FrancophonIA/ELRC3.0 huggingface dataset:
English: In GS-US-380-1844, the mean change from baseline in CD4+ cell count at Week 48 was -31 cells/mm3 in patients who switched to B/F/TAF and 4 cells/mm3 in patients who stayed on abacavir/dolutegravir/lamivudine.
Croatian: U ispitivanju GS-US-380-1844, srednja vrijednost promjene u odnosu na početni broj stanica CD4 + u 48. tjednu bila je -31 stanica/mm3 u bolesnika koji su prebačeni na B/F/TAF i 4 stanice/mm3 u onih koji su ostali na abakaviru/dolutegraviru/lamivudinu.
English: Voriconazole (300 mg twice daily), Bictegravir1
Croatian: Vorikonazol (300 mg dvaput na dan), biktegravir1
English: ABC/DTG/ 3TC (n = 315)d
Croatian: ABC/DTG/ 3TC
English: DTG + F/TAF (n = 325)e
Croatian: DTG + F/ TAF
English: The mean baseline CD4+ cell count was 723 cells/mm3 (range 124-2,444).
Croatian: 723 stanice/mm3 (raspon 124-2444).
English: Sofosbuvir: AUC: ↔
Croatian: Sofosbuvir: AUC: ↔ Cmax: ↔
English: HIV-1 infected, virologically -suppressed patients
Croatian: Bolesnici zaraženi virusom HIV-1 u kojih je virus suprimiran
English: No dose adjustment is required upon co-administration.
Croatian: Nije potrebna prilagodba doze nakon istodobne primjene.
English: In Study GS-US-380-1489, patients were randomised in a 1:1 ratio to receive either bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (n = 314) or abacavir/dolutegravir/lamivudine (600/50/300 mg) (n = 315) once daily.
Croatian: U ispitivanju GS-US-380-1489 bolesnici su bili randomizirani u omjeru 1:1 kako bi primali biktegravir/emtricitabin/tenofoviralafenamid (B/F/TAF) (n = 314) ili abakavir/dolutegravir/lamivudin (600/50/300 mg) (n = 315) jedanput na dan.
English: AUC: ↑ 306% Cmax: ↔
Croatian: Biktegravir: AUC: ↑ 306% Cmax: ↔
English: Nineteen percent of patients identified as Hispanic/Latino.
Croatian: Kao Hispanoamerikanci/Latinoamerikanci izjasnilo se 19% bolesnika.
English: • emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
Croatian: • emtricitabin, antiretrovirusni lijek poznat kao nukleozidni inhibitor reverzne transkriptaze (NRTI)
English: Co-administration of oxcarbazepine, phenobarbital, or phenytoin may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Croatian: Istodobna primjena s okskarbazepinom, fenobarbitalom ili fenitoinom može smanjiti koncentracije biktegravira i tenofoviralafenamida u plazmi.
English: Baseline ATVor DRV-based regimen (n = 287)
Croatian: Početni režim na temelju ATV-a ili DRV-a
English: Co-administration of carbamazepine may decrease bictegravir plasma concentrations.
Croatian: Istodobna primjena s karbamazepinom može smanjiti koncentracije biktegravira u plazmi.
English: In GS-US-380-1878, the mean change from baseline in CD4+ cell count at Week 48 was 25 cells/mm3 in patients who switched to B/F/TAF and 0 cells/mm3 in patients who stayed on their baseline regimen.
Croatian: U ispitivanju GS-US-380-1878, srednja vrijednost promjene u odnosu na početni broj stanica CD4 + u 48. tjednu bila je 25 stanica/mm3 u bolesnika koji su prebačeni na B/F/TAF i 0 stanica/mm3 u onih koji su ostali na početnom režimu liječenja.
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Croatian: Tenofoviralafenamid pokazao je antivirusnu aktivnost u staničnoj kulturi protiv svih skupina virusa HIV-1 (M, N, O) uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,10 do 12,0 nM) i aktivnost protiv virusa HIV-2 (vrijednosti EC50 bile su u rasponu od 0,91 do 2,63 nM).
English: Tenofovir alafenamide: AUC: ↔
Croatian: Tenofoviralafenamid: AUC: ↔
English: HIV-1 infected, treatment-naïve patients
Croatian: Bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni
English: • abnormal dreams
Croatian: • abnormalni snovi • glavobolja
English: Midazolam: AUC: ↔
Croatian: Midazolam: AUC: ↔ Cmax: ↔
English: There were no discontinuations due to renal adverse events through Week 96 in patients administered Biktarvy in clinical studies.
Croatian: U bolesnika koji su u kliničkim ispitivanjima primali lijek Biktarvy, do 96. tjedna nije bilo prekida liječenja uzrokovanih štetnih događajima povezanima s bubrezima.
English: Antifungals
Croatian: Antimikotici
English: Tenofovir alafenamide is rapidly absorbed following oral administration with peak plasma concentrations occurring at 0.5-2.0 hours after administration of B/F/TAF.
Croatian: Nakon peroralne primjene, tenofoviralafenamid se brzo apsorbira i postiže vršne koncentracije u plazmi 0,5-2,0 sata nakon primjene B/F/TAF-a.
English: Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza umrežena karmelozanatrij magnezijev stearat
English: In Study GS-US-380-1878, the efficacy and safety of switching from either abacavir/lamivudine or emtricitabine/tenofovir disoproxil fumarate (200/300 mg) plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) to B/F/TAF were evaluated in a randomised, open-label study of virologically-suppressed HIV-1 infected adults (n = 577).
Croatian: U randomiziranom, otvorenom ispitivanju GS-US-380-1878, procjenjivani su djelotvornost i sigurnost prebacivanja odraslih bolesnika zaraženih virusom HIV-1 (n = 577) s virološkom supresijom s režima abakavir/lamivudin ili emtricitabin/tenofovirdizoproksilfumarat (200/300 mg) plus atazanavir ili darunavir (pojačan kobicistatom ili ritonavirom) na B/F/TAF.
English: AUC: ↔ Cmin: ↔ Cmax: ↔
Croatian: Emtricitabin: AUC: ↔ Cmin: ↔ Cmax: ↔
English: Bictegravir is absorbed following oral administration with peak plasma concentrations occurring at 2.0-4.0 hours after administration of B/F/TAF.
Croatian: Nakon peroralne primjene, biktegravir se apsorbira i postiže vršne koncentracije u plazmi 2,0-4,0 sata nakon primjene B/F/TAF-a.
English: AUC: ↑ 61% Cmax: ↔
Croatian: Biktegravir: AUC: ↑ 61% Cmax: ↔
English: Co-administration of itraconazole or posaconazole may increase bictegravir plasma concentrations.
Croatian: Istodobna primjena itrakonazola ili posakonazola može povisiti koncentracije biktegravira u plazmi.
English: There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir or tenofovir alafenamide in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni biktegravira ili tenofoviralafenamida u trudnica ograničeni
English: Tabulated summary of adverse reactions The adverse reactions in Table 2 are listed by system organ class and frequency.
Croatian: Nuspojave u tablici 2 navedene su prema klasifikaciji organskih sustava i učestalosti.
English: Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in loading tenofovir into peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
Croatian: A djelotvorniji od tenofovirdizoproksilfumarata u koncentriranju tenofovira u mononuklearnim stanicama periferne krvi (PBMC), (uključujući limfocite i druge ciljne stanice virusa HIV-a) i makrofagima.
English: Package leaflet: Information for the user Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete biktegravir/emtricitabin/tenofoviralafenamid
English: Talk to your doctor if you are taking: • medicines used for treating HIV and/or hepatitis B, containing:
Croatian: • lijekove za liječenje infekcije virusom HIV-a i/ili hepatitisa B, koji sadrže:
English: In Study GS-US-380-1844, the efficacy and safety of switching from a regimen of dolutegravir + abacavir/lamivudine or abacavir/dolutegravir/lamivudine to B/F/TAF were evaluated in a randomised, double-blind study of virologically-suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 563).
Croatian: U randomiziranom, dvostruko slijepom ispitivanju GS-US-380-1844, procjenjivani su djelotvornost i sigurnost prebacivanja odraslih bolesnika zaraženih s virusom HIV-1 (n = 563) s virološkom supresijom (HIV-1 RNK < 50 kopija/ml) s režima dolutegravir + abakavir/lamivudin ili abakavir/dolutegravir/lamivudin na B/F/TAF.
English: The active substances are bictegravir, emtricitabine and tenofovir alafenamide.
Croatian: Djelatne tvari su biktegravir, emtricitabin i tenofoviralafenamid.
English: AUC: ↓ 54% Cmax: ↓ 57%
Croatian: Tenofoviralafenamid: AUC: ↓ 54% Cmax: ↓ 57%
English: • joint pain (arthralgia)
Croatian: • bol u zglobovima (artralgija)
English: Tenofovir alafenamide
Croatian: tenofoviralafenamid
English: angioedema3,4, rash, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon:
Croatian: angioedem3, 4, osip, svrbež, urtikarija4
English: Co-administration of rifampicin may decrease tenofovir alafenamide plasma concentrations.
Croatian: Istodobna primjena rifampicina može smanjiti koncentracije tenofoviralafenamida u plazmi.
English: There are limited safety and efficacy data for Biktarvy in patients co-infected with HIV-1 and hepatitis C virus (HCV).
Croatian: HIV-1 i virusom hepatitisa C (HCV) ograničeni su.
English: There were no discontinuations due to hepatic adverse events through Week 96 in Biktarvy clinical studies.
Croatian: U kliničkim ispitivanjima lijeka Biktarvy, do 96. tjedna nije bilo prekida liječenja uzrokovanih štetnim događajima povezanima s jetrom.
English: • itching (pruritus)
Croatian: • svrbež (pruritus) • osip
English: Co-administration with St. John's wort is contraindicated, due to the effect of St. John's wort on the bictegravir component of Biktarvy.
Croatian: Istodobna primjena lijeka Biktarvy s gospinom travom kontraindicirana je zbog djelovanja gospine trave na biktegravir, sastojak lijeka Biktarvy.
English: Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir) (see also table below).
Croatian: (npr. makrolidi, ciklosporin, verapamil, dronedaron, glekaprevir/pibrentasvir) (vidjeti također tablicu u nastavku).
English: Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Croatian: Jedna filmom obložena tableta sadrži 50 mg biktegravira u obliku biktegravirnatrija, 200 mg emtricitabina i 25 mg tenofoviralafenamida u obliku tenofoviralafenamidfumarata.
English: Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Croatian: Jedna filmom obložena tableta lijeka Biktarvy sadrži 50 mg biktegravira u obliku biktegravirnatrija, 200 mg emtricitabina i 25 mg tenofoviralafenamida u obliku tenofoviralafenamidfumarata.
English: Co-administration of rifabutin may decrease tenofovir alafenamide plasma concentrations.
Croatian: Istodobna primjena rifabutina može smanjiti koncentracije tenofoviralafenamida u plazmi.
English: Co-administration of rifapentine may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Croatian: Istodobna primjena rifapentina može smanjiti koncentracije biktegravira i tenofoviralafenamida u plazmi.
English: In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
Croatian: A u PBMC-ovima (uključujući limfocite i druge ciljne stanice HIV-a) i makrofazima te pomoću karboksilesteraze-1 u hepatocitima.
English: Tablet core
Croatian: Tablični sažetak nuspojava
English: AUC: ↔ Cmax: ↔
Croatian: Sertralin: AUC: ↔ Cmax: ↔
English: SEDATIVES/HYPNOTICS Midazolam (2 mg, oral syrup, single dose),
Croatian: Midazolam (jedna doza od 2 mg, sirup), biktegravir/emtricitabin/
English: Co-administration may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Croatian: Istodobna primjena može smanjiti koncentracije biktegravira i tenofoviralafenamida u plazmi.
English: Co-administration may decrease bictegravir plasma concentrations.
Croatian: Istodobna primjena može smanjiti koncentracije biktegravira u plazmi.
English: HIV-1 isolates with the K65R mutation have low level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Croatian: Izolati virusa HIV-1 s mutacijom K65R pokazuju malo smanjenje osjetljivosti na abakavir,
English: • mineral supplements or vitamins containing magnesium or iron  See section 2 for more information on taking these medicines with Biktarvy.
Croatian: • vitaminske ili mineralne dodatke prehrani koji sadrže magnezij ili željezo.
English: Gilead Sciences Poland Sp. z o.o.
Croatian: Gilead Sciences Belgium SPRL-BVBA
English: No special hazard for humans was revealed in conventional studies of carcinogenic potential and toxicity to reproduction and development.
Croatian: Nije otkriven poseban rizik za ljude na temelju konvencionalnih ispitivanja kancerogenog potencijala te reproduktivne i razvojne toksičnosti Ispitivanja reproduktivne toksičnosti u štakora i kunića nisu pokazala učinke na parenje, plodnost, graviditet ili fetalne parametre.
English: Rifabutin (300 mg once daily), Bictegravir1
Croatian: Rifabutin (300 mg jedanput na dan),
English: Get advice from a doctor or pharmacist if you are taking:
Croatian: Obavijestite svog liječnika ako uzimate:
English: In 16 HIV/HBV co-infected adults administered Biktarvy (8 HIV/HBV treatment-naïve adults in Study GS-US-380-1490; 8 HIV/HBV suppressed adults in Study GS-US-380-1878), the safety profile of Biktarvy was similar to that in patients with HIV-1 monoinfection (see section 5.1).
Croatian: GS-US-380-1878), sigurnosni profil lijeka Biktarvy bio je sličan onome u bolesnika zaraženih samo virusom HIV-1 (vidjeti dio 5.1).
English: Biktarvy [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Biktarvy [Samo vanjsko pakiranje]
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Croatian: Gilead Sciences, S.L. Tel: + 34 (0) 91 378 98 30
English: Bictegravir/Emtricitabine/ Tenofovir alafenamide
Croatian: Sofosbuvir/velpatasvir/
English: In Studies GS-US-380-1489 and GS-US-380-1490, the mean increase from baseline in CD4+ cell count at Week 96 was 262, 288, and 281 cells/mm3 in the pooled B/F/TAF, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
Croatian: U ispitivanjima GS-US-380-1489 i GS-US-380-1490, srednja vrijednost promjene u odnosu na početni broj stanica CD4 + u 96. tjednu bila je 262 stanica/mm3 u skupini bolesnika koji su primali
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400/100/100 + 100 mg3 once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide (Inhibition of P-gp/BCRP)
Croatian: (400/100/100 + 100 mg3 jedanput na dan), biktegravir/emtricitabin/
English: No virologic data at week 48 or 96 window Discontinued study drug due to AE or deathg
Croatian: HIV-1 RNK ≥ 50 kopija/mlf Bez viroloških podataka u okviru 48. ili 96. tjedna
English: Cmax, Cmin
Croatian: Srednja vrijednost postotka promjene za AUC, Cmax, Cmin
English: ANTIDEPRESSANTS Sertraline (50 mg single dose), Tenofovir alafenamide6
Croatian: Sertralin (jedna doza 50 mg),
English: • anticonvulsants used to treat epilepsy, containing: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin
Croatian: - karbamazepin, okskarbazepin, fenobarbital ili fenitoin
English: Bictegravir (simultaneous administration with food): AUC: ↔
Croatian: Biktegravir (otopina antacida 2 sata poslije, natašte): AUC: ↔ Cmax: ↔
English: At Week 48, 7 patients were HBV suppressed (HBV DNA < 29 IU/mL) and had HIV-1 RNA < 50 copies/mL.
Croatian: U 48 tjednu, 7 bolesnika imalo je suprimiran HBV (HBV DNK
English: • ulcer-healing medicines containing sucralfate  Tell your doctor if you are taking any of these medicines.
Croatian: Obavijestite svog liječnika ako uzimate neki od ovih lijekova.
English: Tel.: + 48 (0) 22 262 8702
Croatian: Gilead Sciences Poland Sp. z o.o. Tel: + 48 (0) 22 262 8702
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Karvea was used for two years or more.
Croatian: Karvea se primjenjivao tijekom dvije godine ili duže.
English: Other information about Karvea
Croatian: Druge informacije o lijeku Karvea
English: The full EPAR for Karvea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Karvea može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Karvea on 27 August 1997.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Karvea vrijedi na prostoru Europske unije od 27. kolovoza 1997.
English: The usual recommended dose of Karvea is 150 mg once a day.
Croatian: Uobičajena preporučena doza lijeka Karvea je 150 mg jedanput na dan.
English: What is the risk associated with Karvea?
Croatian: Koji su rizici povezani s lijekom Karvea?
English: For more information about treatment with Karvea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Karvea pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Karvea.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te svoje preporuke o uvjetima za primjenu lijeka Karvea.
English: Karvea was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Croatian: Karvea je uspoređen s placebom (liječenjem bez djelatne tvari) u 712 bolesnika i s drugim antihipertenzivima (atenololom, enalaprilom ili amlodipinom) u 823 bolesnika.
English: Why has Karvea been approved?
Croatian: Zašto je Karvea odobren?
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Croatian: Također je ispitana primjena lijeka Karvea u kombinaciji s hidroklorotiazidom u 1.736 bolesnika.
English: For the treatment of kidney disease, Karvea was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Croatian: Za liječenje bolesti bubrega, Karvea je ispitan u dva velika ispitivanja koja su obuhvatila ukupno 2.326 bolesnika sa šećernom bolešću tipa
English: In this study, Karvea was compared with placebo and with amlodipine.
Croatian: U ovom ispitivanju, Karvea je uspoređen s placebom i s amlodipinom.
English: Karvea is a medicine that contains the active substance irbesartan.
Croatian: Karvea je lijek koji sadrži djelatnu tvar irbesartan.
English: The active substance in Karvea, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Irbesartan, djelatna tvar u lijeku Karvea je „antagonist receptora angiotenzina II”, što znači da ova tvar blokira djelovanje hormona u tijelu naziva angiotenzin II.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Croatian: Kad se koristio s hidroklorotiazidom, dva lijeka ostvarila su kombinirani učinak.
English: This is a summary of the European public assessment report (EPAR) for Karvea.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Karvea.
English: Karvea must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients.
Croatian: Karvea se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na irbesartan ili na bilo koju drugu pomoćnu tvar.
English: In patients with hypertension and type 2 diabetes, Karvea is added to some other treatments for hypertension.
Croatian: U bolesnika s hipertenzijom i šećernom bolešću tipa 2, Karvea se dodaje drugim terapijama za hipertenziju.
English: What is Karvea?
Croatian: Što je Karvea?
English: The second study looked at whether Karvea increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Croatian: Drugo je ispitivanje istražilo je li Karvea povećao vrijeme potrebno za udvostručenje razine kreatinina u krvi bolesnika (marker bolesti bubrega), dok im je bila potrebna transplantacija bubrega ili dijaliza, odnosno do njihove smrti.
English: Karvea is also used to treat kidney disease in adults with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Croatian: Karvea se također koristi za liječenje bolesti bubrega u odraslih s hipertenzijom i šećernom bolešću tipa 2 (šećerna bolest koja ne ovisi o inzulinu).
English: The most common side effect with Karvea (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels).
Croatian: Najčešća nuspojava s lijekom Karvea (koje se mogu javiti u više od 1 na 10 osoba) je hiperkalemija (visoka razina kalija u krvi).
English: In the blood pressure studies, Karvea was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Croatian: U ispitivanjima krvnoga tlaka, Karvea je bio djelotvorniji od placeba u smanjivanju dijastoličkog krvnog tlaka i imao je slično djelovanje kao drugi antihipertenzivi.
English: Karvea in combination with aliskirencontaining medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Croatian: U kombinaciji s lijekovima koji sadrže aliskiren (koristi se za liječenje esencijalne hipertenzije) Karvea se ne smije koristiti u bolesnika s dijabetesom, ili umjerenim do ozbiljnim oštećenjem funkcije bubrega.
English: In the second kidney disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, or death during the study by 20% in comparison with placebo.
Croatian: U drugom ispitivanju bolesti bubrega, Karvea je tijekom ispitivanja smanjio relativan rizik od udvostručavanja razina kreatinina u krvi koje zahtjeva transplantaciju bubrega ili dijalizu odnosno uzrokuju smrt, za 20% u usporedbi s placebom.
English: What is Karvea used for?
Croatian: Za što se Karvea koristi?
English: The CHMP decided that Karvea's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) odlučilo je da koristi od lijeka Karvea nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: What benefit has Karvea shown during the studies?
Croatian: Koje su koristi lijeka Karvea dokazane u ispitivanjima?
English: In the first kidney disease study, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Croatian: U prvom ispitivanju bolesti bubrega Karvea je bio djelotvorniji od placeba u smanjivanju rizika od nastanka oštećenja funkcije bubrega kako je izmjereno izlučivanjem proteina.