natgillin/translations-raw huggingface dataset:
Patienter med de sjældne arvelige problemer galactoseintolerance, Lapp lactosemangel eller glucosegalactosemalabsorption bør ikke tage dette lægemiddel. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Rotteundersøgelser indikerer at optagelsen i hjernevæv er begrænset, distributionen ind og ud af det lymfatiske system er hurtig og ekskretionen i mælk fra diegivende rotter er ekstensiv. 
Studies in rats indicated that uptake into brain tissue was limited, distribution into and out of the lymphatic system was rapid, and excretion into the milk of lactating rats was extensive.
Virusbelastningen forblev < 200 kopier/ml i 48 uger hos alle patienterne. 
Viral load remained < 200 copies/mL for 48 weeks in all patients.
Data fra en steadystate undersøgelse på raske frivillige indikerer, at der er en daglig variation i indinavir farmakokinetikken. 
Data from a steady state study in healthy volunteers indicate that there is a diurnal variation in the pharmacokinetics of indinavir.
62 patienter fuldførte undersøgelsen til uge 96. 
Sixty-two patients completed the study to week 96.
• tacrolimus, ciclosporin - anvendes hovedsageligt efter organtransplantation 
• tacrolimus, ciclosporin - used mainly after organ transplantation
• alvorlige smerter, ømhed eller svækkelse af Deres muskler - der er større risiko for dette, hvis De tager kolesterolsænkende lægemidler kaldet statiner (såsom simvastatin). 
• severe pain, tenderness or weakness in your muscles - this is more likely to happen if you are taking cholesterol-lowering medicines called ‘statins' (such as simvastatin).
Seks af disse 11 patienter (55 %) havde middel indinavir plasmakoncentrationer 8 timer efter doseringen (Cmin) under assaygrænsen for pålidelig kvantificering. 
Six of these 11 (55 %) patients had mean indinavir plasma concentrations 8 hours postdose (Cmin) below assay threshold of reliable quantification.
Der sås ingen signifikant forskel i eksponeringen, når behandlingen blev givet sammen med et fuldfedt måltid. 
No significant difference in exposure was seen when the regimen was given with a high-fat meal.
De observerede aminosyresubstitutioner sås at akkumulere sekventielt og ikke i nogen konsistent rækkefølge, sandsynligvis på grund af vedvarende virusreplikation. 
The observed amino acid substitutions appeared to accumulate sequentially and in no consistent order, probably as a result of ongoing viral replication.
18 patienter fuldførte undersøgelsen til uge 48. 
Eighteen patients completed the study to week 48.
Virkning af mad 
Food effect
Hvis De opdager symptomer på infektion, skal De straks fortælle det til Deres læge. 
If you notice any symptoms of infection, please inform your doctor immediately.
• Aktivt stof: Indinavir. 
• The active substance is indinavir.
Ritonavir anvendes til at øge indholdet af CRIXIVAN i blodet eller, mindre hyppigt og i højere doser, til behandling af hiv. 
Ritonavir is used for increasing the blood levels of CRIXIVAN or, less frequently and then at higher doses, for HIV treatment.
Mindst 11 aminosyresteder i proteasen er blevet associeret med indinavirresistens: L10, K20, L24, M46, I54, L63, I64, A71, V82, I84 og L90. 
At least eleven amino acid sites in the protease have been associated with indinavir resistance: L10, K20, L24, M46, I54, L63, I64, A71, V82, I84, and L90.
Der sås ingen eksterne, viscerale eller skeletale forandringer hos kaniner eller hunde. 
No external, visceral, or skeletal changes were observed in rabbits or dogs.
Lactose Dette lægemiddel indeholder 299,2 mg lactose pr. 800 mg dosis (maksimal enkeltdosis). 
This medicinal product contains 299.2 mg of lactose in each 800 mg dose (maximum single dose).
• autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) kan også opstå, efter De er begyndt at tage medicin til behandling af din hiv-infektion. 
• autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Brug ikke lægemidlet efter den udløbsdato, der står på flasken eller æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the bottle or carton after ‘EXP'.
• hvis De er allergisk over for indinavir eller et af de øvrige indholdstoffer i CRIXIVAN (angivet i punkt 6). 
• if you are allergic to indinavir or any of the other ingredients of this medicine (listed in Section 6).
Administration af indinavir sammen med et måltid med højt indhold af kalorier, fedt og protein resulterede i en svækket og reduceret absorption med en reduktion på ca. 80 % i AUC og 86 % reduktion i Cmax. 
Administration of indinavir with a meal high in calories, fat, and protein resulted in a blunted and reduced absorption with an approximate 80 % reduction in AUC and an 86 % reduction in Cmax.
Derfor skal De fortsat gå til kontrol hos Deres læge, mens De tager CRIXIVAN. 
So you still need to keep seeing your doctor while you are taking CRIXIVAN.
Det anbefales at hiv-smittede kvinder, for at undgå overførsel af hiv, ikke under nogen omstændigheder ammer deres børn. 
It is recommended that HIV infected women do not breast feed their infants under any circumstances in order to avoid transmission of HIV.
Tag ikke enten CRIXIVAN eller ritonavir, hvis noget af ovenstående gælder for Dem. 
Do not take either CRIXIVAN or ritonavir if any of the above applies to you.
Ritonavir oral opløsning bør ikke administreres samtidigt med amprenavir oral opløsning til børn på grund af risikoen for toksicitet fra hjælpestofferne i de to formuleringer. 
Ritonavir oral solution should not be coadministered with amprenavir oral solution to children due to the risk of toxicity from excipients in the two formulations.
Forsigtighed tilrådes og klinisk monitorering af patienterne anbefales. 
Caution is warranted and clinical monitoring of patients is recommended.
Designet for undersøgelsen tager ikke hensyn til en definitiv vurdering af saquinavirs indvirkning på indinavir, men antyder at der er mindre end to gange stigning i indinavirs AUC8t ved samtidig administration med saquinavir. 
The design of the study does not allow for definitive evaluation of the effect of saquinavir on indinavir, but suggests there is less than a two-fold increase in indinavir AUC8h during co-administration with saquinavir
Meget almindelige (≥ 1/10); Almindelige (≥ 1/100 til < 1/10); Ikke almindelige (≥ 1/1.000 til < 1/100); Sjældne (≥ 1/10.000 til < 1/1.000); Meget sjældne (< 1/10.000); Ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Very common (≥ 1/10); Common (≥ 1/100 to  1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to  1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data).
Det bør bemærkes at faldet i suppression af virus-RNA sås hyppigere, når behandling med indinavir blev initieret ved lavere doser end den anbefalede orale dosis på 2,4 g/dag. 
It should be noted that the decrease in suppression of viral RNA levels was seen more frequently when therapy with indinavir was initiated at doses lower than the recommended oral dose of 2.4 g/day.
De rette doser for denne kombination mht. effekt og sikkerhed er ikke fastlagt. 
The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis carinii pneumoni. 
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
De kan også få andre bivirkninger, mens De tager dette lægemiddel, såsom øget blødning hos blødere, muskelproblemer, tegn på infektion og knogleproblemer. 
There are also other side effects that you may get while taking this medicine such as increased bleeding in haemophiliacs, muscle problems, signs of infection, and bone problems.
Der blev udført reproduktionsundersøgelser med rotter, kaniner og hunde (ved doser der gav systemisk eksponering sammenlignelig med eller lidt større end human eksponering), og disse viste ingen tegn på teratogenicitet. 
Developmental toxicity studies were performed in rats, rabbits and dogs (at doses which produced systemic exposures comparable to or slightly greater than human exposure) and revealed no evidence of teratogenicity.
• Hvis De også tager ritonavir, kan De tage CRIXIVAN på et hvilket som helst tidspunkt på dagen med eller uden mad. 
• If you are also taking ritonavir, then you can take CRIXIVAN at any time of the day with or without food.
• øge CD4 (T)-celletallet i Deres krop. 
• raise your CD4 (T) cell count.
Administration De hårde kapsler bør synkes hele. 
Method of administration The hard capsules should be swallowed whole.
Den renale clearance (116 ml/min) af indinavir er koncentrationsuafhængig i det kliniske dosisinterval. 
Renal clearance (116 mL/min) of indinavir is concentration-independent over the clinical dose range.
CRIXIVAN bør administreres af læger med erfaring i behandling af hiv-infektion. 
CRIXIVAN should be administered by physicians who are experienced in the treatment of HIV infection.
Patienterne bør imidlertid informeres om, at svimmelhed og sløret syn er rapporteret under behandling med indinavir. 
However, patients should be informed that dizziness and blurred vision have been reported during treatment with indinavir.
Asymptomatisk pyuri af ukendt ætiologi sås hos 10,9 % (6/55) af de pædiatriske patienter, der fik CRIXIVAN. 
Asymptomatic pyuria of unknown etiology was noted in 10.9 % (6/55) of paediatric patients who received CRIXIVAN.
Hvis De har fået at vide af Deres læge, at De ikke kan tåle eller fordøje visse sukkerarter, skal De tale med Deres læge, før De tager dette lægemiddel. 
If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Som resultat af den korte halveringstid 1,8 ± 0,4 timer, sås kun minimal stigning i plasmakoncentrationer efter gentagne doser. 
As a result of the short half-life, 1.8 ± 0.4 hours, only a minimal increase in plasma concentrations occurred after multiple dosing.
Kan administreres uden restriktioner mht. tidspunkt for administration eller mad. 
Can be administered without any restrictions with respect to time of administration or food.
Indinavirs farmakokinetik hos disse 11 patienter 6 uger efter fødslen var generelt magen til den som blev set hos ikke-gravide patienter i et andet studie (se pkt. 
The pharmacokinetics of indinavir in these 11 patients at 6 weeks postpartum were generally similar to those observed in non-pregnant patients in another study (see section 4.6).
Så snart en diagnose er stillet, bør der tages passende forholdsregler for behandling af hæmolytisk anæmi, hvilket kan omfatte seponering af indinavir. 
Once a diagnosis is apparent, appropriate measures for the treatment of haemolytic anaemia should be instituted which may include discontinuation of indinavir.
Nedsat suppression af virus-RNA forekom hos nogle patienter; CD4-celletallet holdt sig imidlertid ofte over niveauet fra før behandlingen. 
Loss of suppression of viral RNA levels occurred in some patients; however, CD4 cell counts were often sustained above pre-treatment levels.
Ved doser mellem 800 mg og 1000 mg er afvigelsen fra dosisproportionalitet mindre udtalt. 
Between 800-mg and 1,000-mg dose levels, the deviation from dose-proportionality is less pronounced.
Det tilhører en gruppe af lægemidler, som kaldes "proteasehæmmere". 
It belongs to a group of medicines called ‘protease inhibitors'.
Denne overordnede sikkerhedsprofil forblev ens for 107 patienter behandlet med CRIXIVAN alene eller i kombination med NRTI i op til 48 uger. 
This overall safety profile remained similar for 107 patients treated with CRIXIVAN monotherapy or in combination with NRTI(s) for up to 48 weeks.
En normal (sur) gastrisk pH kan være nødvendig for optimal absorption af indinavir, hvorimod syre hurtigt nedbryder didanosin, som er formuleret med buffermidler for at øge pH. 
A normal (acidic) gastric pH may be necessary for optimum absorption of indinavir whereas acid rapidly degrades didanosine which is formulated with buffering agents to increase pH.
Taget i betragtning at betydeligt lavere eksponering før fødslen er set i en lille undersøgelse af hiv-inficerede gravide patienter, og de begrænsede data fra denne population, anbefales det ikke at bruge indinavir til hiv-inficerede gravide patienter (se pkt. 
Given that substantially lower antepartum exposures have been observed in a small study of HIV-infected pregnant patients and the limited data in this patient population, indinavir use is not recommended in HIV-infected pregnant patients (see section 5.2).
Virkning CRIXIVAN bruges mod hiv og medvirker til at nedsætte antallet af hiv-partikler i Deres blod. 
How CRIXIVAN works CRIXIVAN treats HIV and helps to lower the number of HIV particles in your blood.
To kliniske undersøgelser med 41 pædiatriske patienter (i alderen 4-15 år) er designet til at karakterisere indinavirs sikkerhed, antiretroviral aktivitet og farmakokinetik i kombination med stavudin og lamivudin. 
Two clinical trials in 41 paediatric patients (4 to 15 years of age) were designed to characterise the safety, antiretroviral activity, and pharmacokinetics of indinavir in combination with stavudine and lamivudine.
• Hvis De ikke kan tage det uden mad, så tag CRIXIVAN med et fedtfattigt, let måltid. 
• If you cannot take it without food then take CRIXIVAN with a low-fat light meal.
I dosisintervallet 200-1000 mg administreret til både raske frivillige og hiv-smittede patienter, fandtes lidt større end dosisproportional stigning af indinavir i urinen. 
Over the 200-1,000-mg dose range administered in both volunteers and HIV infected patients, there was a slightly greater than dose-proportional increase in urinary recovery of indinavir.
Resistens var korreleret til akkumulering af mutationer i det virale genom, som førte til ekspression af aminosyresubstitutioner i den virale protease. 
Resistance was correlated with the accumulation of mutations in the viral genome that resulted in the expression of amino acid substitutions in the viral protease.
Mange af de protease-aminosyresubstitutioner, som er fundet at være associeret med resistens over for ritonavir og saquinavir, er også forbundet med resistens over for indinavir. 
Many of the protease amino acid substitutions reported to be associated with resistance to ritonavir and saquinavir were also associated with resistance to indinavir.
Dosisreduktion af rifabutin og dosisøgning af CRIXIVAN er ikke bekræftet i kliniske undersøgelser. 
Dose reduction of rifabutin and dose increase of Crixivan has not been confirmed in clinical studies.
Opbevar CRIXIVAN i den originale flaske og hold flasken tæt tillukket, så kapslerne beskyttes mod fugt. 
Store CRIXIVAN in the original bottle and keep the bottle tightly closed to protect it from moisture.
Rifampicin er en stærk CYP3A4-induktor og har forårsaget et fald på 92 % i indinavirs AUC, hvilket kan medføre virologisk svigt og resistensudvikling. 
Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 92 % decrease in indinavir AUC which can result in virological failure and resistance development.
I hiv-inficerede pædiatriske patienter, gav et dosisregimen af indinavir hårde kapsler, 500 mg/m2 hver 
In HIV infected paediatric patients, a dose regimen of indinavir hard capsules, 500 mg/m every
CRIXIVAN kan ikke kurere hiv. 
CRIXIVAN is not a cure for HIV.
Analyser af plasma- og urinprøver, fra personer som fik indinavir, viste at indinavirmetabolitter har ringe proteinasehæmmende aktivitet. 
Analysis of plasma and urine samples from subjects who received indinavir indicated that indinavir metabolites had little proteinase inhibitory activity.
SÆRLIGE OPBEVARINGSBETINGELSER 
SPECIAL STORAGE CONDITIONS:
Tal også med Deres læge, apotekspersonalet eller sundhedspersonalet, før De tager CRIXIVAN, hvis De tager nogen af følgende lægemidler, da Deres læge måske vil justere dosis af Deres lægemidler: 
In addition, talk to your doctor, pharmacist or nurse before taking CRIXIVAN if you are taking any of the following medicines since your doctor may want to adjust the dose of your medicines:
Tal med lægen, hvis De skal tage både CRIXIVAN og ritonavir. 
Talk to your doctor if you are going to take both CRIXIVAN and ritonavir.
Der sås ingen eksterne eller viscerale forandringer hos rotter, dog sås øget forekomst af overtallige ribben samt cervikale ribben. 
No external or visceral changes were observed in rats, however, increases in the incidence of supernumerary ribs and of cervical ribs were seen.
Generelt blev disse hændelser ikke forbundet med renal dysfunktion og blev løst med hydrering og midlertidig seponering af behandlingen (fx 1-3 dage). 
In general, these events were not associated with renal dysfunction and resolved with hydration and temporary interruption of therapy (e.g., 1-3 days).
CRIXIVAN anvendes til behandling af humant immundefekt-virus (hiv) hos voksne. 
CRIXIVAN is used to treat Human Immunodeficiency Virus (HIV) in adults.
Forhøjet levervægt forekom hos rotter behandlet med indinavir i doser  40 mg/kg/dag og blev ledsaget af hepatocellulær hypertrofi ved doser  320 mg/kg/dag. 
An increase in hepatic weight occurred in rats treated with indinavir at doses  40 mg/kg/day and was accompanied by hepatocellular hypertrophy at doses  320 mg/kg/day.
Administration af indinavir til gravide Rhesusaber i tredje trimester fremkaldte ikke en tilsvarende eksacerbation hos nyfødte; imidlertid sås kun begrænset placentaoverførsel af indinavir. 
Administration of indinavir to pregnant Rhesus monkeys during the third trimester did not cause a similar exacerbation in neonates; however, only limited placental transfer of indinavir occurred.
Mindre end 20 % af indinavir udskilles renalt. 
Less than 20 % of indinavir is excreted renally.
Kombinationen af trazodon og indinavir/ritonavir bør anvendes med forsigtighed ved at initiere behandling med trazodon i laveste dosering og monitorere mht. klinisk respons og tolerabilitet. 
The combination of trazodone with indinavir/ritonavir should be used with caution, initiating trazodone at the lowest dose and monitoring for clinical response and tolerability.
En anden publiceret undersøgelse vurderede effekt og sikkerhed for indinavir/ritonavir 400/100 mg hver 12. time hos 40 antiretroviralt naive patienter. 
Another published study evaluated the efficacy and safety of indinavir/ritonavir 400/100 mg every 12 hours in 40 antiretroviral-naïve patients.
Samtidig administration af ritonavir og ketoconazol medførte øget incidens af gastrointestinale og hepatiske bivirkninger. 
Coadministration of ritonavir and ketoconazole caused an increased incidence of gastrointestinal and hepatic adverse events.
Derfor bør behandling med indinavir initieres ved den anbefalede dosis for at øge suppressionen af virusreplikation og dermed hæmme udviklingen af resistent virus. 
Therefore, therapy with indinavir should be initiated at the recommended dose to increase suppression of viral replication and therefore inhibit the emergence of resistant virus.
Farmakokinetikken for indinavir taget som indinavirsulfatsalt (fra åbnede, hårde kapsler) blandet i æblemos var generelt sammenlignelig med farmakokinetikken for indinavir taget fastende som hårde kapsler. 
The pharmacokinetics of indinavir taken as indinavir sulphate salt (from opened hard capsules) mixed in apple sauce were generally comparable to the pharmacokinetics of indinavir taken as hard capsules, under fasting conditions.
SEDATIVA/HYPNOTIKA Midazolam (parenteral) 
SEDATIVES/HYPNOTICS Midazolam (parenteral)
• Synk kapslerne hele med vand, mælk med lavt fedtindhold, juice, te eller kaffe. 
• Swallow the capsules whole with a drink of water, skimmed or low fat milk, juice, tea or coffee.
Se også indlægssedlen for ritonavir. 
Also look at the Package Leaflet for ritonavir.
AUC og maksimale plasmakoncentrationer var generelt lig dem, der tidligere er observeret hos hiv-inficerede voksne, som fik den anbefalede dosis på 800 mg hver 8. time; man bør være opmærksom på at plasmakoncentrationerne 8 timer efter dosering var lavere. 
The AUC and peak plasma concentrations were generally similar to those previously observed in HIV-infected adults receiving the recommended dose of 800 mg every 8 hours; it should be observed that the plasma concentrations 8 hours post dose were lower.
Fuldstændig krydsresistens fandtes mellem indinavir og ritonavir, medens krydsresistens over for saquinavir varierede mellem isolaterne. 
Complete cross resistance was noted between indinavir and ritonavir; however, cross resistance to saquinavir varied among isolates.
Anbefalingen er baseret på begrænsede farmakokinetiske data (se pkt. 
The recommendation is based on limited pharmacokinetic data (see section 5.2).
Hvis behandling med rifabutin er påkrævet, bør alternative lægemidler til behandling af hiv-infektion søges. 
If rifabutin treatment is required, alternative agents for treating HIV infection should be sought.
Den anbefalede dosis CRIXIVAN er: 
The recommended dose of CRIXIVAN is:
Disse bivirkninger var: kvalme (35,3 %), hovedpine (25,2 %), diarré (24,6 %), asteni/træthed (24,3 %), udslæt (19,1 %), smagsforstyrrelse (19,1 %), tør hud (16,2 %), abdominalsmerter (14,6 %), opkastning (11,0 %) og svimmelhed (10,7 %). 
These adverse reactions were: nausea (35.3 %), headache (25.2 %), diarrhoea (24.6 %), asthenia/fatigue (24.3 %), rash (19.1 %), taste perversion (19.1 %), dry skin (16.2 %), abdominal pain (14.6 %), vomiting (11.0 %), dizziness (10.7 %).
Isoleret asymptomatisk hyperbilirubinæmi, stigning i ALAT og ASAT 
isolated asymptomatic hyperbilirubinaemia, increased ALT and AST
Indinavir bindes reversibelt til det proteaseaktive site, hæmmer kompetitivt enzymet og forebygger derved den spaltning af det virale precursor polyprotein, som sker under modning af den nydannede, virale partikel. 
Indinavir binds reversibly to the protease active site and inhibits competitively the enzyme, thereby preventing cleavage of the viral precursor polyproteins that occurs during maturation of the newly formed viral particle.
Nefrolitiasis er set ved behandling med indinavir hos voksne patienter med en kumuleret frekvens på 12,4 % (interval på tværs af de enkelte forsøg: 4,7 % til 34,4 %). 
Nephrolithiasis has occurred with indinavir therapy in adult patients with a cumulative frequency of 12.4 % (range across individual trials: 4.7 % to 34.4 %).
Yderligere bivirkninger: 
Additional side effects include:
ANTIKOAGULANTIA Warfarin 
ANTICOAGULANT Warfarin
Den gennemsnitlige urinudskillelse af uomdannet lægemiddel efter administration af enkeltdoser givet i fastende tilstand var 10,4 % efter en 700 mg dosis og 12 % efter en 1000 mg dosis. 
Mean urinary excretion of unchanged medicinal product following single dose administration in the fasted state was 10.4 % following a 700-mg dose, and 12.0 % following a 1,000-mg dose.
CRIXIVAN kan påvirke behandlingen med nogle lægemidler. 
CRIXIVAN can affect the way some other medicines work.
Indinavir hæmmer ikke de eukaryote proteaser, human renin, human katepsin D, human elastase og human faktor Xa i signifikant grad. 
Indinavir did not significantly inhibit the eukaryotic proteases human renin, human cathepsin D, human elastase, and human factor Xa.
Ligeledes synes effekten på CD4-celletal at være mere udtalt hos patienter behandlet med indinavir i kombination med nukleosidanaloger sammenlignet med indinavir alene. 
Similarly, effects on CD4 cell count tend to be more pronounced in patients treated with indinavir in combination with nucleoside analogues compared with indinavir alone.
For sildenafil og tadalafil gælder de samme anbefalinger som for indinavir uden ritonavirboosting (se tabel 1). 
For sildenafil and tadalafil, same recommendations as for indinavir without ritonavir boosting (see Table 1).
• mørkfarvning af huden 
• darkening skin colour