natgillin/translations-raw huggingface dataset:
Samtidig administration af lopinavir/ritonavir og lægemidler, der primært metaboliseres af CYP3A, kan resultere i forhøjede plasmakoncentrationer af det andet lægemiddel og dermed forøge eller forlænge dets effekt og bivirkninger. 
Co-administration of lopinavir/ritonavir 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.
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 daglig og supraterapeutisk 800/200 mg to gange daglig LPV/r. 
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.
Almindelig Overfølsomhed inklusive urticaria og angioødem Ikke almindelig 
Hypersensitivity including urticaria and angioedema
Bedømmelse af in-vitro resistens 
In vitro selection of resistance
Hos hiv-inficerede patienter med mild til moderat svækket leverfunktion, er der set en stigning på omkring 30 % i lopinavir eksposition, men dette forventes ikke at have nogen klinisk relevans. 
In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed but is not expected to be of clinical relevance (see section 5.2).
Dosering en gang dagligt: Farmakokinetikken for lopinavir/ritonavir en gang dagligt er blevet evalueret hos hiv-inficerede forsøgspersoner, som var naive over for antiretroviral behandling. 
Once-daily dosing: the pharmacokinetics of once daily lopinavir/ritonavir have been evaluated in HIVinfected subjects naïve to antiretroviral treatment.
I løbet af 48 ugers behandling var andelen af patienter, med bekræftet viral rebound ≥ 50 kopier/ml, højere hos de pædiatriske patienter, som fik lopinavir/ritonavir-tabletter en gang dagligt (12 %), end hos de patienter, som fik dosering to gange daglig (8 %, p = 0,19), hovedsagligt på grund af lavere behandlingsoverholdelse i gruppen med en daglig administration. 
The percentage of patients with confirmed viral rebound ≥50 copies/ml during 48 weeks of follow-up was higher in the paediatric patients receiving lopinavir/ritonavir tablets once daily (12%) than in patients receiving the twice-daily dosing (8%, p = 0.19), mainly due to lower adherence in the once-daily group.
Almindelig Myalgi, muskuloskeletale smerter inklusive artralgi og rygsmerter, muskellidelser så som svaghed og spasmer 
Myalgia, musculoskeletal pain including arthralgia and back pain, muscle disorders such as weakness and spasms
Farmakokinetiske parametre af lopinavir/ritonavir 300/75 mg/m2 to gange dagligt og 230/57,5 mg/m2 to gange dagligt er blevet undersøgt på i alt 53 pædiatriske patienter i alderen fra 6 måneder til 12 år. 
The pharmacokinetics of lopinavir/ritonavir oral solution 300/75 mg/m2 twice daily and 230/57.5 mg/m2 twice daily have been studied in a total of 53 paediatric patients, ranging in age from 6 months to 12 years.
Kvalme, opkastning, mavesmerter, åndedrætsbesvær og svær muskelsvaghed i benene og armene, da disse symptomer kan være tegn på forhøjede mælkesyreniveauer. 
− 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.
Farmakokinetiske parametre af lopinavir/ritonavir er ikke blevet undersøgt hos patienter med nyreinsufficiens, men da renal clearance af lopinavir er ubetydelig, forventes ingen nedgang af kroppens samlede clearance hos patienter med nyreinsufficiens. 
Lopinavir/ritonavir pharmacokinetics have not been studied in patients with renal insufficiency; however, since the renal clearance of lopinavir is negligible, a decrease in total body clearance is not expected in patients with renal insufficiency.
Sedativer/hypnotika Oral midazolam, triazolam Forhøjede plasmakoncentrationer af oral midazolam samt triazolam. 
Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam.
Da øgede koncentrationer af HMG-CoA-reduktase-hæmmere kan forårsage myopati, inklusive rhabdomyolyse, er kombinationen af disse stoffer med Lopinavir/Ritonavir Mylan kontraindiceret (se pkt. 
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these agents with Lopinavir/Ritonavir Mylan is contraindicated (see section 4.3).
M06-802 var et randomiseret åbent studie, der sammenlignede sikkerhed, tolerabilitet og antiviral aktivitet ved dosering en gang dagligt og dosering to gange dagligt af lopinavir/ritonavir-tabletter hos 599 forsøgspersoner med målbar virusbelastning, mens de fik deres nuværende antivirale behandling. 
M06-802 was a randomised open-label study comparing the safety, tolerability and antiviral activity of oncedaily and twice daily dosing of lopinavir/ritonavir tablets in 599 subjects with detectable viral loads while receiving their current antiviral therapy.
Hvis du bliver klar over, at du har taget for meget lopinavir/ritonavir, skal du straks kontakte din læge. 
− If you realise you have taken more lopinavir/ritonavir than you were supposed to, contact your doctor right away.
- 1 flaske med 60 filmovertrukne tabletter. 
- 1 bottle of 60 film-coated tablets.
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, lopinavir/ritonavir can cause side effects, although not everybody gets them.
Lopinavir AUC over et 12 timers doseringsinterval var i gennemsnit 113,2  60,5 g•h/ml. 
Lopinavir AUC over a 12 hour dosing interval averaged 113.2 ± 60.5 μg•h/ml.
Indtag af en enkelt 400/100 mg dosis af lopinavir/ritonavir tabletter og et måltid (med højt fedtindhold 872 kcal, 56 % fra fedt) var ikke forbundet med nogen signifikante ændringer i Cmax og AUCinf i forhold til fastende betingelser. 
Administration of a single 400/100 mg dose of lopinavir/ritonavir tablets under fed conditions (high fat, 872 kcal, 56% from fat) compared to fasted state was associated with no significant changes in Cmax and AUCinf.
Patienter med kronisk hepatitis B eller C, som har fået antiretroviral kombinationsbehandling, har øget risiko for at få alvorlige bivirkninger og potentielt dødelige leverbivirkninger. 
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Hvis samtidig administration er uundgåelig ved osteo-artikulære infektioner, anbefales tæt klinisk overvågning for muskulære bivirkninger kraftigt (se pkt. 
When used for osteo-articular infections, where the coadministration is unavoidable, close clinical monitoring for muscular adverse events is strongly recommended (see section 4.4).
De almindeligste bivirkninger relateret til lopinavir/ritonavir-behandling i de kliniske studier var diarré, kvalme, opkastning, hypertriglyceridæmi og hyperkolesterolæmi. 
The most common adverse reactions related to lopinavir/ritonavir therapy during clinical trials were diarrhoea, nausea, vomiting, hypertriglyceridaemia and hypercholesterolemia.
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 befrugtningen. 
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.
Almindelig Erektil dysfunktion, menstruationsforstyrrelseramenoré, menoragi 
Erectile dysfunction, menstrual disordersamenorrhoea, menorrhagia
Følgende skema indeholder doseringsvejledninger for lopinavir/ritonavir 100 mg/25 mg tabletter baseret på legemsvægt og BSA. 
The following table contains dosing guidelines for lopinavir/ritonavir 100/25 mg tablets based on body weight and BSA.
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. 
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.
(hæmning af CYP3A/efflukstransportører) 
(inhibition of CYP3A/efflux transporters)
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. 
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.
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. 
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.
Lopinavir/ritonavir nedsætter ikke risikoen for at smitte andre med hiv. 
− Lopinavir/ritonavir does not reduce the risk of passing HIV to others.
Virologisk respons for forsøgspersoner ved uge 48 studie 802 En gang dagligt To gange dagligt 
Virologic Response of Study Subjects at Week 48 Study 802 QD
Samtidig administration med fusidinsyre er kontraindiceret ved dermatologiske infektioner (se pkt. 
The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section 4.5).
Almindelig Blodglucoseforstyrrelser herunder diabetes mellitus, hypertriglyceridæmi, hyperkolesterolæmi, vægttab, nedsat appetit 
Blood glucose disorders including diabetes mellitus, hypertriglyceridaemia, hypercholesterolemia, weight decreased, decreased appetite
Rifampicin i kombination med lopinavir/ritonavir forårsager stor reduktion i lopinavir-koncentrationer, hvilket kan resultere i et signifikant fald i lopinavirs terapeutiske effekt. 
Rifampicin in combination with lopinavir/ritonavir causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect.
Hæmofili A og B, da lopinavir/ritonavir kan øge risikoen for blødning. 
− Haemophilia type A and B as lopinavir/ritonavir might increase the risk of bleeding.
For forsigtighedsregler ved administration af parenteral midazolam, se pkt. 
For caution on parenterally administered midazolam, see section 4.5.
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. 
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.
Risikoen for diarre kan være større hos patienter, som får lopinavir/ritonavir en gang dagligt. 
The risk of diarrhoea may be greater with once daily dosing of lopinavir/ritonavir.
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. 
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.
Gennemsnitligt AUC for lopinavir over et 24-timers doseringsinterval var 206,5 ± 89,7 µg·t/ml. 
Lopinavir AUC over a 24 hour dosing interval averaged 206.5 ± 89.7 μg h/ml.
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). 
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).
Andre formuleringer af dette lægemiddel kan være mere velegnede til børn. 
Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
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. 
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.
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. 
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.
Fortæl det altid til lægen, hvis du får kvalme, opkastning eller mavesmerter, da dette kan være tegn på pankreatitis (betændelse i bugspytkirtlen). 
Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis (inflammation of the pancreas).
Phosphordiesterase-5hæmmere (PDE5) 
Phosphodiesterase (PDE5) inhibitors
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). 
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).
- 1 flaske med 120 filmovertrukne tabletter. 
- 1 bottle of 120 film-coated tablets.
Det er vigtigt at bemærke, at tilfælde af pankreatitis er blevet rapporteret hos patienter, der fik lopinavir/ritonavir, deriblandt patienter der udviklede hypertriglyceridæmi. 
It is important to note that cases of pancreatitis have been reported in patients receiving lopinavir/ritonavir, including those who developed hypertriglyceridaemia.
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. 
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.
Lopinavir/Ritonavir Mylans sikkerhed og virkning er ikke fastsat hos patienter med alvorlig underliggende leversygdom. 
The safety and efficacy of lopinavir/ritonavir has not been established in patients with significant underlying liver disorders.
Hvis du tager lopinavir/ritonavir en gang dagligt 
If you are taking lopinavir/ritonavir once a day
Forsigtighed skal ligeledes udvises og nedsatte, doser af lopinavir/ritonavir bør overvejes, hvis lopinavir/ritonavir anvendes sammen med rosuvastatin. 
Caution must also be exercised and reduced doses should be considered if lopinavir/ritonavir is used concurrently with rosuvastatin.
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. 
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).
Maraviroc-dosis bør nedsættes til 150 mg to gange daglig ved samtidig administration af Lopinavir/Ritonavir Mylan 400/100 mg to gange daglig. 
The dose of maraviroc should be decreased to 150 mg twice daily during co-administration with Lopinavir/Ritonavir Mylan 400/100 mg twice daily.
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 %). 
M98-940 was an open-label study of a liquid formulation of lopinavir/ritonavir in 100 antiretroviral naïve (44%) and experienced (56%) paediatric patients.
Metaboliske parametre Kropsvægt og niveauerne af lipid og glucose i blodet kan stige under antiretroviral behandling (se pkt. 
Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
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. 
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.
Lopinavir: ↔ (I forhold til 400/100 mg to gange dagligt administreret alene) 
Lopinavir: ↔ (Relative to 400/100 mg BID administered alone)
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Lopinavir/Ritonavir Mylan. 
Talk to your doctor or pharmacist before taking Lopinavir/Ritonavir Mylan.
Lopinavir/ritonavir bør bruges med forsigtighed til sådanne patienter (se pkt. 
Lopinavir/ritonavir should be used with caution in such patients (see section 5.1).
Personer, der tager lopinavir/ritonavir, kan stadig udvikle infektioner eller andre sygdomme forbundet med hiv og AIDS. 
People taking lopinavir/ritonavir may still develop infections or other illnesses associated with HIV disease and AIDS.
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. 
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.
Cmax: ↓ (I forhold til 800 mg tre gange daglig alene) 
Cmax: ↓ (relative to indinavir 800 mg TID alone)
EXP Skal anvendes inden for 120 dage efter anbrud. 
EXP After first opening, use within 120 days.
Kombination af lopinavir/ritonavir med: - tadalafil til behandling af pulmonal arteriel hypertension anbefales ikke (se pkt. 
The combination of lopinavir/ritonavir with: - tadalafil, indicated for the treatment of pulmonary arterial hypertension, is not recommended
Antipsykotika 
Antipsychotics
3. trimester n = 23 
2nd Trimester n =
Trazodon: AUC: ↑ 2.4-gange 
Trazodone: AUC: ↑ 2.4-fold
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. 
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).
Da lopinavirs og ritonavirs renale clearance er forsvindende lille, forventes der ikke øgede plasmakoncentrationer hos patienter med nyreinsufficiens. 
Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
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 
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
Lopinavir/ritonavir kan øge koncentrationerne af lægemidler, der anvendes samtidig, og dette kan resultere i en stigning i disses relaterede kardiale bivirkninger. 
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.
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. 
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
Den gennemsnitlige laveste steady-state koncentration før morgen dosis var 8,1  5,7 g/ml. 
The mean steady-state trough concentration prior to the morning dose was 8.1 ± 5.7 μg/ml.
Felodipin, nifedipin, nicardipin: Koncentrationerne kan være øget på grund af lopinavir/ritonavirs hæmning af CYP3A. 
Felodipine, Nifedipine, Nicardipine: Concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
30x1 filmovertrukne tabletter 
30x1 Film-coated tablets