FrancophonIA/ELRC3.0 huggingface dataset:
English: The systemic exposure to lopinavir/ritonavir at the maternal and developmental toxic dosages was lower than the intended therapeutic exposure in humans.
Danish: Den systematiske eksponering til lopinavir/ritonavir ved de maternelt og udviklingsmæssigt toksiske doser er lavere end den anbefalede terapeutiske eksponering hos mennesker.
English: Kaletra does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 or CYP1A2 at clinically relevant concentrations (see section 4.3).
Danish: Kaletra hæmmer ikke CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 eller CYP1A2 i klinisk relevante koncentrationer (se pkt.
English: • allergic reactions including hives and inflammation in the mouth;
Danish: • allergiske reaktioner inklusive udslæt og betændelse i munden;
English: Subsequently, all patients were continued on the 300/75 mg per m2 dose.
Danish: Derefter fortsatte alle patienter med 300/75 mg per m2.
English: Benzodiazepines Midazolam
Danish: Benzodiazepiner Midazolam
English: It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Danish: Det skal erindres, at en dosis på 150 mg to gange om ugen, måske ikke giver en optimal eksponering for rifabutin, hvilket kan medføre risiko for rifamycinresistens og behandlingssvigt.
English: Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M.
Danish: I denne gruppe var følgende mutationer i hiv-protease forbundet med nedsat følsomhed overfor lopinavir in vitro: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V og L90M.
English: • breakdown of muscle fibres resulting in the release of muscle fibre contents (myoglobin) into the bloodstream;
Danish: • nedbrydelse af muskelfibre, som resulterer i frigivelse af muskelfiberprotein (myoglobin) ind i blodbanen;
English: 2nd Trimester n = 17*
Danish: 2. trimester n = 17*
English: Monitoring plasma concentrations of methadone is recommended.
Danish: Overvågning af plasmakoncentrationerne af methadon anbefales.
English: Patients with pre-existing liver dysfunction including chronic 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 hepatitis har en øget frekvens af leverfunktionsabnormiteter ved antiretroviral kombinationsbehandling og bør kontrolleres efter gældende praksis.
English: Anticoagulants Warfarin
Danish: Antikoagulantia Warfarin
English: Anxiety Uncommon Abnormal dreams, libido decreased
Danish: Angst Ikke almindelig Abnorme drømme, nedsat libido
English: Mechanism of interaction
Danish: Interaktionsmekanisme
English: Clinical recommendation concerning co-administration with Kaletra
Danish: Kliniske anbefalinger vedrørende samtidig administration med Kaletra
English: Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Danish: Desuden kan gradvis dosisreduktion over en længere periode være nødvendig i tilfælde af tilbagetrækning af glukokortikoid.
English: Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safely.
Danish: Undlad at køre bil eller betjene maskiner, hvis du får en eller flere bivirkninger (f.eks. kvalme), som påvirker din evne til at gøre dette på forsvarlig vis.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with lopinavir/ritonavir and close monitoring should be performed during treatment.
Danish: Der skal udføres passende laboratorietest inden start på behandling med lopinavir/ritonavir, og leverfunktionen bør monitoreres tæt under behandlingen.
English: • In addition to the opportunistic infections, 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: Foruden opportunistiske infektioner kan autoimmune sygdomme (skyldes, at immunsystemet går til angreb på rask kropsvæv) også forekomme efter, at du er startet på at tage medicin til behandling af din hiv-infektion.
English: In general, rebound isolates either retained (if cross-resistant at baseline) or developed significant cross-resistance to indinavir, saquinavir and atazanavir.
Danish: I almindelighed enten beholdt (hvis krydsresistente ved baseline) eller udviklede isolater, der var rebound, signifikant krydsresistens mod indinavir, saquinavir eller atazanavir.
English: The signs of toxicity observed in mice, rats or dogs included decreased activity, ataxia, emaciation, dehydration and tremors.
Danish: Tegn på toksicitet i mus, rotter eller hunde inkluderede nedsat aktivitet, ataksia, emaciatio, dehydrering og tremor.
English: Carcinogenicity studies in rats revealed no tumourigenic findings.
Danish: Karcinogenicitetsstudier i rotter viste ingen fund af tumorer.
English: Let the syringe dry completely before you use that syringe for dosing.
Danish: Lad sprøjten tørre fuldstændigt, før du anvender den sprøjten til dosering igen.
English: In dogs, prominent U waves on the electrocardiogram have been observed associated with prolonged PR interval and bradycardia.
Danish: Tydelige U-bølger på elektrokardiogrammet er blevet observeret i hunde i forbindelse med forlænget PR-interval og bradycardia.
English: Uncommon Tinnitus, vertigo
Danish: Ikke almindelig Tinnitus, vertigo
English: Carbamazepine and Phenobarbital
Danish: Carbamazepin og phenobarbital
English: The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus).
Danish: De 19 isolater demonstrerede en 4.3-gange stigning i IC50 sammenlignet med baseline-isolater (fra 6.2- til 43-gange, sammenlignet med vild-type virus).
English: Unchanged lopinavir accounted for approximately 2.2% and 19.8% of the administered dose in urine and faeces, respectively.
Danish: Uændret lopinavir udgjorde cirka 2,2 % og 19,8 % af den indgivne dosis i henholdsvis urin og fæces.
English: There were no reported events of failure attributed to therapy limiting toxicity.
Danish: Der var ingen rapporterede tilfælde af behandlingsvigt forbundet med behandlingsbegrænsende toksicitet.
English: Use in adults
Danish: Brug til voksne
English: EU/1/01/172/005 - multipack: 120 (3 packs of 40) film-coated tablets EU/1/01/172/008 - carton of 120 film-coated tablets
Danish: EU/1/01/172/005 - multipakning: 120 (3 æsker a 40) filmovertrukne tabletter EU/1/01/172/008 - karton med 120 filmovertrukne tabletter
English: The dose should be administered using a calibrated 2 ml or 5 ml oral dosing syringe best corresponding to the volume prescribed.
Danish: Dosen bør administreres med en kalibreret 2 ml eller 5 ml oral doseringssprøjte, som bedst svarer til den ordinerede dosis.
English: Reduced serum thyroxin led to an increased release of TSH with resultant follicular cell hypertrophy in the thyroid glands of rats.
Danish: Nedsat serum thyroxin forårsagede en stigning i frigivelse af TSH med efterfølgende follikulær celle hypertrofi i skjoldbruskkirtlerne hos rotter.
English: Paediatric dosing guidelines for the dose 230/57.5 mg/m2 > 6 months to < 18 years
Danish: Pædiatrisk doseringsvejledning for dosen 230/57,5 mg/m2 > 6 måneder til < 18 år
English: • elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]);
Danish: • elbasvir/grazoprevir (bruges til at behandle kronisk hepatitis C-virus [HCV]);
English: Age: ≥ 6 weeks and < 6 months (N=21)
Danish: Alder: ≥ 6 uger og < 6 måneder (N=21)
English: • yellowing of the skin or whites of eyes (jaundice);
Danish: • gulfarvning af huden eller det hvide i øjnene (gulsot),
English: Kaletra should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events.
Danish: Kaletra må ikke tages sammen med lægemidler, hvis clearance er stærkt afhængige af CYP3A og for hvilke forhøjede plasmakoncentrationer er forbundet med alvorlige og/eller livstruende tilfælde.
English: Children less than 14 days of age and premature neonates Kaletra oral solution should not be administered to neonates before a postmenstrual age (first day of the mother's last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been reached (see section 4.4).
Danish: Kaletra oral opløsning må ikke administreres til nyfødte før en postmenstruel alder (første dag af moderens sidste menstruationscyklus før fødslen plus tiden efter fødslen) på 42 uger, og og en alder på mindst 14 dage er opnået efter fødsel (Se pkt.
English: While rosuvastatin is poorly metabolised by CYP3A4, an increase of its plasma concentrations was observed.
Danish: Da rosuvastatin metaboliseres dårligt af CYP3A4, er der set en stigning i dets plasmakoncentrationer.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduction in the activity of the immune system), higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Længden af antiretroviral kombinationsbehandling, brug af kortikosteroider, indtagelse af alkohol, svær immunsuppresion (nedsat aktivitet i immumsystemet), højere legemsmasseindeks (BMI) m.m. kan være nogle af de risikofaktorer, der er, for at udvikle denne sygdom.
English: Pull up the plunger until the correct dose amount is shown on the plunger.
Danish: Træk stemplet ud indtil den korrekte dosis ses på stemplet.
English: • No dose adjustment is required for lopinavir/ritonavir during pregnancy and postpartum.
Danish: • Det er ikke nødvendigt at dosisjustere lopinavir/ritonavir under graviditet eller efter fødslen.
English: Kaletra 800/200 mg was administered in combination with emtricitabine 200 mg and tenofovir DF 300 mg as part of a once-daily regimen.
Danish: Kaletra 800/200 mg blev administreret i kombination med emtricitabin 200 mg og tenofovir DF 300 mg, som en del af et engang-dagligt-regime.
English: Alcohol and propylene glycol are potentially harmful for those suffering from liver disease, kidney disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children.
Danish: Alkohol og propylenglykol er potentielt skadeligt for patienter, der lider af leversygdomme, nyresygdom, alkoholisme, epilepsi, hjerneskader eller hjernesygdomme og ligeledes for gravide og børn.
English: Once-daily dosing: the pharmacokinetics of once daily Kaletra have been evaluated in HIV-infected subjects naïve to antiretroviral treatment.
Danish: Dosering en gang dagligt: Farmakokinetik for Kaletra en-gang-dagligt er evalueret i hiv-inficerede forsøgspersoner, som var naive over for antiretroviral behandling.
English: If the benefit is considered to outweigh the risk and Kaletra must be used, patients should be carefully monitored for safety.
Danish: Hvis fordelen vurderes at opveje risikoen, og Kaletra skal anvendes, skal patienten sikkerhedsovervåges omhyggelligt.
English: HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro.
Danish: Hiv-1-isolater med nedsat følsomhed overfor lopinavir er blevet udvalgt in vitro.
English: • Haemophilia type A and B as Kaletra might increase the risk of bleeding.
Danish: • Hæmofili A og B, da Kaletra kan øge risikoen for blødning.
English: Overdoses with Kaletra oral solution have been reported (including fatal outcome).
Danish: Der er rapporteret om overdosering med Kaletra oral opløsning (herunder letale tilfælde).
English: Pharmacokinetic differences due to race have not been identified.
Danish: Der er ikke identificeret farmakokinetiske forskelle relateret til race.
English: Place the dosing syringe in your child's mouth towards the cheek and gently push the plunger down to release the medicine.
Danish: Placer doseringssprøjten i dit barns mund, ind mod kinden og tryk forsigtigt stemplet ned for at frigøre medicinen.
English: The in vitro antiviral EC50 of lopinavir is approximately 10-fold lower than that of ritonavir.
Danish: Antiviral EC50 af lopinavir in vitro er cirka 10 gange lavere sammenlignet med ritonavir.
English: Undesirable effects in clinical studies and post-marketing in adult patients System organ class
Danish: Bivirkninger i kliniske studier og postmarketing for voksne Systemorganklasse
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of lopinavir/ritonavir (i.e. 400/100 mg twice daily).
Danish: Medmindre andet er anført, er studierne, som er nærmere beskrevet nedenfor, udført med den anbefalede dosis af lopinavir/ritonavir (dvs. 400/100 mg to gange dagligt).
English: Analysis of resistance in ARV-naïve patients
Danish: Analyse af resistens hos ARV-naive patienter
English: Genotypic and phenotypic analysis of viruses selected in these passages suggest that the presence of ritonavir, at these concentration ratios, does not measurably influence the selection of lopinavir-resistant viruses.
Danish: Genotypiske og fænotypiske analyser af udvalgte virus fra disse inkubationer indikerer at tilstedeværelsen af ritonavir, i de anvendte koncentrationer, ikke påvirker selektionen af lopinavir-resistente virus målbart.
English: The 230/57.5 mg/m2 dosage might be insufficient in some children when co-administered with nevirapine or efavirenz.
Danish: Doseringen på 230/57,5 mg/m2 kan være utilstrækkelig hos nogle børn ved samtidig administration med nevirapin eller efavirenz.
English: • oral contraceptive or using a patch contraceptive to prevent pregnancy (see section below titled
Danish: • oral prævention eller depotplaster til forebyggelse af graviditet (se nedenstående afsnit med overskriften Præventionsmidler);
English: In the QD group, no patient demonstrated lopinavir resistance, and in the BID group, 1 patient who had significant protease inhibitor resistance at baseline demonstrated additional lopinavir resistance on study.
Danish: I QD-gruppen, viste ingen af patienterne lopinavir-resistens, og i BID-gruppen, viste 1 patient, som havde signifikant proteasehæmmer-resistens ved baseline, yderligere lopinavir-resistens i studiet.
English: Antibiotic
Danish: Antibiotika
English: As a general rule, it is recommended that mothers infected by HIV do not breastfeed their babies under any circumstances in order to avoid transmission of HIV.
Danish: For at undgå overførsel af hiv anbefales det generelt, at mødre smittet med hiv ikke under nogen omstændigheder ammer deres spædbørn.
English: Kaletra pharmacokinetics have not been studied in older people.
Danish: Farmakokinetiske parametre af Kaletra er ikke blevet undersøgt hos ældre mennesker.
English: Based on weight (mg/kg)
Danish: Baseret på vægt (mg/kg)
English: Thyroid-stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending lopinavir/ritonavir treatment.
Danish: Thyroidea-stimulerende hormon (TSH) skal som minimum monitoreres hos patienter i behandling med levothyroxin den første måned efter start og/eller afslutning på lopinavir/ritonavirbehandling.
English: Very common Diarrhoea, nausea Common
Danish: Meget almindelig Diarre, kvalme Almindelig
English: The efficacy data favouring the twice-daily regimen are reinforced by a differential in pharmacokinetic parameters significantly favouring the twice-daily regimen (see section 5.2).
Danish: Disse effekt-data, som favoriserer dosering to gange dagligt, understøttes af forskelle i farmakokinetiske parametre, der er signifikant bedre for to-gange-dagligt regimet (se pkt.
English: The absolute bioavailability of lopinavir co-formulated with ritonavir in humans has not been established.
Danish: Den absolutte biotilgængelighed af lopinavir formuleret med ritonavir er ikke blevet bestemt.
English: • anti-tuberculosis medicine (bedaquiline, delamanid);
Danish: • lægemiddel mod tuberkulose (bedaquilin, delamanid);
English: No pattern of birth defects suggestive of a common etiology was seen.
Danish: Der blev ikke set noget mønster i fødselsdefekter, som kan tyde på en fælles ætiologi.
English: However, dialysis can remove both alcohol and propylene glycol in the case of overdose with Kaletra oral solution.
Danish: Dialyse kan dog fjerne både ethanol og propylenglycol i tilfælde af overdosis af Kaletra oral opløsning.
English: Kaletra oral solution contains up to 0.3 g of glycerol per dose.
Danish: Kaletra oral opløsning indeholder op til 0,3 g glycerol per dosis.
English: Total amounts of alcohol and propylene glycol from all medicines that are to be given to infants should be taken into account in order to avoid toxicity from these excipients.
Danish: Der bør tages hensyn til den totale mængde ethanol og propylenglycol fra alle lægemidler, som gives til spædbarnet, for at undgå toksicitet fra disse hjælpestoffer.
English: Concomitant administration of glecaprevir/pibrentasvir and Kaletra is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Danish: Samtidig administration af glecaprevir/pibrentasvir og Kaletra anbefales ikke på grund af øget risiko for ALT-stigninger forbundet med øget eksponering for glecaprevir.
English: • abnormal dreams;
Danish: • unormale drømme
English: Healthcare professionals should be aware that Kaletra oral solution is highly concentrated and contains 42.4% alcohol (v/v) and 15.3% propylene glycol (w/v).
Danish: Sundhedspersonalet skal være opmærksomme på, at Kaletra oral opløsning er meget koncentreret og indeholder 42,4% ethanol (v/v) og 15,3% propylenglycol (w/v).
English: Particular caution must be used when prescribing Kaletra and medicinal products known to induce QT interval prolongation such as: chlorpheniramine, quinidine, erythromycin, clarithromycin.
Danish: Særlig forsigtighed skal udvises ved ordinering af Kaletra og lægemidler med kendt forlængende virkning på QT-intervaller såsom: chlorpheniramin, quinidin, erthromycin, clarithromycin.
English: Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur.
Danish: Pankreatitis bør overvejes, hvis kliniske symptomer (kvalme, opkast, smerter i underlivet) eller unormale laboratorieværdier (såsom øget serumlipase eller amylaseværdier), der tyder på pankreatitis, forekommer.
English: Modest prolongation of the PR interval was also noted in subjects receiving lopinavir/ritonavir in the same study on Day 3.
Danish: På dag 3 blev også set beskeden forlængelse af PR-intervallet hos individer, som fik lopinavir/ritonavir i det samme studie.
English: Lack of resistance to lopinavir was confirmed by phenotypic analysis.
Danish: Mangel på resistens mod lopinavir blev bekræftet med fænotype-analyse.
English: Besides propylene glycol as described above, Kaletra oral solution contains alcohol (42% v/v) which is potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
Danish: Udover propylenglycol, som beskrevet ovenfor, indeholder Kaletra oral opløsning også alkohol (42 % v/v), der er potentielt skadeligt for patienter, der lider af leversygdomme, alkoholisme, epilepsi, hjerneskader eller sygdomme og ligeledes for gravide og børn.
English: • If a side effect is preventing you from taking Kaletra as directed tell your doctor right away.
Danish: • Hvis en bivirkning forhindrer dig i at tage Kaletra som anvist, skal du straks informere din læge om det.
English: Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope).
Danish: Dermed øges risikoen for sildenafilassocierede bivirkninger (som omfatter hypotension og synkope).
English: If the co-administration of Kaletra with bupropion is judged unavoidable, this should be done under close clinical monitoring for bupropion efficacy, without exceeding the recommended dosage, despite the observed induction.
Danish: Hvis samtidig administration af Kaletra med bupropion vurderes at være uundgåelig, bør dette, på trods af den observerede induktion, gøres under nøje klinisk overvågning af bupropions effekt uden at overskride den anbefalede dosis.
English: In case of co-administration of Kaletra with contraceptives containing ethinyl oestradiol (whatever the contraceptive formulation e.g. oral or patch), additional methods of contraception must be used.
Danish: I tilfælde af samtidig administration af Kaletra med kontraceptiva, som indeholder ethinylestradiol (uanset kontraceptiva-formuleringen, f.eks. peroral eller plaster), skal der anvendes supplerende svangerskabsforebyggende metoder.
English: It should not be given when intestinal obstruction is present.
Danish: Det må ikke gives, hvis der er passagehindring i tarmen.
English: Mean age of patients enrolled was 41 years (range: 21 to 73); 51% were Caucasian and 66% were male.
Danish: Gennemsnitsalderen for de undersøgte patienter var 41 år (interval: 21 til 73); 51% var kaukasiske og 66% var mænd.
English: Astemizole, terfenadine
Danish: Astemizol, terfenadin
English: • abnormal closure of one of the valves (tricuspid valve in your heart);
Danish: • unormal lukning af en af hjerteklapperne (trikuspidklappen i hjertet);
English: Resistance to nelfinavir, defined as the presence of the D30N or L90M mutation in protease, was observed in 41/96 (43%) patients.
Danish: Resistens mod nelfinavir, defineret som tilstedeværelse af D30N eller L90M-mutation i protease, blev observeret hos 41/96 (43%) patienter.
English: • abnormally high level of bilirubin (a pigment produced from the breakdown of red blood cells)
Danish: • unormalt højt niveau af bilirubin (et farvestof, der dannes ved nedbrydelse af de røde blodlegemer) i blodet;
English: Pre-dose lopinavir concentrations decline with time during multiple dosing, stabilising after approximately 10 days to 2 weeks.
Danish: Lopinavir koncentrationer før dosering falder med tiden under flergangsdosering indtil et stabilt punkt nås efter cirka 10 dage til 2 ugers behandling.
English: • upper respiratory tract infection.
Danish: • øvre luftvejsinfektion.
English: Increased plasma concentrations of alfuzosin which may lead to severe hypotension.
Danish: Forhøjede plasmakoncentrationer af alfuzosin, som kan medføre alvorlig hypotension.
English: Co-administration of voriconazole and low dose ritonavir (100 mg BID) as contained in Kaletra should be avoided unless an assessment of the benefit/risk to patient justifies the use of voriconazole.
Danish: Samtidig administration af voriconazol og lav-dosis ritonavir (100 mg to gange dagligt), som findes i Kaletra, bør undgås, medmindre en vurdering af fordele/ulemper for patienten retfærdiggør anvendelsen af voriconazol.
English: Both treatment arms included zidovudine 180 mg/m2 every 12 hours and lamivudine 4 mg/kg every 12 hours.
Danish: Begge behandlingsarme inkluderede zidovudin 180 mg/m2 hver 12. time og lamivudin 4 mg/kg hver 12. time.
English: • neratinib (used to treat breast cancer);
Danish: • neratinib (bruges til at behandle brystkræft);
English: Overall, the in vitro characterisation of phenotypic cross-resistance between lopinavir and other protease inhibitors suggest that decreased susceptibility to lopinavir correlated closely with decreased susceptibility to ritonavir and indinavir, but did not correlate closely with decreased susceptibility to amprenavir, saquinavir, and nelfinavir.
Danish: Alt i alt, antyder in vitro karakteriseringen af den fænotypiske krydsresistens mellem lopinavir og andre proteasehæmmere at nedsat følsomhed overfor lopinavir er tæt korreleret til en nedsat følsomhed overfor ritonavir og indinavir, mens der ikke er tæt korrelation med nedsat følsomhed overfor amprenavir, saquinavir og nelfinavir.