natgillin/translations-raw huggingface dataset:
Coadministration of lurasidone with mild (e.g. armodafinil, amprenavir, aprepitant, prednisone, rufinamide) or moderate (e.g. bosentan, efavirenz, etravirine, modafinil, nafcillin) inducers of CYP3A4 would be expected to give a &lt; 2-fold reduction in lurasidone exposure during co-administration and for up to 2 weeks after discontinuation of mild or moderate CYP3A4 inducers.
Može se očekivati da će istovremena primjena lurasidona s blagim CYP3A4 induktorima (npr. armodafinil, amprenavir, aprepitant, prednison, rufinamid) ili umjerenim CYP3A4 induktorima (npr. bosentan, efavirenz, etravirin, modafinil, nafcilin) izazvati &lt; 2 puta smanjenu izloženost lurasidonu tijekom istovremene primjene, kao i do 2 tjedna nakon što se iz liječenja isključe blagi ili umjereni induktori CYP3A4.
CoAprovel should not be used in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) (see section 4.3).
CoAprovel ne smiju uzimati bolesnici s teško oštećenom funkcijom bubrega (klirens kreatinina &lt; 30 ml/min) (vidjeti dio 4.3).
Colitis occurred in 48 (1.7%) patients, including Grade 2, 3 or 4 cases in 10 (0.4%), 31 (1.1%) and 2 ( &lt; 0.1%) patients, respectively, receiving pembrolizumab.
Kolitis se javio u 48 (1,7%) bolesnika liječenih pembrolizumabom, uključujući slučajeve 2. stupnja u 10 (0,4%) bolesnika, slučajeve 3. stupnja u 31 (1,1%) bolesnika i slučajeve 4. stupnja u 2 ( &lt; 0,1%) bolesnika.
Combination therapy with ribavirin and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49 % vs 5 %, p &lt; 0.0001).
Kombinirana terapija ribavirinom i interferonom alfa-2b povećala je trajan virološki odgovor 10 puta više nego liječenje samo interferonom alfa-2b (49% u odnosu na 5%, p &lt; 0,0001).
Combination therapy with ribavirin and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49% vs 5 %, p &lt; 0.0001).
Kombinirana terapija ribavirinom i interferonom alfa-2b povećala je trajan virološki odgovor koji je bio 10 puta viši nego kod liječenja samo interferonom alfa-2b (49 % u odnosu na 5 %, p &lt; 0,0001).
Combined data from ACT 1 &amp; 2
Zbirni podaci iz ACT 1 i ACT 2
Combined studies 1 &amp; 2
Skupni rezultati ispitivanja 1 &amp; 2
Common ( ≥ 1/100 to &lt; 1/10): Bradycardia with or without hypotension or syncope, tachycardia.
Često ( ≥ 1/100 i &lt; 1/10): bradikardija sa ili bez hipotenzije ili sinkope, tahikardija
Common ( &gt; 1/100, &lt; 1/10): headache
Često ( &gt; 1/100 i &lt; 1/10): glavobolja
Common ( &gt; 1/100, &lt; 1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Često ( &gt; 1/100 i &lt; 1/10): crvenilo na mjestu injekcije, oteknuće na mjestu injekcije, otvrdnuće na mjestu injekcije, ekimoza i bol na mjestu injekcije, vrućica, malaksalost, umor i tresavica
Common ( &gt; 1/100, &lt; 1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Često ( &gt; 1/100 i &lt; 1/10): crvenilo na mjestu injekcije, oteknuće na mjestu injekcije, otvrdnuće na mjestu injekcije, ekimoza i bol na mjestu injekcije, vrućica, opća malaksalost, umor i tresavica
common ( &gt; 1/100, &lt; 1/10): recurrent ischaemia, cardiac failure, myocardial infarction, cardiogenic shock, pericarditis, pulmonary oedema
često ( &gt; 1/100 i &lt; 1/10): recidivirajuća ishemija, zatajenje srca, infarkt miokarda, kardiogeni šok, perikarditis, plućni edem
Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhea, rash, muscle ache, joint ache, chills, fever ≥38oC, injection site redness ( &gt; 50mm) and injection site firmness ( &gt; 50mm)
Često (mogu se javiti u do 1 na 10 osoba): promjene prehrambenih navika, mučnina, povraćanje, proljev, osip, bol u mišićima, bol u zglobovima, zimica, vrućica ≥38oC, crvenilo na mjestu injiciranja ( &gt; 50 mm) i otvrdnuće na mjestu injiciranja ( &gt; 50 mm)
Common (≥ 1/100 &lt; 1/10)
Često (≥ 1/100 &lt; 1/10)
Common (≥ 1/100 to &lt; 1/10)
Često (≥ 1/100 do &lt; 1/10)
Common (≥ 1/100 to &lt; 1/10)
Često (≥ 1/100 i &lt; 1/10)
Common (≥ 1/100 to &lt; 1/10)
Često (≥1/100 do &lt; 1/10)
Common (≥ 1/100 to &lt; 1/10)
Često (≥1/100 i &lt; 1/10)
Common (≥ 1/100 to &lt; 1/10) cases of leukocytosis (White Blood Count [WBC] &gt; 100 x 109/l) have been reported (see section 4.4).
Prijavljeni su česti (≥ 1/100 do &lt; 1/10) slučajevi leukocitoze (broj leukocita &gt; 100 x 109/l) (vidjeti dio 4.4).
Common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100).
Često (≥1/100 do &lt; 1/10), manje često (≥1/1000 do &lt; 1/100).
Common (≥ 1/100 to &lt; 1/10): Injection site discomfort.
Često (≥ 1/100 i &lt; 1/10): nelagoda na mjestu injekcije
Common (≥ 1/100 to &lt; 1/10): Postural hypotension, hypotension.
Često (≥ 1/100 i &lt; 1/10): posturalna hipotenzija, hipotenzija
Common (≥ 1/100 to &lt; 1/10); Uncommon (≥ 1/1,000 to &lt; 1/100) ); Rare (≥1/10,000 to &lt; 1/1,000); Very rare ( &lt; 1/10,000).
&lt; 1/10); manje često (≥ 1/1000 i &lt; 1/100); rijetko (≥1/10 000 i &lt; 1/1000); vrlo rijetko ( &lt; 1/10 000).
Common (≥ 1/100 to &lt; 1/10); Uncommon (≥ 1/1,000 to &lt; 1/100); Rare (≥ 1/10,000 to &lt; 1/1,000); Very rare ( &lt; 1/10,000); Not known (cannot be estimated from the available data)
Često (≥1/100 i &lt; 1/10); manje često (≥1/1000 i &lt; 1/100); rijetko (≥1/10 000 i &lt; 1/1000); vrlo rijetko ( &lt; 1/10 000); nepoznato (ne može se procijeniti na temelju dostupnih podataka).
Common (≥ 1/100 to &lt; 1/10); Uncommon (≥ 1/1,000 to &lt; 1/100); Rare (≥1/10,000 to &lt; 1/1,000); Very rare ( &lt; 1/10,000).
&lt; 1/10); manje često (≥ 1/1000 i &lt; 1/100); rijetko (≥1/10 000 i &lt; 1/1000); vrlo rijetko ( &lt; 1/10 000).
Common (≥1/100 to &lt; 1/10)
Manje često (≥1/1000 i &lt; 1/100)
Common (≥1/100 to &lt; 1/10)
Često (≥ 1/100 do &lt; 1/10)
Common (≥1/100 to &lt; 1/10)
Često (≥ 1/100 i &lt; 1/10)
Common (≥1/100 to &lt; 1/10)
Često (≥1/100 do &lt; 1/10)
Common (≥1/100 to &lt; 1/10)
Često (≥1/100 i &lt; 1/10)
Common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100) and rare (1/10,000 to &lt; 1/1,000) adverse reactions occurring in patients treated with febuxostat are listed below.
Česte (≥ 1/100 i &lt; 1/10), manje česte (≥ 1/1000 i &lt; 1/100) i rijetke ( 1/10 000 i &lt; 1/1000) nuspojave koje se pojavljuju kod bolesnika liječenih febuksostatom su dolje navedene.
Common (≥1/100 to, &lt; 1/10)
Često (≥1/100 i &lt; 1/10)
Common ( 1/100 to &lt; 1/10)
Često ( 1/100 do &lt; 1/10)
Common ( 1/100 to &lt; 1/10)
Često ( 1/100 i &lt; 1/10)
Common ( 1/100 to &lt; 1/10)
Često (1/100 i &lt; 1/10)
common ( 1/100 to &lt; 1/10)
česte ( 1/100 do &lt; 1/10)
Common (1/100 to &lt; 1/10)
Često (≥1/100 i &lt; 1/10)
Common (1/100 to &lt; 1/10)
Često (1/100 do &lt; 1/10)
Common (1/100 to &lt; 1/10)
Često (1/100 i &lt; 1/10)
Common (1/100, &lt; 1/10)
Često (1/100, &lt; 1/10)
Common ARs (≥1/100 to &lt; 1/10)
Česte nuspojave (1/100 i &lt; 1/10)
Common ARs (1/100 to &lt; 1/10)
Česte nuspojave (1/100 i &lt; 1/10)
Common signs and symptoms of cyanide poisoning include: nausea, vomiting, headache, altered mental status (e.g. confusion, disorientation), chest tightness, dyspnoea, tachypnoea or hyperpnoea (early), bradypnoea or apnoea (late), hypertension (early) or hypotension (late), cardiovascular collapse, seizures or coma, mydriasis, and plasma lactate concentration &gt; 8 mmol/L.
Česti znaci i simptomi trovanja cijanidom uključuju: mučninu, povraćanje, glavobolju, izmijenjeni mentalni status (npr. konfuzija, gubitak orijentacije), stezanje u prsima, dispneju, tahipneju ili hiperpneju (ranu), bradipneju ili apneju (kasnu), hipertenziju (ranu) ili hipotenziju (kasnu), kardiovaskularni kolaps, napadaje ili komu, midrijazu i plazmatske razine laktata &gt; 8 mmol/l.
common ≥ 1/100 to &lt; 1/10
često ≥ 1/100 i &lt; 1/10
Common ≥ 1/100 to &lt; 1/10; Uncommon ≥ 1/1,000 to &lt; 1/100; Rare ≥ 1/10,000 to &lt; 1/1,000;
Često ≥ 1/100 i &lt; 1/10; Manje često ≥ 1/1000 i &lt; 1/100; Rijetko ≥ 1/10 000 i &lt; 1/1000;
Common ≥1/100 and &lt; 1/10 Uncommon ≥1/1,000 and &lt; 1/100 Rare ≥1/10,000 and &lt; 1/1,000
često ≥ 1/100 i &lt; 1/10 manje često ≥ 1/1000 i &lt; 1/100 rijetko ≥ 1/10 000 i &lt; 1/1000
Common  1/100 and &lt; 1/10 Uncommon  1/1,000 and &lt; 1/100 Rare  1/10,000, &lt; 1/1,000
Često  1/100 i &lt; 1/10 Manje često  1/1000 i &lt; 1/100 Rijetko  1/10 000 &lt; 1/1000
Common  1/100 to &lt; 1/10 Uncommon  1/1,000 to &lt; 1/100 Rare  1/10,000 to &lt; 1/1,000
Često 1/100 do &lt; 1/10 Manje često 1/1000 do &lt; 1/100 Rijetko 1/10 000 do &lt; 1/1000
Common 1/100 to &lt; 1/10 Uncommon 1/1,000 to &lt; 1/100 Rare 1/10,000 to &lt; 1/1,000
Često  1/100 do &lt; 1/10 Manje često  1/1000 do &lt; 1/100 Rijetko  1/10 000 do &lt; 1/1000
Common: (≥1/100 to &lt; 1/10) Uncommon: (≥1/1,000 to &lt; 1/100) Rare: (≥1/10,000 to &lt; 1/1,000)
Često: ( 1/100 i &lt; 1/10) Manje često: ( 1/1000 i &lt; 1/100) Rijetko: ( 1/10 000 i &lt; 1/1000)
Common: Injection site swelling/induration and erythema &gt; 2.4 cm, tenderness interfering with movement, fever &gt; 39 °C.
Često: otok/otvrdnuće i eritem &gt; 2,4 cm na mjestu primjene injekcije, osjetljivost koja ometa kretnje, vrućica &gt; 39°C.
Common: leucopenia (leucocytes &gt; 2 G/l)
Često: leukopenija (leukociti &gt; 2 g/l).
Common: leucopenia (leucocytes &gt; 2 G/L)
Često: leukopenija (leukociti &gt; 2 g/l).
Common: New onset or worsening psoriasis including pustular psoriasis (primarily palm &amp; soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Često: novonastala psorijaza ili pogoršanje postojeće uključujući pustularnu psorijazu (primarno palmarnu i plantarnu), urtikarija, osip, svrbež, hiperhidroza, suha koža, gljivični dermatitis, ekcem, alopecija
Common: Pyrexia &gt; 39°C; vaccination-site movement impairment (due to pain); vaccination-site erythema or induration/swelling 2.5 cm–7.0 cm (after infant series)
Često: pireksija &gt; 39°C; ograničene kretnje uda u koji se primijenilo cjepivo (zbog bola); eritem na mjestu primjene cjepiva ili otvrdnuće/oteklina 2,5 cm–7,0 cm (nakon dojenačke serije)
Common: rash, injection site redness ( &gt; 50 mm), injection site firmness ( &gt; 50 mm), joint ache, fever ≥ 38°C, chills
Često: osip, crvenilo na mjestu injiciranja ( &gt; 50 mm), otvrdnuće na mjestu injiciranja ( &gt; 50 mm), bol u zglobovima, vrućica ≥ 38°C, zimica
Common: ≥ 1/100 to &lt; 1/10
Vrlo često: ≥ 1/10 Često: ≥ 1/100 do &lt; 1/10
Common: ≥ 1/100 to &lt; 1/10
Često: ≥ 1/100 do &lt; 1/10
Common:  1/100 to &lt; 1/10 Uncommon:  1/1,000 to &lt; 1/100 Rare:  1/10,000 to &lt; 1/1,000
Često:  1/100 i &lt; 1/10 Manje često:  1/1000 i &lt; 1/100 Rijetko:  1/10 000 i &lt; 1/1000
Common:  1/100 to &lt; 1/10 Uncommon:  1/1,000 to &lt; 1/100 Rare:  1/10,000 to &lt; 1/1,000
Često:  1/100 i &lt; 1/10 Manje često:  1/1000 i &lt; 1/100 Rijetko:  1/10000 i &lt; 1/1000
Common: 1/100 to &lt; 1/10 Uncommon: 1/1,000 to &lt; 1/100
Često: ≥ 1/100 i &lt; 1/10 Manje često: ≥ 1/1000 i &lt; 1/100
Compared to patients &lt; 65 years, older patients are more likely to experience adverse reactions.
U usporedbi s bolesnicima mlađim od 65 godina, veća je vjerojatnost da će stariji bolesnici imati nuspojave.
Compared to placebo, treatment with Eperzan resulted in statistically significant reductions from baseline in HbA1c (-0.8% for Eperzan versus -0.1% for placebo, p &lt; 0.05) and FPG (-1.3 mmol/l for Eperzan versus +0.4 mmol/l for placebo, p &lt; 0.05) at 52 weeks.
U usporedbi s placebom, liječenje lijekom Eperzan dovelo je do statistički značajnog smanjenja vrijednosti HbA1c (-0,8% za Eperzan naspram -0,1% za placebo, p &lt; 0,05) i glukoze u plazmi natašte (-1,3 mmol/l za Eperzan naspram +0,4 mmol/l za placebo, p &lt; 0,05) nakon 52 tjedna u odnosu na početne vrijednosti.
Compared to the global phase III CRC trial (CORRECT) with predominantly (~80%) Caucasian patients enrolled, a higher incidence of liver enzyme increases was observed in Stivarga-treated patients in the Asian phase III CRC trial (CONCUR) with predominantly ( &gt; 90%) East Asian patients enrolled.
U usporedbi s globalnim ispitivanjem faze III KRK-a (CORRECT) s bolesnicima pretežno (~80%) bjelačkog podrijetla, u bolesnika liječenih lijekom Stivarga u azijskom ispitivanju faze III KRK-a (CONCUR) u koje su bili uključeni bolesnici pretežno ( &gt; 90%) iz istočne Azije bila je opažena viša incidencija povećanja jetrenih enzima.
Compared to the historical adult population receiving fosamprenavir with ritonavir 700 mg / 100 mg twice daily, a subset of five pediatric subjects ages 6 to &lt; 24-months receiving fosamprenavir / ritonavir 45/7 mg/kg twice daily demonstrated that despite an approximate 5-fold increase in fosamprenavir and ritonavir doses on a mg/kg basis, plasma amprenavir AUC(0-) was approximately 48 % lower, Cmax 26 % lower, and C 29 % lower in the paediatric subjects.
U usporedbi s ranije ispitivanom odraslom populacijom koja je primala fosamprenavir s ritonavirom u dozama 700 mg/100 mg 2 puta dnevno, podskupina od 5 pedijatrijskih ispitanika u dobi od 6 do 24 mjeseca koji su primali fosamprenavir/ritonavir u dozi od 45/7 mg/kg 2 puta dnevno pokazala je, unatoč oko 5 puta povećanju doza fosamprenavira i ritonavira prema mg/kg, da je u pedijatrijskih ispitanika AUC(0-) amprenavira u plazmi oko 48 % niži, Cmax 26 % niži, i C 29 % niži.
Compared with patients with normal renal function, the mean (%CV) tenofovir exposure increased from 2,185 (12%) ng·h/ml in subjects with CrCl &gt; 80 ml/min to respectively 3,064 (30%) ng·h/ml, 6,009 (42%) ng·h/ml and 15,985 (45%) ng·h/ml in patients with mild, moderate and severe renal impairment.
U usporedbi s pacijentima s normalnom funkcijom bubrega srednja se vrijednost (% koeficijenta varijacije) izloženosti tenofoviru povećala s 2.185 (12%) ng·h/ml u ispitanika s CrCl &gt; 80 ml/min na 3.064 (30%) ng·h/ml u pacijenata s blagim oštećenjem funkcije bubrega, 6.009 (42%) ng·h/ml u pacijenata s umjerenim oštećenjem bubrega i 15.985 (45%) ng·h/ml u pacijenata s teškim oštećenjem bubrežne funkcije.
Compared with younger subjects ( &lt; 65), more subjects ≥65 years old had adverse reactions that led to study drug dose modifications (interruptions or reductions) (23% versus 17%).
U usporedbi s mlađim ispitanicima (u dobi &lt; 65 godina), više je ispitanika u dobi od ≥65 godina imalo nuspojave koje su dovele do prilagodbe doze ispitivanog lijeka (privremeni prekid ili smanjenje doze) (23% naspram 17%).
Compared with younger subjects ( &lt; 65), more subjects 65 years old had adverse reactions that led to study drug dose reductions (22% versus 12%) or interruptions (39% versus 27%).
U usporedbi s mlađim ispitanicima ( &lt; 65), više je ispitanika od 65 godina ili starijih imalo nuspojave koje su dovele do smanjenja doze ispitivanog lijeka (22% prema 12%) ili prekid liječenja (39% prema 27%).
Comparison of 218 patients with mild renal impairment at baseline (CrCl 51 to 80 ml/min) to 297 patients with normal renal function at baseline (CrCl &gt; 80 ml/min) treated with Teysuno in combination with cisplatin in the FLAGS study indicated that there were no clinically significant differences in safety between patients with mild renal impairment and patients with normal renal function.
Usporedba 218 bolesnika s blagim oštećenjem bubrega na početku liječenja (CrCl 51 do 80 ml/min) s 297 bolesnika s normalnom bubrežnom funkcijom na početku liječenja (CrCl &gt; 80 ml/min) liječenih lijekom Teysuno u kombinaciji s cisplatinom u FLAGS studiji, indicirala je da nema klinički značajnih razlika u sigurnosti primjene između bolesnika s blagim oštećenjem bubrega i onih s normalnom funkcijom bubrega.
Comparison of 218 patients with mild renal impairment at baseline (CrCl 51 to 80 ml/min) to 297 patients with normal renal function at baseline (CrCl &gt; 80 ml/min) treated with Teysuno in combination with cisplatin in the FLAGS study indicated that there were no clinically significant differences in safety between patients with mild renal impairment and patients with normal renal function.
Usporedba 218 bolesnika s blagim oštećenjem bubrega na početku liječenja (CrCl 51 do 80 ml/min) s 297 bolesnika s normalnom bubrežnom funkcijom na početku liječenja (CrCl &gt; 80 ml/min) liječenih lijekom Teysuno u kombinaciji s cisplatinom u FLAGS studiji, indicirala je da nema klinički značajnih razlika u sigurnosti primjene između bolesnika sa blagim oštećenjem bubrega i onih s normalnom funkcijom bubrega.
Comparison of safety between 71 patients ≥70 years old (elderly) and 450 patients &lt; 70 years old treated with Teysuno in combination with cisplatin in the FLAGS study demonstrated that the incidence of all Grade 3 or higher adverse reactions (62% vs 52%), all serious adverse reactions (30% vs 19%), and the rate of premature withdrawal due to adverse reactions from both Teysuno and cisplatin (21% vs 12%) appeared to be higher among patients ≥70 years old.
Usporedba sigurnosti primjene lijeka između 71 bolesnika u dobi ≥ 70 godina (stariji bolesnici) i 450 bolesnika u dobi &lt; 70 godina liječenih lijekom Teysuno u kombinaciji s cisplatinom u FLAGS studiji je pokazala da je incidencija svih nuspojava stupnja 3 ili višeg (62 % prema 52 %), svih ozbiljnih nuspojava (30 % prema 19 %) kao i udio preranog povlačenja iz studije zbog nuspojava oba lijeka: lijeka Teysuno i cisplatina (21 % prema 12 %) bila viša kod bolesnika u dobi ≥ 70 godina.
Comparison of safety between 71 patients ≥70 years old (elderly) and 450 patients &lt; 70 years old treated with Teysuno in combination with cisplatin in the FLAGS study demonstrated that the incidence of all Grade 3 or higher adverse reactions (62% vs 52%), all serious adverse reactions (30% vs 19%), and the rate of premature withdrawal due to adverse reactions from both Teysuno and cisplatin (21% vs 12%) appeared to be higher among patients ≥70 years old.
Usporedba sigurnosti primjene lijeka između 71 bolesnika u dobi ≥ 70 godina (stariji bolesnici) i 450 bolesnika u dobi &lt; 70 godina liječenih lijekom Teysuno u kombinaciji s cisplatinom u FLAGS studiji je pokazala da je incidencija svih nuspojava stupnja 3 ili višeg (62 % prema 52 %), svih ozbiljnih nuspojava (30 % prema 19 %) kao i udio preranog povlačenja iz studije zbog nuspojava, oba lijeka: lijeka Teysuno i cisplatina (21 % prema 12 %) bila viša kod bolesnika u dobi ≥ 70 godina.
Comparison versus placebo: a p &lt; 0.001; b p &lt; 0.01
Usporedba s placebom: a p &lt; 0,001; b p &lt; 0,01
Competact should not be used in patients with renal failure or renal dysfunction (creatinine clearance &lt; 60 ml/min) (see sections 4.3 and 4.4).
Competact se ne smije primjenjivati u bolesnika s bubrežnim zatajenjem ili poremećenom funkcijom bubrega (klirens kreatinina &lt; 60 ml/min) (vidjeti dijelove 4.3 i 4.4).
Concentration of free thyroxin (FT4) post baseline &lt; LLN was reported in 8.0% of patients treated with Stivarga and 6.6% of patients receiving placebo.
Koncentracija slobodnog tiroksina (FT4) nakon početnih vrijednosti &lt; DGN bila je prijavljena u 8,0% bolesnika liječenih lijekom Stivarga i u 6,6% bolesnika koji su primali placebo.
Concentration of free triiodothyronine (FT3) post baseline below lower limit of normal ( &lt; LLN) was reported in 25.6% of patients treated with Stivarga and in 20.9% of patients receiving placebo.
Koncentracija slobodnog trijodtironina (FT3) nakon početnih vrijednosti ispod donje granice normale ( &lt; DGN) bila je prijavljena u 25,6% bolesnika liječenih lijekom Stivarga i 20,9% bolesnika koji su primali placebo.
Concentrations of alendronate in plasma following therapeutic oral doses are too low for analytical detection ( &lt; 5 ng/ml).
Koncentracija alendronata u plazmi nakon peroralne primjene terapijskih doza ( &lt; 5 ng/ml) preniska je za analitičko dokazivanje.
Concomitant administration of &gt; 40 mg simvastatin (see section 4.5).
Istodobna primjena simvastatina &gt; 40 mg (vidjeti dio 4.5).
Concomitant use of Copalia HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Istodobna primjena Copalia HCT s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR &lt; 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
Concomitant use of Copalia with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Istodobna primjena Copalie s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR &lt; 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
Concomitant use of Dafiro HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Istodobna primjena Dafiro HCT s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR &lt; 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
Concomitant use of Dafiro with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Istodobna primjena Dafira s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR &lt; 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
Concomitant use of Exforge with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Istodobna primjena Exforgea s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR &lt; 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see section 4.3).
Istodobna primjena telmisartana s aliskirenom je kontraindicirana kod bolesnika s oštećenjem bubrega (GFR &lt; 60 ml/min/1,73 m2) (vidjeti dio 4.3).
Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR &lt; 60 ml/min/1.73 m2) (see sections 4.4 and 4.5).
Istodobna primjena s lijekovima koji sadrže aliskiren u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR &lt; 60 ml/min/1,73 m2) (vidjeti dijelove 4.4 i 4.5).
Confidence interval around observed difference of response rates; P-value &lt; 0.0001 from logistic regression model, including stratification factors.
Interval pouzdanosti oko opažene razlike u stopama odgovora; P-vrijednost &lt; 0,0001 za model logističke regresije, uključujući faktore stratifikacije.
Confidence interval around observed difference of response rates; P-value from CMH test controlling for stratification factors = 0.0199 for de novo, and &lt; 0.0001 for not de novo.
Interval pouzdanosti oko opažene razlike u stopama odgovora; P-vrijednost iz CMH testa za kontrolu stratifikacijskih faktora = 0,0199 za de novo i &lt; 0,0001 za ne de novo.
Confirmed ALT or AST &gt; 3 x ULN and bilirubin &gt; 2 x ULN
Potvrđena ALT ili AST &gt; 3 x GGN i bilirubin &gt; 2 x GGN
Confirmed HBeAg seroconversion occurred in 47 % (118/252) of subjects treated with lamivudine and 93 % (320/345) of subjects receiving lamivudine became HBV DNA negative (VERSANT [version 1], bDNA assay, LLOD &lt; 0.7 MEq/ml) during the study.
Serokonverzija HBeAg potvrđena je u 47% (118/252) bolesnika liječenih lamivudinom, a 93% (320/345) bolesnika liječenih lamivudinom postalo je tijekom ispitivanja HBV DNK negativno (VERSANT [verzija 1], bDNA test, LLOD &lt; 0.7 MEq/ml).