FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are also taking ritonavir, then you can take CRIXIVAN at any time of the day with or without food.
Danish: • Hvis De også tager ritonavir, kan De tage CRIXIVAN på et hvilket som helst tidspunkt på dagen med eller uden mad.
English: • raise your CD4 (T) cell count.
Danish: • øge CD4 (T)-celletallet i Deres krop.
English: Method of administration The hard capsules should be swallowed whole.
Danish: Administration De hårde kapsler bør synkes hele.
English: Renal clearance (116 mL/min) of indinavir is concentration-independent over the clinical dose range.
Danish: Den renale clearance (116 ml/min) af indinavir er koncentrationsuafhængig i det kliniske dosisinterval.
English: CRIXIVAN should be administered by physicians who are experienced in the treatment of HIV infection.
Danish: CRIXIVAN bør administreres af læger med erfaring i behandling af hiv-infektion.
English: However, patients should be informed that dizziness and blurred vision have been reported during treatment with indinavir.
Danish: Patienterne bør imidlertid informeres om, at svimmelhed og sløret syn er rapporteret under behandling med indinavir.
English: Asymptomatic pyuria of unknown etiology was noted in 10.9 % (6/55) of paediatric patients who received CRIXIVAN.
Danish: Asymptomatisk pyuri af ukendt ætiologi sås hos 10,9 % (6/55) af de pædiatriske patienter, der fik CRIXIVAN.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Danish: 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.
English: As a result of the short half-life, 1.8 ± 0.4 hours, only a minimal increase in plasma concentrations occurred after multiple dosing.
Danish: Som resultat af den korte halveringstid 1,8 ± 0,4 timer, sås kun minimal stigning i plasmakoncentrationer efter gentagne doser.
English: Can be administered without any restrictions with respect to time of administration or food.
Danish: Kan administreres uden restriktioner mht. tidspunkt for administration eller mad.
English: 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).
Danish: 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.
English: Once a diagnosis is apparent, appropriate measures for the treatment of haemolytic anaemia should be instituted which may include discontinuation of indinavir.
Danish: Så snart en diagnose er stillet, bør der tages passende forholdsregler for behandling af hæmolytisk anæmi, hvilket kan omfatte seponering af indinavir.
English: Loss of suppression of viral RNA levels occurred in some patients; however, CD4 cell counts were often sustained above pre-treatment levels.
Danish: Nedsat suppression af virus-RNA forekom hos nogle patienter; CD4-celletallet holdt sig imidlertid ofte over niveauet fra før behandlingen.
English: Between 800-mg and 1,000-mg dose levels, the deviation from dose-proportionality is less pronounced.
Danish: Ved doser mellem 800 mg og 1000 mg er afvigelsen fra dosisproportionalitet mindre udtalt.
English: It belongs to a group of medicines called ‘protease inhibitors'.
Danish: Det tilhører en gruppe af lægemidler, som kaldes "proteasehæmmere".
English: This overall safety profile remained similar for 107 patients treated with CRIXIVAN monotherapy or in combination with NRTI(s) for up to 48 weeks.
Danish: Denne overordnede sikkerhedsprofil forblev ens for 107 patienter behandlet med CRIXIVAN alene eller i kombination med NRTI i op til 48 uger.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: How CRIXIVAN works CRIXIVAN treats HIV and helps to lower the number of HIV particles in your blood.
Danish: Virkning CRIXIVAN bruges mod hiv og medvirker til at nedsætte antallet af hiv-partikler i Deres blod.
English: 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.
Danish: 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.
English: • If you cannot take it without food then take CRIXIVAN with a low-fat light meal.
Danish: • Hvis De ikke kan tage det uden mad, så tag CRIXIVAN med et fedtfattigt, let måltid.
English: 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.
Danish: I dosisintervallet 200-1000 mg administreret til både raske frivillige og hiv-smittede patienter, fandtes lidt større end dosisproportional stigning af indinavir i urinen.
English: 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.
Danish: Resistens var korreleret til akkumulering af mutationer i det virale genom, som førte til ekspression af aminosyresubstitutioner i den virale protease.
English: Many of the protease amino acid substitutions reported to be associated with resistance to ritonavir and saquinavir were also associated with resistance to indinavir.
Danish: 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.
English: Dose reduction of rifabutin and dose increase of Crixivan has not been confirmed in clinical studies.
Danish: Dosisreduktion af rifabutin og dosisøgning af CRIXIVAN er ikke bekræftet i kliniske undersøgelser.
English: Store CRIXIVAN in the original bottle and keep the bottle tightly closed to protect it from moisture.
Danish: Opbevar CRIXIVAN i den originale flaske og hold flasken tæt tillukket, så kapslerne beskyttes mod fugt.
English: 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.
Danish: Rifampicin er en stærk CYP3A4-induktor og har forårsaget et fald på 92 % i indinavirs AUC, hvilket kan medføre virologisk svigt og resistensudvikling.
English: In HIV infected paediatric patients, a dose regimen of indinavir hard capsules, 500 mg/m every
Danish: I hiv-inficerede pædiatriske patienter, gav et dosisregimen af indinavir hårde kapsler, 500 mg/m2 hver
English: CRIXIVAN is not a cure for HIV.
Danish: CRIXIVAN kan ikke kurere hiv.
English: Analysis of plasma and urine samples from subjects who received indinavir indicated that indinavir metabolites had little proteinase inhibitory activity.
Danish: Analyser af plasma- og urinprøver, fra personer som fik indinavir, viste at indinavirmetabolitter har ringe proteinasehæmmende aktivitet.
English: SPECIAL STORAGE CONDITIONS:
Danish: SÆRLIGE OPBEVARINGSBETINGELSER
English: 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:
Danish: 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:
English: Talk to your doctor if you are going to take both CRIXIVAN and ritonavir.
Danish: Tal med lægen, hvis De skal tage både CRIXIVAN og ritonavir.
English: No external or visceral changes were observed in rats, however, increases in the incidence of supernumerary ribs and of cervical ribs were seen.
Danish: Der sås ingen eksterne eller viscerale forandringer hos rotter, dog sås øget forekomst af overtallige ribben samt cervikale ribben.
English: In general, these events were not associated with renal dysfunction and resolved with hydration and temporary interruption of therapy (e.g., 1-3 days).
Danish: Generelt blev disse hændelser ikke forbundet med renal dysfunktion og blev løst med hydrering og midlertidig seponering af behandlingen (fx 1-3 dage).
English: CRIXIVAN is used to treat Human Immunodeficiency Virus (HIV) in adults.
Danish: CRIXIVAN anvendes til behandling af humant immundefekt-virus (hiv) hos voksne.
English: 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.
Danish: 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.
English: 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.
Danish: Administration af indinavir til gravide Rhesusaber i tredje trimester fremkaldte ikke en tilsvarende eksacerbation hos nyfødte; imidlertid sås kun begrænset placentaoverførsel af indinavir.
English: Less than 20 % of indinavir is excreted renally.
Danish: Mindre end 20 % af indinavir udskilles renalt.
English: 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.
Danish: 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.
English: Another published study evaluated the efficacy and safety of indinavir/ritonavir 400/100 mg every 12 hours in 40 antiretroviral-naïve patients.
Danish: En anden publiceret undersøgelse vurderede effekt og sikkerhed for indinavir/ritonavir 400/100 mg hver 12. time hos 40 antiretroviralt naive patienter.
English: Coadministration of ritonavir and ketoconazole caused an increased incidence of gastrointestinal and hepatic adverse events.
Danish: Samtidig administration af ritonavir og ketoconazol medførte øget incidens af gastrointestinale og hepatiske bivirkninger.
English: 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.
Danish: Derfor bør behandling med indinavir initieres ved den anbefalede dosis for at øge suppressionen af virusreplikation og dermed hæmme udviklingen af resistent virus.
English: 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.
Danish: 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.
English: SEDATIVES/HYPNOTICS Midazolam (parenteral)
Danish: SEDATIVA/HYPNOTIKA Midazolam (parenteral)
English: • Swallow the capsules whole with a drink of water, skimmed or low fat milk, juice, tea or coffee.
Danish: • Synk kapslerne hele med vand, mælk med lavt fedtindhold, juice, te eller kaffe.
English: Also look at the Package Leaflet for ritonavir.
Danish: Se også indlægssedlen for ritonavir.
English: 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.
Danish: 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.
English: Complete cross resistance was noted between indinavir and ritonavir; however, cross resistance to saquinavir varied among isolates.
Danish: Fuldstændig krydsresistens fandtes mellem indinavir og ritonavir, medens krydsresistens over for saquinavir varierede mellem isolaterne.
English: The recommendation is based on limited pharmacokinetic data (see section 5.2).
Danish: Anbefalingen er baseret på begrænsede farmakokinetiske data (se pkt.
English: If rifabutin treatment is required, alternative agents for treating HIV infection should be sought.
Danish: Hvis behandling med rifabutin er påkrævet, bør alternative lægemidler til behandling af hiv-infektion søges.
English: The recommended dose of CRIXIVAN is:
Danish: Den anbefalede dosis CRIXIVAN er:
English: 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 %).
Danish: 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 %).
English: isolated asymptomatic hyperbilirubinaemia, increased ALT and AST
Danish: Isoleret asymptomatisk hyperbilirubinæmi, stigning i ALAT og ASAT
English: 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.
Danish: 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.
English: 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 %).
Danish: 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 %).
English: Additional side effects include:
Danish: Yderligere bivirkninger:
English: ANTICOAGULANT Warfarin
Danish: ANTIKOAGULANTIA Warfarin
English: 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.
Danish: 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.
English: CRIXIVAN can affect the way some other medicines work.
Danish: CRIXIVAN kan påvirke behandlingen med nogle lægemidler.
English: Indinavir did not significantly inhibit the eukaryotic proteases human renin, human cathepsin D, human elastase, and human factor Xa.
Danish: Indinavir hæmmer ikke de eukaryote proteaser, human renin, human katepsin D, human elastase og human faktor Xa i signifikant grad.
English: 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.
Danish: Ligeledes synes effekten på CD4-celletal at være mere udtalt hos patienter behandlet med indinavir i kombination med nukleosidanaloger sammenlignet med indinavir alene.
English: For sildenafil and tadalafil, same recommendations as for indinavir without ritonavir boosting (see Table 1).
Danish: For sildenafil og tadalafil gælder de samme anbefalinger som for indinavir uden ritonavirboosting (se tabel 1).
English: • darkening skin colour
Danish: • mørkfarvning af huden
English: Concomitant administration of indinavir and quetiapine may increase plasma concentrations of quetiapine leading to quetiapine-related toxicity, including coma.
Danish: Samtidig administration af indinavir og quetiapin kan øge plasmakoncentrationen af quetiapin og medføre quetiapin-relateret toksicitet herunder koma.
English: When loss of viral RNA suppression occurred, it was typically associated with replacement of circulating susceptible virus with resistant viral variants.
Danish: Når nedsat virus-RNA-suppression opstod, var det typisk forbundet med erstatning af cirkulerende følsomme virus med resistente virusvarianter.
English: 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.
Danish: 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.
English: STEROIDS Dexamethasone
Danish: STEROIDER Dexamethason
English: 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.
Danish: Patienter med allerede eksisterende leverdysfunktion inklusive kronisk, aktiv hepatitis har en øget frekvens af leverfunktionsabnormiteter ved antiretroviral kombinationsbehandling og bør kontrolleres efter gældende praksis.
English: Hyperbilirubinaemia occurred more frequently at doses exceeding 2.4 g/day compared to doses less than 2.4 g/day.
Danish: Hyperbilirubinæmi forekom hyppigere ved doser over 2,4 g/dag i sammenligning med doser under 2,4 g/dag.
English: It is not known whether indinavir is dialyzable by peritoneal or haemodialysis.
Danish: Det vides ikke om indinavir er dialyserbart ved peritonealdialyse eller hæmodialyse.
English: Hyperbilirubinaemia, reported predominantly as elevated indirect bilirubin, has occurred in 14 % of patients during treatment with indinavir.
Danish: Hyperbilirubinæmi, fortrinsvis rapporteret som forhøjet indirekte bilirubin, er observeret hos 14 % af patienterne under behandling med indinavir.
English: • oral contraceptive medicines (‘The Pill') containing norethindrone or ethinyl estradiol
Danish: • orale præventionsmidler (p-piller), der indeholder norethindron eller ethinylestradiol
English: HIV Transmission
Danish: Overførsel af hiv
English: An increased incidence of nephrolithiasis has been observed in patients with underlying liver disorders when treated with indinavir.
Danish: Der er set øget incidens af nefrolitiasis hos patienter med underliggende leversygdomme, når de behandles med indinavir.
English: CRIXIVAN is used at the same time as other HIV treatments (antiretroviral medicines).
Danish: CRIXIVAN anvendes sammen med andre former for hiv-behandling (antiretrovirale lægemidler).
English: 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).
Danish: 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.
English: 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).
Danish: 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).
English: Cases of interstitial nephritis with medullary calcification and cortical atrophy have been observed in patients with asymptomatic severe leucocyturia (> 100 cells/high power field).
Danish: Der er set tilfælde af interstitiel nefritis med medullær kalcifikation og kortikal atrofi hos patienter med asymptomatisk svær leukocyturi (>100 celler/højt styrkefelt).
English: Medicinal products by therapeutic areas
Danish: Lægemidler i henhold til terapeutisk område
English: Indinavir inhibits recombinant HIV-1 and HIV-2 protease with an approximate tenfold selectivity for HIV-1 over HIV-2 proteinase.
Danish: Indinavir hæmmer rekombinant hiv-1 og hiv-2 protease med ca. 10 gange selektivitet for hiv-1 i forhold til hiv-2 proteinase.
English: 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).
Danish: 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).
English: Atazanavir as well as indinavir are associated with indirect (unconjugated) hyperbilirubinemia due to inhibition of UDP-glucuronosyltransferase (UGT).
Danish: Både atazanavir og indinavir associeres med indirekte (ukonjugeret) hyperbilirubinæmi på grund af hæmning af UDP-glucuronosyltransferase (UGT).
English: Indinavir should be used cautiously with other medicinal products that are potent inducers of CYP3A4.
Danish: Indinavir bør anvendes med forsigtighed sammen med andre lægemidler, som er potente CYP3A4 induktorer.
English: 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.
Danish: 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.
English: Combination contraindicated due to an increased risk of myopathy including rhabdomyolysis.
Danish: Kombination er kontraindiceret pga. risiko for myopati, herunder rhabdomyolyse.
English: Interactions and dose recommendations with other medical products - UNBOOSTED INDINAVIR
Danish: Interaktioner og dosisrekommandationer sammen med andre lægemidler - IKKEBOOSTET INDINAVIR
English: In Rhesus monkeys, administration of indinavir to neonates caused a mild exacerbation of the transient physiologic hyperbilirubinaemia seen in this species after birth.
Danish: Hos Rhesusaber fremkaldte administration af indinavir til nyfødte mild eksacerbation af den forbigående fysiologiske hyperbilirubinæmi, der ses hos disse arter efter fødsel.
English: Not studied, combined administration may result in increased warfarin levels.
Danish: Ikke undersøgt; kombineret administration kan medføre øget warfarinkoncentration.
English: The safety and efficacy of indinavir has not been established in patients with significant underlying liver disorders.
Danish: Indinavirs sikkerhed og virkning er ikke fastlagt hos patienter med signifikante underliggende leversygdomme.