FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevirapine 200 mg twice daily nevirapine AUC ↑ 27% nevirapine Cmin ↑ 47% nevirapine Cmax ↑ 18% darunavir: concentrations were consistent with historical data (↑ nevirapine from CYP3A inhibition)
Slovenian: nevirapin 200 mg dvakrat na dan nevirapin AUC ↑ 27 % nevirapin Cmin ↑ 47 % nevirapin Cmax ↑ 18 % koncentracije darunavirja so bile skladne s starejšimi podatki (↑ nevirapina zaradi zaviranja CYP3A)
English: A dose reduction of the co-administered drug may be needed in these cases.
Slovenian: V takšnih primerih bo morda treba zmanjšati odmerek sočasno uporabljenega zdravila.
English: - The other ingredients are cellulose, microcrystalline; crospovidone, hydroxypropylcellulose; silica, colloidal anhydrous; silicified microcrystalline cellulose (cellulose, microcrystalline; silica, colloidal anhydrous) and magnesium stearate (E470b) in the tablet core and poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) - only for 400 mg film-coated tablets and red iron oxide (E172) in film coating.
Slovenian: - Druge sestavine zdravilaso mikrokristalna celuloza, krospovidon, hidroksipropilceluloza, brezvodni koloidni silicijev dioksid, silicizirana mikrokristalna celuloza (mikrokristalna celuloza, brezvodni koloidni silicijev dioksid) in magnezijev stearat (E470b) v jedru tablete ter polivinilalkohol, makrogol, titanov dioksid (E171), smukec (E553b), rumeni železov oksid (E172) - samo v 400 mg filmsko obloženih tabletah, in rdeči železov oksid (E172) v filmski oblogi.
English: Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats, but not humans, to thyroid neoplasms.
Slovenian: Ponavljajoče aplikacije darunavirja pri podganah so povzročile indukcijo mikrosomskih jetrnih encimov in zvečano izločanje ščitničnih hormonov, zaradi česar je tveganje za pojav ščitničnih novotvorb pri podganah (ne pa tudi pri ljudeh) zvečano.
English: With baseline CD4+ cell count ≥
Slovenian: Z začetnim št. celic CD4+ ≥
English: The evidence of efficacy of darunavir co-administered with ritonavir (600/100 mg twice daily) in ART-experienced patients is based on the 96 weeks analysis of the Phase III trial TITAN in ARTexperienced lopinavir naïve patients, on the 48 week analysis of the Phase III trial ODIN in ARTexperienced patients with no DRV-RAMs, and on the analyses of 96 weeks data from the Phase IIb trials POWER 1 and 2 in ART-experienced patients with high level of PI resistance.
Slovenian: Učinkovitost 600 mg darunavirja dvakrat na dan skupaj s 100 mg ritonavirja dvakrat na dan pri bolnikih, ki imajo izkušnje z ART Dokazi o učinkovitosti darunavirja z ritonavirjem (600/100 mg dvakrat na dan) pri bolnikih z izkušnjami z ART temeljijo na analizi podatkov po 96 tednih zdravljenja v kliničnem preskušanju faze III (preskušanje TITAN) pri bolnikih z izkušnjami z ART, ki še niso prejemali lopinavirja, na analizi podatkov po 48 tednih preskušanja faze III (ODIN) pri bolnikih z izkušnjami z ART, ki nimajo mutacij, povezanih z odpornostjo proti darunavirju, ter na analizi podatkov po 96 tednih zdravljenja iz kliničnih preskušanj faze IIb (preskušanja POWER 1 in 2) pri bolnikih z izkušnjami z ART z visoko stopnjo odpornosti proti PI.
English: Although the effect on CYP2C8 has only been studied in vitro, co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C8 (such as paclitaxel, rosiglitazone, repaglinide) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Slovenian: Kljub temu da so učinke na CYP2C8 preskušali samo in vitro, lahko sočasna uporaba darunavirja, ritonavirja in zdravil, ki se presnavljajo predvsem s CYP2C8 (paklitaksel, rosiglitazon, repaglinid), povzroči zmanjšanje sistemske izpostavljenosti tem zdravilom, kar lahko zmanjša ali skrajša njihov terapevtski učinek.
English: The observed hepatocellular and thyroid tumours in rodents are considered to be of limited relevance to humans.
Slovenian: Ocenjujejo, da so hepatocelularne in ščitnične novotvorbe, ki so jih opazili pri glodalcih, za ljudi manjšega pomena.
English: Both arms used an optimised background regimen (OBR) of ≥ 2 NRTIs.
Slovenian: V obeh krakih preskušanja so uporabljali optimiziran osnovni režim zdravljenja (OBR) z ≥ 2 NRTI.
English: At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, with darunavir/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to darunavir/ritonavir 600/100 mg twice daily for both ITT and OP populations.
Slovenian: Po 48 tednih so dokazali, da je virološki odziv (določen kot odstotek bolnikov s plazemsko koncentracijo HIV-1 RNK < 50 kopij/ml) pri zdravljenju s kombinacijo darunavir/ritonavir 800/100 mg enkrat na dan neinferioren (pri vnaprej določeni 12 % meji neinferiornosti) v primerjavi z zdravljenjem s kombinacijo darunavir/ritonavir 600/100 mg dvakrat na dan tako pri ITT kot tudi pri OP populaciji bolnikov.
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir (e.g. rifampicin, St John's wort, lopinavir).
Slovenian: Pričakovano je, da zdravila, ki inducirajo aktivnost encima CYP3A, zvečajo očistek darunavirja in ritonavirja in posledično znižajo plazemske koncentracije darunavirja in ritonavirja (npr. rifampicin, šentjanževka, lopinavir).
English: Darunavir with low dose ritonavir may increase the exposure to grazoprevir.
Slovenian: Darunavir z majhnim odmerkom ritonavirja lahko zveča izpostavljenost grazoprevirju.
English: Tenofovir disoproxil 245 mg once daily tenofovir AUC ↑ 22% tenofovir Cmin ↑ 37% tenofovir Cmax ↑ 24% darunavir AUC ↑ 21% darunavir Cmin ↑ 24% darunavir Cmax ↑ 16% (↑ tenofovir from effect on MDR-1 transport in the renal tubules)
Slovenian: dizoproksiltenofovirat 245 mg enkrat na dan tenofovir AUC ↑ 22 % tenofovir Cmin ↑ 37 % tenofovir Cmax ↑ 24 % darunavir AUC ↑ 21 % darunavir Cmin ↑ 24 % darunavir Cmax ↑ 16 % (↑ tenofovirja zaradi učinka na MDR-1 transport v ledvičnih tubulih)
English: Darunavir Krka600 mg tablets can be used to construct the twice daily 600 mg regimen.
Slovenian: Darunavir Krka 600 mg tablete lahko uporabljate za režim odmerjanja 600 mg dvakrat na dan.
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with boosted darunavir has not been established.
Slovenian: Varnega in učinkovitega odmerka sildenafila (za zdravljenje pljučne arterijske hipertenzije) skupaj z okrepljenim darunavirjem niso ugotovili.
English: Immune reconstitution inflammatory syndrome
Slovenian: Vnetni sindrom imunske obnove
English: Cobicistat decreases the estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Slovenian: Kobicistat zavira tubularno sekrecijo kreatinina in s tem zmanjšuje ocenjeni očistek kreatinina.
English: The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis and pyrexia.
Slovenian: Najpogostejši resni neželeni učinki so akutna ledvična odpoved, miokardni infarkt, sindrom obnove imunskega odgovora, trombocitopenija, osteonekroza, driska, hepatitis in zvišana telesna temperatura.
English: 400 mg film-coated tablets:
Slovenian: 400 mg filmsko obložene tablete:
English: Rilpivirine 150 mg once daily rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
Slovenian: rilpivirin 150 mg enkrat na dan rilpivirin AUC ↑ 130 % rilpivirin Cmin ↑ 178 % rilpivirin Cmax ↑ 79 % darunavir AUC ↔ darunavir Cmin ↓ 11 % darunavir Cmax ↔
English: Darunavir and ritonavir are metabolised by CYP3A.
Slovenian: Darunavir in ritonavir se presnavljata s CYP3A.
English: When administered without food, the relative bioavailability of darunavir in the presence of low dose ritonavir is 30% lower as compared to intake with food.
Slovenian: Pri jemanju darunavirja (v prisotnosti ritonavirja v majhnem odmerku) brez hrane je njegova relativna biološka uporabnost za 30 % manjša kot pri jemanju s hrano, zato je treba tablete darunavirja jemati z ritonavirjem in s hrano.
English: Thyroid follicular cell adenomas were noted in male rats.
Slovenian: Pri samcih podgan so opazili ščitnične folikularne adenome.
English: Based on theoretical considerations boosted darunavir may increase the exposure to glecaprevir and pibrentasvir.
Slovenian: Glede na teoretična izhodišča je mogoče pričakovati, da lahko okrepljen darunavir zveča izpostavljenost glekaprevirju in pibrentasvirju.
English: Darunavir must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Slovenian: Darunavir je treba vedno dajati peroralno skupaj z majhnim odmerkom ritonavirja kot farmakokinetičnim ojačevalcem in v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Even if you feel better, do not stop taking Darunavir Krka or ritonavir without talking to your doctor.
Slovenian: Tudi če se počutite bolje, ne smete prenehati z jemanjem zdravila Darunavir Krka ali ritonavirja, ne da bi se posvetovali s svojim zdravnikom.
English: Silicified microcrystalline cellulose (Cellulose, microcrystalline; Silica, colloidal anhydrous) Magnesium stearate (E470b)
Slovenian: mikrokristalna celuloza krospovidon hidroksipropilceluloza brezvodni koloidni silicijev dioksid silicizirana mikrokristalna celuloza (mikrokristalna celuloza, brezvodni koloidni silicijev dioksid) magnezijev stearat (E470b)
English: Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Slovenian: - atorvastatin, pravastatin, rosuvastatin(za zmanjševanje vrednosti holesterola); lahko se zveča tveganje za poškodbo mišic.
English: What Darunavir Krka contains - The active substance is darunavir.
Slovenian: Kaj vsebuje zdravilo Darunavir Krka - Učinkovina je darunavir.
English: 800 mg film-coated tablets:
Slovenian: 800 mg filmsko obložene tablete:
English: In the rat, the combination of darunavir with ritonavir lead to a small increase in effect on RBC parameters, liver and thyroid and increased incidence of islet fibrosis in the pancreas (in male rats only) compared to treatment with darunavir alone.
Slovenian: Pri podganah je v primerjavi s samim darunavirjem, pri kombinaciji darunavirja z ritonavirjem prišlo do majhnega zvečanja učinkov na parametre eritrocitov, jeter in ščitnice ter zvečanja pojavnosti fibroze otočkov trebušne slinavke (samo pri samcih).
English: Amlodipine Diltiazem Felodipine Nicardipine Nifedipine Verapamil
Slovenian: ZAVIRALCIKALCIJEVIH KANALČKOV amlodipin diltiazem felodipin nikardipin nifedipin verapamil
English: b fold change in EC50 “Patients with no/non-naïve use of ENF” are patients who did not use ENF or who used ENF but not for the first time “Patients with naïve use of ENF” are patients who used ENF for the first time
Slovenian: Vsi bolniki Bolniki, ki še niso/niso prvič jemali ENF Bolniki, ki so prvič jemali ENF
English: The recommended dose regimen is 800 mg once daily with ritonavir 100 mg once daily taken with food.
Slovenian: Priporočeno odmerjanje je 800 mg enkrat na dan skupaj s 100 mg ritonavirja enkrat na dan, s hrano.
English: 400 mg once daily didanosine AUC ↓ 9% didanosine Cmin ND didanosine Cmax ↓ 16% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Slovenian: 400 mg enkrat na dan didanozin AUC ↓ 9 % didanozin Cmin ND didanozin Cmax ↓ 16 % darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: Darunavir Krka, 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 Darunavir Krka 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: (induction of CYP450 enzymes)
Slovenian: (indukcija encimov CYP450)
English: If this is noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Slovenian: Če je bilo to opaženo več kot 12 ur od časa, ko je odmerek po navadi zaužit, izpuščenega odmerka ne sme zaužiti in nadaljuje z naslednjim odmerkom po običajnem režimu odmerjanja.
English: ART-naïve paediatric patients (3 to 17 years of age and weighing at least 40 kg) The recommended dose regimen is 800 mg once daily with ritonavir 100 mg once daily taken with food.
Slovenian: Pediatrični bolniki, ki nimajo izkušenj z ART (stari 3 do 17 let in s telesno maso najmanj 40 kg) Priporočeno je odmerjanje 800 mg darunavirja enkrat na dan, skupaj s 100 mg ritonavirja enkrat na dan, s hrano.
English: This strength is not suitable for dosages below 600 mg.
Slovenian: Ta jakost ni primerna za odmerke, manjše od 600 mg. S tem zdravilom ni možno doseči vseh pediatričnih odmerkov.
English: 12 ART-naïve HIV-1 infected paediatric patients aged from 12 to 17 years and weighing at least 40 kg who received darunavir tablets with low dose ritonavir once daily in combination with other antiretroviral agents (see section 5.1).
Slovenian: - 12 s HIV-1okuženih pediatričnih bolnikov, ki nimajo izkušenj z ART,starih 12 do 17 let in s telesno maso najmanj 40 kg, ki so prejemali tablete darunavirja skupaj z majhnim odmerkom ritonavirja enkrat na dan in z drugimi protiretrovirusnimi zdravili (glejte poglavje 5.1).
English: If this is noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Slovenian: Če je bilo to opaženo več kot 6 ur od časa, ko je odmerek po navadi zaužit, izpuščenega odmerka ne sme zaužiti in nadaljuje z naslednjim odmerkom po običajnem režimu odmerjanja.
English: Darunavir/ritonavir may be considered as an alternative.
Slovenian: Kot alternativno zdravljenje se lahko uporabi kombinacija darunavir/ritonavir.
English: The recommendations for darunavir boosted with ritonavir are adequate also for darunavir boosted with cobicistat with regard to substrates of CYP3A4, CYP2D6, P-glycoprotein, OATP1B1 and OATP1B3 (see contraindications and recommendations presented in the section above).
Slovenian: Za substrate CYP3A4, CYP2D6, P-glikoprotein, OATP1B1 in OATP1B3 so priporočila enaka kot za darunavir, okrepljen z ritonavirjem (glejte kontraindikacije in priporočila, navedena v prejšnjih odstavkih).
English: Boceprevir 800 mg three times daily boceprevir AUC ↓ 32% boceprevir Cmin ↓ 35% boceprevir Cmax ↓ 25% darunavir AUC ↓ 44% darunavir Cmin ↓ 59% darunavir Cmax ↓ 36%
Slovenian: boceprevir 800 mg trikrat na dan boceprevir AUC ↓ 32 % boceprevir Cmin ↓ 35 % boceprevir Cmax ↓ 25 % darunavir AUC ↓ 44 % darunavir Cmin ↓ 59 % darunavir Cmax ↓ 36 %
English: No mother to child transmission occurred in the infants born to the 31 subjects who stayed on the antiretroviral treatment through delivery.
Slovenian: Pri nobenem novorojencu od 31 preiskovank, ki so prejemale protiretrovirusno zdravljenje vse do poroda, ni prišlo do prenosa z matere na otroka.
English: Dose-related increases in the incidences of hepatocellular adenomas and carcinomas were observed in males and females of both species.
Slovenian: Pri samcih in samicah obeh vrst so opazili od odmerka odvisno zvečanje pojavnosti hepatocelularnih adenomov in karcinomov.
English: This dose must not exceed the recommended adult dose, which is 600 milligram Darunavir Krka together with 100 milligram of ritonavir two times per day or 800 milligram Darunavir Krka together with 100 milligram ritonavir once a day.
Slovenian: Ta odmerek ne sme preseči priporočenega odmerka za odrasle, ki je 600 mg zdravila Darunavir Krka, skupaj s 100 mg ritonavirja, dvakrat na dan ali 800 mg zdravila Darunavir Krka, skupaj s 100 mg ritonavirja, enkrat na dan.
English: darunavir/ritonavir N=80
Slovenian: Izidi po 48. tednu darunavir/ritonavir n = 80
English: Blood and lymphatic system disorders uncommon thrombocytopenia, neutropenia, anaemia, leukopenia rare increased eosinophil count
Slovenian: Bolezni krvi in limfatičnega sistema občasni trombocitopenija, nevtropenija, anemija, levkopenija redki zvečano število eozinofilcev
English: Nucleo(s/t)ide reverse transcriptase inhibitors (NRTIs) Didanosine
Slovenian: Nukleozidni zaviralci reverzne transkriptaze (NRTI) didanozin
English: During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Slovenian: V kliničnem preskušanju zdravil darunavir/ritonavir (n = 3.063) se je pri 0,4 % bolnikov pojavil hud kožni izpuščaj, ki ga je lahko spremljala zvišana telesna temperatura in/ali zvišane koncentracije transaminaz.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of darunavir used in combination with cobicistat or low dose ritonavir treatment.
Slovenian: Pri bolnikih s kroničnim hepatitisom, cirozo in pri bolnikih, ki imajo pred zdravljenjem zvišane koncentracije transaminaz, je treba razmisliti o pogostejšem spremljanju koncentracij AST/ALT, kar še posebej velja v prvih mesecih zdravljenja z darunavirjem v kombinaciji s kobicistatom ali z majhnim odmerkom ritonavirja.
English: Darunavir Krka might increase the risk of bleeding.
Slovenian: Zdravilo Darunavir Krka lahko zveča tveganje za krvavitve.
English: Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Slovenian: V sklopu in vitro in in vivo testov (vključno s testom reverznih bakterijskih mutacij (Ames), testom kromosomskih aberacij v človeških limfocitih in in vivo mikronukleusnem testu pri miših) darunavir ni bil mutagen ali genotoksičen.
English: In the morning, take one 600 milligram Darunavir Krka tablet together with 100 milligram ritonavir.
Slovenian: - Zjutraj vzemite eno tableto zdravila Darunavir Krka po 600 mg skupaj s 100 mg ritonavirja.
English: Sedative/hypnotics are extensively metabolised by CYP3A.
Slovenian: Pomirjevala/uspavala se obsežno presnavljajo s CYP3A.
English: Darunavir Krka 600 mg film coated tablets must not be chewed or crushed.
Slovenian: Darunavir Krka 600 mg filmsko obložene tablete se ne smejo žvečiti ali drobiti.
English: Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child's doctor will determine this) The doctor will work out the right dose based on the weight of the child (see table below).
Slovenian: Odmerek za otroke, starejše od 3 let in s telesno maso najmanj 15 kilogramov, ki so že prejemali protiretrovirusna zdravila (to bo določil otrokov zdravnik) Zdravnik bo določil odmerek na osnovi otrokove telesne mase (glejte spodnjo preglednico).
English: The use of boosted darunavir and these anticoagulants is not recommended.
Slovenian: Sočasna uporaba okrepljenega darunavirja in navedenih antikoagulantov ni priporočljiva.
English: TLOVR non-VF censored algorithm based on HIV-1 RNA < 50 copies/ml, except for TITAN (HIV-1 RNA < 400 copies/ml) IAS-USA lists
Slovenian: PI darunavir amprenav ir atazanavi indinavir lopinavir sakvinavi tipranavir ne-VF (virologic failure) cenzuriran algoritem TLOVR (time to loss of virologic response), na osnovi HIV-1 RNK < 50 kopij/ml, razen za preskušanje TITAN (HIV-1 RNK < 400 kopij/ml) po seznamih IAS-USA (International AIDS Society-USA)
English: Darunavir Krka is not for use in children younger than 3 years of age or weighing less than 15 kilograms.
Slovenian: Zdravilo Darunavir Krka se ne sme uporabljati pri otrocih, mlajših od 3 let ali s telesno maso manj kot 15 kg.
English: OPIOID ANTAGONIST Naloxegol
Slovenian: ANTAGONISTI OPIOIDNIH RECEPTORJEV naloksegol
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Slovenian: Zato ne moremo izključiti izpodrivanja z drugimi zdravili, ki se z veliko afiniteto vežejo na alfa1-kisli glikoprotein (glejte poglavje 4.5).
English: Efavirenz in combination with darunavir /ritonavir 800/100 mg once daily may result in sub-optimal darunavir Cmin.
Slovenian: Pri uporabi kombinacije zdravil efavirenz in darunavir/ritonavir 800/100 mg enkrat na dan se Cmin darunavirja lahko zniža pod optimalno vrednost.
English: Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2).
Slovenian: Darunavir Krka 400 mg in 800 mg tablete se lahko uporabljajo za zagotavljanje ustreznega odmerjanja za zdravljenje okužbe z virusom HIV-1 pri odraslih in pediatričnih bolnikih, starih 3 leta in več in s telesno maso najmanj 40 kg:
English: Up to same dose levels, there was no teratogenicity with darunavir in rats and rabbits when treated alone nor in mice when treated in combination with ritonavir.
Slovenian: V enakih odmerkih darunavir ni povzročil teratogenih učinkov pri podganah in kuncih, ki so jim dajali samo darunavir, pa tudi ne pri miših, ki so jim darunavir dajali v kombinaciji z ritonavirjem.
English: Darunavir co-administered with cobicistat should not be used in combination with another antiretroviral agent that requires pharmacoenhancement by means of co-administration with an inhibitor of CYP3A4 (see section 4.5).
Slovenian: Kombinacija darunavirja s kobicistatom se ne sme uporabljati skupaj s protiretrovirusnimi učinkovinami, ki zahtevajo farmakokinetično okrepitev s sočasnim jemanjem zaviralca CYP3A4 (glejte poglavje 4.5).
English: darunavir/ritonavir N=12
Slovenian: Izidi po 48. tednu darunavir/ritonavir n = 12
English: Take your other HIV medicines used in combination with Darunavir Krka and ritonavir as recommended by your doctor.
Slovenian: - Po navodilih zdravnika vzemite tudi ostala zdravila proti HIV, ki jih uporabljate v kombinaciji z zdraviloma Darunavir Krka in ritonavir.
English: Skin and subcutaneous tissue disorders common rash (including macular, maculopapular, papular, erythematous and pruritic rash), pruritus uncommon angioedema, generalised rash, allergic dermatitis, urticaria, eczema, erythema, hyperhidrosis, night sweats, alopecia, acne, dry skin, nail pigmentation rare
Slovenian: Bolezni kože in podkožja pogosti izpuščaj (vključno z makuloznim makulopapuloznim, papuloznim, eritematoznim in pruritičnim izpuščajem), pruritus občasni angioedem, generaliziran izpuščaj, alergijski dermatitis, urtikarija, ekcem, eritem, hiperhidroza, nočno znojenje, alopecija, akne, suha koža, obarvanje nohtov redki
English: Concomitant use of sildenafil or tadalafil for the treatment of pulmonary arterial hypertension and boosted darunavir may increase plasma concentrations of sildenafil or tadalafil.
Slovenian: Pri sočasni uporabi sildenafila ali tadalafila (za zdravljenje pljučne arterijske hipertenzije) in okrepljenega darunavirja lahko pride do zvišanja plazemskih koncentracij sildenafila ali tadalafila.
English: Of the 44 patients taking ritonavir oral solution, 27 switched to the 100 mg capsule formulation and exceeded the weightbased ritonavir dose without changes in observed safety.
Slovenian: Od 44 bolnikov, ki so jemali peroralno raztopino ritonavirja, jih je 27 prešlo na jemanje 100 mg kapsul.
English: Ritonavir inhibits CYP3A, thereby increasing the plasma concentrations of darunavir considerably.
Slovenian: Ritonavir zavira CYP3A in tako močno zviša plazemske koncentracije darunavirja.