natgillin/translations-raw huggingface dataset:
&gt; 1.5 x ULN) in the tenofovir disoproxil fumarate treatment group and 0% (0/32) of patients in the placebo group had HBV DNA &lt; 400 copies/ml.
≥ 105 kopij/ml, ALT v serumu &gt; 1,5 x ZMN) v skupini, zdravljeni z dizoproksiltenofovirijevim fumaratom in 0% (0/32) bolnikov v skupini s placebom, imelo HBV DNA &lt; 400 kopij/ml.
&gt; 1.5 x – 3 x ULN
&gt; 1,5–3x ULN
&gt; 10 kg: Continue with dose of
&gt; 10 kg: Nadaljujte z odmerkom
&gt; 10 x ULN*
10 x ZMN
&gt; 10 x ULN*
&gt; 10 x ZMN
&gt; 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
&gt; 10.000-krat močnejši za PDE5 kot za PDE3, encim, ki se nahaja v srcu in krvnih žilah.
&gt; 100,000 copies/mL
&gt; 100.000 kopij/ml
&gt; 100,000 copies/mL (n = 44)
&gt; 100.000 kopij/ml (n = 44)
&gt; 100,000 copies/mL) and the class of the second agent (NRTI or other classes).
(≤ 100.000 kopij/ml ali &gt; 100.000 kopij/ml) in razred drugega zdravila (NRTI ali drugi razredi).
&gt; 100,000 copies/mL.
&gt; 100.000 kopij/ml.
&gt; 100,000/µl to ≤ 150,000/µl
&gt; 100.000/µl do  150.000/µl
&gt; 12 months (n=282)
&gt; 12 mesecev (n = 282)
&gt; 12 years to &lt; 18 years and bodyweight &lt; 33 kg
&gt; 12 let do &lt; 18 let in s telesno maso &lt; 33 kg
&gt; 15 kg to 23 kg
&gt; 15 do 23 kg
&gt; 150 for two consecutive weeks
&gt; 150 dva tedna zapored
&gt; 150,000/µl
&gt; 150.000/µl
&gt; 150,000/µl to  250,000/µl
&gt; 150.000/µl do  250.000/µl
&gt; 1500 µmol/L.min following 1 mg/kg.
1500 µmol/l·min po odmerku 1 mg/kg.
&gt; 18 weeks.
18 tednov.
&gt; 1st-line therapy
več kot prva linija zdravljenja
&gt; 2 million copies/mL
&gt; 2 milijona kopij/ml
&gt; 2 months, and reduced the skeletal morbidity rate.
&gt; 2 meseca in zmanjšala stopnjo obolevnosti skeleta.
&gt; 2-6 months
&gt; 2–6 mesecev
&gt; 2.0 to ≤ 5.0 x ULN
&gt; 2,0 do ≤ 5,0 x ZMN
&gt; 2.5 to ≤ 5.0 x ULN
&gt; 2,5 do ≤ 5,0 x ZMN
&gt; 2.50 to ≤ 5.00 x ULN
&gt; 2,50 do ≤ 5,00 x ZMN
&gt; 200 cells/mm3
&gt; 200 celic/mm3
&gt; 200 copies/ml.
&gt; 200 kopij/ml.
&gt; 23 kg to 40 kg
&gt; 23 do 40 kg
&gt; 24 hours
&gt; 24 ur
&gt; 25% of the bone marrow infiltrated by lymphoma cells
več kot 25 % kostnega mozga infiltriranega z limfomskimi celicami
&gt; 25,000/mm3
&gt; 25.000/mm3
&gt; 250 mg/dL or &gt; 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
ali &gt; 13,9 mmol/l) ali s ketoacidozo hipertiroidizem 3. stopnje
&gt; 250,000/µl
&gt; 250.000/µl
&gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
&gt; 3,0 mg/dl so bili iz kliničnih preskušanj z zdravilom Zometa izključeni.
&gt; 3 and ≤ 5 x ULN: Confirm by another liver test;if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
&gt; 3 in ≤ 5 × ZMN: Potrdite z drugo preiskavo jeter; če je stanje potrjeno, se morate odločiti za nadaljevanje ali prekinitev zdravljenja z zdravilom Thelin za vsakega bolnika posebej.
&gt; 3 and  5  ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
&gt; 3 in  5  ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen, se za vsakega posameznega bolnika odločite, ali boste z zdravljenjem z zdravilom STAYVEER nadaljevali, morebiti znižali odmerek ali dajanje zdravila STAYVEER prekinili (glejte poglavje 4.2).
&gt; 3 and  5  ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue Tracleer, possibly at a reduced dose, or to stop Tracleer administration (see section 4.2).
&gt; 3 in  5  ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen, se za vsakega posameznega bolnika odločite, ali boste z zdravljenjem z zdravilom Tracleer nadaljevali, morebiti znižali odmerek ali dajanje zdravila Tracleer prekinili (glejte poglavje 4.2).
&gt; 3 hours to
&gt; 3 ure do
&gt; 3 to 5 x ULN
&gt; 3- do 5-kratna
&gt; 3 to 5 x ULN
&gt; 3- do 5-kratna ZMN
&gt; 3 x ULN
&gt; 3-kratna ULN
&gt; 3 x ULN to 5x ULN
&gt; 3- do 5-kratna ZMN
&gt; 3 × ULN*
&gt; 3 x ULN
&gt; 3.0 to ≤ 5.0 x ULN
&gt; 3,0 to ≤ 5,0 x ZMN
&gt; 3.5 excess 13C = Positive
 3,5 presežek 13C = pozitivno
&gt; 30 to ≤ 50
&gt; 30 do ≤ 50
&gt; 300 mg/dl)
&gt; 3.000 mg/l)
&gt; 3½ months up to 4 months
&gt; 3 mesece in pol do 4 mesece
&gt; 4 mg/dL (adults)
Odrasli &gt; 4 mg/dl
&gt; 4 mg/dl (for &gt; 4 weeks)
&gt; 4 mg/dl (za &gt; 4 tedne)
&gt; 4 mg/dL (for &gt; 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
&gt; 4 mg/dl ( &gt; 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b)
&gt; 4 mg/dL (for &gt; 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
≥ 4 mg/dl ( &gt; 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b)
&gt; 4 seizures during 3 month baseline period
&gt; 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem
&gt; 4 weeks and &lt; 5 weeks
&gt; 4 tedne in &lt; 5 tednov
&gt; 4 weeks and &lt; 6 weeks
&gt; 4 tedne in &lt; 6 tednov
&gt; 40 weeks
&gt; 40 tednov
&gt; 400 copies/mL at virologic failure, at Week 48, at Week 96, at Week 144 or at the time of early study drug discontinuation.
96. tednu, v 144. tednu ali ob zgodnji prekinitvi jemanja študijskega zdravila.
&gt; 45 min improvement in both nighttime and daytime sleep (%)(5)
&gt; 45-minutno izboljšanje spanja ponoči in podnevi (%)(5)
&gt; 5 and ≤ 8 x ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
&gt; 5 in ≤ 8 × ZMN: Potrdite z drugo preiskavo jeter; če je stanje potrjeno, končajte zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se vrednosti ne normalizirajo.
&gt; 5 and ≤ 8 x ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Če je stanje potrjeno, prekinite zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se ne normalizirajo.
&gt; 5 and  8  ULN The result should be confirmed by a second liver test; if confirmed, treatment should be stopped and aminotransferase levels monitored at least every 2 weeks.
&gt; 5 in  8  ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen, je treba zdravljenje prekiniti in spremljati ravni aminotransferaz vsaj na vsaka 2 tedna.
&gt; 5 mg/dl
Kreatinin v serumu
&gt; 5 mg/dL (for &gt; 4 weeks) (children and adolescents treated with interferon alfa-2b) or
≥ 5 mg/dl ( &gt; 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b) ali
&gt; 5 weeks
&gt; 5 tednov
&gt; 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to &lt; 1.5 x IULN and transaminase levels to &lt; 2.5 x IULN.
&gt; 5-kratno IULN, je treba zdravljenje z zdravilom Glivec prekiniti, dokler se koncentracija bilirubina ne vrne na &lt; 1,5-kratno IULN oziroma koncentracija aminotransferaz na &lt; 2,5-kratno IULN.
&gt; 5 x ULN
&gt; 5-kratna ULN
&gt; 5 x ULN
&gt; 5-kratna ZMN
&gt; 5% blasts in bone marrow, ECOG performance status ≤ 2, life expectancy of ≥ 12 weeks, who did not have autologous haematopoietic stem cell transplantation (HSCT) within 6 weeks prior to start of BLINCYTO treatment, allogeneic HSCT within 3 months prior to start of BLINCYTO treatment, or previous treatment with BLINCYTO), the safety and efficacy of BLINCYTO were evaluated.
≥ 12 tednov ter niso imeli avtologne presaditve krvotvornih matičnih celic v 6 tednih pred začetkom zdravljenja z zdravilom BLINCYTO, alogenske presaditve krvotvornih matičnih celic v 3 mesecih pred začetkom zdravljenja z zdravilom BLINCYTO ali predhodnega zdravljenja z zdravilom BLINCYTO).
&gt; 5.0 x ULN
&gt; 5,0 x ZMN
&gt; 50 and
&gt; 50 in ≤ 200 celic/mm3
&gt; 50 and ≤ 200 cells/mm3
&gt; 50 in ≤ 200 celic/mm3
&gt; 50 kg Body Weight
telesna masa &gt; 50 kg
&gt; 500 IU/l
&gt; 500 i.e./l
&gt; 500 ng/ml at baseline
&gt; 500 ng/ml ob izhodišču
&gt; 500 ng/ml at Week 12
&gt; 500 ng/ml v 12. tednu
&gt; 500 ng/ml at Week 52
&gt; 500 ng/ml v 52. tednu
&gt; 54 weeks ( &lt; 0.001)
&gt; 54 tednov ( &lt; 0,001)
&gt; 5x ULN
&gt; 5-kratna ZMN
&gt; 6 months
&gt; 6 mesecev
&gt; 6 weeks
&gt; 6 tednov
&gt; 60 4.0 mg zoledronic acid
&gt; 60 4,0 mg zoledronske kisline
&gt; 60 years of age or
tarost nad 60 let ali
&gt; 600,000 IU/ml
&gt; 600.000 i.e./ml
&gt; 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
0,5 x 109/l za &gt; 7 dni, ponovite postopek, opisan pod zaporedno številko 1, in nato ponovno uvedite zdravljenje, in sicer z zmanjšanim odmerkom 80 mg enkrat na dan (druga ponovitev).
&gt; 70 kg (4.6 µg/ml, 17.8 µg/ml, 545 µg*d/ml).
17,8 µg/ml, 545 µg*d/ml).
&gt; 75 years of age if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine with low body weight ( &lt; 60 kg) if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine
o stari &gt; 75 let in sočasno prejemajo samo acetilsalicilno kislino ali acetilsalicilno kislino in klopidogrel ali tiklopidin imajo nizko telesno maso ( &lt; 60 kg), če sočasno prejemajo samo acetilsalicilno kislino ali acetilsalicilno kislino in klopidogrel ali tiklopidin
&gt; 75,000/l, only 14% of 309 patients had a count ≤ 25,000/l during the study.
Izmed 309 bolnikov, ki so imeli začetno število trombocitov &gt; 75.000/l, jih je le 14% imelo med preskušanjem število trombocitov  25.000/l.
&gt; 8 x ULN or any of the above with associated clinical symptoms of liver injury: Treatment must be stopped and re-introduction of Tracleer is not to be considered.
&gt; 8 x ZMN ali vsaka od zgoraj navedenih, pri čemer se pojavijo klinični simptomi okvarjenega delovanja jeter: Zdravljenje morate prekiniti in ponovna uvedba zdravljenja z zdravilom Tracleer ni dovoljena. da je zdravljenje z zdravilom Tracleer povezano z znižanjem hemoglobina
&gt; 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
&gt; 8 × ZMN: zdravljenje je treba končati in ponovna uvedba zdravila Thelin ne pride v poštev.
&gt; 8  ULN Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
&gt; 8  ZMN Zdravljenje moramo prekiniti in ponovna uvedba zdravljenja z zdravilom STAYVEER ni dovoljena.
&gt; 8  ULN Treatment must be stopped and re-introduction of Tracleer is not to be considered.
&gt; 8  ZMN Zdravljenje moramo prekiniti in ponovna uvedba zdravljenja z zdravilom Tracleer ni dovoljena.
&gt; 80 ml/min) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, plasma clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min) and on average 2 times lower in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
očistek &gt; 80 ml/min), ki so imeli ortopedsko operacijo in so dobivali fondaparinuks v odmerku 2,5 mg enkrat na dan, je pri bolnikih z blago okvaro delovanja ledvic (kreatininski očistek 50 do 80 ml/min) plazemski očistek 1,2 do 1,4- krat manjši in v povprečju 2-krat manjši pri bolnikih z zmerno okvaro delovanja ledvic (kreatininski očistek 30 do 50 ml/min).
&gt; 9 months
&gt; 9 mesecev
&gt; age appropriate ULN**
nad starostno ustrezno zgornjo mejo normale
&gt; 1 log reduction in HIV RNA or
Zmanjšanje HIV RNA za &gt; 1 log ali &lt; 50 kopij/ml
&gt; 1 mg/kg/day but no maternal reproductive toxicity was observed up to 3 mg/kg/day (estimate exposure &gt; 2.3 times the AUC in patients administered the RDD).
 1 mg/kg/dan, toda nobenega toksičnega vpliva na sposobnost razmnoževanja samic niso opazili pri odmerkih do 3 mg/kg/dan (ocena izpostavljenosti  2,3-kratnik vrednosti AUC pri bolnikih, ki prejemajo RDD).
&gt; 1 to ≤ 2 years
&gt; 1 do ≤ 2 leti
&gt; 1 to ≤2 years
&gt; 1 do ≤ 2 leti
&gt; 1,000 µg/l
&gt; 1.000 µg/l
&gt; 1,500cells/mm3 and platelets recover to a level &gt; 100,000 cells/mm3.
3 število trombocitov na &gt; 100.000 celic/mm .
&gt; 1.0 x 109/l and/or platelets
ANC &gt; 1,0 x 109/l in/ali število trombocitov
&gt; 10 to ≤20 x ULN
&gt; 10- do ≤ 20-kratna vrednost ULN
&gt; 10 ULN
&gt; 10 ULN
&gt; 10 × ULN (grade 4)
&gt; 10 × ZNM (4. stopnja)
&gt; 10% (N=72)
&gt; 10 % (N=72)
&gt; 10% to ≤15%
&gt; 10 % do ≤ 15
&gt; 10,000 – 100,000 copies/ml
&gt; 10.000 – 100.000 kopij/ml
&gt; 10.0 × ULN (Grade 4)
&gt; 10,0 × ZNM (4. stopnja)
&gt; 100,000 copies/ml
&gt; 100,000 kopij/ml
&gt; 100,000 copies/ml
&gt; 100.000 kopij/ml
&gt; 100,000 copies/ml, n (%)
&gt; 100.000 kopij/ml, n (%)
&gt; 12 to ≤18 years
&gt; 12 do ≤ 18 let
&gt; 14 ml/kg/month of PRBC (approx.
&gt; 14 ml/kg/mesec koncentriranih eritrocitov (približno
&gt; 15% to ≤20%
&gt; 15 % do ≤ 20
&gt; 18 to ≤64 years
&gt; 18 do ≤ 64 let
&gt; 1X – 3X upper normal limit
&gt; 1X – 3X nad zgornjo referenčno mejo
&gt; 2 months N=5 (%)
&gt; 2 meseca n = 5 (%)
&gt; 2 to ≤5 years
&gt; 2 do ≤ 5 let
&gt; 2,000 µg/l
&gt; 2.000 µg/l
&gt; 2,000 µg/l
prilagajanje
&gt; 2,500 µg/l
pri &gt; 2.500 µg/l
&gt; 20 hours.
&gt; 20 ur.
&gt; 20 ULN
&gt; 20 ULN
&gt; 20 x ULN
&gt; 20-kratna vrednost ULN
&gt; 20 × ULN (Grade 4)
&gt; 20 × ZMN (4. stopnja)
&gt; 20 × ULN (Grade 4)
&gt; 20 × ZNM (4. stopnja)
&gt; 20% none
&gt; 20
&gt; 20% to ≤25%
&gt; 20 % do ≤ 25
&gt; 2xULN (N=139)
&gt; 2xZMN (N=139)
&gt; 3 and ≤ 5 x ULN: Confirm levels and if confirmed, reduce the daily dose or stop treatment and monitor liver function at least every 2 weeks.
&gt; 3 in ≤5 x ZMN: potrdite vrednosti in če so potrjene, znižajte dnevni odmerek ali zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
&gt; 3 and ≤ 5 x ULN: Confirm by another liver test; if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
&gt; 3 in ≤ 5 × ZMN Potrdite z drugo preiskavo jeter; če je stanje potrjeno, se morate odločiti za nadaljevanje ali prekinitev zdravljenja z zdravilom Thelin za vsakega bolnika posebej.
&gt; 3 and  5 x ULN: Confirm levels and if confirmed, reduce the daily dose or stop treatment and monitor liver function at least every 2 weeks.
&gt; 3 in ≤5 x ZMN: potrdite vrednosti in če so potrjene, znižajte dnevni odmerek ali zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
&gt; 3 times ULN (Grade 2 or higher) with concurrent bilirubin &gt; 2 times ULN
&gt; 3-kratnik ULN (2. ali višje stopnje) s sočasnimi vrednostmi bilirubina &gt; 2-kratnik ULN
&gt; 3 to ≤5 x ULN
&gt; 3- do ≤ 5-kratna vrednost ULN
&gt; 3 ULN
&gt; 3 ULN
&gt; 3-10 × ULN (grade 3)
&gt; 3-10 × ZNM (3. stopnja)
&gt; 3.5 times the ULN associated with alkaline phosphatase &gt; 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
&gt; 3,5-kratno ULN ter hkrati alkalno fosfatazo &gt; 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
&gt; 30 minutes increase and a standard deviation &lt; 2 hours during double-masked phase
&gt; 30-minutno podaljšanje in standardni odklon &lt; 2 uri med dvojno slepo fazo
&gt; 32 weeks
&gt; 32 tednov
&gt; 33% above pre- treatment average
&gt; 33 % nad povprečjem vrednosti pred zdravljenjem
&gt; 35 years
≥35 let
&gt; 3X upper normal limit
&gt; 3X nad zgornjo referenčno mejo
&gt; 4 units/month for an adult)
&gt; 4 enote/mesec pri odraslem)
&gt; 4 watery stools/day or ≥2 days
&gt; 4 vodeni iztrebki/dan ali ≥ 2 dni
&gt; 45 minutes increase in average nighttime sleep duration
&gt; 45-minutno podaljšanje povprečnega trajanja spanja ponoči
&gt; 45 minutes increase in average nighttime sleep duration
&gt; 45-minutno skrajšanje povprečnega trajanja spanja podnevi
&gt; 5 and ≤ 8 x ULN: Confirm levels and if confirmed stop treatment and monitor liver function at least every 2 weeks.
&gt; 5 in ≤8 x ZMN: potrdite vrednosti in če so potrjene, zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
&gt; 5 and  8 x ULN: Confirm levels and if confirmed stop treatment and monitor liver function at least every 2 weeks.
&gt; 5 in ≤8 x ZMN: potrdite vrednosti in če so potrjene, zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
&gt; 5 times ULN
&gt; 5-kratnik ULN do
&gt; 5 to ≤10 x ULN
&gt; 5- do ≤ 10-kratna vrednost ULN
&gt; 5 to ≤12 years
&gt; 5 do ≤ 12 let
&gt; 5 ULN
&gt; 5 ULN
&gt; 5% to ≤10%
&gt; 5 % do ≤ 10
&gt; 5-20 × ULN* (Grade 3)
&gt; 5-20 × ZNM* (3. stopnja)
&gt; 5.0 × ULN (Grade 4)
&gt; 5,0 × ZNM (4. stopnja)
&gt; 5.0x ULN
&gt; 5,0 x ZNM
&gt; 5.5 and &lt; 6.7 mmol/l ( &gt; 100 and &lt; 120 mg/dl)
&gt; 5,5 in &lt; 6,7 mmol/l ( &gt; 100 in &lt; 120 mg/dl)
&gt; 50 years
≥50 let
&gt; 50,000 copies/mL
&gt; 50.000 kopij/ml
&gt; 54 weeks
&gt; 54 tednov
&gt; 6 to 8 hours after first dose
V obdobju od 6 do 8 ur po prejemu prvega odmerka
&gt; 60 years
&gt; 60 let
&gt; 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
&gt; 8 × ZMN: Zdravljenje je treba končati, ponovna uvedba zdravila Thelin pa ne pride v poštev.
&gt; 80 years
50,0
&gt; 80 years
71 do 80 let
&gt; 80 years
&gt; 80 let
&gt; 80 years
[22,9;
&gt; 800,000 IU/mL
&gt; 800.000 i.e./ml
&gt; 800,000 IU/mL†
&gt; 800.000 i.e./ml
&gt; 99% of Xiapex-treated patients developed high titers of antibodies to both AUX-I and AUX-II.
&gt; 99 % bolnikov, zdravljenih z zdravilom Xiapex, razvilo visoke titre protiteles proti AUX-I in AUX-II.
&gt; =100,000 copies/mL
&gt; =100.000 kopij/ml
&gt; R (Resistant)
&gt; R (odporen)
&gt; R (Resistant)
&gt; R (Odporni)
&gt; R (Resistant)
&gt; R (odpornost)
&gt; ULN (N=87)
&gt; ZMN (N=87)
[-1.36, -0.51], p &lt; 0.0001. There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Tudi v skupini z 0,5 mg razagilina je bilo v primerjavi s placebom statistično pomembno izboljšanje, vendar je bil obseg izboljšanja manjši.
[-5.7, -2.7]; p &lt; 0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p &lt; 0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p &lt; 0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
&lt; 0.0001; za razagilin 2 mg v primerjavi s placebom -3,6, 95 % CI [-5,0, -2,1]; p &lt; 0.0001; UPDRS motorični, del II: za razagilin 1 mg v primerjavi s placebom -2,7, 95 % CI [-3,87, -1,55]; p &lt; 0.0001; za razagilin 2 mg v primerjavi s placebom -1,68, 95 % CI [-2,85, -0,51]; p = 0.0050).
[-5.7, -2.7]; p &lt; 0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p &lt; 0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p &lt; 0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
motorični, del II: za razagilin 1 mg v primerjavi s placebom -2,7, 95% CI [-3,87, -1,55]; p &lt; 0,0001; za razagilin 2 mg v primerjavi s placebom -1,68, 95% CI [-2,85, -0,51]; p = 0,0050).
[CK elevation &gt; ULN - 2.5 x ULN]
[zvišanje vrednosti kreatin-kinaze od &gt; ZMN do 2,5-kratnika ZMN]
[eGFR] &lt; 60 ml/min/1.73 m2, see sections 4.4, 4.8, 5.1 and 5.2).
[eGFR] &lt; 60 ml/min/1,73 m2, glejte poglavja 4.4, 4.8, 5.1 in 5.2).
[Justification for not including Braille accepted]
&lt; Sprejeta je utemeljitev, da Braillova pisava ni potrebna. &gt;
[Very common (≥ 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), very rare ( &lt; 1/10,000)]
[zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/.000), zelo redki ( &lt; 1/10.000)]
[Very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to ≤1/100); not known (cannot be estimated from the available data)]
[Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100); neznana (ni mogoče oceniti iz razpoložljivih podatkov)]
A 1.4- to 1.7-fold increase in exposure (maximum plasma concentration and area under the plasma concentration-time curve) to selexipag and its active metabolite was observed in subjects with severe renal impairment (eGFR &lt; 30 mL/min/1.73 m2).
Pri osebah s hudo okvaro ledvic (eGFR &lt; 30 ml/min/1,73 m2) so opazili 1,4- do 1,7-kratno povečanje izpostavljenosti (največja koncentracija v plazmi in površina pod krivuljo plazemskih koncentracij v odvisnosti od časa) seleksipagu in njegovemu aktivnemu presnovku.
A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would result in &lt; 10% change in dasabuvir exposures.
Sprememba telesne mase za 10 kg od telesne mase 76 kg (mediana telesna masa v študijah 3. faze) bi povzročila &lt; 10-odstotno spremembo izpostavljenosti dasabuvirju.
A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in &lt; 10% change in ombitasvir exposures, and no change in paritaprevir exposures.
Sprememba telesne mase za10 kg od 76 kg (mediana telesna masa v študijah 3. faze) bi imela za posledico &lt; 10 % spremembo izpostavljenosti ombitasvirju in nobene spremembe izpostavljenosti paritaprevirju.
A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of
15 minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina &lt; 50 ml/min, niso proučevali.
A 15 minute infusion time has not been studied in cancer patients with CLCr &lt; 50 mL/min.
15 minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina &lt; 50 ml/min, niso proučevali.
A 15 minute infusion time has not been studied in cancer patients with CLCr &lt; 50 mL/min.
15-minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina &lt; 50 ml/min, niso proučevali.
A 15 minute infusion time has not been studied in cancer patients with CLCr &lt; 50 mL/min.
minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina &lt; 50 ml/min, niso proučevali.
A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in &gt; 90% of subjects after two doses regardless of the schedule.
Ne glede na shemo, je &gt; 90°% preiskovancev pod dveh odmerkih imelo 4-kraten porast titra nevtralizacijskih protiteles proti A/Indonesia/5/2005.
A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance &lt; 50 ml/min; see section 5.2).
Bolnikom z zmerno ali hudo okvaro ledvic (očistek kreatinina &lt; 50 ml/min; glejte poglavje 5.2) je priporočljivo začetni in vzdrževalni odmerek zdravila Trobalt zmanjšati za 50 %.
A Adverse reactions reported in ≥ 2 % of subjects treated with the combined use of saxagliptin + dapagliflozin in the pooled safety analysis, or if reported in &lt; 2 % in the pooled safety analysis, they were based on the individual mono-components data.
A Neželeni učinki, o katerih so poročali pri ≥ 2 % bolnikov, zdravljenih s kombinacijo saksagliptina in dapagliflozina v kumulativni analizi varnosti, ali so o njih poročali pri &lt; 2 % v kumulativni analizi varnosti in so temeljili na podatkih o posameznih učinkovinah.
a ANC &lt; 0.5 x 109/l
Če se pojav/a ANC &lt; 1,0 x
A basal antral follicle count &gt; 20.
bazalno število antralnih foliklov &gt; 20,
A central analysis of ECG data demonstrated new QTc &gt; 500 msec in one patient (0.2%).
Glede na centralno analizo EKG podatkov je do podaljšanja intervala QTc na &gt; 500 ms na novo prišlo pri enem bolniku (0,2 %).
A clinical pharmacology study of fluticasone furoate/vilanterol showed that severe renal impairment (creatinine clearance &lt; 30mL/min) did not result in significantly greater exposure to fluticasone furoate or vilanterol or more marked corticosteroid or beta2-agonist systemic effects compared with healthy subjects.
Klinična farmakološka študija flutikazonfuroata/vilanterola je pokazala, da huda okvara ledvic (očistek kreatinina &lt; 30 ml/min) ne povzroči bistveno večje izpostavljenosti flutikazonfuroatu ali vilanterolu ali izrazitejših kortikosteroidnih ali beta2-agonističnih sistemskih učinkov v primerjavi z zdravimi preiskovanci.