FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Eviplera (see section 4.4).
Croatian: Kao i s drugim antiretrovirusnim lijekovima, u primjeni lijeka Eviplera treba se rukovoditi nalazima ispitivanja rezistencije i/ili prethodno dobivenim podacima o rezistenciji (vidjeti dio 4.4).
English: Raltegravir (400 mg twice daily)/ Tenofovir disoproxil
Croatian: Raltegravir (400 mg dvaput na dan)/ tenofovirdizoproksil
English: Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see section 4.2).
Croatian: Lijek Eviplera ne smije se primjenjivati istovremeno s rilpivirinkloridom osim ako je potrebna prilagodba doze zbog rifabutina (vidjeti dio 4.2).
English: You must remain under the care of your doctor while taking Eviplera.
Croatian: Za vrijeme uzimanja lijeka Eviplera morate ostati pod skrbi svog liječnika.
English: If a patient misses a dose of Eviplera by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Eviplera a prošlo je više od 12 sati, bolesnik ne smije uzeti propuštenu dozu nego jednostavno treba nastaviti uzimati doze prema uobičajenom rasporedu.
English: Stayed on Baseline Regimen (SBR) arm n = 159
Croatian: Skupina ostala na početnom režimu liječenja n = =159
English: Resistance to emtricitabine/lamivudine Resistance to rilpivirine Resistance to efavirenz
Croatian: Rezistencija na rilpivirin Rezistencija na efavirenz
English: 3 Adverse reaction identified for tenofovir disoproxil.
Croatian: 3 Nuspojava utvrđena tenofovirdizoproksil.
English: Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see sections 4.2 and 4.5).
Croatian: Lijek Eviplera ne smije se primjenjivati istovremeno s rilpivirinkloridom osim ako je potrebna prilagodba doze zbog rifabutina (vidjeti dijelove 4.2 i 4.5).
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see section 4.4).
Croatian: U starijih bolesnika postoji veća vjerojatnost da imaju smanjenu funkciju bubrega pa je stoga potreban oprez kad se starije bolesnike liječi lijekom Eviplera (vidjeti dio 4.4).
English: Where discontinuation of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil are available.
Croatian: Kada je indiciran prekid terapije jednom od djelatnih tvari lijeka Eviplera ili ako je potrebno prilagoditi dozu, postoje odvojeni pripravci emtricitabina, rilpivirinklorida i tenofovirdizoproksila.
English: Eviplera should not be administered concomitantly with adefovir dipivoxil (see section 4.5).
Croatian: Eviplera se ne smije primjenjivati istovremeno s adefovirdipivoksilom (vidjeti dio 4.5).
English: Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment are considered to outweigh the potential risks (see sections 4.2 and 4.4).
Croatian: Stoga se u bolesnika s blagim oštećenjem bubrega Eviplera treba primjenjivati samo ako se smatra da je moguća korist liječenja veća od mogućih rizika (vidjeti dijelove 4.2 i 4.4).
English: Didanosine The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1).
Croatian: Ne preporučuje se istovremena primjena lijeka Eviplera i didanozina (vidjeti dio 4.4 i tablicu 1).
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/mL and 2,050 (50.8%) ng•h/mL, respectively, in normal subjects compared with 289 (46.0%) ng/mL and 2,310 (43.5%) ng•h/mL in subjects with moderate hepatic impairment, and 305 (24.8%) ng/mL and 2,740 (44.0%) ng•h/mL in subjects with severe hepatic impairment.
Croatian: U normalnih ispitanika srednje vrijednosti (%CV) Cmax i AUC0-∞ tenofovira bile su 223 (34,8%) ng/ml odnosno 2.050 (50,8%) ng•h/ml, u usporedbi s 289 (46,0%) ng/ml i 2.310 (43,5%) ng•h/ml u ispitanika s umjerenim oštećenjem jetre te 305 (24,8%) ng/ml i 2.740 (44,0%) ng•h/ml u ispitanika s teškim oštećenjem jetre.
English: No dose adjustments are required when initiating co-administration of methadone with Eviplera.
Croatian: Nije potrebna prilagodba doze kad se metadon počinje istovremeno primjenjivati s lijekom Eviplera.
English: Co-administration of Eviplera and didanosine is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil, which may increase the risk of didanosine-related adverse reactions (see section 4.5).
Croatian: Istovremena primjena lijeka Eviplera i didanozina ne preporučuje se, budući da je izloženost didanozinu značajno povećana nakon istovremene primjene tenofovirdizoproksila, što može povećati rizik od nuspojava povezanih s didanozinom (vidjeti dio 4.5).
English: Missing data during window but on study drug
Croatian: Podaci o ispitivanom lijeku nedostaju iz okvira ispitivanja, ali lijek se primjenjuje
English: HIV-1 containing the K103N, Y181C, or rilpivirine-associated substitutions with resistance to NNRTIs were susceptible to tenofovir.
Croatian: Virusi HIV-1 koji su sadržavali K103N, Y181C ili supstitucije povezane s rilpivirinom s rezistencijom na nenukleozidne inhibitore reverzne transkriptaze bili su osjetljivi na tenofovir.
English: By baseline CD4+ cell count (x 106 cells/L)
Croatian: Prema početnom broju stanica CD4+ (x 106 stanica/l)
English: The efficacy of Eviplera is based on the analyses of 96 week data from two randomised, double-blind, controlled studies C209 and C215.
Croatian: Bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni Djelotvornost lijeka Eviplera temelji se na analizama podataka iz 96. tjedna prikupljenih u dva randomizirana, dvostruko slijepa, kontrolirana ispitivanja C209 i C215.
English: EU/1/11/737/001 30 film-coated tablets.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/737/001 30 filmom obloženih tableta.
English: angioedema1, 3, 6, severe skin reactions with systemic symptoms7 Musculoskeletal and connective tissue disorders Very common: elevated creatine kinase1
Croatian: angioedem1, 3, 6, teške kožne reakcije sa sistemskim simptomima7
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Croatian: H2-receptora koji se mogu dozirati jedanput na dan.
English: Metformin (850 mg single dose)/ Rilpivirine
Croatian: Metformin (850 mg jednostruka doza)/ rilpivirin
English: Of the 24 patients treated with Eviplera who had the NNRTI-associated K103N substitution pre-existing at baseline in their HIV-1, 17 of 18 patients in the Eviplera arm and 5 of 6 patients in the SBR arm maintained virologic suppression after switching to Eviplera through 48 weeks and 24 weeks of treatment, respectively.
Croatian: Od 24 bolesnika liječena lijekom Eviplera koji su imali supstituciju K103N povezanu s NNRTI koja je kod njihovog virusa HIV-1 postojala već na početku, virološka supresija bila je održana tijekom 48 tjedana u 17 od 18 bolesnika u skupini prebačenoj na lijek Eviplera i tijekom 24 tjedna u 5 od 6 bolesnika u skupini bolesnika koji su ostali na početnom režinu.
English: In the pooled analysis for C209 and C215 of patients who received a background regimen of emtricitabine/tenofovir disoproxil, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz arm. Table 4 displays selected demographic and baseline disease characteristics.
Croatian: U analizi objedinjenih podataka iz ispitivanja C209 i C215 za bolesnike koji su primali osnovni terapijski režim emtricitabinom/tenofovirdizoproksilom, demografske značajke i početne značajke bolesti bile su uravnotežene između skupine na rilpivirinu i skupine na efavirenzu.
English: In combination studies of tenofovir with NRTIs (abacavir, didanosine, emtricitabine, lamivudine, stavudine, and zidovudine), NNRTIs (delavirdine, efavirenz, nevirapine, and rilpivirine), and PIs (amprenavir, indinavir, nelfinavir, ritonavir, and saquinavir), additive to synergistic effects were observed.
Croatian: U ispitivanjima kombinacije tenofovira s nukleozidnim inhibitorima reverzne transkriptaze (abakavir, didanozin, emtricitabin, lamivudin, stavudin i zidovudin), nenukleozidnim inhibitorima reverzne transkriptaze (delavirdin, efavirenz, nevirapin i rilpivirin) i inhibitorima proteaze (amprenavir, indinavir, nelfinavir, ritonavir i sakvinavir) primijećeni su aditivni do sinergistički učinci.
English: The bioequivalence of one Eviplera film-coated tablet with one emtricitabine 200 mg hard capsule, one rilpivirine (as hydrochloride) 25 mg film-coated tablet and one tenofovir disoproxil 245 mg film-coated tablet was established following single dose administration to fed, healthy subjects.
Croatian: Bioekvivalencija jedne Eviplera filmom obložene tablete s jednom emtricitabin 200 mg tvrdom kapsulom, jednom rilpivirin (u obliku klorida) 25 mg filmom obložene tablete i jedne tenofovirdizoproksil 245 mg filmom obložene tablete utvrđena je nakon primjene jednostruke doze zdravim ispitanicima na pun želudac.
English: How to take Eviplera
Croatian: Kako uzimati Evipleru
English: 8 This adverse reaction was identified through post-marketing surveillance for tenofovir disoproxil but not observed in randomised controlled clinical studies or the expanded access program for tenofovir disoproxil.
Croatian: Ova nuspojava je bila identificirana tijekom praćenja lijeka nakon stavljanja lijeka u promet tenofovirdizoproksila no nije zabilježena u randomiziranim kontroliranim kliničkim ispitivanjima ili programu proširenog pristupa tenofovirdizoproksila.
English: If you vomit more than 4 hours after taking Eviplera you do not need to take another tablet until your next regularly scheduled tablet.
Croatian: Ako povraćate kad je prošlo više od 4 sata od uzimanja Eviplere, ne uzimajte drugu tabletu sve dok ne bude vrijeme za sljedeću prema uobičajenom rasporedu.
English: Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil
Croatian: Eviplera 200 mg/25 mg/245 mg filmom obložene tablete emtricitabin/rilpivirin/tenofovirdizoproksil
English: Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Croatian: Prekid terapije lijekom Eviplera u bolesnika istovremeno inficiranih HIV-om i HBV-om može biti povezan s teškim akutnim pogoršanjima hepatitisa (vidjeti dio 4.4).
English: Co-administration of Eviplera with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Croatian: Primijećeno je da istovremena primjena lijeka Eviplera s inhibitorima protonske pumpe smanjuje koncentracije rilpivirina u plazmi (zbog povišenja želučanog pH), što potencijalno može dovesti do gubitka terapijskog učinka lijeka Eviplera (vidjeti dio 4.3).
English: Sildenafil (50 mg single dose)/ Rilpivirine1
Croatian: Sildenafil (50 mg jednostruka doza)/ rilpivirin1
English: If Eviplera is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Croatian: Ako se prekine liječenje lijekom Eviplera u bolesnika istovremeno zaraženih HIV-om i virusom hepatitisa B (HBV) te bolesnike treba pomno nadzirati zbog praćenja pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
English: Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Croatian: Stoga se Eviplera ne preporučuje u bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.2 i 4.4).
English: If a patient vomits more than 4 hours after taking Eviplera they do not need to take another dose of Eviplera until the next regularly scheduled dose.
Croatian: Ako bolesnik povraća nakon više od 4 sata od uzimanja lijeka Eviplera, ne treba uzeti drugu dozu lijeka Eviplera sve do sljedeće doze prema uobičajenom rasporedu.
English: Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively.
Croatian: Stanični enzimi fosforiliraju emtricitabin i tenofovir u emtricitabin trifosfat odnosno tenofovirdifosfat.
English: • Inflammation of the kidney, passing a lot of urine and feeling thirsty
Croatian: • upala bubrega, mokrenje velikih količina mokraće i osjećaj žeđi
English: Co-administration of Eviplera and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Croatian: Primijećeno je da istovremena primjena lijeka Eviplera i lijekova koji induciraju CYP3A smanjuje koncentracije rilpivirina u plazmi, što potencijalno može dovesti do gubitka terapijskog učinka lijeka Eviplera (vidjeti dio 4.3).
English: In the cumulative week 96 pooled resistance analysis for patients receiving rilpivirine in combination with emtricitabine/tenofovir disoproxil, a greater risk of virologic failure for patients in the rilpivirine arm was observed within the first 48 weeks of these studies (11.5% in the rilpivirine arm and 4.2% in the efavirenz arm) while low rates of virologic failure, similar between the treatment arms, were observed from the week 48 to week 96 analysis (15 patients or 2.7% in the rilpivirine arm and 14 patients or 2.6% in the efavirenz arm).
Croatian: U analizi objedinjenih podataka o rezistenciji iz 96. tjedna u bolesnika koji su primali rilpivirin u kombinaciji s emtricitabinom/tenofovirdizoproksilom opažen je veći rizik od virološkog neuspjeha u bolesnika u skupini koja je primala rilpivirin tijekom prvih 48 tjedana u ovim kliničkim ispitivanjima (11,5% u skupini koja je primala rilpivirin i 4,2% u skupini koja je primala efavirenz), dok su niske stope virološkog neuspjeha, koje su bile slične u obje terapijske skupine, bile opažene u analizi podataka iz razdoblja od 48. do 96. tjedna (15 bolesnika ili 2,7% u skupini koja je primala rilpivirin i 14 bolesnika ili 2,6% u skupini koja je primala efavirenz).
English: No dose adjustment of Eviplera is required in patients with mild or moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze lijeka Eviplera u bolesnika s blagim ili umjerenim oštećenjem jetre.
English: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Croatian: Neklinički podaci o emtricitabinu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: In combination studies of emtricitabine with NRTIs (abacavir, didanosine, lamivudine, stavudine, tenofovir, and zidovudine), NNRTIs (delavirdine, efavirenz, nevirapine, and rilpivirine), and PIs (amprenavir, nelfinavir, ritonavir, and saquinavir), additive to synergistic effects were observed.
Croatian: U ispitivanjima kombinacije emtricitabina s nukleozidnim inhibitorima reverzne transkriptaze (abakavir, didanozin, lamivudin, stavudin, tenofovir i zidovudin), nenukleozidnim inhibitorima reverzne transkriptaze (delavirdin, efavirenz, nevirapin i rilpivirin) i inhibitorima proteaze (amprenavir, nelfinavir, ritonavir i sakvinavir) primijećeni su aditivni do sinergistički učinci.
English: If you are taking an H2-antagonist such as famotidine, cimetidine, nizatidine or ranitidine.
Croatian: • H2-antagonisti (famotidin, cimetidin, nizatidin ili ranitidin)
English: Antimycobacterials Rifabutin/Emtricitabine
Croatian: Antimikobakterijski lijekovi Rifabutin/emtricitabin
English: Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000
Croatian: Eviplera je indicirana za liječenje odraslih bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) bez poznatih mutacija povezanih s rezistencijom na skupinu nenukleozidnih inhibitora reverzne transkriptaze (NNRTI), tenofovir ili emtricitabin, i virusnim opterećenjem ≤ 100 000 HIV-1 RNK kopija/ml (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment (CPT Score C).
Croatian: Rilpivirinklorid nije ispitivan u bolesnika s teškim oštećenjem jetre (CPT stadij C).
English: Paracetamol (500 mg single dose)/ Rilpivirine1
Croatian: Paracetamol (500 mg jednostruka doza)/ rilpivirin1
English: Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Croatian: Treba izbjegavati primjenu lijeka Eviplera istovremeno ili neposredno nakon primjene nefrotoksičnih lijekova.
English: Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinised maize starch, polysorbate 20, croscarmellose sodium, and magnesium stearate.
Croatian: Jezgra tablete: mikrokristalična celuloza, laktoza hidrat, povidon, prethodno geliran kukuruzni škrob, polisorbat 20, umrežena karmelozanatrij i magnezijev stearat
English: • Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Croatian: • Rilpivirin, nenukleozidni inhibitor reverzne transkriptaze (NNRTI).
English: If a patient misses a dose of Eviplera within 12 hours of the time it is usually taken, the patient should take Eviplera with food as soon as possible and resume the normal dosing schedule.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Eviplera, a prošlo je manje od 12 sati od uobičajenog uzimanja doze, bolesnik treba uzeti lijek Eviplera s hranom čim prije i nastaviti uzimati doze prema uobičajenom rasporedu.
English: somnolence2
Croatian: somnolencija2
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg + 100 mg once daily)5/ Rilpivirine/Emtricitabine (25 mg/200 mg once daily)6
Croatian: Sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/100 mg + 100 mg jedanput dnevno)5/ rilpivirin/emtricitabin (25 mg/200 mg jedanput dnevno)6
English: Tenofovir displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 to 2.2 µM) and strain specific activity against HIV-2 (EC50 values ranged from 1.6 to 5.5 µM).
Croatian: Tenofovir je pokazao antivirusno djelovanje u staničnoj kulturi protiv podtipova A, B, C, D, E, F, G i O virusa HIV-1 (vrijednosti EC50 u rasponu od 0,5 do 2,2 µM) i specifično djelovanje protiv soja HIV-2 (vrijednosti EC50 u rasponu od 1,6 do 5,5 µM).
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil/Emtricitabine
Croatian: INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5)
English: • The active substances are emtricitabine, rilpivirine and tenofovir disoproxil.
Croatian: • Djelatne tvari su emtricitabin, rilpivirin i tenofovirdizoproksil.
English: Herpesvirus antiviral agents Famciclovir/Emtricitabine
Croatian: Antivirusni lijekovi protiv virusa herpesa Famciklovir/emtricitabin
English: In this analysis, the NNRTI resistance-associated mutations that developed most commonly in these patients were: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y and F227C.
Croatian: U toj su analizi mutacije povezane s rezistencijom na nenukleozidne inhibitore reverzne transkriptaze koje su se najčešće razvile u tih bolesnika bile: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y i F227C.
English: How to store Eviplera
Croatian: Kako čuvati Evipleru
English: Cases of severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including but not limited to rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia.
Croatian: Tijekom praćenja lijeka Eviplera nakon stavljanja lijeka u promet zabilježeni su slučajevi teških kožnih reakcija sa sistemskim simptomima, uključujući između ostaloga osipe praćene vrućicom, mjehurima na koži, konjunktivitisom, angioedemom, povećanom funkcijom jetre prema nalazima pretraga i/ili eozinofilijom.
English: (rilpivirine) and 5/14 (efavirenz) were in patients with a baseline viral load of ≤ 100,000 copies/mL.
Croatian: Među njima je virološki neuspjeh bio prisutan u 5/15 (rilpivirin) i 5/14 (efavirenz) bolesnika s početnim virusnim opterećenjem od ≤ 100 000 kopija/ml.
English: If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with food.
Croatian: Ako bolesnik povraća unutar 4 sata od uzimanja lijeka Eviplera, treba uzeti drugu tabletu Eviplera s hranom.
English: Very common: increased pancreatic amylase2, vomiting1, 2, 3, diarrhoea1, 3, nausea1, 2, 3
Croatian: povišena pankreasna amilaza2, povraćanje1, 2, 3, proljev1, 3, mučnina1, 2, 3
English: Concomitant use not recommended
Croatian: Lijekovi s kojima se istovremena primjena ne preporučuje
English: Emtricitabine and tenofovir disoproxil are excreted in human milk.
Croatian: Pokazalo se da se emtricitabin i tenofovirdizoproksil izlučuju u majčino mlijeko.
English: More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Croatian: Rezistenciju povezanu s lamivudinom/emtricitabinom razvilo je više bolesnika s virološkim neuspjehom liječenih rilpivirinom nego onih s virološkim neuspjehom liječenih efavirenzom (vidjeti dio 5.1).
English: 25-O-desacetyl-rifabutin:
Croatian: 25-O-dezacetil-rifabutin: AUC: ↔
English: c There were 17 new virologic failures between the week 48 primary analysis and week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
Croatian: c Od primarne analize u 48. tjednu do 96. tjedna bilo je 17 novih slučajeva virološkog neuspjeha (6 bolesnika s početnim virološkim opterećenjem ≤ 100 000 kopija/ml i 11 bolesnika s početnim virološkim opterećenjem od > 100 000 kopija/ml).
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Croatian: Rilpivirin je diarilpirimidinski nenukleozidni inhibitor reverzne transkriptaze virusa HIV-1.
English: Co-administration of Eviplera and didanosine is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena lijeka Eviplera i didanozina (vidjeti dio 4.4).
English: Raltegravir/Rilpivirine
Croatian: Raltegravir/rilpivirin
English: d There were 10 new virologic failures between the week 48 primary analysis and week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL).
Croatian: d Od primarne analize u 48. tjednu do 96. tjedna bilo je 10 novih slučajeva virološkog neuspjeha (3 bolesnika s početnim virološkim opterećenjem ≤ 100 000 kopija/ml i 7 bolesnika s početnim virološkim opterećenjem > 100 000 kopija/ml).
English: Integrase strand transfer inhibitors Raltegravir/Emtricitabine
Croatian: Inhibitori prijenosa niza integraze Raltegravir/emtricitabin
English: • Back pain caused by kidney problems, including kidney failure.
Croatian: • bolovi u leđima prouzročeni tegobama s bubrezima, uključujući zatajenje bubrega.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see sections 4.2 and 5.2).
Croatian: U starijih je bolesnika veća vjerojatnost da će imati smanjenu funkciju bubrega pa je stoga potreban oprez kad se starije bolesnike liječi lijekom Eviplera (vidjeti dijelove 4.2 i 5.2).
English: Antifungals Ketoconazole/Emtricitabine
Croatian: Antimikotici Ketokonazol/emtricitabin