natgillin/translations-raw huggingface dataset:
The safety of entecavir in paediatric patients from 2 to < 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189).
Varnost entekavirja pri pediatričnih bolnikih, starih od 2 do < 18 let, temelji na podatkih dveh kliničnih preskušanj, ki še potekata, in sicer enem farmakokinetičnem preskušanju 2. faze (študija 028) in enem preskušanju 3. faze (študija 189) pri bolnikih s kronično okužbo s HBV.
The safety of Epclusa has not been assessed in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
Varnost zdravila Epclusa ni bila ocenjena pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD), zaradi katere bolnik potrebuje hemodializo.
The safety of Eurartesim has been evaluated in two phase III open-label studies involving
Varnost zdravila Eurartesim so ocenili v dveh odprtih študijah faze III, ki sta vključevali
The safety of FABLYN in the treatment of osteoporosis was also assessed in a Phase 2 placebo- controlled trial in Japanese, Korean and Taiwanese women.
Varnost zdravila FABLYN za zdravljenje osteoporoze so ocenili tudi v preskušanju faze 2, kontroliranem s placebom, pri Japonkah, Korejkah in Tajvankah.
The safety of Fexeric for the treatment of hyperphosphataemia has been investigated in 18 clinical trials involving a total of 1388 CKD 5D patients with treatment duration of up to 2 years and 145 CKD ND patients with treatment duration of 12 weeks to 1 year.
Varnost zdravila Fexeric pri zdravljenju hiperfosfatemije so preučevali v 18 kliničnih preskušanjih, ki so vključila skupno 1.388 bolnikov s KLB 5D, pri katerih je zdravljenje trajalo do dve leti, in 145 bolnikov s KLB ND, pri katerih je zdravljenje trajalo od 12 tednov do enega leta.
The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Varnost fibrinskih lepil/hemostatikov za uporabo med nosečnostjo ali dojenjem ni bila preverjena v nadzorovanih kliničnih študijah.
The safety of fondaparinux 2.5 mg has been evaluated in:
Varnost fondaparinuksa 2,5 mg so ocenjevali pri:
The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous Thrombo- Embolism and treated with fondaparinux for an average of 7 days.
Varnost fondaparinuksa so ovrednotili pri 2.517 bolnikih, zdravljenih zaradi venske trombembolije s fondaparinuksom, povprečno 7 dni dolgo.
The safety of Fortacin was evaluated based on 596 male patients who applied it during clinical trials.
Varnost zdravila Fortacin so ocenili pri 596 moških bolnikih, ki so zdravilo uporabljali v času kliničnih preskušanj.
The safety of FORTEKOR PLUS has not been established in breeding, pregnant or lactating dogs.
Varnost zdravila FORTEKOR PLUS ni bila preizkušena pri psih, ki so namenjeni za vzrejo ali so v obdobju brejosti ali laktacije.
The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle and pigs.
Varnost uporabe gamitromicina v obdobju brejosti in laktacije pri kravah in svinjah ni bila raziskana.
The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle and pigs.
Varnost uporabe gamitromicina v obdobju brejosti in laktacije pri kravah ni bila raziskana.
The safety of Genvoya in HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106).
Varnost zdravila Genvoya pri predhodno nezdravljenih pediatričnih bolnikih, okuženih s HIV-1, starih od 12 do < 18 let, so ocenili v 48 tednih v odprti klinični študiji (GS-US-292-0106).
The safety of Genvoya was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Varnost zdravila Genvoya so ocenili pri približno 70 bolnikih s hkratno okužbo s HIV/HBV, ki so se trenutno zdravili zaradi HIV v odprti klinični študiji (GS-US-292-1249).
The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renaldisease (ESRD) requiring haemodialysis.
Varnost zdravila Harvoni ni bila ocenjena pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR-estimated glomerular filtration rate] < 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere bolnik potrebuje hemodializo (glejte poglavje 5.2).
The safety of Hexyon in children over 24 months of age has not been studied in clinical trials. b- Tabulated list of adverse reactions
Varnost cepiva Hexyon pri otrocih starejših od 24 mesecev ni bila raziskana v kliničnih preskušanjih. b- Seznam neželenih učinkov v preglednici
The safety of Ilaris compared to placebo was investigated in two pivotal Phase III studies (see section 5.1).
Varnost zdravila Ilaris v primerjavi s placebom so proučevali v dveh ključnih študijah faze III (glejte poglavje 5.1).
The safety of Ilaris compared with placebo was investigated in a pivotal phase III trial that consisted of an 8-week, open-label period (Part I), a 24- week, randomised, double-blind and placebo-controlled withdrawal period (Part II), and a 16-week open label period on Ilaris (Part III).
Varnost zdravila Ilaris v primerjavi s placebom so proučevali v ključni študiji faze III, ki je bila razdeljena na naslednja obdobja: 8-tedensko odprto zdravljenje (1. obdobje), 24-tedensko randomizirano dvojno slepo, s placebom kontrolirano obdobje opuščanja (2. obdobje) in 16-tedensko odprto zdravljenje z zdravilom Ilaris (3. obdobje).
The safety of immunisation with live or attenuated viral vaccines following Gazyvaro therapy has not been studied and vaccination with live virus vaccines is not recommended during treatment and until B cell recovery.
Varnost imunizacije z živimi ali oslabljenimi virusnimi cepivi po zdravljenju z zdravilom Gazyvaro ni raziskana in cepljenje z živimi virusnimi cepivi med zdravljenjem in do okrevanja celic B ni priporočljivo.
The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom MabThera pri bolnikih z ne- Hodgkinovim limfomom (NHL) in KLL niso proučevali in cepljenje z živimi virusnimi cepivi ni priporočljivo.
The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom MabThera pri bolnikih z NHL in KLL niso proučevali in cepljenje z živimi virusnimi cepivi ni priporočljivo.
The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL patients and vaccination with live virus vaccines is not recommended.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom MabThera pri bolnikih z NHL niso proučevali in cepljenje z živimi virusnimi cepivi ni priporočljivo.
The safety of Imprida HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.
Varnost zdravila Imprida HCT so ocenjevali pri uporabi njegovega najvišjega odmerka 10 mg/320 mg/25 mg, in sicer v eni kotrolirani kratkotrajni (8-tedenski) klinični študiji z
The safety of Improvac was studied in laboratory and field safety studies.
Varnost zdravila Improvac so raziskovali v laboratorijskih in terenskih varnostnih študijah.
The safety of IMVANEX has been assessed in 18 clinical trials in which 5,028 Vaccinia-naïve individuals received two doses 1 x 108 TCID50 four weeks apart while 534 Vaccinia- and IMVANEX-experienced individuals received a single booster dose.
Varnost cepiva IMVANEX so ocenili v 18 kliničnih preskušanjih, v katerih je 5.028 posameznikov, ki predhodno še niso bili cepljeni z virusom vakcinija, prejelo dva odmerka 1 x 108 TCID50 v časovnem razmiku štirih tednov, 534 posameznikov, ki so bili z virusom vakcinija in cepivom IMVANEX že cepljeni, pa je prejelo en poživitveni odmerek.
The safety of Jakavi was assessed in 110 patients with PV in an open-label, randomised, controlled phase 3 RESPONSE study.
Varnost zdravila Jakavi so ocenjevali pri 110 bolnikih s pravo policitemijo v odprti, randomizirani, kontrolirani študiji faze 3 z imenom RESPONSE.
The safety of Kaletra has been investigated in over 2600 patients in Phase II-IV clinical trials, of which over 700 have received a dose of 800/200 mg (6 capsules or 4 tablets) once daily.
Varnost zdravila Kaletra so raziskali pri več kot 2600 bolnikih v kliničnih preskušanjih II. do IV. faze, v katerih jih je preko 700 prejemalo odmerek 800/200 mg (6 kapsul ali 4 tablete) enkrat dnevno.
The safety of Ketoconazole HRA has been evaluated based on published literature and use of ketoconazole as an antifungal treatment.
Varnost zdravila Ketokonazol HRA so ocenili na podlagi objavljene literature in uporabe ketokonazola kot antimikotika.
The safety of lacosamide in children aged below 16 years has not yet been established.
Varnost lakozamida pri otrocih, mlajših od 16 let, še ni bila dokazana.
The safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers in more than 20,000 patients, including 198 patients who received lapatinib in combination with capecitabine, 149 patients who received lapatinib in combination with trastuzumab and 654 patients who received lapatinib in combination with letrozole (see section 5.1).
Varnost lapatiniba so vrednotili tako pri samostojnem zdravljenju kot pri uporabi v kombinaciji z drugimi kemoterapevtiki pri različnih vrstah raka pri več kot 20.000 bolnikih, vključno z 198 bolniki, ki so prejemali lapatinib skupaj s kapecitabinom, 149 bolnikih, ki so prejemali lapatinib v kombinaciji s trastuzumabom in 654 bolniki, ki so prejemali lapatinib skupaj z letrozolom (glejte poglavje 5.1).
The safety of linagliptin 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with metformin has been evaluated in over 6800 patients with type 2 diabetes mellitus.
Varnost linagliptina v odmerkih po 2,5 mg dvakrat na dan (ali bioekvivalentih po 5 mg enkrat na dan) v kombinaciji z metforminom so ocenili pri več kot 6.800 bolnikih s sladkorno boleznijo tipa 2.
The safety of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients and 76 healthy volunteers treated at least once with lipegfilgrastim.
Varnost lipegfilgrastima je bila ovrednotena na podlagi rezultatov kliničnih študij, ki so vključevale 506 bolnikov in 76 zdravih prostovoljcev, ki so vsaj enkrat dobili lipegfilgrastim.
The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from viral enteritis)..
Varnost maropitanta pri zdravljenju v ciljni populaciji (npr. mladi psi, ki trpijo za virusnim eneteritisom), ki traja več kot 5 dni, ni bila raziskana.
The safety of more than one treatment course of Xiapex for Peyronie’s disease is not known.
Varnost več kot enega postopka zdravljenja z zdravilom Xiapex za Peyroniejevo bolezen ni znana.
The safety of NeuroBloc outside the approved indication has not been established and the risks (including dysphagia and respiratory difficulties) may outweigh the benefits.
Varnost zdravila NeuroBloc zunaj odobrene indikacije ni bila dokazana, zato je možno, da so tveganja (vključno z disfagijo in dihalnimi težavami) večja od koristi.
The safety of omalizumab has been studied in the cynomolgus monkey, since omalizumab binds to cynomolgus and human IgE with similar affinity.
Varnost omalizumaba so proučevali pri opicah cinomolgus, ker se omalizumab s podobno afiniteto veže na IgE teh opic in na človeški IgE.
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF4411).
Varnost peroralnega zdravljenja z ibandronsko kislino 2,5 mg na dan so proučevali v 4 s placebom kontroliranih kliničnih študijah pri 1.251 bolnikih; velika večina bolnikov je sodelovala v ključni triletni študiji zlomov (MF 4411).
The safety of oritavancin has been evaluated in over 2,400 patients with acute bacterial skin and skin structure infections in clinical studies.
Varnost oritavancina so ovrednotili pri več kot 2.400 bolnikih z akutnimi bakterijskimi okužbami kože ali kožnih struktur v kliničnih študijah.
The safety of ospemifene has been assessed in 1,892 VVA patients with doses ranging from 5 – 90 mg per day.
Varnost ospemifena so ocenili pri 1.892 bolnicah z VVA z odmerki od 5 do 90 mg na dan.
The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined.
Varnost uporabe Oxyglobina pri brejih psicah ali psicah v laktaciji ni bila ugotovljena.
The safety of Panretin gel has been assessed in clinical studies of more than 469 patients with AIDS- related KS, 439 of whom were treated with an alitretinoin concentration of 0.1%.
Varnost zdravila Panretin gel je bila ocenjena v kliničnih raziskavah z več kot 469 bolniki, obolelimi z AIDS povezanim KS, od katerih je bilo 439 zdravljenih z 0,1 %-nim alitretinoinom.
The safety of pembrolizumab has been evaluated in 2,799 patients with advanced melanoma or NSCLC across three doses (2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks) in clinical studies.
Varnost pembrolizumaba so v kliničnih študijah ocenili pri 2.799 bolnikih z napredovalim melanomom ali NSCLC s tremi odmerki (2 mg/kg na 3 tedne in 10 mg/kg na 2 ali 3 tedne).
The safety of Perjeta administered for more than 6 cycles in the neoadjuvant setting has not been established.
Varnost zdravila Perjeta pri dajanju več kot 6 ciklov pri neoadjuvantnem zdravljenju ni dokazana.
The safety of Perjeta has been evaluated in more than 1,600 patients in the randomized trials CLEOPATRA (n=808), NEOSPHERE (n=417) and TRYPHAENA (n=225) and in Phase I and phase II trials conducted in patients with various malignancies and predominantly treated with Perjeta in combination with other antineoplastic agents.
Varnost zdravila Perjeta so ocenili pri več kot 1600 bolnikih, ki so bili vključeni v randomizirana klinična preskušanja CLEOPATRA (n = 808), NEOSPHERE (n = 417) in TRYPHAENA (n = 225) in v preskušanja faze I in II, v katera so bili vključeni bolniki z različnimi malignimi boleznimi, ki so bili zdravljeni pretežno z zdravilom Perjeta v kombinaciji z drugimi antineoplastičnimi zdravili.
The safety of Perjeta in Phase I and II studies was generally consistent with that observed in the CLEOPATRA, NEOSPHERE and TRYPHAENA trials, although the incidence and most common adverse drug reactions (ADRs) varied depending on whether Perjeta was administered as monotherapy or with concomitant anti-neoplastic agents.
Varnost zdravila Perjeta v preskušanjih faze I in II je bila na splošno skladna z opažanji v preskušanjih CLEOPATRA, NEOSPHERE in TRYPHAENA, čeprav so se incidenca in najpogostejši neželeni učinki razlikovali glede na to, ali je bilo zdravilo Perjeta uporabljeno v monoterapiji ali sočasno z drugimi antineoplastičnimi zdravili.
The safety of Pixuvri was evaluated in 407 patients.
Varnost zdravila Pixuvri so ocenili pri 407 bolnikih.
The safety of Praxbind has been evaluated in 224 healthy subjects as well as 123 patients in an ongoing phase III trial, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate).
Varnost zdravila Praxbind so ocenili pri 224 zdravih preizkušancih in pri 123 bolnikih v potekajočem preskušanju III. faze, ki so imeli nenadzorovano krvavitev ali pri katerih je bila potrebna nujna operacija ali poseg in so se zdravili z zdravilom Pradaxa (dabigatran eteksilat).
The safety of Rasilez HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Varnost zdravila Rasilez HCT so ocenjevali v 9 kliničnih preskušanjih z več kot 3.900 bolniki, med katerimi je bilo več kot 700 bolnikov zdravljenih več kot 6 mesecev, 190 pa več kot 1 leto.
The safety of Reconcile has not been established in dogs less than 6 months of age or weighing less than 4 kg.
Varnost zdravila Reconcile ni bila preverjena pri psih mlajšimi od 6 mesecev ali z manj kot 4 kg telesne mase.
The safety of Reconcile has not been established in dogs less than 6 months of age or weighing less than 4 kg.
Varnost zdravila Reconcile ni preverjena pri psih, mlajših od 6 mesecev ali z manj kot 4 kg telesne mase.
The safety of reinitiating Avastin therapy in patients previously experiencing PRES is not known.
Varnost ponovne uvedbe zdravljenja z zdravilom Avastin pri bolnikih, pri katerih se je v preteklosti že pojavil sindrom posteriorne reverzibilne encefalopatije, ni znana.
The safety of reinitiating axitinib therapy in patients previously experiencing PRES is not known.
Kako varna je ponovna uvedba zdravljenja z aksitinibom pri bolnikih, pri katerih je v preteklosti prišlo do PRES, ni znano.
The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly.
Varnost ponavljajočih se odmerkov pri otrocih (starih 2 letih in več) in mladostnikih, pri bolnikih z okvaro ledvic ali starejših bolnikih ni bila ugotovljena.
The safety of rivaroxaban has been evaluated in eleven phase III studies including 32,625 patients exposed to rivaroxaban (see Table 1).
Varnost rivaroksabana so ocenili v enajstih kliničnih preskušanjih III. faze, v katere je bilo vključenih 32.625 bolnikov, ki so prejemali rivaroksaban (glejte preglednico 1).
The safety of seasonal live attenuated influenza vaccine (LAIV) in children with severe asthma and active wheezing has not been adequately studied.
Varnost sezonskega cepiva z živim oslabljenim virusom gripe (LAIV – Live Attenuated Influenza Vaccine) pri otrocih s hudo astmo in aktivnim piskajočim dihanjem ni dovolj raziskana.
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Varnost sevelamera (bodisi kot karbonata in kloridne soli) je bila raziskana v številnih kliničnih preskušanjih, ki so zajela skupaj 969 bolnikov na hemodializi, pri katerih je zdravljenje trajalo med 4 do 50 tednov (724 bolnikov, zdravljenih s sevelamerijevim kloridom, in 245 s sevelamerijevim karbonatom), 97 bolnikov na peritonealni dializi, pri katerih je zdravljenje trajalo 12 tednov (vsi zdravljeni s sevelamerijevim kloridom) in 128 bolnikih s KBL, ki niso na dializi, pri katerih je zdravljenje trajalo med 8 do 12 tednov (79 bolnikov, zdravljenih s sevelamerijevim kloridom, in 49 s sevelamerijevim karbonatom).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated:
Ker varnost sildenafila ni raziskana v naslednjih podskupinah bolnikov, je uporaba sildenafila pri le- teh kontraindicirana:
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Varnost sildenafila ni razsikana pri naslednjih podskupinah bolnikov, pri katerih je njegova uporaba zato kontraindicirana: huda okvara jeter, hipotenzija (krvni tlak <90/50 mmHg), nedavna možganska kap ali miokardni infarkt in znane dedne degenerativne bolezni mrežnice, npr. retinitis pigmentosa (manjši del teh bolnikov ima genetske motnje mrežničnih fosfodiesteraz).
The safety of sildenafil has not been studied in the following sub-groups of patients, and its use is therefore contraindicated:
Ker varnost sildenafila ni raziskana v naslednjih podskupinah bolnikov, je uporaba sildenafila pri le- teh kontraindicirana:
The safety of SonoVue was evaluated in 4653 adult patients who participated in 58 clinical trials.
Varnost zdravila SonoVue so ocenili pri 4653odraslih bolnikih, vključenih v 58 kliničnih preskušanj.
The safety of subcutaneous tocilizumab in RA includes a double-blind, controlled, multicenter study, SC-I.
Varnost uporabe subkutanega tocilizumaba pri zdravljenju revmatoidnega artritisa vključuje dvojno slepo, kontrolirano, multicentrično študijo SC-I.
The safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated.
Varnost zdravila Taltz v kombinaciji z drugimi imunomodulatorji ali fototerapijo ni bila ovrednotena.
The safety of tedizolid phosphate has been evaluated in a total of 1,485 subjects receiving at least one dose of tedizolid phosphate administered either orally or intravenously.
Varnost tedizolid fosfata je bila ocenjena pri skupno 1.485 preiskovancih, ki so prejeli najmanj en odmerek tedizolid fosfata, uporabljen peroralno ali intravensko.
The safety of tenofovir disoproxil fumarate in the setting of ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Varnost dizoproksiltenofovirijevega fumarata skupaj z ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem ni bila ugotovljena.
The safety of tenofovir disoproxil fumarate when co-administered with ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Varnost dizoproksiltenofovirijevega fumarata skupaj z ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem ni bila ugotovljena.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Varnost dizoproksiltenofovirijevega fumarata ob sočasni uporabi z ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem (npr. kobicistatom) ni bila ugotovljena.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom) ni bila ugotovljena.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Varnost dizoproksiltenofovirijevega fumarata ob sočasni uporabi z ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom) ni bila ugotovljena.
The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Varnost dizoproksiltenofovirata skupaj z ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem ni bila ugotovljena.
The safety of the combination
Varnosti kombinacije indinavirja
The safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Varnost sočasnega jemanja klopidogrela, fibrinsko specifičnih ali fibrinsko nespecifičnih trombolitikov in heparinov je bila ovrednotena pri bolnikih z akutnim miokardnim infarktom.