FrancophonIA/ELRC3.0 huggingface dataset:
English: The capsules and liquid must be taken with food, but the tablets can be taken with or without food.
Danish: Kapslerne og væsken skal tages sammen med et måltid, mens tabletterne kan tages med eller uden et måltid.
English: What is Kaletra and what is it used for?
Danish: Hvad er Kaletra, og hvad anvendes det til?
English: Kaletra does not cure HIV infection or AIDS, but it may hold off damage to the immune system, and the development of infections and diseases associated with AIDS.
Danish: Kaletra helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Studies have shown that Kaletra is effective at reducing viral load (the amount of virus found in the blood) to very low levels (below 400 copies/ml).
Danish: Undersøgelser har vist, at Kaletra er effektivt til at reducere virusindholdet (mængden af virus fundet i blodet) til meget lave niveauer (under 400 kopier/ml).
English: Why is Kaletra approved?
Danish: Hvorfor blev Kaletra godkendt?
English: Kaletra is available as tablets, capsules and oral liquid.
Danish: Kaletra fås som tabletter, kapsler og oral væske.
English: When the enzyme is blocked, the virus does not reproduce normally slowing down its multiplication in the body.
Danish: Når enzymet blokeres, formerer virusset sig ikke normalt, og formeringen af den i kroppen bliver langsommere.
English: Kaletra must not be used by patients with severe liver disease or by patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Kaletra and are harmful at high levels in the blood.
Danish: Kaletra må ikke anvendes til patienter med svær leversygdom eller patienter, som tager perikum (en drogetilberedning til behandling af depression) eller lægemidler, der nedbrydes på samme måde som Kaletra, og som er skadelige i store mængder i blodet.
English: Kaletra is effective at reducing HIV viral loads to below 400 copies/ml in the majority of adults and children from 14 days of age.
Danish: Kaletra er effektivt til at reducere hivvirusindholdet til under 400 kopier/ml hos de fleste voksne og børn i alderen over 14 dage.
English: What are the risks associated with Kaletra?
Danish: Hvilke risici er der forbundet med Kaletra?
English: The medicine is taken once or twice daily in adults, and the dose depends on the type of virus the patient is infected with.
Danish: Lægemidlet skal tages én eller to gange dagligt hos voksne, og dosen afhænger af, hvilken type virus patienten er smittet med. Dosen til behandling af børn afhænger af vægt og højde.
English: Kaletra can only be obtained with a prescription and should be prescribed by a doctor with experience treating HIV infection.
Danish: Kaletra udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
English: The most common side effects with Kaletra in adults (seen in more than 1 patient in 10) are upper respiratory tract infection (colds), nausea (feeling sick) and diarrhoea.
Danish: De hyppigste bivirkninger ved Kaletra hos voksne (som optræder hos mere en 1 ud af 10 patienter) er infektioner i de øvre luftveje (forkølelser), kvalme og diarré.
English: Both active substances in Kaletra are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of HIV.
Danish: Begge aktive stoffer i Kaletra er proteasehæmmere, dvs. de blokerer enzymet protease, der medvirker ved formeringen af hiv.
English: Kaletra is an HIV medicine used in combination with other medicines to treat adults and children from over 14 days of age who are infected with HIV-1.
Danish: Kaletra er et lægemiddel, der anvendes i kombination med andre lægemidler til behandling af hiv-1inficerede voksne og børn i alderen over 14 dage.
English: For more information about treatment with Kaletra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kaletra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Studies in children from 14 days of age showed between 71% and 85% of patients having very low levels of the virus after 48 weeks of treatment with Kaletra.
Danish: Undersøgelser hos børn i alderen over 14 dage viste, at mellem 71 % og 85 % af patienterne havde et meget lavt virusindhold efter 48 ugers behandling med Kaletra.
English: In Kaletra, lopinavir provides the activity against the virus while ritonavir mainly works as a ‘booster' to slow down the rate at which lopinavir is broken down by the liver.
Danish: Det er lopinavir, der giver Kaletra dets virkning mod virus, mens ritonavir primært fungerer som "forstærker" ved at nedsætte den hastighed, hvormed lopinavir nedbrydes i leveren.
English: In one study of adults who had not been treated for HIV before, 79% of the patients taking Kaletra (259 out of 326) had very low levels of the virus after 24 weeks, compared with 71% of the patients taking nelfinavir (233 out of 327).
Danish: I én undersøgelse af ikke tidligere hivbehandlede voksne havde 79 % af de patienter, der fik Kaletra (259 ud af 326), et meget lavt virusindhold efter 24 uger sammenholdt med 71 % af de patienter, der fik nelfinavir (233 ud af 327).
English: A second adult study in patients who had previously taken a protease inhibitor, 73% of the patients taking Kaletra (43 out of 59) had very low levels of the virus after 16 weeks, compared with 54% of the patients taking the comparator medicines (32 out of 59).
Danish: I en anden undersøgelse af voksne, der tidligere havde fået en proteasehæmmer, havde 73 % af de patienter, der fik Kaletra (43 ud af 59), et meget lavt virusindhold efter 16 uger sammenholdt med 54 % af de patienter, der fik sammenligningslægemidlerne (32 ud af 59).
English: For practical information about using Kaletra, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kaletra, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Kaletra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Kaletra fremgår af indlægssedlen.
English: What benefits of Kaletra have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kaletra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kaletra have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Kaletra.
English: How is Kaletra used?
Danish: Hvordan anvendes Kaletra?
English: How does Kaletra work?
Danish: Hvordan virker Kaletra?
English: Γ.Α.Σταµάτης & Σια Λτδ.
Danish: Γ.Α.Σταμάτης & Σια Λτδ.
English: • Allergic reactions.
Danish: • Allergiske reaktioner.
English: In some patients additional factor VIII was given.
Danish: Til nogle patienter blev der yderligere givet faktor VIII.
English: Other side effects which have also been reported:
Danish: Andre bivirkninger, som er blevet rapporteret:
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk observeret inden for de første få uger eller måneder efter påbegyndelsen af CART.
English: Alternative contraceptive measures should be considered.
Danish: Alternative kontraceptiva bør overvejes.
English: Use with caution.
Danish: Bruges med forsigtighed.
English: These are called CD4 white blood cells.
Danish: Disse kaldes CD4 hvide blodceller.
English: • Take all the mixture you make each time.
Danish: • Indtag hele den blanding du laver hver gang.
English: Effect of Food on Oral Absorption
Danish: Virkning af føde på oral absorption
English: Protocol No.
Danish: Protokol nr.
English: The terminal half-life in plasma was typically 3.5 to 5 hours.
Danish: Terminalhalveringstiden i plasma var typisk 3,5 til 5 timer.
English: Grades 3&4
Danish: Grad 3&4
English: • The mixed solution can be stored for up to 6 hours in a refrigerator.
Danish: • Den blandede opløsning kan opbevares i op til 6 timer i køleskab.
English: See the Package Leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: However, such an effect cannot be ruled out.
Danish: Dog kan en sådan virkning ikke med sikkerhed udelukkes.
English: You may continue to get infections or other illnesses due to your HIV.
Danish: Du kan fortsat få infektioner eller andre sygdomme på grund af din hiv-infektion.
English: It helps to reduce the number of HIV
Danish: Det hjælper med at reducere antallet af hiv-partikler
English: 1 week
Danish: 1 uge
English: ITT (NC = F) Observed data LOCF
Danish: ITT (NC = F) Observerede data LOCF
English: • Do not use after the expiry date stated on the label and carton.
Danish: • Brug ikke Viracept efter den udløbsdato, der står på etiketten og pakningen.
English: • Infection.
Danish: • Infektion.
English: Knowledge about the mechanism is incomplete.
Danish: Kendskabet til virkningsmekanismen er ufuldstændigt.
English: If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours.
Danish: Hvis blandingen ikke indtages med det samme, skal den opbevares i køleskab, men opbevaringstiden må ikke overstige 6 timer.
English: Viracept tablets are generally recommended for adults and older children.
Danish: Viracept-tabletter anbefales generelt til voksne og til ældre børn.
English: ↑ Indicates increase, ↓ indicates decrease, ↔ indicates minimal change (< 10 %)
Danish: ↑ Indikerer stigning, ↓ indikerer fald, ↔ indikerer minimal ændring (< 10 %)
English: The virologic and immunologic responses should be monitored to assure these children achieve response to therapy.
Danish: De virologiske og immunologiske reaktioner bør overvåges for at sikre at disse børn opnår respons på behandlingen.
English: Amino acid position 30 appeared to be the most frequent mutation site.
Danish: Aminosyreposition 30 viste sig at være det hyppigste mutationssted.
English: • Abnormal results from blood tests that measure how well your liver or muscles are working.
Danish: • Abnorme resultater i blodprøver, som måler hvor godt din lever og muskler fungerer.
English: The reason for this high variability is not known but may be due to inconsistent food intake in paediatric patients.
Danish: Årsagen til denne store variabilitet kendes ikke, men kan skyldes den inkonsistente fødeindtagelse hos pædiatriske patienter.
English: See section 2 and 6.1 for further information on excipients.
Danish: 2 og 6.1 for yderligere information vedrørende hjælpestoffer.
English: PSUR: The Marketing Authorisation Holder will submit yearly PSURs.
Danish: PSUR: Indehaveren af markedsføringstilladelsen vil indsende årlige PSURs.
English: • You are taking any of the medicines listed in the first part of Section 2 ‘Taking other medicines', ‘Do not take Viracept'.
Danish: • Du tager et af de lægemidler, der er anført i den først del af afsnit 2 under ”Brug af anden medicin” og ”Tag ikke Viracept”.
English: During these trials less than 13% of patients in total discontinued treatment due to adverse events.
Danish: Under disse forsøg var der færre end 13 % af alle patienterne, som afbrød behandlingen på grund af uønskede hændelser.
English: It is very important that the correct number of tablets be taken at each dose.
Danish: Det er meget vigtigt, at det korrekte antal tabletter tages ved hver dosis.
English: The list also includes marked laboratory abnormalities that have been observed with nelfinavir (at 48 weeks).
Danish: Listen indeholder også tydelige laboratorieabnormaliteter, som har været observeret med nelfinavir (ved 48 uger).
English: • Increase the number of some cells in your blood that help fight infection.
Danish: • Øge antallet af nogle af de celler i dit blod, som hjælper med at bekæmpe infektion.
English: Take the medicine pack with you.
Danish: Tag lægemiddelpakningen med.
English: Children:
Danish: Børn:
English: As these data come from the spontaneous reporting system, the frequency of the adverse reactions is not confirmed.
Danish: Da disse data kommer fra det spontane rapporteringssystem, er frekvensen af disse bivirkninger ikke bekræftet.
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til websites om sjældne sygdomme, og
English: The results from the two studies are summarized below.
Danish: Resultaterne fra de to studier er opsummeret nedenunder.
English: VIRACEPT should be given during pregnancy only if the expected benefit justifies the possible risk to the foetus.
Danish: VIRACEPT bør kun gives under graviditet hvis de forventede fordele opvejer de mulige risici for fostret.
English: Sedatives/Anxiolytics Midazolam
Danish: Sedativa/anxiolytika Midazolam
English: • You have liver disease caused by hepatitis B or C. Your doctor may wish to carry out regular blood tests.
Danish: • Du har en leversygdom forårsaget af hepatitis B eller C. Din læge kan ønske at tage regelmæssige blodprøver.
English: This belongs to a group of medicines called ‘anti-retrovirals'.
Danish: Den tilhører en gruppe af lægemidler, som kaldes antiretrovirale lægemidler.
English: Effects on drug levels % Change
Danish: Påvirkninger på lægemiddelkoncentrationer % ændring
English: Since it is recommended that didanosine be administered on an empty stomach, VIRACEPT should be administered (with food) one hour after or more than 2 hours before didanosine.
Danish: Da det anbefales, at didanosin indgives på tom mave, bør VIRACEPT administreres (med et måltid) én time efter eller mere end to timer før didanosin.
English: Among other things, very large doses of Viracept might cause problems with your heart rhythm.
Danish: Blandt andet kan meget høje doser af Viracept medføre problemer med din hjerterytme.
English: Neutropenia/leukopenia was the most frequently observed laboratory abnormality.
Danish: Neutropeni/leukopeni var den mest observerede laboratorie-abnormalitet.
English: A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Danish: Det er muligt at der er en årsagssammenhæng, selvom virkningsmekanismen ikke er klarlagt.
English: Therefore, no special precautions or dose adjustments are required in these patients.
Danish: Der er derfor ikke behov for særlige sikkerhedsforanstaltninger eller dosisjustering hos disse patienter.
English: They should be swallowed whole and taken with a meal.
Danish: De skal synkes hele og indtages sammen med et måltid.
English: Summary of Steady-state AUC24 of nelfinavir in Paediatric Studies
Danish: Opsummering af steady-state AUC24 for nelfinavir i pædiatriske studier
English: About 400 children (aged from 0 to 13 years) received Viracept in clinical trials.
Danish: Cirka 400 børn (i alderen 0 til 13 år) fik Viracept i kliniske studier.
English: The combination should be used with caution and a lower dose of trazodone should be considered.
Danish: Kombinationen bør anvendes med forsigtighed, og en lavere dosis af trazodon bør overvejes.
English: • Yellow skin or eyes.
Danish: • Gulfarvning af hud eller øjne.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om Viracept på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Endothelin receptor antagonists Bosentan
Danish: Endothelinreceptorantagonister Bosentan
English: Total number of tablets per day
Danish: Samlet antal tabletter per dag
English: The dosing regimens and associated AUC24 values are summarized below.
Danish: Dosering og tilhørende AUC24 værdier opsummeres nedenunder.
English: • You have high blood sugar (diabetes).
Danish: • Du har højt blodsukker (diabetes).
English: Clinical experience in pregnant women is limited.
Danish: Der er begrænsede kliniske erfaringer med gravide kvinder.
English: Table 1 below shows the usual doses.
Danish: Tabel 1 nedenfor viser den sædvanlige dosis.
English: How much you take each time (in milligrams) 1250 mg
Danish: Hvor meget du tager hver gang (i milligram) 1250 mg
English: They are particularly reduced in numbers when you have HIV infection.
Danish: De er særligt nedsat, når du har hiv.
English: Contact your doctor if you notice changes in body fat.
Danish: Kontakt din læge, hvis du bemærker ændringer i kropsfedtet.
English: The different ways are shown in separate tables below.
Danish: De forskellige måder vises nedenfor i to separate tabeller.
English: • If you mix the powder, but do not take it straight away you can store it for up to 6 hours in a
Danish: • Hvis du blander pulveret, men indtager det ikke med det samme, kan du opbevare det i op til 6
English: The Viracept tablets must be taken by mouth.
Danish: Viracept-tabletterne skal indtages gennem munden.
English: Take all your doses at the right time each day.
Danish: Tag alle dine doser på det rigtige tidspunkt hver dag.
English: This helps your body to get the full benefit from your medicine.
Danish: Det hjælper din krop til at få det fulde udbytte af medicinen.
English: Isolates from all 9 patients possessed one or more mutations in the viral protease gene.
Danish: I isolaterne fra alle 9 patienter var der en eller flere mutationer i det virale proteasegen.
English: The side effects seen in children are similar to those seen in adults.
Danish: Bivirkningerne set hos børn er tilsvarende dem set hos voksne.
English: • Low numbers of a type of white blood cell that fights infections (neutrophils).
Danish: • Lavt antal af en type hvide blodceller, som bekæmper infektioner (neutrofiler).
English: • You have kidney problems.
Danish: • Du har nyreproblemer.
English: Sildenafil at a starting dose not exceeding 25 mg in 48 hours.
Danish: Sildenafil kan anvendes ved en startdosis, der ikke overstiger 25 mg indenfor 48 timer.
English: Important information about some of the ingredients of Viracept
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Viracept
English: Do not take Viracept if any of the above apply to you.
Danish: Tag ikke Viracept, hvis noget af ovenstående gælder for dig.
English: No dosage adjustment for needed for either product
Danish: Dosisjustering er ikke nødvendig for nogen af produkterne
English: The absolute bioavailability of VIRACEPT has not been determined.
Danish: Den absolutte biotilgængelighed af VIRACEPT er ikke fastlagt.
English: Other possible side effects, where you should talk to your doctor If you get any of the side effects on this list, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Danish: Andre bivirkninger, hvor du bør tale med din læge Hvis du får nogle af bivirkningerne på denne liste, eller hvis du bemærker nogle bivirkninger, som ikke er nævnt i denne indlægsseddel, skal du informere din læge.
English: Therefore you must keep taking appropriate precautions to avoid giving the virus to others when you are taking Viracept.
Danish: Derfor skal du fortsætte med at tage passende forholdsregler for at forhindre, at du giver virusen videre til andre, selv om du tager Viracept.
English: Viracept powder is for people who cannot take tablets.
Danish: Viracept pulver er til patienter, som ikke kan tage tabletter.
English: • The active substance in Viracept is nelfinavir.
Danish: • Det aktive indholdsstof i Viracept er nelfinavir.
English: Like all medicines, Viracept can have side effects, although not everybody gets them.
Danish: Viracept kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Additional adverse reactions have been reported in the post-marketing experience and are listed below.
Danish: Yderligere bivirkninger har været rapporteret efter markedsføring og er anført nedenfor.
English: How much you take each time (in grams)
Danish: Hvor meget du tager hver gang (i gram)
English: • Do not breast-feed while taking Viracept because HIV may be passed to the baby.
Danish: • Du må ikke amme, mens du tager Viracept, idet du kan give hiv videre til barnet
English: Carcinogenicity: Two year oral carcinogenicity studies with nelfinavir mesilate were conducted in mice and rats.
Danish: Carcinogenicitet: To års carcinogenicitetsstudier med nelfinavirmesilat blev udført på rotter og mus.
English: The most commonly reported side effect in children is diarrhoea.
Danish: Den mest almindelige bivirkning hos børn er diarré.
English: • Do not add liquid to the powder in its original container
Danish: • Tilsæt ikke væske til pulveret i dets oprindelige beholder.
English: 14 2-13 years
Danish: 2-13 år
English: 6 weeks
Danish: 6 uger
English: Systemic exposures were 3 to 4 times those for humans given therapeutic doses.
Danish: Den systemiske belastning var 3-4 gange højere end hos mennesker, som fik terapeutiske doser.
English: Distribution: Nelfinavir in serum is extensively protein-bound (≥ 98 %).
Danish: Fordeling: Nelfinavir i serum er kraftigt proteinbundet (≥ 98 %).
English: The clinical relevance of these in vitro data is unknown.
Danish: Den kliniske relevans af disse in vitro data er ukendt.
English: Inhaled/nasal steroid Fluticasone
Danish: Inhaleret/nasalt steroid Fluticason
English: Rosuvastatin may also be administered with nelfinavir but patients should be monitored.
Danish: Rosuvastatin kan også administreres med nelfinavir, men patienterne bør monitoreres.
English: • Take all your doses at the right time each day.
Danish: • Tag alle dine doser på det rigtige tidspunkt hver dag.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • senest 60 dage efter en vigtig milepæl er nået (pharmacovigilance eller risikominimering)
English: The long-term consequences of these events are currently unknown.
Danish: Langtidskonsekvenserne heraf er på nuværende tidspunkt ukendte.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis det hos disse patienter kan påvises, at leversygdommen forværres, bør det overvejes at afbryde eller stoppe behandlingen.
English: Contact your doctor straight away if you notice any of the following side effects:
Danish: Kontakt din læge med det samme, hvis du oplever nogle af de nedenstående bivirkninger:
English: • Do not stop taking this medicine without talking to your doctor first.
Danish: • Stop ikke med at tage medicinen uden at tale med din læge først.
English: • Cases of diabetes mellitus or increased blood sugar levels have been reported in patients receiving this treatment or another protease inhibitor.
Danish: • Tilfælde af diabetes mellitus eller forhøjede blodsukkerniveauer er rapporteret hos patienter, som fik denne behandling eller anden proteasehæmmer.
English: Do not stop taking this medicine without talking to your doctor first.
Danish: Stop ikke med at tage dette lægemiddel uden at tale med din læge først.
English: • However if it is nearly time for your next dose, skip the missed dose.
Danish: • Hvis det er tæt på tidspunktet for den næste dosis, skal du dog springe den glemte dosis over.
English: This will make sure that you get the right amount of your medicine.
Danish: Det sikrer, at du får den rigtige mængde af
English: Limited clinical trial data from patients receiving one or more of these medicinal products with nelfinavir indicated that a clinically significant effect on safety and efficacy is not expected.
Danish: Begrænsede kliniske data fra patienter, der behandles med et eller flere af disse produkter og nelfinavir, indikerede at klinisk signifikant virkning på sikkerhed og effekt ikke forventes.