natgillin/translations-raw huggingface dataset:
Procoralan 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Procoralan 5 mg tablete su duguljaste filmom obložene tablete boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom “5” na jednoj strani, a na drugoj.
Profender for cats ( &gt; 2.5–5 kg)
Profender za mačke ( &gt; 2,5 kg – 5 kg)
Profender for cats ( &gt; 5–8 kg)
Profender za mačke ( &gt; 5 kg – 8 kg)
Profender for Large Cats ( &gt; 5 – 8 kg)
Profender za velike mačke ( &gt; 5 – 8 kg)
Profender for Medium Cats ( &gt; 2.5 – 5 kg)
Profender sa srednje velike mačke ( &gt; 2,5 – 5 kg)
Profender spot-on solution for large cats ( &gt; 5-8 kg)
Profender spot-on otopina za velike mačke ( &gt; 5 kg – 8 kg)
Profender spot-on solution for medium cats ( &gt; 2.5-5 kg)
Profender spot-on otopina za srednje velike mačke (≥2,5 kg – 5 kg)
Progression-free survival was evaluated in several relevant subgroups: gender, race, ECOG performance status, stratification factors (age, disease population, prior anti-myeloma therapies [2, &gt; 2]), selected parameters of prognostic significance (baseline beta-2 microglobulin level, baseline albumin levels, baseline renal impairment, and cytogenetic risk), and exposure and refractoriness to prior anti-myeloma therapies.
Preživljenje bez progresije bolesti evaluirano je u nekoliko važnih podskupina: po spolu, rasi, ECOG statusu, stratifikacijskim čimbenicima (dob, populacija s bolešću, prethodne antimijelomske terapije [2, &gt; 2]), odabranim prognostički značajnim parametrima (početna razina beta-2 mikroglobulina, početna razina albumina, početno oštećenje bubrega i citogenetski rizik) te izloženosti i refraktornosti prije antimijelomskih terapija.
Progression-free survival was statistically significantly improved in patients receiving Cyramza as compared with patients receiving placebo (HR 0.483; 95%CI: 0.376 to 0.620; p &lt; 0.0001), corresponding to a 52% reduction in the risk of progression or death and an increase in median PFS to 2.1 months for Cyramza from 1.3 months for placebo.
Preživljenje bez progresije bolesti statistički se značajno poboljšalo u bolesnika koji su primali lijek Cyramza u odnosu na one koji su primali placebo (HR 0,483; 95% CI: 0,376 do 0,620; p=0,0001) te se rizik od progresije ili smrti smanjio za 52%, a medijan PFS-a produljio na 2,1 mjesec uz primjenu lijeka Cyramza u odnosu na 1,3 mjeseca uz placebo.
Progression-free survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.635; 95% CI: 0.536 to 0.752; p &lt; 0.0001).
Preživljenje bez progresije bolesti statistički se značajno poboljšalo u bolesnika liječenih lijekom Cyramza i paklitakselom u odnosu na one koji su primali placebo i paklitaksel (HR 0,635; 95% CI: 0,536 do 0,752; p=0,0001).
Prolia demonstrated a 40% relative reduction (0.5% absolute risk reduction) in the risk of hip fracture over 3 years (p &lt; 0.05).
Prolia je pokazala 40%-tno relativno smanjenje (0,5%-tno smanjenje apsolutnog rizika) rizika frakture kuka tijekom 3 godine (p &lt; 0,05).
Prolia demonstrated a significant relative risk reduction of new vertebral fractures: 85% (1.6% absolute risk reduction) at 1 year, 69% (2.2% absolute risk reduction) at 2 years and 62% (2.4% absolute risk reduction) at 3 years (all p &lt; 0.01).
Prolia je značajno smanjila relativan rizik novih fraktura kralježnice: 85% (1,6% smanjenje apsolutnog rizika) tijekom 1 godine, 69% (2,2% smanjenje apsolutnog rizika) tijekom 2 godine i 62% (2,4% smanjenje apsolutnog rizika) tijekom 3 godine (za sve p &lt; 0,01).
Prolia increased BMD by 9.2% at the lumbar spine, 6.0% at the total hip, 4.8% at the femoral neck, 7.9% at the hip trochanter, 3.5% at the distal 1/3 radius and 4.1% at the total body over 3 years (all p &lt; 0.0001).
Prolia je tijekom 3 godine povisila BMD za 9,2% u lumbalnoj kralježnici, 6,0% za cijeli kuk, 4,8% na vratu femura, 7,9% na trohanteru kuka, 3,5% u distalnoj trećini radijusa i 4,1% za cijelo tijelo (za sve p &lt; 0,0001).
Prolia is not recommended in paediatric patients (age &lt; 18) as the safety and efficacy of Prolia in these patients have not been established.
Prolia se ne preporučuje za primjenu u djece (dob &lt; 18) jer u tih bolesnika nije utvrđena sigurnost i djelotvornost lijeka Prolia.
Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 2 years: 7.6% at lumbar spine, 4.7% at total hip, 3.6% at femoral neck, 5.9% at hip trochanter, 6.1% at distal 1/3 radius and 4.2% at total body (all p &lt; 0.0001).
Na svim mjerenim mjestima Prolia je u usporedbi s placebom značajno povisila BMD tijekom dvije godine: 7,6% na lumbalnoj kralježnici, 4,7% na cijelom kuku, 3,6% na vratu femura, 5,9% na trohanteru kuka, 6,1% distalne trećine radijusa i 4,2% cijelog tijela (za sve p &lt; 0,0001).
Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 3 years: 7.9% at the lumbar spine, 5.7% at the total hip, 4.9% at the femoral neck, 6.9% at the hip trochanter, 6.9% at the distal 1/3 radius and 4.7% at the total body (all p &lt; 0.0001).
Na svim kliničkim mjestima mjerenja Prolia je, u usporedbi s placebom, značajno povisila BMD tijekom tri godine: 7,9% na lumbalnoj kralježnici, 5,7% na cijelom kuku, 4,9% na vratu femura, 6,9% na trohanteru kuka, 6,9% distalne trećine radijusa i 4,7% cijelog tijela (za sve p &lt; 0,0001).
Prolia significantly reduced the risk of new vertebral fractures at 1, 2 and 3 years (p &lt; 0.0001) (see table 2).
Prolia je značajno smanjila rizik od novih fraktura kralježnice tijekom prve, druge i treće godine (p &lt; 0.0001) (vidjeti tablicu 2).
Prolonged cardiopulmonary resuscitation ( &gt; 2 minutes) within the past 2 weeks
produljena kardiopulmonalna reanimacija ( &gt; 2 minute) u proteklih 2 tjedna
Prolonged-release exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance &lt; 30 ml/min) (see section 4.4).
Ne preporučuje se primjena eksenatida s produljenim oslobađanjem u bolesnika u završnom stadiju bubrežne bolesti ni u bolesnika s teškim oštećenjem bubrega (klirens kreatinina &lt; 30 ml/min) (vidjeti dio 4.4).
Prophylaxis of VTE - 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).
Profilaksa VTE - Bolesnici s klirensom kreatinina &lt; 50 ml/min imaju povećan rizik od krvarenja i treba ih liječiti uz oprez (vidjeti dio 4.2, 4.3 i 5.2).
Proportion (%) of patients with HIV-1 RNA &lt; 50 copies/mL by subgroup
Bolesnici zaraženi virusom HIV-1 kod kojih je virus suprimiran
Proportion Achieving HbA1c &lt; 7%
Udio bolesnika koji su postigli HbA1c &lt; 7
Proportion of patients achieving HbA1c &lt; 7 %
Udio bolesnika koji su postigli HbA1c &lt; 7
Proportion of Patients in CAL30001 with &lt; 50 copies/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Udio bolesnika u ispitivanju CAL30001 s &lt; 50 kopija/mL u 48. tjednu prema indeksu genotipske osjetljivosti u OBT i broju početnih mutacija
Proportion of Patients in CNA30021with &lt; 50 cps/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Udio bolesnika u ispitivanju CNA30021 koji su u 48. tjednu imali &lt; 50 kopija/ml prema indeksu genotipske osjetljivosti u OBT i broju početnih mutacija
Proportion of patients who met serum uric acid target ( &lt; 6.0 mg/dL)
Udio bolesnika koji su postigli ciljnu razinu mokraćne kiseline u serumu ( &lt; 6,0 mg/dl)
Proportion of Patients with Serum Uric Acid Levels &lt; 6.0 mg/dL (357 µmol/L) Last Three Monthly Visits
Udio bolesnika s razinama mokraćne kiseline u serumu &lt; 6,0 mg/dl (357 µmol/l) Zadnje tri mjesečne kontrole
Proportion undetectable ( &lt; 300 copies/ml)b
Nemjerljivi udio ( &lt; 300 kopija/ml)b
Proportion with HIV-1 RNA &lt; 400 copies/ml
Udio s HIV-1 RNK &lt; 400 kopija/ml
Proportion with HIV-1 RNA &lt; 400 copies/ml
Udio sa HIV-1 RNK &lt; 400 kopija/ml
Proportion with HIV-1 RNA &lt; 50 copies/ml
Udio sa HIV-1 RNK &lt; 50 kopija/ml
Proportion with HIV-1 RNA &lt; 50 copies/ml
Udio sa HIV-1 RNA &lt; 50 kopija/ml
Proportions of patients achieving HbA1c &lt; 7% targets (%)
Udio bolesnika koji su postigli ciljni HbA1c &lt; 7% (%)
Proportions of Subjects in the Once Daily versus Twice Daily Abacavir+Lamivudine Randomisation of ARROW with Plasma HIV-1 RNA &lt; 80 copies/ml: Subgroup Analysis by Formulation
Udio ispitanika s HIV-1 RNK u plazmi &lt; 80 kopija/ml nakon randomizacije za primjenu abakavira + lamivudina jedanput na dan naspram dvaput na dan u ispitivanju ARROW: analiza podskupina prema formulaciji lijeka
Proportions with HIV-1 RNA &lt; 50 copies/ml (50% versus 47%) and &lt; 400 copies/ml (54% versus 57%) at week 48 were also similar in each group (ITT population).
U obje skupine (uključena populacija) bio je sličan i udio bolesnika s HIV-1 RNK &lt; 50 kopija/ml (50% prema 47%,) te onih s &lt; 400 kopija/ml (54% prema 57%) u 48 tjednu.
Proportions with HIV-1 RNA &lt; 50 copies/ml (50% versus 47%) and &lt; 400 copies/ml (54% versus 57%) were also similar in each group (ITT population).
U obje skupine (populacija s namjerom liječenja) bio je sličan i udio bolesnika s HIV-1 RNK &lt; 50 kopija/ml (50% naspram 47%), te onih s &lt; 400 kopija/ml (54% naspram 57%).
ProQuad elicits rates of antibody responses against measles, mumps, and rubella similar to those observed after vaccination with the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc.
ProQuad postiže stope odgovora protutijela na viruse morbila, parotitisa i rubele koji je sličan onom primijećenom nakon cijepljenja cjepivom protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc.
Protein binding/distribution: bexarotene is highly bound ( &gt; 99%) to plasma proteins.
Vezanje za proteine/distribucija: Beksaroten se u visokom postotku veže ( &gt; 99%) za proteine plazme.
Published clinical data support concomitant administration of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. with other childhood vaccinations, including DTaP (or DTwP), IPV (or OPV), HIB (Haemophilus influenzae type b), HIB-HBV (Haemophilus influenzae type b with Hepatitis B vaccine), and VAR (varicella).
Objavljeni klinički podaci podupiru istodobnu primjenu prethodnog kombiniranog cjepiva protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc. s drugim dječjim cjepivima, uključujući DTaP (ili DTwP), IPV (ili OPV), HIB (Haemophilus influenzae tipa b), HIB-HBV (Haemophilus influenzae tipa b s cjepivom protiv hepatitisa B) i VAR (vodene kozice).
Pull dose knob out until it stops and the is in the dose window.
Izvucite gumb za doziranje dok se ne zaustavi i dok se u prozorčiću ne pojavi simbol .
Pull the dose knob out until appears.
Izvlačite gumb za doziranje dok se ne pojavi .
PUSH &amp; HOLD
PRITISNITE I DRŽITE
QTc &gt; 500 msec or &gt; 60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia
QTc &gt; 500 msec ili promjena &gt; 60 msec u odnosu na početnu vrijednost i torsade de pointes ili polimorfna ventrikularna tahikardija ili znakovi/simptomi ozbiljne aritmije
QTc prolongation &gt; 470 msec (females) or &gt; 450 msec (males)
Produljenjem QTc intervala &gt; 470 msek (žene) ili &gt; 450 msek (muškarci)
QTc &gt; 500 ms at baseline
QTc &gt; 500 ms na početku liječenja
QTcF &lt; 500 msec) were uncommon (0.1 % to 1 %) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
≥ 500 milisekundi [ms] bilo kada nakon početne vrijednosti u bolesnika s početnom vrijednošću QTcF &lt; 500 ms) bila su manje česta (0,1% do 1%) u bolesnika liječenih olanzapinom, bez značajnih razlika u povezanim srčanim događajima u usporedbi s placebom.
QTcF exceeding 500 msec was observed in &lt; 1% of patients.
Produženje QTcF veće od 500 msek opaženo je u &lt; 1% bolesnika.
QTcF increase from baseline exceeding 60 msec was observed in &lt; 1% of patients while on the study medicinal product.
Produženje QTcF veće od 60 msek u odnosu na početnu vrijednost opaženo je u &lt; 1% bolesnika tijekom primjene ispitivanog lijeka.
QTcF of &gt; 500 msec was observed in &lt; 1% of these patients.
QTcF od &gt; 500 msek opažen je u &lt; 1% ovih bolesnika.
QTcF prolongation was &gt; 20 ms in over 91% of patients, &gt; 60 ms in 35%, &gt; 100 ms in 1.7%.
Produljenje QTcF intervala bilo je &gt; 20 ms u više od 91% bolesnika, &gt; 60 ms u njih 35%, a &gt; 100 ms u njih 1,7%.
QUESTIONS &amp; ANSWERS
PITANJA I ODGOVORI
RADIANT-3 (study CRAD001C2324), a phase III, multicentre, randomised, double-blind study of Afinitor plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pNET, demonstrated a statistically significant clinical benefit of Afinitor over placebo by a 2.4-fold prolongation of median progression-free-survival (PFS) (11.04 months versus 4.6 months), (HR 0.35; 95% CI: 0.27, 0.45; p &lt; 0.0001) (see Table 5 and Figure 2).
RADIANT-3 (ispitivanje CRAD001C2324), multicentrično, randomizirano, dvostruko slijepo ispitivanje faze III, u kojem je uspoređivana kombinacija Afinitora i najboljeg potpornog liječenja s kombinacijom placeba i najboljeg potpornog liječenja u bolesnika s uznapredovalim pNET-om, pokazalo je statistički značajnu kliničku dobit za Afinitor u odnosu na placebo, s 2,4-puta duljim medijanom preživljenja bez progresije bolesti (11,04 mjeseca naspram 4,6 mjeseci), (omjer hazarda 0,35; 95% CI: 0,27; 0,45; p &lt; 0,0001) (vidjeti Tablicu 5 i Sliku 2).
Radiographic progression-free survival as assessed by the investigator using RECIST v 1.1 for soft tissue and appearance of 2 or more bone lesions in bone scan was 8.3 months for patients treated with enzalutamide and 2.9 months for patients who received placebo (HR = 0.404, 95% CI: [0.350, 0.466]; p &lt; 0.0001).
Preživljenje bez radiološke progresije bolesti prema procjeni ispitivača pomoću RECIST kriterija verzija 1.1 za meko tkivo i pojave 2 ili više koštanih lezija na snimci kostiju iznosilo je 8,3 mjeseca u bolesnika liječenih enzalutamidom i 2,9 mjeseci u bolesnika koji su primali placebo (omjer hazarda = 0,404, 95% CI: [0,350, 0,466]; p &lt; 0,0001).
Radiographic Progression: Comparison of Enbrel vs Methotrexate in Patients with RA of &lt; 3 Years Duration
Radiografska progresija: usporedba Enbrela s metotreksatom u bolesnika s RA u trajanju od
Radioiodine-refractory was defined as one or more measurable lesions either with a lack of iodine uptake or with progression in spite of radioactive-iodine (RAI) therapy, or having a cumulative activity of RAI of &gt; 600 mCi or 22 GBq with the last dose at least 6 months prior to study entry.
Refraktornost na radioaktivni jod bila je definirana kao jedna ili više mjerljivih lezija bez unosa joda ili s progresijom unatoč terapiji radioaktivnim jodom (RAI) ili kumulativna aktivnost RAI od &gt; 600 mCi ili 22 GBq sa zadnjom dozom najmanje 6 mjeseci prije ulaska u ispitivanje.
Ramucirumab therapy should be permanently discontinued if the urine protein level is &gt; 3 g/24 hours or in the event of nephrotic syndrome.
Liječenje ramucirumabom mora se trajno obustaviti ako je razina proteina u mokraći &gt; 3 g/24 sata ili ako se razvije nefrotski sindrom.
Randomisation was stratified by geographic region, time to progression from the start of first-line therapy ( &lt; 6 months versus ≥6 months) and disease measurability.
Randomizacija je bila stratificirana prema geografskoj regiji, vremenu od početka prvolinijske terapije do progresije bolesti ( &lt; 6 mjeseci naspram ≥ 6 mjeseci) i mjerljivosti bolesti.
Randomisation was stratified by geographic region, tumour KRAS status (mutant or wild-type), and time to disease progression (TTP) after commencing first-line treatment ( &lt; 6 months versus ≥6 months).
Randomizacija je bila stratificirana prema geografskoj regiji, statusu gena KRAS u tumoru (mutacija ili divlji tip) i vremenu do progresije bolesti nakon početka prvolinijskog liječenja ( &lt; 6 mjeseci naspram ≥ 6 mjeseci).
Randomisation was stratified by PD-L1 expression (≥5% vs. &lt; 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system.
Randomizacija je bila stratificirana prema ekspresiji PD-L1 (ekspresija na tumorskoj staničnoj membrani ≥ 5% naspram &lt; 5%), BRAF statusu te metastatskom stadiju prema klasifikaciji Američkog udruženja za rak (engl.
Randomisation was stratified by screening HIV-1 RNA level ( &lt; 100,000 copies/ml and &gt; 100,000 copies/mL).
Randomizacija je stratificirana pomoću probira HIV-1 RNK vrijednosti ( &lt; 100 000 kopija/ml i &gt; 100 000 kopija/ml).
Randomisation was stratified by screening HIV-1 RNA level (≤ 100,000 copies/ml or &gt; 100,000 copies/ml).
Randomozacija je stratificirana probiranjem na razinu HIV-1 RNK (≤ 100 000 kopija/ml ili &gt; 100 000 kopija/ml).
Randomisation was stratified by screening HIV-1 RNA level (≤100,000 copies/ml or &gt; 100,000 copies/ml).
Randomizacija je bila stratificirana prema rezultatima probira na razinu HIV-1 RNK (≤ 100 000 kopija/ml ili &gt; 100 000 kopija/ml).
Randomisation was stratified by weight loss over the prior 3 months (≥ 10% versus &lt; 10%), geographic region, and location of the primary tumour (gastric versus GEJ).
Randomizacija je bila stratificirana prema gubitku tjelesne težine tijekom prethodna 3 mjeseca (≥ 10% naspram &lt; 10%), geografskoj regiji i lokaciji primarnog tumora (želudac naspram gastroezofagealnog spoja).
Randomization was stratified by screening HIV RNA level (≤50,000 copies/ml; and &gt; 50,000 copies/ml) and by hepatitis B or C status (positive or negative).
Randomizacija je bila stratificirana probirom na temelju razine HIV-RNK (≤ 50 000 kopija/ml i &gt; 50 000 kopija/ml) i statusa hepatitisa B ili C (pozitivan ili negativan).
Rapid weight loss at a rate of &gt; 1.5 kg per week has been reported in patients treated with exenatide.
U bolesnika koji su liječeni eksenatidom prijavljen je nagli gubitak tjelesne težine po stopi od &gt; 1,5 kg na tjedan.
Rare ( &gt; 1/10,000, &lt; 1/1,000):
Rijetko ( &gt; 1/10 000 i &lt; 1/1000):
rare (more than 1 but less than 10 animals in 10,000 animals) very rare (less than 1 animal in 10,000 animals, including isolated reports)
rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve). &gt;
rare (more than 1 but less than 10 animals in 10,000 animals) very rare (less than 1 animal in 10,000 animals, including isolated reports).
rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve). &gt;
rare (more than 1 but less than 10 animals in 10,000 animals) very rare (less than 1 animal in 10,000 animals, including isolated reports). &gt;
rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
Rare (≥ 1/10,000 to &lt; 1/1,000)
Rijetko (≥ 1/10 000 i &lt; 1/1000)
Rare (≥ 1/10,000 to &lt; 1/1000)
Rijetko (≥ 1/10 000 i &lt; 1/1000)
Rare (≥ 1/10,000 to  1/1,000); Very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
 1/1000), vrlo rijetko ( &lt; 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Rare (≥ 1/10,000, &lt; 1/1,000)
Rijetko (≥ 1/10 000, &lt; 1/1000)
Rare (≥1/10,000 to &lt; 1/1,000)
Rijetko (≥ 1/10 000 i &lt; 1/1000)
Rare (≥1/10,000 to &lt; 1/1,000)
Rijetko (≥1/10 000 i &lt; 1/1000)
Rare (≥1/10,000 to &lt; 1/1,000)
Rijetko (≥1/10000 i &lt; 1/1000)
Rare (≥1/10,000 to &lt; 1/1,000) Very rare ( &lt; 1/10,000)
Manje često (≥1/1 000 do &lt; 1/100) Rijetko (≥1/10 000 do &lt; 1/1 000) Vrlo rijetko ( &lt; 1/10 000)
Rare (≥1/10,000 to &lt; 1/1,000); Very rare ( &lt; 1/10,000); Not known (cannot be established from the available data).
&lt; 1/1000); vrlo rijetko ( &lt; 1/10 000), nepoznato (ne može se ustanoviti iz dostupnih podataka).
Rare ( 1/10,000 and &lt; 1/1,000)
Rijetko ( 1/10 000 do &lt; 1/1000)
Rare ( 1/10,000 to &lt; 1/1,000)
Rijetko ( 1/10 000 do &lt; 1/1000)
Rare ( 1/10000 and
Rijetko ( 1/10000 do &lt; 1/1000)
Rare (1/10,000 to &lt; 1/1,000)
Rijetko ( 1/10 000 i &lt; 1/1000)
Rare (1/10,000 to &lt; 1/1,000)
Rijetko (1/10 000 to &lt; 1/1000)
Rare cases of neutropenia &lt; 0.5x109/l (CTCAE Grade 4) were reported.
Prijavljeni su rijetki slučajevi neutropenije &lt; 0,5x109/l (stupanj 4 prema CTCAE-u).
rare ≥ 1/10,000 to &lt; 1/1,000
rijetko ≥ 1/10 000 i &lt; 1/1000
Rare: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes
Rijetko: pancitopenija (vjerojatno povezana s antiproliferativnim mehanizmom djelovanja), leukopenija (leukociti &lt; 2 g/l), eozinofilija
Rare: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes &lt; 2 G/l), eosinophilia
Rijetko: pancitopenija (vjerojatno povezana s antiproliferativnim mehanizmom djelovanja), leukopenija (leukociti &lt; 2 g/l), eozinofilija
Rare: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes &lt; 2 G/L), eosinophilia
Rijetko: pancitopenija (vjerojatno povezana s antiproliferativnim mehanizmom djelovanja), leukopenija (leukociti &lt; 2 g/l), eozinofilija
Rasilamlo is not recommended in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73 m2).
Rasilamlo se ne preporučuje bolesnicima s teškim oštećenjem bubrežne funkcije (GFR &lt; 30 ml/min/1,73 m2).
Rasilamlo is not recommended in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73 m2).
Rasilamlo se ne preporučuje u bolesnika s teškim oštećenjem bubrežne funkcije (GFR &lt; 30 ml/min/1,73 m2).
Rasilamlo may be administered with other antihypertensive medicinal products with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) &lt; 60 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.1).
Rasilamlo se može primjenjivati s drugim antihipertenzivnim lijekovima izuzimajući primjenu u kombinaciji s inhibitorima angiotenzin konvertirajućeg enzima (ACEI) ili blokatorima receptora angiotenzina II (ARB) u bolesnika sa šećernom bolešću ili oštećenjem bubrežne funkcije (brzina glomerularne filtracije (GFR) &lt; 60 ml/min/1,73 m2) (vidjeti dijelove 4.3, 4.4 i 5.1).
Rasilez HCT was studied in a placebo-controlled trial including 2,762 hypertensive patients with diastolic blood pressure ≥ 95 mmHg and &lt; 110 mmHg (mean baseline blood pressure of 153.6/99.2 mmHg).
Rasilez HCT je ispitivan u placebo kontroliranom kliničkom ispitivanju u kojem su bila uključena 2762 hipertenzivna bolesnika s dijastoličkim krvnim tlakom ≥95 mmHg i &lt; 110 mmHg (srednja vrijednost početnog krvnog tlaka je bila 153,6/99,2 mmHg).
Rasilez is not recommended in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73 m2).
Rasilez se ne preporučuje u bolesnika s teškim oštećenjem bubrežne funkcije (GFR &lt; 30 ml/min/1,73 m2).
Rasilez is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) &lt; 30 ml/min/1.73 m2).
Rasilez se ne preporučuje bolesnicima s teškim oštećenjem bubrežne funkcije (brzina glomerularne filtracije (GFR) &lt; 30 ml/min/1,73 m2).