FrancophonIA/ELRC3.0 huggingface dataset:
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 en 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: (inhibition of CYP3A/efflux transporters)
Danish: (hæmning af CYP3A/efflukstransportører)
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: Read the list of medicines above ‘Do not take Lopinavir/Ritonavir Mylan with any of the following medicines' for information on medicines that you must not take with lopinavir/ritonavir.
Danish: Se listen over lægemidler ovenfor ‘Tag ikke Lopinavir/Ritonavir Mylan sammen med nogen af følgende lægemidler' for at få oplysninger om lægemidler, som du ikke må tage sammen med lopinavir/ritonavir.
English: − Lopinavir/ritonavir does not reduce the risk of passing HIV to others.
Danish: Lopinavir/ritonavir nedsætter ikke risikoen for at smitte andre med hiv.
English: Virologic Response of Study Subjects at Week 48 Study 802 QD
Danish: Virologisk respons for forsøgspersoner ved uge 48 studie 802 En gang dagligt To gange dagligt
English: The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section 4.5).
Danish: Samtidig administration med fusidinsyre er kontraindiceret ved dermatologiske infektioner (se pkt.
English: Blood glucose disorders including diabetes mellitus, hypertriglyceridaemia, hypercholesterolemia, weight decreased, decreased appetite
Danish: Almindelig Blodglucoseforstyrrelser herunder diabetes mellitus, hypertriglyceridæmi, hyperkolesterolæmi, vægttab, nedsat appetit
English: Rifampicin in combination with lopinavir/ritonavir causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect.
Danish: Rifampicin i kombination med lopinavir/ritonavir forårsager stor reduktion i lopinavir-koncentrationer, hvilket kan resultere i et signifikant fald i lopinavirs terapeutiske effekt.
English: − Haemophilia type A and B as lopinavir/ritonavir might increase the risk of bleeding.
Danish: Hæmofili A og B, da lopinavir/ritonavir kan øge risikoen for blødning.
English: For caution on parenterally administered midazolam, see section 4.5.
Danish: For forsigtighedsregler ved administration af parenteral midazolam, se pkt.
English: Through Week 48, genotypic resistance testing results were available from 75 patients in the QD group and 75 patients in the BID group who had incomplete virologic response.
Danish: Testresultater for genotyperesistens var tilgængelige til og med uge 48 fra 75 patienter i gruppen med en daglig administration og 75 patienter i gruppen med to daglige administrationer, som havde ufuldstændigt virologisk respons.
English: The risk of diarrhoea may be greater with once daily dosing of lopinavir/ritonavir.
Danish: Risikoen for diarre kan være større hos patienter, som får lopinavir/ritonavir en gang dagligt.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide and triamcinolone.
Danish: Systemiske kortikosteroidvirkninger, inklusive Cushings syndrom og adrenal suppression, er rapporteret hos patienter, der fik ritonavir og inhaleret eller intranasalt administreret fluticasonpropionat; dette kan også forekomme med andre kortikosteroider, som metaboliseres via P450 3A, f.eks. budesonid og triamcinolon.
English: Lopinavir AUC over a 24 hour dosing interval averaged 206.5 ± 89.7 μg h/ml.
Danish: Gennemsnitligt AUC for lopinavir over et 24-timers doseringsinterval var 206,5 ± 89,7 µg·t/ml.
English: The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was characterised by analysing the longitudinal isolates from 19 protease inhibitor-experienced subjects in 2 Phase II and one Phase III studies who either experienced incomplete virologic suppression or viral rebound subsequent to initial response to lopinavir/ritonavir and who demonstrated incremental in vitro resistance between baseline and rebound (defined as emergence of new mutations or 2-fold change in phenotypic susceptibility to lopinavir).
Danish: Bedømmelse af resistens mod lopinavir hos patienter, hvor tidligere behandling med proteasehæmmere var mislykkedes, var karakteriseret ved analyse af isolater fra længderetningen fra 19 proteasehæmmer-erfarne forsøgspersoner i 2 fase II- og et fase III-studie, som enten oplevede ufuldstændig virologisk undertrykkelse eller viral rebound efter initial respons på lopinavir/ritonavir, og som udviste trinvis voksende in-vitro-resistens mellem baseline og rebound (defineret som tilsynekomst af nye mutationer eller 2-gange ændring i fænotype-følsomhed for lopinavir).
English: Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
Danish: Andre formuleringer af dette lægemiddel kan være mere velegnede til børn.
English: Do not take Lopinavir/Ritonavir Mylan if: - you are allergic to lopinavir, ritonavir or any of the other ingredients of this medicine (listed in section 6); - you have severe liver problems.
Danish: Tag ikke Lopinavir/Ritonavir Mylan hvis: du er allergisk over for lopinavir, ritonavir eller et af de øvrige indholdsstoffer i Lopinavir/Ritonavir Mylan (angivet i punkt 6); du har alvorlige leverproblemer.
English: Adult patients who have not previously taken other antiviral medicines can also take lopinavir/ritonavir tablets once daily as an 800 mg/200 mg dose.
Danish: Voksne patienter, som ikke tidligere har taget anden antiviral medicin, kan også tage lopinavir/ritonavir-tabletter en gang daglig som en 800 mg/200 mg dosis.
English: Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis (inflammation of the pancreas).
Danish: Fortæl det altid til lægen, hvis du får kvalme, opkastning eller mavesmerter, da dette kan være tegn på pankreatitis (betændelse i bugspytkirtlen).
English: Phosphodiesterase (PDE5) inhibitors
Danish: Phosphordiesterase-5hæmmere (PDE5)
English: KONCERT/PENTA 18 is a prospective multicentre, randomised, open-label study that evaluated the pharmacokinetic profile, efficacy and safety of twice-daily versus once-daily dosing of lopinavir/ritonavir 100 mg/25 mg tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173).
Danish: KONCERT/PENTA 18 er et prospektivt, randomiseret, åbent, multicenter studie, som evaluerede den farmakokinetiske profil, virkning og sikkerhed af vægtbaseret dosering af lopinavir/ritonavir 100 mg/25 mg tabletter to gange dagligt over for en gang dagligt som en del af antiretroviral kombinationsbehandling (cART) hos virologisk supprimerede hiv-1-inficerede børn (n=173).
English: - 1 bottle of 120 film-coated tablets.
Danish: - 1 flaske med 120 filmovertrukne tabletter.
English: It is important to note that cases of pancreatitis have been reported in patients receiving lopinavir/ritonavir, including those who developed hypertriglyceridaemia.
Danish: Det er vigtigt at bemærke, at tilfælde af pankreatitis er blevet rapporteret hos patienter, der fik lopinavir/ritonavir, deriblandt patienter der udviklede hypertriglyceridæmi.
English: Co-administration of increased doses of fosamprenavir (1400 mg BID) with lopinavir/ritonavir (533/133 mg BID) to protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ritonavir.
Danish: Samtidig administration af øgede fosamprenavir-doser (1400 mg to gange daglig med lopinavir/ritonavir (533/133 mg to gange daglig) til proteasehæmmer-erfarne patienter resulterede i en højere forekomst af gastrointestinale bivirkninger og stigninger i triglycerider med kombinationsregimenet uden stigning i den virologiske effekt ved sammenligning med standarddoser af fosamprenavir/ritonavir.
English: The safety and efficacy of lopinavir/ritonavir has not been established in patients with significant underlying liver disorders.
Danish: Lopinavir/Ritonavir Mylans sikkerhed og virkning er ikke fastsat hos patienter med alvorlig underliggende leversygdom.
English: If you are taking lopinavir/ritonavir once a day
Danish: Hvis du tager lopinavir/ritonavir en gang dagligt
English: Caution must also be exercised and reduced doses should be considered if lopinavir/ritonavir is used concurrently with rosuvastatin.
Danish: Forsigtighed skal ligeledes udvises og nedsatte, doser af lopinavir/ritonavir bør overvejes, hvis lopinavir/ritonavir anvendes sammen med rosuvastatin.
English: Concomitant use of lopinavir/ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4, such as budesonide and triamcinolone, is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Danish: Samtidig brug af lopinavir/ritonavir og fluticason eller andre glukokortikoider, som metaboliseres af CYP3A4, såsom budesonid og triamcinolon, anbefales ikke, med mindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (se pkt.
English: The dose of maraviroc should be decreased to 150 mg twice daily during co-administration with Lopinavir/Ritonavir Mylan 400/100 mg twice daily.
Danish: Maraviroc-dosis bør nedsættes til 150 mg to gange daglig ved samtidig administration af Lopinavir/Ritonavir Mylan 400/100 mg to gange daglig.
English: M98-940 was an open-label study of a liquid formulation of lopinavir/ritonavir in 100 antiretroviral naïve (44%) and experienced (56%) paediatric patients.
Danish: M98-940 var et åbent studie af en flydende formulering af lopinavir/ ritonavir med 100 pædiatriske patienter, der enten var antiretroviralt behandlingsnaive (44 %) eller med forudgående behandling med antiretrovirale midler (56 %).
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Danish: Metaboliske parametre Kropsvægt og niveauerne af lipid og glucose i blodet kan stige under antiretroviral behandling (se pkt.
English: Activity of other protease inhibitors against isolates that developed incremental resistance to lopinavir after lopinavir/ritonavir therapy in protease inhibitor experienced patients: The presence of cross resistance to other protease inhibitors was analysed in 18 rebound isolates that had demonstrated evolution of resistance to lopinavir during 3 Phase II and one Phase III studies of lopinavir/ritonavir in protease inhibitor-experienced patients.
Danish: Aktivitet af andre proteasehæmmere for isolater, som udviklede voksende resistens mod lopinavir efter behandling med lopinavir/ritonavir hos proteasehæmmer-erfarne-patienter: Tilstedeværelse af krydsresistens mod andre proteasehæmmere blev analyseret i 18 rebound-isolater, som havde vist udvikling af resistens mod lopinavir under 3 fase II-studier og et fase III- studie med lopinavir/ritonavir i proteasehæmmer-erfarne-patienter.
English: Lopinavir: ↔ (Relative to 400/100 mg BID administered alone)
Danish: Lopinavir: ↔ (I forhold til 400/100 mg to gange dagligt administreret alene)
English: Talk to your doctor or pharmacist before taking Lopinavir/Ritonavir Mylan.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Lopinavir/Ritonavir Mylan.
English: Lopinavir/ritonavir should be used with caution in such patients (see section 5.1).
Danish: Lopinavir/ritonavir bør bruges med forsigtighed til sådanne patienter (se pkt.
English: People taking lopinavir/ritonavir may still develop infections or other illnesses associated with HIV disease and AIDS.
Danish: Personer, der tager lopinavir/ritonavir, kan stadig udvikle infektioner eller andre sygdomme forbundet med hiv og AIDS.
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 ved dosering to gange dagligt (n=87) hos den pædiatriske population, som fik lopinavir/ritonavir 100 mg/25 mg tabletter, sammenlignelig med resultaterne for virkning og sikkerhed i tidligere studier af lopinavir/ritonavir givet to gange dagligt hos voksen og børn.
English: Cmax: ↓ (relative to indinavir 800 mg TID alone)
Danish: Cmax: ↓ (I forhold til 800 mg tre gange daglig alene)
English: EXP After first opening, use within 120 days.
Danish: EXP Skal anvendes inden for 120 dage efter anbrud.
English: The combination of lopinavir/ritonavir with: - tadalafil, indicated for the treatment of pulmonary arterial hypertension, is not recommended
Danish: Kombination af lopinavir/ritonavir med: - tadalafil til behandling af pulmonal arteriel hypertension anbefales ikke (se pkt.
English: Antipsychotics
Danish: Antipsykotika
English: 2nd Trimester n =
Danish: 3. trimester n = 23
English: Trazodone: AUC: ↑ 2.4-fold
Danish: Trazodon: AUC: ↑ 2.4-gange
English: Particular caution must be used when prescribing sildenafil or tadalafil in patients receiving Lopinavir/Ritonavir Mylan with increased monitoring for adverse events including hypotension, syncope, visual changes and prolonged erection (see section 4.4).
Danish: Der skal udvises særlig forsigtighed, når sildenafil eller tadalafil ordineres til patienter, som får Lopinavir/Ritonavir Mylan med øget overvågning af bivirkninger inklusive hypotension, synkope, synsændringer og forlænget erektion (se pkt.
English: Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Danish: Da lopinavirs og ritonavirs renale clearance er forsvindende lille, forventes der ikke øgede plasmakoncentrationer hos patienter med nyreinsufficiens.
English: HIV RNA < 50 copies/ml*† Mean increase from baseline in CD4+ T-cell count (cells/mm3) 207 * intent to treat analysis where patients with missing values are considered virologic failures † p<0.001
Danish: Gennemsnitlig stigning i CD4+ T-celletal (celler/mm3) fra baseline * ”intent-to-treat” - analyse, hvor patienter med manglende værdier anses for at have virologisk svigt † p< 0,001
English: Indeed, lopinavir/ritonavir could increase concentrations of the co-administered medicinal products and this may result in an increase of their associated cardiac adverse reactions.
Danish: Lopinavir/ritonavir kan øge koncentrationerne af lægemidler, der anvendes samtidig, og dette kan resultere i en stigning i disses relaterede kardiale bivirkninger.
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: 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 g/ml.
English: Felodipine, Nifedipine, Nicardipine: Concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Danish: Felodipin, nifedipin, nicardipin: Koncentrationerne kan være øget på grund af lopinavir/ritonavirs hæmning af CYP3A.
English: 30x1 Film-coated tablets
Danish: 30x1 filmovertrukne tabletter
English: Co-administration of lopinavir/ritonavir 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 lopinavir/ritonavir 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: − ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV]);
Danish: − ombitasvir/paritaprevir/ritonavir med eller uden dasabuvir bruges til at behandle kronisk hepatitis C-virus [HCV]);
English: Abacavir, Zidovudine
Danish: Abacavir, zidovudin
English: Co-administration of delamanid with a strong inhibitor of CYP3A (as lopinavir/ritonavir) may increase exposure to delamanid metabolite, which has been associated with QTc prolongation.
Danish: Samtidig administration af delamanid og en potent CYP3A-hæmmer (ritonavir) kan øge eksponeringen for delamanidmetabolitten, hvilket er sat i forbindelse med QTc-forlængelse.
English: Etravirine:
Danish: Etravirin:
English: Consequently, concomitant administration of Lopinavir/Ritonavir Mylan and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Danish: Som konsekvens heraf anbefales samtidig administration af Lopinavir/Ritonavir Mylan og disse glukokortikoider ikke, medmindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske virkninger af kortikosteroid (se pkt.
English: Read the list of medicines below under ‘Other medicines and Lopinavir/Ritonavir Mylan' for information on certain other medicines which require special care.
Danish: Se listen med lægemidler nedenfor under ‘Brug af anden medicin sammen med Lopinavir/Ritonavir Mylan' for at få oplysninger om visse andre lægemidler, som kræver, at der udvises særlig forsigtighed.
English: − Lopinavir/ritonavir must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital and phenytoin.
Danish: Lopinavir/ritonavir må ikke tages en gang daglig med efavirenz, nevirapin, carbamazepin, phenobarbital og phenytoin.
English: Increased risk of side-effects (respiratory depression, sedation) due to higher plasma concentrations because of CYP3A4 inhibition by lopinavir/ritonavir.
Danish: Forøget risiko for bivirkninger (respirationsdepression, sedation) på grund af højere plasmakoncentrationer, som skyldes lopinavir/ritonavir hæmning af CYP3A4.
English: Concomitant medicinal product levels increased Alpha1-adrenoreceptor antagonist
Danish: Lægemidler hvor samtidig administration giver øgede koncentrationer Adrenerg alfa1antagonist
English: MARKETING AUTHORISATION NUMBER EU/1/15/1067/001 - 60 Film-coated tablets EU/1/15/1067/002 - 60x1 Film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1067/001 - 60 filmovertrukne tabletter EU/1/15/1067/002 - 60x1 filmovertrukne tabletter
English: Study M05-730 was a randomised, open-label, multicentre trial comparing treatment with lopinavir/ritonavir 800/200 mg once daily plus tenofovir DF and emtricitabine versus lopinavir/ritonavir 400/100 mg twice daily plus tenofovir DF and emtricitabine in 664 antiretroviral treatment-naïve patients.
Danish: Studie M05-730 var et randomiseret, åbent multicenter-studie, som sammenlignede behandling med lopinavir/ritonavir 800/200 mg en gang dagligt plus tenofovir DF og emtricitabin mod lopinavir/ritonavir 400/100 mg to gange dagligt plus tenofovir DF og emtricitabin hos 664 antiretroviral-behandlingsnaive patienter.
English: Cmax: ↑ 6-fold Initially, bosentan Cmin: ↑ by approximately 48-fold.
Danish: Initialt, bosentan Cmin : ↑ omkring 48gange.
English: Rare reports of 2nd or 3rd degree atroventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving drugs known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving lopinavir/ritonavir.
Danish: Hos patienter, der får lopinavir/ritonavir, er der rapporteret om sjældne tilfælde af 2. eller 3. grads atrioventrikulær blok hos patienter med underliggende strukturel hjertesygdom og eksisterende overledningsforstyrrelser eller hos patienter, der får lægemidler, der er kendt for at forlænge PR-intervallet (sådan som verapamil eller atazanavir).
English: Ombitasvir/paritaprevir/rito navir + dasabuvir
Danish: Ombitasvir/paritaprevir/ ritonavir + dasabuvir
English: Lopinavir/ritonavir has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes (including CYP2C9 and CYP2C19) and by glucuronidation.
Danish: Det er vist in vivo, at lopinavir/ritonavir inducerer sin egen metabolisme samt øger biotransformationen af visse lægemidler, som metaboliseres ved hjælp af cytocrom P450 enzymer og ved glucuronidering.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with Lopinavir/Ritonavir Mylan.
Danish: Klinisk overvågning af terapeutisk effekt og bivirkninger anbefales, når disse lægemidler administreres samtidig med Lopinavir/Ritonavir Mylan.
English: Adult patients who have previously taken other antiviral medicines can take lopinavir/ritonavir tablets once daily as an 800 mg/200 mg dose if their doctor decides it is appropriate.
Danish: Voksne patienter, som tidligere har taget anden antiviral medicin kan tage lopinavir/ritonavir -tabletter en gang dagligt som en 800 mg/200 mg dosis, hvis deres læge beslutter, at det er hensigtsmæssigt.
English: Increased plasma concentrations of paritaprevir; thereby, increasing the risk of alanine transaminase (ALT) elevations (see section 4.5).
Danish: Forhøjede plasmakoncentrationer af paritaprevir, derved øges risikoen for alanintransaminase (ALT) forhøjelser (se pkt.
English: Increased plasma concentrations of lurasidone which may increase the potential for serious and/or life threatening reactions (see section 4.5)
Danish: Forhøjede plasmakoncentrationer af lurasidon som kan forøge risikoen for alvorlige og/eller livstruende reaktioner (se pkt.
English: Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life-threatening reactions (see section 4.5).
Danish: Forhøjede plasmakoncentrationer af ranolazin som kan forøge risikoen for alvorlige og/eller livstruende reaktioner (se pkt.
English: Concentrations may be affected when co-administered with lopinavir/ritonavir due to CYP2C9 induction.
Danish: Koncentrationerne kan falde ved samtidig administration med lopinavir/ritonavir på grund af CYP2C9-induktion.
English: Rifabutin, 150 mg QD Rifabutin (parent drug and active 25O-desacetyl metabolite):
Danish: Rifabutin (moderstof og den aktive 25-O-desacetyl metabolit):
English: Lopinavir/ritonavir does this by slowing down the spread of the infection in your body.
Danish: Det gør lopinavir/ritonavir ved at nedsætte den hastighed, hvormed infektionen breder sig i kroppen.
English: Therefore, Lopinavir/Ritonavir Mylan can be started safely 2 weeks after cessation of St John's wort.
Danish: Derfor kan behandling med Lopinavir/Ritonavir Mylan kan startes sikkert 2 uger efter ophør med at behandle med perikon.