natgillin/translations-raw huggingface dataset:
Distributionen af indinavir over placentabarrieren er signifikant hos rotter, men begrænset hos kaniner.
Distribution of indinavir across the placental barrier was significant in rats, but limited in rabbits.
• Dette skyldes, at lavere eller manglende doser kan øge risikoen for, at hiv bliver resistent over for CRIXIVAN
• This is because reducing or missing doses will make it more likely that HIV will become resistant to CRIXIVAN.
Der har været rapporter om human overdosis med CRIXIVAN.
There have been reports of human overdose with CRIXIVAN.
Meget almindelige (berører flere end 1 person ud af 10):
Very common (affects more than 1 in 10 people):
Den kumulerede frekvens af nefrolitiasishændelser stiger med stigende eksponering for CRIXIVAN; risikoen over tid forbliver dog relativt konstant.
The cumulative frequency of nephrolithiasis events increases with increasing exposure to CRIXIVAN; however, the risk over time remains relatively constant.
Der er også rapporteret bivirkninger efter markedsføring*; da disse er kommet fra spontane rapporter kan incidensen ikke vurderes.
Adverse reactions have also been reported during post-marketing experience* as they are derived from spontaneous reports, incidences cannot be determined.
Fordeling Indinavir bindes ikke i udstrakt grad til humane plasmaproteiner (39 % ubundet).
Distribution Indinavir was not highly bound to human plasma proteins (39 % unbound).
Der er ingen tilgængelige data vedrørende potentiel effekt af CRIXIVAN-behandling på fertiliteten hos mænd eller kvinder.
There are no data available regarding potential effects of CRIXIVAN treatment on male or female fertility.
Den gennemsnitlige halveringstid for indinavir steg til ca. 2,8 timer.
The mean half-life of indinavir increased to approximately 2.8 hours.
Hvis der er tegn på forværret leversygdom hos disse patienter, bør det overvejes enten at afbryde eller seponere behandlingen.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
• 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.
• 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.
Det er uvist, om indinavir udskilles i human mælk.
It is not known whether indinavir is excreted in human milk.
Der er vist at den systemiske eksponering for indinavir under graviditet er relativt formindsket (PACTG 358).
During pregnancy, it has been demonstrated that the systemic exposure of indinavir is relevantly decreased (PACTG 358.
• allergier
• allergies
Almindelige (berører færre end 1 person ud af 10):
Common (affects less than 1 in 10 people):
Der er ingen signifikant virkning af ikkeboostet indinavir på methadons AUC (se tabel 1 ovenfor).
There is no significant effect of unboosted indinavir on methadone AUC (see Table 1 above).
CRIXIVAN indeholder et stof, som kaldes indinavir.
CRIXIVAN contains a substance called indinavir.
Informer Deres læge hurtigst muligt, hvis De får alvorlige muskelsmerter eller oplever svækkelse.
Inform your doctor as soon as possible if you develop severe muscle pain or weakness.
De hårde kapsler bør synkes hele.
Hard capsules should be swallowed whole.
Patientkarakteristika Farmakokinetikken af indinavir synes ikke at påvirkes af race.
Characteristics in patients Pharmacokinetics of indinavir do not appear to be affected by race.
På basis af aktuelle, farmakodynamiske data, skal indinavir anvendes i kombination med andre antiretrovirale stoffer.
On the basis of current pharmacodynamic data, indinavir must be used in combination with other antiretroviral agents.
CsA-koncentrationen kræver progressiv dosisjustering med anvendelse af terapeutisk lægemiddelmonitorering.
CsA levels require progressive dose adjustment using therapeutic medicinal product monitoring.
Den antiretrovirale aktivitet var uændret, når didanosin blev administreret 3 timer efter behandling med indinavir.
Antiretroviral activity was unaltered when didanosine was administered 3 hours after treatment with indinavir.
De kan stadig smitte andre med hiv, selvom De tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral behandling.
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
I tilfælde af samtidig antiviral behandling for hepatitis B eller C bør de relevante produktinformationer for disse behandlingsregimer gennemgås.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Specifik dosisrekommandation kan ikke gives.
No specific dose recommendation can be given.
Indinavir- og didanosinformuleringer, der indeholder buffer, bør administreres med mindst en times mellemrum på tom mave.
Indinavir and didanosine formulations containing buffer should be administered at least one hour apart on an empty stomach.
Tag ikke CRIXIVAN, hvis De tager nogen af disse lægemidler eller har taget dem for nyligt.
Do not take CRIXIVAN if you are taking or have recently taken any of these medicines.
De skal normalt tage mindre CRIXIVAN, hvis De også tager ritonavir.
You usually take less CRIXIVAN if you are also taking ritonavir.
Hiv spredes via blodet eller ved seksuel omgang med en person med hiv.
HIV is spread by blood or sexual contact with a person with HIV.
Dosisjustering af midazolam bør overvejes, især hvis der gives mere end en enkelt dosis midazolam.
Dose adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Der sås ingen karcinogenicitet hos mus ved den maksimalt tolererede dosis, svarende til en systemisk eksposition ca. 2-3 gange højere end klinisk eksposition.
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.
30 forsøgspersoner fuldførte 48 ugers behandling.
Thirty subjects completed 48 weeks of treatment.
Der er ingen klinisk signifikante forskelle i indinavirs farmakokinetik hos hiv-seropositive kvinder sammenlignet med hiv-seropositive mænd.
There are no clinically significant differences in the pharmacokinetics of indinavir in HIV seropositive women compared to HIV seropositive men.
Tag ikke CRIXIVAN:
Do not take CRIXIVAN:
Dosisjustering bør overvejes på basis af patientens kliniske respons på methadonbehandlingen.
Dose adjustment should be considered based on the patient's clinical response to methadone therapy.
Mødre bør instrueres i at ophøre med amning under behandling.
Mothers should be instructed to discontinue breast feeding during treatment.
Den maksimale, ikke-letale, orale dosis indinavir var mindst 5000 mg/kg hos rotter og mus, den højeste dosis undersøgt i akutte toksicitetsundersøgelser.
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.
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).