FrancophonIA/ELRC3.0 huggingface dataset:
English: Rolapitant had no significant effects on the pharmacokinetics of dexamethasone when oral dexamethasone was administered on Days 1 to 3 after a single 180 mg dose of rolapitant was coadministered on Day 1.
Danish: Rolapitant havde ingen signifikant indvirkning på dexamethasons farmakokinetik, når oral dexamethason blev administreret på dag 1 til 3, efter at en enkelt 180 mg dosis rolapitant blev administreret samtidigt på dag 1.
English: There are limited data in patients with severe renal impairment (see section 5.2).
Danish: Der foreligger begrænsede data for patienter med svært nedsat nyrefunktion (se pkt.
English: Rolapitant (N=264) Rate (%)
Danish: Rolapitant (N = 264), andel (%)
English: Control (N=273) Rate
Danish: Kontrol (N = 273), andel
English: No Significant Nausea
Danish: Ingen signifikant kvalme Akut fase
English: Varuby in patients who require chronic administration of strong inducers (e.g. rifampicin, carbamazepine, enzalutamide, phenytoin) is not recommended (see section 4.4).
Danish: Varuby anbefales ikke til patienter, der har behov for kronisk administration af potente induktorer (f.eks. rifampicin, carbamazepin, enzalutamid, phenytoin) (se pkt.
English: Control (N=535) Rate
Danish: Kontrol (N = 535), andel
English: In Study 3, a multicentre, randomised, double-blind, parallel group, controlled clinical study in moderately emetogenic chemotherapy, the rolapitant regimen (180 mg rolapitant, 2 mg oral granisetron and 20 mg oral dexamethasone) was compared with control therapy (placebo, 2 mg oral granisetron and 20 mg oral dexamethasone) on Day 1 in patients receiving a moderately emetogenic chemotherapy regimen that included 53% of patients receiving a combination of anthracycline and cyclophosphamide (AC).
Danish: I studie 3, et randomiseret, dobbeltblindt, kontrolleret multicenterstudie med parallelgrupper med moderat emetogen kemoterapi (MEC), blev rolapitantregimet (180 mg rolapitant, 2 mg oral granisetron og 20 mg oral dexamethason) sammenlignet med kontrolbehandling (placebo, 2 mg oral granisetron og 20 mg oral dexamethason) på dag 1 hos patienter, der fik et moderat emetogent kemoterapiregime.
English: At a maternal dose equivalent to 9 mg/kg per day rolapitant free base (approximately 0.5 times the recommended human dose on a body surface area basis), there was a decrease in memory in female pups in a maze test and a decrease in pup body weight.
Danish: Ved en maternel dosis svarende til 9 mg/kg rolapitant fri base pr. dag (ca. 0,5 gange den anbefalede dosis til mennesker ud fra kropsareal) blev der set en dårligere hukommelse hos hununger i en labyrinttest og et fald i ungernes kropsvægt.
English: There are no data in patients with severe hepatic impairment (see section 5.2).
Danish: Der foreligger ingen data for patienter med svært nedsat leverfunktion (se pkt.
English: Rolapitant is eliminated mainly through the hepatobiliary route, with minor contributions from renal elimination.
Danish: Rolapitant elimineres hovedsageligt via lever/galde og i mindre grad via nyrerne.
English: Varuby 90 mg tablets Rolapitant
Danish: Varuby 90 mg tabletter Rolapitant
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Varuby indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Delayed phase: >24 to 120 hours postcisplatin treatment; Acute phase: 0 to 24 hours post-cisplatin treatment; Overall phase: 0 to 120 hours postcisplatin treatment b Unadjusted P-values are obtained from Cochran-Mantel Haenszel test, stratified for sex. c Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test, stratified by study and sex. N.S.=Not significant (p>0.05) *Not significant after applying pre-specified multiplicity adjustment.
Danish: Sen fase: > 24 til 120 timer efter cisplatinbehandling, akut fase: 0 til 24 timer efter cisplatinbehandling, samlede fase: 0 til 120 timer efter cisplatinbehandling b Ikke-justerede P-værdier opnået vha. Cochran-Mantel-Haenszel-test, stratificeret for køn.
English: Enzyme inducers
Danish: Enzyminduktorer
English: Efficacy Endpointsa
Danish: Effektendepunktera
English: P-Valueb
Danish: P-værdib
English: Effects of Varuby on the pharmacokinetics of other active substances
Danish: Varubys virkning på andre aktive stoffers farmakokinetik
English: Varuby 90 mg film-coated tablets Rolapitant
Danish: Varuby 90 mg filmovertrukne tabletter Rolapitant
English: Due to its strong inducing effect, St John's wort is contraindicated with rolapitant (see section 4.3).
Danish: Perikon er på grund af sin potente inducerende effekt kontraindiceret sammen med rolapitant (se pkt.
English: Abdominal discomfort Change of bowel habit Dry mouth
Danish: Abdominalt ubehag Ændringer i afføringsmønster Mundtørhed
English: Delayed Acute Overall
Danish: Sen fase Akut fase Samlede fase
English: Rolapitant (N=271) Rate (%)
Danish: Rolapitant (N = 271),
English: Talk to your doctor, pharmacist or nurse before taking this medicine if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel, hvis: • du har alvorlige problemer med leveren eller nyrerne
English: Varuby 90 mg film-coated tablets
Danish: Varuby 90 mg filmovertrukne tabletter
English: Chemotherapy can cause the body to release “substance P.” Substance P attaches to nerve cells in the brain's vomiting centre and makes you feel sick or be sick.
Danish: Kemoterapi kan få kroppen til at frigive ”substans P”.
English: P-Valuea
Danish: P-værdia
English: In population pharmacokinetic analyses, creatinine clearance (CLcr) at baseline did not show a significant effect on rolapitant pharmacokinetics in cancer patients with mild (CLcr: 60 to 90 mL/min) or moderate (CLcr: 30 to 60 mL/min) renal impairment compared to cancer patients with normal kidney function.
Danish: I farmakokinetiske populationsanalyser hos cancerpatienter med let (CLcr: 60 til 90 ml/min.)
English: If you do not want to take this medicine, discuss this with your doctor.
Danish: Tal med din læge, hvis du ikke ønsker at tage dette lægemiddel.
English: Control (N=262)
Danish: Kontrol (N = 262), andel
English: Delayed Overall
Danish: Sen fase Samlede fase
English: Delayed Acute
Danish: Akut fase
English: - If you have any further questions, ask your doctor, or pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: The following additional pre-specified endpoints were also evaluated: complete response in the acute phase (0 to 24 hours) and overall phase (0 to 120 hours); no emesis in each
Danish: Følgende yderligere præspecificerede endepunkter blev også evalueret: fuldstændigt respons i den akutte fase (0 til 24 timer) og i den samlede fase (0 til 120 timer), ingen emese i de enkelte CINVfaser, ingen signifikant kvalme i de enkelte CINV-faser og tid til første emese eller brug af nødmedicin.
English: Uncommon: may affect up to 1 in 100 people - sore or painful muscles
Danish: Ikke almindelige: kan forekomme hos op til 1 ud af 100 personer
English: Time (Hours) to First Emesis or Use of Rescue Medication p=<0.001 for the between-group comparison
Danish: Tid (timer) til første emese eller brug af nødmedicin
English: Overall a Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test. N.S.=Not significant (p>0.05) The estimated time to first emesis or use of rescue medicinal product in patients receiving a MEC regimen is depicted by the Kaplan-Meier plot in Figure 2.
Danish: Den estimerede tid til første emese eller brug af nødmedicin hos patienter, som fik et MEC-regime, er vist med Kaplan-Meier-plottene i figur 2.
English: Overall
Danish: Samlede fase
English: What Varuby is and what it is used for What you need to know before you take Varuby How to take Varuby
Danish: Det skal du vide, før du begynder at tage Varuby Sådan skal du tage Varuby Bivirkninger
English: Gastrooesophageal reflux disease
Danish: Gastroøsofageal refluks Opkastningsfornemmelse
English: P-Valuec
Danish: P-værdic
English: Highly emetogenic chemotherapy regimen Day 1
Danish: Stærkt emetogent kemoterapiregime
English: - feeling dizzy, difficulty concentrating, lack of energy, feeling sleepy (somnolence) or trouble sleeping (insomnia) - stomach problems including stomach discomfort, bloating, nausea, pain, indigestion, and diarrhoea - low levels of white blood cells which fight infections (shown in blood tests) - infection in the mouth - mouth sores - decreased appetite - hiccups - weakness
Danish: • maveproblemer som ubehag i maven, oppustethed, kvalme, smerter, fordøjelsesbesvær og diarré
English: How Varuby works
Danish: Nedsat leverfunktion
English: What Varuby looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: If you take more Varuby than you should
Danish: Hvis du har taget for meget Varuby
English: Asthenia
Danish: Diarré
English: Acute
Danish: Asteni
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevares lægemidlet utilgængeligt for børn.
English: These measures will help protect the environment.
Danish: Dette er med til at beskytte miljøet.
English: Comparison based on historic control.
Danish: Sammenligning baseret på historisk kontrol.
English: - Main inclusion criteria:
Danish: - Primære inklusionskriterier:
English: Tell your doctor about your situation
Danish: Fortæl lægen om din situation
English: Talk to your doctor first.
Danish: Tal med lægen først.
English: Date of first authorisation: 28 August 2008 Date of latest renewal: 23 August 2018
Danish: Dato for første markedsføringstilladelse: 28. august 2008 Dato for seneste fornyelse: 23. august 2018
English: Amiodarone Bepridil
Danish: Amiodaron Bepridil
English: Treatment difference (95% CI)
Danish: Behandlingsforskel (95 % CI)
English: • on a stable antiretroviral regimen for at least 8 weeks.
Danish: • Stabilt antiretroviralt regime i de sidste 8 uger.
English: The clinical relevance of this interaction has not been demonstrated.
Danish: Den kliniske relevans af denne interaktion er ikke påvist.
English: This difference between treatment arms was statistically significant.
Danish: Denne forskel mellem behandlingsgrupperne var statistisk signifikant.
English: Alternatives to diazepam should be considered.
Danish: Alternativer til diazepam bør overvejes.
English: N = number of subjects with data; n = number of observations.
Danish: N = antal forsøgspersoner med ; n = antal observationer.
English: Examples are: low red blood cells.
Danish: Et eksempel er et lavt antal røde blodlegemer.
English: The clinical data do not raise safety concern but are very limited.
Danish: De kliniske data giver ikke anledning til bekymring for sikkerheden, men de er dog ret begrænsede.
English: V179F was never present without Y181C.
Danish: V179F forekom aldrig uden Y181C.
English: Combining two NNRTIs has not been shown to be beneficial.
Danish: Kombination af to NNRTI-midler har ikke vist sig gavnlig.
English: These can be seen in the results of blood and/or urine tests.
Danish: Dette kan ses ved blod- og/eller urinprøver.
English: In other cases, increased monitoring and/or a change in the dose of the medicine may be needed.
Danish: I andre tilfælde er der behov for øget kontrol og/eller ændring i doseringen af medicinen.
English: Your doctor will explain these to you.
Danish: Din læge vil forklare dig om dette.
English: The doctor will inform you exactly how much INTELENCE the child should take.
Danish: Lægen vil fortælle dig, præcist hvor meget INTELENCE dit barn skal tage.
English: The results below are pooled data from the two trials.
Danish: Resultaterne nedenfor er poolede data fra de to forsøg.
English: Mean ± SD (median)
Danish: Middel ± SD (median)
English: Your doctor will discuss with you which combination of medicines is best for you.
Danish: Lægen vil tale med dig om, hvilken kombination af lægemidler der er bedst for dig.
English: However, some combinations are not recommended.
Danish: Nogle kombinationer anbefales dog ikke.
English: With an associated boosted PI:
Danish: I kombination med en boostet PI:
English: ≥ 50 and < 200 ≥ 200 and < 350
Danish: ≥ 50 og < 200 ≥ 200 og < 350
English: Use in adults Other form(s) of this medicine may be more suitable for adults.
Danish: Brug til voksne Andre former af dette lægemiddel er muligvis bedre egnede til voksne.
English: The terminal elimination half-life of etravirine was approximately 30-40 hours.
Danish: Etravirins terminale elimineringshalveringstid var ca. 30-40 timer.
English: Tell your doctor immediately if you are pregnant.
Danish: Fortæl det straks til lægen, hvis du er gravid.
English: Age at screening Treatment group
Danish: Alder ved screening Behandlingsgruppe
English: The tablet can be divided into two equal doses.
Danish: Tabletten kan deles i to lige store doser.
English: It is part of a treatment reducing the amount of virus in the blood.
Danish: Det er en del af en behandling, som reducerer virusmængden i blodet.
English: Systemic dexamethasone should be used with caution or alternatives should be considered, particularly for chronic use.
Danish: Systemisk dexamethason bør anvendes med forsigtighed, eller alternativer bør overvejes, især ved kronisk anvendelse.
English: Treatment of overdose with INTELENCE consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af overdosering med INTELENCE består af generelle understøttende foranstaltninger, herunder monitorering af vitale tegn og observation af klinisk status.
English: Results from a mass balance study with radioactive
Danish: Resultater fra et massebalanceforsøg med radioaktivt mærket
English: The frequency rate of the side effects associated with INTELENCE is given below.
Danish: Hyppigheden af de bivirkninger, der forbindes med INTELENCE, er angivet nedenfor.
English: Any AIDS defining illness and/or death n (%)
Danish: Enhver AIDS-definerende sygdom og/eller død n ( %)
English: In rare instances, very serious rash has been reported which can be potentially life-threatening.
Danish: I sjældne tilfælde er rapporteret meget alvorligt udslæt, som kan være livstruende.
English: Therefore, INTELENCE should be taken following a meal.
Danish: INTELENCE bør derfor indtages efter et måltid.
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Danish: Bivirkningerne er anført efter systemorganklasse (SOC) og frekvens.
English: There were no new clinically relevant safety findings in the mothers or in the newborns in this trial.
Danish: Der var ingen nye klinisk relevante sikkerhedsfund hos mødre eller nyfødte i dette forsøg.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Danish: Frekvenserne defineres 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) og meget sjælden
English: Even if you feel better, do not stop taking INTELENCE or your other anti-HIV medicines.
Danish: Selv om du har det bedre, må du ikke holde op med at tage INTELENCE eller anden hiv-medicin.
English: INTELENCE has only been used in a limited number of patients of 65 years or older.
Danish: INTELENCE er kun blevet anvendt til et begrænset antal patienter på 65 år og derover.
English: INTELENCE must always be given in combination with other antiretroviral medicinal products.
Danish: INTELENCE skal altid gives i kombination med andre antiretrovirale lægemidler.
English: Make sure that you check the following points and tell your doctor if any of these apply to you.
Danish: Læs følgende punkter, og fortæl det til lægen, hvis nogle af dem gælder for dig.
English: Instructions for taking INTELENCE for all patients It is important that you take INTELENCE following a meal.
Danish: Vejledning i brug af INTELENCE til alle patienter Det er vigtigt, at du tager INTELENCE efter et måltid.
English: * based on population pharmacokinetic analyses
Danish: * baseret på farmakokinetiske populationsanalyser
English: It is recommended that digoxin levels be monitored when digoxin is combined with INTELENCE.
Danish: Det anbefales at monitorere digoxinniveauet, når digoxin kombineres med INTELENCE.
English: Enfuvirtide concentrations not studied and no effect is expected.
Danish: Enfuvirtidkoncentrationer er ikke undersøgt, og der forventes ingen virkning.
English: Do not stop taking INTELENCE without talking to your doctor first HIV therapy may increase your sense of well-being.
Danish: Du må ikke holde op med at tage INTELENCE uden at tale med lægen først Hiv-behandling kan øge dit velbefindende.
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
Danish: Kendte og teoretiske interaktioner med udvalgte antiretrovirale og non-antiretrovirale lægemidler er angivet i tabel 1.
English: Trial characteristics - Design: randomised (1:1), double-blinded, placebo-controlled.
Danish: Forsøgskarakteristika - Design: randomiseret (1:1), dobbeltblindet, placebokontrolleret.
English: Doing so could increase the risk of the virus developing resistance.
Danish: Hvis du gør det, øges risikoen for, at virus udvikler resistens.
English: Follow your doctor's instruction carefully on which medicines can be combined.
Danish: Følg omhyggeligt lægens anvisninger om hvilken medicin, der kan kombineres.
English: If you take INTELENCE on an empty stomach, only half the amount of INTELENCE is absorbed.
Danish: Hvis du tager INTELENCE på tom mave, bliver kun halvdelen af stoffet optaget i kroppen.
English: Results of this analysis (week 48 data) by ENF stratum are shown in table 3.
Danish: Resultaterne af denne analyse (data i uge 48) efter ENF-stratum vises i tabel 3.
English: Therefore, always tell your doctor which other anti-HIV medicines you take.
Danish: Fortæl derfor altid lægen, hvilke andre hiv-lægemidler du tager.
English: INTELENCE works by reducing the amount of HIV in your body.
Danish: INTELENCE virker ved at reducere mængden af hiv-virus i kroppen.
English: Do not give this medicine to children less than 6 years of age and weighing less than 16 kg because the potential benefits and risks have not yet been established.
Danish: Du må ikke give dette lægemiddel til børn under 6 år, der vejer mindre end 16 kg, da de mulige fordele og ulemper endnu ikke er fastslået.
English: With no associated boosted PI (out of the recommended indication for etravirine): rifabutin
Danish: Uden kombination med en boostet PI (uden for den anbefalede indikation for etravirin): rifabutin
English: For instructions on dispersion of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om dispergering af lægemidlet før administration, se pkt.
English: If you forget to take INTELENCE
Danish: Hvis du har glemt at tage INTELENCE
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer skal evalueres og behandling iværksættes efter behov.
English: Significantly fewer patients in the etravirine arm reached a clinical endpoint (AIDS-defining illness and/or death) as compared to the placebo arm (p = 0.0408).
Danish: Signifikant færre patienter i etravirin-gruppen nåede et klinisk endpoint (AIDS-defineret sygdom og/eller død) sammenlignet med placebogruppen (p = 0,0408).
English: The use of warm (> 40°C) or carbonated beverages should be avoided.
Danish: Undgå brug af varme drikke (> 40 °C) eller drikke med kulsyre.
English: Animal toxicology studies have been conducted with etravirine in mice, rats, rabbits and dogs.
Danish: Der er udført toksikologiske dyreforsøg med etravirin på mus, rotter, kaniner og hunde.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with INTELENCE.
Danish: Det anbefales at monitorere International Normalised Ratio (INR), når warfarin kombineres med INTELENCE.
English: Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.
Danish: Det anbefales at øge klinisk og laboratoriemæssig monitorering for suppression af hiv og HCV.
English: This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Danish: Dermed forbedres immunsystemet, og risikoen for at udvikle sygdomme, som er forbundet med hivinfektionen, nedsættes.
English: Etravirine is excreted in human milk.
Danish: Etravirin udskilles i human mælk.
English: Warnings and precautions Talk to your doctor or pharmacist before taking INTELENCE.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteketspersonalet, før du tager INTELENCE.
English: Interactions with medicinal products
Danish: Interaktion med lægemidler
English: Since there was a significant interaction effect between treatment and ENF, the primary analysis was done for 2 ENF strata (patients reusing or not using ENF versus patients using ENF de novo).
Danish: Eftersom der var en signifikant interaktionseffekt mellem behandlingen og ENF, blev den primære analyse udført for to ENF-strata (patienter, som igen brugte eller ikke brugte ENF, over for patienter, som brugte ENF de novo).
English: • 1 or more NNRTI resistance-associated mutations (RAMs) at screening or from prior genotypic analysis (i.e., archived resistance)
Danish: • Én eller flere NNRTI-resistensassocierede mutationer ved screening eller fra tidligere genotypeanalyse (dvs. arkiveret resistens)
English: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas
Danish: Interaktioner og dosisanbefalinger med andre lægemidler Lægemidler efter terapeutisk område
English: Follow your doctor's advice on the type of meal you should be taking with INTELENCE.
Danish: Følg lægens rådgivning om, hvilken type mad du bør tage sammen med INTELENCE.
English: Driving and using machines Do not drive or operate machines if you feel sleepy or dizzy after taking your medicines.
Danish: Du må ikke færdes i trafikken eller betjene maskiner, hvis du føler dig søvnig eller svimmel, efter at du har taget din medicin.
English: Using the oral solution may be considered for dose reduction.
Danish: Brug af den orale opløsning kan overvejes til dosisreduktion.
English: Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Treatment-experienced adult patients
Danish: Behandlingserfarne voksne patienter
English: Treatment differences are based on Least Square Means from an ANCOVA model including the stratification factors.
Danish: Behandlingsforskelle er baseret på mindste kvadraters gennemsnit (Least Square Means) fra en ANCOVA-model, som inkluderer stratificeringsfaktorer.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Disse symptomer skyldes formodentlig en bedring i kroppens immunforsvar, som sætter kroppen i stand til at bekæmpe infektioner, der har været til stede i kroppen uden at give synlige symptomer.
English: No changes in methadone dosage were required based on clinical status during or after the period of INTELENCE co-administration.
Danish: Ændringer i metadondosis er ikke påkrævet på baggrund af klinisk status under eller efter perioden med samtidig indgift af INTELENCE.
English: Stevens-Johnson Syndrome a, erythema multiforme very rare toxic epidermal necrolysis a, DRESS
Danish: Stevens-Johnsons syndrom a, erytema multiforme meget sjælden toksisk epidermal nekrolyse a, DRESS
English: However, unbound concentrations have not been assessed.
Danish: Ubundne koncentrationer er dog ikke vurderet.