FrancophonIA/ELRC3.0 huggingface dataset:
English: • red blood cells in the urine;
Danish: • røde blodlegemer i urinen;
English: In this picture we have pulled out the plunger so that you can see each part clearly.
Danish: På billedet er stemplet trukket ud, så du tydeligt kan se hver del.
English: Weight and metabolic parameters
Danish: Vægt og metaboliske parameter
English: • If you cannot contact your doctor, go to the hospital.
Danish: • Hvis du ikke kan komme i kontakt med din læge, skal du henvende dig på hospitalet.
English: It is unknown whether the combination of Kaletra causes a similar increase in trazodone exposure.
Danish: Det vides ikke, om kombinationen af Kaletra forårsager lignende stigning i trazodon-eksposition.
English: • It is recommended that HIV-infected women do not breast-feed their infants because there is a possibility that the baby can be infected with HIV through your breast milk.
Danish: • Det anbefales, at hiv-smittede kvinder ikke ammer deres spædbørn, da der er risiko for, at barnet kan blive smittet med hiv gennem mælken.
English: The extent of increase depends on the timing of ritonavir administration.
Danish: Størrelsen af stigningen afhænger af tidspunktet for administration af ritonavir.
English: Based on the data mentioned, the malformative risk is unlikely in humans.
Danish: På grundlag af de nævnte data er der sandsynligvis ingen risiko for misdannelser hos mennesker.
English: On rare occasions these muscle disorders have been serious.
Danish: Disse muskellidelser har i sjældne tilfælde været alvorlige.
English: While exposure eliciting these changes were comparable to or below human clinical exposure, dosages in animals were over 6-fold the recommended clinical dose.
Danish: Mens den eksponering, der gav disse forandringer var sammenlignelige med eller under den kliniske eksponering i mennesker, var doseringen i dyr over 6 gange den anbefalede kliniske dosering.
English: It is therefore important that you remain under the supervision of your doctor while taking Kaletra.
Danish: Det er derfor vigtigt, at din læge fortsat overvåger dig, mens du tager Kaletra.
English: It belongs to a group of medicines called protease inhibitors.
Danish: Det tilhører en gruppe af lægemidler, der kaldes proteasehæmmere.
English: > 25 to 35
Danish: > 25 til 35
English: Currently available data are described in section 5.2 but no recommendation on the posology can be made.
Danish: Nuværende forhåndenværende data er beskrevet i punkt 5.2, men der kan ikke gives nogen anbefaling vedrørende dosering.
English: There are limited pharmacokinetic data in children below 2 years of age.
Danish: Der er en begrænset mængde farmakokinetiske data fra børn under 2 år.
English: Oral solution The solution is light yellow to orange.
Danish: Oral opløsning Opløsningen er lys gul til orange.
English: At the recommended adult dose(s) of this medicine, the estimated blood alcohol concentration in your body is about 0.002 - 0.01 g/dL.
Danish: Ved den anbefalede dosis til voksne for dette lægemiddel er den estimerede koncentration af alkohol i blodet omkring 0,002 - 0,01 g/dl.
English: Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
Danish: Der skal tages relevante forholdsregler (f.eks. brug af kondom) for at forebygge, at sygdommen overføres til andre gennem seksuel kontakt.
English: High doses of ketoconazole and itraconazole (> 200 mg/day) are not recommended.
Danish: Høje doser af ketoconazol og itraconazol (> 200 mg/dag) anbefales ikke.
English: Co-administration is contraindicated.
Danish: Samtidig administration er kontraindiceret.
English: The frequency category includes all reported events of moderate to severe intensity, regardless of the individual causality assessment.
Danish: Hyppighedskategorien inkluderer alle rapporterede tilfælde af moderat til svær grad uanset den individuelle kausalitetsvurdering.
English: Virologic Response of Study Subjects at Week 48 and Week 96 Week 48
Danish: Virologisk respons for forsøgspersoner ved uge 48 og uge 96 Uge 48
English: Buproprion and its active metabolite, hydroxybupropion:
Danish: Buproprion og dets aktive metabolit, hydroxybupropion:
English: 60 ml oral solution
Danish: 60 ml oral opløsning
English: • Kaletra should always be taken twice every day to help control your HIV infection, no matter how much better you feel.
Danish: • Du skal altid tage Kaletra to gange dagligt for at bidrage med kontrollere din hiv-infektion, lige meget hvor meget bedre du føler dig.
English: Kaletra may cause changes in your heart rhythm and the electrical activity of your heart.
Danish: Kaletra kan forårsage ændringer i din hjerterytme og i den elektriske aktivitet i hjertet.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningstørrelser er nødvendigvis markedsført.
English: At least 13 lopinavir oxidative metabolites have been identified in man.
Danish: Der er identificeret mindst 13 lopinavir metabolitter i mennesket.
English: This effect may be due to induction of bupropion metabolism.
Danish: Denne virkning kan skyldes induktion af bupropionmetabolisme.
English: Effects on the electrocardiogram
Danish: Indvirkning på elektrokardiogram
English: • Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
Danish: • Din læge har ordineret Kaletra som hjælp til at kontrollere din hiv-infektion (humant immundefektvirus-infektion).
English: Replace the bottle cap after each dose.
Danish: Skift flaskens låg efter hver dosis.
English: If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Danish: Hvis en rejsning varer mere end 4 timer, skal du søge lægehjælp omgående for at undgå permanent skade af penis.
English: Important information about some of the ingredients of Kaletra
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Kaletra
English: This is similar to an adult drinking 4-22 ml of beer or 1-4 ml of wine.
Danish: For en voksen svarer det til at drikke 4-22 ml øl eller 1-4 ml vin.
English: Antiretroviral Experienced (N=56)
Danish: Antiretroviral erfarne (N=56)
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Danish: I mere end halvdelen af de meddelte tilfælde fortsattes behandlingen med proteasehæmmere, eller behandlingen blev genoptaget, hvis behandlingen var seponeret.
English: Pharmaco-therapeutic group: antivirals for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR10
Danish: Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug, antivirale midler til behandling af hiv-infektioner, kombinationer, ATC-kode: J05AR10
English: Check with your pharmacist that you have the correct size of syringe.
Danish: Check med apotekspersonalet, at du har den korrekte sprøjtestørrelse.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Danish: Hvis der er tegn på forværret leversygdom hos disse patienter bør det derfor overvejes enten at afbryde eller seponere behandlingen.
English: 15 to 25
Danish: 15 til 25
English: Events noted as having frequency “Not known” were identified via post-marketing surveillance.
Danish: Bivirkninger opført med hyppigheden ”ikke kendt” er identificeret via postmarketing overvågning.
English: • impotence, abnormally heavy or extended menstrual flow or a lack of menstruation;
Danish: • impotens, unormalt kraftig menstruation eller manglende menstruation;
English: More frequent therapeutic concentration monitoring is recommended until plasma levels of these products have been stabilised.
Danish: Hyppigere overvågning af terapeutiske koncentrationer anbefales, indtil disse produkters plasmaniveauer er stabiliseret.
English: Kaletra oral solution:
Danish: Kaletra oral opløsning:
English: Mutations V82A, I54V and M46I emerged most frequently.
Danish: Mutation V82A, I54V og M46I forekom med største hyppighed.
English: Based on BSA (mg/m2)*
Danish: Baseret på BSA (mg/m2)*
English: • feeling tired, lack of strength and energy, headache including migraine;
Danish: • følelse af træthed, mangel på kræfter og energi, hovedpine inklusive migræne;
English: The prevalence of birth defects after any trimester exposure to lopinavir is comparable to the prevalence observed in the general population.
Danish: Prævalensen af fødselsdefekter efter eksponering for lopinavir i et vilkårligt trimester er sammenlignelig med den prævalens, som ses i den almindelige befolkning.
English: In some cases the hepatic dysfunction was serious.
Danish: I nogle tilfælde var leverdysfunktionen alvorlig.
English: Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
Danish: Der er rapporteret postmarketing tilfælde, som indikerer en mulig interaktion mellem levothyroxin og produkter, der indeholder ritonavir.
English: Use in children
Danish: Brug til børn
English: Patients had a mean age of 5 years (range 6 months to 12 years) with 14 patients less than 2 years old and 6 patients one year or less.
Danish: Patienterne havde en gennemsnitsalder på 5 år (interval 6 måneder til 12 år) og færre end 14 % var under 2 år og 6 patienter var et år eller derunder.
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 trazodon-dosis bør overvejes.
English: Component of a multipack, can't be sold separately.
Danish: Delpakning af multipakning, kan ikke sælges seperat.
English: Treatment of overdose with Kaletra is to consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af overdosering med Kaletra bør bestå i generelle forholdsregler såsom overvågning af vitale tegn og observation af patientens kliniske tilstand.
English: Greater effects may be expected when fluticasone propionate is inhaled.
Danish: Der kan forventes større effekt, når fluticasonpropionat inhaleres.
English: Interactions with medicinal products
Danish: Interaktioner med lægemidler
English: These effects have been assumed to be caused by electrolyte disturbance.
Danish: Disse effekter antages at skyldes elektrolytforstyrrelse.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumocystis jiroveci pneumoni.
English: No subject experienced an increase in QTcF of ≥ 60 ms from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 ms.
Danish: Ingen individer oplevede en stigning i QTcF på ≥ 60 msek fra baseline eller et QTcF-interval, som oversteg den potentielt kliniske relevante grænse på 500 msek.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab
English: Tissue distribution studies conducted in the rat did not suggest significant cardiac retention of the active substance; 72-hour AUC in heart was approximately 50% of measured plasma AUC.
Danish: Vævsdistributions studier udført på rotter viste ikke nogen signifikant kardialtension af den aktive substans; 72-timers AUC i hjertet var ca. 50 % af den målte plasma AUC.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer bør vurderes og behandling påbegyndes efter behov.
English: Kaletra contains glycerol which is harmful in high doses.
Danish: Kaletra indeholder glycerol, der er skadeligt ved høje doser.
English: Antibiotics Clarithromycin
Danish: Antibiotika Clarithromycin
English: Adults and adolescents
Danish: Voksne og unge
English: Your doctor will advise on the amount of Kaletra to be taken.
Danish: Din læge vil rådgive dig om hvor meget Kaletra, der skal tages.
English: No clinical relevant interaction expected.
Danish: Der forventes ingen klinisk relevant interaction.
English: • increased cholesterol levels in your blood, increased triglycerides (a form of fat) levels in your blood, high blood pressure;
Danish: • forhøjet kolesterolniveau i dit blod, forhøjet triglyceridniveau (en slags fedt) i dit blod, højt blodtryk;
English: Pharmacokinetic Parameter
Danish: Farmakokinetiske parametre
English: Patients were administered either the tablet or the soft capsule formulation for 8 weeks, after which all patients were administered the tablet formulation once daily or twice daily for the remainder of the study.
Danish: Patienterne fik enten tablet- eller den bløde kapselformulering i 8 uger, hvorefter alle patienterne i den resterende del af studiet fik tabletformuleringen en eller to gange dagligt.
English: They may modify or increase the effect of other medicines.
Danish: Det kan ændre eller øge effekten af andre lægemidler.
English: • a sound in one ear or both ears, such as buzzing, ringing or whistling;
Danish: • en lyd i et eller begge ører som f.eks. en brummen, ringen eller fløjtetone;
English: • It is important that all doses of Kaletra oral solution are taken with food.
Danish: • Det er vigtigt, at alle doser af Kaletra oral opløsning tages sammen med mad.
English: Hazard Ratio for Death or Failure of First-line Therapy Relative to ART Deferred Treatment: CHER Study 40 week arm (N=13)
Danish: Hazard Ratio for død eller svigt af første-linje behandling i forhold til ART udskudt behandling: CHER-studie 40 uger arm (N=13)
English: 15 to 20 kg > 20 to 25 kg > 25 to 30 kg > 30 to 35 kg > 35 to 40 kg
Danish: 15 til 20 kg > 20 til 25 kg > 25 til 30 kg > 30 til 35 kg > 35 til 40 kg
English: Maximum PR interval was 286 ms and no second or third degree heart block was observed (see section 4.4).
Danish: Det maksimale PR-interval var 286 msek og der blev ikke observeret nogen anden eller tredie grads hjerte-blokade (se pkt.
English: • Diabetes as increased blood sugars has been reported in patients receiving Kaletra.
Danish: • Diabetes, da der er rapporteret om forhøjet blodsukker hos patienter i behandling med Kaletra.
English: Each bottle contains 120 tablets.
Danish: Hver beholder indeholder 120 tabletter.
English: In most of these cases patients have had a prior history of pancreatitis and/or concurrent therapy with other medicinal products associated with pancreatitis.
Danish: I størstedelen af disse tilfælde havde patienterne en forhistorie med pankreatitis og/eller var i samtidig behandling med andre lægemidler forbundet med pankreatitis.
English: Since these patients had not previously been exposed to either Kaletra or efavirenz, part of the response may be attributed to the antiviral activity of efavirenz, particularly in patients harbouring highly lopinavir resistant virus.
Danish: Da disse patienter ikke tidligere har været udsat for hverken Kaletra eller efavirenz, kan en del af dette respons skyldes efavirenz' antivirale aktivitet, især hos patienter der er inficeret med virus med udtalt lopinavir-resistens.
English: Kaletra tablets have also shown less pharmacokinetic variability under all meal conditions compared to Kaletra soft capsules.
Danish: Kaletra tabletter har vist mindre farmakokinetisk variabilitet under alle former for måltider sammenlignet med Kaletra bløde kapsler.
English: * n = 18 for Cmax ** n = 16 for Cpredose
Danish: * n = 18 for Cmax ** n = 16 for Cfør dosis
English: • Muscle pain, tenderness or weakness, particularly in combination with these medicines.
Danish: • Muskelsmerter, ømhed eller svækkelse, især i kombination med disse lægemidler.
English: Two pack sizes are available:
Danish: Der er to pakningsstørrelser tilgængelige:
English: ‘ml' mark
Danish: ‘ml' mærke
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Danish: Hvis du bemærker nogen symptomer på infektion eller andre symptomer såsom muskelsvaghed, svaghed som starter i hænder og fødder og bevæger sig op gennem kroppen, hjertebanken, rysten eller hyperaktivitet, skal du omgående kontakte din læge for at få den nødvendige behandling.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Nærmere oplysninger om dette lægemiddel er tilgængelig på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu
English: Thereby, increasing the risk of extreme sedation and respiratory depression from these agents.
Danish: Derved øges risikoen for langvarig sedation og respirationsdepression forårsaget af disse lægemidler.
English: Mutations L33F, I50V and V32I combined with I47V/A were also observed.
Danish: Mutation L33F, I50V og V32I kombineret med I47V/A blev også observeret.
English: It may modify or increase the effects of other medicines.
Danish: Det kan ændre eller øge virkningen af andre lægemidler.
English: Kaletra is administered orally and should always be taken with food (see section 5.2).
Danish: Kaletra indgives oralt og bør altid tages sammen med mad (se punkt 5.2).
English: For Kaletra oral solution, the corresponding increases in lopinavir AUC and Cmax were 80% and 54%, respectively.
Danish: For Kaletra oral opløsning er de tilsvarende stigninger i AUC og Cmax henholdsvis 80 og 54 %.
English: If you are taking Kaletra once a day
Danish: Hvis du tager Kaletra en gang dagligt
English: There is no specific antidote for overdose with Kaletra.
Danish: Der er ingen specifik modgift mod en overdosis af Kaletra.
English: • Do not use Kaletra after the expiry date which is stated on the pack.
Danish: • Brug ikke Kaletra efter den udløbsdato, der står på pakningen.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C bør de relevante produktinformationer for disse behandlingsregimer gennemgås grundigt.
English: If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage.
Danish: Hvis påkrævet kan eliminering af ikke-absorberede aktivt stof opnås ved emesis eller maveskylning.
English: • Tell your doctor immediately if you are planning to have a baby, you are pregnant, think you may be pregnant or if you are breast-feeding.
Danish: • Fortæl omgående din læge, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, eller hvis du ammer.
English: Kaletra contains 42% v/v alcohol.
Danish: Kaletra indeholder 42 % v/v alkohol.
English: Caution is warranted and therapeutic drug concentration monitoring is recommended when available.
Danish: Forsigtighed tilrådes, og overvågning af den terapeutiske lægemiddelkoncentration anbefales, når den er tilgængelig.
English: The dose increase did not result in a significant increase in the plasma lopinavir concentration.
Danish: Forhøjelse af dosis gav ikke en signifikant stigning i plasmakoncentrationen af lopinavir.
English: Individual SmPCs should be consulted.
Danish: De individuelle produktresumeér bør konsulteres.
English: • astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);
Danish: • astemizol eller terfenadin (bruges normalt til behandling af allergisymptomer - disse lægemidler kan være tilgængelige uden recept);
English: Kaletra should be prescribed by physicians who are experienced in the treatment of HIV infection.
Danish: Kaletra bør ordineres af en læge, der har erfaring med behandling af hiv-infektioner.
English: Paediatric population aged from 14 days and older The oral solution formulation is the recommended option for the most accurate dosing in children based on body surface area or body weight.
Danish: Pædiatrisk population i alderen fra 14 dage og ældre Formuleringen oral opløsning anbefales som den mest præcise dosering af børn baseret på legemsoverflade eller kropsvægt.
English: Virologic failure* *Defined as confirmed plasma HIV-1 RNA level > 400 copies/ml at 24 weeks or viral rebound > 4000 copies/ml after Week 24.
Danish: Virologisk svigt* *Defineret som bekræftet plasma hiv-1 RNA niveau > 400 kopier/ml ved 24 uger eller viralt rebound > 4000 kopier/ml efter uge 24.
English: Serum cholesterol was elevated in rodents but not dogs, while triglycerides were elevated only in mice.
Danish: Serum kolesterol var forhøjet i gnavere, men ikke i hunde, mens triglycerider udelukkende var forhøjet i mus.
English: How should I store Kaletra and for how long?
Danish: Hvordan skal jeg opbevarer Kaletra og hvor længe
English: Thirty-nine patients (39%) discontinued the study, including 16 (16%) discontinuations due to adverse events, one of which was associated with a death.
Danish: 39 patienter (39%) afbrød studiet, inklusive 16 (16%) som afbrød på grund af bivirkninger, en af dem var associeret med et dødsfald.
English: The mean changes from baseline in PR interval ranged from 11.6 ms to 24.4 ms in the 12 hour interval post dose.
Danish: De gennemsnitlige ændringer i PR-interval fra baseline strækker sig fra 11,6 ms til 24,4 ms i et interval på 12 timer efter dosen.
English: Use in children of 2 years of age and above
Danish: Brug til børn på 2 år og opefter
English: Lopinavir/ritonavir has been evaluated in over 3000 women during pregnancy, including over 1000 during the first trimester.
Danish: Lopinavir/ritonavir er undersøgt i over 3000 gravide kvinder, hvoraf over 1000 i det første trimester.
English: Special attention should be given to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors and overdose.
Danish: Der skal udvises særlig opmærksomhed ved nøjagtig beregning af Kaletra-dosis, overførsel af medicinbestillinger, dispenseringsinformation og doseringsinstruktioner for at minimere risikoen for fejlmedicinering og overdosering.
English: • Kaletra contains the active substances lopinavir and ritonavir.
Danish: • Kaletra indeholder de aktive stoffer lopinavir og ritonavir.
English: Like all medicines, Kaletra can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Do not transfer it to any other container.
Danish: Hæld den ikke over i en anden beholder.
English: Mild renal tubular degeneration was confined to mice exposed with at least twice the recommended human exposure; the kidney was unaffected in rats and dogs.
Danish: Let renal tubular degenerering blev udelukkende observeret i mus, der blev eksponeret til mindst to gange den anbefalede humane eksponering, nyrene var upåvirkede i rotter og hunde.
English: Dose adjustment has not been evaluated in clinical practice.
Danish: Justering af dosis er ikke evalueret i klinisk praksis.
English: Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
Danish: Kaletra er ikke specifikt afprøvet med hensyn til mulige virkninger på evnen til at køre bil eller betjene maskiner.
English: • a flare-up of symptoms related to an inactive infection in your body (immune reconstitution);
Danish: • en opblussen af symptomer relateret til en inaktiv infektion i din krop (immunrekonstitution);
English: If more convenient for patients, the Kaletra 200/50 mg tablets may also be considered alone or in combination with the Kaletra 100/25 mg tablet to achieve the recommended dose.
Danish: Hvis det mere bekvemt for patienterne, kan Kaletra 200/50 mg tabletter også overvejes alene eller i kombination med Kaletra 100/25 mg tabletter for at opnå den anbefalede dosis.
English: Fluvastatin or Pravastatin
Danish: Fluvastatin eller pravastatin