FrancophonIA/ELRC3.0 huggingface dataset:
English: Predicted difference of response rates (95% CI) for the week 48 analysis: 1.6% (-2.2%; 5.3%) and for the week 96 analysis: -0.4% (-4.6%; 3.8%); both p-value < 0.0001 (non-inferiority at 12% margin) from logistic regression model, including stratification factors and study.
Slovenian: tedna predvidena razlika med deleži bolnikov z odzivom (s 95% IZ) za analizo v 48. tednu: 1,6% (-2,2%; 5,3%) in za analizo v 96. tednu: -0,4% (-4,6%; 3,8%); obe vrednosti p < 0,0001 (ne-inferiornost z 12-odstotnim varnostnim robom), z uporabo modela logistične regresije s prilagajanjem na dejavnike za stratifikacijo in na študijo Virološki neuspeh zdravljenja v združeni analizi učinkovitosti: vključeni so preiskovanci, pri katerih se je bolezen poslabšala (potrjeno virusno breme ≥ 50 kopij/ml, po tem, ko so se že odzvali na zdravljenje) ali pri katerih ni prišlo do odziva na zdravljenje (virusno breme < 50 kopij/ml ni bilo potrjeno, in so bodisi nadaljevali ali prekinili zdravljenje zaradi premajhnega učinka ali izgube učinka).
English: No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women.
Slovenian: Spol Med moškimi in ženskami niso opažali klinično pomembnih razlik v farmakokinetiki rilpivirina.
English: From the week 96 pooled resistance analysis, the resistance outcome for patients with protocol defined virological failure, and paired genotypes (baseline and failure) is shown in table 5.
Slovenian: Rezultati združene analize testiranja odpornosti po 96 tednih pri virološko neuspešnih bolnikih (kot je bilo določeno v protokolu) in enakim genotipom (ob začetku zdravljenja in ob ugotovitvi neuspešnosti), so prikazani v preglednici 5.
English: ANTI-INFECTIVES Antiretrovirals HIV NRTIs/N[t]RTIs
Slovenian: ZDRAVILA ZA ZDRAVLJENJE OKUŽB Protiretrovirusna zdravila nukleozidni in nukleotidni zaviralci HIV reverzne transkriptaze (HIV NRTI/N[t]RTI) didanozin*
English: If you take an antacid (a medicine to treat diseases related to the acid in the stomach such as aluminium / magnesium hydroxide, calcium carbonate).
Slovenian: Če jemljete katerega od antacidov (zdravila, ki jih uporabljamo pri kislinsko pogojenih boleznih želodca, mednje sodijo na primer aluminijev/magnezijev hidroksid in kalcijev karbonat).
English: Rifapentine
Slovenian: rifapentin
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Slovenian: Rilpivirin deluje tako, da nekompetitivno zavira reverzno transkriptazo HIV-1.
English: At 96 weeks, the proportion of patients with < 50 HIV-1 RNA copies/ml receiving rilpivirine 25 mg (N=93) compared to patients receiving efavirenz (N=89) was 76% and 71%, respectively.
Slovenian: Po 96 tednih je bil v skupini bolnikov, ki so prejemali 25 mg rilpivirina (N=93), delež bolnikov z < 50 kopij RNK HIV-1/ml 76% v primerjavi z 71% bolnikov, ki so prejemali efavirenz (N=89).
English: Throughout co-administration of rilpivirine with rifabutin, the rilpivirine dose should be increased from 25 mg once daily to 50 mg once daily.
Slovenian: Ob sočasnem jemanju rilpivirina z rifabutinom je treba odmerek rilpivirina zvečati s 25 mg enkrat na dan na 50 mg enkrat na dan.
English: In the week 240 resistance analysis of the TMC278-C213 trial, rilpivirine resistance-associated mutations (RAMs) were observed in 46.7% (7/15) of subjects with virologic failure and post-baseline genotypic data.
Slovenian: Pri mladostnikih, ki še niso prejemali protiretrovirusnih zdravil V analizi rezistence po 240 tednih zdravljenja v študiji TMC278-C213 so pri 46,7% (7/15) preiskovancev z virološkim neuspehom zdravljenja in genotipskimi podatki po izhodišču, opazili mutacije povezane z rezistenco na rilpivirin (RAMs).
English: EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT (see section 4.5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifampicin, rifapentine - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole,
Slovenian: Zaradi indukcije encima CYP3A ali zvišanja vrednosti pH v želodcu lahko pride do znatnih znižanj koncentracij rilpivirina v plazmi, kar lahko zmanjša njegov terapevtski učinek (glejte poglavje 4.5), zato zdravila EDURANT ne smete uporabljati v kombinaciji z: - antikonvulzivi: karbamazepin, okskarbazepin, fenobarbital, fenitoin, - protimikobakterijskimi zdravili: rifampicin, rifapentin, - zaviralci protonske črpalke: omeprazol, esomeprazol, lansoprazol, pantoprazol in rabeprazol, - sistemsko danim glukokortikoidom deksametazonom (razen če gre za enkraten odmerek),
English: 50 mg single dose sildenafil AUC ↔ sildenafil Cmin NA sildenafil Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Slovenian: 50 mg enkraten odmerek sildenafil AUC ↔ sildenafil Cmin NS sildenafil Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: 300 mg once daily tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Slovenian: 300 mg enkrat na dan tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine.
Slovenian: Sočasna okužba z virusom hepatitisa B in/ali z virusom hepatitisa C Rezultati analize populacijske farmakokinetike kažejo, da sočasna okužba z virusom hepatitisa B in/ali C nima klinično pomembnega vpliva na izpostavljenost rilpivirinu.
English: 20 mg once daily omeprazole AUC ↓ 14% omeprazole Cmin NA omeprazole Cmax ↓ 14% rilpivirine AUC ↓ 40% rilpivirine Cmin ↓ 33% rilpivirine Cmax ↓ 40%
Slovenian: 20 mg enkrat na dan omeprazol AUC ↓ 14% omeprazol Cmin NS omeprazol Cmax ↓ 14% rilpivirin AUC ↓ 40% rilpivirin Cmin ↓ 33% rilpivirin Cmax ↓ 40%
English: ANTICOAGULANTS Dabigatran etexilate
Slovenian: ANTITROMBOTIKI dabigatran eteksilat
English: Similar efficacy for rilpivirine was seen in each trial demonstrating non-inferiority to efavirenz.
Slovenian: V obeh študijah je bila učinkovitost rilpivirina podobna, kot učinkovitost efavirenza, kar dokazuje, da rilpivirin ni slabši od efavirenza (dokazana je ne-inferiornost rilpivirina).
English: In the week 48 pooled resistance analysis from the Phase III trials, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
Slovenian: Pri analizi združenih podatkov o rezistenci po 48 tednih iz preskušanj faze III, so bili pri 62 bolnikih (od skupno 72) z virološkim neuspehom zdravljenja v skupini, ki je prejemala rilpivirin, podatki o odpornosti prisotni ob izhodišču in v času neuspeha zdravljenja.
English: In THRIVE, randomisation was stratified by screening viral load and by N(t)RTI BR.
Slovenian: V študiji THRIVE je bila randomizacija stratificirana po količini virusnega bremena na začetnem pregledu za izbor preiskovancev (screening) in po osnovni shemi zdravljenja z N(t)RTI.
English: 6 cells/l in patients receiving efavirenz.
Slovenian: 6 celic/l, v skupini z efavirenzom pa
English: Lopinavir/ritonavir (soft gel capsule)* 400/100 mg twice daily lopinavir AUC ↔ lopinavir Cmin ↓ 11% lopinavir Cmax ↔ rilpivirine AUC ↑ 52% rilpivirine Cmin ↑ 74% rilpivirine Cmax ↑ 29%
Slovenian: lopinavir/ritonavir (mehke želatinske kapsule)* 400/100 mg dvakrat na dan lopinavir AUC ↔ lopinavir Cmin ↓ 11% lopinavir Cmax ↔ rilpivirin AUC ↑ 52% rilpivirin Cmin ↑ 74% rilpivirin Cmax ↑ 29%
English: Didanosine*
Slovenian: famotidin*
English: rilpivirine AUC ↑ 49% rilpivirine Cmin ↑ 76% rilpivirine Cmax ↑ 30%
Slovenian: rilpivirin AUC ↑ 49% rilpivirin Cmin ↑ 76% rilpivirin Cmax ↑ 30%
English: ANTIDIABETICS Metformin* 850 mg single dose metformin AUC ↔ metformin Cmin NA metformin Cmax ↔
Slovenian: 850 mg enkratni odmerek metformin AUC ↔ metformin Cmin NS metformin Cmax ↔
English: At the recommended dose of 25 mg once daily, no dose adjustment is required when rilpivirine is co-administered with ketoconazole.
Slovenian: Pri sočasni uporabi priporočenega odmerka (25 mg enkrat na dan) rilpivirina s ketokonazolom prilagajanje odmerkov ni potrebno.
English: Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48/96.
Slovenian: na osnovi normalnega približka preiskovanci, pri katerih je prišlo do virološkega odziva (dvakrat zaporedoma izmerjeno virusno breme < 50 kopij/ml), ki se je ohranil do konca 48./96.
English: When rifabutin co-administration is stopped, the rilpivirine dose should be decreased to 25 mg once daily.
Slovenian: Po ukinitvi sočasnega jemanja rifabutina je treba odmerek rilpivirina zmanjšati na 25 mg enkrat na dan.
English: Hepatitis B and/or hepatitis C virus co-infection
Slovenian: 6 celic/l odstotek bolnikov s sočasno okužbo z virusom hepatitisa B/C
English: Co-administration of rilpivirine with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of EDURANT.
Slovenian: Pri sočasni uporabi rilpivirina z učinkovinami, ki povečajo vrednost pH v želodcu, lahko pride do zmanjšanja koncentracije rilpivirina v plazmi, kar lahko zmanjša terapevtski učinek zdravila EDURANT.
English: Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Slovenian: Zdravila EDURANT ne smete jemati skupaj z naslednjimi zdravili, ker le-ta lahko vplivajo na delovanje zdravila EDURANT ali drugih zdravil: - karbamazepin, okskarbazepin, fenobarbital, fenitoin (zdravila, ki jih uporabljamo pri epilepsiji in preprečujejo napade krčev), - rifampicin, rifapentin (zdravila za zdravljenje bakterijskih okužb kot je tuberkuloza), - omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (zaviralci protonske črpalke; zdravila za preprečevanje in zdravljenje želodčne razjede, zgage ali refluksa).
English: Rilpivirine-treated Resistance
Slovenian: Zdravljeni z rilpivirinom odpornost
English: If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the medicine with a meal as soon as possible and resume the normal dosing schedule.
Slovenian: Če se bolnik v 12 urah po času, ko običajno jemlje zdravilo, spomni, da je pozabil vzeti odmerek zdravila EDURANT, mora zdravilo vzeti s hrano čimprej, in nato nadaljevati z jemanjem zdravila po običajnem razporedu.
English: Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Slovenian: Nespremenjeni rilpivirin v blatu predstavlja povprečno 25% danega odmerka, v urinu pa so nespremenjeni rilpivirin našli le v sledovih (< 1% odmerka).
English: HIV PIs - without co-administration of low dose ritonavir Unboosted PIs (atazanavir, fosamprenavir, indinavir, nelfinavir)
Slovenian: medsebojnega delovanja niso preučevali zaviralci HIV proteaze (HIV PI) - brez sočasne uporabe nizkih odmerkov ritonavirja neokrepljeni zaviralci proteaze (atazanavir, fosamprenavir, indinavir, nelfinavir)
English: If you are taking any of the above, ask your doctor about alternatives.
Slovenian: Če jemljete katerokoli izmed naštetih zdravil, se z zdravnikom pogovorite o možnosti zamenjave zdravila.
English: The exposure to total rilpivirine after intake of rilpivirine 25 mg once daily as part of an antiretroviral regimen was lower during pregnancy (similar for the 2
Slovenian: Izpostavljenost celokupnemu rilpivirinu po vnosu 25 mg rilpivirina na dan, kot delu protiretrovirusnega zdravljenja, je bila manjša med nosečnostjo (podobno v drugem in tretjem trimesečju) kot v obdobju po porodu (glejte preglednico 7).
English: 400 mg once daily didanosine AUC ↑ 12% didanosine Cmin NA didanosine Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Slovenian: 400 mg enkrat na dan didanozin AUC ↑ 12% didanozin Cmin NS didanozin Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial TMC278-C213 (33 to 93 kg), similar to what was observed in adults.
Slovenian: Telesna masa pediatričnih bolnikov v preskušanju TMC278-C213 (33 do 93 kg) ni vplivala na farmakokinetiko rilpivirina.
English: nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3
Slovenian: Pri ženskah, ki so med drugim trimesečjem nosečnosti prejemale 25 mg rilpivirina na dan kot del protiretrovirusnega zdravljenja, so bile povprečne intraindividualne vrednosti Cmax, AUC24h in Cmin za celokupni rilpivirin za 21%, 29% in 35% manjše kot v obdobju po porodu.
English: Rilpivirine + BR N=686
Slovenian: zdravila po osnovni shemi n=686
English: Concomitant use of EDURANT with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine.
Slovenian: Pri sočasni uporabi zdravila EDURANT in azolnih antimikotikov lahko pride do zvišanja plazemskih koncentracij rilpivirina.
English: More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Slovenian: Do z lamivudin/emtricitabinom povezane odpornosti je prišlo pri večjem številu virološko neuspešnih bolnikov, ki so se zdravili z rilpivirinom, kot pri virološko neuspešnih bolnikih, ki so se zdravili z efavirenzom (glejte poglavje 5.1).
English: The evidence of efficacy of rilpivirine is based on the analyses of 96 week data from 2 randomised, double-blinded, active-controlled, Phase III trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE).
Slovenian: Odrasli bolniki, okuženi s HIV-1, ki predhodno niso prejemali protiretrovirusnih zdravil Dokazi za učinkovitost rilpivirina temeljijo na analizi podatkov po 96 tednih zdravljenja v dveh randomiziranih, dvojno slepih, aktivno nadzorovanih študijah faze III TMC278-C209 (ECHO) in TMC278-C215 (THRIVE).
English: However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Slovenian: Pri uvajanju sočasne uporabe metadona z rilpivirinom prilagajanje odmerkov ni potrebno, priporočeno pa je klinično spremljanje, saj je pri nekaterih bolnikih treba prilagoditi vzdrževalno zdravljenje z metadonom.
English: If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of EDURANT until the next regularly scheduled dose.
Slovenian: Če bolnik bruha več kot 4 ure po tem, ko je vzel zdravilo mu, pred naslednjim običajnim odmerkom, ni potrebno vzeti dodatnega odmerka zdravila EDURANT.
English: Non-response Virologic failure
Slovenian: Brez odziva na zdravljenje virološki neuspeh zdravljenja celokupno
English: Co-administration of rilpivirine and medicinal products that inhibit CYP3A has been observed to increase the plasma concentrations of rilpivirine.
Slovenian: Pri sočasni uporabi rilpivirina z učinkovinami, ki zavirajo CYP3A, so opazili zvečanje koncentracije rilpivirina v plazmi.
English: Cimetidine Nizatidine Ranitidine
Slovenian: cimetidin nizatidin ranitidin medsebojnega delovanja niso preučevali
English: In ECHO, the BR was fixed to the N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine.
Slovenian: V študiji ECHO je bila osnovna shema zdravljenja vezana na N(t)RTI tenofovir dizoproksil fumarat in emtricitabin.
English: Baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in the ECHO and THRIVE trials (pooled analysis)
Slovenian: Preglednica 3: Izhodiščni podatki o bolezni pri odraslih preiskovancih, okuženih s HIV-1 in ki predhodno niso prejemali protiretrovirusnih zdravil, v študijah ECHO in THRIVE (združena analiza)
English: Rifampicin* 600 mg once daily rifampicin AUC ↔ rifampicin Cmin NA rifampicin Cmax ↔ 25-desacetyl-rifampicin AUC ↓ 9% 25-desacetyl-rifampicin Cmin NA 25-desacetyl-rifampicin Cmax ↔ rilpivirine AUC ↓ 80% rilpivirine Cmin ↓ 89% rilpivirine Cmax ↓ 69%
Slovenian: rifampicin* 600 mg enkrat na dan rifampicin AUC ↔ rifampicin Cmin NS rifampicin Cmax ↔ 25-deacetil-rifampicin AUC ↓ 9% 25-deacetil-rifampicin Cmin ↔ NS 25-deacetil-rifampicin Cmax ↔ rilpivirin AUC ↓ 80% rilpivirin Cmin ↓ 89% rilpivirin Cmax ↓ 69%
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Slovenian: V analizi podatkov od 48. do 96. tedna je prišlo pri bolnikih, zdravljenih z rilpivirinom do 24 (3,5%) in pri bolnikih, zdravljenih z efavirenzom do 14 (2,1%) dodatnih viroloških odpovedi.
English: How to store EDURANT
Slovenian: Shranjevanje zdravila EDURANT
English: These rilpivirine resistance-associated mutations should only guide the use of EDURANT in the treatment-naïve population.
Slovenian: Te mutacije, povezane z odpornostjo na rilpivirin, so vodilo samo pri uporabi zdravila EDURANT pri populaciji, ki še ni prejemala protiretrovirusnih zdravil.
English: By baseline CD4 count (× 10
Slovenian: Glede na začetno št. celic CD4 (10
English: The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Slovenian: Pri bolnikih z ledvično insuficienco niso preučevali farmakokinetike rilpivirina.
English: Skin and subcutaneous tissue disorders common rash
Slovenian: Bolezni kože in podkožja pogosti izpuščaj
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: EDURANT must be taken with a meal to obtain optimal absorption.
Slovenian: Za optimalno absorpcijo je treba zdravilo EDURANT zaužiti skupaj z obrokom.
English: ANTIARRHYTHMICS Digoxin*
Slovenian: ANTIARITMIKI digoksin*
English: Didanosine should be administered at least two hours before or at least four hours after rilpivirine.
Slovenian: Didanozin je treba jemati najmanj dve uri pred odmerjanjem zdravila EDURANT oziroma najmanj štiri ure po odmerjanju rilpivirina.
English: Blood and lymphatic system disorders common decreased white blood cell count decreased haemoglobin decreased platelet count
Slovenian: Bolezni krvi in limfatičnega sistema pogosti zmanjšanje števila levkocitov, zmanjšanje koncentracije hemoglobina, zmanjšanje števila trombocitov
English: Common: - abnormal dreams - rash - stomach pain - depression - tiredness - vomiting - drowsiness - decreased appetite - sleep disorders - stomach discomfort - depressed mood - dry mouth
Slovenian: Pogosti: - nenormalne sanje - izpuščaj - bolečine v trebuhu - depresija
English: The BR consisted of 2 investigator-selected N(t)RTIs: zidovudine plus lamivudine or tenofovir disoproxil fumarate plus emtricitabine.
Slovenian: Osnovno shemo zdravljenja sta sestavljali dve zdravili N(t)RTI po izboru raziskovalca: zidovudin in lamivudin ali tenofovir dizoproksil fumarat in emtricitabin.
English: In the pooled analysis for ECHO and THRIVE, demographics and baseline characteristics were balanced between the rilpivirine arm and the efavirenz arm. Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms.
Slovenian: V združeni analizi študij ECHO in THRIVE so bili demografski podatki in izhodiščne karakteristike približno enako razporejeni v obeh skupinah bolnikov: pri tistih, ki so prejemali rilpivirin in pri tistih, ki so prejemali efavirenz.
English: ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.
Slovenian: V preglednici 2 so navedeni neželeni učinki o katerih so poročali pri odraslih bolnikih, zdravljenih z rilpivirinom.
English: H2-receptor antagonists should not be taken in a twice a day regimen.
Slovenian: Antagonistov histaminskih receptorjev H2 ne bi smeli odmerjati dvakrat na dan. Z zdravnikom se pogovorite o drugačnem razporedu odmerjanja.
English: Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
Slovenian: Pri uporabi 25 mg rilpivirina na dan, med nosečnostjo so opazili manjšo izpostavljenost rilpivirinu.
English: EDURANT has not been studied in patients with severe hepatic impairment (Child-Pugh score C).
Slovenian: Pri bolnikih s hudo okvaro jeter (Child-Pugh stopnje C) uporabe zdravila EDURANT niso preučevali.
English: In THRIVE, the BR consisted of 2 investigator-selected N(t)RTIs: tenofovir disoproxil fumarate plus emtricitabine or zidovudine plus lamivudine or abacavir plus lamivudine.
Slovenian: V študiji THRIVE sta osnovno shemo zdravljenja sestavljala dva N(t)RTI po izboru raziskovalca: tenofovir dizoproksil fumarat in emtricitabin ali zidovudin in lamivudin ali abakavir in lamivudin.
English: Famotidine* 40 mg single dose taken 2 hours before rilpivirine rilpivirine AUC ↓ 76% rilpivirine Cmin NA rilpivirine Cmax ↓ 85%
Slovenian: 40 mg v enkratnem odmerku 2 uri pred odmerjanjem rilpivirina rilpivirin AUC ↓ 76% rilpivirin Cmin NS rilpivirin Cmax ↓ 85%
English: Famotidine* 40 mg single dose taken 4 hours after rilpivirine rilpivirine AUC ↑ 13% rilpivirine Cmin NA rilpivirine Cmax ↑ 21%
Slovenian: 40 mg v enkratnem odmerku 4 ure po odmerjanju rilpivirina rilpivirin AUC ↑ 13% rilpivirin Cmin NS rilpivirin Cmax ↑ 21%
English: Interaction Geometric mean change (%)
Slovenian: Medsebojno delovanje Sprememba geometrijske sredine
English: Reproductive toxicology studies
Slovenian: Patološki laboratorijski izvidi
English: Dose dependent decreases in rilpivirine plasma concentrations are expected.
Slovenian: Pričakovano je od odmerka odvisno zmanjšanje plazemskih koncentracij rilpivirina.
English: If a patient misses a dose of EDURANT by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule.
Slovenian: V primeru, da se bolnik spomni na pozabljeni odmerek zdravila EDURANT več kot 12 ur po tem, ko bi ga moral vzeti, naj pozabljeni odmerek izpusti in nadaljuje z jemanjem zdravila po običajnem razporedu.
English: The trials were identical in design, with the exception of the background regimen (BR).
Slovenian: Študiji sta imeli enako zasnovo, razlikovali sta se le po shemi osnovnega zdravljenja.
English: Discontinued due to adverse event (AE)
Slovenian: prekinitev zdravljenja iz drugega razloga (ne zaradi neželenega učinka)¶
English: In the week 96 pooled resistance analysis of the Phase III trials (ECHO and THRIVE), 42 out of 86 subjects with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis).
Slovenian: Odrasli bolniki, okuženi s HIV-1, ki predhodno niso prejemali protiretrovirusnih zdravil Po podatkih analize združene rezistence po 96 tednih zdravljenja iz študij faze III (ECHO in THRIVE) se je pri 42 od 86 preiskovancev z virološkim neuspehom zdravljenja z rilpivirinom pokazala zaradi zdravljenja nastala rezistenca na rilpivirin (genotipska analiza).
English: Your doctor will advise on which HIV medicines can be combined with EDURANT and together you will decide which combination fits your needs best.
Slovenian: Zdravnik vam bo povedal, katera zdravila za okužbo s HIV je mogoče kombinirati z zdravilom EDURANT.