FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Kaletra with a high fat meal (872 kcal, 55.8% from fat) increased lopinavir AUC and Cmax by 96% and 43%, respectively, for soft capsules, and 130% and 56%, respectively, for oral solution.
Danish: Administration af Kaletra og et måltid med højt fedtindhold (872 kcal, 55,8 % fra fedt) øgede lopinavir AUC og Cmax med henholdsvis 96 og 43 % for bløde kapsler og henholdsvis 130 og 56 % for den orale opløsning.
English: Ranolazine
Danish: Ranolazin
English: For caution on parenterally administered midazolam, see section
Danish: For forsigtighedsregler ved administration af parenteral midazolam, se pkt.
English: Because lopinavir and ritonavir are highly protein bound, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Danish: Da lopinavir og ritonavir er stærkt proteinbundne, er det usandsynligt, at de vil kunne fjernes i signifikante mængder ved hæmodialyse eller peritonealdialyse.
English: Ranitidine: ↔
Danish: Ranitidin: ↔
English: No data are available in patients with severe hepatic impairment.
Danish: Der er ingen tilgængelige data for patienter med stærkt nedsat leverfunktion.
English: • pimozide (used to treat schizophrenia);
Danish: • pimozid (bruges til behandling af skizofreni);
English: Blister multipacks containing 120 tablets (1 pack of 120 tablets or 3 packs each containing 40 tablets) are also available.
Danish: Blister multipakninger, som indeholder 120 tabletter (1 pakning á 120 tabletter eller 3 pakninger, som indeholder 40 tabletter) er også tilgængelige.
English: • Kaletra must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital and phenytoin.
Danish: • Kaletra må ikke tages en gang dagligt med efavirenz, nevirapin, carbamazepin, phenobarbital og phenytoin.
English: • Thirst, frequent urination, blurred vision or weight loss as this may indicate raised sugar levels in the blood.
Danish: • Tørst, hyppig vandladning, sløret syn eller vægttab, da disse symptomer kan være tegn på forhøjede blodsukkerniveauer.
English: Buprenorphine: ↔
Danish: Buprenorphin: ↔
English: • inflammation of the first section of the small intestine just after the stomach, wound or ulcer in the digestive tract, bleeding from the intestinal tract or rectum;
Danish: • betændelse i den første del af tyndtarmen lige efter maven, sår i fordøjelseskanalen, blødning fra fordøjelseskanalen eller endetarmen;
English: If this co-administration is judged unavoidable, increased dose of Kaletra at 400 mg/400 mg twice daily may be administered with rifampicin under close safety and therapeutic drug monitoring.
Danish: Hvis den samtidige administration vurderes at være uundgåelig, kan en øget dosis af Kaletra på 400 mg/400 mg to gange dagligt administreres med rifampicin under nøje sikkerheds-og terapeutisklægemiddelovervågning.
English: Outcomes at Week 24: Study M97-765
Danish: Resultater ved uge 24: Studie M97-765
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors.
Danish: Der har været flere meddelelser om øget blødningstendens med spontane hudblødninger og ledblødninger hos patienter med hæmofæli type A og B under behandling med proteasehæmmere.
English: • anti-epilepsy medicines (e.g. carbamazepine, phenytoin, phenobarbital, lamotrigine and valproate);
Danish: • lægemidler mod epilepsi (f.eks. carbamazepin, phenytoin, phenobarbital, lamotrigin og valproat);
English: In children 2 years of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b).
Danish: Sikkerhedsprofilen hos børn på 2 år og ældre, svarer til den, der ses hos voksne (se tabellen i punkt b).
English: • eye disorder, abnormal vision;
Danish: • øjenforstyrrelser, unormalt syn;
English: Recommended number of 100/25 mg tablets twice-daily
Danish: Anbefalet antal 100/25 mg tabletter 2 gange dagligt
English: Co-administration of Kaletra and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse reactions.
Danish: Samtidig indtagelse af Kaletra og lægemidler, der primært metaboliseres af CYP3A, kan resultere i forhøjede plasmakoncentrationer af det andet lægemiddel og dermed forøge eller forlænge dets effekt og reaktioner.
English: The maximum mean (95% upper confidence bound) differences in QTcF from placebo were 3.6 (6.3) and 13.1(15.8) for 400/100 mg twice daily and supratherapeutic 800/200 mg twice daily LPV/r, respectively.
Danish: De maksimale gennemsnitlige (95% øvre konfidensgrænse) forskelle i QTcF fra placebo var henholdsvis 3,6 (6,3) og 13,1(15,8) for 400/100 mg to gange dagligt og supraterapeutisk 800/200 mg to gange dagligt LPV/r.
English: For adults and children weighing greater than 15 kg.
Danish: Til voksne og børn, der vejer mere end 15 kg.
English: Caution must also be exercised and reduced doses should be considered if Kaletra is used concurrently with rosuvastatin.
Danish: Forsigtighed skal ligeledes udvises og nedsatte doser af Kaletra bør overvejes, hvis Kaletra anvendes sammen med rosuvastatin.
English: Bedaquiline: AUC: ↑ 22%
Danish: Bedaquilin: AUC: ↑ 22%
English: Co-administration of Kaletra with these medicinal products is expected to substantially increase their concentrations and may result in associated adverse events such as hypotension, syncope, visual changes and prolonged erection (see section 4.5).
Danish: Samtidig administration af Kaletra og disse lægemidler forventes at øge deres koncentrationer væsentligt, og det kan resultere i associerede bivirkninger såsom hypotension, synkope, synsændringer og forlænget erektion (se pkt.
English: Lopinavir AUC over a 24 hour dosing interval averaged 206.5 ± 89.7 µg•h/ml.
Danish: Den gennemsnitlige lopinavir-AUC over et 24-timers doseringsinterval var 206,5 ± 89,7 µg·t/ml.
English: In children 14 days of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b).
Danish: Sikkerhedsprofilen hos børn på 14 dage og ældre, svarer til den, der ses hos voksne (se tabellen i punkt b).
English: Lopinavir: ↔ (Relative to 400/100 mg BID administered alone)
Danish: Lopinavir: ↔ (I forhold til 400/100 mg to gange dagligt administeret alene)
English: The effective (peak to trough) half-life of lopinavir over a 12 hour dosing interval averaged 5 − 6 hours, and the apparent oral clearance (CL/F) of lopinavir is 6 to 7 l/h.
Danish: Lopinavirs effektive halveringstid (fra maksimum til minimum) over et doseringsinterval på 12 timer er i gennemsnit 5-6 timer, og lopinavirs tilsyneladende orale clearance (CL/F) er 6 til 7 l/h.
English: Oral contraceptives Ethinyl Oestradiol
Danish: Orale kontraceptiva Ethinylestradiol
English: Lamotrigine:
Danish: Lamotrigin:
English: Lopinavir/ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes.
Danish: Lopinavir/ritonavir var ikke mutagent eller klastogent i flere in vitro og in vivo tests, inklusive Ames bakterielle tilbagemutationsmåling, muselymfomtest, musemikronukleustest og måling af kromosomændringer i humane lymfocytter.
English: • antibiotics (e.g. rifabutin, rifampicin, clarithromycin);
Danish: • antibiotika (f.eks. rifabutin, rifampicin, clarithromycin);
English: In patients currently taking Kaletra and starting lamotrigine: no dose adjustments to the recommended dose escalation of lamotrigine should be necessary.
Danish: Hos patienter, som tager Kaletra og initierer lamotrigin: Dosisjustering af den anbefalede lamotrigindosistitreting bør ikke være nødvendig.
English: At 30 weeks age of gestation, the dose was increased to 500/125 mg (two 200/50 mg tablets plus one 100/25 mg tablet) twice daily until subjects were 2 weeks postpartum.
Danish: Ved gestationsalder på 30 uger, blev dosis øget til 500/125 mg (to 200/50 mg tabletter plus en 100/25 mg tablet) to gange dagligt indtil 2 uger efter, at forsøgspersonerne havde født.
English: How to take Kaletra
Danish: Sådan skal du tage Kaletra
English: Kaletra oral solution contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
Danish: Kaletra oral opløsning indeholder op til 0,8 g fruktose per dosis, når det indtages ifølge anbefalingerne.
English: Patients taking the oral solution, particularly those with renal impairment or with decreased ability to metabolise propylene glycol (e.g. those of Asian origin), should be monitored for adverse reactions potentially related to propylene glycol toxicity (i.e. seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis) (see section 4.3).
Danish: Patienter der tager den orale opløsning, særligt dem med nyresvigt eller med nedsat evne til at metabolisere propylenglycol (f.eks. patienter af asiatisk oprindelse) bør overvåges for utilsigtede hændelser potentielt relateret til propylenglycol toksisitet (f.eks. krampeanfald, stupor, takykardi, hyperosmolaritet, laktakacidose, renal toksisitet, hæmolyse).
English: Given twice daily with food
Danish: To gange dagligt
English: Check with your doctor or pharmacist if you are not sure how you should take your medicine.
Danish: Spørg din læge, apotekspersonalet eller sygeplejerske, hvis du ikke er sikker på, hvordan du skal bruge den orale doseringssprøjte.
English: Patients were randomised to either 230 mg lopinavir/57.5 mg ritonavir per m2 or 300 mg lopinavir/75 mg ritonavir per m2. Naïve patients also received nucleoside reverse transcriptase inhibitors.
Danish: Patienterne blev randomiseret til enten 230 mg lopinavir/57,5 mg ritonavir per m2 eller 300 mg lopinavir/75 mg ritonavir per m2. Behandlingsnaive patienter fik også nukleosid revers transkriptasehæmmere.
English: Cmax Cpredose μg /mL
Danish: Cmax Cfør dosis μg /ml
English: • Nausea, vomiting, abdominal pain, difficulty breathing and severe weakness of the muscles in the legs and arms as these symptoms may indicate raised lactic acid levels.
Danish: • Kvalme, opkastning, mavesmerter, åndedrætsbesvær og svær muskelsvaghed i benene og armene, da disse symptomer kan være tegn på forhøjede mælkesyreniveauer.
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Danish: Kombinationen kan medføre forøget risiko for kardiovaskulære bivirkninger associeret med salmeterol, inklusive QT-forlængelse, palpitationer og sinus takykardi.
English: Immunosuppressants Cyclosporin, Sirolimus (rapamycin), and Tacrolimus
Danish: Immunsuppressiva Ciclosporin, sirolimus (rapamycin) og tacrolimus
English: Put the syringe back together and draw up and expel tap water a few times to rinse.
Danish: Sæt sprøjten sammen igen og sug vandhanevand op og sprøjt det ud igen et par gange for at rense den.
English: M06-802 was a randomised open-label study comparing the safety, tolerability and antiviral activity of once-daily and twice-daily dosing of lopinavir/ritonavir tablets in 599 subjects with detectable viral loads while receiving their current antiviral therapy.
Danish: M06-802 var et randomiseret åbent studie, der sammenlignede sikkerhed, tolerabilitet og antiviral aktivitet af dosering en gang dagligt og dosering to gange dagligt af lopinavir/ritonavir-tabletter hos 599 forsøgspersoner med målbar viral belastning, mens de fik deres nuværende antivirale behandling.
English: For smaller volumes an alternative pack is available.
Danish: En alternativ pakningsstørelse er tilgænglig til mindre voluminer.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with Kaletra.
Danish: Klinisk overvågning af terapeutisk effekt og bivirkninger anbefales, når disse lægemidler administreres samtidig med Kaletra.
English: Lopinavir: AUC: ↔
Danish: Indinavir: AUC: ↔
English: Bottle containing 60 film-coated tablets.
Danish: Beholder, som indeholder 60 filmovertrukne tabletter.
English: Lopinavir/ritonavir 800/200 mg QD was administered with ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
Danish: Lopinavir/ritonavir 800/200 mg en gang dagligt blev administreret med ombitasvir/paritaprevir/ritonavir med eller uden dasabuvir.
English: 2 tablets (200/50 mg)
Danish: 2 tabletter (200/50 mg)
English: The most common adverse reactions related to Kaletra therapy during clinical trials were diarrhoea, nausea, vomiting, hypertriglyceridaemia and hypercholesterolemia.
Danish: De almindeligste bivirkninger relateret til Kaletra-behandling i de kliniske studier var diarré, kvalme, opkastning, hypertriglyceridæmi og hyperkolesterolæmi.
English: If you or your child stop taking Kaletra
Danish: Hvis du eller dit barn holder op med at tage Kaletra
English: Co-administration of Kaletra with rifampicin is not recommended.
Danish: Samtidig administration af Kaletra og af rifampicin kan ikke anbefales.
English: A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
Danish: En mere udtalt effekt på bedaquilin plasma-eksponering kan observeres under langvarig samtidig administration med lopinavir/ritonavir.
English: d. Paediatric populations
Danish: d. Pædiatriske patienter
English: Amiodarone, dronedarone
Danish: Amiodaron, dronedaron
English: Common: may affect up to 1 in 10 people
Danish: Almindelige kan påvirke op til 1 ud af 10 personer
English: Phosphodiesterase (PDE5) inhibitors
Danish: Phosphordiesterase-5 (PDE5)-hæmmere
English: If you or your child forget to take Kaletra
Danish: Hvis du eller dit barn har glemt at tage Kaletra
English: Patients were randomised in a 1:1 ratio to receive either Kaletra 800/200 mg once daily (n = 333) or Kaletra 400/100 mg twice daily (n = 331).
Danish: Patienterne blev randomiseret i en 1:1 fordeling til at få enten Kaletra 800/200 mg en gang dagligt (n = 333) eller Kaletra 400/100 mg to gange dagligt (n = 331).
English: The adverse clinical signs observed in dogs included salivation, emesis and diarrhoea/abnormal stool.
Danish: De kliniske bivirkninger observeret i hunde inkluderer spytafsondring, emesis, og diarré/unormal afføring.
English: In contrast, similar concentrations of lopinavir/ritonavir demonstrated no repolarisation delay in the canine cardiac Purkinje fibres.
Danish: Der blev derimod ved lignende koncentrationer ikke demonstreret nogen repolariserings forsinkelse på kanin hjerte Purkinje fibre.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksisitet (se pkt.
English: Ritonavir is a potent CYP3A inhibitor which inhibits the metabolism of lopinavir and therefore, increases plasma levels of lopinavir.
Danish: Ritonavir er en potent CYP3A-hæmmer, hvilket hæmmer metabolismen af lopinavir og derved øger plasma niveauer af lopinavir.
English: One hundred patients were originally treated with Kaletra in the study (including 51 patients receiving 400/100 mg twice daily and 49 patients at either 200/100 mg twice daily or 400/200 mg twice daily).
Danish: 100 patienter blev oprindeligt behandlet med Kaletra i studiet (inklusive 51 patienter, der fik 400/100 mg to gange dagligt og 49 patienter på enten 200/100 mg to gange dagligt eller 400/200 to gange dagligt).
English: The in vitro antiviral activity of lopinavir against 112 clinical isolates taken from patients failing therapy with one or more protease inhibitors was assessed.
Danish: Lopinavirs antivirale effekt in vitro blev undersøgt mod 112 kliniske isolater udtaget fra patienter, hvor behandling med en eller flere proteasehæmmere havde været uden effekt.
English: The following tables contain dosing guidelines for Kaletra oral solution based on body weight and BSA.
Danish: Nedenstående tabeller indeholder doseringsvejledninger for Kaletra oral opløsning baseret på legemsvægt og legemsoverfladeareal ( BSA).
English: Therefore, this co-administration should be avoided unless judged strictly necessary (see section 4.5).
Danish: Samtidig administration bør derfor undgås medmindre, det er absolut nødvendigt (se pkt.4.5 ).
English: • 120 ml (2 bottles x 60 ml).
Danish: • 120 ml (2 flasker x 60 ml).
English: Through 360 weeks of treatment, genotypic analysis of viral isolates was successfully conducted in 19 of 28 patients with confirmed HIV RNA above 400 copies/ml revealed no primary or active site mutations in protease (amino acids at positions 8, 30, 32, 46, 47, 48, 50, 82, 84 and 90) or protease inhibitor phenotypic resistance.
Danish: Gennem 360 ugers behandling blev der udført en succesfuld genotype-analyse af virale isolater hos 19 ud af 28 patienter med bekræftet hiv-RNA over 400 kopier/ml og ingen primære eller aktive sitemutationer i protease (aminosyrer i positionerne 8, 30, 32, 46, 47, 48, 50, 82, 84 og 90) eller proteasehæmmer-fænotyperesistens blev vist.
English: Outcomes at Week 48: Study M98-863 Kaletra (N=326)
Danish: Resultater ved uge 48: Studie M98-863 Kaletra (N=326)
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymtomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Hypertension Uncommon Deep vein thrombosis
Danish: Hypertension Ikke almindelig Dyb venetrombose
English: In another open-label pharmacokinetic study, 19 HIV-infected pregnant women received lopinavir/ritonavir 400/100 mg twice daily as part of combination antiretroviral therapy during pregnancy from before conception.
Danish: I et andet åbent farmakokinetisk studie, fik 19 hiv-inficerede gravide kvinder lopinavir/ritonavir 400/100 mg to gange dagligt som en del af en antiretroviral kombinationsbehandling under graviditeten fra før graviditetens begyndelse.
English: Methadone
Danish: Methadon
English: Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Danish: Da lopinavir og ritonavirs renale clearance er forsvindende lille, forventes der ikke øgede plasmakoncentrationer hos patienter med nyreinsufficiens.
English: See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction.
Danish: 4.5 vedrørende samtidig administration af sildenafil til patienter med erektil dysfunktion.
English: Hypromellose, titanium dioxide, macrogols type 400 (polyethylene glycol 400), hydroxypropyl cellulose, talc, colloidal anhydrous silica, macrogols type 3350 (polyethylene glycol 3350), yellow ferric oxide E172, polysorbate 80.
Danish: Hypromellose, titandioxid, macrogoler type 400 (polyetylen glycol 400), hydroxypropylcellulose, talkum, kolloid vandfri silica, macrogoler type 3350 (polyetylen glycol 3350), gul jernoxid E172, polysorbat 80.
English: • medicines used for smoking cessation (e.g. bupropion);
Danish: • lægemidler, som bruges til rygeophør (f.eks.bupropion);
English: Since Kaletra is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Danish: Da Kaletra er stærkt proteinbundet, vil dialyse ikke i væsentligt omfang kunne bidrage til udskillelse af stoffet.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant:
English: Kaletra oral solution is supplied in amber coloured multiple-dose polyethylene terephthalate (PET) bottles in a 60 ml size.
Danish: Kaletra oral opløsning leveres i gulbrune flerdosis polyetylenpthalat (PET) flasker på 60 ml.
English: In adult patients, in cases where once-daily dosing is considered necessary for the management of the patient, Kaletra tablets may be administered as 800/200 mg (four 200/50 mg tablets) once daily with or without food.
Danish: Til voksne patienter kan Kaletra-tabletter i tilfælde, hvor dosering en gang dagligt vurderes at være nødvendigt i behandlingen af patienten, administreres en gang dagligt som 800/200 mg (fire 200/50 mg tabletter) med eller uden føde.
English: Refer to the afatinib SmPC for dosage adjustment recommendations.
Danish: Se produktresuméet for afatinib vedrørende anbefalinger for dosisjustering.
English: Cmax: ↑
Danish: AUC: ↑ Cmax: ↑
English: Table 8
Danish: Tabel 8
English: The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Kaletra (see section 4.4).
Danish: Rivaroxaban anbefales ikke til patienter i behandling med Kaletra (se pkt.
English: nevirapine
Danish: nevirapin
English: Kaletra is not a cure for HIV infection or AIDS.
Danish: Kaletra helbreder ikke hiv-infektion eller AIDS.
English: The Kaletra dose should be titrated upward only after rifampicin has been initiated (see section 4.4).
Danish: Kaletra-dosis bør først titreres opad, når behandling med rifampicin er indledt (se pkt.
English: AUC: ↑ 2.17-fold Cmax: ↑ 2.04-fold Ctrough: ↑ 2.36-fold (inhibition of CYP3A/efflux transporters)
Danish: AUC: ↑ 2,17-gange Cmax: ↑ 2,04-gange Ctrough: ↑ 2,36-gange (hæmning af CYP3A/effluks transportører)
English: Voriconazole
Danish: Voriconazol
English: For children unable to swallow tablets, please refer to the Kaletra oral solution Summary of Product Characteristics.
Danish: Til børn, som ikke er i stand til at synke tabletter, se venligst produktresuméet for Kaletra oral opløsning.
English: Antiviral activity of Kaletra in patients failing protease inhibitor therapy The clinical relevance of reduced in vitro susceptibility to lopinavir has been examined by assessing the virologic response to Kaletra therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
Danish: Antiviral aktivitet af Kaletra hos patienter, hvor behandling med proteasehæmmere ikke virker Den kliniske relevans af nedsat følsomhed for lopinavir in vitro er blevet undersøgt ved at bestemme det virologiske respons for Kaletra terapi, med hensyn til basal viral genotype og fænotype ved baseline, hos 56 patienter, der tidligere var blevet behandlet med proteasehæmmere uden effekt.
English: At week 48, the efficacy and safety with twice-daily dosing (n=87) in the paediatric population given lopinavir/ritonavir 100 mg/25 mg tablets was consistent with the efficacy and safety findings in previous adult and paediatric studies using lopinavir/ritonavir twice daily.
Danish: Ved uge 48 var virkning og sikkerhed af dosering to gange dagligt (n=87) hos den pædiatriske population, som fik lopinavir/ritonavir100 mg/25 mg tabletter, sammenlignelig med resultater for virkning og sikkerhed i tidligere studier af lopinavir/ritonavir hos voksen og børn, doseret to gange dagligt.
English: The mean steady-state trough concentration prior to the morning dose was 8.1 ± 5.7 µg/ml.
Danish: Den gennemsnitlige laveste steady-state koncentration før morgen dosis var 8,1 ± 5,7 µg/ml.
English: • 300 ml (5 bottles x 60 ml).
Danish: • 300 ml (5 flasker x 60 ml).
English: Integrase inhibitor Raltegravir
Danish: Integrase-hæmmer Raltegravir