natgillin/translations-raw huggingface dataset:
Patients who had a BCVA score of &lt; 84 OR retinal thickness &gt; 250 microns by optical coherence tomography OCT and in the investigator’s opinion treatment would not put the patient at risk; were eligible to receive an OZURDEX treatment in an open label extension.
Bolniki, pri katerih je bil rezultat BCVA &lt; 84 ALI debelina mrežnice &gt; 250 mikronov, ki so jo izmerili z optično koherenčno tomografijo, in pri katerih po mnenju raziskovalca zdravljenje ne bi pomenilo tveganja, so izpolnjevali merila za prejem zdravljenja z zdravilom OZURDEX v odprtem podaljšanju študije.
Patients who had a QTcF &gt; 500 msec at screening, had a recent history of myocardial infarction within 6 months before randomization, had symptomatic congestive heart failure, or had any other overt CV disease were excluded from the clinical studies.
V klinične študije niso bili vključeni bolniki, ki so imeli ob presejanju QTcF &gt; 500 msec, ali so imeli v anamnezi miokardni infarkt v 6 mesecih pred randomizacijo, so imeli kongestivno srčno popuščanje ali kakšno drugo manifestno kardiovaskularno bolezen.
Patients who had the following were excluded from the trial: creatinine clearance rates &lt; 50 mL/min, NYHA Class III to IV congestive heart failure, or myocardial infarction within the last 4 months, disease progression during the treatment with a bortezomib-containing regimen, or progression during the first 3 months of initiating treatment with lenalidomide and dexamethasone, or progression at any time during treatment with lenalidomide and dexamethasone if this was the subject’s most recent line of therapy.
V preskušanje niso bili vključeni bolniki, ki so imeli: očistek kreatinina &lt; 50 ml/min, zastojno srčno popuščanje v III. do IV. razredu po NYHA, ali miokardni infarkt v zadnjih 4 mesecih, napredovanje bolezni med zdravljenjem s shemo, ki je vključevala bortezomib, ali napredovanje v prvih 3 mesecih po začetku zdravljenja z lenalidomidom in deksametazonom, ali napredovanje kadar koli med zdravljenjem z lenalidomidom in deksametazonom, če je le-to predstavljalo zadnjo uporabljeno linijo zdravljenja za preiskovanca.
Patients who have baseline neutrophil counts &lt; 1500 cells/mm3.
Bolniki, ki imajo izhodiščno število nevtrofilcev &lt; 1.500 celic/mm3.
Patients who met all of the criteria for a CR except for recovery of platelet counts to &gt; 100 x 109/l
Bolniki, ki izpolnjujejo vsa merila za PR, razen obnovitve števila trombocitov na &gt; 100 x 109/l
Patients who responded to Fampyra increased their walking speed on average by 26.3% vs 5.3% on placebo (p &lt; 0.001) (MS-F203) and 25.3% vs 7.8% (p &lt; 0.001) (MS-F204).
Bolniki, ki so se odzivali na zdravilo Fampyra, so v povprečju povečali hitrost svoje hoje za 26,3 % v primerjavi s 5,3 % pri bolnikih na placebu (p &lt; 0,001) (MS-F203) in 25,3 % v primerjavi s 7,8 % (p &lt; 0,001) (MS-F204).
Patients whose menstrual bleeding became normal (PBAC &lt;
Bolnice, pri katerih je menstruacijska krvavitev postala normalna (PBAC &lt; 75) v
Patients with a baseline viral load &gt; 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment emergent resistance to the NNRTI class.
Bolniki z začetno virusno obremenitvijo &gt; 100,000 HIV-1 RNA kopij/ml, pri katerih se je pojavil virološki neuspeh, so imeli višjo stopnjo rezistence na NNRTI, nastale med zdravljenjem.
Patients with a baseline viral load &gt; 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment emergent resistance to the NNRTI class.
Bolniki z začetno virusno obremenitvijo &gt; 100.000 HIV-1 RNA kopij/ml, pri katerih se je pojavil virološki neuspeh, so imeli višjo stopnjo rezistence na NNRTI, nastale med zdravljenjem.
Patients with a baseline viral load &gt; 100,000 HIV-1 RNA copies/ml who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
Stopnja z zdravljenjem povezane odpornosti na zaviralce ne-nukleozidne reverzne transkriptaze (NNRTI) je bila večja pri virološko neuspešnih bolnikih z začetnim virusnim bremenom &gt; 100.000 kopij RNK HIV-1/ml.
Patients with a CPT score &gt; 12 were excluded.
Bolnike z rezultatom CPT &gt; 12 so izključili.
Patients with a CrCl &lt; 30 mL/min were excluded from the study (see section 5.1).
Bolniki z očistkom kreatinina &lt; 30 ml/min so bili iz študije izključeni (glejte poglavje 5.1).
Patients with a high tumour burden and/or a high circulating lymphocyte count ( &gt; 25 x 109/L) and/or renal impairment (CrCl &lt; 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Bolniki z velikim tumorskim bremenom in/ali velikim številom limfocitov v krvnem obtoku ( &gt; 25 x 109/l) in/ali ledvično okvaro (očistek kreatinina &lt; 70 ml/min) imajo večje tveganje za sindrom razpada tumorja in morajo prejeti profilakso.
Patients with a high tumour burden and/or high circulating lymphocyte count in CLL [ &gt; 25 x 109/L] may be at increased risk of severe IRRs.
Bolniki s KLL in velikim tumorskim bremenom in/ali velikim številom krožečih limfocitov v krvi [ &gt; 25 x 109/l]) imajo lahko večje tveganje za hude reakcije, povezane z infuzijo.
Patients with a low body weight ( &lt; 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
Bolniki z majhno telesno maso ( &lt; 60 kg) imajo večjo verjetnost za povečane koncentracije posakonazola v plazmi in jih je treba skrbno spremljati glede neželenih učinkov.
Patients with a platelet count of 100,000/mm3 to 200,000/mm3 before starting Jakavi had a higher frequency of grade 3 or 4 thrombocytopenia compared to patients with platelet count &gt; 200,000/mm3 (64.2% versus 38.5%).
Pri bolnikih, ki so imeli že pred zdravljenjem z zdravilom Jakavi število trombocitov od 100.000/mm3 do 200.000/mm3, je pogosteje prišlo do trombocitopenije stopnje 3 ali 4 kot pri bolnikih, ki so imeli število trombocitov &gt; 200.000/mm3 (64,2 % v primerjavi z 38,5 %).
Patients with additional risk of endometrial cancer, e.g. patients suffering from hypertension or diabetes, having high BMI ( &gt; 30) or history of hormone replacement therapy should be closely monitored (see also section 4.8).
Bolnice z dodatnim tveganjem za raka endometrija, npr. tiste s hipertenzijo ali sladkorno boleznijo, velikim indeksom telesne mase (BMI &gt; 30) ali anamnezo hormonske nadomestne terapije, morate skrbno spremljati (glejte tudi poglavje 4.8 ).
Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Pri bolnikih z alanin-aminotransferazo (ALT) ali aspartat-aminotransferazo (AST) &gt; 3 x zgornja meja normale (ULN-upper limit of normal) je bila incidenca nevtropenije 4. stopnje in febrilne nevtropenije višja.
Patients with ALT &gt; 3 x ULN and bilirubin &gt; 2 x ULN were not studied (see section 4.4).
Bolnikov z ALT &gt; 3 x ULN in bilirubinom &gt; 2 x ULN niso preučevali (glejte poglavje 4.4).
Patients with ALT or AST &gt; 2 times the ULN prior to treatment were not included in clinical studies; treatment initiation is not recommended in patients with ALT or AST &gt; 2 times the ULN.
Bolniki z ALT ali AST &gt; 2-kratna ULN pred zdravljenjem niso bili vključeni v klinične študije; uvedba zdravljenja se pri bolnikih z ALT ali AST &gt; 2-kratna ULN ne priporoča.
Patients with ALT or AST &gt; 3 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Pri bolnikih z ALT ali AST &gt; 3 x zgornja meja normale je bila incidenca nevtropenije 4. stopnje in febrilne nevtropenije višja.
Patients with baseline HbA1c &gt; 10% to ≤ 12%
Bolniki z izhodiščno ravnijo HbA1c od &gt; 10% do ≤ 12
Patients with baseline neutrophil counts &lt; 1,500 cells/mm3 ( &lt; 1,000 cells/mm3 for AIDS-KS) should not receive paclitaxel.
Bolniki z izhodiščnim številom nevtrofilcev &lt; 1.500 celic/mm3 ( &lt; 1.000 celic/mm3 pri AIDS-KS) ne smejo prejemati paklitaksela.
Patients with baseline neutrophil counts of &lt; 1.5 x 109/L and/or thrombocyte counts of
Bolnikov, ki imajo pred zdravljenjem število nevtrofilcev &lt; 1,5 x 109/l in/ali število trombocitov
Patients with baseline neutrophil counts of &lt; 1.5 x 109/L and/or thrombocyte counts of &lt; 100 x 109/L should not be treated with capecitabine.
Bolniki, ki imajo osnovno število neutrofilcev &lt; 1.5 x 109/L in/ali število trombocitov &lt; 100 x 109/L, ne smejo biti zdravljeni s kapecitabinom.
Patients with BCR-ABL &gt; 10% at 3 months
BCR-ABL &gt; 10% v 3. mesecu
Patients with BMI &gt; 30 kg/m2
Bolniki z ITM &gt; 30 kg/m2
Patients with body weight &lt; 50 kg are at increased risk of bleeding.
Bolniki s telesno maso &lt; 50 kg imajo povečano tveganje za krvavitev.
Patients with body weight &lt; 60 kg
Bolniki s telesno maso &lt; 60 kg
Patients with body weight &gt; 100 kg
Bolniki s telesno maso &gt; 100 kg
Patients with both CIRS &gt; 6 and CrCl &lt; 70 mL/min are more at risk of infections, including severe infections (see section 4.8).
Bolniki, ki imajo hkrati CIRS &gt; 6 in očistek kreatinina &lt; 70 ml/min, imajo večje tveganje za okužbe, vključno s hudimi okužbami (glejte poglavje 4.8).
Patients with cardiac disease or risk factors such as a baseline LVEF value of &lt; 45% by multigated radionuclide (MUGA) scan, clinically significant cardiovascular abnormalities (equal to New York Heart Association [NYHA] grade 3 or 4), myocardial infarction within the last 6 months, severe arrhythmia, uncontrolled hypertension, uncontrolled angina, or prior cumulative doses of doxorubicin or equivalent exceeding 450 mg/m2 should receive careful risk versus benefit consideration before receiving treatment with Pixuvri.
Pri bolnikih s srčno boleznijo ali dejavniki tveganja, kot so izhodiščna vrednost LVEF &lt; 45 % pri večkratno proženem radionuklidnem slikanju (multigated radionuclide scan, MUGA), klinično pomembne kardiovaskularne nepravilnosti (3. ali 4. stopnje po lestvici Newyorškega združenja za srce [NYHA]), miokardni infarkt v zadnjih 6 mesecih, huda aritmija, nenadzorovana hipertenzija, nenadzorovana angina pektoris ali predhodni kumulativni odmerki doksorubicina ali enakovrednega zdravila, ki presegajo 450 mg/m2, je treba pozorno oceniti tveganje in koristi pred začetkom zdravljenja z zdravilom Pixuvri.
Patients with chronic renal failure, patients with creatinine clearance &lt; 50 ml/minute and/or on haemodialysis.
Bolniki s kronično ledvično odpovedjo, bolniki z očistkom kreatinina &lt; 50 ml/min in/ali hemodializo;
Patients with creatinine clearance &lt; 30 ml/min and dialysis patients:
Bolniki z očistkom kreatinina &lt; 30 ml/min in bolniki na dializi:
Patients with creatinine clearance &lt; 50 ml/minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SmPC).
Bolniki z očistkom kreatinina &lt; 50 ml/minuto se ne smejo zdraviti z zdravilom PegIntron v kombinaciji z ribavirinom (glejte SmPC za ribavirin).
Patients with creatinine clearance &lt; 50 ml/minute must not be treated with ribavirin (see section 4.3).
Bolnikov, pri katerih je očistek kreatinina &lt; 50 ml/min, ne smete zdraviti z ribavirinom (glejte poglavje 4.3).
Patients with creatinine clearance &lt; 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SmPC).
Bolniki z očistkom kreatinina &lt; 50 ml/minuto se ne smejo zdraviti z zdravilom ViraferonPeg v kombinaciji z ribavirinom (glejte SmPC za ribavirin).
Patients with creatinine clearance &lt; 50 ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Pri bolnikih s kreatininskim očistkom &lt; 50 ml/min obstaja povečano tveganje za krvavitve ter VTE in jih moramo obravnavati previdno (glejte poglavja 4.2, 4.3 in 5.2).
Patients with creatinine clearance &gt; 60 ml/min have been included in efficacy/safety studies of topotecan.
Bolniki z očistkom kreatinina &gt; 60 mL/min so bili vključeni v raziskavo o učinkovitosti/varnosti topotekana.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of &lt; 2.
Incidenca resnih okužb je bila večja pri bolnikih z izhodiščnim stanjem zmogljivosti 2 po ECOG (Eastern Cooperative Oncology Group) kot pri bolnikih z izhodiščnim stanjem zmogljivosti &lt; 2 po ECOG.
Patients with ECOG performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of &lt; 2.
Incidenca resnih okužb je bila pri bolnikih z izhodiščnim stanjem zmogljivosti 2 po ECOG večja kot pri bolnikih s stanjem zmogljivosti &lt; 2 po ECOG.
Patients with ECOG PS &gt; 1, significant hepatic or renal co-morbidities were not included in the study.
Bolniki, ki so imeli stanje zmogljivosti po ECOG višje od 1, ter tisti s hudimi ledvičnimi ali jetrnimi obolenji niso bili vključeni v študijo.
Patients with eGFR 45 mL/min/1.73 m2 to &lt; 60 mL/min/1.73 m2
Bolniki z ocenjeno glomerulno filtracijo od 45 ml/min/1,73 m2 do &lt; 60 ml/min/1,73 m2
Patients with elevated liver enzymes (ALT/AST &gt; 2 x ULN) or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Bolnike z zvišanimi jetrnimi encimi (ALT/AST &gt; 2 x ULN) ali s celotnim bilirubinom ≥1,5 x ULN so izključili iz kliničnih preskušanj.
Patients with elevated liver enzymes (ALT/AST &gt; 2 x ULN) or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Bolnike z zvišanimi jetrnimi encimi (ALT/AST &gt; 2 x ULN; ULN=upper level of normal – zgornja meja normalnih vrednosti) ali celotnim bilirubinom ≥1,5 x ULN so izključili iz kliničnih preskušanj.
Patients with elevated liver enzymes &gt; 2 ULN were excluded from the main trials.
Bolnike s povečanimi jetrnimi encimi na &gt; 2 ULN so izključili iz glavnih preskušanj.
Patients with elevated liver enzymes &gt; 2 ULN were excluded in controlled clinical trials investigating the VTE prevention following elective hip or knee replacement surgery.
Bolnike s povečanimi jetrnimi encimi na &gt; 2 ULN so izključili iz nadzorovanih kliničnih preskušanj, v katerih so proučevali preprečevanje VTE po operativni vstavitvi umetnega kolka ali kolena.
Patients with elevated liver enzymes &gt; 2 ULN were excluded in the main trials.
Bolnike s povečanimi jetrnimi encimi na &gt; 2 ULN so izključili iz glavnih preskušanj.
Patients with elevated liver enzymes &gt; 2 upper limit of normal (ULN) were excluded in clinical trials investigating the VTE prevention following elective hip or knee replacement surgery.
Bolnike s povečanimi jetrnimi encimi na več kot 2-kratno zgornjo mejo normalnih vrednosti (ULN) so iz kliničnih preskušanj v katerih so proučevali preprečevanje VTE po operativni vstavitvi umetnega kolka izključili.
Patients with elevated liver enzymes &gt; 2 upper limit of normal (ULN) were excluded in clinical trials investigating the VTE prevention following elective hip or knee replacement surgery.
Bolnike s povečanimi jetrnimi encimi na več kot 2-kratno zgornjo mejo normalnih vrednosti (ULN) so iz kliničnih preskušanj, v katerih so proučevali preprečevanje VTE po operativni vstavitvi umetnega kolka ali kolena.
Patients with elevated liver enzymes &gt; 2 upper limit of normal (ULN) were excluded in the main trials
Bolnike s povečanimi jetrnimi encimi na več kot 2-kratno zgornjo mejo normalnih vrednosti (ULN) so izključili iz glavnih preskušanj.
Patients with elevated liver enzymes &gt; 2 upper limit of normal (ULN) were excluded inthe main trials
Bolnike s povečanimi jetrnimi encimi na več kot 2-kratno zgornjo mejo normalnih vrednosti (ULN) so izključili iz glavnih preskušanj.
Patients with elevated liver enzymes alanine aminotransferase (ALT)/aspartate aminotransferase (AST) &gt; 2 x ULN or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Bolniki s povečanimi vrednostmi jetrnih encimov alanin-aminotransferaze (ALT)/aspartat- aminotransferaze (AST) &gt; 2-kratna zgornja meja normale ali z vrednostmi skupnega bilirubina ≥ 1,5- kratne zgornje meje normale niso bili vključeni v klinična preskušanja.
Patients with elevated liver enzymes ALT/AST &gt; 2 x ULN or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Bolniki s povečanimi vrednostmi jetrnih encimov (vrednosti ALT/AST &gt; 2-kratna zgornja meja normale) ali z vrednostmi skupnega bilirubina ≥ 1,5-kratne zgornje meje normale niso bili vključeni v klinična preskušanja.
Patients with estimated creatinine clearance &lt; 60 ml/min.
Bolniki z oceno očistka kreatinina &lt; 60 ml/min.
Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline serum albumin
Med zdravljenjem z azacitidinom so poročali o progresivni jetrni komi in smrti bolnikov z razširjeno tumorsko boleznijo zaradi metastatskega obolenja, še zlasti pri bolnikih z izhodiščnim serumskim albuminom &lt; 30 g/l.
Patients with FVC baseline &lt; 50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) &lt; 30% predicted at baseline were excluded from the trials.
Bolniki s predvideno izhodiščno vrednostjo FVC &lt; 50 % ali predvideno izhodiščno vrednostjo difuzijske zmogljivosti za ogljikov monoksid (DLCO korigirano z vrednostjo hemoglobina ) &lt; 30 %, so bili izključeni iz kliničnih preskušanj.
Patients with haemoptysis ( &gt; 60 ml) were excluded from the clinical studies so no data exist on the use of TOBI Podhaler in these patients.
Bolnikov s hemoptizo ( &gt; 60 ml) niso vključevali v klinične študije, zato podatki o uporabi zdravila TOBI Podhaler pri teh bolnikih niso na voljo.
Patients with hepatic impairment, including those with pre-treatment ALT or AST &gt; 3x ULN, should not be treated with Eucreas (see sections 4.2, 4.3 and 4.8).
Zdravilo Eucreas se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavja 4.2, 4.3 in 4.8).
Patients with hepatic impairment, including those with pre-treatment ALT or AST &gt; 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8).
Zdravilo Icandra se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavja 4.2, 4.3 in 4.8).
Patients with hepatic impairment, including those with pre-treatment ALT or AST &gt; 3x ULN, should not be treated with Zomarist (see sections 4.2, 4.3 and 4.8).
Zdravilo Zomarist se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavja 4.2, 4.3 in 4.8).
Patients with high baseline HbA1c &gt; 10%
Bolniki z visoko izhodiščno vrednostjo HbA1c &gt; 10
patients with HIV-1 RNA &lt; 200 copies/ml
bolniki s HIV-1 RNA &lt; 200 kopij/ml
patients with HIV-1 RNA &lt; 50 copies/ml
bolniki s HIV-1 RNA &lt; 50 kopij/ml
Patients with inadequate liver function (National Cancer Institute – Common Terminology Criteria for Adverse Events Grade 3 liver function tests (AST, ALT &gt; 5 x ULN for &gt; 2 weeks; bilirubin &gt; 3 x ULN) and renal function (CrCl &lt; 30 mL/min) were excluded.
Bolniki z nezadostnim delovanjem jeter (jetrni testi 3. stopnje po National Cancer Institute – Common Terminology Criteria for Adverse Events (AST, ALT &gt; 5 x ZNM (“zgornje normalne meje”) &gt; 2 tedna; bilirubin &gt; 3 x ZNM) in delovanjem ledvic (očistek kreatinina &lt; 30 ml/min) so bili izključeni.
Patients with left ventricular ejection fraction &lt; 45 % or left ventricular shortening fraction &lt; 0.2 were not studied.
Študija ni proučevala bolnikov z iztisnim deležem levega prekata &lt; 45 % ali skrčitvenim deležem levega prekata &lt; 0,2.
Patients with low body weight ( &lt; 60 kg)
Bolniki z majhno telesno maso ( &lt; 60 kg)
Patients with low body weight ( &lt; 60 kg) had a higher incidence of PPE, proteinuria, of Grade 3 or 4 hypocalcaemia and hyponatraemia, and a trend towards a higher incidence of Grade 3 or 4 decreased appetite.
Bolniki z majhno telesno maso ( &lt; 60 kg) so imeli večjo incidenco PPE, proteinurije, hipokalciemije in hiponatriemije stopnje 3 ali 4 in nagnjenost k večji incidenci zmanjšanega apetita stopnje 3 ali 4.
Patients with low tumour burden ( &lt; 50%) responded best to BLINCYTO treatment with CR/CRh* rate of 72.9% (CI 59.7 – 83.6).
Bolniki z majhnim tumorskim bremenom ( &lt; 50 %) so se na zdravljenje z zdravilom BLINCYTO odzvali najbolje in so imeli delež CR/CRh* 72,9 % (IZ 59,7-83,6).
Patients with MDRH &amp; R-TB
bolniki z MDRH &amp; R-TB
Patients with mild (60≤ CLcr &lt; 90 mL/min) and moderate (30≤ CLcr &lt; 60 mL/min) renal impairment were enrolled in single-arm Studies 1001 and 1005.
Bolniki z blago (60 ≤ očistek kreatinina [CLcr] &lt; 90 mL/min) in zmerno (30 ≤ CLcr &lt; 60 mL/min) okvaro ledvic so bili vključeni v enoskupinski Študiji 1001 in 1005.
Patients with mild and moderate renal impairment had at steady state an average 1.8-fold and 3.6-fold higher pre-dosedabigatran plasma concentrations compared with patients with CrCL &gt; 80 mL/min, respectively.
Bolniki z blago in zmerno ledvično okvaro so imeli v ravnotežnem stanju pred odmerkom povprečno 1,8- oziroma 3,6-krat večje koncentracije dabigatrana v plazmi kot tisti s CrCl &gt; 80 ml/min.
Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but &lt; 80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function.
Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina ≥ 30 ml/min, vendar &lt; 80 ml/min), ki so bili vključeni v študije tretje faze, so opazili zmanjšano učinkovitost v primerjavi z bolniki z normalno ledvično funkcijo.
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and acetylsalicylic acid ( &gt; 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Bolniki z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina od 45 do 79 ml/min) naj se izogibajo jemanju nesteroidnih protivnetnih zdravil (NSAID), denimo, ibuprofena in acetilsalicilne kisline ( &gt; 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and aspirin ( &gt; 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Bolniki z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina od 45 do 79 ml/min) naj se izogibajo jemanju nesteroidnih protivnetnih zdravil (NSAID), denimo, ibuprofena in acetilsalicilne kisline ( &gt; 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and aspirin ( &gt; 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Bolniki z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina od 45 do 79 ml/min) naj se izogibajo jemanju nesteroidnih protivnetnih zdravil (NSAIDs – non steroidal anti-inflammatory drugs), kot sta ibuprofen in acetilsalicilna kislina ( &gt; 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).