FrancophonIA/ELRC3.0 huggingface dataset:
English: The weight-based dose of darunavir and ritonavir in paediatric patients is provided in the table below.
Slovenian: Odmerek darunavirja in ritonavirja glede na telesno maso pri pediatričnih bolnikih je naveden v spodnji preglednici.
English: ≥ 30 kg to < 40 kg
Slovenian:  30 kg do < 40 kg
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 kar 30 % manjša kot pri jemanju s hrano, zato je treba tablete darunavirja jemati z ritonavirjem in s hrano.
English: Boosted darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole or fluconazole may increase darunavir concentrations.
Slovenian: Okrepljeni darunavir lahko zveča plazemske koncentracije antimikotikov in posakonazol, izavukonazol, itrakonazol ali flukonazol lahko zvečajo koncentracije darunavirja.
English: zoldipem (sedative agents) - Perphenazine, risperidone, thioridazine (to treat psychiatric conditions) - Metformin (to treat type 2 diabetes).
Slovenian: - perfenazin, risperidon, tioridazin (za zdravljenje psihiatričnih stanj) - metformin (za zdravljenje sladkorne bolezni tipa 2).
English: Cobicistat 150 mg given with darunavir 800 mg once daily enhances darunavir pharmacokinetic parameters in a comparable way to ritonavir (see section 5.2).
Slovenian: Pri uporabi 150 mg kobicistata z 800 mg darunavirja enkrat na dan je zvečanje farmakokinetičnih parametrov primerljivo z ritonavirjem (glejte poglavje 5.2).
English: Ritonavir inhibits CYP3A, thereby increasing the plasma concentrations of darunavir considerably.
Slovenian: Ritonavir zavira CYP3A in tako močno zveča plazemske koncentracije darunavirja.
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: During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with low dose ritonavir, a high frequency of liver reactions was seen with rifampicin.
Slovenian: Ko so manjšo izpostavljenost poskušali nadomestiti s zvečanjem odmerka drugih zaviralcev proteaz v kombinaciji z majhnim odmerkom ritonavirja, so poročali o večji pogostnosti jetrnih neželenih učinkov, povezanih z rifampicinom.
English: Due to a decrease in the exposure (AUC) of darunavir by 40%, appropriate doses of the combination have not been established.
Slovenian: Ustrezne koncentracije kombinacije niso bile ugotovljene, ker se je izpostavljenost (AUC) darunavirju zmanjšala za 40 %.
English: The recommended dose regimen is 800 mg once daily with cobicistat 150 mg once daily or ritonavir 100 mg once daily taken with food.
Slovenian: Priporočeni režim odmerjanja darunavirja je 800 mg enkrat na dan, skupaj s 150 mg kobicistata enkrat na dan ali s 100 mg ritonavirja enkrat na dan, s hrano.
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 in ritonavirja z zdravili, ki se presnavljajo predvsem s CYP2C8 (kot so paklitaksel, rosiglitazon, repaglinid), povzroči zmanjšanje sistemske izpostavljenosti tem zdravilom, kar lahko zmanjša ali skrajša njihov terapevtski učinek.
English: Co-administration with boosted darunavir may cause a large increase in the concentration of these medicines.
Slovenian: Sočasna uporaba z okrepljenim darunavirjem lahko povzroči veliko zvečanje koncentracij teh zdravil.
English: Darunavir Mylan 400 mg and 800 mg film-coated tablets contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Slovenian: Zdravili Darunavir Mylan 400 mg in 800 mg filmsko obložene tablete vsebujeta manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ''brez natrija''.
English: Darunavir boosted with cobicistat is more sensitive to CYP3A induction than ritonavir-boosted darunavir: co-administration of darunavir/cobicistat with medicinal products that are strong inducers of CYP3A (e.g. St John's wort, rifampicin, carbamazepine, phenobarbital, and phenytoin) is contraindicated (see section 4.3).
Slovenian: Darunavir, okrepljen s kobicistatom, je bolj občutljiv na indukcijo s CYP3A od darunavirja, okrepljenega z ritonavirjem: sočasna uporaba učinkovin darunavir/kobicistat z zdravili, ki so močni induktorji CYP3A (npr. šentjanževka, rifampicin, karbamazipin, fenobarbital in fenitoin), je kontraindicirana (glejte poglavje 4.3).
English: 300 mg once daily atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% #darunavir AUC ↔ darunavir Cmin ↔ #darunavir Cmax ↔
Slovenian: 300 mg enkrat na dan atazanavir AUC ↔ atazanavir Cmin ↑ 52 % atazanavir Cmax ↓ 11 % #darunavir AUC ↔ darunavir Cmin ↔ #darunavir Cmax ↔
English: Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
Slovenian: Zdravim prostovoljcem so dajali enkratne odmerke do 3.200 mg peroralne raztopine samega darunavirja in do 1.600 mg darunavirja v tabletah, v kombinaciji z ritonavirjem brez kakršnihkoli škodljivih simptomatičnih učinkov.
English: If parenteral midazolam is coadministered with boosted darunavir, it should be done in an intensive care unit (ICU) or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Slovenian: Če je treba okrepljeni darunavir uporabljati sočasno s parenteralno obliko midazolama, ju je treba odmerjati na oddelku intenzivne terapije ali v podobni enoti, kar zagotavlja skrbno spremljanje bolnika in ustrezno zdravljenje v primeru depresije dihanja in/ali dolgotrajne sedacije.
English: If concomitant use of darunavir co-administered with low dose ritonavir with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Slovenian: Če je indicirana sočasna uporaba darunavirja z majhnim odmerkom ritonavirja s sildenafilom, vardenafilom ali tadalafilom, je priporočljivo uporabiti sildenafil v enkratnem odmerku največ 25 mg v 48 urah, vardenafil v enkratnem odmerku največ 2,5 mg v 72 urah ali tadalafil v enkratnem odmerku največ 10 mg v 72 urah.
English: Rare acute renal failure, renal failure, nephrolithiasis, increased blood creatinine, proteinuria, bilirubinuria, dysuria, nocturia, pollakiuria decreased creatinine renal clearance
Slovenian: Bolezni sečil občasni akutna ledvična odpoved, ledvična odpoved, nefrolitiaza, povišan kreatinin v krvi, proteinurija, bilirubinurija, disurija, nikturija, polakisurija redki zmanjšan ledvični očistek kreatinina
English: Rare conjunctival hyperaemia, dry eye visual disturbance
Slovenian: Očesne bolezni občasni konjunktivalna hiperemija, suho oko redki motnje vida
English: The interaction profile of darunavir may differ depending on whether ritonavir or cobicistat is used as pharmacoenhancer.
Slovenian: Profil medsebojnega delovanja darunavirja je odvisen od tega ali je farmakokinetični ojačevalec ritonavir ali kobicistat.
English: Co-administration with boosted darunavir may lead to a substantial increase in exposure to dabigatran or ticagrelor.
Slovenian: Sočasna uporaba z okrepljenim darunavirjem lahko pomembno zveča izostavljenost dabigatranu ali tikagrelorju
English: Concomitant use of other PDE-5 inhibitors for the treatment of erectile dysfunction with darunavir co-administered with low dose ritonavir should be done with caution.
Slovenian: Pri sočasni uporabi zaviralcev PDE-5 (za zdravljenje motenj erekcije) z darunavirjem z majhnim odmerkom ritonavirja je potrebna previdnost.
English: Mylan Healthcare Sp. z o.o.
Slovenian: Mylan Sp. z o.o.
English: Common side effects (may affect up to 1 in 10 people) - vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence - headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - bruhanje, občutek siljenja na bruhanje, bolečina ali napetost v trebuhu, dispepsija, napenjanje - glavobol, utrujenost, omotica, zaspanost, odrevenelost, mravljinčenje ali bolečina v rokah ali nogah, izguba moči, nezmožnost zaspati.
English: OR - 600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing
Slovenian: ALI - 600 miligramov darunavirja (dve tableti po 300 miligramov darunavirja ali 1 tableta po
English: Darunavir co-administered with low dose ritonavir should not be used in combination with these medicines.
Slovenian: Darunavirja z majhnim odmerkom ritonavirja se ne sme uporabljati v kombinaciji s temi zdravili.
English: Darunavir Mylan 75 mg film-coated tablets Darunavir Mylan 150 mg film-coated tablets Darunavir Mylan 300 mg film-coated tablets Darunavir Mylan 600 mg film-coated tablets
Slovenian: Darunavir Mylan 75 mg filmsko obložene tablete Darunavir Mylan 150 mg filmsko obložene tablete Darunavir Mylan 300 mg filmsko obložene tablete Darunavir Mylan 600 mg filmsko obložene tablete
English: Medicinal products that affect darunavir/ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Slovenian: Zdravila, ki vplivajo na izpostavljenost darunavirju/ritonavirju Darunavir in ritonavir se presnavljata z encimom CYP3A.
English: Darunavir co-administered with low dose ritonavir must not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3).
Slovenian: Darunavirja z majhnim odmerkom ritonavirja ne smete sočasno uporabljati z zdravili, katerih očistek je močno odvisen od CYP3A in pri katerih je zvečana sistemska izpostavljenost povezana z resnimi in/ali življenjsko nevarnimi neželenimi učinki (majhna terapevtska širina) (glejte poglavje 4.3).
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 zmanjšajo plazemske koncentracije darunavirja in ritonavirja (npr. rifampicin, šentjanževka, lopinavir).
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Slovenian: Med kliničnim preskušanjem zdravila (n=2.613 preiskovancev, predhodno zdravljenih s protiretrovirusno terapijo, ki so se začeli zdraviti z darunavirjem/ritonavirjem 600 mg/100 mg dvakrat na dan) se je pri 51,3 % preiskovancev pojavil najmanj en neželen učinek.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction
Slovenian: ZAVIRALCI FOSFODIESTRAZE TIPA (PDE-5) Za zdravljenje motenj erekcije: avanafil sildenafil tadalafil vardenafil
English: Viruses isolated from patients on darunavir/ritonavir 600/100 mg twice daily experiencing virologic failure by rebound that were susceptible to tipranavir at baseline remained susceptible to tipranavir after treatment in the vast majority of cases.
Slovenian: Virusi, izolirani pri bolnikih, ki so prejemali darunavir/ritonavir 600 mg/100 mg dvakrat na dan, pri katerih je prišlo do virološke odpovedi in so bili na začetku preskušanj občutljivi za tipranavir, so v veliki večini primerov ostali občutljivi za tipranavir tudi po zdravljenju.
English: rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68%
Slovenian: rifabutin Cmax darunavir AUC ↑ 53 % darunavir Cmin ↑ 68 % darunavir Cmax ↑ 39 %
English: Darunavir Mylan contains the active substance darunavir.
Slovenian: Zdravilo Darunavir Mylan vsebuje učinkovino darunavir.
English: Darunavir/ritonavir
Slovenian: β s kombinacijo darunavir/ritonavir
English: In-use shelf life after first opening HDPE bottle: 100 days.
Slovenian: Rok uporabnosti po prvem odprtju HDPE plastenke: 100 dni.
English: In a multiple dose study with darunavir co-administered with ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n=8) and moderate (ChildPugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
Slovenian: Preskušanje večkratnega odmerjanja darunavirja z ritonavirjem (600 mg/100 mg dvakrat na dan), je pokazalo, da so bile celokupne plazemske koncentracije darunavirja pri posameznikih z blago (razred A po Child-Pughovi lestvici, n=8) in srednje hudo (razred B po Child-Pughovi lestvici, n=8) jetrno okvaro primerljive s tistimi pri zdravih posameznikih.
English: ≥ 15 kg to < 30 kg
Slovenian:  15 kg do < 30 kg
English: Do not take Darunavir Mylan
Slovenian: Ne jemljite zdravila Darunavir Mylan
English: Always take with cobicistat or ritonavir and food.
Slovenian: Zdravilo vedno jemljite s kobicistatom ali z ritonavirjem in hrano.
English: ● 21 ART-experienced HIV-1 infected paediatric patients aged from 3 to < 6 years and weighing 10 kg to < 20 kg (16 participants from 15 kg to < 20 kg) who received darunavir oral suspension with low dose ritonavir twice daily in combination with other antiretroviral agents.
Slovenian: • 21 s HIV-1 okuženih pediatričnih bolnikov, starih od 3 do < 6 let in s telesno maso 10 kg do < 20 kg (16 preiskovancev s telesno maso 15 kg do < 20 kg), predhodno zdravljenih z ART, ki so prejemali peroralno suspenzijo darunavirja skupaj z majhnim odmerkom ritonavirja dvakrat na dan in drugimi protiretrovirusnimi zdravili.
English: Digoxin 0.4 mg single dose digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin from probable inhibition of P-gp)
Slovenian: digoksin enkratni odmerek 0,4 mg digoksin AUC ↑ 61 % digoksin Cmin ND digoksin Cmax ↑ 29 % (↑ koncentracije digoksina verjetno zaradi izaviranja Pgp)
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-1 okuženih pediatričnih bolnikov, predhodno nezdravljenih z ART, starih od 12 do 17 let in s telesno maso najmanj 40 kg, ki so prejemali filmsko obložene tablete darunavirja skupaj z majhnim odmerkom ritonavirja enkrat na dan in z drugimi protiretrovirusnimi zdravili (glejte poglavje 5.1).
English: Therefore, protein displacement of medicinal products highly bound to α1-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: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/ml.
Slovenian: ODIN je randomizirano, odprto preskušanje faze III, v katerem so primerjali režim darunavirja/ritonavirja 800 mg/100 mg enkrat na dan z režimom darunavirja/ritonavirja 600 mg/100 mg dvakrat na dan pri s HIV-1 okuženih bolnikih, predhodno zdravljenih z ART, pri katerih ob uključitvi v preskušanje testi genotipa niso pokazali nobene z rezistenco na darunavir povezane mutacije (npr.: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) in so imeli plazemsko koncentracijo HIV-1 RNK > 1.000 kopij/ml.
English: The exposure to total darunavir and ritonavir after intake of darunavir/ritonavir 600/100 mg twice daily and darunavir/ritonavir 800/100 mg once daily as part of an antiretroviral regimen was generally lower during pregnancy compared with postpartum.
Slovenian: Izpostavljenost celokupnemu darunavirju in ritonavirju po vnosu kombinacije zdravil darunavir/ritonavir v odmerku 600 mg/100 mg dvakrat na dan ali 800 mg/100 mg enkrat na dan kot delu protiretrovirusnega zdravljenja je bila na splošno manjša med nosečnostjo kot po porodu.
English: Tell your doctor if you take: - Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Slovenian: Povejte svojemu zdravniku, če jemljete: - amlodipin, diltiazem, dizopiramid, karvedilol, felodipin, flekainid, lidokain, metoprolol, meksiletin, nifedipin, nikardipin, propafenon, timolol, verapamil (za bolezni srca), ker se lahko zvečajo terapevtski ali neželeni učinki teh zdravil.
English: HIV-1 infected patients who were eligible for this trial had a screening genotype showing no darunavir RAMs and plasma HIV-1 RNA ≥ 1,000 copies/ml.
Slovenian: Z virusom HIV-1 okuženi bolniki, ki so bili primerni za to študijo, so imeli v izbirnem (screening) postopku genotip brez mutacij, ki bi bile povezane z odpornostjo na darunavir, in koncentracijo HIV-1 RNA v plazmi ≥ 1000 kopij/ml.
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 darunavirja/ritonavirja (n=3.063) so se pri 0,4 % bolnikov pojavile hude kožne reakcije, ki jih je lahko spremljala zvišana telesna temperatura in/ali zvišane koncentracije transaminaz.
English: After a 400/100 mg
Slovenian: Izločanje Po 400 mg/100 mg odmerku s
English: Darunavir Mylan 75 mg film-coated tablets are available in blister packs containing 480 tablets and in plastic bottles containing 480 tablets.
Slovenian: Zdravilo Darunavir Mylan 75 mg filmsko obložene tablete je na voljo v pretisnih omotih s po 480 filmsko obloženimi tabletami in v plastenkah s po 480 filmsko obloženimi tabletami.
English: Darunavir 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: Darunavir uporabljamo za zdravljenje odraslih in otrok, starejših od 3 let, s telesno maso najmanj 15 kilogramov, ki so okuženi z virusom HIV in so že uporabljali druga protiretrovirusna zdravila.
English: If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using darunavir/ritonavir, interruption or discontinuation of treatment should be considered promptly.
Slovenian: Če pri bolnikih, ki se zdravijo z darunavirjem/ritonavirjem, opazite znake novih ali poslabšanje obstoječih motenj v delovanju jeter (vključno s klinično pomembnim zvišanjem koncentracije jetrnih encimov in/ali simptomi kot so utrujenost, anoreksija, navzea, zlatenica, temen urin, boleča jetra, hepatomegalija), je nemudoma treba razmisliti o prekinitvi ali ukinitvi zdravljenja.
English: Immune system disorders Uncommon immune reconstitution inflammatory syndrome, (drug) hypersensitivity
Slovenian: Bolezni imunskega sistema občasni vnetni sindrom obnove imunskega odgovora, preobčutljivost (na zdravilo)
English: EXP Once opened, use within 100 days
Slovenian: EXP Po odprtju porabiti v 100 dneh.
English: The rash is usually mild to moderate.
Slovenian: Izpuščaj je običajno v blagi do zmerno hudi obliki.
English: Treatment-experienced darunavir/cobicistat 800/150 mg once daily N=18 Number of subjects with virologic failurea and genotype data that develop mutationsb at endpoint, n/N
Slovenian: Predhodno zdravljeni z ART darunavir/kobicistat 800 mg/150 mg enkrat na dan N=18 Število preiskovancev z virološkim neuspehom zdravljenjaa in podatki o genotipu, ki omogoča razvoj mutacijb ob zaključku zdravljenja, n/N primarne (poglavitne)
English: One dose is between 15 and 30 kilograms
Slovenian: med 15 in 30 kilogrami
English: This dose must not exceed the recommended adult dose, which is 800 milligram darunavir together with 100 milligram ritonavir once a day.
Slovenian: Ta odmerek ne sme preseči priporočenega odmerka za odrasle, ki je 800 mg darunavirja skupaj s 100 miligrami ritonavirja, enkrat na dan.
English: HIV RNA < 50 copies/ml a
Slovenian: HIV RNK < 50 kopij/ml a
English: During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing darunavir/ritonavir + raltegravir compared to those containing darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir.
Slovenian: Med kliničnim razvojem raltegravirja pri bolnikih, predhodno zdravljenih s protiretrovirusnim zdravljenjem, se je izpuščaj, ne glede na vzrok, pojavljal pogosteje pri shemi odmerjanja darunavir/ritonavir skupaj z raltegravirjem, v primerjavi s shemo odmerjanja, ki je vsebovala samo darunavir/ritonavir ali samo raltegravir.
English: Darunavir cannot work properly without ritonavir.
Slovenian: Brez ritonavirja darunavir ne more pravilno delovati.
English: 150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
Slovenian: 150 mg dvakrat na dan maravirok AUC ↑ 305 % maravirok Cmin ND maravirok Cmax ↑ 129 % Koncentracije darunavirja in ritonavirja so bile primerljive s podatki iz starejših preskušanj.
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 zvečanja plazemskih koncentracij sildenafila ali tadalafila.
English: Adverse reactions observed with darunavir/ritonavir in clinical trials and post-marketing
Slovenian: Neželeni učinki darunavirja/ritonavirja opaženi v kliničnih študijah in v obdobju trženja zdravila
English: 6/l (see section 4.1) a regimen of 800 mg once daily with cobicistat 150 mg once daily or ritonavir 100 mg once daily taken with food may be used.
Slovenian: 6/l (glejte poglavje 4.1), lahko uporabljate odmerjanje 800 mg darunavirja na dan, skupaj s 150 mg kobicistata enkrat na dan ali s 100 mg ritonavirja enkrat na dan, s hrano.
English: HDPE bottle pack This medicinal product does not require any special storage conditions.
Slovenian: Steklenička HDPE Za shranjevanje zdravila niso potrebna posebna navodila.
English: Applicable to darunavir boosted with either ritonavir or cobicistat: - The combination product lopinavir/ritonavir (see section 4.5).
Slovenian: Darunavir okrepljen z ritonavirjem ali s kobicistatom: - Kombinacija zdravil lopinavir/ritonavir (glejte poglavje 4.5).
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking darunavir.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne upravljajte strojev in ne vozite avtomobila, če ste po jemanju darunavirja omotični.