natgillin/translations-raw huggingface dataset:
Darunavir 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.
Darunavir, primijenjen istodobno s niskom dozom ritonavira, indiciran je u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje bolesnika koji su inficirani virusom humane imunodeficijencije (HIV-1).
HIV-1 RNA < 50 copies/ml a
HIV-1 RNK < 50 kopija/ml a
Renal impairment No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
U bolesnika s oštećenjem bubrega nije potrebna prilagodba doze (vidjeti dijelove 4.4 i 5.2).
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.
Istodobna primjena darunavir i ritonavira s drugim lijekovima koji inhibraju CYP3A može smanjiti klirens darunavira i ritonavira i tako dovesti do povišenja koncentracija darunavira i ritonavira u plazmi.
Carbamazepine 200 mg twice daily carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
Karbamazepin 200 mg dva puta na dan karbamazepin AUC ↑ 45% karbamazepin Cmin ↑ 54% karbamazepin Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
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 ↔
Amitriptilin Desipramin Imipramin Nortriptilin Trazodon paroksetin AUC ↓ 39% paroksetin Cmin ↓ 37% paroksetin Cmax ↓ 36% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔ sertralin AUC ↓ 49% sertralin Cmin ↓ 49% sertralin Cmax ↓ 44% darunavir AUC ↔ darunavir Cmin ↓ 6% darunavir Cmax ↔
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.
U žena koje su primale darunavir/ritonavir 600/100 mg dva puta na dan tijekom drugog tromjesečja trudnoće, srednje intra-individualne vrijednosti za ukupni darunavir Cmax, AUC12h u Cmin bile su 28%, 26% odnosno 26% niže, uspoređujući s postpartalnim razdobljem; tijekom trećeg tromjesečja trudnoće, ukupne vrijednosti za darunavir Cmax, AUC12h i Cmin bile su 18%, 16% niže, odnosno 2% više, uspoređujući s postpartalnim razdobljem.
However, dizziness has been reported in some patients during treatment with regimens containing darunavir co-administered with low dose ritonavir and should be borne in mind when considering a patient's ability to drive or operate machinery (see section 4.8).
Međutim, prijavljena je omaglica kod nekih bolesnika tijekom liječenja režimima koji su sadržavali darunavir primijenjen istodobno s niskom dozom ritonavira, što se mora imati na umu kada se procjenjuje bolesnikova sposobnost vožnje ili upravljanja strojevima (vidjeti dio
Blister carton 240 film-coated tablets 240 x 1 film-coated tablets
Kutija za blistere 240 filmom obloženih tableta 240 x 1 filmom obložena tableta
Concentrations of these medicinal products may be increased when co-administered with darunavir with low dose ritonavir resulting in the potential for increased adverse events usually associated with these agents.
Koncentracije tih lijekova mogu se povećati kada se primjenjuju istodobno s darunavirom s niskom dozom ritonavira rezultirajući potencijalom za povećanje nuspojava obično povezanih s tim lijekovima.
Clinical monitoring is recommended when coadministering darunavir with low dose ritonavir with these antidepressants and a dose adjustment of the antidepressant may be needed.
Preporučuje se kliničko praćenje kada se ti antidepresivi primjenjuju istodobno s darunavirom s niskom dozom ritonavira, a može biti potrebna prilagodba doze antidepresiva.
- Darunavir 75 milligram and 150 milligram tablets have been developed for use in children, but can also be used in adults in some cases.
- Tablete darunavira od 75 miligrama i 150 miligrama razvijene su za primjenu kod djece, ali ih u nekim slučajevima mogu uzimati i odrasli.
Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment.
Prije početka terapije darunavirom/ritonavirom, moraju se provesti odgovarajuća laboratorijska ispitivanja, te se bolesnike mora pratiti tijekom liječenja.
Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with boosted darunavir.
Preporučeno je kliničko praćenje terapijskih učinaka i nuspojava kada se ovi lijekovi primjenjuju istodobno s pojačanim darunavirom.
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.
Mora se s oprezom istodobno primjenjivati druge inhibitore PDE-5 za liječenje erektilne disfunkcije s darunavirom primijenjenim istodobno s niskom dozom ritonavira.
Boosted darunavir must not be used concomitantly with products containing St John's wort (Hypericum perforatum) (see section 4.3).
Pojačani darunavir ne smije se istodobno primjenjivati s proizvodima koji sadržavaju gospinu travu (Hypericum perforatum) (vidjeti dio 4.3).
Darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole, or fluconazole may increase darunavir concentrations.
Darunavir može povećati koncentracije antifungika u plazmi, a posakonazol, izavukonazol, itrakonazol ili flukonazol mogu povećati koncentracije darunavira. (CYP3A inhibicija i/ili P-gp inhibicija)
These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5)
Te djelatne tvari, primjerice uključuju: - alfuzozin - amiodaron, bepridil, dronedaron, ivabradin, kinidin, ranolazin - astemizol, terfenadin - kolhicin kada se primjenjuje kod bolesnika s oštećenjem bubrega i/ili jetre (vidjeti dio 4.5) - ergot derivate (npr. dihidroergotamin, ergometrin, ergotamin, metilergonovin) - elbasvir/grazoprevir - cisaprid - dapoksetin - domperidon - naloksegol - lurasidon, pimozid, kvetiapin, sertindol (vidjeti dio 4.5)
When administered concomitantly with darunavir and low dose ritonavir, the patient's tolerability of bosentan should be monitored.
Kada se bosentan daje istodobno s darunavirom primijenjenim istodobno s niskom dozom ritonavira, mora se pratiti bolesnikova podnošljivost bosentana.
Darunavir co-administered with low dose ritonavir is contraindicated with triazolam or oral midazolam (see section 4.3).
Darunavir s niskom dozom ritonavira je kontraindiciran s triazolamom ili midizolamom (vidjeti dio 4.3)
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.
6/l (vidjeti dio 4.1) može se primijeniti režim doziranja od 800 mg jedanput na dan uz 150 mg kobicistata jedanput na dan ili ritonavir od 100 mg jedanput na dan, s hranom.
- In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
- Nakon što počnete uzimati lijekove za liječenje HIV infekcije dodatno uz oportunističke infekcije, također se mogu javiti autoimuni poremećaji (stanje u kojem imunosni sustav napada zdravo tjelesno tkivo).
For additional clinical study results in ART-experienced adults and paediatric patients, refer to the Summary of Product Characteristics for darunavir 75 mg, 150 mg, 300 mg or 600 mg tablets.
Rezultate dodatnih kliničkih ispitivanja u odraslih i pedijatrijskih bolesnika prethodno liječenih ART-om, vidjeti u Sažetku opisa svojstava lijeka za darunavir 75 mg, 150 mg, 300 mg ili 600 mg tablete.
Reproductive system and breast disorders Uncommon erectile dysfunction, gynaecomastia General disorders and administration site conditions Common
Poremećaji reproduktivnog sustava i dojki manje često erektilna disfunkcija, ginekomastija
ethinylestradiol Cmax  14% € with darunavir/cobicistat ethinylestradiol AUC ↓ 44% ethinylestradiol Cmin ↓ 62% ethinylestradiol Cmax ↓ 32% norethindrone AUC ↓ 14% norethindrone Cmin ↓ 30% norethindrone Cmax ↔ β with darunavir/ritonavir
etinilestradiol Cmax  14% € s darunavirom/kobicistatom etinilestradiol AUC ↓ 44%β etinilestradiol Cmin ↓ 62%β etinilestradiol Cmax ↓ 32%β noretindron AUC ↓ 14%β noretindron Cmin ↓ 30%β noretindron Cmax ↔β β s darunavirom/ritonavirom
Uncommon hepatic enzyme increased hepatitis*, cytolytic hepatitis*
Poremećaji jetre i žuči često manje često povišeni jetreni enzimi hepatitis*, citolitički hepatitis*
● 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).
● 12 pedijatrijskih bolesnika u dobi od 12 do 17 godina i težine najmanje 40 kg, koji nisu prethodno liječeni ART-om, a inficirani su virusom HIV-1 te su primali tablete darunavira s niskom dozom ritonavira jedanput na dan u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 5.1).
Lovastatin and simvastatin are expected to have markedly increased plasma concentrations when co-administered with darunavir co-administered with low dose ritonavir.
Za lovastatin i simvastatin se očekuje značajno povišenje koncentracija u plazmi kada se primjenjuju istodobno s darunavirom primijenjenim istodobno s niskom dozom ritonavira. (inhibicija CYP3A)
Darunavir co-administered with low dose ritonavir must not be used concomitantly with products containing St John's wort (Hypericum perforatum) (see section 4.3).
Darunavir istodobno primijenjen s niskom dozom ritonavira ne smije se istodobno primjenjivati s proizvodima koji sadržavaju gospinu travu (Hypericum perforatum) (vidjeti dio 4.3).
● 80 ART-experienced HIV-1 infected paediatric patients aged from 6 to 17 years and weighing at least 20 kg who received darunavir tablets with low dose ritonavir twice daily in combination with other antiretroviral agents.
● 80 pedijatrijskih bolesnika u dobi od 6 do 17 godina i težine najmanje 20 kg, prethodno liječenih ART-om, a inficirani su virusom HIV-1 te su primali tablete darunavira s niskom dozom ritonavira dva puta na dan u kombinaciji s drugim antiretrovirusnim lijekovima.
Uncommon diabetes mellitus, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia gout, anorexia, decreased appetite, decreased weight, increased weight, hyperglycaemia, insulin resistance, decreased high density lipoprotein, increased appetite, polydipsia, increased blood lactate dehydrogenase
Poremećaji metabolizma i prehrane često manje često dijabetes melitus, hipertrigliceridemija, hiperkolesterolemija, hiperlipidemija giht, anoreksija, smanjen apetit, smanjena tjelesna težina, povećana tjelesna težina, hiperglikemija, rezistencija na inzulin, sniženi lipoproteini visoke gustoće, povećan apetit, polidipsija, povišena laktat dehidrogenaza u krvi
HIV Protease inhibitors (PIs) - without additional co-administration of low dose ritonavir† Atazanavir
Inhibitori Proteaze (IP) HIV-a - bez istodobne primijene dodatne niske doze ritonavira † Atazanavir
For dosage recommendations in children, see the Summary of Product Characteristics for darunavir 75 mg, 150 mg, 300 mg, 600 mg tablets.
Za preporučena doziranja kod djece vidjeti Sažetak opisa svojstava lijeka za darunavir 75 mg, 150 mg, 300 mg, 600 mg tablete.
Blister carton 480 film-coated tablets 480 x 1 film-coated tablets
Kutija za blistere 480 filmom obloženih tableta 480 x 1 filmom obložena tableta
ANTIANGINA/ANTIARRHYTHMIC Disopyramide
ANTIANGINICI/ANTIARITMICI Dizopiramid
HDPE bottle pack with a PP screw cap containing 30, 60, 90 tablets.
Boca od polietilena visoke gustoće (HDPE) s navojnim čepom od polipropilena koja sadrži 30, 60 i 90 tableta.
PVC/PE/PVDC-Al blister pack containing 30, 60 and 120 tablets and 120x1 tablets.
PVC/PE/PVDC-Al blister pakiranje koje sadrži 30, 60 i 120 tableta i 120x1 tabletu.
Based on theoretical considerations darunavir coadministered with cobicistat is expected to increase metformin plasma concentrations.
Temeljem teorijskih postavki očekuje se da će darunavir istodobno primijenjen s kobicistatom povećati koncentracije metformina u plazmi.
The weight-based dose of darunavir and ritonavir in paediatric patients is provided in the table below.
Doza darunavira i ritonavira na temelju tjelesne težine u pedijatrijskih bolesnika, prikazana je u tablici niže.
Pravastatin 40 mg single dose pravastatin AUC ↑ 81%¶
Pravastatin 40 mg jednokratna doza pravastatin AUC ↑ 81%¶ pravastatin Cmin ND pravastatin Cmax ↑ 63%
HIV Protease inhibitors (PIs) - without additional co-administration of low dose ritonavir Atazanavir
Inhibitori Proteaze (IP) HIV-a - bez istodobne primijene dodatne niske doze ritonavira Atazanavir
30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
30 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta
Rare diarrhoea vomiting, nausea, abdominal pain, increased blood amylase, dyspepsia, abdominal distension, flatulence pancreatitis, gastritis, gastrooesophageal reflux disease, aphthous stomatitis, retching, dry mouth, abdominal discomfort, constipation, increased lipase, eructation, oral dysaesthesia stomatitis, haematemesis, cheilitis, dry lip, coated tongue
Poremećaji probavnog sustava vrlo često često manje često rijetko proljev povraćanje, mučnina, bol u abdomenu, povišene amilaze u krvi, dispepsija, distenzija abdomena, flatulencija pankreatitis, gastritis, gastroezofagealna refluksna bolest, aftozni stomatitis, dizanje želuca, suha usta, nelagoda u abdomenu, konstipacija, povišena lipaza, podrigivanje, oralna dizestezija stomatitis, hematemeza, heilitis, suhe usne, obložen jezik
- Darunavir Mylan 75 mg and 150 mg tablets have been developed for use in children weighing less than 40 kilograms, but can also be used in adults in some cases.
- Tablete lijeka Darunavir Mylan od 75 mg i 150 mg razvijene su za primjenu kod djece težine do 40 kg, ali ih u nekim slučajevima mogu uzimati i odrasli.
Reproductive system and breast disorders Uncommon gynaecomastia*
Poremećaji reproduktivnog sustava i dojki manje često ginekomastija*
Children Darunavir is not for use in children younger than 3 years of age or weighing less than 15 kilograms.
Darunavir nije namijenjen za primjenu kod djece mlađe od 3 godine ili tjelesne težine manje od 15 kilograma.
with darunavir/cobicistat 800/150 mg
§ s darunavirom/kobicistatom 800/150 mg
Human experience of acute overdose with darunavir co-administered with low dose ritonavir is limited.
Iskustvo akutnog predoziranja kod ljudi darunavirom primijenjenim istodobno s niskom dozom ritonavira je ograničeno.
Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold #darunavir/ritonavir atorvastatin AUC ↑ 290% Ω
Atorvastatin 10 mg jedanput na dan atorvastatin AUC ↑ 3-4 puta atorvastatin Cmin ↑ ≈5,5-10 puta atorvastatin Cmax ↑ ≈2 puta darunavir/ritonavir atorvastatin AUC ↑ 290%
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.
Nakon 48 tjedana, pokazalo se da virološki odgovor definiran kao postotak bolesnika s razinom u plazmi HIV-1 RNK < 50 kopija/ml nije inferioran uz liječenje darunavirom/ritonavirom od 800/100 mg jedanput na dan (pri prethodno definiranoj granici neinferiornosti od 12%) u usporedbi s dozom darunavira/ritonavira od 600/100 mg dva puta na dan u ITT i OP populacijama.
See the Summary of Product Characteristics for darunavir 75 mg, 150 mg, 300 mg or 600 mg tablets.
Vidjeti Sažetak opisa svojstava lijeka za darunavir 75 mg, 150 mg, 300 mg ili 600 mg tablete.
It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with darunavir coadministered with low dose ritonavir.
Preporučuje se praćenje protrombinskog vremena (INR, od engl. international normalised ratio) kada se varfarin primjenjuje u kombinaciji s darunavirom primijenjenim istodobno s niskom dozom ritonavira.
Therefore, darunavir must only be used in combination with low dose ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Stoga se darunavir mora primjenjivati samo u kombinaciji s niskom dozom ritonavira koji služi kao farmakokinetički pojačivač (vidjeti dijelove 4.4 i
How to store Darunavir Mylan
Kako čuvati lijek Darunavir Mylan
600 mg once daily efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% #darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction)
600 mg jedanput na dan efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% #darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz zbog inhibicije CYP3A) (↓ darunavir zbog indukcije CYP3A)
HDPE bottle pack with a PP screw cap containing 480 tablets.
Boca od polietilena visoke gustoće (HDPE) s navojnim čepom od polipropilena koja sadrži 480 tableta.
Each tablet contains 75 milligrams of darunavir.
Jedna tableta sadrži 75 miligrama darunavira.
- Darunavir Mylan 75 milligram and 150 milligram tablets have been developed for use in children, but can also be used in adults in some cases.
- Tablete lijeka Darunavir Mylan od 75 miligrama i 150 miligrama razvijene su za primjenu kod djece, ali ih u nekim slučajevima mogu uzimati i odrasli.
Human experience of acute overdose with darunavir co-administered with cobicistat or low dose ritonavir is limited.
Iskustvo akutnog predoziranja kod ljudi darunavirom primijenjenim istodobno s kobicistatom ili niskom dozom ritonavira je ograničeno.
Darunavir 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).
Darunavir, primijenjen istodobno s kobicistatom, indiciran je u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje infekcije virusom humane imunodeficijencije (HIV-1) u odraslih bolesnika (vidjeti dio 4.2).
Other c
Tip C
Triazolam and oral (taken by mouth) midazolam to help you sleep and/or relieve anxiety Cisapride to treat some stomach conditions
Svrha uzimanja lijeka avanafil liječenje erektilne disfunkcije astemizol ili terfenadin liječenje simptoma alergije triazolam i oralni (uzima se kroz usta) midazolam pomaže Vam spavati i/ili ublažava tjeskobu cisaprid liječenje nekih stanja želuca kolhicin (ako imate tegobe s bubregom i/ili jetrom)
In women receiving darunavir/cobicistat during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
U žena koje uzimaju darunavir/kobicistat tijekom drugog tromjesečja trudnoće, srednje intra-individualne vrijednosti Cmax, AUC24h i Cmin za ukupni darunavir bile su 49%, 56% odnosno 92% niže, u usporedbi s postpartalnim razdobljem; tijekom trećeg tromjesečja trudnoće, vrijednosti Cmax, AUC24h i Cminza ukupni darunavir bile su 37%, 50% i 89% niže, u usporedbi s postpartalnim razdobljem.
For clinical trial results in ART-naïve paediatric patients aged 12 to 17 years, refer to the Summary of Product Characteristics for darunavir 400 mg and 800 mg tablets.
Rezultate kliničkih ispitivanja u pedijatrijskih bolesnika koji nisu liječeni ART-om u dobi od 12 do 17 godina, pogledajte u Sažetku opisa svojstava lijeka za darunavir 400 mg i 800 mg tablete.
The use of darunavir coadministered with low dose ritonavir and these anticoagulants is not recommended.
Ne preporučuje se istodobna primjena darunavira s niskom dozom ritonavira i ovih antikoagulansa.
This dose must not exceed the recommended adult dose, which is 800 milligram darunavir together with 100 milligram ritonavir once a day.
Ova doza ne smije prekoračiti preporučenu dozu za odrasle, što je 800 miligrama darunavira zajedno sa 100 miligrama ritonavira jedanput na dan.
EXP Once opened, use within 100 days
Nakon otvaranja iskoristiti u roku od 100 dana
Atazanavir: comparison of atazanavir/ritonavir 300/100 mg once daily vs. atazanavir 300 mg once daily in combination with darunavir/ritonavir 400/100 mg twice daily.
Atazanavir: usporedba atazanavir/ritonavir 300/100 mg jedanput na dan naspram atazanavir 300 mg jedanput na dan u kombinaciji s darunavir/ritonavir 400/100 mg dva puta na dan.
Darunavir Mylan 150 mg film-coated tablets are available in blister packs containing 240 tablets and in plastic bottles containing 60 and 240 tablets.
Darunavir Mylan 150 mg filmom obložene tablete dostupne su u blister pakiranjima koja sadržavaju 240 tableta i plastičnim bocama koje sadržavaju 60 i 240 tableta.
Therefore, coadministration of darunavir with low dose ritonavir and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Stoga je istodobna primjena darunavira s niskom dozom ritonavira i sildenafila kada se primjenjuje za liječenje plućne arterijske hipertenzije kontraindicirana (vidjeti dio 4.3).
This dose must not exceed the recommended adult dose, which is 600 milligram darunavir together with 100 milligram of ritonavir two times per day or 800 milligram darunavir together with 100 milligram ritonavir once a day.
Ova doza ne smije prijeći preporučenu dozu za odrasle, koja je 600 miligrama darunavira zajedno sa 100 miligrama ritonavira dva puta na dan ili 800 miligrama darunavira zajedno sa 100 miligrama ritonavira jedanput na dan.
Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N
Broj ispitanika s virološkim neuspjehom i spareni genotip na početku/na kraju liječenja, koji su razvili mutacije b na ishodu ispitivanja, n/N Primarne (velike) IP mutacije
Exposure to these immunosuppressants will be increased when co-administered with darunavir co-administered with low dose ritonavir.
Izloženost tim imunosupresivima bit će povećana ako se primjenjuju istodobno s darunavirom primijenjenim istodobno s niskom dozom ritonavira. (CYP3A inhibicija)
Rare acute renal failure, renal failure, nephrolithiasis, increased blood creatinine, proteinuria, bilirubinuria, dysuria, nocturia, pollakiuria decreased creatinine renal clearance
Poremećaji bubrega i mokraćnog sustava manje često rijetko akutno zatajenje bubrega, zatajenje bubrega, nefrolitijaza, povišen kreatinin u krvi, proteinurija, bilirubinurija, dizurija, nokturija, polakizurija snižen bubrežni klirens kreatinina