natgillin/translations-raw huggingface dataset:
Samtidig administration af indinavir og quetiapin kan øge plasmakoncentrationen af quetiapin og medføre quetiapin-relateret toksicitet herunder koma. 
Concomitant administration of indinavir and quetiapine may increase plasma concentrations of quetiapine leading to quetiapine-related toxicity, including coma.
Når nedsat virus-RNA-suppression opstod, var det typisk forbundet med erstatning af cirkulerende følsomme virus med resistente virusvarianter. 
When loss of viral RNA suppression occurred, it was typically associated with replacement of circulating susceptible virus with resistant viral variants.
Administration sammen med lette måltider (fx tørt ristet brød med syltetøj eller marmelade, æblejuice og kaffe med skummetmælk eller fedtfri mælk og sukker eller cornflakes med skummetmælk eller fedtfri mælk og sukker) resulterede i en plasmakoncentration sammenlignelig med de tilsvarende fastende værdier. 
Administration with light meals (e.g., dry toast with jam or fruit conserve, apple juice, and coffee with skimmed or fat-free milk and sugar or corn flakes, skimmed or fat-free milk and sugar) resulted in plasma concentrations comparable to the corresponding fasted values.
STEROIDER Dexamethason 
STEROIDS Dexamethasone
Patienter med allerede eksisterende leverdysfunktion inklusive kronisk, aktiv hepatitis har en øget frekvens af leverfunktionsabnormiteter ved antiretroviral kombinationsbehandling og bør kontrolleres efter gældende praksis. 
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Hyperbilirubinæmi forekom hyppigere ved doser over 2,4 g/dag i sammenligning med doser under 2,4 g/dag. 
Hyperbilirubinaemia occurred more frequently at doses exceeding 2.4 g/day compared to doses less than 2.4 g/day.
Det vides ikke om indinavir er dialyserbart ved peritonealdialyse eller hæmodialyse. 
It is not known whether indinavir is dialyzable by peritoneal or haemodialysis.
Hyperbilirubinæmi, fortrinsvis rapporteret som forhøjet indirekte bilirubin, er observeret hos 14 % af patienterne under behandling med indinavir. 
Hyperbilirubinaemia, reported predominantly as elevated indirect bilirubin, has occurred in 14 % of patients during treatment with indinavir.
• orale præventionsmidler (p-piller), der indeholder norethindron eller ethinylestradiol 
• oral contraceptive medicines (‘The Pill') containing norethindrone or ethinyl estradiol
Overførsel af hiv 
HIV Transmission
Der er set øget incidens af nefrolitiasis hos patienter med underliggende leversygdomme, når de behandles med indinavir. 
An increased incidence of nephrolithiasis has been observed in patients with underlying liver disorders when treated with indinavir.
CRIXIVAN anvendes sammen med andre former for hiv-behandling (antiretrovirale lægemidler). 
CRIXIVAN is used at the same time as other HIV treatments (antiretroviral medicines).
Samtidig administration kan resultere i fald i plasmakoncentrationer af indinavir, og som konsekvens heraf øget risiko for suboptimal behandling og facilitering af resistensudvikling (se pkt. 
Co-administration may result in decreased plasma concentrations of indinavir and as a consequence an increased risk for suboptimal treatment and facilitation of development of resistance (see section 4.5).
I kontrollerede, kliniske undersøgelser, udført over hele verden, blev indinavir administreret alene eller i kombination med andre antiretrovirale stoffer (zidovudin, didanosin, stavudin og/eller lamivudin) til ca. 2.000 patienter, af hvilke hovedparten var voksne mænd af europæisk afstamning (15 % kvinder). 
In controlled clinical trials conducted world-wide, indinavir was administered alone or in combination with other antiretroviral agents (zidovudine, didanosine, stavudine, and/or lamivudine) to approximately 2,000 patients, the majority of whom were adult Caucasian males (15 % females).
Der er set tilfælde af interstitiel nefritis med medullær kalcifikation og kortikal atrofi hos patienter med asymptomatisk svær leukocyturi (>100 celler/højt styrkefelt). 
Cases of interstitial nephritis with medullary calcification and cortical atrophy have been observed in patients with asymptomatic severe leucocyturia (> 100 cells/high power field).
Lægemidler i henhold til terapeutisk område 
Medicinal products by therapeutic areas
Indinavir hæmmer rekombinant hiv-1 og hiv-2 protease med ca. 10 gange selektivitet for hiv-1 i forhold til hiv-2 proteinase. 
Indinavir inhibits recombinant HIV-1 and HIV-2 protease with an approximate tenfold selectivity for HIV-1 over HIV-2 proteinase.
Blandt patienter der oplevede viral RNA rebound under monoterapi med indinavir, 800 mg hver 8 time, sås der hos de fleste patienter kun substitution i 3 af disse positioner: V82 (til A eller F), M46 (til I eller L) og L10 (til I eller R). 
Among patients experiencing viral RNA rebound during indinavir monotherapy at 800 mg q8h, substitutions at only three of these sites were observed in the majority of patients: V82 (to A or F), M46 (to I or L), and L10 (to I or R).
Både atazanavir og indinavir associeres med indirekte (ukonjugeret) hyperbilirubinæmi på grund af hæmning af UDP-glucuronosyltransferase (UGT). 
Atazanavir as well as indinavir are associated with indirect (unconjugated) hyperbilirubinemia due to inhibition of UDP-glucuronosyltransferase (UGT).
Indinavir bør anvendes med forsigtighed sammen med andre lægemidler, som er potente CYP3A4 induktorer. 
Indinavir should be used cautiously with other medicinal products that are potent inducers of CYP3A4.
Ved lignende eksposition hos rotter sås en øget forekomst af thyroide adenomer, sandsynligvis relateret til en stigning i frigørelsen af thyroideastimulerende hormon sekundært til en stigning i thyroxinclearance. 
In rats, at similar exposure levels, an increased incidence of thyroid adenomas was seen, probably related to an increase in release of thyroid stimulating hormone secondary to an increase in thyroxine clearance.
Kombination er kontraindiceret pga. risiko for myopati, herunder rhabdomyolyse. 
Combination contraindicated due to an increased risk of myopathy including rhabdomyolysis.
Interaktioner og dosisrekommandationer sammen med andre lægemidler - IKKEBOOSTET INDINAVIR 
Interactions and dose recommendations with other medical products - UNBOOSTED INDINAVIR
Hos Rhesusaber fremkaldte administration af indinavir til nyfødte mild eksacerbation af den forbigående fysiologiske hyperbilirubinæmi, der ses hos disse arter efter fødsel. 
In Rhesus monkeys, administration of indinavir to neonates caused a mild exacerbation of the transient physiologic hyperbilirubinaemia seen in this species after birth.
Ikke undersøgt; kombineret administration kan medføre øget warfarinkoncentration. 
Not studied, combined administration may result in increased warfarin levels.
Indinavirs sikkerhed og virkning er ikke fastlagt hos patienter med signifikante underliggende leversygdomme. 
The safety and efficacy of indinavir has not been established in patients with significant underlying liver disorders.
Der kunne ikke gives dosisrekommandation for indinavir/ritonavir sammen med rifabutin, derfor anbefales kombinationen ikke. 
No dose recommendations for indinavir/ritonavir with rifabutin could be given, therefore the combination is not recommended.
• "hæmofili" (blødersygdom) - CRIXIVAN kan øge risikoen for, at De bløder. 
• ‘haemophilia' - CRIXIVAN may make you more likely to bleed.
Indinavir, med eller uden ritonavir, bør ikke administreres samtidigt med lægemidler, som har et snævert terapeutisk vindue, og som er substrater af CYP3A4. 
Indinavir with or without ritonavir should not be administered concurrently with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4.
 atorvastatinkoncentration Atorvastatin er mindre afhængig af CYP3A4 mht. metabolisme end lovastatin eller simvastatin 
 atorvastatin concentration Atorvastatin is less dependent on CYP3A4 for metabolism than lovastatin or simvastatin
Denne formodning er baseret på begrænsede publicerede data (se pkt. 
The suggestion is based on limited published data (see section 5.2).
CRIXIVAN 800 mg hver 8. time + zidovudin 200 mg hver 8. time og lamivudin 150 mg to gange dagligt). 
Crixivan, 800 mg every 8 hours + zidovudine 200 mg every 8 hours and lamivudine 150 mg twice a day).
Derfor kan andre substanser, der enten metaboliseres ad samme vej eller modificerer CYP3A4-aktivitet, influere på indinavirs farmakokinetik. 
Therefore, other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of indinavir.
• sildenafil, vardenafil, tadalafil - anvendes mod impotens 
• sildenafil, vardenafil, tadalafil - used for impotence
I nogle tilfælde har nefrolitiasis været associeret med nyreinsufficiens eller akut nyresvigt; i størstedelen af disse tilfælde var nyreinsufficiens og akut nyresvigt reversible. 
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.
3 år for HDPE-beholder indeholdende 90 og 180 hårde kapsler. 
3 years for HDPE bottles containing 90 and 180 hard capsules.
Koncentrationen af ciclosporin (CsA) øges markant hos patienter på PIer, herunder indinavir. 
Cyclosporine A (CsA) levels markedly increase in patients on PIs, including indinavir.
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. 
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.
PDE5-HÆMMER Sildenafil, tadalafil 
PDE5 INHIBITOR Sildenafil, tadalafil
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. 
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.
Phenytoin kan reducere ritonavirs serumkoncentration. 
Phenytoin may decrease serum levels of ritonavir.
Samtidig brug af lægemidler, der inducerer CYP3A4, såsom carbamazepin, phenobarbital og phenytoin, kan reducere indinavirs plasmakoncentration. 
Concomitant use of medicinal products that are inducers of CYP3A4, such as carbamazepine, phenobarbital and phenytoin may reduce indinavir plasma concentrations.
• lavt antal røde blodlegemer (blodmangel) 
• low red blood cell count
• nyreproblemer (inklusive nyrebetændelse, nyresten, eller rygsmerter med eller uden blod i urinen) 
• kidney problems (including inflammation of the kidneys, kidney stones, or back pain with or without blood in your urine)
Alternativt kan CRIXIVAN administreres med et fedtfattigt, let måltid. 
Alternatively, CRIXIVAN may be administered with a low-fat, light meal.
Divalproex, lamotrigin, phenytoin 
Divalproex, lamotrigine, phenytoin
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. 
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.
Nefrolitiasis, i nogle tilfælde med nyreinsufficiens eller akut nyresvigt; pyelonefritis, interstitiel nefritis, i nogle tilfælde associeret med krystalaflejringer af indinavir. 
nephrolithiasis, in some cases with renal insufficiency or acute renal failure; pyelonephritis, interstitial nephritis, sometimes associated with indinavir crystal deposits.
Indinavirs farmakokinetik (400 mg) sammen med ritonavir (100 mg) givet to gange dagligt blev undersøgt i to undersøgelser. 
The pharmacokinetics of indinavir (400 mg) with ritonavir (100 mg) dosed twice daily was examined in two studies.
• venlafaxin, trazodon - anvendes mod depression 
• venlafaxine, trazodone - used for depression
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. 
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.
Hvis indinavir indgives sammen med ritonavir, kan den mulige interaktion øges. 
If indinavir is given with ritonavir, the potential interaction may be increased.
Samme anbefalinger som for indinavir uden ritonavirboosting (se tabel 1). 
Same recommendations as for indinavir without ritonavir boosting (see Table 1).
I denne åbne ikkerandomiserede undersøgelse med én arm blev patienterne behandlet med stavudin og lamivudin plus indinavir/ritonavir 400/100 mg hver 12. time. 
In this open label nonrandomized single arm study, patients were treated with stavudine and lamivudine plus indinavir/ritonavir 400/100 mg every 12 hours.
En dosisøgning af indinavir til 1000 mg hver 8. time bør overvejes, hvis det gives sammen med nevirapin. 
A dose increase of indinavir to 1,000 mg every 8 hours should be considered if given with nevirapine.
Andre anti-infektiva Atovaquon 
Other Anti-infectives Atovaquone
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. 
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).
Der er observeret fald i methadons AUC sammen med andre ritonavir-boostede proteasehæmmere. 
Decreases in methadone AUC has been observed with other ritonavir-boosted protease inhibitors.
Indinavir ændrede ikke type, frekvens eller sværhedsgrad af de vigtigste, kendte bivirkninger forbundet med anvendelse af zidovudin, didanosin eller lamivudin. 
Indinavir did not alter the type, frequency, or severity of known major adverse effects associated with the use of zidovudine, didanosine, or lamivudine.
Der foreligger begrænsede data vedrørende indinavirs farmakokinetik i forbindelse med ritonavir i lav dosis. 
Limited data are available on the pharmacokinetics of indinavir in association with low dose ritonavir.
Ikke kendt* Debuterende diabetes mellitus eller hyperglykæmi, eller forværring af allerede eksisterende diabetes mellitus, hypertriglyceridæmi, hyperkolesterolæmi. 
Not known* new onset diabetes mellitus or hyperglycaemia, or exacerbation of pre-existing diabetes mellitus, hypertriglyceridaemia, hypercholesterolaemia.
Ritonavir kan inducere glucuronidering af methadon. 
Ritonavir may induce glucuronidation of methadone.
Dosering Den anbefalede dosis af indinavir er 800 mg oralt hver 8. time. 
Posology The recommended dose of indinavir is 800 mg orally every 8 hours.
• Tag ikke CRIXIVAN sammen med mad, der har højt indhold af kalorier, fedt og protein. 
• Do not take CRIXIVAN with food that is high in calories, fat and protein.
90 hårde kapsler 180 hårde kapsler 
90 hard capsules 180 hard capsules
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. 
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.
Ikke kendt* Anafylaktiske reaktioner 
Not known* anaphylactoid reactions
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 %. 
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 %.
Undersøgelsen kan bestå af urinanalyse, serumcarbamid og serumcreatinin samt ultralyd af blære og nyrer. 
Evaluation may consist of urinalysis, serum BUN and creatinine, and ultrasound of the bladder and kidneys.
• delavirdin, efavirenz, nevirapin - anvendes mod hiv 
• delavirdine, efavirenz, nevirapine - used for HIV
Patienter med svær leverinsufficiens er ikke undersøgt. 
Patients with severe hepatic impairment have not been studied.
Tilsvarende kan indinavir ændre farmakokinetikken for substanser, der metaboliseres ad samme vej. 
Similarly, indinavir might also modify the pharmacokinetics of other substances that share this metabolic pathway.
Kombineret administration, som endnu ikke er undersøgt, forventes at øge koncentrationen af midazolam signifikant, især når midazolam gives peroralt. 
Not studied, combined administrations are expected to significantly increase concentrations of midazolam, particularly when midazolam is given orally.
Ritonavir kan øge digoxinkoncentrationen på grund af modificering af Pglycoproteinmedieret digoxinefflux. 
Ritonavir may increase digoxin levels due to modification of P-glycoprotein mediated digoxin efflux.
Dette vil være med til at mindske risikoen for, at De får nyresten. 
This will help lower the risk of you getting kidney stones.
En boostet dosis på 800 mg indinavir/100 mg ritonavir to gange dagligt medfører øget risiko for bivirkninger. 
A boosted dose of 800 mg indinavir/100 mg ritonavir twice daily results in increased risk of adverse events.
Indinavir AUC:  28 % Nevirapin:  (CYP3A-induktion) 
Indinavir AUC:  28 % Nevirapine:  (CYP3A induction)
• theophyllin - anvendes mod astma 
• theophylline - used for asthma
Under forsøg på at overvinde den øgede eksponering ved at øge dosis af andre proteasehæmmere sammen med ritonavir, sås en høj frekvens af leverreaktioner. 
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.
Specifikke interaktionsundesøgelser er ikke udført med den boostede dosis af indinavir 400 mg og ritonavir 100 mg. 
No specific interaction studies have been performed with the boosted dose 400 mg indinavir with 100 mg ritonavir.
• morfin, fentanyl - anvendes mod smerter 
• morphine, fentanyl - used for pain
Der skal endvidere udvises forsigtighed, hvis indinavir anvendes samtidigt med atorvastatin. 
Caution must also be exercised if indinavir is used concurrently with atorvastatin.
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. 
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.
Andre lægemidler kan også påvirke behandlingen med CRIXIVAN. 
Also some other medicines can affect the way CRIXIVAN works.
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. 
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.
Forhøjet thyroideavægt og thyroidal follikelcellehyperplasi som følge af forhøjet thyroxinclearance sås hos rotter behandlet med indinavir i doser  160 mg/kg/dag. 
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.
Flasken indeholder et fugtabsorberende middel, som skal blive i flasken. 
The bottle contains desiccant canisters that should remain in the bottle.
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' 
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.
Indinavir må ikke gives sammen med ritonavir til patienter med dekompenseret leversygdom, da ritonavir hovedsageligt metaboliseres og elimineres via leveren (se pkt. 
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).
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. 
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.
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). 
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).
• midazolam (ved injektion) - anvendes til akutte krampeanfald (epileptisk anfald) og til bedøvelse, før visse indgreb 
• midazolam (by injection) - used for acute fits (seizures) and to send patients to sleep before some medical procedures
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. 
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).
Dosisreduktion af indinavir til 600 mg hver 8. time bør overvejes, når itraconazol eller ketoconazol administreres samtidigt (se pkt. 
A dose reduction of indinavir to 600 mg every 8 hours should be considered when administering itraconazole or ketoconazole concurrently (see section 4.5).
Regimen med boostet indinavir. 
Indinavir boosted regimen.
• atorvastatin, rosuvastatin, pravastatin, fluvastatin - anvendes til at sænke kolesteroltallet 
• atorvastatin, rosuvastatin, pravastatin, fluvastatin - used to lower cholesterol