FrancophonIA/ELRC3.0 huggingface dataset:
English: In women receiving darunavir/ritonavir 600/100 mg twice daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC12h and Cmin were 28%, 26% and 26% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC12h and Cmin values were 18%, 16% lower and 2% higher, respectively, as compared with postpartum.
Slovenian: Pri ženskah, ki so med drugim trimesečjem nosečnosti prejemale zdravili darunavir/ritonavir v odmerkih 600/100 mg dvakrat na dan, so bile med posameznicami povprečne vrednosti celokupnega darunavirja Cmax, AUC12h in Cmin za 28%, 26% oziroma 26% manjše kot v obdobju po porodu.
English: The weight-based dose regimen for PREZISTA and ritonavir is provided in the tables above.
Slovenian: Odmerek zdravil PREZISTA in ritonavirja glede na telesno maso je naveden v zgornjih preglednicah.
English: Concomitant use of everolimus and boosted PREZISTA is not recommended.
Slovenian: Sočasna uporaba everolimusa in okrepljenega zdravila PREZISTA ni priporočljiva.
English: Number of subjects with virologic failure a and genotype data that develop mutations b at endpoint, n/N
Slovenian: Število preiskovancev z virološkim neuspehom zdravljenja a in podatki o genotipu, ki omogoča razvoj mutacij b ob zaključku zdravljenja, n/N primarne (poglavitne)
English: How to store PREZISTA
Slovenian: Shranjevanje zdravila PREZISTA
English: After therapy with PREZISTA has been initiated, patients should be advised not to alter the dosage, dose form or discontinue therapy without discussing with their health care provider.
Slovenian: Bolnike je treba poučiti, da med zdravljenjem brez predhodnega posveta z zdravnikom ne smejo spreminjati odmerka, farmacevtske oblike ali prekiniti zdravljenja.
English: PREZISTA must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Slovenian: Zdravilo PREZISTA je treba vedno dajati peroralno skupaj z majhnim odmerkom ritonavirja kot zdravilno učinkovino za farmakokinetično okrepitev in v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Rare side effects (may affect up to 1 in 1,000 people) - a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver,
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - reakcija, ki jo imenujemo DRESS (hud izpuščaj, ki ga včasih spremlja zvišana telesna temperatura, utrujenost, otekanje obraza in bezgavk, zvečano število eozinofilcev (vrsta belih krvnih celic), učinki na jetra, ledvice ali pljuča) - srčni infarkt, počasno bitje srca, palpitacije (močno bitje srca) - motnje vida
English: PREZISTA 400 mg tablets contain sunset yellow FCF (E110) which may cause an allergic reaction.
Slovenian: Zdravilo PREZISTA 400 mg tablete vsebujejo barvilo sončno rumeno FCF (E110), ki lahko povzroči alergijsko reakcijo.
English: Amitriptyline Desipramine Imipramine Nortriptyline Trazodone paroxetine AUC ↓ 39% paroxetine Cmin ↓ 37% paroxetine Cmax ↓ 36% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔ sertraline AUC ↓ 49% sertraline Cmin ↓ 49% sertraline Cmax ↓ 44% darunavir AUC ↔ darunavir Cmin ↓ 6% darunavir Cmax ↔
Slovenian: ANTIDEPRESIVI paroksetin 20 mg enkrat na dan sertralin 50 mg enkrat na dan amitriptilin dezipramin imipramin nortiptilin trazodon paroxetin AUC ↓ 39% paroxetin Cmin ↓ 37% paroxetin Cmax ↓ 36% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔ sertralin AUC ↓ 49% sertralin Cmin ↓ 49% sertralin Cmax ↓ 44% darunavir AUC ↔ darunavir Cmin ↓ 6% darunavir Cmax ↔
English: PREZISTA co-administered with low dose ritonavir must not be used concomitantly with products containing St John's wort (Hypericum perforatum) (see section 4.3).
Slovenian: Med jemanjem zdravila PREZISTA z majhnim odmerkom ritonavirja se ne sme uporabljati pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum)(glejte poglavje 4.3).
English: Efficacy of PREZISTA 600 mg twice daily co-administered with 100 mg ritonavir twice daily in ART-experienced patients
Slovenian: Učinkovitost zdravila PREZISTA 600 mg dvakrat na dan skupaj s 100 mg ritonavirja dvakrat na dan, pri bolnikih, ki imajo izkušnje z ART
English: Light orange oval shaped tablet of 19.1 mm, debossed with “400MG” on one side and “TMC” on the other side.
Slovenian: Svetlo oranžna ovalna tableta, dolga 19,1 mm, z vtisnjeno oznako “400MG” na eni strani in “TMC” na drugi.
English: Human experience of acute overdose with PREZISTA co-administered with low dose ritonavir is limited.
Slovenian: Izkušnje z akutnim prevelikim odmerjanjem zdravila PREZISTA z majhnim odmerkom ritonavirja pri ljudeh so omejene.
English: PREZISTA co-administered with low dose ritonavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila PREZISTA skupaj z majhnim odmerkom ritonavirja in z amjodaronom, bepridilom, dronedaronom, ivabradinom, kinidinom ali ranolazinom je kontraindicirana (glejte poglavje 4.3).
English: (Rifabutin is an inducer and substrate of CYP3A.)
Slovenian: Rifabutin je induktor in substrat encimov CYP3A.
English: Monitoring of renal function may be indicated when boosted PREZISTA is given in combination with tenofovir disoproxil, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Slovenian: Kadar se okrepljeno zdravilo PREZISTA uporablja v kombinaciji z dizoproksiltenofoviratom, še posebej pri bolnikih s sistemsko ali ledvično boleznijo, ali pri bolnikih, ki jemljejo nefrotoksična zdravila, bo morda potrebno spremljanje ledvične funkcije.
English: Etravirine 100 mg twice daily etravirine AUC ↓ 37% etravirine Cmin ↓ 49% etravirine Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
Slovenian: etravirin 100 mg dvakrat na dan etravirin AUC ↓ 37% etravirin Cmin ↓ 49% etravirin Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
English: A dosage reduction of rifabutin by 75% of the usual dose of 300 mg/day (i.e. rifabutin 150 mg once every other day) and increased monitoring for rifabutin related adverse events is warranted in patients receiving the combination with PREZISTA co-administered with ritonavir.
Slovenian: Pri bolnikih, ki jemljejo kombinacijo zdravila PREZISTA in ritonavirja, je priporočljivo zmanjšanje običajnega odmerka 300 mg/dan rifabutina za 75% (to je 150 mg rifabutina enkrat vsak drugi dan) in povečano spremljanje z rifabutinom povezanih neželenih učinkov.
English: Concomitant use of colchicine and darunavir co-administered with low dose ritonavir may increase the exposure to colchicine.
Slovenian: Pri sočasni uporabi kolhicina in darunavirja skupaj z majhnim odmerkom ritonavirja, se lahko zveča izpostavljenost kolhicinu.
English: Co-administration of boosted PREZISTA and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba okrepljenega zdravila PREZISTA z amjodaronom, bepridilom, dronedaronom, ivabradinom, kinidinom ali ranolazinom je kontraindicirana (glejte poglavje 4.3).
English: 120 tablets in a plastic bottle.
Slovenian: 120 tablet v plastičnem vsebniku.
English: For additional clinical study results in ART-experienced adults and paediatric patients, refer to the Summary of Product Characteristics for PREZISTA 75 mg, 150 mg, 300 mg or 600 mg tablets and 100 mg/ml oral suspension.
Slovenian: Za dodatne rezultate kliničnih študij pri bolnikih z izkušnjami z ART, glejte Povzetke glavnih značilnosti zdravil PREZISTA 75 mg, 150 mg, 300 mg ali 600 mg tablete in PREZISTA 100 mg/ml peroralna suspenzija.
English: What PREZISTA looks like and contents of the pack Film-coated, white, caplet shaped tablet, mentioning TMC on one side, 75 on the other side.
Slovenian: Izgled zdravila PREZISTA in vsebina pakiranja Filmsko obložena, bela ovalna tableta z oznako TMC na eni strani in 75 na drugi.
English: Therefore, co-administration of boosted PREZISTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Slovenian: Zato je sočasna uporaba okrepljenega zdravila PREZISTA in sildenafila za zdravljenje pljučne arterijske hipertenzije kontraindicirana (glejte poglavje 4.3).
English: PREZISTA 800 mg film-coated tablets Each film-coated tablet contains 800 mg of darunavir (as ethanolate).
Slovenian: PREZISTA 800 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 800 mg darunavirja (v obliki etanolata).
English: PREZISTA 300 mg film-coated tablets 2 years
Slovenian: PREZISTA 300 mg filmsko obložene tablete 2 leti
English: Co-administration with the combination product lopinavir/ritonavir (see section 4.5).
Slovenian: Sočasno dajanje s kombinacijo zdravil lopinavir/ritonavir (glejte poglavje 4.5).
English: PREZISTA 75 mg film-coated tablets darunavir
Slovenian: PREZISTA 75 mg filmsko obložene tablete darunavir
English: PREZISTA co-administered with low dose ritonavir can be expected to increase the plasma concentrations of calcium channel blockers.
Slovenian: Pri sočasni uporabi z zdravilom PREZISTA skupaj z majhnim odmerkom ritonavirja lahko pričakujemo zvišanje plazemskih koncentracij zaviralcev kalcijevih kanalčkov.
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 15 kg) PREZISTA twice daily taken with ritonavir taken with food is usually recommended.
Slovenian: Pediatrični bolniki (stari 3 do 17 let in s telesno maso najmanj 15 kg), ki že imajo izkušnje z ART Običajno priporočeno odmerjanje je zdravilo PREZISTA dvakrat na dan, skupaj z ritonavirjem, s hrano.
English: Tenofovir alafenamide ↔ Tenofovir ↑
Slovenian: emtricitabin/alafenamidt enofovirat alafenamidtenofovirat↔ tenofovir
English: What PREZISTA looks like and contents of the pack Film-coated, orange, oval shaped tablet, mentioning TMC114 on one side, 300MG on the other side.
Slovenian: Izgled zdravila PREZISTA in vsebina pakiranja Filmsko obložena, oranžna ovalna tableta z oznako TMC114 na eni strani in 300MG na drugi.
English: In case a dose of PREZISTA and/or ritonavir is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible.
Slovenian: V primeru, da je bil odmerek zdravila PREZISTA in/ali ritonavirja izpuščen in je bilo to opaženo v 6 urah od časa, ko je ponavadi zaužit, je treba bolniku svetovati, naj čimprej vzame predpisani odmerek zdravila PREZISTA in ritonavirja s hrano.
English: PREZISTA/ritonavir 800/100 mg once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count < 100 cells x 10
Slovenian: Režima PREZISTA/ritonavir 800/100 mg enkrat na dan pri bolnikih, ki imajo izkušnje z ART ne smemo uporabljati pri bolnikih z eno ali več z rezistenco na darunavir povezanimi mutacijami (DRV-RAM) ali s koncentracijo HIV-1 RNK ≥ 100.000 kopij/ml ali s številom CD4+ celic < 100 celic x 10
English: The plastic bottle comes with a child resistant cap and must be opened as follows: - Push the plastic screw cap down while turning it counter clockwise.
Slovenian: Plastenka ima za otroke varno zaporko, ki jo odprete takole: Potisnite plastično navojno zaporko navzdol in jo pri tem obračajte v nasprotni smeri urinega kazalca.
English: The combination of avanafil and boosted PREZISTA is contraindicated (see section 4.3).
Slovenian: Kombinacija avanafila in okrepljenega zdravila PREZISTA je kontraindicirana (glejte poglavje 4.3).
English: PREZISTA must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Slovenian: Zdravilo PREZISTA se mora vedno uporabljati peroralno z majhnim odmerkom farmakokinetičnega ojačevalca ritonavirja, in v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 5.2).
English: PREZISTA 150 mg film-coated tablets Each film-coated tablet contains 150 mg of darunavir (as ethanolate).
Slovenian: PREZISTA 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg darunavirja (v obliki etanolata).
English: Lopinavir/ ritonavir 800/200 mg per day N=346
Slovenian: lopinavir/ ritonavir 800/200 mg /dan N=346
English: Concominant use of everolimus or irinotecan and PREZISTA co-administered with low dose ritonavir is not recommended.
Slovenian: Sočasna uporaba everolimusa ali irinotekana in zdravila PREZISTA skupaj z majhnim odmerkom ritonavirja ni priporočljiva.
English: Co-administration of darunavir and ritonavir with other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and ritonavir, which may result in increased plasma concentrations of darunavir and ritonavir.
Slovenian: Sočasna uporaba darunavirja in ritonavirja z drugimi zdravili, ki zavirajo CYP3A lahko zmanjša očistek darunavirja in ritonavirja ter povzroči zvišanje njunih plazemskih koncentracij.
English: In the 96 week analysis, the safety profile of PREZISTA/ritonavir 800/100 mg once daily in treatment-naïve subjects was similar to that seen with PREZISTA/ritonavir 600/100 mg twice daily in treatment-experienced subjects except for nausea which was observed more frequently in treatment-naïve subjects.
Slovenian: Pri analizi podatkov po 96 tednih zdravljenja je bila varnost zdravil PREZISTA/ritonavir 800/100 mg enkrat na dan pri bolnikih, ki še niso bili zdravljeni s protiretrovirusnimi zdravili, podobna, kot varnost zdravil PREZISTA/ ritonavir 600/100 mg dvakrat na dan pri bolnikih, ki so se že zdravili s protiretrovirusnimi zdravili.
English: • ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Slovenian: • z izkušnjami z ART, ki nimajo z rezistenco za darunavir povezanih mutacij (DRV-RAM) in imajo plazemsko koncentracijo HIV-1 RNK < 100.000 kopij/ml in število CD4+ celic ≥ 100
English: PREZISTA is used to treat HIV infected adults as well as HIV infected children of 3 years of age and above, and at least 15 kilogram body weight (see How to take PREZISTA).
Slovenian: Zdravilo PREZISTA uporabljamo za zdravljenje odraslih in otrok, starih 3 leta ali starejših, s telesno maso najmanj 15 kilogramov, ki so okuženi z virusom HIV (glejte Kako jemati zdravilo PREZISTA).
English: PREZISTA/ ritonavir 600/100 mg twice daily n=131
Slovenian: PREZISTA/ ritonavir 600/100 mg dvakrat na dan n=131
English: Combination of rifampicin with PREZISTA with concomitant low dose ritonavir (see section 4.5).
Slovenian: Kombinacija rifampicina in zdravila PREZISTA skupaj z majhnim odmerkom ritonavirja (glejte poglavje 4.5).
English: 450 mg PREZISTA/60 mg ritonavir twice daily
Slovenian: 450 mg PREZISTA/60 mg ritonavir dvakrat na dan
English: ≥ 30 kg to < 40 kg 675 mg (6.8 ml)
Slovenian: ≥ 30 kg do < 40 kg 675 mg (6,8 ml) PREZISTA/100 mg (1,2 ml)
English: This cannot be administered with these 300 milligram tablets.
Slovenian: Ta odmerek se ne da doseči s 300-miligramskimi tabletami.
English: Hence, concomitant use of boosted PREZISTA and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Slovenian: Zato je sočasna uporaba okrepljenega zdravila PREZISTA in kombinacije zdravil lopinavir/ritonavirj kontraindicirana (glejte poglavje 4.3).
English: 800 mg (8 ml) PREZISTA/100 mg (1.2 ml) ritonavir once daily
Slovenian: 800 mg (8 ml) PREZISTA/100 mg (1,2 ml) ritonavir enkrat na dan
English: Therefore, co-administration of PREZISTA with low dose ritonavir and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Slovenian: Zato je sočasna uporaba zdravila PREZISTA skupaj z majhnim odmerkom ritonavirja in sildenafilom za zdravljenje pljučne arterijske hipertenzije kontraindicirana (glejte poglavje 4.3).
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA.
Slovenian: Pri uporabi zdravil PREZISTA se je pojavil hepatitis, povezan z zdravilom (akutni hepatitis, citolitični hepatitis).
English: PREZISTA, co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).
Slovenian: Zdravilo PREZISTA je v kombinaciji s kobicistatom in z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih bolnikov, okuženih z virusom humane imunske pomanjkljivosti (HIV-1) (glejte poglavje 4.2).
English: Darunavir is approximately 95% bound to plasma protein.
Slovenian: Darunavir je v približno 95% vezan na plazemske beljakovine, predvsem na plazemski α1-kisli glikoprotein.
English: PREZISTA/ ritonavir 800/100 mg once daily N=343
Slovenian: PREZISTA/ ritonavir 800/100 mg enkrat na dan N=343
English: PREZISTA must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Slovenian: Zdravilo PREZISTA je treba vedno dajati peroralno skupaj s kobicistatom ali z majhnim odmerkom ritonavirja kot zdravilnima učinkovinama za farmakokinetično okrepitev in v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA used in combination with cobicistat or low dose ritonavir and patients should be monitored during treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom PREZISTA v kombinaciji s kobicistatom ali z majhnim odmerkom ritonavirja je treba opraviti ustrezne laboratorijske teste in spremljati bolnika med zdravljenjem.
English: PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).
Slovenian: Zdravilo PREZISTA je v kombinaciji z majhnim odmerkom ritonavirja in z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje bolnikov okuženih z virusom humane imunske pomanjkljivosti (HIV-1) (glejte poglavje 4.2).
English: - Take your other HIV medicines used in combination with PREZISTA and ritonavir as recommended by your doctor.
Slovenian: - Po navodilih zdravnika, vzemite tudi ostala zdravila proti HIV, ki jih uporabljate v kombinaciji z zdraviloma PREZISTA in ritonavir.
English: Adverse reactions are listed by system organ class (SOC) and frequency category.
Slovenian: Povzetek neželenih učinkov zdravila v preglednici Neželeni učinki so navedeni spodaj po organskih sistemih (OS) in po kategoriji pogostnosti.
English: HIV-1 RNA < 50 copies/ml All patients
Slovenian: HIV-1 RNK < 50 kopij/ml vsi bolniki z začetno HIV-RNK
English: What PREZISTA looks like and contents of the pack Film-coated, white, oval shaped tablet, mentioning TMC on one side, 150 on the other side.
Slovenian: Izgled zdravila PREZISTA in vsebina pakiranja Filmsko obložena, bela ovalna tableta z oznako TMC na eni strani in 150 na drugi.
English: Non-inferiority in virologic response to the PREZISTA/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Slovenian: Po 48 tednih zdravljenja z zdravilom PREZISTA/ritonavir so neinferiornost virološkega odziva (določena kot odstotek bolnikov s koncentracijo HIV-1 RNK v plazmi < 50 kopij/ml, pri v naprej določeni meji 12%), dokazali z analizo po 48. tednih tako za populacijo, ki je bila vključena v preskušanje (ITT - Intent-To-Treat), kot tudi za populacijo, ki je preskušanje zaključila, skladno s protokolom (OP - On Protocol).
English: Saquinavir: comparison of saquinavir/ritonavir 1,000/100 mg twice daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.
Slovenian: sakvinavir: primerjava jemanja učinkovin sakvinavir/ritonavir 1.000/100 mg dvakrat na dan s kombinacijo sakvinavir/darunavir/ritonavir 1.000/400/100 mg dvakrat na dan darunavir: primerjava jemanja učinkovin darunavir/ritonavir 400/100 mg dvakrat na dan s kombinacijo darunavir/ritonavir 400/100 mg in sakvinavir 1.000 mg dvakrat na dan
English: 800 mg PREZISTA/100 mg ritonavir once daily ritonavir oral solution: 80 mg/ml
Slovenian: 800 mg PREZISTA/100 mg ritonavir enkrat na dan peroralna raztopina ritonavirja: 80 mg/ml
English: Concomitant use of salmeterol and boosted darunavir may increase plasma concentrations of salmeterol.
Slovenian: Pri sočasni uporabi salmeterola in okrepljenega zdravila PREZISTA lahko pride do zvišanja plazemskih koncentracij salmeterola.
English: 600 mg PREZISTA/100 mg ritonavir twice daily ritonavir oral solution: 80 mg/ml
Slovenian: 600 mg PREZISTA/100 mg ritonavir dvakrat na dan peroralna raztopina ritonavirja: 80 mg/ml
English: 800 mg (8 ml) PREZISTA/100 mg (1.2 ml) ritonavir once daily ritonavir oral solution: 80 mg/ml rounded up for suspension dosing convenience
Slovenian: 800 mg (8 ml) PREZISTA/100 mg (1,2 ml) ritonavir enkrat na dan peroralna raztopina ritonavirja: 80 mg/ml zaokroženo zaradi lažjega prilagajanja odmerjanja suspenzije
English: Monitoring of renal function may be indicated when PREZISTA co-administered with low dose ritonavir is given in combination with tenofovir disoproxil, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Slovenian: Kadar se PREZISTA z majhnim odmerkom ritonavirja daje v kombinaciji z dizoproksiltenofoviratom, še posebej pri bolnikih s sistemsko ali ledvično boleznijo, ali pri bolnikih, ki jemljejo nefrotoksična zdravila, bo morda potrebno spremljanje ledvične funkcije.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, hypromellose.
Slovenian: - Pomožne snovi so mikrokristalna celuloza, koloidni brezvodni silicijev dioksid, krospovidon, magnezijev stearat, hipromeloza.
English: 60 tablets in a plastic bottle.
Slovenian: 60 tablet v plastičnem vsebniku.
English: The combination of rifapentine and PREZISTA with concomitant low dose ritonavir is not recommended.
Slovenian: Kombinacija rifapentina in zdravila PREZISTA skupaj z majhnim odmerkom ritonavirja ni priporočljiva.
English: PREZISTA/ritonavir, the PREZISTA/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4).
Slovenian: PREZISTA/ritonavir 600/100 mg dvakrat na dan (glejte poglavje 4.4).
English: 60 milligram (0.8 milliliter)
Slovenian: 460 miligramov (4,6 mililitra) 60 miligramov (0,8 mililitra)
English: The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172).
Slovenian: Filmska obloga tablete vsebuje polivinilalkohol (delno hidroliziran), makrogol 3350, titanov dioksid (E171), smukec, rdeči železov oksid (E172).
English: In women receiving darunavir/ritonavir 800/100 mg once daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 33%, 31% and 30% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 29%, 32% and 50% lower, respectively, as compared with postpartum.
Slovenian: Pri ženskah, ki so med drugim trimesečjem nosečnosti prejemale zdravili darunavir/ritonavir v odmerkih 800/100 mg enkrat na dan, so bile med posameznicami povprečne vrednosti celokupnega darunavirja Cmax, AUC24h in Cmin za 33%, 31% oziroma 30% manjše kot v obdobju po porodu.
English: When administered concomitantly with PREZISTA and low dose ritonavir, the patient's tolerability of bosentan should be monitored.
Slovenian: Ob sočasni uporabi z zdravilom PREZISTA in majhnim odmerkom ritonavirja je treba spremljati kako bolnik prenaša bosentan.