natgillin/translations-raw huggingface dataset:
Darunavir must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Darunavir se uvijek mora primjenjivati peroralno s niskom dozom ritonavira koji pospješuje farmakokinetiku i u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 5.2).
If efavirenz is to be used in combination with darunavir /ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4).
Ako se efavirenz primjenjuje u kombinaciji s darunavirom/ritonavirom, mora se primijeniti darunavir/ritonavir 600/100 mg u režimu doziranja dvaput na dan (vidjeti dio 4.4).
Darunavir must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Darunavir se uvijek mora primjenjivati peroralno s kobicistatom ili niskom dozom ritonavira kao farmakokinetičkim pojačivačem, te u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 5.2).
#, a comparable systemic exposure to sildenafil was observed for a single intake of 100 mg sildenafil alone and a single intake of 25 mg sildenafil co-administered with darunavir and low dose ritonavir.
Sildenafil Tadalafil Vardenafil sistemska izloženost sildenafilu unosom jednokratne doze od 100 mg samo sildenafila i unosa jednokratne doze od 25 mg sildenafila istodobno primijenjenog s darunavirom i niskom dozom ritonavira.
The interaction profile of darunavir depends on whether ritonavir or cobicistat is used as pharmacokinetic enhancer.
Interakcijski profil darunavira ovisi o tome je li kao farmakokinetički pojačivač korišten ritonavir ili kobicistat.
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).
Farmakokinetički pojačivači i istodobno primijenjeni lijekovi Profil interakcija darunavira različit je i ovisan o tome je li pojačan s ritonavirom ili s kobicistatom: - Darunavir pojačan s kobicistatom osjetljiviji je na CYP3A indukciju: stoga je kontraindicirana istodobna primjena darunavira/kobicistata i snažnih induktora CYP3A (vidjeti dio 4.3), te se ne preporučuje istodobna primjena sa slabim do umjerenim induktorima CYP3A (vidjeti dio 4.5).
Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0.
Pripisane vrijednosti izračunate prema TLOVR algoritmu Bolesnik koji nije završio ispitivanje zabilježen je kao neuspjeh: bolesnicima koji su prijevremeno prekinuli ispitivanje pripisana je promjena jednaka 0.
Concomitant use of sildenafil or tadalafil for the treatment of pulmonary arterial hypertension and darunavir coadministered with low dose ritonavir may increase plasma concentrations of sildenafil or tadalafil.
Istodobna primjena sildenafila ili tadalafila za liječenje plućne arterijske hipertenzije i darunavira primijenjenog istodobno s niskom dozom ritonavira može povećati koncentracije sildenafila ili tadalafila u plazmi. (CYP3A inhibicija)
6/l (see section
6/l (vidjeti dijelove
Cobicistat and ritonavir inhibit CYP3A, thereby increasing the plasma concentrations of darunavir considerably.
Kobicistat i ritonavir inhibiraju CYP3A te na taj način značajno povećavaju koncentracije darunavira u plazmi.
Once daily dosing Weight
Doziranje jedanput na dan
Concomitant use of bosentan and boosted darunavir may increase plasma concentrations of bosentan.
Istodobna primjena bosentana i pojačanog darunavira može povećati koncentracije bosentana u plazmi.
Patients with no/nonnaïve use of ENF Patients with naïve use of ENF
Bolesnici koji prije nisu liječeni s ENF
Concomitant use of sildenafil or tadalafil for the treatment of pulmonary arterial hypertension and boosted darunavir may increase plasma concentrations of sildenafil or tadalafil.
Istodobna primjena sildenafila ili tadalafila za liječenje plućne arterijske hipertenzije i pojačanog darunavira može povećati koncentracije sildenafila ili tadalafila u plazmi. (CYP3A inhibicija)
The use of these medicines with darunavir/cobicistat is contraindicated (see section 4.3).
Primjena ovih lijekova s darunavirom/kobicistatom je kontraindicirana (vidjeti dio 4.3).
Boosted darunavir and rilpivirine can be used without dose adjustments.
Pojačan darunavir i rilpivirin mogu se primijeniti bez prilagodbe doze.
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.
It is not recommended to coadminister boosted darunavir and boceprevir.
Ne preporučuje se istodobna primjena pojačanog darunavira i boceprevira.
Concominant use of everolimus or irinotecan and darunavir coadministered with low dose ritonavir is not recommended.
Istodobno uzimanje everolimusa ili irinotekana i darunavira s niskom dozom ritonavira se ne preporučuje.
Based on theoretical considerations darunavir co-administered 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.
Postpartum (6-12 weeks) (n=6)
Postpartalno razdoblje (6-12 tjedana) (n=6)
Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 800/100 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum
Farmakokinetički rezultati ukupnog darunavira nakon primjene darunavira/ritonavira 800/100 mg jedanput dnevno kao dijela antiretrovirusnog režima liječenja tijekom drugog trimestra trudnoće, trećeg trimestra trudnoće i postpartalnog razdoblja
Postpartum (6-12 weeks) (n=12)
Postpartalno razdoblje (6-12 tjedana) (n=12)
ethinylestradiol AUC ↓ 44% ethinylestradiol Cmin ↓ 62% ethinylestradiol Cmax ↓ 32% norethindrone AUC ↓ 14% norethindrone Cmin ↓ 30% norethindrone Cmax ↔ with darunavir/ritonavir
etinilestradiol AUC ↓ 44% etinilestradiol Cmin ↓ 62% etinilestradiol Cmax ↓ 32% noretindron AUC ↓ 14% noretindron Cmin ↓ 30% noretindron Cmax ↔ s darunavirom/ritonavirom
With baseline HIV-RNA ≥
S početnom HIV-RNK
800 milligram Darunavir Krka (2 tablets containing 400 milligram of Darunavir Krka or 1 tablet containing 800 milligram of Darunavir Krka) together with 100 milligram ritonavir once daily.
800 miligrama lijeka Darunavir Krka (2 tablete koje sadrže 400 miligrama lijeka Darunavir Krka ili 1 tableta koja sadrži 800 miligrama lijeka Darunavir Krka) zajedno sa 100 miligrama ritonavira jedanput na dan.
Boosted darunavir can be used with these NRTIs without dose adjustment.
Pojačan darunavir može se primijeniti s ovim NRTI lijekovima bez prilagodbe doze.
Therefore, therapy with darunavir/cobicistat should not be initiated during pregnancy, and women who become pregnant during therapy with darunavir/cobicistat should be switched to an alternative regimen (see sections 4.2 and 4.6).
Stoga se liječenje darunavirom/kobicistatom ne smije započinjati tijekom trudnoće, a žene koje zatrudne tijekom liječenja darunavirom/kobicistatom trebaju prijeći na zamjenski režim (vidjeti dijelove 4.2 i 4.6).
darunavir/ ritonavir darunavir/ ritonavir 800/100 mg darunavir/ ritonavir darunavir/ ritonavir 600/100 mg
darunavir/ ritonavir 800/100 mg lopinavir/ ritonavir 800/200 mg
Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).
Smjernice za primjenu darunavira moraju se temeljiti na genotipskim i fenotipskim pretragama (kada su dostupne) kao i dosadašnjem liječenju (vidjeti dijelove 4.2, 4.4 i 5.1).
Darunavir co-administered with low dose ritonavir can be co-administered with proton pump inhibitors without dose adjustments.
Darunavir primijenjen istodobno s niskom dozom ritonavira može biti primijenjen istodobno s inhibitorima protonske pumpe bez prilagodbe doze.
Therefore, therapy with darunavir/cobicistat should not be initiated during pregnancy, and women who become pregnant during therapy with darunavir/cobicistat should be switched to an alternative regimen (see sections 4.4 and 4.6).
Stoga se liječenje darunavirom/kobicistatom ne smije započinjati tijekom trudnoće, a žene koje zatrudne tijekom liječenja darunavirom/kobicistatom trebaju prijeći na zamjenski režim (vidjeti dijelove 4.4 i 4.6).
Darunavir co-administered with low dose ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Darunavir primijenjen istodobno s niskom dozom ritonavira se smije primjenjivati tijekom trudnoće samo ako potencijalna korist opravdava potencijalni rizik.
Etravirine 100 mg twice daily etravirine AUC ↓ 37% etravirine Cmin ↓ 49% etravirine Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
Etravirin 100 mg dvaput na dan etravirin AUC ↓ 37% etravirin Cmin ↓ 49% etravirin Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
The combination product lopinavir/ritonavir (see section 4.5).
Istodobna primjena s kombinacijom lijekova lopinavir/ritonavir (vidjeti dio 4.5).
Dexamethasone may decrease plasma concentrations of darunavir.
Deksametazon može smanjiti koncentracije darunavira u plazmi. (indukcija CYP3A)
Lopinavir/ritonavir 400/100 mg twice daily + OBR N=297
Lopinavir/ritonavir 400/100 mg dvaput na dan + OOR N=297
In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
U bolesnika prethodno liječenih ART-om DRV-RAM*, a imaju plazmatsku HIV1 RNK < 100 000 kopija/ml i broj CD4+ stanica ≥ 100 stanica x 10
Therapy with darunavir/cobicistat should not be initiated during pregnancy, and women who become pregnant during therapy with darunavir/cobicistat should be switched to an alternative regimen (see sections 4.2 and 4.4).
Liječenje darunavirom/kobicistatom se ne smije započinjati tijekom trudnoće, a žene koje zatrudne tijekom liječenja darunavirom/kobicistatom trebaju prijeći na zamjenski režim (vidjeti dijelove 4.2 i 4.4).
Boosted darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole or fluconazole may increase darunavir concentrations.
Pojačan darunavir može povećati koncentracije antifungika u plazmi , a posakonazol, izavukonazol, itrakonazol ili flukonazol mogu povećati koncentracije darunavira. (CYP3A inhibicija i/ili P-gp inhibicija)
Recommended dose for treatment-experienced paediatric patients (3 to 17 years) with darunavir and ritonavir
Preporučena doza darunavira i ritonavira a za pedijatrijske bolesnike (od 3 do 17 godina) koji su prethodno liječeni
Carbamazepine 200 mg twice daily carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
Karbamazepin 200 mg dvaput na dan karbamazepin AUC ↑ 45% karbamazepin Cmin ↑ 54% karbamazepin Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
You must eat a meal or a snack within 30 minutes prior to taking your Darunavir Krka and ritonavir.
Unutar 30 minuta prije uzimanja lijeka Darunavir Krka i ritonavira morate pojesti obrok ili nešto prigristi.
ANTIFUNGALS Voriconazole
ANTIMIKOTICI Vorikonazol
If you notice after 12 hours, then skip the intake and take the next doses as usual.
Ako primijetite da ste propustili uzeti lijek nakon 12 sati, preskočite propuštenu dozu i uzmite iduću dozu u sljedećem redovnom terminu za uzimanje lijeka.
Do not stop taking Darunavir Krkawithout talking to your doctor first Anti-HIVmedicinesmaymake you feel better.
Nemojte prestati uzimati lijek Darunavir Krka bez prethodnog razgovora s liječnikom
If you notice after 6 hours, then skip the intake and take the next doses as usual.
Ako primijetite da ste propustili uzeti lijek nakon 6 sati, preskočite propuštenu dozu i uzmite iduću dozu u sljedećem redovnom terminu za uzimanje lijeka.
The combination of rifampicin and darunavir with concomitant low dose ritonavir is contraindicated (see section 4.3).
Kombinacija rifampicina i darunavira primijenjenog istodobno s niskom dozom ritonavira je kontraindicirana (vidjeti dio 4.3).
based on published data with darunavir/ritonavir
darunavir/ritonavi
Concomitant use of bosentan and darunavir co-administered with low dose ritonavir may increase plasma concentrations of bosentan.
Istodobna primjena bosentana i darunavira primijenjenog s niskom dozom ritonavira može povećati koncentracije bosentana u plazmi.
Based on theoretical considerations boosted darunavir is expected to increase the exposure of lomitapide when coadministered.
Temeljeno na teorijskim postavkama, očekuje se da će pojačani darunavir povećati izloženost lomitapidu kada se primjenjuju istodobno. (CYP3A inhibicija)
450 mg darunavir /60 mg ritonavir twice daily
450 mg darunavir /60 mg ritonavir dvaput na dan
Concomitant use of everolimus and boosted darunavir is not recommended.
Istodobna primjena everolimusa i pojačanog darunavira se ne preporučuje.
The interaction profile of darunavir depends on whether ritonavir is used as pharmacokinetic enhancer.
Profil interakcija darunavira ovisan je o tome je li kao farmakokinetički pojačivač primijenjen ritonavir.
Reproductive system and breast disorders uncommon gynaecomastia*
Poremećaji reproduktivnog sustava i dojki manje često ginekomastija*
Take Darunavir Krka always together with ritonavir.
- Lijek Darunavir Krka uvijek uzimajte zajedno s ritonavirom.
Combinations with optimised background regimen (OBRs) other than ≥ 2 NRTIs have not been studied in this population.
U toj populaciji nisu ispitivane druge kombinacije s optimiziranim osnovnim režimom (OOR) osim s ≥ 2 NRTI (nukleozidni/nukleotidni inhibitori reverzne transkriptaze, od engl.
#, a comparable systemic exposure to sildenafil was observed for a single intake of 100 mg sildenafil alone and a single intake of 25 mg sildenafil co-administered with
U ispitivanju interakcija primijećena je usporediva sistemska izloženost sildenafilu unosom jednokratne doze od 100 mg samo sildenafila i unosa jednokratne doze od 25 mg sildenafila istodobno primijenjenog s darunavirom i
Darunavir Krka 400 milligram and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.
Tablete Darunavir Krka od 400 miligrama i 800 miligrama primjenjuju se samo za dostizanje režima doziranja od 800 miligrama jedanput na dan.
Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir used in combination with cobicistat or low dose ritonavir and patients should be monitored during treatment.
Prije početka terapije darunavirom koji se uzima u kombinaciji s kobicistatom ili niskom dozom ritonavira, moraju se provesti odgovarajuća laboratorijska ispitivanja, te se bolesnike mora pratiti tijekom liječenja.
Second trimester of pregnancy (n=7)
Drugo tromjesečje trudnoće (n=7)
Concomitant use of boosted darunavir with lovastatin and simvastatin is therefore contraindicated (see section 4.3).
Istodobna primjena pojačanog darunavira s lovastatinom i simvastatinom je zbog toga kontraindicirana (vidjeti dio 4.3).
Dose for children 3 years of age and above, weighing more than 40 kilograms who have taken antiretroviral medicines before (your child's doctor will determine this) The dose is either:
Doza za djecu u dobi od 3 godine i više, težine najmanje 40 kilograma koja su prethodno uzimala antiretrovirusne lijekove (to će odrediti liječnik Vašeg djeteta)
In women receiving darunavir/ritonavir 800/100 mg once daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 33%, 31% and 30% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 29%, 32% and 50% lower, respectively, as compared with postpartum.
U žena koje su primale darunavir/ritonavir 800/100 mg jedanput dnevno tijekom drugog tromjesečja trudnoće, srednje intra-individualne vrijednosti za ukupni darunavir Cmax, AUC24h i Cmin bile su 33%, 31% odnosno 30% niže, uspoređujući s postpartalnim razdobljem; tijekom trećeg tromjesečja trudnoće, ukupne vrijednosti za darunavir Cmax, AUC24h i Cmin bile su 29%, 32% odnosno 50% niže, uspoređujući s postpartalnim razdobljem.
Second trimester of pregnancy (n=17)
Drugo tromjesečje trudnoće (n=17)
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.
Obavijestite liječnika ako uzimate: - amlodipin, diltiazem, dizopiramid, karvedilol, felodipin, flekainid, lidokain, metoprolol, meksiletin, nifedipin, nikardipin, propafenon, timolol, verapamil (za bolest srca), jer se terapijski učinak ili nuspojave tih lijekova mogu pojačati - apiksaban, edoksaban, rivaroksaban, varfarin (smanjuje zgrušavanje krvi), jer terapijski učinak ili nuspojave mogu biti izmijenjene; liječnik će Vam možda htjeti provjeriti krvnu sliku - hormonska kontracepcija na bazi estrogena i hormonska nadomjesna terapija, jer im Darunavir Krka može smanjiti učinkovitost.
Third trimester of pregnancy (n=6)
Treće tromjesečje trudnoće (n=6)
Darunavir Krka 400 mg film-coated tablets:
Darunavir Krka 400 mg filmom obložene tablete:
Concomitant use of salmeterol and boosted darunavir is not recommended.
Ne preporučuje se istodobna primjena salmeterola i pojačanog darunavira.
Due to an increase in the unbound darunavir plasma concentrations, darunavir should be used with caution in patients with mild or moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Darunavir se mora s oprezom primjenjivati u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre zbog povišenja koncentracija nevezanog darunavira u plazmi (vidjeti dijelove 4.2, 4.3 i 5.2).
Boosted darunavir may increase the exposure to grazoprevir.
Pojačan darunavir može povećati Istodobna primjena pojačanog
Clinical monitoring is recommended when co-administering boosted darunavir with β-blockers.
Preporučeno je kliničko praćenje kada se pojačan darunavir istodobno primjenjuje s βblokatorima.
Co-administration is contraindicated (see section 4.3)
Istodoba primjena je kontraindicirana (vidjeti dio 4.3)
800 mg darunavir/100 mg ritonavir once daily ritonavir oral solution: 80 mg/ml
800 mg darunavir/100 mg ritonavir jedanput na dan ritonavir oralna otopina: 80 mg/ml
Darunavir/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 36 pregnant women (18 in each arm) during the second and third trimesters, and postpartum.
U kliničkom ispitivanju s 36 trudnica (po 18 u svakoj skupini), procijenjena je terapija darunavirom/ritonavirom (600/100 mg dvaput na dan ili 800/100 mg jedanput na dan) u kombinaciji s osnovnim režimom liječenja tijekom drugog i trećeg trimestra, te postpartalno.
Saquinavir 1,000 mg twice daily darunavir AUC ↓ 26% darunavir Cmin ↓ 42% darunavir Cmax ↓ 17% saquinavir AUC ↓ 6% saquinavir Cmin ↓ 18% saquinavir Cmax ↓ 6% Saquinavir: comparison of saquinavir/ritonavir 1,000/100 mg twice
Sakvinavir 1000 mg dvaput dnevno darunavir AUC ↓ 26% darunavir Cmin ↓ 42% darunavir Cmax ↓ 17% sakvinavir AUC ↓ 6% sakvinavir Cmin ↓ 18% sakvinavir Cmax ↓ 6% Sakvinavir: usporedba sakvinavira/ritonavira 1000/100 mg dvaput na dan naspram sakvinavira/darunavira/ritonavira 1000/400/100 mg dvaput na dan Darunavir: usporedba darunavira/ritonavira 400/100 mg dvaput na dan naspram darunavira/ritonavira 400/100 mg u kombinaciji sa sakvinavirom 1000 mg dvaput na dan.
ART-experienced adult patients The recommended dose regimens are as follows: In ART-experienced patients with no darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10 6/l
Odrasli bolesnici prethodno liječeni ART-om Preporučeni režim doziranja je slijedeći: - U bolesnika prethodno liječenih ART-om, bez mutacija povezanih s rezistencijom na darunavir (DRV-RAM, od engl. darunavir resistance associated mutations)* a imaju plazmatsku HIV-1 RNK < 100 000 kopija/ml i broj CD4+ stanica ≥ 100 stanica x 10
ANTIEMETICS Domperidone
ANTIEMETICI
Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets
Darunavir Krka 400 mg filmom obložene tablete Darunavir Krka 800 mg filmom obložene tablete
A dosage reduction of rifabutin by 75% of the usual dose of 300 mg/day (i.e. rifabutin 150 mg once every other day) and increased monitoring for rifabutin related adverse events is warranted in patients receiving the combination with darunavir co-administered with ritonavir.
U bolesnika koji primaju kombinaciju lijekova s darunavirom istodobno primijenjenog s ritonavirom potrebno je 75% smanjenje doze rifabutina u odnosu na uobičajenu dozu od 300 mg/dan (npr. rifabutin 150 mg jedanput svaki drugi dan) te pojačano praćenje štetnih događaja povezanih s rifabutinom.
Concomitant use of other PDE-5 inhibitors for the treatment of erectile
INHIBITORI FOSFODIESTERAZE, TIP 5 (PDE-5) Za liječenje erektilne disfunkcije Avanafil
No post weaning functions were affected with darunavir alone or in combination with ritonavir.
Djelovanja darunavira primijenjenog samog ili u kombinaciji s ritonavirom na funkcije nakon prestanka laktacije nije bilo.
HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline
HIV-1 RNK < 50 kopija/ml Postotak promjene CD4+ od početne vrijednosti
Darunavir Krka 600 mg film-coated tablets
Darunavir Krka 600 mg filmom obložene tablete
Indinavir: comparison of indinavir/ritonavir 800/100 mg twice daily vs. indinavir/darunavir/ritonavir 800/400/100 mg twice daily.
Indinavir: usporedba indinavira/ritonavira 800/100 mg dvaput na dan naspram indinavira/darunavira/ritonavira 800/400/100 mg dvaput na dan.
The use of darunavir co-administered with low dose ritonavir and these anticoagulants is not recommended.
Ne preporučuje se istodobna primjena primjena darunavira istodobno primijenjenog s niskom dozom ritonavira i ovih antikoagulansa.
Proportion (%) of patients with response (HIV-1 RNA < 50 copies/ml at week 24) to darunavir coadministered with ritonavir (600/100 mg twice daily) by baseline genotype a, and baseline darunavir
Udio (%) bolesnika s odgovorom (HIV-1 RNK< 50 kopija/ml u 24. tjednu) na darunavir primijenjen istodobno s ritonavirom (600/100 mg dvaput na dan) po početnom genotipu ai početnoj PV darunavira te prema primjeni enfuvirtida (ENF): Poput tretirane analize POWER i DUET ispitivanja.
No dose adjustment is required for darunavir/ritonavir in patients with renal impairment (see sections 4.4 and 5.2).
U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze darunavira/ritonavira (vidjeti dijelove 4.4 i 5.2).
Treatment difference darunavir / ritonavir 600/100 mg twice daily n=131
Razlika liječenja darunavir/ritonavir 600/100 mg dvaput na dan n=131