FrancophonIA/ELRC3.0 huggingface dataset:
English: Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1.0 log10 versus baseline.
Slovenian: Virološki odziv je bil določen kot zmanjšanje kopij HIV-1 RNK v plazmi za najmanj 1,0 log10 glede na začetno vrednost.
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation 95% confidence intervals.
Slovenian: pripis zadnje izmerjene vrednosti (LOCF - Last Observation Carried Forward) 95 % intervali zaupanja
English: In the virologic failures of the ARTEMIS trial no cross-resistance with other PIs was observed.
Slovenian: V preskušanju ARTEMIS pri primerih virološkega neuspeha zdravljenja niso opažali navzkrižne odpornosti proti drugim zaviralcem proteaz.
English: The recommended dose of darunavir with low dose ritonavir for paediatric patients is based on body weight and should not exceed the recommended adult dose (600/100 mg twice daily or 800/100 mg once daily).
Slovenian: Priporočeni odmerek darunavirja skupaj z majhnim odmerkom ritonavirja je določen glede na telesno maso in ne sme preseči priporočenega odmerka za odrasle (600/100 mg dvakrat na dan ali 800/100 mg enkrat na dan).
English: Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
Slovenian: V obeh krakih preskušanja so uporabljali osnovni režim zdravljenja, ki je bil sestavljen iz 300 mg tenofovirdizoproksil fumarata enkrat na dan in 200 mg emtricitabina enkrat na dan.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Poročali so tudi o avtoimunskih boleznih (kot sta Gravesova bolezen in avtoimunski hepatitis), vendar je čas do njihovega nastanka različen in se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: Tell your doctor about your situation BEFORE and DURING your treatment Make sure that you check the following points and tell your doctor if any of these apply to you.
Slovenian: Prebrati morate naslednje točke in svojemu zdravniku povedati, če kaj od tega velja za vas.
English: in certain patients who have used antiretroviral medicines before (your doctor will determine this).
Slovenian: - Pri nekaterih bolnikih, ki so že prejemali protiretrovirusna zdravila (to bo določil zdravnik).
English: Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Slovenian: Darunavir in ritonavir sta zaviralca CYP3A, CYP2D6 in P-gp.
English: Study was conducted with tenofovir disoproxil fumarate 300 mg once daily.
Slovenian: Izvedena je bila študija s 300 mg dizoproksiltenofovirat fumarata enkrat na dan.
English: The child must take Darunavir Krka with food.
Slovenian: - Otrok mora zdravilo Darunavir Krka zaužiti s hrano.
English: (not applicable for darunavir coadministered with ritonavir)
Slovenian: (ne velja za uporabo darunavirja skupaj z ritonavirjem)
English: The safety and efficacy of darunavir have not been established in patients with severe underlying liver disorders and darunavir is therefore contraindicated in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s sočasno hudo okvaro jeter niso dokazali varnosti in učinkovitosti darunavirja, zato je darunavir pri bolnikih s hudo okvaro jeter kontraindiciran.
English: The exposure to cobicistat was lower during pregnancy, potentially leading to suboptimal boosting of darunavir.
Slovenian: Med nosečnostjo je bila izpostavljenost kobicistatu manjša, kar je lahko povzročilo zmanjšano okrepitev darunavirja.
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Slovenian: Darunavir je pokazal protivirusno delovanje in vitro proti širokemu razponu primarnih izolatov HIV-1 skupine M (A, B, C, D, E, F, G) in skupine O, z vrednostmi EC50 od < 0,1 do 4,3 nM.
English: Based upon the safety profile of darunavir/ritonavir, the increase in darunavir exposure in the presence of rifabutin does not warrant a dose adjustment for darunavir/ritonavir.
Slovenian: Glede na varnostni profil kombinacije zdravil darunavir/ritonavir, zvečanje izpostavljenosti darunavirju v prisotnosti ritonavirja ne zahteva zmanjšanja odmerka zdravil darunavir/ritonavir.
English: Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir (see sections 4.3, 4.4 and
Slovenian: Darunavir ima zato lahko različne kontraindikacije in priporočila za sočasno uporabo z drugimi zdravili, odvisno od tega, ali je okrepljen z ritonavirjem (glejte poglavja 4.3, 4.4 in 4.5).
English: If there is a need to combine darunavir/ritonavir and carbamazepine, patients should be monitored for potential carbamazepine-related adverse events.
Slovenian: Če je potrebna sočasna uporaba kombinacije darunavir/ritonavir in karbamazepina, je treba bolnike spremljati zaradi možnosti pojava neželenih učinkov, povezanih s karbamazepinom.
English: There is no specific antidote for overdose with darunavir.
Slovenian: Za preveliko odmerjanje darunavirja ni specifičnega antidota.
English: ≥ 15 kg to < 30 kg
Slovenian: ≥ 15 kg do < 30 kg
English: The intravenous clearance of darunavir alone (150 mg) and in the presence of low dose ritonavir was 32.8 l/h and 5.9 l/h, respectively.
Slovenian: Intravenski očistek samega darunavirja (150 mg) je bil 32,8 l/h, v prisotnosti ritonavirja v majhnem odmerku pa 5,9 l/h.
English: Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
Slovenian: Drugih učinkov na parjenje ali plodnost pri zdravljenju z darunavirjem v odmerkih do 1.000 mg/kg/dan in pri stopnjah izpostavljenosti (0,5kratnik AUC) pod vrednostmi pri klinično priporočenem odmerku za človeka ni bilo.
English: Darunavir is primarily metabolised by CYP3A.
Slovenian: Darunavir se presnavlja predvsem s CYP3A.
English: Limited data are available in patients with HIV-1 clades other than B (see section 5.1).
Slovenian: Podatkov o zdravljenju bolnikov z drugimi podtipi virusa HIV-1 (razen podtipa B) je malo (glejte poglavje 5.1).
English: Darunavir Krka is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.
Slovenian: Zdravilo Darunavir Krka uporabljamo za zdravljenje odraslih in otrok, starih 3 leta ali več in s telesno maso najmanj 15 kg, ki so okuženi z virusom HIV in so že prejemali druga protiretrovirusna zdravila.
English: HMG CO-A REDUCTASE INHIBITORS Lovastatin
Slovenian: ZAVIRALCI HMG-COA REDUKTAZE lovastatin simvastatin
English: Tell your doctor if you have haemophilia.
Slovenian: - Povejte svojemu zdravniku, če imate hemofilijo.
English: once daily N=294
Slovenian: enkrat na dan n = 294
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of darunavir/ritonavir.
Slovenian: Na podlagi ugotovitev bo v prisotnosti zdravil darunavir/ritonavir morda treba odmerke karbamazepina zmanjšati za 25 % do 50 %.
English: Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
Slovenian: Čeprav darunavirja niso proučevali pri bolnikih z okvaro ledvic, pa je populacijska analiza farmakokinetike pokazala, da farmakokinetika darunavirja ni pomembno spremenjena pri bolnikih z zmerno okvaro ledvic, okuženih s HIV (očistek kreatinina med 30-60 ml/min, n = 20) (glejte poglavji 4.2 in 4.4).
English: Concomitant treatment with any of the following medicinal products given the expected decrease in plasma concentrations of darunavir, ritonavir and cobicistat and the potential for loss of therapeutic effect (see sections 4.4 and 4.5).
Slovenian: Sočasno zdravljenje s katerim koli od naslednjih zdravil zaradi pričakovanega znižanja plazemskih koncentracij darunavirja, ritonavirja in kobicistata ter možne izgube terapevtskega učinka (glejte poglavji 4.4 in 4.5).
English: No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, darunavir should be used with caution in these patients.
Slovenian: Pri bolnikih z blago (razred A po Child-Pughovi lestvici) ali zmerno (razred B po Child-Pughovi lestvici) okvaro jeter ni potrebno prilagajati odmerka, vseeno pa je potrebna previdnost pri uporabi darunavirja pri teh bolnikih.
English: ≥ 30 kg to < 40 kg
Slovenian: ≥ 30 kg do < 40 kg
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response NC=F
Slovenian: pripisane vrednosti, izračunane z uporabo algoritma TLOVR na osnovi normalne aproksimacije razlike v % odziva neodzivni bolniki (NC (Non Completer) = F (Failure))
English: Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/ml).
Slovenian: Darunavir je pokazal učinkovitost proti laboratorijskim sevom in kliničnim izolatom HIV-1 ter proti laboratorijskim sevom HIV-2 v akutno okuženih celičnih linijah T celic, človeških mononuklearnih celicah iz periferne krvi in človeških monocitih/makrofagih z medianimi vrednostmi EC50 v razponu od 1,2 do 8,5 nM (0,7 do 5,0 ng/ml).
English: An OBR consisting of at least 2 NRTIs with or without enfuvirtide (ENF) was used in both trials.
Slovenian: V obeh preskušanjih so uporabljali OBR, ki je vključeval najmanj 2 NRTI, z ali brez enfuvirtida (ENF).
English: If a once daily dose of darunavir and/or ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible.
Slovenian: Če je bil enkrat dnevni odmerek darunavirja in/ali ritonavirja izpuščen in je bilo to opaženo v 12 urah od časa, ko je po navadi zaužit, je treba bolniku svetovati, naj čim prej vzame predpisani odmerek darunavirja in ritonavirja s hrano.
English: These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Slovenian: Ti lahko vključujejo rumenenje kože ali očesnih beločnic, temno obarvan (v barvi čaja) urin, svetlo blato (odvajanje blata), slabost, bruhanje, izgubo apetita ali bolečino oziroma bolečino in nelagodje na desni strani telesa, pod rebri.
English: Patients should be instructed to take darunavir with low dose ritonavir within 30 minutes after completion of a meal.
Slovenian: Bolnike je treba poučiti, da najkasneje v 30 minutah po obroku vzamejo darunavir skupaj z majhnim odmerkom ritonavirja.
English: TREATMENT FOR PREMATURE EJACULATION Dapoxetine
Slovenian: ZDRAVLJENJE PREZGODNJE EJAKULACIJE dapoksetin
English: Ethinylestradiol (3 mg/0.02 mg once daily)
Slovenian: ESTROGENSKI HORMONSKI KONTRACEPTIVI drospirenon etinilestradiol (3 mg/0,02 mg enkrat na dan)
English: Concentrations of these medicinal products may be increased when coadministered with boosted darunavir resulting in the potential for increased adverse events usually associated with these agents.
Slovenian: Koncentracije teh zdravil se lahko pri sočasnem dajanju z okrepljenim darunavirjem zvišajo, kar lahko zveča možnost za neželene učinke, ki se običajno pojavljajo pri uporabi teh zdravil.
English: Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).
Slovenian: Izvidi genotipskega in fenotipskega testiranja (če so na voljo) ter zgodovina zdravljenja morajo biti vodilo pri uporabi darunavirja (glejte poglavja 4.2, 4.4 in 5.1).
English: Didanosine is to be administered on an empty stomach, thus it should be administered 1 hour before or 2 hours after darunavir/ritonavir given with food.
Slovenian: Didanozin je treba jemati na tešče, zato ga je potrebno zaužiti 1 uro pred ali 2 uri po odmerjanju zdravil darunavir/ritonavir.
English: In patients taking Darunavir Krka and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Darunavir Krka skupaj z raltegravirjem (za zdravljenje okužbe z virusom HIV), se izpuščaji lahko pojavijo pogosteje (večinoma blagi do zmerni) kot pri bolnikih, ki teh dveh zdravil ne jemljejo skupaj.
English: Darunavir boosted with cobicistat is more sensitive for CYP3A induction: concomitant use of darunavir/cobicistat and strong CYP3A inducers is therefore contraindicated (see section 4.3),and concomitant use with weak to moderate CYP3A inducers is not recommended (see section 4.5).
Slovenian: - Darunavir, okrepljen s kobicistatom, je bolj občutljiv za indukcijo s CYP3A: sočasna uporaba učinkovin darunavir/kobicistat in močnih induktorjev CYP3A je kontraindicirana (glejte poglavje 4.3); sočasna uporaba s šibkimi ali zmernimi induktorji CYP3A ni priporočljiva (glejte poglavje 4.5).
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Slovenian: V kliničnem preskušanju zdravil darunavir/ritonavir (n = 3.063) se je hepatitis pojavil pri 0,5 % bolnikov, ki so prejemali kombinirano protiretrovitusno zdravljenje z zdraviloma darunavir/ritonavir.
English: Treatment with darunavir/cobicistat 800/150 mg once daily during pregnancy results in low darunavir exposure.
Slovenian: Zdravljenje s kombinacijo darunavir/kobicistat 800/150 mg enkrat na dan med nosečnostjo povzroča zmanjšanje izpostavljenosti darunavirju.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Slovenian: Podatki o sočasni uporabi parenteralnega midazolama in drugih zaviralcev proteaz kažejo na možnost 3- do 4-kratnega zvečanja plazemskih koncentracij midazolama.
English: The Darunavir Krka 400 or 800 milligram tablet is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Slovenian: Tablete zdravila Darunavir Krka po 400 ali 800 mg se ne smejo uporabljati pri otrocih, mlajših od 3 let ali s telesno maso manj kot 40 kg.
English: Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)
Slovenian: Odmerek za odrasle, ki še niste prejemali protiretrovirusnih zdravil (to bo določil zdravnik)
English: Darunavir Krka is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Slovenian: Zdravilo Darunavir Krka je protiretrovirusno zdravilo, ki se uporablja za zdravljenje okužbe z virusom imunske pomanjkljivosti pri človeku (HIV).
English: Fluconazole Isavuconazole Itraconazole Posaconazole
Slovenian: flukonazol izavukonazol itrakonazol posakonazol klotrimazol
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX Difference in means
Slovenian: b na osnovi normalne aproksimacije razlike v % odziva podtipi A1, D, F1, G, K, CRF02_AG, CRF12_BF in CRF06_CPX razlika povprečnih vrednosti pripis zadnje izmerjene vrednosti (LOCF - Last Observation Carried Forward)
English: Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
Slovenian: Darunavir Krka 600 mg tablete se lahko uporabljajo za zagotavljanje ustreznega odmerjanja (glejte poglavje 4.2): - za zdravljenje okužbe z virusom HIV-1 pri odraslih bolnikih, ki imajo izkušnje s protiretrovirusnim zdravljenjem (ART - antiretroviral therapy), vključno s tistimi, ki so prejeli že več različnih vrst zdravljenj.
English: The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
Slovenian: Vrsta hrane ne vpliva na izpostavljenost darunavirju (glejte poglavja 4.4, 4.5 in 5.2).
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 15% R(-) methadone Cmax ↓ 24% darunavir /cobicistat may, in contrast, increase methadone plasma concentrations (see cobicistat SmPC).
Slovenian: R(-) metadon AUC ↓ 16 % R(-) metadon Cmin ↓ 15 % R(-) metadon Cmax ↓ 24 % Ravno nasprotno je pri sočasni uporabi z zdraviloma darunavir/kobicistat pričakovati zvečanje plazemskih koncentracij metadona (glejte SmPC za kobicistat).
English: Darunavir was rapidly absorbed following oral administration.
Slovenian: Darunavir se je po peroralni uporabi hitro absorbiral.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (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 ob uvedbi CART hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali prikrite oportunistične okužbe in povzroči resna klinična stanja ali poslabšanje simptomov.
English: Pravastatin 40 mg single dose pravastatin AUC ↑ 81% pravastatin Cmin ND pravastatin Cmax ↑ 63%
Slovenian: pravastatin enkratni odmerek 40 mg pravastatin AUC ↑ 81 % pravastatin Cmin ND pravastatin Cmax ↑ 63 %
English: The table below shows the efficacy data of the 48 week analysis from the TITAN trial.
Slovenian: V preglednici so prikazani podatki analize učinkovitosti po 48 tednih iz preskušanja TITAN.
English: For use in these patients, more suitable formulations containing darunavir should be checked for their availability.
Slovenian: Za uporabo pri teh bolnikih so morda na voljo druge ustreznejše farmacevtske oblike z darunavirjem.
English: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Slovenian: - kortikosteroide, vključno z betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom, triamcinolonom.
English: The child must take the appropriate doses of Darunavir Krka and ritonavir two times per day or once a day.
Slovenian: - Predpisani odmerek zdravil Darunavir Krka in ritonavirja mora otrok zaužiti dvakrat na dan ali enkrat na dan.
English: The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, nausea, rash, headache and vomiting.
Slovenian: V kliničnih preskušanjih in spontanih poročilih so najpogosteje poročali o driski, navzei, izpuščaju, glavobolu in bruhanju.
English: Pharmacokinetic enhancer and concomitant medications Darunavir has different interaction profiles depending on whether the compound is boosted with ritonavir or cobicistat:
Slovenian: Farmakokinetični ojačevalec in sočasna zdravila Darunavir ima različen profil medsebojnega delovanja z drugimi zdravili, ki je odvisen od tega, ali je učinkovina okrepljena z ritonavirjem ali s kobicistatom:
English: In addition, patients on a stable dose of these antidepressants who start treatment with boosted darunavir should be monitored for antidepressant response.
Slovenian: Pri bolnikih na stabilnem odmerku teh antidepresivov, ki začenjajo zdravljenje z okrepljenim darunavirjem, je treba spremljati učinek zdravljenja z antidepresivom.
English: Therefore, darunavir must only be used in combination with a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Slovenian: Darunavir smete torej uporabljati samo v kombinaciji s farmakokinetičnim ojačevalcem (glejte poglavji 4.4 in 5.2).
English: * these adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
Slovenian: * v kliničnih preskušanjih darunavirja/kobicistata o teh neželenih učinkih niso poročali, vendar so jih opazili pri zdravljenju s kombinacijo darunavir/ritonavir in so pričakovani tudi pri uporabi kombinacije darunavir/kobicistat
English: Darunavir in combination with cobicistat or ritonavir has no or negligible influence on the ability to drive and use machines.
Slovenian: V kombinaciji s kobicistatom ali z ritonavirjem darunavir nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV infected patients.
Slovenian: Pri zdravljenju tuberkuloze pri bolnikih, okuženih s HIV, je treba je upoštevati uradne smernice.
English: As limited information is available on the use of darunavir in patients aged 65 and over, caution should be exercised in the administration of darunavir in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Slovenian: Ker so podatki o uporabi darunavirja pri bolnikih, starih 65 let ali več, omejeni, je pri teh bolnikih potrebna previdnost, saj je pri njih pogosteje prisotno zmanjšanje jetrne funkcije, imajo pogosteje še druge sočasne bolezni in pogosteje potrebujejo še druga zdravila (glejte poglavji 4.2 in 5.2).
English: These results were confirmed in the analyses of data at 96 weeks of treatment in the ARTEMIS trial.
Slovenian: Te rezultate je potrdila analiza podatkov po 96 tednih zdravljenja v preskušanju TITAN.
English: This should be taken into consideration if darunavir with cobicistat is administered to patients in whom the estimated creatinine clearance is used to adjust doses of co-administered medicinal products (see section 4.2 and cobicistat SmPC).
Slovenian: To je treba upoštevati, če se darunavir v kombinaciji s kobicistatom odmerja bolnikom, pri katerih se ocenjeni očistek kreatinina uporablja pri prilagajanju odmerjanja sočasno uporabljenih zdravil (glejte poglavje 4.2 in Povzetek glavnih značilnosti zdravila za kobicistat).
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Slovenian: Če bolnik šentjanževko že uporablja, je treba prekiniti njeno jemanje in, če je mogoče, preveriti virusno breme.
English: The table below shows the development of HIV-1 protease mutations and loss of susceptibility to PIs in virologic failures at endpoint in the ARTEMIS, ODIN and TITAN trials.
Slovenian: Spodnja preglednica prikazuje razvoj mutacij proteaze HIV-1 in zmanjšanje občutljivosti za zaviralce proteaz (PI - protease inhibitors) pri bolnikih z virološko odpovedjo v preskušanjih ARTEMIS, ODIN in TITAN.
English: (CYP3A and OATP1B inhibition)
Slovenian: (zaviranje CYP3A in OATP1B)
English: Caution should be used in pregnant women with concomitant medications which may further decrease darunavir exposure (see sections 4.5 and 5.2).
Slovenian: Pri nosečnicah, ki sočasno jemljejo zdravila, ki lahko dodatno zmanjšajo izpostavljenost darunavirju, je potrebna previdnost (glejte poglavji 4.5 in 5.2).
English: Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Slovenian: KORTIKOSTEROIDI Kortikosteroidi, ki se presnavljajo predvsem s CYP3A (vključno z betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom, triamcinolonom)
English: Pregnant or breast-feeding mothers should not take Darunavir Krka with ritonavir unless specifically directed by the doctor.
Slovenian: Med nosečnostjo in dojenjem ne smete jemati zdravila Darunavir Krka skupaj z ritonavirjem, razen če vam jemanje izrecno naroči vaš zdravnik.