FrancophonIA/ELRC3.0 huggingface dataset:
English: - high blood pressure, flushing - red or dry eyes - fever, swelling of lower limbs due to fluids, malaise, irritability, pain - symptoms of infection, herpes simplex - erectile dysfunction, enlargement of breasts - sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive
Croatian: - vrućica, oticanje nogu zbog nakupljanja tekućine, opća slabost, razdražljivost, bol - simptomi infekcije, herpes simpleks - erektilna disfunkcija, povećanje dojki - teškoće sa spavanjem, pospanost, depresija, tjeskoba, abnormalni snovi, smanjeni spolni nagon.
English: Darunavir Mylan contains sodium
Croatian: Darunavir Mylan sadrži natrij
English: The combination of avanafil and darunavir with low dose ritonavir is contraindicated (see section 4.3).
Croatian: Kombinacija avanafila i darunavira s niskom dozom ritonavira je kontraindicirana (vidjeti dio 4.3).
English: It is not recommended to co-administer boosted darunavir and boceprevir.
Croatian: Ne preporučuje se istodobna primjena pojačanog darunavira i boceprevira.
English: Efficacy of darunavir 600 mg twice daily co-administered with 100 mg ritonavir twice daily in ARTexperienced patients
Croatian: Djelotvornost darunavira od 600 mg dva puta na dan primijenjenog istodobno sa 100 mg ritonavira dva puta na dan u bolesnika prethodno liječenih ART-om
English: kidney or lung] - heart attack, slow heart beating, palpitations - visual disturbance - chills, feeling abnormal - a feeling of confusion or disorientation, altered mood, restlessness - fainting, epileptic fits, changes or loss of taste - mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue - running nose - skin lesions, dry skin - stiffness of muscles or joints, joint pain with or without inflammation - changes in some values of your blood cells or chemistry.
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) reakcija koja se naziva DRESS [teški osip, koji može biti praćen vrućicom, umorom, oticanjem lica ili limfnih čvorova, povišenjem eozinofila (vrsta bijelih krvnih stanica), učincima na jetru, bubreg ili pluća] srčani udar, spori otkucaji srca, osjećaj lupanja srca poremećaj vida zimica, nenormalno osjećanje osjećaj smetenosti ili dezorijentacije, promijenjeno raspoloženje, nemir nesvjestica, epileptički napadaji, promjene ili gubitak okusa ranice u ustima, povraćanje krvi, upala usnica, suhe usnice, obložen jezik curenje nosa oštećenja kože, suha koža ukočenost mišića ili zglobova, bolovi u zglobovima s ili bez upale promjene nekih vrijednosti stanica ili kemijskih nalaza u Vašoj krvi.
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔* * Using cross-study comparisons to historical pharmacokinetic data
Croatian: LIJEKOVI KOJI DJELUJU NA HIV Inhibitori prijenosa lanca integraze Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓ 38% dolutegravir Cmax ↓ 11% darunavir ↔*
English: 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) - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Croatian: 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) - triazolam, peroralno primijenjen midazolam (mjere opreza za parenteralnu primjenu midazolama, vidjeti dio 4.5) - sildenafil - kada se primjenjuje za liječenje plućne arterijske hipertenzije, avanafil - simvastatin, lovastatin i lomitapid (vidjeti dio 4.5) - dabigatran, tikagrelor (vidjeti dio 4.5).
English: No dose adjustment is required for darunavir/ritonavir in patients with renal impairment (see sections 4.4 and 5.2).
Croatian: U bolesnika s oštećenjem bubrega nije potrebna prilagodba doze darunavira/ritonavira (vidjeti dijelove 4.4 i 5.2).
English: Darunavir 400 mg tablets are only to be used to construct the once daily 800 mg regimen.
Croatian: Tablete darunavira od 400 mg primjenjuju se samo za dostizanje režima doziranja od 800 mg jedanput na dan.
English: All subjects darunavir/cobicistat 800/150 mg once daily + OBR N=313
Croatian: Svi ispitanici darunavir/kobicistat 800/150 mg jedanput na dan + OOR N=313
English: 60 film-coated tablets 240 film-coated tablets
Croatian: Filmom obložena tableta 60 filmom obloženih tableta 240 filmom obloženih tableta
English: and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Croatian: HIV-1 RNK < 100 000 kopija/ml i broj CD4+ stanica ≥ 100 stanica x 10
English: Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 150 milligram cobicistat or 100 milligram ritonavir once daily.
Croatian: Doza za odrasle koji su već prije uzimali antiretrovirusne lijekove (to će odrediti Vaš liječnik) Doza može biti: - 800 miligrama darunavira (2 tablete koje sadrže 400 miligrama darunavira ili 1 tableta koja sadrži 800 miligrama darunavira) zajedno sa 150 miligrama kobicistata ili 100 miligrama ritonavira jedanput na dan.
English: Concomitant use of boosted darunavir and elbasvir/grazoprevir is contraindicated (see section 4.3).
Croatian: Istodobna primjena pojačanog darunavira i elbasvira/grazoprevira je kontraindicirana (vidjeti dio 4.3).
English: Based on theoretical considerations boosted darunavir is expected to increase the exposure of lomitapide when co-administered.
Croatian: Temeljeno na teorijskim postavkama, očekuje se da će pojačani darunavir povećati izloženost lomitapidu kada se primjenjuju istodobno. (CYP3A inhibicija)
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).
Croatian: Smjernice za primjenu lijeka darunavir moraju se temeljiti na genotipskim i fenotipskim pretragama (kada su dostupne) kao i dosadašnjem liječenju (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Lopinavir/ ritonavir 400/100 mg twice daily + OBR N=297
Croatian: Lopinavir/ritonavir 400/100 mg dva puta na dan + OOR n=297
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144% ║ based on published data with darunavir/ritonavir rosuvastatin AUC ↑ 93%§ rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND§
Croatian: na temelju objavljenih podataka s darunavirom/ritonavirom rosuvastatin AUC ↑ 93%§ rosuvastatin Cmax ↑ 277% rosuvastatin Cmin NO§
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144% ║ based on published data with darunavir/ritonavir
Croatian: Rosuvastatin 10 mg jedanput na dan rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144%║
English: - Rifabutin (against bacterial infections) - Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Methadone (to treat opiate dependance) - Carbamazepine, clonazepam (to prevent seizures or to treat certain types of nerve pain) - Colchicine (to treat gout or familial Mediterranean fever) - Bosentan (to treat high blood pressure in the pulmonary circulation) - Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used as injection,
Croatian: Vorikonazol se smije uzimati samo nakon medicinske procjene. - rifabutin (protiv bakterijskih infekcija) - sildenafil, vardenafil, tadalafil (za erektilnu disfunkciju ili povišeni krvni tlak u plućnom krvotoku) - amitriptilin, desipramin, imipramin, nortriptilin, paroksetin, sertralin, trazodon (za liječenje depresije i tjeskobe) - maravirok (za liječenje HIV infekcije) - metadon (za liječenje ovisnosti o opijatima) - karbamazepin, klonazepam (za sprečavanje epileptičkih napadaja ili za liječenje određenih vrsta neurološke boli) - kolhicin (za liječenje gihta ili obiteljske mediteranske vrućice) - bosentan (za liječenje povišenog krvnog tlaka u plućnom krvotoku) - buspiron, klorazepat, diazepam, estazolam, flurazepam, midazolam kada se koristi u obliku injekcije, zolpidem (sedativi)
English: Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) - The usual dose of darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.
Croatian: Doza za djecu u dobi od 3 godine i više, težine najmanje 40 kilograma koja nisu prethodno uzimala antiretrovirusne lijekove (to će odrediti liječnik Vašeg djeteta) - Uobičajena doza darunavira je 800 miligrama (2 tablete koje sadrže 400 miligrama darunavira ili 1 tableta koja sadrži 800 miligrama darunavira) zajedno sa 100 miligrama ritonavira jednaput na dan.
English: Bottle carton 480 film-coated tablets
Croatian: Kutija za bocu 480 filmom obloženih tableta
English: For patients with renal or hepatic impairment colchicine with boosted darunavir is contraindicated (see sections 4.3 and 4.4).
Croatian: Za bolesnike s oštećenjem bubrega ili jetre kolhicin s pojačanim darunavirom je kontraindiciran (vidjeti dijelove 4.3 i
English: If efavirenz is to be used in combination with darunavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Croatian: Ako je potrebno primjenjivati efavirenz u kombinaciji s darunavirom, za darunavir/ritonavir se mora primijeniti režim od 600/100 mg dva puta na dan.
English: Concomitant use of salmeterol and darunavir coadministered with low dose ritonavir may increase plasma concentrations of salmeterol.
Croatian: Istodobna primjena salmeterola i darunavira primijenjenog istodobno s niskom dozom ritonavira može povećati koncentracije salmeterola u plazmi.
English: HIV-1 RNA < 50 copies/ml a b median CD4+ cell count change from baseline (x 10
Croatian: HIV-1 RNK < 50 kopija/mla b medijan promjene broja CD4+ stanica od početne vrijednosti (x 106/l)c a
English: Darunavir Mylan 400 mg film-coated tablets Darunavir Mylan 800 mg film-coated tablets
Croatian: Darunavir Mylan 400 mg filmom obložene tablete Darunavir Mylan 800 mg filmom obložene tablete
English: 10 kg to < 15 kg N=5
Croatian: Darunavir/ritonavir 10 kg do < 15 kg N=5
English: 600 mg darunavir/100 mg ritonavir twice daily a ritonavir oral solution: 80 mg/ml
Croatian: 600 mg darunavir/100 mg ritonavir, dva puta na dan a oralna otopina ritonavira: 80 mg/ml
English: Darunavir Mylan 150 mg film-coated tablets Each film-coated tablet contains 150 mg of darunavir.
Croatian: Darunavir Mylan 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg darunavira.
English: 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).
Croatian: Darunavir se mora s oprezom primjenjivati kod bolesnika s blagim ili umjerenim oštećenjem jetre zbog povišenja koncentracija nevezanog darunavira u plazmi (vidjeti dijelove 4.2, 4.3 i 5.2).
English: 3 years In-use shelf life after first opening HDPE bottle: 100 days
Croatian: Rok valjanosti nakon prvog otvaranja boce od polietilena visoke gustoće (HDPE): 100 dana 6.4 Posebne mjere pri čuvanju lijeka
English: Darunavir co-administered with low dose ritonavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Croatian: Istodobna primjena darunavira istodobno primijenjenog s niskom dozom ritonavira i amiodarona, bepridila, dronedarona, ivabradina, kinidina ili ranolazina je kontraindicirana (vidjeti dio 4.3).
English: Darunavir Mylan 400 mg film-coated tablets 3 years
Croatian: Darunavir Mylan 400 mg filmom obložene tablete 3 godine
English: Concomitant use of bosentan and darunavir coadministered with low dose ritonavir may increase plasma concentrations of bosentan.
Croatian: Istodobna primjena bosentana i darunavira s niskom dozom ritonavira može povećati koncentracije bosentana u plazmi.
English: Darunavir is used to treat adults and children 3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and - who have not used antiretroviral medicines before.
Croatian: Darunavir se koristi za liječenje odraslih i djece u dobi od 3 godine i starije, tjelesne težine najmanje 40 kilograma, koji su zaraženi HIV-om - te nisu prethodno liječeni drugim antiretrovirusnim lijekovima. - te u određenih bolesnika koji su prethodno liječeni drugim antiretrovirusnim lijekovima (ovo će odrediti Vaš liječnik).
English: HDPE bottle pack with a PP screw cap containing 30 and 120 tablets.
Croatian: Boca od polietilena visoke gustoće (HDPE) s navojnim čepom od polipropilena koja sadrži 30 i 120 tableta.
English: 800 mg darunavir/100 mg ritonavir once daily a ritonavir oral solution: 80 mg/ml
Croatian: 800 mg darunavir/100 mg ritonavir jedanput na dan a ritonavir oralna otopina: 80 mg/ml
English: 450 mg darunavir/60 mg ritonavir twice daily
Croatian: 450 mg darunavir/60 mg ritonavir, dva puta na dan
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving darunavir co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Croatian: Bolesnici istodobno inficirani virusom hepatitisa B i/ili hepatitisa C Od 1968 prethodno liječenih bolesnika, a primali su darunavir primijenjen istodobno s ritonavirom od 600/100 mg dva puta na dan, 236 bolesnika bilo je istodobno inficirano hepatitisom B ili C.
English: 30 film-coated tablets 120 film-coated tablets
Croatian: Filmom obložena tableta 30 filmom obloženih tableta 120 filmom obloženih tableta
English: Each tablet contains 600 milligram of darunavir.
Croatian: Jedna tableta sadrži 600 miligrama darunavira.
English: Bottle carton 60 film-coated tablets 240 film-coated tablets
Croatian: Kutija za bocu 60 filmom obloženih tableta 240 filmom obloženih tableta
English: Darunavir Mylan 75 mg film-coated tablets darunavir
Croatian: Darunavir Mylan 75 mg filmom obložene tablete darunavir
English: Blister carton 30 film-coated tablets 60 film-coated tablets 60 x 1 film-coated tablets
Croatian: Kutija za blistere 30 filmom obloženih tableta 60 filmom obloženih tableta 60 x 1 filmom obložena tableta
English: Do not stop taking Darunavir Mylan without talking to your doctor first Anti-HIV medicines make you feel better.
Croatian: Nemojte prestati uzimati lijek Darunavir Mylan bez prethodnog razgovora s liječnikom.
English: 60 film-coated tablets 100 film-coated tablets
Croatian: Filmom obložena tableta 60 filmom obloženih tableta 100 filmom obloženih tableta
English: d d
Croatian: D.
English: lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21% based upon non dose normalised values
Croatian: lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21%
English: Blister carton 30 film-coated tablets 30 x 1 film-coated tablets
Croatian: Kutija za blistere 30 filmom obloženih tableta 30 x 1 filmom obložena tableta
English: 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.
Croatian: U kliničkom ispitivanju s 36 trudnica (po 18 u svakoj skupini), procijenjena je terapija darunavir/ritonavir (600/100 mg dva puta na dan ili 800/100 mg jedanput dnevno) u kombinaciji s osnovnim režimom liječenja tijekom drugog i trećeg trimestra, te postpartalno.
English: Cold form PVC/Al/OPA-Al blister pack containing 30, 60 and 120 tablets and 120x1 tablets.
Croatian: Hladno oblikovano PVC/Al/OPA-Al blister pakiranje koje sadrži 30, 60 i 120 tableta i 120x1 tabletu.
English: administered 1 hour before or 2 hours after boosted darunavir given with food.
Croatian: Didanozin treba primijeniti na prazan želudac, odnosno treba ga primijeniti 1 sat prije ili 2 sata nakon pojačanog darunavira koji se uzima s hranom.
English: Darunavir Mylan 800 mg film-coated tablets 3 years
Croatian: Darunavir Mylan 800 mg filmom obložene tablete 3 godine
English: Bottle carton 60 film-coated tablets 100 film-coated tablets
Croatian: Kutija za bocu 60 filmom obloženih tableta 100 filmom obloženih tableta
English: Boosted darunavir and raltegravir can be used without dose adjustments.
Croatian: Pojačani darunavir i raltegravir mogu se primijeniti bez prilagodbe doze.
English: Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg twice daily in combination with atazanavir 300 mg once daily.
Croatian: Darunavir: usporedba darunavir/ritonavir 400/100 mg dva puta na dan naspram darunavir/ritonavir 400/100 mg dva puta na dan u kombinaciji s atazanavirom 300 mg jedanput na dan.
English: 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).
Croatian: Ako se efavirenz primjenjuje u kombinaciji s darunavirom/ritonavirom, mora se primijeniti darunavir/ritonavir 600/100 mg u režimu doziranja dva puta na dan (vidjeti dio 4.4).
English: Therefore, coadministration of boosted darunavir and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Croatian: Stoga je istodobna primjena pojačanog darunavira i sildenafila kada se primjenjuje za liječenje plućne arterijske hipertenzije kontraindicirana (vidjeti dio
English: The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that darunavir/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 800/100 mg once daily.
Croatian: Farmakokinetika darunavira u kombinaciji s ritonavirom uzetih jedanput na dan, kod 12 pedijatrijskih bolesnika koji nisu prethodno liječeni, u dobi od 12 do < 18 godina s težinom najmanje 40 kg, pokazala je da darunavir/ritonavir 800/100 mg jedanput na dan rezultira izloženošću darunaviru koja je usporediva s onom kod odraslih koji primaju darunavir/ritonavir od 800/100 mg jedanput na dan.
English: Each film-coated tablet contains 150 mg of darunavir.
Croatian: Jedna filmom obložena tableta sadrži 150 mg darunavira.
English: ● In ART-experienced patients with no darunavir resistance associated mutations (DRV-RAMs)*
Croatian: ● su prethodno liječeni ART-om, koji nemaju mutacije povezane s rezistencijom na darunavir
English: Each tablet contains 400 milligrams of darunavir.
Croatian: Jedna tableta sadrži 400 miligrama darunavira.
English: Rare asthenia, fatigue pyrexia, chest pain, peripheral oedema, malaise, feeling hot, irritability, pain chills, abnormal feeling, xerosis
Croatian: Opći poremećaji i reakcije na mjestu primjene često manje često rijetko astenija, umor pireksija, bol u prsištu, periferni edem, malaksalost, osjećaj vrućine, iritabilnost, bol zimica, nenormalno osjećanje, kseroza
English: Co-administration of boosted daruanvir with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Croatian: Istodobna primjena pojačanog darunavira s ovim antikoagulansima može povećati koncentracije antikoagulansa, što može povećati rizik od krvarenja. (CYP3A i/ili P-gp inhibicija)
English: Co-administration of boosted darunavir and alfuzosin is contraindicated (see section 4.3).
Croatian: Istodobna primjena pojačanog darunavira i alfuzozina je kontraindicirana (vidjeti dio 4.3).
English: Cold form PVC/Al/OPA-Al blister pack containing 30 and 60 tablets and 60x1 tablets.
Croatian: Hladno oblikovano PVC/Al/OPA-Al blister pakiranje koje sadrži 30 i 60 tableta i 60x1 tabletu.
English: Darunavir Mylan 800 mg film-coated tablets PVC/PE/PVDC-Al blister pack Do not store above 25°C.
Croatian: Darunavir Mylan 800 mg filmom obložene tablete PVC/PE/PVDC-Al blister pakiranje
English: Darunavir/ ritonavir 600/100 mg twice daily n=131
Croatian: Darunavir/ ritonavir 600/100 mg dva puta na dan n=131
English: toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Croatian: toksična epidermalna nekroliza*, akutna generalizirana egzantematozna pustuloza* Poremećaji mišićno-koštanog sustava i vezivnog tkiva često manje često mijalgija osteonekroza*
English: Darunavir Mylan 300 mg film-coated tablets are available in blister packs containing 30, 60 and 120 tablets and in plastic bottles containing 30 and 120 tablets.
Croatian: Darunavir Mylan 300 mg filmom obložene tablete dostupne su u blister pakiranjima koja sadržavaju 30, 60 i 120 tableta i plastičnim bocama koje sadržavaju 30 i 120 tableta.
English: Cold form PVC/Al/OPA-Al blister pack containing 30 tablets and 30x1 tablets.
Croatian: Hladno oblikovano PVC/Al/OPA-Al blister pakiranje koje sadrži 30 tableta i 30x1 tabletu.
English: Number of subjects with virologic failure and paired baseline/endpoint phenotypes, showing loss of susceptibility to PIs at endpoint compared to baseline, n/N
Croatian: Broj ispitanika s virološkim neuspjehom i odgovarajući fenotip na početku/na kraju liječenja koji pokazuju gubitak osjetljivosti na IP na ishodu u usporedbi s onim na početku liječenja, n/N Inhibitori proteaze (IP)
English: For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for darunavir 400 mg and 800 mg tablets.
Croatian: Za rezultate kliničkog ispitivanja u odraslih bolesnika koji nisu prethodno liječeni ART-om, vidjeti Sažetak opisa svojstava lijeka za darunavir 400 mg i 800 mg tablete.
English: Each tablet contains 800 milligram of darunavir.
Croatian: Jedna tableta sadrži 800 miligrama darunavira.
English: Darunavir Mylan 600 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 30 and 60 tablets and 60x1 tablets.
Croatian: Darunavir Mylan 600 mg filmom obložene tablete PVC/PE/PVDC-Al blister pakiranje koje sadrži 30 i 60 tableta i 60x1 tabletu.
English: Each film-coated tablet contains 800 mg of darunavir.
Croatian: Jedna filmom obložena tableta sadrži 800 mg darunavira.
English: Darunavir Mylan 800 mg film-coated tablets Each film-coated tablet contains 800 mg of darunavir.
Croatian: Darunavir Mylan 800 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 800 mg darunavira.
English: White to off-white, capsule shaped, biconvex film-coated tablets approximately 12.75 mm by 6.3 mm debossed with ‘M' on one side and ‘DV2' on the other side.
Croatian: Bijela do gotovo bijela, bikonveksna filmom obložena tableta oblika kapsule približne veličine 12,75 mm × 6,3 mm s utisnutom oznakom „M” na jednoj strani i „DV2” na drugoj strani.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu .
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/ema/.