natgillin/translations-raw huggingface dataset:
There was no excess in major bleeds with clopidogrel + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.4% clopidogrel + ASA vs.
U studiji CURE, u kojoj je klopidogrel pimjenjivan istodobno s ASK, nije bilo povećanja broja velikih krvarenja tijekom 7 dana nakon ugrađivanja srčane premosnice u bolesnika koji su lijekove prestali uzimati više od pet dana prije kirurškog zahvata.
There was no formation of anti-ofatumumab antibodies in patients with CLL after treatment with Arzerra.
Nakon liječenja ofatumumabom u bolesnika s KLL-om nisu se razvila protutijela na ofatumumab.
There was no formation of anti-ofatumumab antibodies in patients with CLL after treatment with ofatumumab.
Nakon liječenja ofatumumabom u bolesnika s KLL-om nisu se razvila protutijela na ofatumumab.
There was no gender difference in severity or treatment discontinuation due to rash.
Razlika u spolu nije bilo kod procjene ozbiljnosti ili prestanka liječenja zbog osipa.
There was no impact of body weight on rilpivirine pharmacokinetics in paediatric patients in study C213 (33 to 93 kg), similar to what was observed in adults.
Nije bilo utjecaja tjelesne težine na farmakokinetiku rilpivirina u pedijatrijskih bolesnika u ispitivanju C213 (33 do 93 kg), slično onome što je uočeno kod odraslih.
There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial C213 (33 to 93 kg), similar to what was observed in adults.
Nije bilo utjecaja tjelesne težine na farmakokinetiku rilpivirina u pedijatrijskih ispitanika u ispitivanju C213 (33 do 93 kg), slično kao što je zabilježeno u odraslih.
There was no impact of co-administration on the other nine pneumococcal serotypes.
Istovremena primjena nije imala utjecaja na preostalih devet pneumokoknih serotipova.
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
Neovisno o tome jesu li djeca primila pola doze ili cijelu dozu za odrasle, nije zabilježeno povećanje učestalosti nakon druge doze, osim kod nekih nuspojava koje su se javljale češće nakon druge doze, što se osobito odnosi na učestalost vrućice u djece mlađe od 6 godina.
There was no increase in tumours at the lowest dose tested in rats, which is approximately 10 times the recommended human doseon a mg/m2 basis.
Nije bilo povećanja tumora u štakora pri najnižim ispitanim dozama, koje su otprilike 10 puta više od preporučene doze za ljude na bazi mg/m2.
There was no increased incidence of serious infections observed in patients with lymphocyte counts
Nije bila zabilježena povećana incidencija ozbiljnih infekcija u bolesnika s brojem limfocita <0,8x109/l ili
There was no increased rate in overall infections or serious infections in patients with low IgA, IgG or IgM.
U bolesnika s niskim vrijednostima IgA, IgG ili IgM nije porasla stopa ukupnih infekcija niti ozbiljnih infekcija.
There was no interference with the immune response to Japanese encephalitis virus (JEV) or to hepatitis A or rabies virus vaccines (see section 5.1).
Nije bilo interferencije s imunološkim odgovorom na cjepivo protiv virusa japanskog encefalitisa (JEV) niti na cjepivo protiv virusa hepatitisa A ili bjesnoće (vidjeti dio 5.1).
There was no interference with the immune response to the JE virus and HAV, respectively.
Nije bilo interferencije s imunološkim odgovorom na virus japanskog encefalitisa (JEV) i virus hepatitisa A (HAV).
There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate (increased of Cmax by about 10 % and AUC by about 20 %).
Nije bilo značajnih interakacija kada se verapamil uzimao 2 sata nakon dabigatraneteksilata (povećanje Cmax za oko 10 % i AUC za oko 20 %).
There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate (increased of Cmax by about 10 % and AUC by about 20 %).
Nije bilo značajnih interakcija kada se verapamil uzimao 2 sata nakon dabigatraneteksilata (povećanje Cmax za oko 10 % i AUC za oko 20 %).
There was no pattern for the bleeding events and no difference between treatment groups in coagulation parameters.
Nije uočen neki specifičan obrazac krvarenja, niti razlike koagulacijskih parametara između skupine liječene Aptivusom s ritonavirom i kontrolne skupine.
There was no pharmacokinetic drug-drug interaction between apremilast and methotrexate in psoriatic arthritis patients.
U bolesnika s psorijatičnim artritisom nije bilo farmakokinetičke interakcije između apremilasta i metotreksata.
There was no pharmacokinetic drug-drug interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate.
Nije bilo farmakokinetičke interakcije između apremilasta i oralnih kontraceptiva koji sadrže etinilestradiol i norgestimat.
There was no protein binding displacement between enzalutamide and other highly bound drugs (warfarin, ibuprofen and salicylic acid) in vitro.
In vitro nije primijećeno međusobno istiskivanje s proteina između enzalutamida i drugih lijekova s visokim afinitetom vezivanja (varfarin, ibuprofen i salicilatna kiselina).
There was no relevant accumulation of rivastigmine or the metabolite NAP226-90 in plasma in patients with Alzheimer’s disease, except that plasma levels were higher on the second day of transdermal patch therapy than on the first.
U plazmi bolesnika s Alzheimerovom bolešću nije bilo značajnog nakupljanja rivastigmina ili metabolita NAP226-90, osim što su razine plazme bile više drugog dana liječenja transdermalnim flasterom nego prvog.
There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years, however this is based on only 21 children less than 2 years including 6 patients between 3 months to 1 year of age.
Nije bilo značajne razlike u učestalosti štetnih događaja između bolesnika mlađih i starijih od 2 godine, no to se temelji na samo 21 djetetu mlađem od 2 godine, uključujući 6 bolesnika između 3 mjeseca i 1 godine starosti.
There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years, however this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age.
Nije bilo značajne razlike u učestalosti štetnih događaja između bolesnika mlađih i starijih od 2 godine, no to se temelji na samo 21 djetetu mlađem od 2 godine, uključujući 6 bolesnika između 3 mjeseca i 1 godine starosti.
There was no resistance observed during a 12-week prophylaxis study in immunocompromised patients.
Kod imunokompromitiranih bolesnika nije opažena otpornost na lijek tijekom ispitivanja profilakse u trajanju od 12 tjedana.
There was no significant difference between seroconversion rates in subjects aged <50 years compared to those aged ≥50 years at Day 28 or Day 56 for either treatment group.
U ispitanika u dobi <50 godina u odnosu na one u dobi ≥ 50 godina 28. ili 56. dana nije bilo značajne razlike između stopa serokonverzije ni u jednoj skupini liječenja.
There was no significant difference in overall survival in this group of patients (HR (95%CI) 0.96 (0.49-1.86)).
Nije bilo značajne razlike u ukupnom preživljenju u toj skupini bolesnika (HR (95% CI): 0,96 (0,49-1,86)).
There was no significant difference in probability of bone fracture (5.1% placebo, 5.1% salmeterol, 5.4% FP and 6.3% salmeterol/fluticasone propionate; hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.22, 95% CI: 0.87 to 1.72, p=0.248.
Nije bilo značajne razlike u vjerojatnosti koštanog prijeloma (5,1% placebo, 5,1% salmeterol, 5,4% FP i 6,3% salmeterol/flutikazonpropionat; omjer hazarda za salmeterol/flutikazonpropionat naspram placeba: 1,22, 95% CI: 0,87 do 1,72, p=0,248).
There was no specific clustering of any type of malignancy.
Nije opaženo specifično grupiranje bilo koje vrste malignoma.
There was no statistical difference between 200 mg and 400 mg caffeine with Rapiscan.
Nije bilo statističke razlike između 200 mg i 400 mg kafeina i Rapiscana.
There was no statistically significant difference between nivolumab and chemotherapy in the preliminary OS analysis that was not adjusted for the potentially confounding effects of subsequent therapy.
Nije primijećena statistički značajna razlika između nivolumaba i kemoterapije u preliminarnoj analizi OS-a koja nije bila prilagođena za potencijalno ometajuće učinke kasnije terapije.
There was no statistically significant difference between pembrolizumab and chemotherapy in the preliminary OS analysis that was not adjusted for the potentially confounding effects of crossover.
Nije bilo statistički značajne razlike između pembrolizumaba i kemoterapije u preliminarnoj analizi OS-a, koja nije bila prilagođena za moguće učinke koji bi mogli ometati prijelaz bolesnika u drugu skupinu.
There was no statistically significant difference in overall survival between the treatment groups at the time of the primary efficacy analysis (HR=0.73; 95%CI: 0.50, 1.07, p=0.1032).
Nije bilo statistički značajne razlike u ukupnom preživljenju između liječenih skupina u vrijeme primarne analize djelotvornosti (HR=0,73; 95% CI: 0,50-1,07; p=0,1032).
There was no statistically significant difference in the incidence of major + CRNM, minor, and all bleeding between the apixaban 2.5 mg twice daily and placebo treatment groups (see Table 11).
Nije bilo statistički značajne razlike u incidenciji značajnih krvarenja + klinički značajnih ali ne velikih krvarenja (CRNM), manjih, i svih krvarenja između skupine koja je liječena apiksabanom u dozi od 2,5 mg dvaput na dan i skupine koja je liječena placebom (vidjeti Tablicu 11).
There was no statistically significant difference in the incidence of major + CRNM, minor, and all bleeding between the apixaban 2.5 mg twice daily and placebo treatment groups (see Table 13).
Nije bilo statistički značajne razlike u incidenciji značajnih krvarenja + klinički značajnih ali ne velikih krvarenja (CRNM), manjih, i svih krvarenja između skupine koja je liječena apiksabanom u dozi od 2,5 mg dvaput na dan i skupine koja je liječena placebom (vidjeti Tablicu 13).
There was no statistically significant difference in the incidence of major bleeding between apixaban and ASA (see Table 7).
Nije bilo statistički značajne razlike između apiksabana i ASK-a u incidenciji značajnog krvarenja (vidjeti Tablicu 7).
There was no statistically significant difference in the incidence of major bleeding between apixaban and ASA (see Table 9).
Nije bilo statistički značajne razlike između apiksabana i ASK-a u incidenciji značajnog krvarenja (vidjeti Tablicu 9).
There was no systematic difference in any of the kinetic parameters as a function of dose level (100 to 700 micromol/kg).
Ni kod kojeg kinetičkog parametra nije bilo sustavne razlike u odnosu na visinu doze (100 do 700 mikromola/kg).
There was no teratogenicity with rilpivirine in rats and rabbits.
Nije bilo teratogenosti kod rilpivirina u štakora i kunića.
There was no treatment-related effect on embryo- fetal development.
Nije bilo učinaka na fetalni razvoj embrija vezanih za terapiju.
There was no tumorigenic response in mice of either sex.
U miševa nije bilo tumorogenog odgovora, bez obzira na spol životinja.
There was no tumourigenic response in mice of either sex.
Niti u ženki niti u mužjaka miša nije bilo tumorogenog odgovora.
There was no tumourigenic response in mice of either sex.
U miševa nije bilo tumorogenog odgovora, bez obzira na spol.
There was no worsening to Grade 3 or 4 in increased ALT, increased alkaline phosphatase, and increased creatinine.
Povišene razine ALT-a, povišene razine alkalne fosfataze i povišene razine kreatinina nisu se pogoršale do 3. ili 4. stupnja.
There was one ALK-positive patient >85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
Od 154 bolesnika u Ispitivanju 1001 s jednom skupinom bolesnika jedan je ALK-pozitivni bolesnik bio u dobi >85 godina (vidjeti također dio 4.2 i 5.2).
There was one death in each group (less than 1%).
Došlo je do jednog smrtnog slučaja u svakoj grupi (manje od 1 %).
There was one fatal case, although it was poorly documented.
Dogodio se jedan slučaj sa smrtnim ishodom, ali je bio slabo dokumentiran.
There was one Grade 4 ADR of hypokalaemia and one of hyponatraemia. c Refer to NCI CTCAE Criteria (Version 4.0) for each Grade of toxicity. d MedDRA preferred terms included are: blood potassium decreased and hypokalaemia. e MedDRA preferred terms included are: blood pressure increased and hypertension. f MedDRA preferred terms included are: abdominal pain, abdominal pain lower, abdominal pain upper, and hepatic pain.
Zabilježen je jedan slučaj hipokalijemije 4. stupnja i jedan slučaj hiponatrijemije 4. stupnja. c Vidjeti NCI CTCAE kriterije (verzija 4.0) za svaki stupanj toksičnosti. d Uključeni preferirani pojmovi prema MedDRA klasifikaciji su: smanjena razina kalija u krvi i hipokalijemija. d Uključeni preferirani pojmovi prema MedDRA klasifikaciji su: povišen krvni tlak i hipertenzija. f Uključeni preferirani pojmovi prema MedDRA klasifikaciji su: bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena i bol u jetri.
There was one hospitalisation related to PAH worsening in the bosentan group and three hospitalisations in the placebo group.
U skupini koja je dobivala bosentan došlo je do jedne hospitalizacije zbog pogoršanja plućne arterijske hipertenzije te do tri hospitalizacije u skupini koja je dobivala placebo.
There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
U kontrolnoj skupini od 77 bolesnika prijavljen- je jedan slučaj zloćudne bolesti (medijan trajanja praćenja bio je 0,8 godina; incidencija 1,3% [95% CI 0,03%-7,0%]).
There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.
Zabilježena je jedna ozbiljna nuspojava u ispitanika s teškom ishemijskom kardiomiopatijom, u kojega je 6 dana nakon ispitivanja došlo do ventrikularne fibrilacije te je nastupila smrt.
There was substantial variability and significant overlap in exposures between patients with hepatic impairment and healthy volunteers.
Postojala je i značajna varijabilnost i preklapanje u izloženostima između bolesnika s oštećenjem jetre i zdravih dobrovoljaca.
There was substantial variability and significant overlap in exposures between patients with renal impairment and healthy volunteers.
Postojala je i značajna varijabilnost i preklapanje u izloženostima između bubrežnih bolesnika i zdravih dobrovoljaca.
There was the reduction of relative risk of recurrent myocardial infarction by 35% compared to treatment with unfractionated heparin (p <0.001).
Zabilježeno je i smanjenje relativnog rizika za reinfarkt miokarda za 35 %, u usporedbi s liječenjem nefrakcioniranim heparinom (p <0,001).
There was the reduction of relative risk of recurrent myocardial infarction by 35% compared to treatment with unfractionated heparin (p <0.001).
Zabilježeno je i smanjenje relativnog rizika za reinfarkt miokarda za 35%, u usporedbi s liječenjem nefrakcioniranim heparinom (p <0,001).
There was, however, an increased infant mortality in the stavudine + didanosine (10%) treatment group compared to the stavudine (2%), didanosine (3%) or zidovudine (6%) groups, with a higher incidence of stillbirths in the stavudine + didanosine group.
Međutim, opažena je povećana smrtnost dojenčadi u skupini liječenoj sa stavudinom + didanozinom (10%), u usporedbi sa skupinama s monoterapijom stavudinom (2%), didanozinom (3%) ili zidovudinom (6%), sa većom incidencijom mrtvorođenih u skupini sa stavudinom + didanozinom.
There were 0.6 % and 0 % of patients with hypotension and 2.8 % and 3.1 % of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively
U skupini podvrgnutoj kombiniranoj terapiji bilo je 0,6% bolesnika s hipotenzijom i 2,8% bolesnika s omaglicom kao nuspojavama, dok je taj postotak u skupini na monoterapiji iznosio 0% za hipotenziju i 3,1% za omaglicu.
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).
Bilo je 10 novih viroloških neuspjeha između primarne analize 48. tjedna i 96. tjedna (3 bolesnika s početnim virusnim opterećenjem ≤ 100 000 kopija/ml i 7 bolesnika s početnim virusnim opterećenjem > 100 000 kopija/ml).
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).
Od primarne analize u 48. tjednu do 96. tjedna bilo je 10 novih slučajeva virološkog neuspjeha (3 pacijenata s početnim virološkim opterećenjem ≤ 100 000 kopija/ml i 7 pacijenata s početnim virološkim opterećenjem > 100 000 kopija/ml).
There were 15 patients who received imatinib and no other second-generation TKI who met these criteria.
Te je kriterije zadovoljilo 15 bolesnika koji su dobivali imatinib i nijedan drugi TKI druge generacije.
There were 23 patients (4.4%) with a QTc increase from baseline >60 msec.
Bilo je 23 bolesnika (4,4%) s povećanjem QTc-a >60 msec u odnosu na početnu vrijednost.
There were 3678 subjects 18-60 years of age, 264 subjects 61-70 years of age, and 41 subjects greater than 70 years of age.
Bilo je 3678 ispitanika u dobi od 18 do 60 godina, 264 ispitanika u dobi od 61 do 70 godina i 41 ispitanik stariji od 70 godina.
There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
U šest dvostruko slijepih, kontroliranih kliničkih ispitivanja sigurnosti i djelotvornosti, provedenih kako bi se ispitali učinci saksagliptina na kontrolu glikemije, randomizirano je 4148 bolesnika sa šećernom bolešću tipa 2, uključujući 3021 bolesnika liječenog lijekom Onglyza.
There were 5 complete responses and 32 partial responses for an ORR of 70% (95% CI: 56%, 82%).
Bilo je 5 potpunih odgovora i 32 parcijalna odgovora za ORR od 70% (95% CI: 56%, 82%).
There were 5897 patients enrolled, representing 49 % of patients originally randomly assigned to receive dabigatran etexilate in RE-LY and 86 % of RELY-ABLE–eligible patients.
Uključeno je 5 897 bolesnika, koji su predstavljali 49 % bolesnika prvotno nasumično odabranih za primanje dabigatraneteksilata u ispitivanju RE-LY te 86 % bolesnika koji su bili pogodni za ispitivanje RELY-ABLE.
There were 7/317 patients (2%) in the emtricitabine/rilpivirine/tenofovir disoproxil fumarate arm and 6/152 patients (4%) in the Delayed Switch arm who permanently discontinued study drug due to a treatment-emergent adverse event (TEAE).
Bilo je 7/317 bolesnika (2%) u skupini koja prima emtricitabin/rilpivirin/tenofovirdizoproksilfumarat i 6/152 bolesnika (4%) u skupini s odgođenim prebacivanjem koji su trajno prekinuli liječenje ispitivanim lijekom zbog štetnog događaja nastalog tijekom liječenja (TEAE).
There were 7/317 patients (2%) in the Eviplera arm and 6/152 patients (4%) in the Delayed Switch arm who permanently discontinued study drug due to a treatment-emergent adverse events (TEAE).
U skupini na lijeku Eviplera bilo je 7/317 pacijenata (2%), a u skupini s odgođenim prebacivanjem 6/152 (4%) pacijenata koji su trajno prekinuli uzimanje ispitivanog lijeka zbog štetnih događaja koji su se pojavili uz liječenje.
There were 77 subjects enrolled into the first study and 109 into the second.
U prvo ispitivanje bilo je uključeno 77 ispitanika, u drugo 109.
There were 80 paediatric CAPS patients (2-17 years of age) included in the studies.
U ispitivanja je bilo uključeno 80 pedijatrijskih bolesnika s CAPS-om (u dobi od 2 do 17 godina).
There were 952 patients with HER2-negative tumours, and a total of 115 patients whose tumour HER2 status was unconfirmed (no tumour sample, no assay result, or other reason).
952 bolesnice imale su HER2- negativne tumore, a ukupno 115 bolesnica je imalo tumor čiji HER2 status nije bio utvrđen (bez uzorka tumora, bez rezultata analize ili zbog drugih razloga).
There were a few cases of subjects with delayed elimination.
Bilo je nekoliko slučajeva odgođene eliminacije.
There were a total of 385 subject exposures involving over 14,500 infusions of Cinryze in these studies.
Ukupno je bilo izloženo 385 ispitanika, što je uključivalo više od 14 500 infuzija lijeka Cinryze u tim ispitivanjima.
There were also reclassifications in the week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Bilo je i reklasifikacija u 48. tjednu kad se radila primarna analiza, najčešće is skupine virološkog neuspjeha u skupinu prekida liječenja zbog drugih razloga (ne zbog štetnog događaja).
There were also reclassifications in the week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons. e.g. lost to follow up, non-compliance, withdrew consent.
Bilo je i reklasifikacija u 48. tjednu kad se radila primarna analiza, najčešće iz skupine virološkog neuspjeha u skupinu prekida liječenja zbog drugih razloga (ne zbog štetnog događaja). npr. izgubljen iz praćenja, nesuradljivost, povlačenje pristanka.
There were also reclassifications in the Week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons. e.g. lost to follow up, non-compliance, withdrew consent.
Također je bilo reklasifikacija primarne analize u 48. tjednu od kojih je najčešća reklasifikacija s virološkog neuspjeha na prekida koji nije uzrokovan štetnim događajem. npr. gubitak iz praćenja, nesuradljivost, povlačenje suglasnosti.
There were also reductions in patients’ symptoms, such as pain and inflammation, and improvements in vision.
Prisutno je također smanjenje u simptomima bolesnika, poput boli i upale, te poboljšanja u vidu.
There were fewer thrombotic events with Soliris treatment than during the same period of time prior to treatment.
Bilo je manje trombotičkih incidenata uz liječenje lijekom Soliris nego tijekom istog vremenskog razdoblja prije liječenja.
There were higher rates of Grade 4 neutropenia (ANC
U prvom ciklusu terapije učestalost neutropenije (ABN
There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
U prvom ciklusu terapije stope neutropenije (ABN < 0,5 x 109/l) i trombocitopenije (< 20 x 109/l) stupnja 4 bile su više u žena nego u muškaraca: 12 % naspram 5 % kod neutropenije i 9 % naspram 3 % kod trombocitopenije.
There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
U prvom ciklusu terapije učestalost neutropenije (ABN < 0,5 x 109/l) i trombocitopenije (< 20 x 109/l) stupnja 4 bila je viša u žena nego u muškaraca: 12% naspram 5% kod neutropenije i 9% naspram 3% kod trombocitopenije.
There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh Class B or C) affects efavirenz pharmacokinetics.
Nije bilo dovoljno podataka da bi se moglo odrediti utječe li umjereno ili teško oštećenje jetre (Child- Pugh stadij B ili C) na farmakokinetiku efavirenza.
There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh class B or C) affects efavirenz pharmacokinetics.
Nije bilo dovoljno podataka o tome utječe li umjereno ili teško oštećenje jetre (Child-Pugh stadij B ili C) na farmakokinetiku efavirenza.
There were isolated reports of severe infusion reactions in clinical trials.
U kliničkim su ispitivanjima u izoliranim slučajevima zabilježene teške reakcije na infuziju.