natgillin/translations-raw huggingface dataset:
Roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 51 ml (pre-bronchodilator FEV1, p &lt; 0.0001), and by 53 ml (post-bronchodilator FEV1, p &lt; 0.0001).
Roflumilast 500 mikrogramov enkrat na dan je statistično pomembno izboljšal pljučno funkcijo v primerjavi s placebom, v povprečju za 51 ml (FEV1 pred bronhodilatatorjem, p &lt; 0,0001) in za 53 ml (FEV1 po bronhodilatatorju, p &lt; 0,0001).
Rosiglitazone should be used with caution in patients with severe renal insufficiency (creatinine clearance &lt; 30 ml/min).
Rosiglitazon je potrebno uporabljati previdno pri bolnikih s hudo ledvično insuficienco (očistek kreatinina &lt; 30 ml/min).
Rotigotine significantly reduced the periodic limb movement index (PLMI) from 50.9 to 7.7 versus 37.4 to 32.7 for placebo (p &lt; 0.0001).
Rotigotin je pomembno zmanjšal indeks periodičnega gibanja udov (Periodic Limb Movement Index - PLMI) iz 50,9 na 7,7 proti 37,4 na 32,7 za placebo (p &lt; 0,0001).
RP &gt; 1.15 * Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ..............
RP &gt; 1,15* Inaktivirana bakterija Erysipelothrix rhusiopathiae, sev R32E11 .ELISA &gt; 3,34 log2 IE50
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
RTC &lt; 15 % blastov v BM in PB, &lt; 30 % blastov+promielocitov v BM in PB, &lt; 20 % bazofilcev v PB, brez bolezni zunaj kostnega mozga, razen v vranici in jetrih (samo za 0102 in 0109).
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver.
RTC &lt; 15 % blastov v BM in PB, &lt; 30 % blastov+promielocitov v BM in PB, &lt; 20 % bazofilcev v
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver.
RTC &lt; 15 % blastov v BM in PB, &lt; 30 % blastov+promielocitov v BM in PB, &lt; 20 % bazofilcev v PB, brez bolezni zunaj kostnega mozga, razen v vranici in jetrih
RTC: &lt; 15 % blasts BM and PB, &lt; 30 % blasts+promyelocytes in BM and PB, &lt; 20 % basophils in PB, no extramedullary disease other than spleen and liver.
RTC: &lt; 15 % blastov v BM in PB, &lt; 30 % blastov+promielocitov v BM in PB, &lt; 20 % bazofilcev v PB, brez obolelosti zunaj kostnega mozga, razen v vranici in jetrih.
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver.
RTC &lt; 15 % blastov v BM in PB, &lt; 30 % blastov+promielocitov v BM in PB, &lt; 20 % bazofilcev v PB, brez obolelosti zunaj kostnega mozga, razen v vranici in jetrih
Ruxolitinib is mainly metabolised by CYP3A4 ( &gt; 50%), with additional contribution from CYP2C9.
Ruksolitinib se presnavlja zlasti s CYP3A4 ( &gt; 50 %), del pa prispeva tudi CYP2C9.
RVR = rapid viral response (HCV RNA negative) by week 4 LVL = ≤ 800,000 IU/ml; HVL = &gt; 800,000 IU/ml (a) It is presently not clear whether a higher dose of ribavirin (e.g.1000/1200 mg/day based on body weight) results in higher SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
1000/1200 mg na dan glede na telesno maso) povzroči višji delež trajnega virološkega odziva kot odmerek 800 mg na dan, kadar je zdravljenje skrajšano na 16 tednov.
S  0.25 mg/L and R  0.5 mg/L
S  0,25 mg/l in R &gt; 0,5 mg/l
S  0.5 mg/L and R  0.5 mg/L
S  0,5 mg/l in R &gt; 0,5 mg/l
S  1 mg/l and R &gt; 1 mg/l
S  1 mg/l in R &gt; 1 mg/l
S  1 mg/l and R &gt; 4 mg/l
S  1 mg/l in R &gt; 4 mg/l
S. pneumoniae S  1 mg/l and R &gt; 1 mg/l
S. pneumoniae S  1 mg/l in R &gt; 1 mg/l
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL’s inactivated vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno aplicirati na isti dan ampak na različni mesti in ne zmešano z Merialovim inaktiviranim cepivom proti steklini. &gt;
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Varnost in učinkovitost zdravila pri bolnicah s hudo ledvično okvaro (kreatininski očistek ≤ 30 ml/min) nista bili ugotovljeni in zato je pri teh bolnicah potrebna previdnost (glejte poglavje 4.4).
Safety and efficacy have not been studied in patients with forced expiratory volume in 1 second (FEV1) &lt; 25% or &gt; 75% predicted, or patients colonised with Burkholderia cepacia.
Varnosti in učinkovitosti zdravila niso proučevali pri bolnikih z vrednostjo forsiranega ekspiracijskega volumna v prvi sekundi (FEV1) manj kot 25 % ali več kot 75 % napovedane vrednosti, ali pri bolnikih, okuženih z bakterijo Burkholderia cepacia.
Safety and efficacy of FABLYN have not been evaluated in patients with liver function test &gt; 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Varnosti in učinkovitosti zdravila FABLYN niso ovrednotili pri bolnicah z okvarjenim delovanjem jeter (vrednost ULN &gt; 1,5), zato je treba zdravilo FABLYN pri teh bolnicah uporabljati previdno.
Safety and efficacy of lasofoxifene have not been evaluated in patients with hepatic insufficiency with liver function test &gt; 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Varnosti in učinkovitosti lasofoksifena niso ovrednotili pri bolnicah z insuficienco jeter, ki so imele vrednost zgornje normalne meje (ULN) večjo od 1,5; zato je treba zdravilo FABLYN pri teh bolnicah uporabljati previdno.
Safety in patients with left ventricular ejection fraction (LVEF) &lt; 50% or NYHA Class III or IV heart failure (in study 301) or NYHA Class II to IV heart failure (in study 302) was not established (see sections 4.8 and 5.1).
Pri bolnikih z iztisnim deležem levega prekata (LVEF – left ventricular ejection fraction) &lt; 50% ali s srčnim popuščanjem razreda III ali IV (študija 301) ali s srčnim popuščanjem razreda II do IV (študija 302) po klasifikaciji NYHA varnosti uporabe zdravila ZYTIGA niso dokazali (glejte poglavji 4.8 in 5.1).
Safety was evaluated in an observational study that included 69,237 children vaccinated with ProQuad 12 months to 12 years old and 69,237 matched children in a historical comparison group who were vaccinated concomitantly with the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Varnost so ocenili v opazovalni študiji, ki je vključevala 69.237 otrok, cepljenih s cepivom ProQuad, starih od 12 mesecev do 12 let, ter 69.237 primerljivih otrok v historični primerjalni skupini, ki so bili sočasno cepljeni s cepivom proti ošpicam, mumpsu in rdečkam, izdelovalca Merck &amp; Co., Inc., in s cepivom z živim virusom noric (Oka/Merck).
Safinamide undergoes almost complete metabolic transformation ( &lt; 10% of the administered dose was found unchanged in urine).
Pri safinamidu so dokazali skoraj popolno presnovno transformacijo (v urinu je bilo prisotnega &lt; 10 % danega odmerka v nespremenjeni obliki).
Same dose (see section 5.2) for elderly patients as for adults ( &lt; 50 years old) should be used.
Za starejše priporočamo uporabo enakega odmerka (glejte poglavje 5.2) kot za odrasle ( &lt; 50 let).
Sample loop: &lt; 200 µl
Zanka za vzorec: &lt; 200 µl
Sanofi Pasteur MSD GmbH, Tel:
Merck Sharp &amp; Dohme d.o.o.
Sanofi Pasteur MSD GmbH, Tel:
Merck Sharp &amp; Dohme d.o.o., Tel: +385 1 66 11
Sanofi Pasteur MSD GmbH, Tel:
Merck Sharp &amp; Dohme OÜ, Tel: +372.
Sanofi Pasteur MSD, Puh/Tel: +358.9.565.88.30
Merck Sharp &amp; Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201
Sanofi Pasteur MSD, Tel: +31.23.567.96.00
Merck Sharp &amp; Dohme OÜ, Tel: +372.6144 200
Sanofi Pasteur MSD, Tel: +46.8.564.888.60
Merck Sharp &amp; Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201
Sanofi Pasteur MSD, Tlf: +45 23 32 69 29 Merck Sharp &amp; Dohme Cyprus Limited
Sanofi Pasteur MSD, Tlf: +45 23 32 69 29
Sanofi Pasteur MSD, Tél: +32.2.726.95.84
Merck Sharp &amp; Dohme OÜ, Tel: +372.614.4200
Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès &amp; Lagrave
1, rue de la vierge Ambarès &amp; Lagrave
Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès &amp; Lagrave
Sanofi Winthrop Industrie 1, route de la vierge, Ambarès &amp; Lagrave
SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥ 6.5 % and &lt; 12 % (12,959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
Študija SAVOR je bila preskušanje srčno-žilnih izidov pri 16.492 bolnikih s HbA1c ≥ 6,5 % in &lt; 12 % (12.959 z ugotovljeno srčno-žilno boleznijo in 3.533 takšnih, ki so imeli le več dejavnikov tveganja), randomiziranih na saksagliptin (n = 8.280) ali placebo (n = 8.212), dodan regionalnemu standardnemu zdravljenju glede HbA1c in srčno-žilnih dejavnikov tveganja.
SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥6.5% and &lt; 12% (12959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
Preskušanje SAVOR je bilo preskušanje kardiovaskularnih izidov pri 16.492 bolnikih s HbA1c ≥ 6,5 % in &lt; 12 % (12.959 z ugotovljeno kardiovaskularno boleznijo in 3.533 takšnih, ki so imeli le več dejavnikov tveganja), randomiziranih na saksagliptin (n = 8.280) ali placebo (n = 8.212), dodana regionalnemu standardnemu zdravljenju, glede HbA1c in kardiovaskularnih dejavnikov tveganja.
Screening Viral Load &gt; 100,000 copies/mL
Presejalno virusno breme &gt; 100.000 kopij/ml
SE = standard error, CI= confidence interval), * p &lt; 0.05, **p &lt; 0.0001
SD = standardna deviacija, IZ= interval zaupanja, *p &lt; 0,05, **p &lt; 0,0001
SE = standard error, CI= confidence interval, * p &lt; 0.05
SD = standardna deviacija, IZ= interval zaupanja, *p &lt; 0,05
SE = standard error, CI= confidence interval, * p &lt; 0.05, **p &lt; 0.0001
SD = standardna deviacija, IZ= interval zaupanja, *p &lt; 0,05, **p &lt; 0,0001
SE = standard error, CI= confidence interval, *p &lt; 0.05, **p &lt; 0.0001
SD = standardna deviacija, IZ= interval zaupanja, *p &lt; 0,05, **p &lt; 0,0001
Second monthly weighing where bodyweight loss &lt; 3% per month since previous weighing
Drugo mesečno tehtanje, kjer je izguba telesne mase &lt; 3 % na mesec v primerjavi s prejšnjim mesečnim tehtanjem
Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations &lt; 400 or &lt; 50 copies/ml, and change from baseline in CD4 cell count.
Sekundarne analize učinkovitosti v 144 tednih so vključile del bolnikov s koncentracijo HIV-1 RNA &lt; 400 ali &lt; 50 kopij/ml in spremembo števila celic CD4 od začetka študije.
See also information under the heading “Do not take Sabervel’’.
Glejte tudi informacije pod naslovom “Ne &lt; jemljite &gt; &lt; uporabljajte &gt; zdravila Sabervel.
See also information under the heading “Do not take Sabervel”.
Glejte tudi informacije pod naslovom “Ne &lt; jemljite &gt; &lt; uporabljajte &gt; zdravila Sabervel.
See also section 3 ‘How to take Tarceva’
Glejte tudi poglavje 3 &lt; Kako jemati zdravilo Tarceva &lt; .
See section 4.8 for how to report adverse reactions.
Glejte poglavje 4.8, kako poročati o neželenih učinkih. &gt;
See section 4. &gt;
Glejte poglavje 4.
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to &lt; 3 years.
Za navodila o pripravi odmerka 0,25 ml za otroke, stare od 2 mesecev do &lt; 3 let, si oglejte poglavje 6.6.
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to &lt; 3 years.
Za navodila o pripravi odmerka 0,25 ml za otroke, stare od 2 mesecev do &lt; 3 leta, glejte poglavje 6.6.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts in adults, adolescents and children (6 to &lt; 12 years of age).
Glejte preglednico 1 za pretvorbeno shemo in preglednici 2 in 3 za shemi za določanje odmerkov pri odraslih, mladostnikih in otrocih (starih 6 do &lt; 12 let).
Seen more frequently for glycopyrronium than placebo in elderly &gt; 75 years only.
Pogosteje so jih opažali pri uporabi glikopironija kot pri uporabi placeba samo pri bolnikih, ki so bili stari več kot 75 let.
Select the applicator size (or combination of applicators, for cats &gt; 7.5 kg) adapted to the cat’s weight.
Izberite primerno velikost aplikatorja (ali kombinacijo alplikatorjev za mačke težje od 7,5 kg), glede na telesno težo zdravljene živali.
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated &amp; ophthalmic), Herpes virus infection*,
sepsa (vključno s septičnim šokom)*, herpes zoster (vključno z diseminiranim in očesnim), okužba s herpes virusom*, bakterijske okužbe*, okužba zgornjih/spodnjih dihal*, glivična okužba*, herpes simplex
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated &amp; ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
sepsa (vključno s septičnim šokom)*, herpes zoster (vključno z diseminiranim in očesnim), okužba s herpes virusom, bakterijske okužbe *, okužba zgornjih/spodnjih dihal*, glivična okužba *, herpes simplex
Sepsis related to leukopaenia was observed infrequently ( &lt; 1%).
V redkih primerih so opažali sepso, povezano z levkopenijo ( &lt; 1%).
Sepsis related to leukopaenia was rarely ( &lt; 1%) observed.
Redka ( &lt; 1%) je bila z levkopenijo povezana sepsa.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 ro &lt; 1/1,000), and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10.000 do &lt; 1/1.000), in akutna odpoved ledvic.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1000), and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10.000 do &lt; 1/1.000), in akutna odpoved ledvic.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000) , and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10.000 do &lt; 1/1.000), in akutna odpoved ledvic.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10,000 to &lt; 1/1,000) in akutna odpoved ledvic.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10.000 do &lt; 1/1.000) in akutna odpoved ledvic.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10.000 do &lt; 1/1.000), in akutna ledvična odpoved.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10.000 do &lt; 1/1.000), in akutna odpoved ledvic.
Serious angioedema may occur rarely (≥1/10,000 to &lt; 1/1,000).
Redko (≥ 1/10.000 do &lt; 1/1.000) se lahko pojavi resen angioedem.
Serious angioedema may occur rarely (≥1/10,000 to &lt; 1/1,000).
Redko (≥1/10.000 do &lt; 1/1.000) se lahko pojavi resen angioedem.
Serious angioedema may occur rarely (≥1/10,000 to &lt; 1/1,000).
Redko se lahko pojavi resen angioedem (≥1/10.000 do &lt; 1/1.000).
Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of &lt; 5 g/dL or a decrease of &gt; 4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Resno hemolizo označujejo ravni LDH v serumu, višje od ravni pred zdravljenjem, v povezavi s katerimkoli od naslednjih znakov: absolutno zmanjšanje velikosti klona PNH za več kot 25 % (ob odsotnosti razredčenja zaradi transfuzije) v času enega tedna ali manj; raven hemoglobina &lt; 5 g/dl ali zmanjšanje za &gt; 4 g/dl v času enega tedna ali manj; angina; sprememba duševnega stanja; 50 % zvišanje ravni serumskega kreatinina; ali tromboza.
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in elderly &gt; 60 years of age, measured by SRH and HI assays were as follows:
Stopnja serozaščite*, delež serokonverzije* in faktor serokonverzije** za protitelesa proti HA na H5N1 A/turkey/Turkey/05 po 2. odmerku pri starejših, starih &gt; 60 let, izmerjeni s testi SRH in HI, so bili, kot sledi:
Serum albumin &lt; 2.8 g/dL (see section 4.4 regarding use in patients with serum albumin ≥2.8 g/dL)
Serumski albumin &lt; 2,8 g/dl (za uporabo pri bolnikih s serumskim albuminom ≥ 2,8 g/dl glejte poglavje 4.4).
Serum creatinine elevations were mostly mild ( &gt; 1-1.5x ULN) to moderate ( &gt; 1.5-3x ULN) and observed to be reversible in nature (see table 4).
Zvišanja serumskega kreatinina so bila večinoma blaga ( &gt; 1-1,5x ULN) do zmerna ( &gt; 1,5-3x ULN); ugotovili so, da so po naravi reverzibilna (glejte preglednico 4).
Sevelamer carbonate Zentiva is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus &gt; 1.78 mmol/L.
Zdravilo Sevelamer carbonate Zentiva je indicirano tudi za nadzor hiperfosfatemije pri odraslih bolnikih s kronično boleznijo ledvic, ki niso na dializi, in imajo raven fosforja v serumu ≥ 1,78 mmol/l.
Sevelamer carbonate Zentiva is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease patients not on dialysis with serum phosphorus &gt; 1.78 mmol/L.
Zdravilo Sevelamer carbonate Zentiva je indicirano tudi za nadzor hiperfosfatemije pri bolnikih s kronično boleznijo ledvic, ki niso na dializi, in imajo raven serumskega fosforja ≥ 1,78 mmol/l.
Seventeen patients had 2 separate adverse reactions, 6 had 3 adverse reactions, 18 had 4 to 8 adverse reactions and 5 had &gt; 8 episodes of pleural effusions.
Sedemnajst bolnikov je imelo 2 ločena neželena učinka, 6 bolnikov 3 neželene učinke, 18 bolnikov od 4 do 8 neželenih učinkov, 5 bolnikov pa &gt; 8 epizod plevralnega izliva.
Severe ( &lt; 30) (n = 6)
huda okvara ( &lt; 30) (n = 6)
Severe (NCI-CTC grade 3) skin reactions were reported in 34% and life-threatening (NCI- CTC grade 4) skin reactions in &lt; 1% of patients who received Vectibix in combination with chemotherapy (n = 1536) (see section 4.8).
Poročali so o hudih kožnih reakcijah (3. stopnja po NCI-CTC) pri 34 % bolnikov in o življenjsko ogrožujočih kožnih reakcijah (4. stopnja po NCI-CTC) pri &lt; 1 % bolnikov, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo (n = 1.536) (glejte poglavje 4.8).
Severe (NCI-CTC grade 3) skin reactions were reported in 34% and life-threatening (NCI-CTC grade 4) skin reactions in &lt; 1% of patients who received Vectibix in combination with chemotherapy (n = 1,536).
Poročali so o hudih kožnih reakcijah (3. stopnja po NCI-CTC) pri 34 % bolnikov in o življenjsko ogrožujočih kožnih reakcijah (4. stopnja po NCI-CTC) pri &lt; 1 % bolnikov, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo (n = 1.536).
Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing &lt; 60 kg
Hude krvavitve so pogostejše pri bolnikih starih ≥ 75 let (vključno s smrtnimi primeri) ali s telesno maso &lt; 60 kg.
Severe hepatic dysfunction (serum albumin &lt; 25 g/l or Child-Pugh score &gt; 10) (Class C).
Hudo poslabšano delovanje jeter (albumin v serumu &lt; 25 g/l ali ocena po Child-Pughu &gt; 10) (stopnja C)
Severe hepatic impairment (Child-Pugh classification C) or severe renal impairment (creatinine clearance &lt; 30 ml/min).
Huda jetrna (Child-Pughova klasifikacija C) ali huda ledvična okvara (očistek kreatinina &lt; 30 ml/min).
Severe hepatic impairment (serum albumin &lt; 25 g/l or Child-Pugh score  10).
za bolnike s hudo okvaro jeter (albumin v serumu &lt; 25 g/l ali ocena ≥ 10 po Child-Pughu),
Severe hepatic impairment (total bilirubin &gt; 3 x ULN).
Huda okvara jeter (celokupni bilirubin &gt; 3-kratna ZNM).
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ &lt; 25% %; children between 12- 35 months: CD4+ &lt; 20%; children between 36-59 months: CD4+ &lt; 15% (see section 4.4).
Huda humoralna ali celična (primarna ali pridobljena) imunska pomanjkljivost, npr. huda kombinirana imunska pomanjkljivost, agamaglobulinemija in AIDS ali simptomatska okužba s HIV ali za starost specifični odstotek CD4+ T-limfocitov pri otrocih do 12 mesecev: CD4+ &lt; 25 %; pri otrocih med 12 in 35 meseci: CD4+ &lt; 20 %; pri otrocih med 36 in 59 meseci: CD4+ &lt; 15 % (glejte poglavje 4.4).
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ &lt; 25% ; children between 12-35 months: CD4+ &lt; 20%; children between 36-59 months: CD4+ &lt; 15% (see section 4.4).
Huda humoralna ali celična (primarna ali pridobljena) imunska pomanjkljivost, npr. huda kombinirana imunska pomanjkljivost, agamaglobulinemija in AIDS ali simptomatska okužba s HIV ali za starost specifični odstotek CD4+ T-limfocitov pri otrocih do 12 mesecev: CD4+ &lt; 25 %; pri otrocih med 12 in 35 meseci: CD4+ &lt; 20 %; pri otrocih med 36 in 59 meseci: CD4+ &lt; 15 % (glejte poglavje 4.4).
Severe hypersensitivity reactions including anaphylaxis occur in &lt; 1 % of patients (see also section 4.8).
Resne reakcije vključno z anafilakso se pojavijo pri manj kot 1 % bolnikov (glejte tudi poglavje 4.8).
Severe hypertension ( &gt; 200 mmHg systolic or 110 mmHg diastolic) occurred in 4.7% of patients with solid tumours.
Huda hipertenzija (sistolični tlak &gt; 200 mmHg ali diastolični tlak &gt; 110 mmHg) se je pojavila pri 4,7 % bolnikov s čvrstimi tumorji.
Severe hypertension occurred in 12% of treatment-naïve patients on sunitinib and &lt; 1% of patients on IFN-.
Huda hipertenzija se je pojavila pri 12 % predhodno nezdravljenih bolnikov, ki so prejemali sunitinib, ter pri &lt; 1 % bolnikov, ki so prejemali IFN-.
Severe hypotension ( &lt; 90/50 mm Hg).
Huda hipotenzija ( &lt; 90/50 mm Hg)
Severe neutropenia ( &lt; 500 cells/mm3) occurred in 20 % and 39% of patients during the first course of treatment and the entire treatment period, respectively.
Huda nevtropenija ( &lt; 500 celic/mm3) se je v prvem krogu zdravljenja pojavila pri 20 % bolnikov, med celotnim zdravljenjem pa pri 39 % bolnikov.
Severe neutropenia ( &lt; 500 cells/mm3) occurred in 26 % of patients treated with Paxene during the entire treatment period.
Huda nevtropenija ( &lt; 500 celic/mm3) se je pojavila pri 26 % bolnikov, ki so jih ves čas zdravljenja zdravili z zdravilom Paxene.
Severe rash: Extent of rash &gt; 50% of body surface area or associated with vesicles, bullae, ulcerations other than SJS
Hud izpuščaj: obsega &gt; 50% telesne površine ali je povezan z mehurčki, mehurji, razjedami, ki niso povezane s SJS