FrancophonIA/ELRC3.0 huggingface dataset:
English: To ensure adequate hydration, it is recommended that adults drink at least 1.5 litres of liquids during the course of 24 hours.
Danish: For at sikre tilstrækkelig hydrering, anbefales det at voksne drikker mindst 1,5 liter væske i løbet af 24 timer.
English: • ingrown toenails with or without infection
Danish: • nedgroede tånegle med eller uden infektion
English: • signs of infection - this may be a previous infection which comes back soon after anti-HIV treatment is started.
Danish: • tegn på infektion - dette kan være en tidligere infektion, der vender tilbage kort efter, anti-hivbehandlingen er startet.
English: Indinavir was rapidly eliminated with a half-life of 1.8 hours.
Danish: Indinavir blev hurtigt elimineret med en halveringstid på 1,8 timer.
English: • Do not stop taking CRIXIVAN without talking to your doctor.
Danish: • Hold ikke op med at tage CRIXIVAN, før De har talt med Deres læge.
English: • blood in your urine.
Danish: • blod i urinen.
English: In patients at increased risk, urinary screening should be considered.
Danish: Hos patienter med forhøjet risiko bør screening af urinen overvejes.
English: In the absence of such studies, caution should be exercised as increased levels of indinavir may occur.
Danish: Da sådanne undersøgelser ikke er udført, bør der udvises forsigtighed, da forhøjede niveauer af indinavir kan forekomme.
English: The resulting immature particles are noninfectious and are incapable of establishing new cycles of infection.
Danish: De derfor umodne partikler er non-infektiøse og ude af stand til at etablere nye infektionscykler.
English: The following side effects have been reported by patients taking CRIXIVAN:
Danish: Følgende bivirkninger er blevet indberettet af patienter, der tager CRIXIVAN:
English: The clinical significance of this finding is unknown.
Danish: Klinisk signifikans af dette fund er ukendt.
English: For optimal absorption, CRIXIVAN should be administered without food but with water 1 hour before or 2 hours after a meal.
Danish: For optimal absorption, skal CRIXIVAN administreres uden mad, men med vand, 1 time før, eller 2 timer efter et måltid.
English: No formal interaction study has been performed.
Danish: Der er ikke udført formel interaktionsundersøgelse.
English: It is important that you take CRIXIVAN exactly as your doctor tells you to - he or she will tell you how long you should take your medicine.
Danish: Det er vigtigt, at De tager CRIXIVAN nøjagtigt efter lægens anvisning - han/hun vil fortælle Dem, hvor lang tid, De skal tage medicinen.
English: Your doctor will monitor how this medicine works for you.
Danish: Deres læge vil overvåge, hvordan lægemidlet virker hos Dem.
English: CRIXIVAN helps to:
Danish: CRIXIVAN hjælper med til at:
English: Most patients continued treatment with CRIXIVAN without dose reduction and bilirubin values gradually declined toward baseline.
Danish: De fleste patienter fortsatte behandlingen med CRIXIVAN uden dosisreduktioin, og bilirubinværdierne faldt gradvis mod baseline.
English: Acute haemolytic anaemia has been reported which in some cases was severe and progressed rapidly.
Danish: Der er rapporteret akut hæmolytisk anæmi, som i nogle tilfælde var alvorlig og hurtigt progredierende.
English: • Take 1 hour before or 2 hours after a meal.
Danish: • Tag CRIXIVAN 1 time før eller 2 timer efter et måltid.
English: If persistent severe leucocyturia is found, further investigation might be warranted.
Danish: Hvis der findes vedholdende, svær leukocyturi, kan yderligere undersøgelser være nødvendige.
English: This is called combination antiretroviral therapy.
Danish: Dette kaldes antiretroviral kombinationsbehandling.
English: The following effects may happen:
Danish: Følgende bivirkninger kan forekomme:
English: You may need to have blood tests to check how your liver is working.
Danish: Lægen vil muligvis tage blodprøver for at kontrollere, hvor godt Deres lever virker.
English: Since CRIXIVAN must be taken at intervals of 8 hours, a schedule convenient for the patient should be developed.
Danish: Da CRIXIVAN skal tages med 8 timers intervaller, bør der udarbejdes en plan, der er tilpasset patienten.
English: A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Danish: Der er en mulig årsagssammenhæng, selvom virkningsmekanismen ikke er klarlagt.
English: CRIXIVAN may not do these things in all patients.
Danish: CRIXIVAN vil måske ikke gøre dette hos alle patienter.
English: Patients with coexisting conditions
Danish: Patienter med samtidigt eksisterende tilstande
English: Some of these events were associated with mild elevation of serum creatinine.
Danish: Nogle af disse hændelser var forbundet med en let stigning i serumkreatinin.
English: On rare occasions the muscle problems can be serious (rhabdomyolysis).
Danish: I sjældne tilfælde kan muskelproblemerne være alvorlige (rabdomyolyse).
English: Please see ‘Do not take CRIXIVAN' and ‘Do not take either CRIXIVAN or ritonavir' above under Section 2 for an important list of medicines that you must not combine with CRIXIVAN.
Danish: Se "Tag ikke CRIXIVAN" og "Tag ikke CRIXIVAN eller ritonavir" oven for under punkt 2 for en vigtig liste over lægemidler, De ikke må kombinere med CRIXIVAN.
English: The recommended doses are:
Danish: De anbefalede doser er:
English: Indinavir did not have any mutagenic or genotoxic activity in studies with or without metabolic activation.
Danish: Indinavir havde ikke nogen mutagen eller genotoksisk aktivitet i undersøgelser med og uden metabolisk aktivering.
English: The Interactions section of the SPC for ritonavir should also be consulted for information about potential interactions.
Danish: Interaktionsafsnittet i ritonavir SPC bør også konsulteres for oplysninger om mulige interaktioner.
English: • feeling numb or unusual feeling of the skin.
Danish: • følelsesløshed eller en underlig fornemmelse i huden
English: Combination not recommended
Danish: Kombination anbefales ikke.
English: There are no data concerning the penetration of indinavir into the central nervous system in humans.
Danish: Der findes ingen data vedrørende passage af indinavir ind i centralnervesystemet hos mennesker.
English: Within studies, this effect is sustained also after prolonged periods of follow-up.
Danish: Denne effekt er vedvarende i undersøgelser, også efter længerevarende follow-up perioder.
English: This is because these foods stop your body being able to take in as much CRIXIVAN and it will not work as well.
Danish: Dette skyldes, at disse former for mad gør, at Deres krop ikke kan optage så meget CRIXIVAN og det derfor ikke vil være lige så effektivt.
English: This happens in some people with advanced HIV infection (AIDS) and who have had HIV related infections before.
Danish: Dette sker hos nogle mennesker med fremskreden hiv-infektion (aids), som tidligere har haft hivrelaterede infektioner.
English: If this happens, do not drive or operate machines.
Danish: Hvis De oplever dette, må De ikke køre bil eller betjene maskiner.
English: Many of these adverse reactions were also identified as common pre-existing or frequently occurring medical conditions in this population.
Danish: Mange af disse bivirkninger blev også fundet almindeligt eller hyppigt forekommende tilstande i denne befolkningsgruppe.
English: Distribution of indinavir across the placental barrier was significant in rats, but limited in rabbits.
Danish: Distributionen af indinavir over placentabarrieren er signifikant hos rotter, men begrænset hos kaniner.
English: • This is because reducing or missing doses will make it more likely that HIV will become resistant to CRIXIVAN.
Danish: • Dette skyldes, at lavere eller manglende doser kan øge risikoen for, at hiv bliver resistent over for CRIXIVAN
English: There have been reports of human overdose with CRIXIVAN.
Danish: Der har været rapporter om human overdosis med CRIXIVAN.
English: Very common (affects more than 1 in 10 people):
Danish: Meget almindelige (berører flere end 1 person ud af 10):
English: The cumulative frequency of nephrolithiasis events increases with increasing exposure to CRIXIVAN; however, the risk over time remains relatively constant.
Danish: Den kumulerede frekvens af nefrolitiasishændelser stiger med stigende eksponering for CRIXIVAN; risikoen over tid forbliver dog relativt konstant.
English: Adverse reactions have also been reported during post-marketing experience* as they are derived from spontaneous reports, incidences cannot be determined.
Danish: Der er også rapporteret bivirkninger efter markedsføring*; da disse er kommet fra spontane rapporter kan incidensen ikke vurderes.
English: Distribution Indinavir was not highly bound to human plasma proteins (39 % unbound).
Danish: Fordeling Indinavir bindes ikke i udstrakt grad til humane plasmaproteiner (39 % ubundet).
English: There are no data available regarding potential effects of CRIXIVAN treatment on male or female fertility.
Danish: Der er ingen tilgængelige data vedrørende potentiel effekt af CRIXIVAN-behandling på fertiliteten hos mænd eller kvinder.
English: The mean half-life of indinavir increased to approximately 2.8 hours.
Danish: Den gennemsnitlige halveringstid for indinavir steg til ca. 2,8 timer.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværret leversygdom hos disse patienter, bør det overvejes enten at afbryde eller seponere behandlingen.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, only take CRIXIVAN if your doctor decides it is clearly necessary.
Danish: • Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De kun tage CRIXIVAN, hvis lægen beslutter, at det er absolut nødvendigt.
English: It is not known whether indinavir is excreted in human milk.
Danish: Det er uvist, om indinavir udskilles i human mælk.
English: During pregnancy, it has been demonstrated that the systemic exposure of indinavir is relevantly decreased (PACTG 358.
Danish: Der er vist at den systemiske eksponering for indinavir under graviditet er relativt formindsket (PACTG 358).
English: • allergies
Danish: • allergier
English: Common (affects less than 1 in 10 people):
Danish: Almindelige (berører færre end 1 person ud af 10):
English: There is no significant effect of unboosted indinavir on methadone AUC (see Table 1 above).
Danish: Der er ingen signifikant virkning af ikkeboostet indinavir på methadons AUC (se tabel 1 ovenfor).
English: CRIXIVAN contains a substance called indinavir.
Danish: CRIXIVAN indeholder et stof, som kaldes indinavir.
English: Inform your doctor as soon as possible if you develop severe muscle pain or weakness.
Danish: Informer Deres læge hurtigst muligt, hvis De får alvorlige muskelsmerter eller oplever svækkelse.
English: Hard capsules should be swallowed whole.
Danish: De hårde kapsler bør synkes hele.
English: Characteristics in patients Pharmacokinetics of indinavir do not appear to be affected by race.
Danish: Patientkarakteristika Farmakokinetikken af indinavir synes ikke at påvirkes af race.
English: On the basis of current pharmacodynamic data, indinavir must be used in combination with other antiretroviral agents.
Danish: På basis af aktuelle, farmakodynamiske data, skal indinavir anvendes i kombination med andre antiretrovirale stoffer.
English: CsA levels require progressive dose adjustment using therapeutic medicinal product monitoring.
Danish: CsA-koncentrationen kræver progressiv dosisjustering med anvendelse af terapeutisk lægemiddelmonitorering.
English: Antiretroviral activity was unaltered when didanosine was administered 3 hours after treatment with indinavir.
Danish: Den antiretrovirale aktivitet var uændret, når didanosin blev administreret 3 timer efter behandling med indinavir.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: De kan stadig smitte andre med hiv, selvom De tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral behandling.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C bør de relevante produktinformationer for disse behandlingsregimer gennemgås.
English: No specific dose recommendation can be given.
Danish: Specifik dosisrekommandation kan ikke gives.
English: Indinavir and didanosine formulations containing buffer should be administered at least one hour apart on an empty stomach.
Danish: Indinavir- og didanosinformuleringer, der indeholder buffer, bør administreres med mindst en times mellemrum på tom mave.
English: Do not take CRIXIVAN if you are taking or have recently taken any of these medicines.
Danish: Tag ikke CRIXIVAN, hvis De tager nogen af disse lægemidler eller har taget dem for nyligt.
English: You usually take less CRIXIVAN if you are also taking ritonavir.
Danish: De skal normalt tage mindre CRIXIVAN, hvis De også tager ritonavir.
English: HIV is spread by blood or sexual contact with a person with HIV.
Danish: Hiv spredes via blodet eller ved seksuel omgang med en person med hiv.
English: Dose adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Dosisjustering af midazolam bør overvejes, især hvis der gives mere end en enkelt dosis midazolam.
English: No carcinogenicity was noted in mice at the maximum tolerated dose, which corresponded to a systemic exposure approximately 2 to 3 times higher than the clinical exposure.
Danish: Der sås ingen karcinogenicitet hos mus ved den maksimalt tolererede dosis, svarende til en systemisk eksposition ca. 2-3 gange højere end klinisk eksposition.
English: Thirty subjects completed 48 weeks of treatment.
Danish: 30 forsøgspersoner fuldførte 48 ugers behandling.
English: There are no clinically significant differences in the pharmacokinetics of indinavir in HIV seropositive women compared to HIV seropositive men.
Danish: Der er ingen klinisk signifikante forskelle i indinavirs farmakokinetik hos hiv-seropositive kvinder sammenlignet med hiv-seropositive mænd.
English: Do not take CRIXIVAN:
Danish: Tag ikke CRIXIVAN:
English: Dose adjustment should be considered based on the patient's clinical response to methadone therapy.
Danish: Dosisjustering bør overvejes på basis af patientens kliniske respons på methadonbehandlingen.
English: Mothers should be instructed to discontinue breast feeding during treatment.
Danish: Mødre bør instrueres i at ophøre med amning under behandling.
English: The maximum non-lethal oral dose of indinavir was at least 5,000 mg/kg in rats and mice, the highest dose tested in acute toxicity studies.
Danish: Den maksimale, ikke-letale, orale dosis indinavir var mindst 5000 mg/kg hos rotter og mus, den højeste dosis undersøgt i akutte toksicitetsundersøgelser.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med de sjældne arvelige problemer galactoseintolerance, Lapp lactosemangel eller glucosegalactosemalabsorption bør ikke tage dette lægemiddel.
English: 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.
Danish: 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.
English: Viral load remained < 200 copies/mL for 48 weeks in all patients.
Danish: Virusbelastningen forblev < 200 kopier/ml i 48 uger hos alle patienterne.
English: Data from a steady state study in healthy volunteers indicate that there is a diurnal variation in the pharmacokinetics of indinavir.
Danish: Data fra en steadystate undersøgelse på raske frivillige indikerer, at der er en daglig variation i indinavir farmakokinetikken.
English: Sixty-two patients completed the study to week 96.
Danish: 62 patienter fuldførte undersøgelsen til uge 96.
English: • tacrolimus, ciclosporin - used mainly after organ transplantation
Danish: • tacrolimus, ciclosporin - anvendes hovedsageligt efter organtransplantation
English: • 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).
Danish: • alvorlige smerter, ømhed eller svækkelse af Deres muskler - der er større risiko for dette, hvis De tager kolesterolsænkende lægemidler kaldet statiner (såsom simvastatin).
English: Six of these 11 (55 %) patients had mean indinavir plasma concentrations 8 hours postdose (Cmin) below assay threshold of reliable quantification.
Danish: Seks af disse 11 patienter (55 %) havde middel indinavir plasmakoncentrationer 8 timer efter doseringen (Cmin) under assaygrænsen for pålidelig kvantificering.
English: No significant difference in exposure was seen when the regimen was given with a high-fat meal.
Danish: Der sås ingen signifikant forskel i eksponeringen, når behandlingen blev givet sammen med et fuldfedt måltid.
English: The observed amino acid substitutions appeared to accumulate sequentially and in no consistent order, probably as a result of ongoing viral replication.
Danish: De observerede aminosyresubstitutioner sås at akkumulere sekventielt og ikke i nogen konsistent rækkefølge, sandsynligvis på grund af vedvarende virusreplikation.
English: Eighteen patients completed the study to week 48.
Danish: 18 patienter fuldførte undersøgelsen til uge 48.
English: Food effect
Danish: Virkning af mad
English: If you notice any symptoms of infection, please inform your doctor immediately.
Danish: Hvis De opdager symptomer på infektion, skal De straks fortælle det til Deres læge.
English: • The active substance is indinavir.
Danish: • Aktivt stof: Indinavir.
English: Ritonavir is used for increasing the blood levels of CRIXIVAN or, less frequently and then at higher doses, for HIV treatment.
Danish: Ritonavir anvendes til at øge indholdet af CRIXIVAN i blodet eller, mindre hyppigt og i højere doser, til behandling af hiv.
English: 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.
Danish: Mindst 11 aminosyresteder i proteasen er blevet associeret med indinavirresistens: L10, K20, L24, M46, I54, L63, I64, A71, V82, I84 og L90.
English: No external, visceral, or skeletal changes were observed in rabbits or dogs.
Danish: Der sås ingen eksterne, viscerale eller skeletale forandringer hos kaniner eller hunde.
English: This medicinal product contains 299.2 mg of lactose in each 800 mg dose (maximum single dose).
Danish: Lactose Dette lægemiddel indeholder 299,2 mg lactose pr. 800 mg dosis (maksimal enkeltdosis).
English: • 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.
Danish: • autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) kan også opstå, efter De er begyndt at tage medicin til behandling af din hiv-infektion.
English: Do not use this medicine after the expiry date which is stated on the bottle or carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flasken eller æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • if you are allergic to indinavir or any of the other ingredients of this medicine (listed in Section 6).
Danish: • hvis De er allergisk over for indinavir eller et af de øvrige indholdstoffer i CRIXIVAN (angivet i punkt 6).
English: 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.
Danish: 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.
English: So you still need to keep seeing your doctor while you are taking CRIXIVAN.
Danish: Derfor skal De fortsat gå til kontrol hos Deres læge, mens De tager CRIXIVAN.
English: It is recommended that HIV infected women do not breast feed their infants under any circumstances in order to avoid transmission of HIV.
Danish: Det anbefales at hiv-smittede kvinder, for at undgå overførsel af hiv, ikke under nogen omstændigheder ammer deres børn.
English: Do not take either CRIXIVAN or ritonavir if any of the above applies to you.
Danish: Tag ikke enten CRIXIVAN eller ritonavir, hvis noget af ovenstående gælder for Dem.
English: 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.
Danish: 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.
English: Caution is warranted and clinical monitoring of patients is recommended.
Danish: Forsigtighed tilrådes og klinisk monitorering af patienterne anbefales.
English: 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
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Danish: De rette doser for denne kombination mht. effekt og sikkerhed er ikke fastlagt.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis carinii pneumoni.
English: 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.
Danish: De kan også få andre bivirkninger, mens De tager dette lægemiddel, såsom øget blødning hos blødere, muskelproblemer, tegn på infektion og knogleproblemer.
English: 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.
Danish: 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.