FrancophonIA/ELRC3.0 huggingface dataset:
English: - Lopinavir/Ritonavir Mylan is not a cure for HIV infection or AIDS - Lopinavir/ritonavir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Slovenian: - Zdravilo Lopinavir/ritonavir Mylan ne pozdravi okužbe z virusom HIV ali AIDS-a. - Lopinavir/ritonavir se uporablja pri otrocih, starih 2 leti ali več, mladostnikih in odraslih, okuženih z virusom HIV, virusom, ki povzroča AIDS.
English: Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Slovenian: Večja koncentracija lovastatina in simvastatina v plazmi; zaradi tega večje tveganje za miopatijo, vključno z rabdomiolizo (glejte poglavje 4.5).
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with carbamazepine and phenobarbital.
Slovenian: Zdravila Lopinavir/ritonavir Mylan se ne sme dajati enkrat dnevno v kombinaciji s karbamazepinom in fenobarbitalom.
English: Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.
Slovenian: Lopinavir/ritonavir je v kombinaciji z drugimi protiretrovirusnimi zdravili indiciran za zdravljenje odraslih, mladostnikov in otrok, starejših od dveh let, okuženih z virusom (HIV-1), ki povzroča imunsko pomanjkljivost.
English: AUC: ↑ 11.86-fold Cmax: ↑ 6.31-fold C24: ↑ 20.70-fold
Slovenian: AUC: ↑ 11,86-krat Cmax: ↑ 6,31-krat C24: ↑ 20,70-krat
English: Monitor for ADRs related to afatinib
Slovenian: Spremljajte neželene učinke, ki so v povezavini z afatinibom.
English: Multiple dosing with 400/100 mg lopinavir/ritonavir twice daily for 2 weeks and without meal restriction produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 12.3 ± 5.4 μg/ml, occurring approximately 4 hours after administration.
Slovenian: Večkratno odmerjanje 400 mg/100 mg lopinavirja/ritonavirja dvakrat na dan 2 tedna in brez omejevanja obrokov je povzročilo povprečno največjo plazemsko koncentracijo (Cmax)  SD lopinavirja 12,3  5,4 g/ml, in sicer približno 4 ure po uporabi.
English: Patients were randomised in a 1:1 ratio to receive either lopinavir/ritonavir 800/200 mg once daily (n = 333) or lopinavir/ritonavir 400/100 mg twice daily (n = 331).
Slovenian: Bolniki so bili v razmerju 1:1 randomizirani na zdravljenje z lopinavirjem/ritonavirjem 800 mg/200 mg enkrat na dan (n = 333) ali lopinavir/ritonavir 400 mg/100 mg dvakrat na dan (n = 331).
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.
Slovenian: Študija M05-730 je bila randomizirano, odprto multicentrično preskušanje, ki je zdravljenje z lopinavirjem/ritonavirjem 800 mg/200 mg enkrat na dan v kombinaciji s tenofovirjem DF in emtricitabinom primerjalo z lopinavirjem/ritonavirjem 400 mg/100 mg dvakrat na dan v kombinaciji s tenofovirjem DF in emtricitabinom pri 664 bolnikih, ki še niso bili deležni protiretrovirusnega zdravljenja.
English: (25/150/100 mg QD + 400 mg BID)
Slovenian: (25/150/100 mg enkrat na dan + 400 mg dvakrat na dan)
English: Dieselweg 25, 3752 LB Bunschoten The Netherlands
Slovenian: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Nizozemska
English: Lopinavir/ritonavir 800/200 mg QD was administered with ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
Slovenian: Lopinavir/ritonavir 800/200 mg enkrat na dan je bil uporabljen z ombitasvirjem/paritaprevirjem/ritonavirj em z ali brez dasabuvirja.
English: 120 Film-coated tablets
Slovenian: 120 filmsko obloženih tablet
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Slovenian: Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART - ''combination antiretroviral therapy'') ali obojim.Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če se jim pojavijo bolečine v sklepih, togost sklepov ali težave z gibljivostjo.
English: Mylan Helathcare Sp. z.o.o.
Slovenian: Mylan Healtchare Sp. z.o.o.
English: Lopinavir/ritonavir tablets must be swallowed whole and not chewed, broken or crushed.
Slovenian: Tablete z lopinavirjem/ritonavirjem je treba pogoltniti cele in jih ni dovoljeno žvečiti, lomiti ali drobiti.
English: The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Lopinavir/Ritonavir Mylan (see section 4.4).
Slovenian: Uporaba rivaroksabana ni priporočljiva pri bolnikih, ki sočasno prejemajo zdravilo Lopinavir/ritonavir Mylan (glejte poglavje 4.4).
English: The mean steady-state trough concentration prior to the morning dose was 8.1 ± 5.7 μg/ml.
Slovenian: Povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja pred jutranjim odmerkom je bila 8,1  5,7 g/ml.
English: Simeprevir 200 mg daily (ritonavir 100 mg BID)
Slovenian: simeprevir 200 mg/dan (ritonavir 100 mg dvakrat na dan)
English: The median fold IC50 of lopinavir for these 18 isolates at baseline and rebound was 6.9- and 63-fold, respectively, compared to wild type virus.
Slovenian: Srednji (mediana) kratnik IC50 lopinavirja pri teh 18 izolatih v primerjavi z divjim tipom virusa je bil izhodiščno 6,9-krat in po preobratu 63-krat.
English: Undesirable effects in clinical studies and post-marketing in adult patients System organ class
Slovenian: Neželeni učink i v k liničnih študijah in v obdobju spremljanja med trženjem zdravila pri odraslih bolnik ih
English: Cmax: ↑ 6-fold Initially, bosentan Cmin: ↑ by approximately 48-fold.
Slovenian: Uvodoma Cmin bosentana: ↑ za približno 48-krat.
English: − If you notice you miss a dose by more than 12 hours after your normal dosing time, do not take the missed dose.
Slovenian: - Če opazite, da ste pozabili vzeti odmerek zdravila več kot 12 ur po predvidenem času jemanja, ne vzemite izpuščenega odmerka.
English: Lopinavir/Ritonavir Mylan 400/100 mg + ritonavir 300 mg) twice daily has allowed compensating for the CYP 3A4 inducer effect of rifampicin.
Slovenian: Prilagoditev odmerka zdravila Lopinavir/ritonavir Mylan 400 mg/400 mg (tj. zdravilo Lopinavir/ritonavir Mylan 400 mg/100 mg + ritonavir 300 mg) dvakrat na dan je omogočila kompenzacijo indukcijskega učinka rifampicina na CYP3A4.
English: What you need to know before you or your child takes Lopinavir/Ritonavir Mylan
Slovenian: Kaj morate vedeti, preden boste vi ali vaš otrok vzeli zdravilo Lopinavir/ritonavir Mylan
English: Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Slovenian: Ledvični očistek lopinavirja in ritonavirja je zanemarljiv, zato pri bolnikih z okvaro ledvic ni pričakovati zvečane koncentracije v plazmi.
English: Due to the risk of QTc prolongation associated with DM-6705, if coadministration of delamanid with Lopinavir/Ritonavir Mylan is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.4 and refer to the delamanid SmPC).
Slovenian: Če je potrebna sočasna uporaba delamanida z zdravilom Lopinavir/ritonavir Mylan, je zaradi tveganja za podaljšanje intervala QTc v povezavi z DM-6705 priporočljivo zelo pogosto spremljanje EKG-ja skozi celotno obdobje zdravljenja (glejte poglavje 4.4 in glejte povzetek glavnih značilnosti zdravila za delamanid).
English: Furthermore, rare increases in PR interval have been reported during lopinavir/ritonavir therapy (see section 4.4).
Slovenian: Poleg tega so med zdravljenjem z lopinavirjem/ritonavirjem opisani redki primeri podaljšanja intervala PR (glejte poglavje 4.4).
English: Co-administration of Lopinavir/Ritonavir Mylan with rifampicin is not recommended as the decrease in lopinavir concentrations may in turn significantly decrease the lopinavir therapeutic effect.
Slovenian: Sočasna uporaba zdravila Lopinavir/ritonavir Mylan in rifampicina ni priporočljiva, kajti zmanjšanje koncentracije lopinavirja lahko bistveno zmanjša terapevtski učinek lopinavirja.
English: − If you notice you miss a dose by more than 6 hours after your normal dosing time, do not take the missed dose.
Slovenian: - Če opazite, da ste pozabili vzeti odmerek zdravila več kot 6 ur po predvidenem času jemanja, ne vzemite izpuščenega odmerka.
English: Lopinavir/ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects.
Slovenian: Podaljšanje interv ala PR Ugotovljeno je, da kombinacija lopinavir/ritonavir nekaterim zdravim odraslim osebam zmerno in asimptomatsko podaljša interval PR.
English: Protocol defined non-inferiority of once daily dosing compared with twice daily dosing was demonstrated if the lower bound of the 95% confidence interval for the difference in proportion of subjects responding (once daily minus twice daily) excluded -12% at Week 48.
Slovenian: Pri 95 % spodnji meji zaupanja za razliko pri deležu bolnikov, ki so se odzvali (enkrat dnevno minus dvakrat dnevno), izključujoč -12 % v 48. tednu, je bilo enkrat dnevno odmerjanje v primerjavi z dvakrat dnevnim odmerjanjem neinferiorno kot definirano po protokolu.
English: They are available in blister multipacks of 120, 120x1 (4 cartons of 30 or 30x1) or 360 (12 cartons of 30) film-coated tablets and in plastic bottles (containing a desiccant, which should not be eaten) of 120 filmcoated tablets and a multipack containing 360 (3 bottles of 120) film-coated tablets.
Slovenian: Zdravilo je na voljo v skupnih pakiranjih s pretisnimi omoti s 120, 120 x 1 (4 škatle po 30 ali 30 x 1) ali 360 (12 škatel po 30) filmsko obloženih tablet in v vsebnikih (s sušilnim sredstvom, ki se ga ne smete zaužiti) s 120 filmsko obloženimi tabletami in v skupnem pakiranju s 360 (3 vsebniki s 120) filmsko obloženimi tabletami.
English: - Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.
Slovenian: - Zdravilo Lopinavir/ritonavir Mylan vsebuje zdravilni učinkovini lopinavir in ritonavir.
English: Myalgia, musculoskeletal pain including arthralgia and back pain, muscle disorders such as weakness and spasms
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva pogosti mialgija, mišično-skeletne bolečine vključno z artralgijo in bolečinami v hrbtu, bolezni mišic kot je šibkost in krči občasni rabdomioliza, osteonekroza
English: If you or your child forget to take Lopinavir/Ritonavir Mylan
Slovenian: Če ste vi ali vaš otrok pozabili vzeti zdravilo Lopinavir/ritonavir Mylan
English: The following table contains dosing guidelines for lopinavir/ritonavir 100/25 mg tablets based on body weight and BSA.
Slovenian: Spodnja preglednica vsebuje smernice za odmerjanje 100 mg/25 mg tablet z lopinavirjem/ritonavirjem na osnovi telesne mase in telesne površine.
English: Please refer to the Aptivus Summary of Product Characteristics for additional information on the use of tipranavir, including genotypic predictors of response, in treatment of lopinavir-resistant HIV-1 infection.
Slovenian: Za dodatne informacije o tipranavirju (vključno z genotipsko napovedjo odziva, pri zdravljenju okužbe z virusom HIV-1, odporne proti lopinavirju) glejte povzetek glavnih značilnosti zdravila Aptivus.
English: Cmin: ↑ 51%
Slovenian: Cmax: ↑ 55%
English: HIV RNA < 50 copies/ml
Slovenian: HIV RNA < 400 kopij/ml HIV RNA < 50 kopij/ml
English: Multipack: 60 (2 cartons of 30) Film-coated tablets Multipack: 60x1 (2 cartons of 30x1) Film-coated tablets
Slovenian: Skupno pakiranje: 60 (2 škatli po 30) filmsko obloženih tablet Skupno pakiranje: 60 x 1 (2 škatli po 30 x 1) filmsko obložena tableta
English: Concomitant administration of Lopinavir/Ritonavir Mylan and alfuzosin is contra-indicated (see section 4.3) as alfuzosin-related toxicity, including hypotension, may be increased.
Slovenian: Sočasna uporaba zdravila Lopinavir/ritonavir Mylan in alfuzosina je kontraindicirana (glejte poglavje 4.3), ker se lahko poveča z alfuzosinom povezana toksičnost, vključno s hipotenzijo.
English: Therefore, concomitant administration of Lopinavir/Ritonavir Mylan with salmeterol is not recommended (see section 4.4).
Slovenian: Zato sočasna uporaba zdravila Lopinavir/ritonavir Mylan s salmeterolom ni priporočljiva (glejte poglavje 4.4).
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).
Slovenian: Pričakovati je treba, da sočasna uporaba lopinavirja/ritonavirja in teh zdravil bistveno poveča njihovo koncentracijo in lahko povzroči spremljajoče neželene učinke, npr. hipotenzijo, sinkopo, motnje vida in dolgotrajno erekcijo (glejte poglavje 4.5).
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).
Slovenian: Bolnikom, ki jemljejo zdravilo Lopinavir/ritonavir Mylan, je treba sildenafil ali tadalafil predpisovati posebno previdno in jih pogosteje kontrolirati glede neželenih učinkov, vključno s hipotenzijo, sinkopo, spremembami vida in dolgotrajno erekcijo (glejte poglavje 4.4).
English: Herbal preparations containing St John's wort must not be combined with lopinavir and ritonavir.
Slovenian: Zdravil rastlinskega izvora s šentjanževko se ne sme kombinirati z lopinavirjem in ritonavirjem.
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
Slovenian: Mutagenost lopinavirja/ritonavirja so preizkusili s skupino preskusov in vitro in in vivo, med drugim z Amesovim preskusom bakterijske reverzne mutacije, mišjim limfomskim preskusom, mikronukleusnim testom pri miših in preskusi kromosomskih aberacij v človeških limfocitih; nobeden ni pokazal, da bi bila kombinacija mutagena ali klastogena.
English: (inhibition of CYP3A/efflux transporters)
Slovenian: (zaviranje CYP3A/izlivnih prenašalcev)
English: 51 patients receiving 400/100 mg twice daily and 49 patients at either 200/100 mg twice daily or 400/200 mg twice daily).
Slovenian: Uvodoma je lopinavir/ritonavir v študiji dobivalo 100 bolnikov (51 bolnikov je dobivalo odmerek 400 mg/100 mg dvakrat na dan, 49 bolnikov pa bodisi 200 mg/100 mg dvakrat na dan ali 400 mg/200 mg dvakrat na dan).
English: Mean baseline CD4+ T-cell count was 254 cells/mm3 (range: 4 to 952 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.3 log10 copies/ml (range: 1.7 to 6.6 log10 copies/ml).
Slovenian: Povprečno izhodiščno število celic CD4+ je bilo 254 celic/mm3 (razpon: od 4 do 952 celic/mm3) in povprečna izhodiščna HIV-1 RNA v plazmi je bila 4,3 log10 kopij/ml (razpon: od 1,7 do 6,6 log10 kopij/ml).
English: Rivaroxaban (Ritonavir 600 mg twice daily)
Slovenian: rivaroksaban (ritonavir 600 mg dvakrat na dan)
English: Ombitasvir/paritaprevir/ritonavir with or without dasabuvir
Slovenian: ombitasvir/paritap revir/ritonavir z ali brez dasabuvirja
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.
Slovenian: Za informacije o zdravilih, ki jih ne smete jemati sočasno z lopinavirjem/ritonavirjem, preberite seznam zdravil zgoraj v poglavju “Ne jemljite zdravila Lopinavir/ritonavir Mylan, če trenutno jemljete katero od naslednjih zdravil”.
English: Concomitant administration of Lopinavir/Ritonavir Mylan and ergot alkaloids are contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section
Slovenian: Sočasna uporaba zdravila Lopinavir/ritonavir Mylan in ergot alkaloidov je kontraindicirana, saj lahko vodi v akutno ergot toksičnost, vključno z vazospazmom in ishemijo (glejte poglavje 4.3).
English: BID Difference [95% CI]
Slovenian: 1xnadan 2xnadan Razlika [95% IZ]
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Slovenian: Srednje povečanje števila T-celic CD4+ od začetk a (celice/mm3)
English: Herbal products St John's wort (Hypericum perforatum)
Slovenian: Zdravila rastlinskega izvora šentjanževka (Hypericum perf oratum)
English: Blood glucose disorders including diabetes mellitus, hypertriglyceridaemia, hypercholesterolemia, weight decreased, decreased appetite
Slovenian: Presnovne in prehranske motnje pogosti motnje glukoze v krvi vključno z sladkorno boleznijo, hipertrigliceridemija, hiperholesterolemija, znižanje telesne mase, zmanjšan apetit občasni zvišanje telesne mase, zvečan apetit
English: If the benefit outweighs the risk, co-administration of bedaquiline with Lopinavir/Ritonavir Mylan must be done with caution.
Slovenian: Če je korist večja od tveganja, je pri sočasni uporabi bedakilina z zdravilom Lopinavir/ritonavir Mylan potrebna previdnost.
English: Mean baseline CD4+ T-cell count was 216 cells/mm3 (range: 20 to 775 cells/mm3) and mean baseline plasma HIV-1 RNA was 5.0 log10 copies/ml (range: 1.7 to 7.0 log10 copies/ml).
Slovenian: Povprečno izhodiščno število celic CD4 je bilo 216 celic/mm3 (razpon: od 20 do 775 celic/mm3) in povprečna izhodiščna HIV-1 RNA v plazmi je bila 5,0 log10 izvodov/ml (razpon: od 1,7 do 7,0 log10 izvodov/ml).
English: Multipack: 120 (4 cartons of 30) Film-coated tablets Multipack: 120x1 (4 cartons of 30x1) Film-coated tablets Multipack: 360 (12 cartons of 30) Film-coated tablets
Slovenian: Skupno pakiranje: 120 (4 škatle po 30) filmsko obloženih tablet Skupno pakiranje: 120 x 1 (4 škatle po 30 x 1) filmsko obložena tableta Skupno pakiranje: 360 (12 škatel po 30) filmsko obloženih tablet
English: Concomitant administration of Lopinavir/Ritonavir Mylan and amiodarone or dronedarone is contraindicated (see section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased.
Slovenian: Sočasna uporaba zdravila Lopinavir/ritonavir Mylan in amiodarona ali dronedarona je kontraindicirana (glejte poglavje 4.3), ker se lahko poveča tveganje za aritmije ali druge resne neželene učinke.
English: HMG Co-A Reductase Inhibitors
Slovenian: Zaviralci HMG Co-A reduktaze lovastatin, simvastatin
English: Across studies, administration of lopinavir/ritonavir 400/100 mg twice daily yields mean steady-state lopinavir plasma concentrations 15 to 20-fold higher than those of ritonavir in HIV-infected patients.
Slovenian: Po podatkih iz več študij je bila med uporabo lopinavirja/ritonavirja 400 mg/100 mg dvakrat na dan pri bolnikih, okuženih z virusom HIV, povprečna plazemska koncentracija lopinavirja v stanju dinamičnega ravnovesja od 15- do 20-krat večja kot koncentracija ritonavirja.
English: If you or your child take more Lopinavir/Ritonavir Mylan than you should
Slovenian: Če ste vi ali vaš otrok vzeli večji odmerek zdravila Lopinavir/ritonavir Mylan, k ot bi smeli
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.
Slovenian: Bolniki so 8 tednov dobivali bodisi tablete bodisi mehke kapsule; po tem obdobju so vsi bolniki med preostalim obdobjem študije dobivali tablete enkrat na dan ali dvakrat na dan. Bolniki so dobivali emtricitabin 200 mg enkrat na dan in tenofovir DF 300 mg enkrat na dan.
English: Hepatitis including AST, ALT and GGT increases Uncommon Hepatic steatosis, hepatomegaly, cholangitis, hyperbilirubinemia
Slovenian: občasni hepatična steatoza, hepatomegalija, holangitis, hiperbilirubinemija neznana zlatenica
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.
Slovenian: Bolnike so randomizirali bodisi na 230 mg lopinavirja/57,5 m g ritonavirja na m2 ali 300 mg lopinavirja/75 mg ritonavirja na m2.
English: Lopinavir: ↔ (Relative to 400/100 mg BID administered alone)
Slovenian: lopinavir: ↔ (v primerjavi s 400 mg/100 mg dvakrat na dan, uporabljenim samostojno)
English: Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating lopinavir/ritonavir (400/100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus stavudine and lamivudine.
Slovenian: Študija M98-863 je randomizirano, dvojno slepo preskušanje s 653 bolniki, naivnimi za protiretrovirusno zdravljenje, ki proučuje lopinavir/ritonavir (400 mg/100 mg dvakrat na dan) v primerjavi z nelfinavirjem (750 mg trikrat na dan) v kombinaciji s stavudinom in lamivudinom Povprečno izhodiščno število celic CD4 je bilo 259 celic/mm3 (razpon: od 2 do 949 celic/mm3),
English: Maximum PR interval was 286 ms and no second or third degree heart block was observed (see section 4.4).
Slovenian: Povprečna sprememba dolžine intervala PR v primerjavi z izhodiščem je bila med 12-urnim obdobjem po odmerku od 11,6 ms do 24,4 ms. Najdaljši interval PR je bil 286 ms, primerov srčnega bloka druge ali tretje stopnje pa ni bilo (glejte poglavje 4.4).
English: If you or your child stop taking Lopinavir/Ritonavir Mylan
Slovenian: Če ste vi ali vaš otrok prenehali jemati zdravilo Lopinavir/ritonavir Mylan
English: AUC: ↑ 2.71-fold Cmax: ↑ 1.87-fold C24: ↑ 3.58-fold
Slovenian: AUC: ↑ 2,71-krat Cmax: ↑ 1,87-krat C24: ↑ 3,58-krat grazoprevir:
English: − increased cholesterol levels in your blood, increased triglycerides (a form of fat) levels in your blood,
Slovenian: - otekanje ali vnetje želodca, črevesja in debelega črevesa; - zvišane vrednosti holesterola v krvi, zvišane vrednosti trigliceridov (oblika maščobe) v krvi,
English: • Once daily administration of lopinavir/ritonavir is not recommended for pregnant women due to the lack of pharmacokinetic and clinical data.
Slovenian: • Zaradi pomanjkanja farmakokinetičnih in kliničnih podatkov pri nosečnicah, uporaba lopinavirja/ritonavirja enkrat na dan ni priporočljiva.
English: Interactions between lopinavir/ritonavir and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, once daily as “QD”, twice daily as “BID” and three times daily as "TID").
Slovenian: V spodnji preglednici so navedena medsebojna delovanja med lopinavirjem/ritonavirjem in sočasno uporabljenimi zdravili (povečanje je označeno z "↑", zmanjšanje z "↓" in ni spremembe z "↔".
English: HDPE bottle with white opaque polypropylene screw cap with aluminium induction sealing liner wad and desiccant.
Slovenian: Je pakirano v HDPE vsebnik z belo poplipropilensko neprozorno navojno zaporko z aluminijastim indukcijskim pečatom in sušilnim sredstvom.
English: Patients should be informed that nausea has been reported during treatment with lopinavir/ritonavir (see section 4.8).
Slovenian: Bolnikom morate povedati, da so poročali o navzeji med zdravljenjem z lopinavirjem/ritonavirjem (glejte poglavje 4.8).
English: Thirty-nine patients (39%) discontinued the study, including 16 (16%) discontinuations due to adverse events, one of which was associated with a death.
Slovenian: Vsi bolniki so med 48. in 72. tednom prešli na odprto uporabo lopinavirja/ritonavirja v odmerku 400 mg/100 mg dvakrat na dan. Devetintrideset bolnikov (39 %) je prenehalo s študijo, vključno s 16 (16 %) prenehanji zaradi neželenih dogodkov, eden izmed teh je bil povezan s smrtjo.