FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose recommendations for indinavir/ritonavir with rifabutin could be given, therefore the combination is not recommended.
Danish: Der kunne ikke gives dosisrekommandation for indinavir/ritonavir sammen med rifabutin, derfor anbefales kombinationen ikke.
English: • ‘haemophilia' - CRIXIVAN may make you more likely to bleed.
Danish: • "hæmofili" (blødersygdom) - CRIXIVAN kan øge risikoen for, at De bløder.
English: Indinavir with or without ritonavir should not be administered concurrently with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4.
Danish: Indinavir, med eller uden ritonavir, bør ikke administreres samtidigt med lægemidler, som har et snævert terapeutisk vindue, og som er substrater af CYP3A4.
English:  atorvastatin concentration Atorvastatin is less dependent on CYP3A4 for metabolism than lovastatin or simvastatin
Danish:  atorvastatinkoncentration Atorvastatin er mindre afhængig af CYP3A4 mht. metabolisme end lovastatin eller simvastatin
English: The suggestion is based on limited published data (see section 5.2).
Danish: Denne formodning er baseret på begrænsede publicerede data (se pkt.
English: Crixivan, 800 mg every 8 hours + zidovudine 200 mg every 8 hours and lamivudine 150 mg twice a day).
Danish: CRIXIVAN 800 mg hver 8. time + zidovudin 200 mg hver 8. time og lamivudin 150 mg to gange dagligt).
English: Therefore, other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of indinavir.
Danish: Derfor kan andre substanser, der enten metaboliseres ad samme vej eller modificerer CYP3A4-aktivitet, influere på indinavirs farmakokinetik.
English: • sildenafil, vardenafil, tadalafil - used for impotence
Danish: • sildenafil, vardenafil, tadalafil - anvendes mod impotens
English: In some cases, nephrolithiasis has been associated with renal insufficiency or acute renal failure; in the majority of these cases renal insufficiency and acute renal failure were reversible.
Danish: I nogle tilfælde har nefrolitiasis været associeret med nyreinsufficiens eller akut nyresvigt; i størstedelen af disse tilfælde var nyreinsufficiens og akut nyresvigt reversible.
English: 3 years for HDPE bottles containing 90 and 180 hard capsules.
Danish: 3 år for HDPE-beholder indeholdende 90 og 180 hårde kapsler.
English: Cyclosporine A (CsA) levels markedly increase in patients on PIs, including indinavir.
Danish: Koncentrationen af ciclosporin (CsA) øges markant hos patienter på PIer, herunder indinavir.
English: The concomitant use of indinavir with nucleoside analogues (to which the patient is naive) may lessen the risk of the development of resistance to both indinavir and the nucleoside analogues.
Danish: Samtidig brug af indinavir og nukleosidanaloger (over for hvilke patienten er naiv) kan mindske risikoen for udvikling af resistens over for både indinavir og nukleosidanaloger.
English: PDE5 INHIBITOR Sildenafil, tadalafil
Danish: PDE5-HÆMMER Sildenafil, tadalafil
English: In clinical trials in paediatric patients (≥ 3 years), the adverse reaction profile was similar to that for adult patients except for a higher frequency of nephrolithiasis of 29 % (20/70) in paediatric patients treated with CRIXIVAN.
Danish: Hos pædiatriske patienter (≥ 3 år) i kliniske undersøgelser var bivirkningsprofilen den samme som hos voksne patienter med undtagelse af en højere frekvens af nefrolitiasis på 29 % (20/70) hos pædiatriske patienter, der var blevet behandlet med CRIXIVAN.
English: Phenytoin may decrease serum levels of ritonavir.
Danish: Phenytoin kan reducere ritonavirs serumkoncentration.
English: Concomitant use of medicinal products that are inducers of CYP3A4, such as carbamazepine, phenobarbital and phenytoin may reduce indinavir plasma concentrations.
Danish: Samtidig brug af lægemidler, der inducerer CYP3A4, såsom carbamazepin, phenobarbital og phenytoin, kan reducere indinavirs plasmakoncentration.
English: • low red blood cell count
Danish: • lavt antal røde blodlegemer (blodmangel)
English: • kidney problems (including inflammation of the kidneys, kidney stones, or back pain with or without blood in your urine)
Danish: • nyreproblemer (inklusive nyrebetændelse, nyresten, eller rygsmerter med eller uden blod i urinen)
English: Alternatively, CRIXIVAN may be administered with a low-fat, light meal.
Danish: Alternativt kan CRIXIVAN administreres med et fedtfattigt, let måltid.
English: Divalproex, lamotrigine, phenytoin
Danish: Divalproex, lamotrigin, phenytoin
English: Clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to CRIXIVAN in  5 % of patients treated with CRIXIVAN monotherapy or in combination with NRTI(s) (n = 309) for 24 weeks are listed below.
Danish: Kliniske bivirkninger, af investigatorerne indberettet som muligvis, sandsynligvis eller definitivt relaterede til CRIXIVAN, hos  5 % af patienterne behandlet med CRIXIVAN, alene eller i kombination med NRTI (n=309), i 24 uger er listet nedenfor.
English: nephrolithiasis, in some cases with renal insufficiency or acute renal failure; pyelonephritis, interstitial nephritis, sometimes associated with indinavir crystal deposits.
Danish: Nefrolitiasis, i nogle tilfælde med nyreinsufficiens eller akut nyresvigt; pyelonefritis, interstitiel nefritis, i nogle tilfælde associeret med krystalaflejringer af indinavir.
English: The pharmacokinetics of indinavir (400 mg) with ritonavir (100 mg) dosed twice daily was examined in two studies.
Danish: Indinavirs farmakokinetik (400 mg) sammen med ritonavir (100 mg) givet to gange dagligt blev undersøgt i to undersøgelser.
English: • venlafaxine, trazodone - used for depression
Danish: • venlafaxin, trazodon - anvendes mod depression
English: In dogs, a slight increase in resorptions was seen; however, all foetuses in medication-treated animals were viable, and the incidence of live foetuses in medication-treated animals was comparable to that in controls.
Danish: Hos hunde sås lille stigning i resorptioner, dog var alle fostre hos medicinbehandlede dyr levedygtige og incidencen af levende fostre hos medicinbehandlede dyr svarede til kontrolgruppens.
English: If indinavir is given with ritonavir, the potential interaction may be increased.
Danish: Hvis indinavir indgives sammen med ritonavir, kan den mulige interaktion øges.
English: Same recommendations as for indinavir without ritonavir boosting (see Table 1).
Danish: Samme anbefalinger som for indinavir uden ritonavirboosting (se tabel 1).
English: In this open label nonrandomized single arm study, patients were treated with stavudine and lamivudine plus indinavir/ritonavir 400/100 mg every 12 hours.
Danish: I denne åbne ikkerandomiserede undersøgelse med én arm blev patienterne behandlet med stavudin og lamivudin plus indinavir/ritonavir 400/100 mg hver 12. time.
English: A dose increase of indinavir to 1,000 mg every 8 hours should be considered if given with nevirapine.
Danish: En dosisøgning af indinavir til 1000 mg hver 8. time bør overvejes, hvis det gives sammen med nevirapin.
English: Other Anti-infectives Atovaquone
Danish: Andre anti-infektiva Atovaquon
English: Because it is unknown whether indinavir will exacerbate physiologic hyperbilirubinaemia in neonates, careful consideration must be given to the use of indinavir in pregnant women at the time of delivery (see section 4.8).
Danish: Da det er uvist, om indinavir vil forværre fysiologisk hyperbilirubinæmi hos nyfødte, må det nøje overvejes, om indinavir skal anvendes til gravide kvinder omkring fødselstidspunktet (se pkt.
English: Decreases in methadone AUC has been observed with other ritonavir-boosted protease inhibitors.
Danish: Der er observeret fald i methadons AUC sammen med andre ritonavir-boostede proteasehæmmere.
English: Indinavir did not alter the type, frequency, or severity of known major adverse effects associated with the use of zidovudine, didanosine, or lamivudine.
Danish: Indinavir ændrede ikke type, frekvens eller sværhedsgrad af de vigtigste, kendte bivirkninger forbundet med anvendelse af zidovudin, didanosin eller lamivudin.
English: Limited data are available on the pharmacokinetics of indinavir in association with low dose ritonavir.
Danish: Der foreligger begrænsede data vedrørende indinavirs farmakokinetik i forbindelse med ritonavir i lav dosis.
English: Not known* new onset diabetes mellitus or hyperglycaemia, or exacerbation of pre-existing diabetes mellitus, hypertriglyceridaemia, hypercholesterolaemia.
Danish: Ikke kendt* Debuterende diabetes mellitus eller hyperglykæmi, eller forværring af allerede eksisterende diabetes mellitus, hypertriglyceridæmi, hyperkolesterolæmi.
English: Ritonavir may induce glucuronidation of methadone.
Danish: Ritonavir kan inducere glucuronidering af methadon.
English: Posology The recommended dose of indinavir is 800 mg orally every 8 hours.
Danish: Dosering Den anbefalede dosis af indinavir er 800 mg oralt hver 8. time.
English: • Do not take CRIXIVAN with food that is high in calories, fat and protein.
Danish: • Tag ikke CRIXIVAN sammen med mad, der har højt indhold af kalorier, fedt og protein.
English: 90 hard capsules 180 hard capsules
Danish: 90 hårde kapsler 180 hårde kapsler
English: In vitro studies with human liver microsomes indicated that CYP3A4 is the only P450 isozyme that plays a major role in the oxidative metabolism of indinavir.
Danish: In vitro undersøgelser med humane levermikrosomer har vist at cytokrom CYP3A4 erdet eneste P450 isozym, som spiller en større rolle i den oxidative metabolisme af indinavir.
English: Not known* anaphylactoid reactions
Danish: Ikke kendt* Anafylaktiske reaktioner
English: Effects on viral load were consistently more pronounced in patients treated with indinavir in combination with nucleoside analogues, but the proportion of patients with serum viral RNA below the limit of quantification (500 copies/mL) varied between studies, at week 24 from 40 % to more than 80 %.
Danish: Effekten på viralmængden var betydeligt mere udtalt hos patienter behandlet med indinavir i kombination med nukleosidanaloger, men andelen af patienter med serumviral RNA under grænsen for kvantifikation (500 kopier/ml) varierede undersøgelserne imellem ved uge 24 fra 40 % til mere end 80 %.
English: Evaluation may consist of urinalysis, serum BUN and creatinine, and ultrasound of the bladder and kidneys.
Danish: Undersøgelsen kan bestå af urinanalyse, serumcarbamid og serumcreatinin samt ultralyd af blære og nyrer.
English: • delavirdine, efavirenz, nevirapine - used for HIV
Danish: • delavirdin, efavirenz, nevirapin - anvendes mod hiv
English: Patients with severe hepatic impairment have not been studied.
Danish: Patienter med svær leverinsufficiens er ikke undersøgt.
English: Similarly, indinavir might also modify the pharmacokinetics of other substances that share this metabolic pathway.
Danish: Tilsvarende kan indinavir ændre farmakokinetikken for substanser, der metaboliseres ad samme vej.
English: Not studied, combined administrations are expected to significantly increase concentrations of midazolam, particularly when midazolam is given orally.
Danish: Kombineret administration, som endnu ikke er undersøgt, forventes at øge koncentrationen af midazolam signifikant, især når midazolam gives peroralt.
English: Ritonavir may increase digoxin levels due to modification of P-glycoprotein mediated digoxin efflux.
Danish: Ritonavir kan øge digoxinkoncentrationen på grund af modificering af Pglycoproteinmedieret digoxinefflux.
English: This will help lower the risk of you getting kidney stones.
Danish: Dette vil være med til at mindske risikoen for, at De får nyresten.
English: A boosted dose of 800 mg indinavir/100 mg ritonavir twice daily results in increased risk of adverse events.
Danish: En boostet dosis på 800 mg indinavir/100 mg ritonavir to gange dagligt medfører øget risiko for bivirkninger.
English: Indinavir AUC:  28 % Nevirapine:  (CYP3A induction)
Danish: Indinavir AUC:  28 % Nevirapin:  (CYP3A-induktion)
English: • theophylline - used for asthma
Danish: • theophyllin - anvendes mod astma
English: During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Danish: Under forsøg på at overvinde den øgede eksponering ved at øge dosis af andre proteasehæmmere sammen med ritonavir, sås en høj frekvens af leverreaktioner.
English: No specific interaction studies have been performed with the boosted dose 400 mg indinavir with 100 mg ritonavir.
Danish: Specifikke interaktionsundesøgelser er ikke udført med den boostede dosis af indinavir 400 mg og ritonavir 100 mg.
English: • morphine, fentanyl - used for pain
Danish: • morfin, fentanyl - anvendes mod smerter
English: Caution must also be exercised if indinavir is used concurrently with atorvastatin.
Danish: Der skal endvidere udvises forsigtighed, hvis indinavir anvendes samtidigt med atorvastatin.
English: Following initiation of indinavir/ritonavir 800/100 BID or lopinavir/ritonavir 400/100 BID, dose reduction of cyclosporine A to 5-20 % of prior dose was needed to maintain cyclosporine A levels within therapeutic range in one study.
Danish: Efter initiering af behandling med indinavir/ritonavir 800/100 BID eller lopinavir/ritonavir 400/100 BID var det nødvendigt med dosisreduktion af ciclosporin til 5-20% af tidligere dosis for at opretholde ciclosporinkoncentrationen inden for det terapeutiske område i én undersøgelse.
English: Also some other medicines can affect the way CRIXIVAN works.
Danish: Andre lægemidler kan også påvirke behandlingen med CRIXIVAN.
English: Combinations of atazanavir with or without ritonavir and Crixivan have not been studied and co-administration of these medicinal products is not recommended due to risk of worsening of these adverse reactions.
Danish: Kombinationer af atazanavir med eller uden ritonavir og CRIXIVAN er ikke undersøgt, og samtidig administration af disse lægemidler er ikke tilrådelig på grund af risikoen for forværring af disse bivirkninger.
English: An increase in thyroidal weight and thyroidal follicular cell hyperplasia, due to an increase in thyroxine clearance, was seen in rats treated with indinavir at doses  160 mg/kg/day.
Danish: Forhøjet thyroideavægt og thyroidal follikelcellehyperplasi som følge af forhøjet thyroxinclearance sås hos rotter behandlet med indinavir i doser  160 mg/kg/dag.
English: The bottle contains desiccant canisters that should remain in the bottle.
Danish: Flasken indeholder et fugtabsorberende middel, som skal blive i flasken.
English: Seven major metabolites were identified and the metabolic pathways were identified as glucuronidation at the pyridine nitrogen, pyridine-N-oxidation with and without 3'-hydroxylation on the indane ring, 3'-hydroxylation of indane, p-hydroxylation of phenylmethyl moiety, and N-depyridomethylation with and without the 3'-hydroxylation.
Danish: Der er fundet 7 hovedmetabolitter og de metaboliske veje er vist at være glukuronidering ved pyridinnitrogenatomet, pyridin-N-oxidation med og uden 3'-hydroxylering på indanringen, 3'-hydroxylering af indan, p-hydroxylering af phenylmethylgruppen, og N-depyridomethylering med og uden 3'
English: Indinavir must not be given with ritonavir to patients with decompensated liver disease as ritonavir is principally metabolized and eliminated by the liver (see section 4.4).
Danish: Indinavir må ikke gives sammen med ritonavir til patienter med dekompenseret leversygdom, da ritonavir hovedsageligt metaboliseres og elimineres via leveren (se pkt.
English: The risk of you having bone problems is higher if you: - drink alcohol - have a high body mass index - have an immune system that is very weak - have been taking corticosteroids at the same time as CRIXIVAN - take combination antiretroviral therapy for a long time.
Danish: Risikoen for, at De får knogleproblemer er større, hvis De: - drikker alkohol - har et højt BMI-tal (er overvægtig) - har at meget svagt immunsystem - har taget kortikosteroider sammen med CRIXIVAN - tager antiretroviral kombinationsbehandling over en længere periode.
English: In one comparative trial, combination therapy with nucleoside analogues (triple therapy with zidovudine plus didanosine) conferred protection against the selection of virus expressing at least one resistanceassociated amino acid substitution to both indinavir (from 13/24 to 2/20 at therapy week 24) and to the nucleoside analogues (from 10/16 to 0/20 at therapy week 24).
Danish: I en sammenlignende undersøgelse, gav kombinationsbehandling med nukleosidanaloger (trippelterapi med zidovudin plus didanosin) beskyttelse mod selektion af virus med mindst en resistensassocieret aminosyresubstitution over for både indinavir (fra 13/24 til 2/20 ved behandlingsuge 24) og over for nukleosidanalogerne (fra 10/16 til 0/20 ved behandlingsuge 24).
English: • midazolam (by injection) - used for acute fits (seizures) and to send patients to sleep before some medical procedures
Danish: • midazolam (ved injektion) - anvendes til akutte krampeanfald (epileptisk anfald) og til bedøvelse, før visse indgreb
English: Nephrolithiasis occurred in approximately 10 % of patients treated with the recommended (unboosted) dose of CRIXIVAN in a pooled analysis of controlled clinical trials (see also below table and in section 4.4).
Danish: Nefrolitiasis forekom hos ca. 10 % af de patienter, der blev behandlet med den anbefalede (uboostede) dosis CRIXIVAN i en poolet analyse af kontrollerede kliniske undersøgelser (se også tabellen nedenfor samt pkt.
English: A dose reduction of indinavir to 600 mg every 8 hours should be considered when administering itraconazole or ketoconazole concurrently (see section 4.5).
Danish: Dosisreduktion af indinavir til 600 mg hver 8. time bør overvejes, når itraconazol eller ketoconazol administreres samtidigt (se pkt.
English: Indinavir boosted regimen.
Danish: Regimen med boostet indinavir.
English: • atorvastatin, rosuvastatin, pravastatin, fluvastatin - used to lower cholesterol
Danish: • atorvastatin, rosuvastatin, pravastatin, fluvastatin - anvendes til at sænke kolesteroltallet
English: Treatment with indinavir alone or in combination with other antiretroviral agents (i.e., nucleoside analogues) has so far been documented to reduce viral load and increase CD4 lymphocytes in patients with CD4 cell counts below 500 cells/mm
Danish: Behandling med indinavir alene eller i kombination med andre antiretrovirale stoffer (dvs. nukleosidanaloger) er indtil nu dokumenteret at reducere den virale belastning og at øge CD4lymfocytter hos patienter med CD4-celletal < 500 celler/mm
English: Refer also to sections 4.2 and 4.3.
Danish: 4.2 og 4.3.
English: For example, no single substitution or pair of substitutions was capable of engendering measurable ( four-fold) resistance to indinavir, and the level of resistance was dependent on the ways in which multiple substitutions were combined.
Danish: Fx kunne ingen enkeltsubstition eller substitutionspar skabe målelig ( fire gange) indinavirresistens, og resistensniveauet var afhængig af måden flere substitutioner kombineredes på.
English: The use of indinavir/ritonavir with quinidine is contraindicated.
Danish: Brugen af indinavir/ritonavir sammen med quinidin er kontraindiceret.
English: • amprenavir, saquinavir, atazanavir - used for HIV
Danish: • amprenavir, saquinavir, atazanavir - anvendes mod hiv
English: • fexofenadine, loratidine - antihistamines used for hay fever and other allergic conditions
Danish: • fexofenadin, loratidin - antihistaminer, der anvendes mod høfeber og andre allergier
English: The bioavailability of a single 800-mg dose of indinavir was approximately 65 % (90 % CI, 58 - 72 %).
Danish: Biotilgængeligheden var ca. 65 % af en enkelt 800 mg dosis af indinavir (90 % CI, 58-72%).
English: Nephrolithiasis and tubulointerstitial nephritis
Danish: Nefrolitiasis og tubulointerstitiel nefritis
English: Adverse reactions, including nephrolithiasis, may lead to treatment interruption.
Danish: Bivirkninger, inklusive nefrolitiasis, kan føre til seponering.
English: The following adverse reactions have been reported during clinical studies in adults and/or postmarketing use for CRIXIVAN monotherapy and/or CRIXIVAN with combination antiretroviral therapy (CART).
Danish: Følgende bivirkninger er rapporteret for CRIXIVAN under kliniske undersøgelser hos voksne og/eller efter markedsføring, når CRIXIVAN blev givet som monoterapi og/eller i kombination med antiretroviral terapi (CART).
English: 3; and the mean increase in percent CD4 cell counts was 1.2 %.
Danish: 3, og middelstigningen af CD4-celletal var, angivet i procent, 1,2 %.
English: 180 hard capsules 270 hard capsules 360 hard capsules
Danish: 180 hårde kapsler 270 hårde kapsler 360 hårde kapsler
English: • amlodipine, felodipine, nifedipine, nicardipine, digoxin, diltiazem - used for high blood pressure and some heart problems.
Danish: • amlodipin, felodipin, nifedipin, nicardipin, digoxin, diltiazem - anvendes mod forhøjet blodtryk og visse hjertelidelser
English: Nephrolithiasis, including flank pain with or without haematuria (including microscopic haematuria), has been reported in approximately 10 % (252/2,577) of patients receiving CRIXIVAN in clinical trials at the recommended dose compared to 2.2 % in the control arms.
Danish: Der er rapporteret om nefrolitiasis, inkluderende lændesmerter med eller uden hæmaturi (inklusive mikroskopisk hæmaturi) hos ca. 10 % (252/2.577) af de patienter, der fik CRIXIVAN i kliniske undersøgelser i den anbefalede dosis sammenlignet med 2,2 % i kontrolgrupperne.
English: In the intent to treat and on treatment analyses the proportion of patients with HIV RNA of < 50 copies/mL was 68.8 % and 88.7 %, respectively, at week 96.
Danish: I analyserne af intent-to-treat og on-treatment var andelen af patienter med hiv RNA < 50 kopier/ml henholdsvis 68,8 % og 88,7 % ved uge 96.
English: IMMUNOSUPPRESSIVES Cyclosporine A
Danish: IMMUNSUPPRESSIVA Ciclosporin
English: Patients with mild-to-moderate hepatic insufficiency and clinical evidence of cirrhosis had evidence of decreased metabolism of indinavir resulting in approximately 60 % higher mean AUC following a 400-mg dose.
Danish: Patienter med mild til moderat leverinsufficiens og kliniske tegn på cirrose viste tegn på nedsat metabolisme af indinavir resulterende i ca. 60 % højere gennemsnitlig AUC efter en 400 mg dosis.
English: Morphine
Danish: Morphin
English: The crystals have not been associated with medicinal product -induced renal injury.
Danish: Krystallerne er ikke blevet sat i forbindelse med lægemiddelinduceret renal skade.
English: The use of rifampicin with indinavir is contraindicated.
Danish: Brug af rifampicin sammen med indinavir er kontraindiceret.
English: In patients with mild-to-moderate hepatic impairment due to cirrhosis, the dose of indinavir should be reduced to 600 mg every 8 hours.
Danish: Hos patienter med let til moderat nedsat leverfunktion på grund af cirrose, bør indinavirdosis reduceres til 600 mg hver 8. time.
English: • indigestion or diarrhoea
Danish: • fordøjelsesproblemer eller diarré
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitor, ATC code JO5AE02
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, proteasehæmmer, ATC kode: J05AE02
English: Medical management in patients with one or more episodes of nephrolithiasis must include adequate hydration and may include temporary interruption of therapy (e.g., 1 to 3 days) during the acute episode of nephrolithiasis or discontinuation of therapy.
Danish: Medicinsk behandling af patienter med en eller flere episoder af nefrolitiasis skal indbefatte tilstrækkelig hydrering og kan involvere midlertidig afbrydelse af behandlingen (fx 1 - 3 dage) under den akutte episode af nefrolitiasis eller seponering af behandlingen.
English: Following a dose regimen of 800 mg every 8 hours, measured peak plasma concentrations (Cmax) after morning, afternoon and evening doses were 15,550 nM, 8,720 nM and 8,880 nM, respectively.
Danish: Efter et dosisregime på 800 mg hver 8. time var de målte peak plasmakoncentrationer (Cmax) efter morgen-, eftermiddags- og aftendosis hhv. 15.550 nM, 8.720 nM og 8.880 nM.