvis du bemærker et eller flere af disse symptomer, skal du kontakte lægen.
English: Contact your doctor, pharmacist or nurse immediately if you experience unexplained muscle pain, tenderness, or weakness while taking this medicine.
Danish: Kontakt straks lægen, apotekspersonalet eller sundhedspersonalet, hvis du oplever uforklarlige muskelsmerter, -ømhed eller -svaghed, mens du tager dette lægemiddel.
English: Hand wash the syringes, plungers, and mixing cup with warm water and dishwashing soap.
Danish: Vask sprøjter, stempler og blandebægre i hånden med varmt vand og opvaskemiddel.
English: Percent of patients with response and associated 95 % confidence interval (CI) are reported.
Danish: Antal patienter (%) med respons samt 95% konfidensinterval (CI) er opgivet.
English: Tell your doctor, pharmacist or nurse immediately if you notice any symptoms of infection, such as fever, and/or feeling unwell.
Danish: Fortæl det straks til din læge, apotekspersonalet eller sundhedspersonalet, hvis du bemærker symptomer på infektion, såsom feber og/eller utilpashed.
English: 60 film-coated tablets Multipack: 180 (3 bottles of 60) film-coated tablets
Danish: 60 filmovertrukne tabletter Multipakning: 180 (3 flasker a 60) filmovertrukne tabletter
English: Contact your doctor promptly if you develop a rash.
Danish: Kontakt straks lægen, hvis du får udslæt.
English: methadone AUC ↔ methadon Cmax ↔
Danish: methadon AUC ↔ methadon Cmax ↔
English: Mutations conferring resistance to raltegravir generally also confer resistance to the integrase strand transfer inhibitor elvitegravir.
Danish: Mutationer, der fører til resistens over for raltegravir, fører generelt også til resistens over for hiv-integrase genomoverførselshæmmeren elvitegravir.
English: For mean CD4 changes, baseline-carryforward was used for virologic failures.
Danish: Til opgørelsen af gennemsnitlige CD4-ændringer blev baseline-carry-forward anvendt ved analyse af virologisk svigt.
English: Ask your doctor, pharmacist or nurse for advice before taking any medicine if you are pregnant or breast-feeding.
Danish: Spørg din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager nogen form for medicin, hvis du er gravid eller ammer.
English: In a single-cycle infection assay, raltegravir inhibited infection of 23 HIV isolates representing 5 non-B subtypes and 5 circulating recombinant forms with IC50 values ranging from 5 to 12 nM.
Danish: I en infektionstest i enkeltserie hæmmede raltegravir infektion af 23 hiv-isolater, der repræsenterede 5 non-B-subtyper og 5 cirkulerende rekombinante former med IC50-værdier fra 5 til 12 nM.
English: Raltegravir at concentrations of 31  20 nM resulted in 95 % inhibition (IC95) of HIV-1 replication (relative to an untreated virus-infected culture) in human T-lymphoid cell cultures infected with the cell-line adapted HIV-1 variant H9IIIB.
Danish: Raltegravir i koncentrationer på 31 ± 20 nM resulterede i 95% hæmning (IC95) af hiv-1 replikation (i forhold til en ubehandlet virusinficeret kultur) i humane T-lymfoide cellekulturer inficeret med cellelinje-adapteret hiv-1 variant H9IIIB.
English: These findings can be extended to raltegravir 1,200 mg once daily and no dosage adjustment is required for these agents.
Danish: Disse resultater kan udvides til raltegravir 1.200 mg en gang dagligt, og dosisjustering er ikke nødvendig for disse lægemidler.
English: IMPAACT P1110 is a Phase I trial to evaluate the safety and pharmacokinetics of raltegravir granules for suspension (GFS) with standard care PMTCT in full term HIV-1-exposed neonates.
Danish: IMPAACT P1110 er et fase I-studie til evaluering af sikkerheden og farmakokinetikken af raltegravir granulat til oral suspension (GFS) ved standardbehandling med PMTCT hos fuldbårne hiv-1eksponerede nyfødte.
English: In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Danish: I tilfælde af overdosering er det hensigtsmæssigt at anvende understøttende standardiserede foranstaltninger, f.eks. fjerne uabsorberet lægemiddel fra mave-tarmkanalen, foretage klinisk monitorering (inklusive elektrokardiogram) og igangsætte understøttende behandling, hvis dette er nødvendigt.
English: • See the instructions for use in the booklet for how to prepare and give a dose of Isentress.
Danish: • Se brugsvejledningen i hæftet for oplysninger om, hvordan dette lægemiddel skal klargøres, og hvordan en dosis Isentress skal gives.
English: Most had a signature mutation at amino acid 155 (N155 changed to H), amino acid 148 (Q148 changed to H, K, or R), or amino acid 143 (Y143 changed to H, C, or R), along with one or more additional integrase mutations (e.g., L74M, E92Q, T97A, E138A/K, G140A/S, V151I, G163R, S230R).
Danish: De fleste havde en signaturmutation ved aminosyre 155 (N155 ændrede sig til H), aminosyre 148 (Q148 ændrede sig til H, K eller R) eller aminosyre 143 (Y143 ændrede sig til H, C eller R) sammen med en eller flere andre integrasemutationer (f.eks. L74M, E92Q, T97A, E138A/K, G140A/S, V151I, G163R, S230R).
English: Viruses harbouring a mutation at amino acid 148, along with one or more other raltegravir resistance mutations, may also have clinically significant resistance to dolutegravir.
Danish: Vira, der skjuler en mutation ved aminosyre 148 sammen med en eller flere andre raltegravir resistensmutationer, kan også medføre klinisk signifikant resistens over for dolutegravir.
English: Therefore ISENTRESS should be used with caution in this population.
Danish: ISENTRESS bør derfor anvendes med forsigtighed til denne patientgruppe.
English: Maximum dose of oral suspension is 100 mg twice daily.
Danish: Maksimal dosis for oral suspension er 100 mg to gange dagligt.
English: For each of the following clinical adverse reactions there was at least one serious occurrence: genital herpes, anaemia, immune reconstitution syndrome, depression, mental disorder, suicide attempt, gastritis, hepatitis, renal failure, accidental overdose.
Danish: For hver af følgende kliniske bivirkninger var der mindst en alvorlig hændelse: genital herpes, anæmi, immunreaktiveringssyndrom, depression, mentale forstyrrelser, selvmordsforsøg, gastritis, hepatitis, nedsat nyrefunktion, accidentel overdosering.
English: • Prior to breaking the seal, this product does not require any special storage conditions.
Danish: • Før forseglingen brydes, kræver dette lægemiddel ingen særlige forholdsregler vedrørende opbevaringen.
English: The doctor will work out the right dose of granules for oral suspension based on the age and weight of the infant or toddler.
Danish: Lægen vil udregne den rigtige dosis af granulat til oral suspension på basis af spædbarnets eller småbarnets alder og vægt.
English: In the second study (n=16), the median cerebrospinal fluid concentration was 3 % (range 1 to 61 %) of the corresponding plasma concentration.
Danish: I det andet studie (n = 16) var den gennemsnitlige koncentration i cerebrospinalvæsken 3% (interval: 1 til 61%) af den tilsvarende plasmakoncentration.
English: It is not recommended to take Isentress with certain antacids (those containing aluminium and/or magnesium).
Danish: Det frarådes at tage Isentress sammen med visse lægemidler mod for meget mavesyre (de, der indeholder aluminium og/eller magnesium).
English: As demonstrated in healthy volunteers administered single oral doses of raltegravir in the fasted state, raltegravir is rapidly absorbed with a tmax of approximately 3 hours postdose.
Danish: Som vist hos raske, frivillige forsøgspersoner, der fik en enkelt oral dosis raltegravir under faste, absorberes raltegravir hurtigt med tmax på cirka 3 timer efter dosering.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In clinical trials, there were 79 patients co-infected with hepatitis B, 84 co-infected with hepatitis C, and 8 patients co-infected with hepatitis B and C who were treated with raltegravir in combination with other agents for HIV-1.
Danish: Patienter koinficeret med hepatitis B- og/eller hepatitis C-virus I kliniske studier var der 79 patienter koinficeret med hepatitis B, 84 koinficeret med med hepatitis C og 8 patienter koinficeret med med hepatitis B og C, som blev behandlet med raltegravir i kombination med andre lægemidler til hiv-1.
English: • NEW Directions for dose preparation
Danish: • NYE anvisninger for klargøring af dosis
English: Pull the plungers out of any syringes you used.
Danish: Tag stemplerne ud af de brugte sprøjter.
English: Myopathy and rhabdomyolysis have been reported.
Danish: Myopati og rabdomyolyse har været rapporteret.
English: In two studies of HIV-1 infected patients who received raltegravir 400 mg twice daily, raltegravir was readily detected in the cerebrospinal fluid.
Danish: I to studier med hiv-1-inficerede patienter, som fik raltegravir 400 mg to gange dagligt, blev raltegravir hurtigt påvist i cerebrospinalvæsken.
English: See section 4.2 for dosing recommendations.
Danish: 4.2 for doserinsanbefalinger.
English: Pink, oval tablet, marked with "227" on one side.
Danish: Lyserød, oval tablet, præget med "227" på den ene side.
English: No effect on fertility was seen in male and female rats at doses up to 600 mg/kg/day which resulted in 3-fold exposure above the exposure at the recommended human dose.
Danish: Der er ikke set virkning på fertiliteten hos han- og hunrotter ved doser på op til 600 mg/kg/dag, hvilket resulterede i en eksponering, der var 3 gange højere end eksponeringen ved den anbefalede dosis til mennesker.
English: If it is less than the prescribed dose, put the tip back into the cup of prepared Isentress and pull back on the plunger until you get to the right dose mark.
Danish: Hvis der er mindre end den ordinerede dosis, skal du sætte sprøjtespidsen ned i bægeret med klargjort Isentress igen og trække stemplet tilbage, indtil du rammer den korrekte dosismarkering.
English: For details on preparation and administration of the suspension, see section 6.6.
Danish: For nærmere oplysninger om klargøring og administration af suspensionen, se pkt.
English: Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking this medicine.
Danish: Der er rapporteret om alvorlige og livstruende hudreaktioner og overfølsomhedsreaktioner hos nogle patienter, der tager dette lægemiddel.
English: The mixture should look cloudy.
Danish: Blandingen skal fremstå som uklar.
English: The signature mutations decrease viral susceptibility to raltegravir and addition of other mutations results in a further decrease in raltegravir susceptibility.
Danish: Signaturmutationerne reducerer den virale modtagelighed over for raltegravir og tilføjelse af andre mutationer medfører en yderligere reduktion af raltegravirs modtagelighed.
English: Isentress must be used in combination with other medicines for HIV.
Danish: Isentress skal tages sammen med anden hiv-medicin.
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Danish: Generelt ved beslutning om anvendelse af antiretrovirale lægemidler til behandling af hiv-infektion hos gravide for dermed at reducere risikoen for vertikal overførsel af hiv til det nyfødte barn, bør data både fra dyrestudier og klinisk erfaring hos gravide tages i betragtning for at kunne beskrive sikkerheden for fostret.
English: In randomised clinical trials raltegravir 400 mg twice daily was administered in combination with fixed or optimised background treatment regimens to treatment-naïve (N=547) and treatmentexperienced (N=462) adults for up to 96 weeks.
Danish: I randomiserede kliniske studier blev raltegravir 400 mg administreret to gange dagligt i kombination med faste regimer eller optimerede baggrundsbehandlingsregimer til behandlingsnaive (N=547) og behandlingserfarne (N=462) voksne i op til 96 uger.
English: Tear or cut open the sachet and add all of the granules to the water in the mixing cup.
Danish: Afriv eller klip folieposen op og hæld alt granulatet ned i vandet i blandebægeret.
English: Common decreased appetite
Danish: Nedsat appetit
English: The dosing recommendations are based on approximately: 1.5 mg/kg/dose.
Danish: Doseringsanbefalingerne er baseret på ca.: 1,5 mg/kg/dosis.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienterne bør tilrådes at søge lægehjælp ved ledsmerter, ledstivhed eller bevægelsesbesvær.
English: In faeces, only raltegravir was present, most of which is likely to be derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species.
Danish: I fæces var kun raltegravir til stede, hvoraf størstedelen sandsynligvis stammer fra hydrolyse af raltegravirglucuronid udskilt i galden, som det sås i de prækliniske arter.
English: Children should keep scheduled doctor's visits because their Isentress dosage should be adjusted as they get older, grow or gain weight.
Danish: Børn skal overholde de planlagte besøg hos lægen, da doseringen af Isentress skal justeres, efterhånden som de bliver ældre, vokser eller stiger i vægt.
English: For patients weighing between 11 and 20 kg, either the chewable tablet or oral suspension can be used, as specified in Table 2.
Danish: Til patienter, der vejer mellem 11 og 20 kg, kan enten tyggetabletten eller den orale suspension anvendes som specificeret i tabel 2.
English: These results indicate that raltegravir is not an inducer or inhibitor of CYP3A4, and raltegravir is thus not anticipated to affect the pharmacokinetics of medicinal products which are CYP3A4 substrates.
Danish: Disse resultater indikerer, at raltegravir ikke inducerer eller hæmmer CYP3A4, og raltegravir forventes således ikke at påvirke farmakokinetikken af de lægemidler, som er CYP3A4-substrater.
English: Grade 2-4 creatine kinase laboratory abnormalities were observed in patients treated with raltegravir.
Danish: Der blev observeret abnorme laboratorieværdier for kreatinkinase, grad 2-4, hos patienter, der blev behandlet med raltegravir.
English: No studies have been conducted to evaluate the drug interactions of ritonavir, tipranavir/ritonavir, boceprevir or etravirine with raltegravir 1,200 mg (2 x 600 mg) once daily.
Danish: Der er ikke udført studier, der evaluerer lægemiddelinteraktionen for ritonavir, tipranavir/ritonavir, boceprevir eller etravirin med raltegravir 1.200 mg (2 x 600 mg) en gang dagligt.
English: Raltegravir achieved virologic responses (using Not Completer=Failure approach) of HIV RNA < 50 copies/mL in 61.7 % of patients at Week 16, in 62.1 % at Week 48 and in 57.0 % at Week 96.
Danish: Raltegravir opnåede virologisk respons (med Non-Completer = Failure-analysen) for hiv-RNA <50 kopier/ml hos 61,7% af patienterne ved uge 16, hos 62,1% ved uge 48 og hos 57,0% ved uge 96.
English: From the clinical trials, a large proportion of patients used atazanavir and / or tenofovir disoproxil fumarate, both agents that result in increases in raltegravir plasma levels, in the optimised background regimens.
Danish: En stor del af patienterne i de kliniske studier fik atazanavir og/eller tenofovirdisoproxilfumarat, og begge lægemidler medførte stigning i raltegravirs plasmakoncentrationer i de optimerede baggrundsregimer.
English: ISENTRESS 600 mg tablets can be administered with or without food as a 1,200 mg once daily dose.
Danish: ISENTRESS 600 mg tabletter kan administreres med eller uden mad som en dosis på 1.200 mg en gang dagligt.
English: There were no clinically important pharmacokinetic differences due to gender, race, ethnicity or body weight in adults for raltegravir 400 mg twice daily, and no clinically meaningful effect on raltegravir pharmacokinetics was concluded.
Danish: Der var ingen klinisk betydningsfulde farmakokinetiske forskelle på grund af køn, race, etnicitet eller kropsvægt hos voksne for raltegravir 400 mg to gange dagligt, og ingen klinisk relevant effekt på raltegravirs farmakokinetik blev fastsat.
English: In some studies, co-administration of raltegravir with darunavir resulted in a modest decrease in darunavir plasma concentrations; the mechanism for this effect is unknown.
Danish: I nogle studier medførte samtidig administration af raltegravir og darunavir et beskedent fald i darunavirs plasmakoncentration; mekanismen for denne virkning er ukendt.
English: Non-Clade B
Danish: Virusundertype Clade B Non-Clade B
English: Patients with chronic hepatitis B or C and treated with combination anti-retroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, der har fået antiretroviral kombinationsbehandling, har større risiko for at få svære og potentielt letale leverbivirkninger.
English: The dosing recommendations are based on approximately: 3 mg/kg/dose.
Danish: Doseringsanbefalingerne er baseret på ca.: 3 mg/kg/dosis.
English: In patients, after 1,200 mg once daily raltegravir dosing, steady state AUC0-24 was 53.7 h·μM, C24 was 75.6 nM, and median Tmax was 1.50 h.
Danish: Efter dosering med raltegravir 1.200 mg en gang dagligt hos patienterne var AUC0-24 ved steady state 53,7 t·μM, C24 var 75,6 nM, og median Tmax var 1,50 timer.
English: Population pharmacokinetic analysis from ONCEMRK (Protocol 292) showed that co-administration of raltegravir 1,200 mg once daily with PPIs or H2 blockers did not result in statistically significant changes in the pharmacokinetics of raltegravir.
Danish: Farmakokinetisk populationsanalyse fra ONCEMRK (Protokol 292) viste, at administration af raltegravir 1.200 mg en gang dagligt sammen med protonpumpehæmmere eller H2-blokkere ikke medførte statistisk signifikante ændringer i raltegravirs farmakokinetik.
English: There were no drug related clinical adverse experiences and three drug-related laboratory adverse experiences (one a transient Grade 4 neutropenia in a subject receiving zidovudine containing prevention of mother to child transmission (PMTCT), and two bilirubin elevations (one each, Grade 1 and Grade 2) considered non-serious and not requiring specific therapy).
Danish: Der var ingen lægemiddelrelaterede kliniske bivirkninger og tre lægemiddelrelaterede bivirkninger fundet i laboratorieundersøgelser (et tilfælde af forbigående grad 4 neutropeni hos en forsøgsperson, der havde fået zidovudin som forebyggende behandling til at forhindre overførsel af hiv-smitte fra mor til barn (PMTCT), og to tilfælde af forhøjet bilirubin (en af hver, grad 1 og grad 2), som blev anset for at være ikke alvorlige og som ikke påkrævede specifik behandling).
English: The 400 mg tablet should not be used to administer the 1,200 mg once daily regimen.
Danish: 400 mg tabletten må ikke anvendes til at administrere regimet med 1.200 mg en gang dagligt.
English: • Do not use this medicine after the expiry date which is stated on the carton and sachet after
Danish: • Tag ikke lægemidlet efter den udløbsdato, der står på kartonen og folieposen efter EXP.
English: Raltegravir 1,200 mg once daily is also rapidly absorbed with median Tmax ~1.5 to 2 hours in the fasted state and generates a sharper absorption peak with a tendency to higher Cmax in comparison to raltegravir twice daily (1 x 400 mg tablet twice daily).
Danish: Raltegravir 1.200 mg en gang dagligt absorberes også hurtigt med median Tmax ~1,5 til 2 timer i fastende tilstand og genererer en skarpere maksimal absorptionsværdi med en tendens til højere Cmax i forhold til raltegravir to gange dagligt (1 x 400 mg tablet to gange dagligt).
English: Administration of multiple doses of raltegravir following a moderate-fat meal did not affect raltegravir AUC to a clinically meaningful degree with an increase of 13 % relative to fasting.
Danish: Administration af raltegravir i multiple doser efter et måltid med moderat fedtindhold påvirkede ikke raltegravirs AUC i klinisk relevant grad med en forhøjelse på 13% i forhold til faste.
English: Raltegravir 1,200 mg is not recommended during pregnancy.
Danish: Raltegravir 1.200 mg frarådes under graviditet.