natgillin/translations-raw huggingface dataset:
Bravecto 112.5 mg chewable tablets for very small dogs (2–4.5 kg) Bravecto 250 mg chewable tablets for small dogs ( &gt; 4.5 –10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs ( &gt; 10 –20 kg) Bravecto 1000 mg chewable tablets for large dogs ( &gt; 20 –40 kg) Bravecto 1400 mg chewable tablets for very large dogs ( &gt; 40–56 kg)
Bravecto 112.5 mg žvečljive tablete za zelo majhne pse (2-4,5 kg) Bravecto 250 mg žvečljive tablete za majhne pse ( &gt; 4.5-10 kg) Bravecto 500 mg žvečljive tablete za srednje velike pse ( &gt; 10-20 kg) Bravecto 1000 mg žvečljive tablete za velike pse ( &gt; 20-40 kg) Bravecto 1400 mg žvečljive tablete za zelo velike pse ( &gt; 40-56 kg)
Bravecto 112.5 mg chewable tablets for very small dogs (2–4.5 kg) Bravecto 250 mg chewable tablets for small dogs ( &gt; 4.5 –10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs ( &gt; 10–20 kg) Bravecto 1000 mg chewable tablets for large dogs ( &gt; 20–40 kg) Bravecto 1400 mg chewable tablets for very large dogs ( &gt; 40–56 kg)
Bravecto 112,5 mg žvečljive tablete za zelo majhne pse (2-4,5 kg) Bravecto 250 mg žvečljive tablete za majhne pse ( &gt; 4.5-10 kg) Bravecto 500 mg žvečljive tablete za srednje velike pse ( &gt; 10-20 kg) Bravecto 1000 mg žvečljive tablete za velike pse ( &gt; 20-40 kg) Bravecto 1400 mg žvečljive tablete za zelo velike pse ( &gt; 40-56 kg)
Bravecto 112.5 mg chewable tablets for very small dogs (2–4.5 kg) Bravecto 250 mg chewable tablets for small dogs ( &gt; 4.5–10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs ( &gt; 10–20 kg) Bravecto 1000 mg chewable tablets for large dogs ( &gt; 20–40 kg) Bravecto 1400 mg chewable tablets for very large dogs ( &gt; 40–56 kg)
Bravecto 112,5 mg žvečljive tablete za zelo majhne pse (2-4,5 kg) Bravecto 250 mg žvečljive tablete za majhne pse ( &gt; 4.5-10 kg) Bravecto 500 mg žvečljive tablete za srednje velike pse ( &gt; 10-20 kg) Bravecto 1000 mg žvečljive tablete za velike pse ( &gt; 20-40 kg) Bravecto 1400 mg žvečljive tablete za zelo velike pse ( &gt; 40-56 kg)
Bravecto 112.5 mg spot-on solution for small cats (1.2 – 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 – 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 – 12.5 kg)
Bravecto 112,5 mg kožni nanos, raztopina za majhne mačke (1,2 – 2,8 kg) Bravecto 250 mg kožni nanos, raztopina za srednje velike mačke ( &gt; 2,8 – 6,25 kg) Bravecto 500 mg kožni nanos, raztopina za velike mačke ( &gt; 6,25 – 12,5 kg)
Bravecto 112.5 mg spot-on solution for small cats (1.2 – 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 – 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 – 12.5 kg)
Bravecto 112,5 mg kožni nanos, raztopina za majhne mačke (1,2 – 2,8 kg) Bravecto 250 mg kožni nanos, raztopina za srednje velike mačke ( &gt; 2,8 – 6,25 kg) Bravecto 500 mg kožni nanos, raztopina za velike mačke ( &gt; 6.,5 – 12,5 kg)
Bravecto 112.5 mg spot-on solution for small cats (1.2 – 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 – 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 – 12.5 kg) fluralaner
Bravecto 112,5 mg kožni nanos, raztopina za majhne mačke (1,2 – 2,8 kg) Bravecto 250 mg kožni nanos, raztopina za srednje velike mačke ( &gt; 2,8 – 6,25 kg) Bravecto 500 mg kožni nanos, raztopina za velike mačke ( &gt; 6,25 – 12,5 kg)
Bravecto 112.5 mg spot-on solution for small cats (1.2 – 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 – 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 – 12.5 kg) fluralaner
Bravecto 112,5 mg kožni nanos, raztopina za majhne mačke (1,2 – 2,8 kg) Bravecto 250 mg kožni nanos, raztopina za srednje velike mačke ( &gt; 2,8 – 6,25 kg) Bravecto 500 mg kožni nanos, raztopina za velike mačke ( &gt; 6.,5 – 12,5 kg) fluralaner
Bravecto 112.5 mg spot-on solution for small cats (1.2 – 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 – 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 – 12.5 kg) fluralaner
Bravecto 112.5 mg kožni nanos, raztopina za majhne mačke (1,2 – 2,8 kg) Bravecto 250 mg kožni nanos, raztopina za srednje velike mačke ( &gt; 2,8 – 6,25 kg) Bravecto 500 mg kožni nanos, raztopina za velike mačke ( &gt; 6,25 – 12,5 kg) fluralaner
Bravecto 112.5 mg spot-on solution for very small dogs (2 – 4.5 kg) Bravecto 250 mg spot-on solution for small dogs ( &gt; 4.5 – 10 kg) Bravecto 500 mg spot-on solution for medium-sized dogs ( &gt; 10 – 20 kg) Bravecto 1000 mg spot-on solution for large dogs ( &gt; 20 – 40 kg) Bravecto 1400 mg spot-on solution for very large dogs ( &gt; 40 – 56 kg)
Bravecto 112,5 mg kožni nanos, raztopina za zelo majhne pse (2-4,5 kg) Bravecto 250 mg kožni nanos, raztopina za majhne pse ( &gt; 4,5-10 kg) Bravecto 500 mg kožni nanos, raztopina za srednje velike pse ( &gt; 10-20 kg) Bravecto 1000 mg kožni nanos, raztopina za velike pse ( &gt; 20-40 kg) Bravecto 1400 mg kožni nanos, raztopina za zelo velike pse ( &gt; 40-56 kg)
Bravecto 112.5 mg spot-on solution for very small dogs (2 – 4.5 kg) Bravecto 250 mg spot-on solution for small dogs ( &gt; 4.5 – 10 kg) Bravecto 500 mg spot-on solution for medium-sized dogs ( &gt; 10 – 20 kg) Bravecto 1000 mg spot-on solution for large dogs ( &gt; 20 – 40 kg) Bravecto 1400 mg spot-on solution for very large dogs ( &gt; 40 – 56 kg) fluralaner
Bravecto 112,5 mg kožni nanos, raztopina za zelo majhne pse (2-4,5 kg) Bravecto 250 mg kožni nanos, raztopina za majhne pse ( &gt; 4,5-10 kg) Bravecto 500 mg kožni nanos, raztopina za srednje velike pse ( &gt; 10-20 kg) Bravecto 1000 mg kožni nanos, raztopina za velike pse ( &gt; 20-40 kg) Bravecto 1400 mg kožni nanos, raztopina za zelo velike pse ( &gt; 40-56 kg) fluralaner
Bravecto 112.5 mg spot-on solution for very small dogs (2-4.5 kg) Bravecto 250 mg spot-on solution for small dogs ( &gt; 4.5 – 10 kg) Bravecto 500 mg spot-on solution for medium-sized dogs ( &gt; 10 - 20 kg) Bravecto 1000 mg spot-on solution for large dogs ( &gt; 20 – 40 kg) Bravecto 1400 mg spot-on solution for very large dogs ( &gt; 40 – 56 kg) fluralaner
Bravecto 112,5 mg kožni nanos, raztopina za zelo majhne pse (2-4,5 kg) Bravecto 250 mg kožni nanos, raztopina za majhne pse ( &gt; 4,5-10 kg) Bravecto 500 mg kožni nanos, raztopina za srednje velike pse ( &gt; 10-20 kg) Bravecto 1000 mg kožni nanos, raztopina za velike pse ( &gt; 20-40 kg) Bravecto 1400 mg kožni nanos, raztopina za zelo velike pse ( &gt; 40-56 kg) fluralaner
Brimica Genuair demonstrated a rapid onset of action within 5 minutes of the first inhalation relative to placebo (p &lt; 0.0001).
Pri zdravilu Brimica Genuair je bilo opaženo hitro začetno delovanje v petih minutah po prvi inhalaciji v primerjavi s placebom (p &lt; 0,0001).
Brimica Genuair improved daily symptoms of COPD such as ‘breathlessness’, ‘chest symptoms’, ‘cough and sputum’ (assessed by E-RS total score) as well as overall night-time symptoms, overall early morning symptoms and symptoms limiting early morning activities compared to placebo, aclidinium and formoterol but the improvements were not always statistically significant.
Zdravilo Brimica Genuair je v primerjavi s placebom, aklidinijem in formoterolom (vsi p &lt; 0,05) izboljšalo tudi dnevne simptome KOPB, kot so »zasoplost«, »simptomi v prsnem košu«, »kašelj in sputum«, (ocenjene na osnovi celokupne ocene E-RS) ter nočne in zgodnje jutranje simptome ter simptome, ki bolnika omejujejo pri zgodnjih jutranjih aktivnostih, vendar izboljšanja niso bila vedno statistično značilna.
Brimica Genuair provided a clinically meaningful improvement in breathlessness (assessed by the Transition Dyspnoea Index [TDI]) with an improvement in the TDI focal score at 6 months compared to placebo of 1.29 units in study ACLIFORM-COPD (p &lt; 0.0001) and 1.44 units in study AUGMENT (p &lt; 0.0001).
Zdravilo Brimica Genuair je v primerjavi s placebom klinično pomembno izboljšalo zadihanost (ocenjeno s pomočjo indeksa ocene dispneje skozi čas [TDI – Transition Dyspnoea Index]) z izboljšanjem skupne ocene TDI po 6 mesecih z rezultatom 1,29 enote v študiji ACLIFORM-COPD (p &lt; 0,0001) in 1,44 enote v študiji AUGMENT (p &lt; 0,001).
Brinzolamide and N-desethyl-brinzolamide are the predominant components found in the urine along with trace levels ( &lt; 1%) of the N-desmethoxypropyl and O-desmethyl metabolites.
Tako v seču najdemo predvsem brinzolamid in N-desetil-brinzolamid poleg N-desmetoksipropilnih in O-desmetilnih presnovkov, ki pa so prisotni le v sledovih ( &lt; 1%).
Brinzolamide and N-desethylbrinzolamide are the predominant components in the urine along with trace levels ( &lt; 1%) of the N-desmethoxypropyl and O-desmethyl metabolites.
V seču najdemo predvsem brinzolamid in N-desetilbrinzolamid, poleg N-desmetoksipropil in O-desmetil presnovkov, ki so prisotni le v sledovih.
Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis ( &gt; 60 ml) in the previous three months.
Zdravilo Bronchitol ni proučeno pri bolnikih z anamnezo pomembnih epizod hemoptize ( &gt; 60 ml) v zadnjih treh mesecih.
BSS &lt; 5 Response
Odziv BSS &lt; 5
By 2 years 39%; P &lt; .0001
po 2 letih 39%; P &lt; 0,0001
By 3 years 50%; P &lt; .0001
po 3 letih 50%; P &lt; 0,0001
By 4 years 40%; P &lt; .0001
po 4 letih 40%; P &lt; 0,0001
By 5 years By 6 years 56%; P &lt; .0001
po 5 letih po 6 letih 56%; P &lt; 0,0001
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA &lt; 400 copies/ml ( &lt; 50 copies/ml) in the REYATAZ + ritonavir arm and the lopinavir + ritonavir arm were 55% (40%) and 56% (46%), respectively.
Po analizi "kot so bili zdravljeni" (z izključitvijo manjkajočih vrednosti) je bil delež bolnikov s HIV RNA &lt; 400 kopij/ml ( &lt; 50 kopij/ml) v kraku z zdravilom REYATAZ + ritonavirjem 55% (40%) in v kraku z lopinavirjem + ritonavirjem 56% (46%).
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA &lt; 400 copies/ml ( &lt; 50 copies/ml) for REYATAZ + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
Z analizo "kot so bili zdravljeni" in ob izključitvi manjkajočih vrednosti, je bil delež bolnikov s HIV RNA &lt; 400 kopij/ml ( &lt; 50 kopij/ml) za REYATAZ + ritonavir 84% (72%) in za lopinavir + ritonavir 82% (72%).
By comparison, vorapaxar exposure (AUC and Cmax) is estimated to be 19-21% lower in patients with a body weight of &gt; 100 kg compared to those weighing 60-100 kg.
Na podlagi primerjave je ocenjeno, da je izpostavljenost vorapaksarju (AUC in Cmax) pri osebah s telesno maso &gt; 100 kg od 19 do 21 % nižja kot pri tistih s telesno maso od 60 do 100 kg.
By intent to treat analysis 65 % of patients had HIV RNA &lt; 400 copies/mL and 50 % had viral load &lt; 50 copies/mL; by on-treatment analysis 96 % of patients had HIV RNA
Pri analizi populacije, ki so jo nameravali zdraviti, je imelo 65 % bolnikov HIV RNA &lt; 400 kopij/ml, 50 % pa virusno breme &lt; 50 kopij/ml; pri analizi zdravljene populacije je imelo 96 % bolnikov HIV
By Year 3 recurrent AR was similar across groups ( &lt; 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups.
Do 3. leta je bila ponovitev akutne zavrnitve podobna v vseh skupinah ( &lt; 3 %), subklinična akutna zavrnitev, odkrita z biopsijo po protokolu po 1 letu, pa je bila v obeh skupinah 5 %.
c &gt; 48 hours of diarrhoea and/or &gt; 7 days of rash d If patient cannot tolerate 20 mg/day, permanent discontinuation of GIOTRIF should be considered
c &gt; 48 ur driske in/ali &gt; 7 dni izpuščaja d Če bolnik ne prenaša odmerka po 20 mg na dan, je treba presoditi o ukinitvi zdravila GIOTRIF.
c p &lt; 0.01 compared with placebo d Patients with Itch NRS &gt; = 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 80 mg Q2W N = 303, Etanercept N = 306
c p &lt; 0,01 v primerjavi s placebom d Bolniki z oceno srbenja na lestvici NRS &gt; = 4 v izhodišču: placebo N = 135, zdravilo Taltz 80 mg Q4W N = 293, zdravilo Taltz 80 mg Q2W N = 303, etanercept N = 306
C) LS mean difference and 95% CI based on an ANCOVA model with treatment group, baseline BCVA category ( &gt; 20/200 and ≤ 20/200) and region (North America vs.
C) Povprečna razlika najmanjših kvadratov (LS) in 95 % intervala zaupanja (IZ) na podlagi modela ANCOVA z dejavniki kot so zdravljena skupina, izhodiščna vrednost BCVA ( &gt; 20/200 in ≤ 20/200) in regija (Severna Amerika vs.
c.1020 G &gt; A
c.1016 T &gt; G
c.1021 G &gt; A
c.1018 T &gt; C
c.1023 A &gt; C
c.1020 G &gt; A
c.1024 C &gt; T
c.1023 A &gt; C
c.1024C &gt; G
c.1021 G &gt; A
c.1025 G &gt; A
c.1024C &gt; G
c.1025 G &gt; C
c.1024 C &gt; T
c.1025 G &gt; T
c.1025 G &gt; A
c.1031 T &gt; C
c.1025 G &gt; C
c.1034 C &gt; G
c.1025 G &gt; T
c.1042 G &gt; C
c.1031 T &gt; C
c.1045 T &gt; C
c.1034 C &gt; G
c.1046 G &gt; A
c.1042 G &gt; C
c.1048 G &gt; C
c.1045 T &gt; C
c.1054 G &gt; C
c.1046 G &gt; A
c.1055 C &gt; A
c.1048 G &gt; C
c.1065 C &gt; A
c.1054 G &gt; C
c.1069 C &gt; T
c.1055 C &gt; A
c.1072 G &gt; A
c.1065 C &gt; A
c.1081 G &gt; A
c.1069 C &gt; T
c.1088 G &gt; C
c.1072 G &gt; A
c.1095 T &gt; A
c.1081 G &gt; A
c.1115 T &gt; A
c.1088 G &gt; C
c.1115 T &gt; C
c.1095 T &gt; A
c.1115 T &gt; G
c.1115 T &gt; A
c.1117 G &gt; C
c.1115 T &gt; C
c.1118 G &gt; A
c.1115 T &gt; G
c.1124_1129del
c.1117 G &gt; C
c.1129_1140dup
c.1118 G &gt; A
c.1130 C &gt; A
c.1124_1129del
c.1132 T &gt; C
c.1129_1140dup
c.1133 G &gt; A
c.1130 C &gt; A
c.1144T &gt; C
c.1132 T &gt; C
c.1145 G &gt; A
c.1133 G &gt; A
c.1146 C &gt; G
c.1144T &gt; C
c.1151 T &gt; A
c.1145 G &gt; A
c.1153 A &gt; C
c.1146 C &gt; G
c.1156 C &gt; T
c.1151 T &gt; A
c.1157 A &gt; C
c.1153 A &gt; C
c.1165 C &gt; G
c.1156 C &gt; T
c.1166 C &gt; G
c.1157 A &gt; C
c.1166 C &gt; T
c.1165 C &gt; G
c.1181_1183dup
c.1166 C &gt; G
c.1187 T &gt; A
c.1166 C &gt; T
c.1192 G &gt; T
c.1181_1183dup
c.1196 G &gt; A or1197 G &gt; A
c.1187 T &gt; A
c.1202 C &gt; G
c.1192 G &gt; T
c.1215 T &gt; A
c.1196 G &gt; A ali1197 G &gt; A
c.1217 A &gt; G
c.1202 C &gt; G
c.1219 A &gt; G
c.1215 T &gt; A
c.1220 T &gt; A
c.1217 A &gt; G
c.1220 T &gt; G
c.1219 A &gt; G
c.140 G &gt; A or 141 G &gt; A
c.140 G &gt; A ali 141 G &gt; A
c.194 G &gt; C (putative splicing site )
c.194 G &gt; C (domnevno mesto za cepitev)
c.194 G &gt; T (putative splicing site )
c.194 G &gt; T (domnevno mesto za cepitev)
c.547 G &gt; A (putative splicing site )
c.547 G &gt; A (domnevno mesto za cepitev)
c.56 T &gt; A
c.53 T &gt; C
c.611 G &gt; A or 612G &gt; A
c.611 G &gt; A ali 612G &gt; A
c.62 T &gt; G
c.61C &gt; T
c.734 G &gt; A or 735G &gt; A
c.734 G &gt; A ali 735G &gt; A
c.779 G &gt; A
c.776 C &gt; G
c.801 G &gt; A (putative splicing site )
c.801 G &gt; A (domnevno mesto za cepitev)
c.860 G &gt; A or 861G &gt; A
c.860 G &gt; A ali 861G &gt; A
c.888 G &gt; A
c.886 A &gt; T
c.893 A &gt; G
c.887 T &gt; C
c: subjects &lt; 75 kg received 100 µg/week peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b . d: Ribavirin dosing was 800 mg for patients &lt; 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients &gt; 75 kg.
c: preiskovanci s telesno maso &lt; 75 kg so prejemali 100 µg peginterferona alfa-2b na teden, preiskovanci s telesno maso ≥ 75 kg pa so prejemali 150 µg peginterferona alfa-2b na teden. d: odmerek ribavirina je znašal 800 mg za bolnike s telesno maso &lt; 60 kg, 1000 mg za bolnike s telesno maso od 60 do 75 kg in 1200 mg za tiste s telesno maso &gt; 75 kg.
c: subjects &lt; 75 kg received 100 µg/week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/week pegylated interferon alfa-2b. d: ribavirin dosing was 800 mg for patients &lt; 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients &gt; 75 kg.
c: preiskovanci s telesno maso &lt; 75 kg so prejemali odmerek 100 µg/teden pegiliranega interferona alfa-2b in preiskovanci s telesno maso ≥ 75 kg so prejemali 150 µg/teden pegiliranega interferona alfa-2b. d: Odmerki ribavirina so bili naslednji: 800 mg za bolnike &lt; 60 kg, 1.000 mg za tiste s telesno maso od 60 do 75 kg in 1.200 mg za bolnike s telesno maso &gt; 75 kg.
CA was defined as the proportion of all subjects treated who did not smoke (not even a puff of a cigarette) from Week 9 through Week 52 and did not have an exhaled CO measurement of &gt; 10 ppm.
Delež CA je bil opredeljen kot odstotek vseh zdravljenih oseb, ki od 9. do vključno 52. tedna niso kadile (niti vdiha cigarete) in jim v izdihanem zraku niso izmerili &gt; 10 ppm CO.
Cabazitaxel is extensively metabolised in the liver ( &gt; 95%), mainly by the CYP3A isoenzyme (80% to 90%).
Kabazitaksel se izdatno presnovi v jetrih ( &gt; 95 %), predvsem z izoencimi CYP3A (80 % do 90 %).
Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin &gt; 3 x ULN) (see sections 4.3, 4.4 and 5.2).
Kabazitaksela se ne sme dajati bolnikom s hudo okvaro jeter (celokupni bilirubin &gt; 3-kratna ZNM (glejte poglavja 4.3, 4.4 in 5.2).
Cabozantinib is a substrate for CYP3A4 metabolism in vitro, as a neutralizing antibody to CYP3A4 inhibited formation of metabolite XL184 N-oxide by &gt; 80% in a NADPH-catalyzed human liver microsomal (HLM) incubation; in contrast, neutralizing antibodies to CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 and CYP2E1 had no effect on cabozantinib metabolite formation.
Kabozantinib je in vitro substrat presnove CYP3A4, kot nevtralizirajoče protitelo za nastanek presnovka XL184 N-oksida, ki ga zavre CYP3A4 za &gt; 80 %, v inkubaciji mikrosomov človeških jeter, kataliziranega z NADPH; nasprotno pa nevtralizirajoča protitelesa za CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 in CYP2E1 niso vplivala na nastanek presnovka kabozantiniba.
Canagliflozin 100 mg as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p &lt; 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
100 mg kanagliflozina je v kombinaciji z metforminom povzročilo podobno znižanje odstotka HbA1c od izhodišča kot glimepirid, odmerek 300 mg pa večje znižanje odstotka HbA1c od izhodišča kot glimepirid (p &lt; 0,05), kar dokazuje neinferiornost kanagliflozina.
Canagliflozin 100 mg once daily as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p &lt; 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
100 mg kanagliflozina je v kombinaciji z metforminom povzročilo podobno znižanje odstotka HbA1c od izhodišča kot glimepirid, odmerek 300 mg pa večje znižanje odstotka HbA1c od izhodišča kot glimepirid (p &lt; 0,05), kar dokazuje neinferiornost kanagliflozina.
Canagliflozin has not been studied in severe renal impairment (eGFR &lt; 30 mL/min/1.73 m2 or CrCl &lt; 30 mL/min) or ESRD.
Pri bolnikih s hudo ledvično okvaro (ocenjena glomerulna filtracija &lt; 30 ml/min/1,73 m2 ali očistek kreatinina &lt; 30 ml/min) ali s končno ledvično odpovedjo kanagliflozina niso preskušali.
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to &lt; 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Občasno (≥ 1/1.000 do &lt; 1/100) so pri bolnikih z rakom, ki so prejemali kemoterapijo po uporabi granulocitne kolonije spodbujajočega faktorja, poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte poglavje 4.4 in poglavje »Opis izbranih neželenih učinkov« spodaj.
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to &lt; 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of G-CSFs; see section 4.4 and subsection “Description of selected adverse reactions” of section 4.8.
Občasno (≥ 1/1000 to &lt; 1/100) so pri bolnikih z rakom, ki so prejemali kemoterapijo, in zdravih dajalcih, pri katerih poteka zbiranje matičnih celic iz periferne krvi, Po uporabi G-CSF poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte poglavje 4.4 in podpoglavje »Opis izbranih neželenih učinkov« poglavja 4.8.
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to &lt; 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of granulocyte colony- stimulating factors; see section 4.4 and subsection C of section 4.8.
Občasno (≥ 1/1000 do &lt; 1/100) so pri bolnikih z rakom, ki so prejemali kemoterapijo, in po izplavljanju matičnih celic v periferno kri pri zdravih dajalcih po uporabi granulocitne kolonije stimulirajočega faktorja, poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte poglavje 4.4 in podpoglavje C poglavja 4.8.
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to &lt; 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of granulocyte colony-stimulating factors (see section 4.4 and section 4.8).
O sindromu povečane prepustnosti kapilar, ki je lahko v primeru zakasnjenega zdravljenja tudi življenjsko ogrožajoč, so občasno (od ≥ 1/1.000 do &lt; 1/100) poročali pri rakavih bolnikih, ki so prejemali kemoterapijo, in zdravih darovalcih, pri katerih je potekalo izplavljanje perifernih krvotvornih matičnih celic po dajanju granulocitne kolonije spodbujajočega faktorja (glejte poglavji 4.4. in 4.8.).
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to &lt; 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of granulocyte colony-stimulating factors; see below and section 4.4.
Občasno (≥ 1/1.000 do &lt; 1/100) so pri bolnikih z rakom, ki so prejemali kemoterapijo in pri zdravih dajalcih, pri katerih se izvaja izplavljanje matičnih celic v periferno kri (PBPC), po uporabi granulocitne kolonije stimulirajočega faktorja, poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte spodaj in poglavje 4.4.
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to &lt; 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilization following administration of granulocyte colony-stimulating factors (see section 4.4 and section 4.8).
O sindromu povečane prepustnosti kapilar, ki je lahko v primeru zakasnjenega zdravljenja tudi življenjsko ogrožajoč, so občasno (od ≥ 1/1000 do &lt; 1/100) poročali pri rakavih bolnikih, ki so prejemali kemoterapijo, in zdravih darovalcih, pri katerih je potekala mobilizacija perifernih krvotvornih matičnih celic po dajanju granulocitne kolonije spodbujajočega faktorja (glejte poglavji 4.4. in 4.8.).
Cardiac arrhythmias particularly tachycardia (0.8% vs &lt; 0.1%) and palpitations (1.5% vs 0.8%) have been reported in lixisenatide patients compared to placebo treated patients.
Pri prejemnikih liksenatida so bile v primerjavi s prejemniki placeba opisane motnje srčnega ritma, zlasti tahikardija (0,8 % v primerjavi z &lt; 0,1 %) in palpitacije (1,5 % v primerjavi z 0,8 %).
Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with MabThera compared to &lt; 1% on observation.
O resnih neželenih dogodkih, povezanih s srcem (vključno z atrijsko fibrilacijo, miokardnim infarktom, popuščanjem levega prekata, ishemijo miokarda), so poročali pri 3 % bolnikov, ki so prejemali zdravilo MabThera in pri manj kot 1 % bolnikov v opazovani skupini.