natgillin/translations-raw huggingface dataset:
The safety and efficacy of Aptivus capsules in children aged 2 to 12 years has not been established.
Sigurnost i djelotvornost Aptivus kapsula u djece dobi 2 do 12 godina starosti nisu ustanovljene.
The safety and efficacy of Aptivus in children under 2 years of age has not been established.
Sigurnost i djelotvornost Aptivusa nisu ustanovljene u djece ispod 2 godine starosti.
The safety and efficacy of Aptivus in children under 2 years of age has not been established.
Sigurnost i djelotvornost Aptivusa u djece ispod 2 godine starosti nisu ustanovljene.
The safety and efficacy of ataluren in patients aged 65 and older have not yet been established. (See Section 5.2)
Sigurnost i djelotvornost atalurena u bolesnika u dobi od 65 godina i starijih nisu još ustanovljene (vidjeti dio 5.2.).
The safety and efficacy of Atripla have not been studied for the treatment of chronic HBV infection.
Nije utvrđena sigurnost i djelotvornost primjene Atriple u liječenju kronične infekcije virusom HBV-a.
The safety and efficacy of Atripla in children under the age of 18 years have not been established (see section 5.2).
Sigurnost i djelotvornost Atriple u djece mlađe od 18 godina nisu ustanovljene (vidjeti dio 5.2).
The safety and efficacy of AUBAGIO in children aged from 10 to less than 18 years has not yet been established.
Sigurnost i djelotvornost lijeka AUBAGIO u djece i adolescenata u dobi od 10 do manje od 18 godina nisu još ustanovljene.
The safety and efficacy of Avastin in children less than 18 years old have not been established.
Sigurnost i djelotvornost primjene lijeka Avastin u djece mlađe od 18 godina nisu ustanovljene.
The safety and efficacy of Avastin in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting or prior bevacizumab treatment, was studied in a phase III randomised, double-blind, placebo-controlled trial (AVF4095g).
Sigurnost i djelotvornost lijeka Avastin u liječenju bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu, koje nisu prethodno primale kemoterapiju za liječenje recidiva i nisu prethodno bile liječene bevacizumabom, ispitivane su u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (AVF4095g).
The safety and efficacy of Avastin in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in two phase III trials (AVF4095g and MO22224) with different patient populations and chemotherapy regimens.
Sigurnost i djelotvornost lijeka Avastin u liječenju recidiva epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma ispitivane su u dvama ispitivanjima faze III (AVF4095g i MO22224) s različitim populacijama bolesnica i različitim kemoterapijskim protokolima.
The safety and efficacy of Avastin, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Sigurnost primjene i djelotvornost lijeka Avastin u kombinaciji s kemoterapijom na bazi platine kao prvom linijom liječenja bolesnika koji boluju od neskvamoznog karcinoma pluća nemalih stanica (NSCLC) ispitana je u ispitivanjima E4599 i BO17704.
The safety and efficacy of AVONEX in children below 12 years of age have not yet been established.
Sigurnost i djelotvornost AVONEXA u djece mlađe od 12 godina nisu još utvrđene.
The safety and efficacy of axitinib in children and adolescents < 18 years have not been established.
Sigurnost i djelotvornost aksitiniba u djece i adolescenata < 18 godina nisu ustanovljene.
The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years has not been established and its use is not recommended in infants, children or adolescents
Sigurnost i djelotvornost AZOPTA u dojenčadi, djece i adolescenata u dobi od 0 do 17 godina nisu ustanovljene, te se njegova primjena u dojenčadi, djece i adolescenata ne preporučuje.
The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years has not been established.
Sigurnost i djelotvornost AZOPTA u dojenčadi, djece i adolescenata u dobi od 0 do 17 godina nisu ustanovljene.
The safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation were assessed in two randomised, partially-blinded, multicenter, 3 year studies with the primary endpoint specified at Year 1.
Djelotvornost i sigurnost primjene belatacepta u sklopu imunosupresivnog režima nakon presađivanja bubrega procjenjivale su se u dva randomizirana, djelomično slijepa, multicentrična ispitivanja u trajanju od 3 godine s primarnom završnom točkom specificiranom u 1. godini.
The safety and efficacy of Benlysta in children and adolescents (less than 18 years of age) has not been established.
Sigurnost i djelotvornost primjene lijeka Benlysta u djece i adolescenata (mlađih od 18 godina) nije ustanovljena.
The safety and efficacy of Beromun in children under 18 years have not been established.
Sigurnost i djelotvornost Beromuna u djece u dobi do 18 godina nisu još ustanovljene.
The safety and efficacy of BindRen has not been studied in patients with:
Sigurnost i djelotvornost BindRena nije ispitana u bolesnika s:
The safety and efficacy of BiResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Sigurnost i djelotvornost lijeka BiResp Spiromax u djece stare 12 godina i mlađe, te u adolescenata, od 13 do 17 godina još nisu ustanovljene.
The safety and efficacy of BLINCYTO have not been studied in patients with severe hepatic impairment.
Sigurnost i djelotvornost lijeka BLINCYTO nisu ispitane u bolesnika s teškim oštećenjem funkcije jetre.
The safety and efficacy of BLINCYTO have not been studied in patients with severe renal impairment.
Sigurnost i djelotvornost lijeka BLINCYTO nisu ispitane u bolesnika s teškim oštećenjem bubrega.
The safety and efficacy of BLINCYTO in paediatric patients have not yet been established.
Sigurnost i djelotvornost lijeka BLINCYTO u pedijatrijskih bolesnika nisu još ustanovljene.
The safety and efficacy of Bondronat in children and adolescents below the age of 18 years have not been established.
Sigurnost i djelotvornost lijeka Bondronat u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Sigurnost i djelotvornost primjene bortezomiba (primijenjenog intravenskom injekcijom) u preporučenoj dozi od 1,3 mg/m2 procjenjivale su se u 2 ispitivanja: randomiziranom, komparativnom ispitivanju faze III (APEX), u usporedbi s deksametazonom (Dex) u 669 bolesnika s relapsom ili refraktornim multiplim mijelomom koji su prethodno bili primili 1-3 linije terapije te ispitivanju faze II u jednoj skupini od 202 bolesnika s relapsom i refraktornim multiplim mijelomom, koji su prethodno primili najmanje 2 linije terapije i u kojih je bolest napredovala za vrijeme posljednje terapije.
The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Sigurnost i djelotvornost primjene bortezomiba (primjenjenog intravenskom injekcijom) u preporučenoj dozi od 1,3 mg/m2 procjenjivale su se u 2 ispitivanja: randomiziranom, komparativnom ispitivanju faze III (APEX), u usporedbi s deksametazonom (Dex) u 669 bolesnika s relapsom ili refraktornim multiplim mijelomom koji su prethodno bili primili 1 – 3 linije terapije te ispitivanju faze II u jednoj skupini od 202 bolesnika s relapsom i refraktornim multiplim mijelomom, koji su prethodno primili najmanje 2 linije terapije i u kojih je bolest napredovala za vrijeme posljednje terapije.
The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Sigurnost i djelotvornost primjene bortezomiba (primjenjenog intravenskom injekcijom) u preporučenoj dozi od 1,3 mg/m2 procjenjivale su se u 2 ispitivanja: randomiziranom, komparativnom ispitivanju faze III (APEX), u usporedbi s deksametazonom (Dex) u 669 bolesnika s relapsom ili refraktornim multiplim mijelomom koji su prethodno bili primili 1-3 linije terapije te ispitivanju faze II u jednoj skupini od 202 bolesnika s relapsom i refraktornim multiplim mijelomom, koji su prethodno primili najmanje 2 linije terapije i u kojih je bolest napredovala za vrijeme posljednje terapije.
The safety and efficacy of bosutinib in children less than 18 years of age have not been established.
Sigurnost i djelotvornost bosutiniba u djece mlađe od 18 godina još nisu ustanovljene.
The safety and efficacy of brivaracetam in children aged less than 16 years have not yet been established.
Sigurnost i djelotvornost brivaracetama u djece mlađe od 16 godina još nisu ustanovljene.
The safety and efficacy of Budesonide/Formoterol Teva in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Sigurnost i djelotvornost lijeka Budezonid/Formoterol Teva u djece stare 12 godina i mlađe, te u adolescenata od 13 do 17 godina nisu još ustanovljene.
The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Sigurnost i djelotvornost lijeka Budezonid/Formoterol Teva Pharma B.V. u djece stare 12 godina i mlađe, te u adolescenata, od 13 do 17 godina nisu još ustanovljene.
The safety and efficacy of CABOMETYX were evaluated in a randomized, open-label, multicenter Phase 3 study.
Sigurnost i djelotvornost CABOMETYXA procijenjene su u randomiziranom, multicentričnom, otvorenom ispitivanju faze 3.
The safety and efficacy of cangrelor in children aged less than 18 years has not been established.
Sigurnost i djelotvornost kangrelora u djece mlađe od 18 godina nisu ustanovljene.
The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicenter clinical trials.
Djelotvornost i sigurnost primjene kaspofungina procjenjivala se u pedijatrijskih bolesnika u dobi od 3 mjeseca do 17 godina u dva prospektivna, multicentrična klinička ispitivanja.
The safety and efficacy of CE/bazedoxifene have not been evaluated in patients with hepatic impairment.
Sigurnost i djelotvornost KE/bazedoksifena nisu ispitivani u bolesnica s oštećenom funkcijom jetre.
The safety and efficacy of CELSENTRI in children younger than 18 years of age has not been established.
Sigurnost i djelotvornost lijeka CELSENTRI u djece mlađe od 18 godina nije utvrđena.
The safety and efficacy of Ceplene in children below 18 years of age have not yet been established.
Sigurnost i djelotvornost Ceplenea u djece mlađe od 18 godina još nije utvrđena.
The safety and efficacy of CHAMPIX in children or adolescents below 18 years have not yet been established.
Sigurnost i djelotvornost lijeka CHAMPIX u djece ili adolescenata mlađih od 18 godina još nisu ustanovljene.
The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established.
Nisu ustanovljene sigurnost primjene i djelotvornost lijeka Cholestagel u bolesnika s disfagijom, poremećajima gutanja, teškim poremećajima gastrointestinalnog motiliteta, upalnom bolešću crijeva, zatajenjem jetre ili opsežnom operacijom gastrointestinalnog trakta.
The safety and efficacy of cinacalcet in the paediatric population have not been established.
Sigurnost i djelotvornost sinakalceta u pedijatrijskoj populaciji nisu ustanovljeni.
The safety and efficacy of Cinryze in children less than 12 years old has not yet been established.
Sigurnost i djelotvornost lijeka Cinryze u djece mlađe od 12 godina nije još ustanovljena.
The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sigurnost primjene i djelotvornost klopidogrela procijenjena je u 4 dvostrukoslijepe studije koje su uključivale preko 80 000 bolesnika: studija CAPRIE, u kojoj se uspoređivao klopidogrel i ASK te CURE, CLARITY i COMMIT studije, u kojima se uspoređivalo djelovanje klopidogrela prema placebu, s tim da su obje terapije davane u kombinaciji s ASK i drugom standardnom terapijom.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sigurnost i djelotvornost klopidogrela procijenjene su tijekom pet dvostruko slijepih ispitivanja u kojima je sudjelovalo više od 88.000 bolesnika: u ispitivanju CAPRIE, usporedbi klopidogrela s ASA- om, te u ispitivanjima CURE, CLARITY, COMMIT i ACTIVE-A u kojima je klopidogrel uspoređivan s placebom, a oba su lijeka davana u kombinaciji s ASA-om i drugom standardnom terapijom.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sigurnost primjene i djelotvornost klopidogrela procijenjena je u 5 dvostrukoslijepih studija koje su uključivale više od 88 000 bolesnika: studija CAPRIE, u kojoj se uspoređivao klopidogrel i ASK te CURE, CLARITY, COMMIT i ACTIVE-A studije, u kojima se uspoređivalo djelovanje klopidogrela u odnosu na placebo, s tim da su obje terapije davane u kombinaciji s ASK i drugom standardnom terapijom.
The safety and efficacy of Coagadex for perioperative management was evaluated in five subjects aged 14 to 59 years with mild (n=2), moderate (n=1), and severe (n=2) disease, who underwent a total of seven surgical procedures.
Sigurnost i djelotvornost lijeka Coagadex za perioperativno zbrinjavanje procijenjeni su kod petero ispitanika u dobi od 14 do 59 godina s blagom (n=2), umjerenom (n=1) i teškom (n=2) bolešću koji su prošli ukupno sedam kirurških zahvata.
The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Nisu ispitane sigurnost i djelotvornost istodobne primjene lijeka CIALIS s drugim inhibitorima PDE5 ili drugim lijekovima za erektilnu disfunkciju.
The safety and efficacy of combinations of Spedra and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Sigurnost i djelotvornost Spedre u kombinaciji s drugim inhibitorima PDE5 ili drugim liječenjima erektilne disfunkcije nisu ispitane.
The safety and efficacy of combinations of Vivanza film-coated tablets with vardenafil orodispersible tablets or other treatments for erectile dysfunction have not been studied.
Djelotvornost i sigurnost primjene kombinacija Vivanza filmom obloženih tableta s vardenafil raspadljivim tabletama za usta ili drugim lijekovima za erektilnu disfunkciju nije ispitana.
The safety and efficacy of combinations of Vivanza orodispersible tablets with Vivanza film-coated tablets or other treatments for erectile dysfunction have not been studied.
Djelotvornost i sigurnost primjene kombinacija Vivanza raspadljivih tableta za usta s Vivanza filmom obloženim tabletama ili drugim lijekovima za erektilnu disfunkciju nije ispitana.
The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 -mL/min vs above 40 mL/min).
Sigurnost i djelotvornost prebacivanja s inhibitora kalcineurina na Rapamune u bolesnika koji održavaju presadak bubrega (6-120 mjeseci nakon presađivanja) procijenjena je u randomiziranom, multicentričnom, kontroliranom ispitivanju u kojem su ispitanici podijeljeni u skupine prema izračunatoj početnoj vrijednosti brzine glomerularne filtracije (20-40 ml/min nasuprot >40 ml/min).
The safety and efficacy of Cosentyx were assessed in 1,003 patients in two randomised, double-blind, placebo-controlled phase III studies in patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease-modifying anti-rheumatic drug (DMARD) therapy.
Sigurnost i djelotvornost Cosentyxa ocijenjene su u 1003 bolesnika u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III u bolesnika s aktivnim psorijatičnim artritisom (≥3 otečena i ≥3 osjetljiva zgloba) unatoč nesteroidnom protuupalnom lijeku (NSAID, engl. non-steroidal anti-inflammatory drug), kortikosteroidu ili terapiji antireumatskim lijekom koji modificira tijek bolesti (DMARD).
The safety and efficacy of Cosentyx were assessed in four randomised, double-blind, placebo-controlled phase III studies in patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy [ERASURE, FIXTURE, FEATURE, JUNCTURE].
Sigurnost i djelotvornost Cosentyxa ocjenjivali su se u četiri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III u bolesnika s umjerenom do teškom plak psorijazom koji su bili kandidati za fototerapiju ili sistemsku terapiju [ERASURE, FIXTURE, FEATURE, JUNCTURE].
The safety and efficacy of CRESEMBA in children aged below 18 years has not yet been established.
Sigurnost i djelotvornost lijeka CRESEMBA u djece mlaĎe od 18 godina nisu ustanovljene.
The safety and efficacy of CRIXIVAN in children under the age of 4 years have not been established (see section 5.1 and 5.2).
Sigurnost i djelotvornost lijeka CRIXIVAN u djece mlađe od 4 godine nisu ustanovljene (vidjeti dijelove 5.1 i 5.2).
The safety and efficacy of Cubicin in children and adolescents aged below 18 years with right-sided infective endocarditis (RIE) due to Staphylococcus aureus or with Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI have not been established.
Sigurnost i djelotvornost Cubicina u djece i adolescenata starosti ispod 18 godina s desnostranim infektivnim endokarditisom (RIE) izazvanim bakterijom Staphylococcus aureus ili s Staphylococcus aureus bakterijemijom (SAB) kada je povezana s RIE-om ili s kompliciranom infekcijom kože ili mekog tkiva nisu ustanovljene.
The safety and efficacy of dabrafenib in non-Caucasian patients have not been established.
Sigurnost i djelotvornost dabrafeniba nisu utvrđeni u bolesnika drugih rasnih skupina osim bijelaca.
The safety and efficacy of Dacogen in children aged < 18 years have not yet been established.
Sigurnost primjene i djelotvornost Dacogena u djece dobi < 18 godina, još nije ustanovljena.
The safety and efficacy of Daklinza in children and adolescents aged <18 years have not yet been established.
Sigurnost i djelotvornost lijeka Daklinza u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of Daklinza in the treatment of HCV infection in patients who are co-infected with HBV have not been investigated.
Nisu ispitivane sigurnost i djelotvornost lijeka Daklinza u liječenju infekcije HCV-om u bolesnika koji imaju istodobnu infekciju HBV-om.
The safety and efficacy of Daklinza in the treatment of HCV infection in patients with Child-Pugh C liver disease have been established in the clinical study ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B. Therefore, a conservative treatment regimen of Daklinza + sofosbuvir +/- ribavirin for 24 weeks is proposed for patients with Child-Pugh C (see sections 4.2 and 5.1).
Sigurnost i djelotvornost lijeka Daklinza u liječenju infekcije HCV-om u bolesnika s bolešću jetre Child-Pugh stadija C ustanovljene su u kliničkom ispitivanju ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana); međutim, stope SVR-a bile su niže nego u bolesnika s bolešću Child-Pugh stadija A i B. Stoga se za bolesnike s bolešću Child-Pugh stadija C preporučuje konzervativan režim liječenja lijekom Daklinza + sofosbuvirom +/- ribavirinom u trajanju od 24 tjedna (vidjeti dijelove 4.2 i 5.1).
The safety and efficacy of dapagliflozin in patients with type 1 diabetes have not been established and dapagliflozin should not be used for treatment of patients with type 1 diabetes.
Sigurnost i djelotvornost dapagliflozina u bolesnika sa šećernom bolešću tipa 1 nisu ustanovljene te se dapagliflozin ne smije primjenjivati u liječenju bolesnika sa šećernom bolešću tipa 1.
The safety and efficacy of dapagliflozin in patients with type 1 diabetes have not been established and Qtern should not be used for treatment of patients with type 1 diabetes.
Sigurnost i djelotvornost dapagliflozina u bolesnika sa šećernom bolešću tipa 1 nisu ustanovljene te se Qtern ne smije primjenjivati u liječenju bolesnika sa šećernom bolešću tipa 1.
The safety and efficacy of dasabuvir have not been established in patients with HCV/HBV co- infection.
Nisu ustanovljene sigurnost i djelotvornost dasabuvira u bolesnika koji su istodobno zaraženi HCV- om / HBV-om.
The safety and efficacy of Defitelio in children aged less than 1 month has not yet been established.
Sigurnost i djelotvornost primjene lijeka Defitelio u djece mlađe od 1 mjeseca nisu još ustanovljene.
The safety and efficacy of delamanid in children and adolescents below 18 years has not yet been established.
Sigurnost i djelotvornost delamanida u djece i adolescenata mlađih od 18 godina još nije utvrđena.
The safety and efficacy of Descovy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Sigurnost i djelotvornost lijeka Descovy u djece mlaĎe od 12 godina ili teţine < 35 kg nisu još ustanovljene.
The safety and efficacy of Descovy in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Sigurnost i djelotvornost primjene lijeka Descovy u bolesnika istodobno zaraţenih virusom HIV-1 i virusom hepatitisa C (HCV) nisu ustanovljene.
The safety and efficacy of Descovy in patients with significant underlying liver disorders have not been established (see sections 4.2 and 5.2).
Sigurnost i djelotvornost primjene lijeka Descovy u bolesnika sa značajnim podleţećim bolestima jetre nisu ustanovljene (vidjeti dijelove 4.2 i 5.2).