FrancophonIA/ELRC3.0 huggingface dataset:
English: Coombs-negative anisocytosis and poikilocytosis were observed in rats, but not in mice or dogs.
Danish: Coombs-negative anisocytose og poikilocystose var observeret hos rotter, men ikke i mus eller hunde.
English: If Kaletra is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis Kaletra administreres sammen med parenteral midazolam, bør det ske på en intensiv plejeenhed (ICU) eller lignende, der sikrer nøje klinisk overvågning og passende medicinsk håndtering, i tilfælde af respirationsdepression og/eller langvarig sedation.
English: The increased digoxin level may lessen over time as P-gp induction develops.
Danish: Det øgede digoxin-niveau kan mindskes med tiden, efterhånden som Pgpinduktion udvikles.
English: 3 tablets (300/75 mg) 4 tablets (400/100 mg) *weight based dosing recommendations are based on limited data
Danish: 3 tabletter (300/75 mg) 4 tabletter (400/100 mg) * anbefalinger af dosis baseret på vægt er baseret på begrænset dokumentation.
English: Therefore, it is reasonable to expect that cardiac lopinavir levels would not be significantly higher than plasma levels.
Danish: Man kan derfor med rimelighed forvente, lopinavir niveauet i hjertet ikke vil være signifikant højere end plasmanivauet.
English: • This medicinal product does not require any special storage conditions.
Danish: • Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Safety, efficacy and pharmacokinetic profiles of the two dose regimens were assessed after 3 weeks of therapy in each patient.
Danish: Sikkerhed, effekt, og farmakokinetiske profiler af de to forskellige doser blev bestemt i hver patient efter 3 ugers behandling.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienter bør rådes til at søge læge, hvis de oplever ømme og smertende led, ledstivhed eller bevægelsesbesvær.
English: • Store in a refrigerator (2°C - 8°C).
Danish: • Opbevares i køleskab (2°C - 8°C).
English: The enrolled population was moderately PI-experienced with more than half of patients having never received prior PI and around 80% of patients presenting a viral strain with less than 3 PI mutations.
Danish: Den undersøgte population var moderat PI-erfarne med mere end halvdelen af patienterne, som aldrig tidligere havde fået PI og omkring 80% af patienterne, som havde en viral stamme med mindre end 3 PI-mutationer.
English: • For children, your doctor will decide the right dose (number of tablets) based on the child's height and weight.
Danish: • Til børn vil lægen fastsætte den korrekte dosis (antal tabletter) på baggrund af barnets højde og vægt.
English: Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.
Danish: Hæmning af hiv-protease forhindrer spaltningen af gag-pol polyproteinet, hvilket resulterer i dannelsen af umodne, ikke-infektiøse virus.
English: It may be difficult to tell which side effects have been caused by Kaletra and which may occur due to other medicines you take at the same time or by the complications of the HIV infection.
Danish: Det kan være vanskeligt at skelne mellem bivirkninger, der er forårsaget af Kaletra, og bivirkninger, der kan opstå pga. andre lægemidler, som du tager samtidig, eller som skyldes komplikationer forbundet med hiv-infektionen.
English: Only at high inadvertent doses, it can cause headache and gastrointestinal upset.
Danish: Kun ved utilsigtet høje doser kan det forårsage hovedpine og gastrointestinale gener.
English: An increase of the dose of Kaletra to 300/75 mg/m2 is needed in these patients.
Danish: En forøgelse af Kaletra-dosis til 300/75 mg/m2 er nødvendig til disse patienter.
English: The clinical significance of reduced abacavir and zidovudine concentrations is unknown.
Danish: Den kliniske betydning af reducerede abacavir- og zidovudin-koncentrationer er ukendt.
English: Of these, isolates from 96 nelfinavir-treated patients and 51 lopinavir/ritonavir-treated patients could be amplified for resistance testing.
Danish: Af disse kunne isolater fra 96 nelfinavir-behandlede forsøgspersoner og 51 lopinavir/ritonavir-behandlede forsøgspersoner undersøges ved amplifisering.
English: Patients should be monitored closely for a decreased VPA effect when Kaletra and valproic acid or valproate are given concomitantly.
Danish: Patienterne bør monitoreres tæt for nedsat VPA-effekt, når Kaletra og valproinsyre eller valproat gives samtidig.
English: A 14C-lopinavir study in humans showed that 89% of the plasma radioactivity after a single 400/100 mg Kaletra dose was due to parent active substance.
Danish: En afprøvning i mennesker med 14C-lopinavir har vist at 89 % af plasmaradioaktiviteten efter en enkelt 400/100 mg Kaletra dosis skyldes den aktive modersubstans.
English: In post-marketing surveillance through the Antiretroviral Pregnancy Registry, established since January 1989, an increased risk of birth defects exposures with Kaletra has not been reported among over 1000 women exposed during the first trimester.
Danish: Gennem postmarketing overvågning i det Antiretrovirale Graviditetsregister, etableret i januar 1989, er der ikke rapporteret en forøget risiko for fødselsdefekter ved eksponering for Kaletra blandt mere end 1000 kvinder, som blev eksponeret i første trimester.
English: Do not take Kaletra with any of the following medicines:
Danish: Tag ikke Kaletra sammen med nogen af følgende lægemidler
English: The study did not contain a control arm of patients not receiving Kaletra.
Danish: Studiet havde ingen kontrolgruppe af patienter, der ikke fik Kaletra.
English: Outcomes at Week 24: Study P1060 Cohort I
Danish: Resultater ved uge 24: Studie P1060 Kohorte I
English: Marked triglyceride elevation is a risk factor for development of pancreatitis.
Danish: Udpræget triglyceridstigning er en risikofaktor for udvikling af pankreatitis.
English: Kaletra does this by slowing down the spread of the infection in your body.
Danish: Det gør Kaletra ved at nedsætte den hastighed, hvormed infektionen breder sig i kroppen.
English: Microsomal triglyceride transfer protein (MTTP) inhibitor
Danish: Mikrosomal triglycerid transfer protein (MTTP) hæmmer
English: Pravastatin is not metabolised by CYP450.
Danish: Pravastatin metaboliseres ikke af CYP450.
English: Do not use the dosing syringes supplied with Kaletra oral solution to administer any other medicines you or your child may be taking.
Danish: Brug ikke doseringssprøjten, som er leveret sammen med Kaletra oral opløsning til at administrere anden medicin, som du eller dit barn tager.
English: Therefore, combination of bedaquiline with lopinavir/ritonavir should be avoided.
Danish: Kombination af bedaquilin med lopinavir/ritonavir bør derfor undgås.
English: 3rd Trimester n = 23
Danish: 3. trimester n = 23
English: The adequate dosing may be achieved with the two available strengths of Kaletra tablets: 100/25 mg and 200/50 mg.*
Danish: Den tilstrækkelige dosis kan opnås med de to tilgængelige styrker af Kaletra tabletter: 100/25 mg og 200/50 mg.*
English: Your doctor will advise on the number of tablets to be taken.
Danish: Din læge vil fortælle dig, hvor mange tabletter du skal tage.
English: The following events have been identified as adverse reactions.
Danish: Nedenstående hændelser er blevet identificeret som bivirkninger.
English: All interaction studies, when otherwise not stated, were performed using Kaletra capsules, which gives an approximately 20% lower exposure of lopinavir than the 200/50 mg tablets.
Danish: Alle interaktionsstudier er, med mindre der er anført noget andet, udført med Kaletra kapsler, som giver en cirka 20 % mindre eksposition af lopinavir end 200/50 mg tabletterne.
English: • decreased ability of the body to handle sugar including diabetes mellitus, weight loss;
Danish: • nedsættelse af kroppens evne til at forbrænde sukker herunder diabetes mellitus, vægttab;
English: Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Danish: På grundlag af kendte metaboliske profiler forventes der ikke klinisk signifikante interaktioner mellem Kaletra og dapson, trimethoprim/sulfamethoxazol, azithromycin eller fluconazol.
English: The safety and efficacy of Kaletra in children aged less than 2 years have not yet been established.
Danish: Sikkerhed og effekt af Kaletra hos børn under 2 år er endnu ikke fastlagt.
English: The safety and efficacy of Kaletra has not been established in patients with significant underlying liver disorders.
Danish: Kaletras sikkerhed og virkning er ikke fastsat hos patienter med alvorlig underliggende leversygdom.
English: • If you take sildenafil or tadalafil and Kaletra together, you may be at risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting more than 4 hours.
Danish: • Hvis du tager sildenafil eller tadalafil og Kaletra sammen, kan du risikere at få bivirkninger såsom lavt blodtryk, besvimelse, synsændringer og rejsning af penis, der varer mere end 4 timer.
English: This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
Danish: Dette lægemiddel indeholder op til 0,8 g fruktose per dosis, når det indtages ifølge anbefalingerne.
English: High density polyethylene (HDPE) bottles closed with propylene caps.
Danish: High-density polyethylen (HDPE) flasker lukket med propylen-låg.
English: You should see the ‘ml' marking aligned to the top of the collar of the barrel.
Danish: Du bør se ”ml” markeringen på linje med toppen af sprøjtecylinderens krave.
English: • Your doctor will decide the right dose based on the child's height and weight.
Danish: • Din læge vil bestemme den rigtige dosis ud fra barnets højde og vægt.
English: The plasma levels of ritonavir are less than 7% of those obtained after the ritonavir dose of 600 mg twice daily.
Danish: Plasmaniveauerne af ritonavir er mindre end 7 % af hvad, der opnås efter en ritonavir dosis på 600 mg to gange dagligt.
English: Analysis of resistance in PI-experienced patients
Danish: Analyse af resistens hos PI-erfarne patienter
English: • plaque building up inside your arteries which could lead to heart attack and stroke;
Danish: • belægninger inde i dine arterier, som kan føre til hjerteanfald eller slagtilfælde;
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you or your child.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: • If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as Kaletra may reduce the effectiveness of oral and patch contraceptives.
Danish: • Hvis du i øjeblikket bruger et oralt præventionsmiddel eller et depotplaster til forebyggelse af graviditet, skal du bruge et supplerende eller en anden type præventionsmiddel (f.eks. kondom), da Kaletra kan forringe virkningen af orale præventionsmidler og depotplastre.
English: Paediatric dosing guidelines based on body weight* > 6 months to 18 years
Danish: Pædiatrisk doseringvejledning baseret på legemsvægt* > 6 måneder til 18 år
English: Hypersensitivity including urticaria and angioedema
Danish: Overfølsomhed inklusive urticaria og angioødem
English: Beta2-adrenoceptor agonist (long acting) Salmeterol
Danish: Beta2-agonist (langtidsvirkende) Salmeterol
English: Lamotrigine and Valproate Lamotrigine:
Danish: Lamotrigin og valproat Lamotrigin:
English: • an abnormality in your electrocardiogram (ECG) called atrioventricular block;
Danish: • en abnormitet i elektrokardiogrammet (EKG) kaldet atrioventrikulært blok;
English: The CHER study was a randomized, open-label study comparing 3 treatment strategies (deferred treatment, early treatment for 40 weeks, or early treatment for 96 weeks) in children with perinatally acquired HIV-1 infection.
Danish: CHER-studiet var et randomiseret, åbent studie, der sammenlignede 3 behandlingsstrategier (udskudt behandling, tidlig behandling i 40 uger eller tidlig behandling i 96 uger) hos børn, der har fået hiv-1infektion perinatalt.
English: Decreased exposure of Kaletra may result in potential loss of virological response.
Danish: Nedsat eksponering for Kaletra kan potentielt give et fald i virologisk respons.
English: Careful monitoring of adverse effects (notably respiratory depression but also sedation) is recommended when fentanyl is concomitantly administered with Kaletra.
Danish: Omhyggelig overvågning af bivirkninger (især respirationsdepression men også sedation) anbefales, når fentanyl gives sammen med Kaletra.
English: If you are taking Kaletra twice a day
Danish: Hvis du tager Kaletra to gange dagligt
English: • decreased sexual desire;
Danish: • nedsat lyst til sex;
English: Pregnant or breast-feeding mothers should not take Kaletra oral solution unless specifically directed by the doctor.
Danish: Gravide eller ammende kvinder må ikke tage Kaletra oral opløsning uden lægens specifikke anvisning.
English: Enlarged spleens with histiocytosis were seen in rats but not other species.
Danish: Forstørret milt med histiocytose blev set hos rotter men ikke i de andre dyrearter.
English: PR interval prolongation
Danish: Forlængelse af PR- interval
English: Hepatic changes indicated cellular swelling with focal degeneration.
Danish: Leverforandringer indikerede cellulær svulmen med fokal degeneration.
English: Diarrhoea, nausea and vomiting may occur at the beginning of the treatment while hypertriglyceridaemia and hypercholesterolemia may occur later.
Danish: Diarré, kvalme og opkastning kan forekomme i begyndelsen af behandlingen, mens hypertriglyceridæmi og hyperkolesterolæmi kan forekomme senere.
English: Headache (including migraine), neuropathy (including peripheral neuropathy), dizziness, insomnia
Danish: Hovedpine (inklusive migræne), neuropati (inklusive perifer neuropati), svimmelhed, søvnløshed
English: Outcomes at Week 24: Study P1030 Age: ≥ 14 days and < 6 weeks (N=10)
Danish: Resultater ved uge 24: Studie P1030 Alder: ≥ 14 dage og < 6 uger (N=10)
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Danish: Når det besluttes at bruge antiretrovirale stoffer til behandling af hiv-infektion hos gravide kvinder og dermed formindske risikoen for vertikal transmission af hiv til nyfødte, bør der som en generel regel tages hensyn til data fra dyrestudier og klinisk erfaring fra gravide kvinder med henblik på at karakterisere sikkerheden for fosteret.
English: • If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine because it contains propylene glycol and alcohol.
Danish: • Tal med din læge eller apotekspersonalet, hvis du er gravid eller ammer, før du tager dette lægemiddel, da det indeholder propylenglykol og alkohol.
English: BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Danish: BSA (m2) = √ (Højde (cm) X Vægt (kg) / 3600)
English: Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Ireland
Danish: Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Irland
English: In vitro experiments with human hepatic microsomes indicate that lopinavir primarily undergoes oxidative metabolism.
Danish: In vitro studier med humant hepatiske mikrosomer indikerer at lopinavir fortrinsvis metaboliseres oxidativt.
English: Patients on a low potassium diet should be cautioned.
Danish: Patienter på kost med lavt kalium skal være opmærksomme.
English: • diarrhoea;
Danish: • diarré;
English: Adequate exposure to lopinavir/ritonavir may be achieved when a higher dose of Kaletra is used but this is associated with a higher risk of liver and gastrointestinal toxicity.
Danish: Man kan opnå tilstrækkelig eksposition til lopinavir/ritonavir, når man anvender en højere dosis af Kaletra, men dette er forbundet med en højere risiko for lever- og gastrointestinal-toksicitet.
English: Among 13 subjects with viral failure in the lopinavir/ritonavir group with resistance data available no resistance to lopinavir/ritonavir was found.
Danish: Blandt 13 forsøgspersoner med virologisk svigt i lopinavir/ritonavir-gruppen, men med tilgængelige resistensdata, blev der ikke fundet nogen resistens overfor lopinavir/ritonavir.
English: Dosage recommendation for paediatric patients aged from 14 days to 6 months
Danish: Doseringsanbefalinger for pædiatriske patienter i alderen 14 dage til 6 måneder
English: For monitoring of blood lipids and glucose, reference is made to established HIV treatment guidelines.
Danish: Med hensyn til monitorering af lipider og glucose i blodet refereres til eksisterende behandlingsguidelines for hiv.
English: Based on the findings in a paediatric study (observed exposures were approximately 35% AUC12 and 75% lower Cmin than in adults), young children from 14 days to 3 months could have sub-optimal exposure with a potential risk of inadequate virologic suppression and emergence of resistance (see section 5.2).
Danish: Baseret på resultater i et pædiatrisk studie (observerede exponeringer var omkring 35% AUC12 og 75% lavere Cmin end hos voksne) er det muligt, at unge børn i alderen 14 dage til 3 måneder, kan have suboptimal exponering, med en potentiel risiko for utilstrækkelig virologisk suppression og dannelse af resistens (se pkt.
English: Kaletra must not be given to these patients (see section 4.3).
Danish: Kaletra må ikke gives til disse patienter (se pkt 4.3).
English: For erectile dysfunction:
Danish: Erektil dysfunktion:
English: Medicinal products that are contraindicated specifically due to the expected magnitude of interaction and potential for serious adverse events are listed in section 4.3.
Danish: Lægemidler, der er kontraindiceret på grund af specifik forventning om betydelige interaktioner og potentiale for alvorlige bivirkninger, er opremset i pkt.
English: This leaflet was last revised in: {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: • severe or life threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).
Danish: • alvorlige eller livstruende hududslæt og blister (Stevens-Johnsons syndrom og erythema multiforme).
English: You must not take Kaletra with colchicine if you have kidney and/or liver problems (see also ‘Do not take Kaletra' above);
Danish: Du må ikke tage Kaletra sammen med colchicin, hvis du har problemer med nyre- og/eller lever (se også punktet ”Tag ikke Kaletra” ovenfor);
English: Kaletra oral solution is available for patients who cannot take tablets.
Danish: Kaletra oral opløsning er tilgængelig til patienter, der ikke kan tage tabletter.
English: • medicines that cause a reaction with alcohol (e.g. disulfiram).
Danish: • lægemidler, som giver en reaktion med alkohol (f.eks. disulfiram).
English: AUC and Cmax ↓ ~50%
Danish: AUC og Cmax ↓ ~50%
English: (equivalent to 245 mg tenofovir disoproxil)
Danish: (ækvivalent med 245 mg tenofovirdisoproxil)
English: Monitor for ADRs related to abemaciclib.
Danish: Monitorer for bivirkinger relateret til abemaciclib.
English: Dosage recommendation for paediatric patients older than 6 months to less than 18 years Without Concomitant Efavirenz or Nevirapine
Danish: Doseringsanbefalinger for pædiatriske patienter ældre end 6 måneder til 18 år Uden samtidig efavirenz eller nevirapin
English: Can cause headache and stomach upset and diarrhoea.
Danish: Kan forårsage hovedpine, mavegener og diarré.
English: • Kaletra does not reduce the risk of passing HIV to others.
Danish: • Kaletra nedsætter ikke risikoen for at smitte andre med hiv.
English: Initiation of digoxin in patients already taking Kaletra is likely to result in lower than expected increases of digoxin concentrations.
Danish: Indledning af digoxin-behandling til patienter, som allerede tager Kaletra, vil sandsynligvis resultere i lavere stigninger digoxin-koncentrationer end forventet.
English: Patients were administered at least two nucleoside/nucleotide reverse transcriptase inhibitors selected by the investigator.
Danish: Patienterne fik mindst to nukleosid/nukleotid-revers-transkriptasehæmmere udvalgt af investigator.
English: The recommended dose of 533/133 mg or 6.5 ml twice daily should not be exceeded.
Danish: Den anbefalede dosis på 533/133 mg eller 6,5 ml må ikke overskrides.
English: Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Danish: Øget monitorering for rifabutin-associerede bivirkninger inklusive neutropeni og uveitis tilrådes på grund af forventet øget eksponering for rifabutin.
English: Body Surface Area (m2)
Danish: Legemsoverflade (m2)
English: Incremental resistance was most common in subjects whose baseline isolates had several protease inhibitor-associated mutations, but < 40-fold reduced susceptibility to lopinavir at baseline.
Danish: Forøgelse af resistens var mest almindelig i forsøgspersoner, hvis baseline-isolater havde adskillige proteasehæmmereassocierede mutationer, men < 40-gange formindsket følsomhed for lopinavir ved baseline.
English: Talk to your doctor or pharmacist before taking Kaletra.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Kaletra.
English: These changes were reversible with withdrawal of the active substance and were absent in mice and dogs.
Danish: Disse forandringer var reversible efter ophør med indtagelse af medikamentet og blev ikke observeret hos mus og hunde.
English: Pull up the plunger until the black ‘O' ring is on the correct dose ‘ml' mark on the barrel.
Danish: Træk stemplet ud indtil den sorte ”O” ring er på den korrekte dosis ”ml” markering på sprøjtecylinderen.
English: Based on the current data available, Kaletra should not be administered once daily in paediatric patients (see section 5.1).
Danish: Baseret på de data, der er tilgængelige på nuværende tidspunkt, bør Kaletra ikke administreres en gang dagligt til pædiatriske patienter (se pkt.
English: The 16 viruses that displayed > 20-fold change in susceptibility all contained mutations at positions 10, 54, 63 plus 82 and/or 84.
Danish: De 16 virus, der udviste > 20 gange forskel i følsomhed havde alle mutationer ved codon 10, 54, 63 og 82 og/eller 84.
English: Animal studies have shown no effects on fertility.
Danish: Dyrestudier indikerer ikke, at Kaletra har effekt på fertiliteten.
English: Patients should be closely monitored for signs related to venetoclax toxicities.
Danish: Patienterne bør overvåges tæt for tegn på venetoclax-toksicitet.
English: • night sweats, itching, rash including raised bumps on the skin, infection of the skin, inflammation of skin or hair pores, accumulation of fluid in the cells or tissues.
Danish: • nattesved, kløe, udslæt inklusive hævede buler på huden, infektion i huden, betændelse i hud eller hårsække, ophobning af væske i celler eller væv.
English: • lack of functioning of the testes;
Danish: • manglende testikelfunktion;
English: Effects on drug levels Geometric Mean Change (%) in AUC, Cmax, Cmin
Danish: Geometrisk gennemsnitsændring (%) i AUC, Cmax, Cmin
English: Paediatric dosing guidelines 2 weeks to 6 months
Danish: Pædiatrisk doseringsvejledning 2 uger til 6 måneder
English: In addition, they contained a median of 3 mutations at amino acid positions 20, 24, 46, 53, 71 and 90.
Danish: Desuden havde de et middeltal på 3 mutationer i aminosyre codon 20, 24, 46, 53, 71 og 90.