FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults, there were no clinically important pharmacokinetic differences between patients with moderate hepatic insufficiency and healthy subjects.
Danish: Hos voksne var der ingen klinisk betydningsfulde farmakokinetiske forskelle mellem patienter med moderat leverinsufficiens og raske personer.
English: • hot flush; high blood pressure
Danish: • Hedeture, forhøjet blodtryk
English: Isentress is an antiviral medicine that works against the Human Immunodeficiency Virus (HIV).
Danish: Isentress er et antivirus, som virker mod humant immundefekt-virus (hiv).
English: One patient experienced drug related clinical adverse reactions of Grade 3 psychomotor hyperactivity, abnormal behaviour and insomnia; one patient experienced a Grade 2 serious drug related allergic rash.
Danish: En patient fik lægemiddelrelaterede kliniske bivirkninger i form af psykomotorisk hyperaktivitet, abnorm adfærd samt insomni af grad 3; en patient fik alvorligt lægemiddelrelateret allergisk udslæt af grad 2.
English: Caution is recommended when co-administering raltegravir 1,200 mg once daily with sensitive OAT1 and/or OAT3 substrates.
Danish: Det anbefales at udvise forsigtighed, når raltegravir 1.200 mg en gang dagligt administreres sammen med følsomme OAT1- og/eller OAT3-substrater.
English: Common abnormal dreams, insomnia, nightmare, abnormal behaviour, depression
Danish: Unormale drømme, insomni, mareridt, unormal adfærd, depression
English: Available pharmacodynamics/toxicological data in animals have shown excretion of raltegravir/metabolites in milk (for details see section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyrestudier viser, at raltegravir/metabolitter udskilles i mælk (se pkt.
English: If you are not sure, call your doctor.
Danish: Er du i tvivl, så spørg lægen.
English: Mix Isentress and water
Danish: Bland Isentress og vand
English: Uncommon palpitations, sinus bradycardia, ventricular extrasystoles
Danish: Ikke almindelig Palpitationer, sinusbradykardi, ventrikulære ekstrasystoler
English: Cancers were reported in treatment-experienced and treatment-naïve patients who initiated raltegravir in conjunction with other antiretroviral agents.
Danish: Cancer blev rapporteret hos behandlingserfarne og behandlingsnaive patienter, som startede i behandling med raltegravir sammen med andre antiretrovirale lægemidler.
English: Safety profiles in the subgroup of patients in Phase III trials taking proton pump inhibitors or H2 antagonists were comparable with those who were not taking these antacids.
Danish: Sikkerhedsprofilen for subgruppen af patienter i fase III, som tog protonpumpehæmmere eller H2-antagonister, var den samme som hos dem, der ikke tog disse lægemidler mod for meget mavesyre.
English: In treatment-naïve patients, the clinical study data on use of raltegravir are limited to use in combination with two nucleotide reverse transcriptase inhibitors (NRTIs) (emtricitabine and tenofovir disoproxil fumarate).
Danish: Ved behandling af naive patienter er anvendelse af raltegravir, på basis af kliniske studiedata, begrænset til anvendelse i kombination med to NRTIer (emtricitabin og tenofovirdisoproxilfumarat).
English: • This medicine has been prescribed for you or your child only.
Danish: • Lægen har ordineret Isentress til dig eller dit barn personligt.
English: Raltegravir Pharmacokinetic Parameters IMPAACT P1066 Following Administration of Doses in Section 4.2
Danish: Raltegravirs farmakokinetiske parametre IMPAACT P1066 efter administration af doser i pkt.
English: BLUE
Danish: BLÅ
English: In the first study (n=18), the median cerebrospinal fluid concentration was 5.8 % (range 1 to 53.5 %) of the corresponding plasma concentration.
Danish: I det ene studie (n = 18) var den gennemsnitlige koncentration i cerebrospinalvæsken 5,8% (interval: 1 til 53,5%) af den tilsvarende plasmakoncentration.
English: The treatment difference (raltegravir - efavirenz) was 4.2 % with an associated 95 % CI of (-1.9, 10.3) establishing that raltegravir is non-inferior to efavirenz (pvalue for non-inferiority < 0.001).
Danish: Behandlingsdifferencen (raltegravir - efavirenz) var 4,2% med associeret 95% konfidensinterval (-1,9; 10,3), hvilket fastslog, at raltegravir er non-inferior til efavirenz (p-værdi for non-inferioritet <0,001).
English: One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which were considered serious.
Danish: En patient oplevede lægemiddelrelaterede abnorme laboratorieværdier, ASAT grad 4 og ALAT grad 3, som blev anset for alvorligt.
English: • rifampicin (a medicine used to treat some infections such as tuberculosis)
Danish: • rifampicin (medicin til behandling af infektioner som fx tuberkulose)
English: Comprehensive drug interaction studies were performed with raltegravir 400 mg twice daily and a limited number of drug interaction studies were performed for raltegravir 1,200 mg once daily.
Danish: Omfattende lægemiddelinteraktionsstudier er udført med raltegravir 400 mg to gange dagligt, og et begrænset antal lægemiddelinteraktionsstudier er udført med raltegravir 1.200 mg en gang dagligt.
English: Less potent UGT1A1 inhibitors (e.g., indinavir, saquinavir) may also increase plasma levels of raltegravir, but to a lesser extent compared with atazanavir.
Danish: Mindre potente UGT1A1-hæmmere (f.eks. indinavir, saquinavir) kan også øge raltegravirs plasmakoncentration, men i mindre grad end atazanavir.
English: • Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Danish: • Tag ikke lægemidlet efter den udløbsdato, der står på flasken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Effect of raltegravir on the pharmacokinetics of other medicinal products
Danish: Raltegravirs virkning på andre lægemidlers farmakokinetik
English: Table 9: Raltegravir Pharmacokinetic Parameters IMPAACT P1110 Following Age and Weight Based Dosing of the Granules for Suspension
Danish: Tabel 9: Raltegravirs farmakokinetiske parametre IMPAACT P1110 efter alders- og vægtbaseret dosering af granulat til oral suspension
English: Depression, including suicidal thoughts and behaviours, has been reported in some patients taking this medicine, particularly in patients with a prior history of depression or psychiatric illness.
Danish: Der er rapporteret om depression, herunder selvmordstanker og -adfærd hos nogle patienter, som tager dette lægemiddel, især hos patienter, som tidligere har haft depression eller psykisk sygdom.
English: Two tablets once a day
Danish: Oral anvendelse To tabletter en gang dagligt
English: In studies of raltegravir 400 mg twice daily, cancers were reported in treatment-experienced and treatment-naïve patients who initiated raltegravir in conjunction with other antiretroviral agents.
Danish: I studier med raltegravir 400 mg to gange dagligt blev cancer rapporteret hos behandlingserfarne og behandlingsnaive patienter, som startede i behandling med raltegravir sammen med andre antiretrovirale lægemidler.
English: Caution should be used in patients with a pre-existing history of depression or psychiatric illness.
Danish: Forsigtighed bør udvises hos patienter med depression eller psykisk sygdom i anamnesen.
English: In clinical studies of treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing raltegravir and darunavir compared to those containing raltegravir without darunavir or darunavir without raltegravir.
Danish: I kliniske studier med behandlingserfarne patienter sås udslæt oftere, uanset kausalitet, ved behandlingsregimer med raltegravir og darunavir end ved de regimer, der indeholdt raltegravir uden darunavir eller darunavir uden raltegravir.
English: • palpitations; slow heart rates; fast or irregular heart beats
Danish: • Hjertebanken, langsom hjerterytme, hurtig eller uregelmæssig hjerterytme
English: Tell your doctor if you have a history of depression or psychiatric illness.
Danish: Fortæl det til lægen, hvis du har eller tidligere har haft depression eller psykisk sygdom.
English: There is limited information regarding the use of raltegravir in the elderly (see section 5.2).
Danish: Der foreligger kun begrænset information om brugen af raltegravir til ældre patienter (se pkt.
English: One patient experienced a Grade 3 serious drug related allergic rash that resulted in treatment discontinuation.
Danish: En patient fik alvorligt lægemiddelrelateret allergisk udslæt af grad 3, som medførte seponering af behandlingen.
English: Effect of other medicinal products on the pharmacokinetics of raltegravir
Danish: Andre lægemidlers virkning på raltegravirs farmakokinetik
English: Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, developmental toxicity and juvenile toxicity, have been conducted with raltegravir in mice, rats, dogs and rabbits.
Danish: Der er udført præ-kliniske toksikologistudier, inklusive konventionelle studier af sikkerhedsfarmakologien, gentagen dosistoksicitet, genotoksicitet, udviklingstoksicitet og juvenil toksicitet, med raltegravir hos mus, rotter, hunde og kaniner.
English: Population PK analysis showed that the effect of emtricitabine/tenofovir disaproxil fumarate on raltegravir pharmacokinetics was minimal (12% increase in relative bioavailability), and was not statistically or clinically significant.
Danish: Farmakokinetisk populationsanalyse viste, at indvirkningen af emtricitabin/tenofovirdisaproxilfumarat på raltegravirs farmakokinetik var minimal (stigning på 12% i relativ biotilgængelighed), og den var ikke statistisk eller klinisk signifikant.
English: Note: The chewable tablets are available as 25 mg and 100 mg tablets.
Danish: Bemærk: Tyggetabletten fås som 25 mg og 100 mg tabletter.
English: ISENTRESS 400 mg tablets can be administered with or without food.
Danish: ISENTRESS 400 mg tabletterne kan administreres med eller uden mad.
English: For patients weighing between 11 and 20 kg, either the granules for oral suspension or the chewable tablet can be used as specified in Table 1 (see section 5.2).
Danish: Til patienter, der vejer mellem 11 og 20 kg, kan enten granulatet til oral suspension eller tyggetabletten anvendes som specificeret i tabel 1 (se pkt.
English: • Before you give Isentress to your child, check the expiration date.
Danish: • Kontroller udløbsdatoen, før du giver Isentress til dit barn.
English: • rifampicin (a medicine used to treat some infections such as tuberculosis), as it may decrease your levels of Isentress.
Danish: • rifampicin (medicin til behandling af infektioner som fx tuberkulose), da det kan nedsætte indholdet af Isentress i blodet.
English: In these 96 children and adolescents, frequency, type and severity of drug related adverse reactions through Week 48 were comparable to those observed in adults.
Danish: Hos disse 96 børn og unge var bivirkningernes frekvens, type og sværhedsgrad til og med uge 48 de samme som set hos voksne patienter.
English: The recommended dose of Isentress is 400 mg by mouth, twice a day for adolescents and children weighing at least 25 kg.
Danish: Den anbefalede dosis Isentress er 400 mg gennem munden to gange dagligt til unge samt børn, der vejer mindst 25 kg.
English: Strong inducers of drug metabolizing enzymes
Danish: Stærke inducere af lægemiddelmetaboliserende enzymer
English: Raltegravir 600 mg tablets (2 x 600 mg once daily) may be administered with or without food.
Danish: Raltegravir 600 mg tabletter (2 x 600 mg en gang dagligt) kan administreres med eller uden mad.
English: ISENTRESS granules for oral suspension contain fructose, sorbitol and sucrose.
Danish: ISENTRESS granulat til oral suspension indeholder fructose, sorbitol og sucrose.
English: Muscle problems
Danish: Muskelproblemer
English: There are no data for the use of raltegravir chewable tablets in pregnant women.
Danish: Der er ingen data for anvendelse af raltegravir tyggetabletter til gravide kvinder.
English: In addition, relative to the raltegravir 400 mg formulation the raltegravir 600 mg formulation used in the 1,200 mg (2 x 600 mg) once daily dosing regimen has higher relative bioavailability (by 21 to 66%).
Danish: I forhold til raltegravir 400 mg formuleringen har raltegravir 600 mg formuleringen, der anvendes i doseringsregimet med 1.200 mg (2 x 600 mg) en gang dagligt, desuden højere relativ biotilgængelighed (med 21 til 66%).
English: Do not change the dose or stop taking this medicine without first talking with your doctor, pharmacist or nurse.
Danish: Du må ikke ændre dosis eller stoppe med at tage lægemidlet uden først at tale med lægen, apotekspersonalet eller sundhedspersonalet.
English: The chewable tablets and the granules for oral suspension have not been studied in HIV-infected adolescents (12 to 18 years) or adults.
Danish: Tyggetabletterne og granulatet til oral suspension er ikke undersøgt hos hiv-inficerede unge (12-18 år) eller voksne.
English: ISENTRESS should be used in combination with other active anti-retroviral therapies (ARTs) (see sections 4.4 and 5.1).
Danish: ISENTRESS bør anvendes i kombination med andre aktive antiretrovirale behandlinger (ARTer) (se pkt.
English: No dosage adjustment is required for patients with mild to moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion.
English: • Isentress granules for oral suspension are not recommended in pregnancy because they have not been studied in pregnant women.
Danish: • Isentress granulat til oral suspension må ikke bruges under graviditet, da det ikke er undersøgt hos gravide.
English: Isentress contains the active substance raltegravir.
Danish: Isentress indeholder det aktive stof raltegravir.
English: No dosage adjustment required for raltegravir or hormonal contraceptives (estrogenand/or progesterone-based).
Danish: Dosisjustering af raltegravir eller hormonelle antikonceptionsmidler (østrogen- og/eller progesteronbaserede) er ikke nødvendig.
English: Your child can take this medicine with or without food or drink.
Danish: Dit barn kan tage dette lægemiddel med eller uden mad eller drikke.
English: Anti-retroviral Pregnancy Registry
Danish: Antiretroviralt graviditetsregister
English: Previous studies of raltegravir 400 mg twice daily showed that co-administration of tenofovir disoproxil fumarate (a component of emtricitabine/tenofovir disaproxil fumarate) increased raltegravir exposure.
Danish: Tidligere studier med raltegravir 400 mg to gange dagligt viste, at samtidig administration af tenofovirdisoproxilfumarat (en komponent af emtricitabin/tenofovirdisaproxilfumarat) øgede eksponeringen for raltegravir.
English: Population PK analysis showed that the effect of gastric pH altering agents on raltegravir pharmacokinetics was minimal (8.8% decrease in relative bioavailability), and was not statistically or clinically significant.
Danish: Farmakokinetisk populationsanalyse viste, at indvirkningen af lægemidler, der ændrer gastrisk pH, på raltegravirs farmakokinetik var minimal (fald på 8,8% i relativ biotilgængelighed), og den var ikke statistisk eller klinisk signifikant.
English: Slowly push in the plunger to give the prepared Isentress.
Danish: Tryk forsigtigt stemplet ned for at give den klargjorte Isentress.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Blandt hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomerne.
English: • drug ingestion in quantities greater than recommended
Danish: • Indtagelse af større mængde lægemiddel end anbefalet.
English: (chelation of metal cations)
Danish: (kelation med metalkation)
English: Do not switch with other strengths or formulations of Isentress without first talking with your doctor, pharmacist or nurse.
Danish: Udskift ikke med andre styrker eller formuleringer af Isentress uden først at tale med lægen, apotekspersonalet eller sundhedspersonalet.
English: Prior to randomisation, OBT were selected by the investigator based on the patient's prior treatment history, as well as baseline genotypic and phenotypic viral resistance testing.
Danish: Før randomisering blev OBT valgt af investigator på baggrund af patientens behandlingsanamnese, samt testning af genotypisk og fænotypisk virusresistens ved baseline.
English: Table 3 Pharmacokinetic Interaction Data in Adults
Danish: Tabel 3 Farmakokinetiske interaktionsdata hos voksne
English: ISENTRESS 600 mg film-coated tablet formulation should not be used in children weighing less than 40 kg.
Danish: Pædiatrisk population ISENTRESS 600 mg filmovertrukne tabletter må ikke anvendes til børn, der vejer under 40 kg.
English: In these 26 infants and toddlers, the frequency, type and severity of drug related adverse reactions through Week 48 were comparable to those observed in adults.
Danish: Hos disse 26 spædbørn og småbørn var bivirkningernes frekvens, type og sværhedsgrad til og med uge 48 de samme som set hos voksne patienter.
English: • 60 sachets of Isentress granules
Danish: • 60 folieposer med Isentress granulat
English: Infants and toddlers 4 weeks to less than 2 years of age IMPAACT P1066 also enrolled HIV-infected, infants and toddlers 4 weeks to less than 2 years of age who had received prior antiretroviral therapy either as prophylaxis for prevention of mother to child transmission (PMTCT) and/or as combination antiretroviral therapy for treatment of HIV infection.
Danish: Spædbørn og småbørn i alderen 4 uger til under 2 år I IMPAACT P1066 deltog også hiv-inficerede spædbørn og småbørn i alderen 4 uger til under 2 år, som tidligere havde fået antiretroviral terapi enten som forebyggende behandling til at forhindre overførsel af hiv-smitte fra mor til barn (PMTCT) og/eller som antiretroviral kombinationsterapi til behandling af hiv-infektion.
English: Rifampicin reduces plasma levels of raltegravir; the impact on the efficacy of raltegravir is unknown.
Danish: Rifampicin reducerer plasmakoncentrationen af raltegravir; indvirkningen på raltegravirs virkning er ukendt.
English: 2 white (1 mL) syringes
Danish: 2 hvide (1 ml) sprøjter
English: Uncommon skin papilloma
Danish: Ikke almindelig Papillomer i huden
English: ISENTRESS is also available in a 400 mg tablet for use in adults, adolescents and children weighing at least 25 kg and able to swallow a tablet.
Danish: ISENTRESS fås også som en 400 mg tablet til anvendelse til voksne, unge og børn, som vejer mindst 25 kg og som er i stand til at sluge en tablet.
English: Uncommon dysphonia, epistaxis, nasal congestion
Danish: Ikke almindelig Dysfoni, epistaxis, nasal kongestion
English: The granules for oral suspension and the chewable tablets have not been studied in HIV-infected adolescents (12 to 18 years) or adults.
Danish: Granulatet til oral suspension og tyggetabletterne er ikke undersøgt hos hiv-inficerede unge (12-18 år) eller voksne.
English: White to off-white, granular powder that may contain yellow or beige to tan particles, in a single-use sachet.
Danish: Hvidt til råhvidt granulat, som kan indeholde gule eller beige til gulbrune partikler i en foliepose til engangsbrug.
English: Contains fructose, sorbitol and aspartame.
Danish: Indeholder fructose, sorbitol og aspartam.
English: The recommended dosage for paediatric patients of at least 25 kg body weight is 400 mg (one tablet) twice daily.
Danish: Den anbefalede dosering til pædiatriske patienter, der vejer mindst 25 kg, er 400 mg (en tablet) to gange dagligt.
English: Thus, the data indicate that the major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation.
Danish: Data indikerer således, at raltegravirs væsentligste clearance-mekanisme hos mennesker er UGT1A1-medieret glucuronidering.
English: Other medicines and Isentress
Danish: Brug af anden medicin sammen med Isentress
English: The tablet can be divided into equal 50 mg doses.
Danish: Tabletten kan deles i to lige store doser af 50 mg.
English: In some studies, co-administration of raltegravir 400 mg tablets twice daily with darunavir resulted in a modest but clinically insignificant decrease in darunavir plasma concentrations.
Danish: I nogle studier medførte samtidig administration af raltegravir 400 mg tabletter to gange dagligt og darunavir et beskedent, men klinisk insignifikant fald i darunavirs plasmakoncentration.
English: In addition, raltegravir inhibited viral replication in cultures of mitogen-activated human peripheral blood mononuclear cells infected with diverse, primary clinical isolates of HIV-1, including isolates from 5 non-B subtypes, and isolates resistant to reverse transcriptase inhibitors and protease inhibitors.
Danish: Desuden hæmmede raltegravir den virale replikation i kulturer af mitogenaktiverede mononukleære celler fra humant perifert blod inficeret med forskellige, primære kliniske isolater af hiv-1, inklusive isolater fra 5 non-B subtyper, og isolater, som var resistente over for reverse transkriptasehæmmere og proteasehæmmere.
English: Discontinue raltegravir and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia, angioedema).
Danish: Raltegravir og andre mistænkte lægemidler skal seponeres omgående, hvis der opstår tegn eller symptomer på alvorlige hud- eller overfølsomhedsreaktioner (inklusive, men ikke begrænset til, alvorligt udslæt eller udslæt med feber, generel utilpashed, træthed, muskel- eller ledsmerter, blærer, sår i munden, konjunktivitis, ansigtsødem, hepatitis, eosinofili, angioødem).
English: ISENTRESS granules for oral suspension can be administered with or without food (see section 5.2).
Danish: ISENTRESS granulat til oral suspension kan administreres med eller uden mad (se pkt.
English: Use with caution in patients who have had myopathy or rhabdomyolysis in the past or have any predisposing issues including other medicinal products associated with these conditions (see section 4.4).
Danish: Anvendes med forsigtighed hos patienter, der tidligere har haft myopati eller rabdomyolyse eller er prædisponerede herfor, inklusive andre lægemidler, der er associeret med disse tilstande (se pkt.
English: 25 to less than 28
Danish: 25 til under 28
English: Patients with rare hereditary problems of fructose intolerance glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med fructoseintolerans, glucose-galactose-malabsorption eller sucraseisomaltase-mangel bør ikke tage dette lægemiddel.
English: • certain kinds of kidney problems
Danish: • Visse typer nyresygdomme
English: Extrapolated from 400 mg twice daily study
Danish: Ekstrapoleret fra studiet med 400 mg to gange dagligt
English: Raltegravir should not be used during breast-feeding.
Danish: Raltegravir må ikke anvendes under amning.
English: gastric pH altering agents: proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine, ranitidine, cimitedine)
Danish: lægemidler, der ændrer gastrisk pH protonpumpehæmmere (f.eks. omeprazol), H2-blokkere (f.eks. famotidin, ranitidin, cimitedin)
English: Depression, including suicidal ideation and behaviours, has been reported, particularly in patients with a pre-existing history of depression or psychiatric illness.
Danish: Der er rapporteret om depression, herunder selvmordstanker og -adfærd, især hos patienter med depression eller psykisk sygdom i anamnesen.