natgillin/translations-raw huggingface dataset:
Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to &lt; 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg (as fumarate) was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg (as fumarate).
Kronični hepatitis B: Izloženost tenofoviru, u stanju dinamičke ravnoteže, u adolescenata (u dobi od 12 do &lt; 18 godina) zaraženih HBV-om koji su primali peroralno dnevnu dozu tenofovirdizoproksila od 245 mg (u obliku tenofovirdizoproksilfumarata) bila je slična izloženosti postignutoj u odraslih koji su primali dozu tenofovirdizoproksila od 245 mg (u obliku tenofovirdizoproksilfumarata) jedanput na dan.
Chronic phase CML is defined when all of the following criteria are met: blasts &lt; 15% in blood and bone marrow, peripheral blood basophils &lt; 20%, platelets &gt; 100 x 109/l.
Kronična faza KML-a se definira kada su ispunjeni svi navedeni kriteriji: blasti &lt; 15% u krvi i koštanoj srži, bazofili u perifernoj krvi &lt; 20%, trombociti &gt; 100 x 109/l.
CI 0.6-0.9) or squamous cell carcinoma (HR = 0.67, 95% CI 0.5-0.9), but not in patients with other histologies (HR 1.04, 95% CI 0.7-1.5), patients with stage IV disease at diagnosis (HR = 0.92, 95% CI 0.7-1.2) or &lt; stage IV disease at diagnosis (HR = 0.65, 95% CI 0.5-0.8).
Pri postavljanju dijagnoze (HR = 0,92; 95% CI 0,7-1,2) ili stadijem bolesti &lt; IV pri dijagnozi (HR = 0,65; 95% CI 0,5-0,8).
CI = Confidence interval; FEV1 = forced expiratory volume in 1 second; ITT = intent to treat (all patients randomised); P = P value; SD = standard deviation; SE = standard error; ANCOVA = analysis of covariance. a ANCOVA with terms for treatment, region, age (16 to 18 years, &gt; 18 years), and baseline FEV1 percent predicted as quartiles. (Note: In Study 204, an additional 38 patients were randomised to Quinsair 120 mg once daily (≥ 18 years, n = 35; ≥ 16 to &lt; 18 years old, n = 3) and an additional 37patients were randomised to Quinsair 240 mg once daily (≥ 18 years, n = 34; ≥ 16 to &lt; 18 years old, n = 3).) b LS Mean difference for Quinsair minus placebo. c Tested using alpha of 0.05.
CI = interval pouzdanosti; FEV1 = forsirani ekspiratorni volumen u 1 sekundi; ITT = namjera liječenja (svih randomiziranih bolesnika); P = P vrijednost; SD = standardna devijacija; SE = standardna pogreška; ANCOVA = analiza kovarijance. a ANCOVA s uvjetima za liječenje, regiju, dob (16 do18 godina, &gt; 18 godina), i početna vrijednost postotka predviđene vrijednosti FEV1 kao kvartile. (Napomena: U Ispitivanju 204, 38 naknadnih bolesnika randomizirano je u skupinu koja je primala Quinsair 120 mg jedan puta na dan (u dobi ≥ 18 godina, n = 35; u dobi ≥ 16 do &lt; 18 godina, n = 3) te naknadnih 37 bolesnika bilo je randomizirano u skupinu koja je primala Quinsair 240 mg jedan puta na dan (u dobi ≥ 18 godina, n = 34; i u dobi ≥ 16 do &lt; 18 godina, n = 3).) b LS srednja razlika za Quinsair minus placebo po metodi Last-square. c Provjera korištenjem alfa 0,05. c Provjera korištenjem alfa 0,05.
Cimzia vs. placebo: *p≤0.01, ** p &lt; 0.001 a.
Cimzia naspram placeba: *p ≤ 0,01, ** p &lt; 0,001 a.
Cimzia vs. placebo: *p≤0.01, ** p &lt; 0.001 a.
Cimzia naspram placeba: *p ≤ 0,01, ** p &lt; 0,001 b.
CIRS-G &gt; 10 (n=137)
CIRS-G &gt; 10 (n=137)
CLCR &lt; 30 ml/min: use is not recommended in patients with severe renal impairment due to insufficient data.
CLCR &lt; 30 ml/min: ne preporučuje se koristiti u bolesnika s teškim oštećenjem bubrega zbog nedostatnih podataka.
CLCR &gt; 60 ml/min: no dose adjustment required.
CLCR &gt; 60 ml/min: nije potrebna prilagodba doze
CLCR &gt; 60 ml/min: no dose adjustment required.
CLCR &gt; 60 ml/min: nije potrebna prilagodba doze.
Clinical Breakpoints S ≤ 0.25 mg/l; R &gt; 0.25 mg/l
Kliničke granične vrijednosti S ≤ 0,25 mg/l; R &gt; 0,25 mg/l
Clinical experience in patients with percent predicted FEV1 (ppFEV1) &lt; 40 is limited and additional monitoring of these patients is recommended during initiation of therapy (see section 4.8).
Zbog ograničenog kliničkog iskustva s bolesnicima u kojih je postotak predviđenog FEV1 (ppFEV1) &lt; 40, preporučuje se dodatno praćenje tih bolesnika za vrijeme započinjanja terapije (vidjeti dio 4.8).
Clinical experience is limited in patients with body weight &lt; 50 kg.
Ograničeno je kliničko iskustvo u bolesnika tjelesne težine &lt; 50 kg.
Clinical monitoring is recommended for patients with ClCr &lt; 90 mL/min.
Klinički nadzor preporučuje se za pacijente s vrijednošću ClCr &lt; 90 ml/min.
Clinical monitoring is recommended for patients with CrCl &lt; 90 mL/min.
Preporučuje se kliničko praćenje pacijenata s CrCl &lt; 90 ml/min.
Clinical remission (defined as Mayo score ≤ 2 with no subscore &gt; 1) was assessed at Week 8.
Klinička remisija (definirana kao Mayo rezultat ≤ 2 bez podrezultata &gt; 1) ocjenjivala se u osmom tjednu.
Clinical remission is defined as CDAI score &lt; 150; Clinical response is defined as reduction in CDAI of at least 100 points or being in clinical remission
Klinička remisija je definirana kao CDAI skor &lt; 150; Klinički odgovor je definiran kao smanjenje u CDAI skoru za barem 100 bodova ili bivanje u kliničkoj remisiji
Clinical remission is defined as CDAI score &lt; 150; Clinical response is defined as reduction in CDAI score by at least 100 points or being in clinical remission
Klinička remisija je definirana kao CDAI skor &lt; 150; Klinički odgovor je definiran kao smanjenje u CDAI skoru za barem 100 bodova ili bivanje u kliničkoj remisiji
Clinical remission is Mayo score ≤ 2 with no subscore &gt; 1;
Klinička remisija je Mayo rezultat ≤ 2 bez podrezultata &gt; 1;
Clinical studies have excluded patients with alanine transaminase (ALT) and/or aspartate transaminase (AST) &gt; 2.5 (or &gt; 5, if related to disease) times the upper limit of the normal range and/or total bilirubin &gt; 1.5 times the upper limit of the normal range.
Bolesnici s vrijednostima alanin transaminaze (ALT) i/ili aspartat transaminaze (AST) &gt; 2,5 (ili &gt; 5 ako je povezano s bolešću) i/ili ukupnog bilirubina &gt; 1,5 puta većim od gornje granice referentnog raspona bili su isključeni iz kliničkih ispitivanja.
Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. is highly immunogenic and generally well tolerated.
Klinička ispitivanja u 284 trostruko seronegativne djece u dobi od 11 mjeseci do 7 godina pokazala su da je prethodno kombinirano cjepivo protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc. visoko imunogeno i da se općenito dobro podnosi.
Clinical studies that were conducted excluded patients with ALT or AST &gt; 2.5 × ULN or, if due to underlying malignancy, &gt; 5.0 × ULN or with total bilirubin &gt; 1.5 × ULN (see section 4.2).
U klinička ispitivanja nisu uključivani bolesnici kojima su vrijednosti AST-a ili ALT- a bile &gt; 2,5× GGN, odnosno, ako su uzrokovane osnovnom malignom bolešću, &gt; 5,0× GGN ili su im vrijednosti ukupnog bilirubina bile &gt; 1,5× GGN (vidjeti dio 4.2).
Clinical studies that were conducted excluded patients with AST or ALT &gt; 2.5 × upper limit of normal (ULN), or if due to underlying malignancy, &gt; 5.0 × ULN or with total bilirubin &gt; 1.5 × ULN.
U klinička ispitivanja nisu uključivani bolesnici kojima su vrijednosti AST-a ili ALT-a bile &gt; 2,5 × gornje granice normale (GGN), odnosno, ako su uzrokovane osnovnom malignom bolešću &gt; 5,0 × GGN ili su im vrijednosti ukupnog bilirubina bile &gt; 1,5 × GGN.
Clinical trials excluded patients with ECOG performance status &gt; 1 and mucosal melanoma.
Klinička ispitivanja isključila su bolesnike s ECOG izvedbenim statusom &gt; 1 i melanomom sluznice.
Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or &lt; 7 % in the two studies (p &lt; 0.05 and p ≤ 0.0001 respectively).
U ta dva ispitivanja, klinički i statistički značajno više ispitanika na eksenatidu s produljenim oslobađanjem u usporedbi s primjenom eksenatida s trenutnim oslobađanjem lijeku Bydureon postiglo je smanjenje HbA1c na ≤ 7% (p &lt; 0,05) ili &lt; 7% (p &lt; 0,0001).
Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or &lt; 7 % in the two studies (p &lt; 0.05 and p ≤ 0.0001 respectively).
U ta dva ispitivanja, klinički i statistički značajno više ispitanika na eksenatidu s produljenim oslobađanjem u usporedbi s primjenom eksenatida s trenutnim oslobađanjem postiglo smanjenje HbA1c na ≤ 7% (p &lt; 0,05) ili &lt; 7% (p &lt; 0,0001).
Clinically important elevations in creatine phosphokinase (CK ≥ 5 times the ULN, &lt; 10 times the ULN without muscular symptoms) were seen in 0.38% of the patients treated with Pravafenix.
Klinički značajna povišenja kreatin fosfokinaze (KF ≥ 5 puta GGN, &lt; 10 puta GGN bez mišićnih simptoma) viđena su kod 0,38% bolesnika liječenih Pravafenixom.
Clinically relevant ADRs reported in ≥1% and &lt; 5% of the ramucirumab plus docetaxel-treated patients in REVEL were hyponatraemia (4.8% ramucirumab plus docetaxel versus 2.4% for placebo plus docetaxel), proteinuria (3.3% ramucirumab plus docetaxel versus 0.8% placebo plus docetaxel) and gastrointestinal perforation (1% ramucirumab plus docetaxel versus 0.3% placebo plus docetaxel).
Klinički značajne nuspojave na lijek prijavljene u ≥ 1% i &lt; 5% bolesnika liječenih ramucirumabom plus docetakselom u ispitivanju REVEL bile su hiponatrijemija (4,8% uz ramucirumab plus docetaksel naspram 2,4% uz placebo plus docetaksel), proteinurija (3,3% uz ramucirumab plus docetaksel naspram 0,8% uz placebo plus docetaksel) i perforacija u probavnom sustavu (1% uz ramucirumab plus docetaksel naspram 0,3% uz placebo plus docetaksel).
Clinically relevant ADRs reported in ≥1% and &lt; 5% of the ramucirumab plus FOLFIRI-treated patients in RAISE: gastrointestinal perforation (1.7% ramucirumab plus FOLFIRI versus 0.6% for placebo plus FOLFIRI).
Klinički značajna nuspojava na lijek prijavljena u ≥ 1% i &lt; 5% bolesnika liječenih ramucirumabom plus protokolom FOLFIRI u ispitivanju RAISE bila je perforacija u probavnom sustavu (1,7% uz ramucirumab plus FOLFIRI naspram 0,6% uz placebo plus FOLFIRI).
Clinically relevant ADRs reported in ≥1% and &lt; 5% of the ramucirumab plus paclitaxel-treated patients in RAINBOW were gastrointestinal perforation (1.2% ramucirumab plus paclitaxel versus 0.3% for placebo plus paclitaxel) and sepsis (3.1% ramucirumab plus paclitaxel versus 1.8% placebo plus paclitaxel).
Klinički značajne nuspojave na lijek prijavljene u ≥ 1% i &lt; 5% bolesnika liječenih ramucirumabom plus paklitakselom u ispitivanju RAINBOW bile su perforacija u probavnom sustavu (1,2% kod primjene ramucirumaba plus paklitaksela naspram 0,3% kod primjene placeba plus paklitaksela) i sepsa (3,1% kod primjene ramucirumaba plus paklitaksela naspram 1,8% kod primjene placeba plus paklitaksela).
Clinically relevant ADRs reported in ≥1% and &lt; 5% of the ramucirumab treated patients in REGARD were: neutropenia, arterial thromboembolic events (see sections 4.2 and 4.4), intestinal obstruction, epistaxis, and rash.
Klinički značajne nuspojave na lijek prijavljene u ≥ 1% i &lt; 5% bolesnika liječenih ramucirumabom u ispitivanju REGARD bile su: neutropenija, arterijski tromboembolijski događaji (vidjeti dijelove 4.2 i 4.4), opstrukcija crijeva, epistaksa i osip.
clinically relevant bradycardia (persistent heart rate &lt; 50 bpm);
klinički značajnom bradikardijom (frekvencija srca trajno &lt; 50 otkucaja u minuti);
Clinically relevant CTC toxicities that were reported in &lt; 1 % of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Klinički značajne toksičnosti prema CTC kriterijima prijavljene u &lt; 1 % bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju supraventrikularne aritmije.
Clinically relevant CTC toxicities that were reported in &lt; 1 % of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju supraventrikularne aritmije.
Clinically relevant CTC toxicities that were reported in &lt; 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Klinički značajne toksičnosti prema CTC kriterijima prijavljene u &lt; 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju aritmiju i motornu neuropatiju.
Clinically relevant CTC toxicities that were reported in &lt; 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed uključuju aritmiju i motoričku neuropatiju.
Clinically relevant CTC toxicities that were reported in &lt; 1% of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju supraventrikularne aritmije.
Clinically relevant CTC toxicities that were reported in &lt; 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed uključuju aritmiju i motoričku neuropatiju.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and &lt; 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Klinički značajne toksičnosti prema CTC kriterijima, prijavljene u ≥ 1 % i &lt; 5 % bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju: infekciju bez neutropenije, febrilnu neutropeniju, alergijsku reakciju/preosjetljivost, povišene vrijednosti kreatinina, motornu neuropatiju, senzornu neuropatiju, multiformni eritem i bol u abdomenu.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and &lt; 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala pemetreksed, ubrajaju se: infekcija bez neutropenije, neutropenijska vrućica, alergijska reakcija/preosjetljivost, povišene vrijednosti kreatinina, motorička neuropatija, senzorna neuropatija, multiformni eritem i bol u abdomenu.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and &lt; 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Klinički značajne toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i &lt; 5% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: zatajenje bubrega, infekciju, pireksiju, febrilnu neutropeniju, povišene vrijednosti AST-a, ALT-a i GGT-a, urtikariju i bol u prsištu.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and &lt; 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed, ubrajaju se: zatajenje bubrega, infekcija, pireksija, neutropenijska vrućica, povišene vrijednosti AST-a, ALT-a i GGT-a, urtikarija i bol u prsištu.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and &lt; 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed, ubrajaju se: zatajenje bubrega, infekcija, vrućica, neutropenijska vrućica, povišene vrijednosti AST-a, ALT-a i GGT-a, urtikarija i bol u prsima.
Clinically relevant CTC toxicity that was reported in &lt; 1 % of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Klinički značajni oblici toksičnost prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant CTC toxicity that was reported in &lt; 1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Klinički značajni oblici toksičnost prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant CTC toxicity that was reported in &lt; 1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant CTC toxicity that was reported in &lt; 1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant toxicity that was reported in &lt; 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prijavljene u &lt; 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsima, aritmiju i motoričku neuropatiju.
Clinically relevant toxicity that was reported in &lt; 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u &lt; 1% bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju supraventrikularne aritmije.
Clinically relevant toxicity that was reported in &lt; 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prema CTC kriterijima prijavljene u &lt; 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijsku reakciju/preosjetljivost, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant toxicity that was reported in &lt; 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prijavljene u &lt; 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsima, aritmiju i motoričku neuropatiju.
Clinically relevant toxicity that was reported in &lt; 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prijavljene u &lt; 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsištu, aritmiju i motoričku neuropatiju.
Clinically relevant toxicity that was reported in &lt; 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prijavljene u &lt; 1% bolesnika randomiziranih u skupinu koja je primaju cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsištu, aritmiju i motoričku neuropatiju.
Clinically relevant toxicity that was reported in &lt; 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prijavljene u &lt; 1% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsištu, aritmiju i motoričku neuropatiju.
Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation, were reported in 1 out of 112 patients ( &lt; 1%) treated with tocilizumab during the controlled and up to and including the open label clinical trial.
Tijekom kontroliranog ispitivanja i u otvorenom dijelu kliničkog ispitivanja u 1 od 112 bolesnika ( &lt; 1%) liječenih tocilizumabom prijavljene su klinički značajne reakcije preosjetljivosti povezane s tocilizumabom, koje su zahtijevale prekid liječenja.
Clinically significant laboratory abnormalities (grades 3 and 4) in this group was low with elevated total bilirubin, AST and ALT reported in 2.4%, 1.6% and &lt; 1% of patients respectively.
Učestalost klinički značajnih laboratorijskih poremećaja (stupanj 3 i 4) u ovoj skupini bila je niska, uz povišeni ukupni bilirubin uočen u 2,4%, AST u 1,6% i ALT u &lt; 1% bolesnika.
Clomipramine is extensively bound to plasma proteins ( &gt; 97 %) in dogs.
Klomipramin se ekstenzivno veže za proteine plazme u pasa ( &gt; 97 %).
Clomipramine is well absorbed ( &gt; 80%) from the gastrointestinal tract in dogs when administered orally but the systemic bioavailability for clomipramine and desmethylclomipramine is 22-26% due to extensive first pass metabolism by the liver.
Klomipramin se dobro apsorbira ( &gt; 80 %) iz probavnog sustava pasa kad se primjenjuje peroralno, ali je sistemska bioraspoloživost za klomipramin i desmetilklomipramin 22 - 26 % zbog ekstenzivnog metabolizma prvog prolaska kroz jetru.
Co-administration with high-dose ritonavir ( &gt; 200 mg every 12 hours) (see section 4.5).
Istodobna primjena s visokim dozama ritonavira (200 mg svakih 12 sati) (vidjeti dio 4.5).
Co-administration with high-dose ritonavir ( &gt; 200 mg every 12 hours) (see section 4.5).
Istodobna primjena s visokim dozama ritonavira ( &gt; 200 mg svakih 12 sati) (vidjeti dio 4.5).
Co-administration with high-dose ritonavir ( &gt; 200 mg twice daily) is contraindicated, as at high doses ritonavir may induce CYP3A4/5 and decrease isavuconazole plasma concentrations (see section 4.3).
Istodobna primjena s visokom dozom ritonavira ( &gt; 200 mg dvaput na dan) je kontraindicirana jer visoke doze ritonavira mogu inducirati CYP3A4/5 i smanjiti koncentracije izavukonazola u plazmi (vidjeti dio 4.3).
Co-primary endpoints: ARR &amp; SAD.
Primarni ishodi: ARR i SAD.