FrancophonIA/ELRC3.0 huggingface dataset:
English: The distribution of etravirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Slovenian: Pri človeku še niso ovrednotili porazdelitve etravirina v druge razdelke razen plazme (npr. v cerebrospinalno tekočino ali izločke genitalnega trakta).
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Slovenian: ANTIEPILEPTIKI karbamazepin fenobarbital fenitoin
English: Metabolism and nutrition disorders common diabetes mellitus, hyperglycaemia, hypercholesterolaemia, increased low density lipoprotein (LDL), hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia, anorexia
Slovenian: Presnovne in prehranske motnje pogosti sladkorna bolezen, hiperglikemija, hiperholesterolemija, zvečanje koncentracije lipoproteinov majhne gostote (LDL), hipertrigliceridemija, hiperlipidemija, dislipidemija, anoreksija
English: Do not take INTELENCE - if you are allergic to etravirine or any of the other ingredients of this medicine (listed in section 6) - if you are taking elbasvir/grazoprevir (a medicine to treat hepatitis C infection).
Slovenian: Ne jemljite zdravila INTELENCE - če ste alergični na etravirin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Remove the unscrewed cap.
Slovenian: Odvito zaporko snemite.
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for antiarrhythmics when co-administered with INTELENCE.
Slovenian: Pri sočasni uporabi antiaritmikov z zdravilom INTELENCE je potrebna previdnost, priporočljivo je spremljanje terapevtskih koncentracij antiaritmikov, če je na voljo.
English: Paediatric population (6 years to less than 18 years of age)
Slovenian: Pediatrična populacija (6 let do manj kot 18 let)
English: It is not recommended to co-administer tipranavir/ritonavir and INTELENCE (see section 4.4).
Slovenian: Sočasna uporaba kombinacije tipranavir/ritonavir in zdravila INTELENCE ni priporočljiva (glejte poglavje 4.4).
English: INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Slovenian: Zdravilo INTELENCE uvrščamo v skupino protiretrovirusnih zdravil, ki jo imenujemo nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
English: 400/100 mg twice daily lopinavir
Slovenian: 400/100 mg dvakrat na dan lopinavir
English: Based on the biliary elimination pathway of azithromycin, no drug interactions are expected between azithromycin and INTELENCE.
Slovenian: Glede na to, da se azitromicin izloča z žolčem, ni pričakovati medsebojnih delovanj med njim in zdravilom INTELENCE.
English: All ranges
Slovenian: Vsi razponi
English: Concomitant systemic use of itraconazole or ketoconazole and etravirine may increase plasma concentrations of etravirine.
Slovenian: Sočasna sistemska uporaba itrakonazola ali ketokonazola z etravirinom lahko zviša plazemske koncentracije etravirina.
English: Note: Imputations according to the TLOVR algorithm (TLOVR = Time to Loss of Virologic Response)
Slovenian: Opomba: Pripisane vrednosti po algoritmu TLOVR (TLOVR = čas do izginotja virološkega odziva)
English: As a precaution it is recommended that concomitant use of etravirine and clopidogrel should be discouraged.
Slovenian: Iz previdnosti se sočasna uporaba etravirina in klopidogrela ne priporoča.
English: Posaconazole, a potent inhibitor of CYP3A4, may increase plasma concentrations of etravirine.
Slovenian: Posakonazol, ki je močan zaviralec CYP3A4, lahko zviša plazemske koncentracije etravirina.
English: INTELENCE should only be used with dolutegravir when co-administered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.
Slovenian: Zdravilo INTELENCE se lahko uporablja z dolutegravirjem le sočasno s kombinacijami atazanavir/ritonavir, darunavir/ritonavir ali lopinavir/ritonavir.
English: Table 8: Population pharmacokinetic estimates for etravirine (all doses combined) in treatment-experienced HIV-1 infected paediatric patients 6 years to less than 18 years of age (PIANO 48 week analysis)
Slovenian: Preglednica 8: Populacijske farmakokinetične ocene etravirina (za vse odmerke) pri s HIV-1 okuženih pediatričnih bolnikih (starih od 6 let do manj kot 18 let), ki so se že zdravili s protiretrovirusnimi zdravili (analiza po 48 tednih preskušanja PIANO)
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Pri bolnikih, okuženih s HIV, ki imajo v času uvedbe CART hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali prikrite oportunistične okužbe in povzroči resna klinična stanja ali poslabšanje simptomov in znakov že znane oportunistične okužbe.
English: It is recommended that digoxin levels be monitored when digoxin is combined with INTELENCE.
Slovenian: Priporočljivo je, da pri kombiniranju z zdravilom INTELENCE spremljate koncentracije digoksina.
English: C0h (ng/ml)
Slovenian: Cmin, ng/ml
English: An increase in the incidences of hepatocellular adenomas and carcinomas were observed in female mice.
Slovenian: Pri samicah miši so opazili zvečanje pojavnosti hepatocelularnih adenomov in karcinomov.
English: Paediatric population (6 years to less than 18 years of age) The pharmacokinetics of etravirine in 101 treatment-experienced HIV-1 infected paediatric patients, 6 years to less than 18 years of age and weighing at least 16 kg, showed that the administered weight-based dosages resulted in etravirine exposure comparable to that in adults receiving etravirine 200 mg twice daily (see sections 4.2 and 5.2) when administered at a dose corresponding to 5.2 mg/kg twice daily.
Slovenian: Farmakokinetika etravirina je pri 101 s HIV-1 okuženem pediatričnem bolniku (starem od 6 let do manj kot 18 let in s telesno maso najmanj 16 kg) ki se je že zdravil s protiretrovirusnimi zdravili, pokazala da je bila izpostavljenost etravirinu pri odmerkih, odvisnih od telesne mase, ki so ustrezali 5,2 mg/kg dvakrat na dan, primerljiva kot pri odraslih, ki so prejemali etravirin 200 mg dvakrat na dan (glejte poglavji 4.2 in 5.2).
English: In the Phase III trials DUET-1 and DUET-2, mutations that developed most commonly in patients with virologic failure to the etravirine containing regimen were V108I, V179F, V179I, Y181C and Y181I, which usually emerged in a background of multiple other NNRTI resistance-associated mutations (RAMs).
Slovenian: V preskušanjih III. faze DUET-1 in DUET-2 so bile mutacije, ki so se najpogosteje razvile pri bolnikih, pri katerih je bila shema zdravljenja z etravirinom virološko neuspešna, naslednje: V108I, V179F, V179I, Y181C in Y181I in so se običajno pojavile ob več drugih osnovnih mutacijah, povezanih z odpornostjo na NNRTI (RAM - Resistance-Associated Mutation).
English: Cmax ↔ 0.91 (0.58-1.42) etravirine
Slovenian: Cmax ↔ 0,91 (0,58-1,42) etravirin
English: Etravirine exhibits activity against wild type HIV-1 in T-cell lines and primary cells with median EC50 values ranging from 0.9 to 5.5 nM. Etravirine demonstrates activity against HIV-1 group M (subtypes A, B, C, D, E, F, and G) and HIV-1 group O primary isolates with EC50 values ranging from 0.3 to 1.7 nM and from 11.5 to 21.7 nM, respectively.
Slovenian: Etravirin je pokazal delovanje tudi proti primarnim izolatom HIV-1 iz skupine M (podtipi A, B, C, D, E, F in G) z vrednostmi EC50 v razponu od 0,3 do 1,7 nM (nmol/l) ter primarnim izolatom HIV-1 iz skupine O z vrednostmi EC50 v razponu od 11,5 do 21,7 nM (nmol/l).
English: Not studied, but no interaction expected based on the renal elimination pathway of ribavirin.
Slovenian: Medsebojnih delovanj niso preučevali, vendar jih glede na to, da se ribavirin izloča preko ledvic, ni pričakovati.
English: Vascular disorders common hypertension rare haemorrhagic stroke
Slovenian: Žilne bolezni pogosti hipertenzija redki hemoragična možganska kap
English: The total etravirine exposure after intake of etravirine 200 mg twice daily as part of an antiretroviral regimen was generally higher during pregnancy compared with postpartum (see Table 9).
Slovenian: Po prejemu 200 mg etravirina dvakrat na dan kot dela protiretrovirusnega zdravljenja je bila celokupna izpostavljenost etravirinu na splošno večja med nosečnostjo kot po porodu (glejte preglednico 9).
English: The mean change in plasma HIV-1 RNA from baseline to week 48 was -1.53 log10 copies/ml, and the mean CD4 cell count increase from baseline was 156 x 10
Slovenian: Povprečna sprememba koncentracije plazemske HIV-1 RNK od začetka do 48. tedna je bila -1,53 log10 kopij/ml, povprečno število CD4 celic se je zvečalo za 156 x 10
English: The combination of oestrogen- and/or progesterone-based contraceptives and INTELENCE can be used without dose adjustment.
Slovenian: Kombinacijo estrogenskih in/ali progesteronskih kontraceptivov in zdravila INTELENCE lahko uporabljate brez prilagoditve odmerka.
English: Other NRTIs
Slovenian: Ostali NRTI
English: ANTIMALARIALS Artemether/ Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether
Slovenian: 6 odmerkov ob času 0, 8, 24, 36, 48, in 60 ur artemeter
English: 150/600/100 mg twice daily maraviroc
Slovenian: 150/600/100 mg dvakrat na dan maravirok
English: If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablet as soon as possible.
Slovenian: Če ste to opazili v roku 6 ur od časa, ko običajno jemljete zdravilo INTELENCE, morate tableto vzeti takoj, ko je mogoče.
English: Co-infection with HBV (hepatitis B virus) or HCV (hepatitis C virus) Caution should be exercised in patients co-infected with hepatitis B or C virus due to the current limited data available.
Slovenian: Sočasna okužba z virusom hepatitisa B (HBV) ali C (HCV) Pri bolnikih, ki so sočasno okuženi z virusom hepatitisa B ali C, je potrebna previdnost, ker so doslej na voljo le omejeni podatki in zvečanje tveganja za zvišanje vrednosti jetrnih encimov ni izključeno.
English: - Do not use warm (40°C and above) or carbonated beverages when taking INTELENCE tablet(s).
Slovenian: - Zdravila INTELENCE ne smete jemati s toplimi napitki (40 °C ali več) ali gaziranimi pijačami.
English: If a patient vomits within 4 hours of taking the medicine, another dose of INTELENCE should be taken following a meal as soon as possible.
Slovenian: Če bolnik bruha v roku 4 ur od zaužitja zdravila, naj vzame dodaten odmerek zdravila INTELENCE čimprej po jedi.
English: If the patient misses a dose of INTELENCE within 6 hours of the time it is usually taken, the patient should take it following a meal as soon as possible and then take the next dose at the regularly scheduled time.
Slovenian: Če bolnik ni vzel odmerka zdravila INTELENCE v roku 6 ur od časa, ko ga običajno jemlje, mora zdravilo vzeti čimprej po jedi, naslednji odmerek pa naj vzame ob običajnem času.
English: The DRESS syndrome is characterised by rash, fever, eosinophilia and systemic involvement (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and eosinophilia).
Slovenian: Za sindrom DRESS so značilni izpuščaj, zvišana telesna temperatura, eozinofilija in sistemski zapleti (vključuje, ni pa omejen na hud izpuščaj ali izpuščaj, ki ga spremljajo zvišana telesna temperatura, slabo počutje, izčrpanost, bolečine v sklepih ali mišicah, izpuščaj z mehurčki, razjede v ustih, konjunktivitis, hepatitis in eozinofilijo).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).
Slovenian: Poročajo, da se med imunsko reaktivacijo lahko pojavijo tudi avtoimunske bolezni (kot je Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.8).
English: 20 mg once daily paroxetine
Slovenian: 20 mg enkrat na dan paroksetin
English: Skin and subcutaneous tissue disorders very common rash common night sweats, dry skin, prurigo uncommon angioneurotic oedema a, swelling face, hyperhidrosis rare
Slovenian: Bolezni kože in podkožja zelo pogosti izpuščaj pogosti nočno potenje, suha koža, prurigo občasni angionevrotični edem a, otekanje obraza, hiperhidroza redki
English: Unchanged etravirine was not detected in urine.
Slovenian: V seču niso našli nespremenjenega etravirina.
English: Age at screening Treatment group
Slovenian: Preskušanje Starost ob vklučitvi v preskušanje Skupina
English: Co-administration with elbasvir/grazoprevir (see section 4.5).
Slovenian: Sočasna uporaba zdravila INTELENCE s kombinacijo elbasvir/grazoprevir (glejte poglavje 4.5).
English: Most frequently, rash was mild to moderate, occurred in the second week of therapy, and was infrequent after week 4.
Slovenian: Izpuščaj je bil najpogosteje blag do zmeren in se je pojavil v drugem tednu zdravljenja, po četrtem tednu zdravljenja pa se je pojavljal redko.
English: TMC125-C213 6 to < 12 years ETR N = 41
Slovenian: TMC125-C213 6 do < 12 let ETR N = 41
English: INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets
Slovenian: INTELENCE 25 mg tablete INTELENCE 100 mg tablete INTELENCE 200 mg tablete
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Slovenian: Pri nekaterih bolnikih z napredovalo okužbo s HIV, ki so imeli v preteklosti oportunistične (spremljajoče) okužbe, se lahko kmalu po uvedbi protiretrovirusnega zdravljenja pojavijo znaki in simptomi spremljajočih (oportunističnih) okužb.
English: In vitro data show that etravirine has inhibitory properties on CYP2C19.
Slovenian: In vitro podatki kažejo, da etravirin zavira delovanje CYP2C19.
English: Tell your doctor immediately if you are pregnant.
Slovenian: Če ste noseči, morate to nemudoma povedati svojemu zdravniku.
English: A subgroup analysis of the virologic response (defined as a viral load < 50 HIV-1 RNA copies/ml) at week 48 by baseline viral load and baseline CD4 count (pooled DUET data) is presented in table 4.
Slovenian: Izsledki analize virološkega odziva na zdravljenje (opredeljenega kot virusno breme < 50 HIV-1 RNK kopij/ml) pri podskupinah v 48. tednu na podlagi začetnega virusnega bremena in začetnega števila celic CD4 (združeni podatki iz obeh preskušanj DUET) so podani v preglednici 4.
English: IMMUNOSUPPRESSANTS Cyclosporin
Slovenian: IMUNOSUPRESIVI ciklosporin sirolimus takrolimus
English: Viral load < 400 copies/ml at week 24, n (%)
Slovenian: Virusno breme < 400 kopij/ml po 24. tednu, n (%)
English: The table is not all-inclusive.
Slovenian: Preglednica ne vsebuje vseh učinkovin.
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Slovenian: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi.
English: Study TMC114HIV3015 evaluated etravirine 200 mg twice daily in combination with other antiretroviral medicinal products in 15 pregnant women during the second and third trimesters of pregnancy and postpartum.
Slovenian: V študiji TMC114HIV3015 so pri 15 nosečnicah med drugim in tretjim trimesečjem nosečnosti in v obdobju po porodu ocenjevali uporabo 200 mg etravirina dvakrat na dan v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Table 7: Population pharmacokinetic estimates of etravirine 200 mg twice daily in HIV-1 infected adult subjects (integrated data from Phase III trials at week 48)*
Slovenian: Preglednica 7: Populacijske farmakokinetične ocene etravirina 200 mg dvakrat na dan pri s HIV-1 okuženih odraslih (združeni podatki iz preskušanj III. faze po 48. tednu)* parameter etravirin 200 mg dvakrat na dan N = 575
English: If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled time.
Slovenian: Če bolnik bruha po več kot 4 urah od takrat, ko je vzel zdravilo, mu ni treba vzeti dodatnega odmerka, dokler ni čas za naslednji redni odmerek.
English: Didanosine 400 mg once daily didanosine
Slovenian: 400 mg enkrat na dan didanozin
English: It is not recommended to co-administer INTELENCE with other NNRTIs.
Slovenian: Sočasna uporaba zdravila INTELENCE z drugimi NNRTI ni priporočljiva.
English: Respiratory, thoracic and mediastinal disorders common exertional dyspnoea uncommon bronchospasm
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja pri naporu občasni bronhospazem
English: The combination of INTELENCE with a boosted PI and rifabutin should be used with caution due to the risk of decrease in etravirine exposure and the risk of increase in rifabutin and 25-O-desacetyl-rifabutin exposures.
Slovenian: Pri sočasni uporabi zdravila INTELENCE z okrepljenim PI in rifabutinom je potrebna previdnost zaradi možnosti zmanjšanja izpostavljenosti etravirinu ter tveganja za povečanje izpostavljenosti rifabutinu in
English: Psychiatric disorders common anxiety, insomnia, sleep disorders uncommon confusional state, disorientation, nightmares,
Slovenian: Psihiatrične motnje pogosti tesnoba, nespečnost, motnje spanja občasni zmedenost, dezorientacija, nočne more, živčnost, nenormalne sanje
English: Concomitant use of etravirine with simeprevir may decrease plasma concentrations of simeprevir.
Slovenian: Sočasna uporaba etravirina in simeprevirja lahko zmanjša plazemske koncentracije simeprevirja.
English: Your doctor will have to check your blood - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections) - clarithromycin, rifabutin (antibiotics) - artemether/lumefantrine (a medicine to treat malaria) - diazepam (medicines to treat trouble with sleeping and/or anxiety) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) - boceprevir (a medicine to treat hepatitis C infection) - atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (cholesterol-lowering medicines) - cyclosporine, sirolimus, tacrolimus (immunosuppressants - medicines used to dampen down your immune system) - sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction and/or pulmonary arterial hypertension) - clopidogrel (a medicine to prevent blood clots).
Slovenian: Svojemu zdravniku morate povedati, če jemljete: - dolutegravir, maravirok, amprenavir/ritonavir in fosamprenavir/ritonavir (zdravila proti HIV) - amiodaron, bepridil, digoksin, dizopiramid, flekainid, lidokain, meksiletin, propafenon in kinidin (zdravila za zdravljenje določenih srčnih bolezni, npr. motenj srčnega ritma) - varfarin (zdravilo za zaviranje strjevanja krvi) - zdravnik bo moral opraviti ustrezne krvne preiskave - flukonazol, itrakonazol, ketokonazol, posakonazol, vorikonazol (zdravila za zdravljenje glivičnih okužb) - klaritromicin, rifabutin (antibiotika) - artemeter/lumefantrin (zdravilo proti malariji) - diazepam (zdravilo za zdravljenje težav s spanjem in/ali tesnobe) - deksametazon (kortikosteroid, ki ga uporabljamo pri različnih stanjih, na primer pri vnetnih in alergijskih reakcijah) - boceprevir (zdravilo za zdravljenje okužbe z virusom hepatitisa C) - atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (zdravila za zniževanje vrednosti holesterola) - ciklosporin, sirolimus, takrolimus (imunosupresivi - zdravila, ki zavirajo delovanje imunskega sistema) - sildenafil, vardenafil, tadalafil (zdravila za zdravljenje motenj erekcije in/ali pljučne arterijske hipertenzije) - klopidogrel (zdravilo za preprečevanje nastanka krvnih strdkov)
English: Immune system disorders common drug hypersensitivity uncommon immune reconstitution syndrome
Slovenian: Bolezni imunskega sistema pogosti preobčutljivost na zdravilo občasni sindrom imunske obnove
English: Viral load < 50 copies/ml at week 24, n (%)
Slovenian: Virusno breme < 50 kopij/ml po 24. tednu, n (%)
English: flatulence, constipation, mouth inflammation, dry mouth; - night sweats, itching, dry skin; - Change in some values of your blood cells or chemistry.
Slovenian: napenjanje, zaprtje, vnetje v ustih, suha usta - nočno potenje, srbenje, suha koža - spremembe števila celic ali biokemijskih vrednosti v krvi, ki jih je mogoče razbrati v izvidih preiskav krvi in urina.
English: Population pharmacokinetic analysis of etravirine in HIV infected patients indicated no apparent difference in the exposure to etravirine between Caucasian, Hispanic and Black subjects.
Slovenian: Analiza populacijske farmakokinetike etravirina pri bolnikih, okuženih s HIV, ni pokazala nikakršnih očitnih razlik glede stopnje izpostavljenosti etravirinu med belci, preiskovanci španskega izvora ali temnopoltimi, pri drugih rasah pa njegove farmakokinetike niso zadostno ovrednotili.
English: The median baseline plasma HIV-1 RNA was 3.9 log10 copies/ml, and the median baseline CD4 cell count was 385 x 10
Slovenian: Ob začetku je bila mediana vrednost HIV-1 RNK 3,9 log10 kopij/ml, mediano število CD4 celic je bilo 385 x 10
English: If you are taking any of these, ask your doctor for advice.
Slovenian: Če jemljete katero od teh zdravil, se posvetujte s svojim zdravnikom.
English: 150 mg twice daily etravirine
Slovenian: 150 mg dvakrat na dan etravirin
English: TMC125-C227 was an exploratory, randomised, active-controlled open-label trial, which investigated the efficacy and safety of etravirine in a treatment regimen, which is not approved under the current indication.
Slovenian: Raziskovalna primerjava posameznih parov bolnikov, zdravljenih z zaviralcem proteaze (PI) pri bolnikih, ki še niso prejemali PI (preskušanje TMC125-C227) Preskušanje TMC125-C227 je bilo raziskovalno, randomizirano odprto, z drugimi zdravili nadzorovano preskušanje, v katerem so raziskovali učinkovitost in varnost etravirina v terapevtski shemi, ki še ni odobrena za sedanjo indikacijo.
English: The trial population included PI-naïve, NNRTI-experienced patients with evidence of NNRTI resistance.
Slovenian: V populacijo bolnikov, zajeto v tem preskušanju, so vključili tiste bolnike, ki še niso prejemali PI, so se pa že zdravili z NNRTI in so imeli znake odpornosti na NNRTI.
English: No dose adjustment is needed for INTELENCE.
Slovenian: Prilagoditev odmerka zdravila INTELENCE ni potrebna.
English: Tipranavir/ritonavir 500/200 mg twice daily tipranavir
Slovenian: tipranavir/ritonavir 500/200 mg dvakrat na dan tipranavir
English: The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reactions cannot be excluded.
Slovenian: Klinični podatki so omejeni in ni mogoče izključiti povečanega tveganja za pojav kožnih reakcij pri bolnikih, ki imajo v anamnezi kožne reakcije, povezane z jemanjem nenukleozidnih zaviralcev reverzne transkriptaze (NNRTI - non-nucleoside reverse transcriptase inhibitor).
English: Co-administration of etravirine with medicinal products primarily metabolised by CYP3A4 may result in decreased plasma concentrations of such medicinal products, which could decrease or shorten their therapeutic effects.
Slovenian: Sočasna uporaba etravirina z zdravili, ki se presnavljajo predvsem preko CYP3A4, lahko povzroči zmanjšanje plazemske koncentracije teh zdravil, kar bi lahko vodilo do oslabitve ali krajšega trajanja njihovih terapevtskih učinkov.
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Slovenian: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).