natgillin/translations-raw huggingface dataset:
Fuzeon is given as a 1 ml injection just below the skin – called a ‘subcutaneous’ injection.
Zdravilo Fuzeon dajemo kot 1-ml injekcijo tik pod kožo – imenujemo jo &lt; subkutana &lt; injekcija.
Fuzeon must be given as an injection just below the skin – called a ‘subcutaneous’ injection.
Zdravilo Fuzeon je treba dati kot injekcijo tik pod kožo – &lt; subkutana &lt; injekcija.
G-CSF (5 μg/kg, SC): days 4-13 or until ANC &gt; 1500 post nadir
G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC &gt; 1500 po doseženem najnižjem številu
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is &lt; 0.1 µM, q6h
G-CSF = rastni dejavnik za granulocite (granulocyte colony stimulating factor), VP-16 = etopozid, MTX = metotreksat, i.v. = intravensko, s.c. = subkutano, i.t. = intratekalno, i.m. = intramuskularno, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2-merkaptoetan sulfonat, iii= oziroma dokler koncentracija MTX ni
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is &lt; 0.1 μM, q6h
G-CSF = rastni dejavnik za granulocite (granulocyte colony stimulating factor), VP-16 = etopozid, MTX = metotreksat, i.v. = intravensko, s.c. = subkutano, i.t. = intratekalno, i.m. = intramuskularno, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L- asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2-merkaptoetan sulfonat, iii= oziroma dokler koncentracija MTX ni &lt; 0,1 µM, Gy= Gray
g. &gt; 5.5 kb del to 3UTR
g. &gt; 5,5 kb del v 3UTR
G3/4 ALT increased ( &lt; 1%)
S3/4 zvišanje ALT ( &lt; 1
G3/4 ALT increased ( &lt; 1%)
S3/4 zvišanje ALT ( &lt; 1 %)
G3/4 ALT increased ( &lt; 2%)
Preiskave
G3/4 ALT increased ( &lt; 2%)
S3/4 zvišanje ALT ( &lt; 2
G3/4 ALT increased ( &lt; 2%)
S3/4 zvišanje ALT ( &lt; 2 %)
G3/4 AST increased ( &lt; 1%);
S3/4 zvišanje AST ( &lt; 1
G3/4 AST increased ( &lt; 1%);
S3/4 zvišanje AST ( &lt; 1 %),
G3/4 AST increased ( &lt; 3%);
S3/4 zvišanje AST ( &lt; 3 %),
G3/4 AST increased ( &lt; 3%);
S3/4 zvišanje AST ( &lt; 3%),
G3/4 AST increased ( &lt; 1%);
zvečanje AST S3/4
G3/4 Blood alkaline phosphatase increased (0.3%)
S3/4 zvišanje alkalne fosfataze v krvi ( &lt; 0,3
G3/4 Blood alkaline phosphatase increased (0.3%)
S3/4 zvišanje alkalne fosfataze v krvi ( &lt; 0,3 %)
G3/4 Blood alkaline phosphatase increased ( &lt; 4%);
S3/4 zvišanje alkalne fosfataze v krvi ( &lt; 4 %),
G3/4 Blood alkaline phosphatase increased ( &lt; 4%);
S3/4 zvišanje alkalne fosfataze v krvi ( &lt; 4 %), S3/4 zvišanje AST ( &lt; 3
G3/4 Blood bilirubin
zvišanje bilirubina v krvi S3/4 ( &lt; 2 %)
G3/4 Blood bilirubin increased (2.1%); G3/4 ALT increased (1.3%)
povišanje ravni bilirubina v krvi S 3/4 ( &lt; 2,1 %), povišanje ravni ALT S 3/4 (1,3 %)
G3/4 Blood bilirubin increased (2.1%); G3/4 ALT increased (1.3%)
povišanje ravni bilirubina v krvi S3/4 ( &lt; 2,1 %), povišanje ravni ALT S3/4 (1,3 %)
G3/4 Blood bilirubin increased (2.1%); G3/4 ALT increased (1.3%)
zvečanje bilirubina v krvi S3/4 (2,1 %), zvečanje ALT S3/4 ( &lt; 1,3 %)
G3/4 Blood bilirubin increased ( &lt; 2%)
povišanje ravni bilirubina v krvi S 3/4 ( &lt; 2 %)
G3/4 Blood bilirubin increased ( &lt; 2%)
S3/4 zvišanje bilirubin v krvi ( &lt; 2 %)
G3/4 Blood bilirubin increased ( &lt; 2%)
S3/4 zvišanje bilirubin v krvi ( &lt; 2%)
G3/4 Blood bilirubin increased ( &lt; 2%)
S3/4 zvišanje bilirubina v krvi ( &lt; 2 %)
G3/4 Blood bilirubin increased ( &lt; 2%)
S3/4 zvišanje bilirubina v krvi ( &lt; 2%)
G3/4 Blood bilirubin increased ( &lt; 2%)
zvečanje bilirubina v krvi S3/4 ( &lt; 2 %)
G3/4 Blood bilirubin increased ( &lt; 2%)
zvišanje bilirubina v krvi S3/4 ( &lt; 2 %)
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
povišanje ravni bilirubina v krvi S 3/4 ( &lt; 2,5 %), povišanje ravni alkalne fosfataze v krvi S 3/4 ( &lt; 2,5 %)
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
povišanje ravni bilirubina v krvi S3/4 ( &lt; 2,5 %), povišanje ravni alkalne fosfataze v krvi S3/4 ( &lt; 2,5 %)
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
S3/4 zvišanje alkalne fosfataze v krvi ( &lt; 2,5
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
zvečanje bilirubina v krvi S3/4 ( &lt; 2,5 %), zvečanje alkalne fosfataze v krvi S3/4 ( &lt; 2,5 %)
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
zvečanje bilirubina v krvi S3/4 ( &lt; 2,5 %), zvečanje zvečanje alkalne fosfataze v krvi S3/4 ( &lt; 2,5 %)
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
zvišanje bilirubina v krvi S3/4 ( &lt; 2,5 %), zvišanje alkalne fosfataze v krvi S3/4 ( &lt; 2,5 %)
G3/4 Blood bilirubin increased ( &lt; 5%);
S3/4 zvišanje bilirubina v krvi ( &lt; 5 %),
G3/4 Blood bilirubin increased ( &lt; 5%); G3/4 Blood alkaline phosphatase increased ( &lt; 4%);
Splošne težave in spremembe na mestu aplikacije
G3/4 Blood bilirubin increased ( &lt; 2%)
Zvečanje bilirubina v krvi S3/4 ( &lt; 2 %)
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
Zvečanje bilirubina v krvi S3/4 ( &lt; 2 %)
Gadoversetamide plasma levels increase linearly with decreasing renal function; in patients with severe renal impairment (CrCl &lt; 30 ml/min) this even leads to a six-fold decreased gadoversetamide clearance and a corresponding six-fold increased extent of exposure AUC and t½.
Ravni gadoversetamida v plazmi se linearno večajo z zmanjšanjem ledvične funkcije; pri bolnikih s hudo ledvično okvaro (CrCl &lt; 30 ml/min) to lahko povzroči tudi šestkratno zmanjšanje očistka gadoversetamida in ustrezno šestkratno povečanje izpostavljenosti AUC in t½.
Galvus is not recommended for use in children and adolescents ( &lt; 18 years).
Uporaba zdravila Galvus pri otrocih in mladostnikih ( &lt; 18 let) ni priporočljiva.
Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST &gt; 3x ULN (see also sections 4.2 and 5.2).
Zdravilo Galvus 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 tudi poglavji 4.2 in 5.2).
Gamithromycin administered subcutaneously into the neck of cattle at a single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with a long plasma half-life ( &gt; 2 days).
Po subkutani aplikaciji gamitromicina v predel vratu pri govedu v enkratnem odmerku 6 mg/kg telesne teže, je absorbcija učinkovine izjemno hitra, z viškom koncentracije v plazmi po 30 do 60 minutah in z dolgo biološko razpolovno dobo ( &gt; 2 dni).
Gamithromycin levels in lung reached a maximum in less than 24 hr, with lung-to-plasma ratio of &gt; 264 indicating that gamithromycin was absorbed rapidly into the target tissue for BRD.
Višek koncentracije gamitromicina v pljučih je v manj kot 24 urah, z razmerjem pljuča – plazma &gt; 264, kar kaže na izjemno hitro absorbcijo gamitromicina v tarčno tkivo za BRD.
Gastrointestinal and CNS haemorrhage were reported in 1% and &lt; 1% of patients, respectively.
O gastrointestinalni krvavitvi so poročali pri 1 % bolnikov, o krvavitvi centralnega živčevja pa pri manj kot 1 % bolnikov.
Gastrointestinal disorders (Common, ≥1/100 to &lt; 1/10)
Bolezni prebavil (pogosti, ≥ 1/100 do &lt; 1/10)
Gastrointestinal disorders: Obese patients [Body mass index (BMI) &gt; 30 kg/m2] treated with Benlysta reported higher rates of nausea, vomiting and diarrhoea relative to placebo, and compared with normal- weight patients (BMI ≥18.5 to ≤30 kg/m2).
Bolezni prebavil: Debeli bolniki [indeks telesne mase (ITM) &gt; 30 kg/m2], zdravljeni z zdravilom Benlysta, so navajali večje deleže navzee, bruhanja in driske glede na placebo in v primerjavi z bolniki z normalno telesno maso (ITM ≥ 18,5 do ≤ 30 kg/m2).
Gastrointestinal perforationl ( &lt; 1%)
perforacija v prebavilih1 ( &lt; 1 %)
Gender/age: there was no apparent difference in the safety profile of entecavir with respect to gender ( 25% women in the clinical trials) or age ( 5% of patients &gt; 65 years of age).
Spol/starost: Varnostni profil entekavirja se glede na spol (≈ 25% žensk v kliničnih preskušanjih) ali starost (≈ 5% bolnikov, starejših od 65 let) očitneje ne razlikuje.
gene therapy who met the definition of adequate metabolic detoxification, therefore baseline value is not applicable. e At baseline 9 of 11 (82%) patients had dAXP &lt; 100 nmol/ml.
Rezultati dAXP temeljijo na analizi odzivnega odstotka bolnikov, ki so po genskem zdravljenju izpolnjevali definicijo ustrezne presnovne detoksifikacije, zato izhodiščna vrednost ne pride v poštev. e Izhodiščno je imelo 9 od 11 (82 %) bolnikov dAXP &lt; 100 nmol/ml.
General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary  37.5°C; rectal  38°C) common: fever (axillary &gt; 39°C; rectal &gt; 39.5°C)
Splošne težave in spremembe na mestu aplikacije: zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37,5 ºC; rektalna
General disorders and Uncommon: chest pain administration site conditions:
Splošne težave in spremembe na Občasni: bolečina v prsnem košu mestu aplikacije:
General disorders and Uncommon: chest pain administration site conditions:
Splošne težave in spremembe Občasni: bolečina v prsnem košu na mestu aplikacije
General risk factors for a cardiac event and those identified in adjuvant breast cancer studies with trastuzumab therapy include advancing age ( &gt; 50 years), low baseline LVEF values ( &lt; 55%), low LVEF levels prior to or following the use of paclitaxel in the adjuvant setting, prior or concomitant use of antihypertensive medicinal products, previous therapy with an anthracycline and high BMI ( &gt; 25 kg/m2).
Med splošnimi dejavniki tveganja za srčni dogodek in tistimi, ki so jih ugotovili v študijah adjuvantnega zdravljenja raka dojk s trastuzumabom, so višja starost ( &gt; 50 let), nizek izhodiščni LVEF ( &lt; 55 %), nizek LVEF pred uporabo paklitaksela ali po njem med adjuvantnim zdravljenjem, predhodna ali sočasna uporaba antihipertenzivnih zdravil, predhodno zdravljenje z antraciklinom in visok ITM ( &gt; 25 kg/m2).
General toxicity observed in animals (rat, dog) upon treatment with guanfacine included prolongation of uncorrected QT interval (heart), atrophic spleen and decreased white blood cells, affected liver – increased bilirubin and ALT levels included, irritated and inflamed intestines, increased creatinine and blood urea nitrogen levels (kidney), corneal clouding (eye) in rat and mouse only, alveolar macrophage infiltration &amp; pneumonitis and reduced spermatogenesis.
Splošna toksičnost, ki so jo ugotovili pri živalih (podgana, pes) pri dajanju gvanfacina, je obsegala podaljšanje nekorigiranega intervala QT (srce), atrofično vranico in zmanjšane bele krvničke, prizadeta jetra – vključno z zvišanjem ravni bilirubina in ALT, razdraženo in vneto črevo, zvišano raven kreatinina in dušika sečnine v krvi (ledvice), zamotnitev roženice (oko) le pri podganah in miših, alveolarno infiltracijo z makrofagi in pnevmonitis, ter zmanjšano spermatogenezo.
Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI &gt; 30 kg/m2) and systemic lupus erythematosus (SLE).
Na splošno pripoznan dejavniki tveganja za VTE vključujejo starost, družinsko anamnezo, hudo debelost (ITM &gt; 30 kg/m2) in sistemski eritematozni lupus (SLE, systemic lupus erythematosus).
Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI &gt; 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Splošno znani dejavniki tveganja za VTE vključujejo uporabo estrogenov, starost, večji kirurški poseg, dolgotrajno imobilizacijo, debelost (ITM &gt; 30 kg/m2), nosečnost/poporodno obdobje, sistemski eritematozni lupus (SLE) in raka.
Generally, the most common adverse events reported in ≥ 65 years old were similar to &lt; 65 years old.
Na splošno so bili najpogostejši neželeni učinki, o katerih so poročali pri bolnikih, starih ≥ 65 let, podobni kot pri bolnikih, starih &lt; 65 let.
Genotype 1 &gt; 600,000
Genotip 1 &gt; 600.000 i.e./ml
Genotype 1 &gt; 600,000 IU/ml
Genotip 1 &gt; 600.000 i.e./ml
Genotype Non-1: The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e.g., age &gt; 40 years, male gender, bridging fibrosis).
Genotip ne-1: Odločitev o podaljšanju terapije na eno leto pri bolnikih z negativno vrednostjo serumske RNA-HCV po šestih mesecih zdravljenja mora temeljiti na drugih prognostičnih dejavnikih (npr. starost &gt; 40 let, moški spol, premostitvena fibroza).
Genotype Non-1: The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e.g., age &gt; 40 years, male gender, bridging fibrosis).
Genotipi ne-1: Odločitev o podaljšanju terapije na eno leto pri bolnikih z negativno vrednostjo serumske RNA-HCV po šestih mesecih zdravljenja mora temeljiti na drugih prognostičnih dejavnikih (npr. starost &gt; 40 let, moški spol, premostitvena fibroza).
Genotypes Non-1: The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e.g., age &gt; 40 years, male gender, bridging fibrosis).
Genotipi ne-1: Odločitev o podaljšanju terapije na eno leto pri bolnikih z negativno vrednostjo serumske RNA-HCV po šestih mesecih zdravljenja mora temeljiti na drugih prognostičnih dejavnikih (npr. starost &gt; 40 let, moški spol, premostitvena fibroza).
Genotypes Non-1: The decision to extend therapy to one year in patients with negative HCVRNA after six months of treatment should be based on other prognostic factors (e.g., age &gt; 40 years, male gender, bridging fibrosis).
Genotipi ne-1: Odločitev o podaljšanju terapije na eno leto pri bolnikih z negativno vrednostjo serumske RNA-HCV po šestih mesecih zdravljenja mora temeljiti na drugih prognostičnih dejavnikih (npr. starost &gt; 40 let, moški spol, premostitvena fibroza).
Genotypic evaluations performed on all patients with HBV DNA &gt; 400 copies/ml at week 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) and 384 (n = 2) of tenofovir disoproxil fumarate monotherapy showed that no mutations associated with tenofovir disoproxil fumarate resistance have developed.
Genotipska ocena, ki so jo opravili pri vseh bolnikih s HBV DNA &gt; 400 kopij/ml v 48. (n = 16), 96. (n = 5), 144. (n = 1), 192. (n = 2), 240. (n = 1), 288. (n = 1) in 384. (n = 2) tednu, ko so prejemali monoterapijo z dizoproksiltenofovirijevim fumaratom, je pokazala, da se niso razvile nobene mutacije, ki bi bile povezane z rezistenco na dizoproksiltenofovirijev fumarat.
Genotypic evaluations were performed on all patients within this group with HBV DNA &gt; 400 copies/ml at week 96 (n = 17), week 144 (n = 7), and week 192 (n = 8).
Genotipsko ocenitev so opravili pri vseh bolnikih v tej skupini s koncentracijo HBV DNA &gt; 400 kopij/ml v 96. tednu (n = 17), 144. tednu (n = 7) in 192. tednu (n = 8).
Genotypic resistance analyses were conducted on samples with plasma HIV-1 RNA &gt; 1000 copies/ml.
Analize genotipske odpornosti so bile opravljene na vzorcih z HIV-1 RNA v plazmi &gt; 1000 kopij/ml.
Genotypic Susceptibility Score* &lt; 2
Ocena genotipske občutljivosti* &lt; 2
Genvoya met the non-inferiority criteria in achieving HIV-1 RNA &lt; 50 copies/mL when compared to E/C/F/TDF.
Zdravilo Genvoya je izpolnilo kriterije enakovrednosti pri doseganju HIV-1 RNA &lt; 50 kopij/ml v primerjavi z E/C/F/TDF.
Genvoya should not be initiated in patients with estimated CrCl &lt; 30 mL/min as there are limited data available regarding the use of Genvoya in this population (see sections 5.1 and 5.2).
Zdravila Genvoya se ne sme uvesti pri bolnikih z ocenjenim CrCl &lt; 30 ml/min, saj so podatki glede uporabe zdravila Genvoya pri tej populaciji omejeni (glejte poglavji 5.1 in 5.2).
Geometric mean topotecan lactone dose-normalized AUC(0-) values for Korean patients were 7.9, 12.9 and 19.7 ng*h/mL in subjects with creatinine clearance values of more than 80 mL/min, 50 to 80 mL/min and 30 to 49 mL/min, respectively (see section 4.2 and 4.4).
Pri korejskih bolnikih so bile geometrične srednje vrednosti AUC(0-) za topotekan lakton, normalizirane glede na odmerek, 7,9, 12,9 oziroma 19,7 ng*h/mL pri posameznikih z očistkom kreatinina &gt; 80 mL/min, 50– 80 mL/min oziroma 30–49 mL/min (glejte poglavji 4.2 in 4.4).
Geometric mean topotecan lactone dose-normalized AUC(0-) values were 9.4, 11.1 and 12.0 ng*h/mL in subjects with creatinine clearance values of more than 80 mL/min, 50 to 80 mL/min and 30 to 49 mL/min, respectively.
Geometrične srednje vrednosti AUC(0-) za topotekan lakton, normalizirane glede na odmerek, so bile 9,4, 11,1 oziroma 12,0 ng*h/mL pri posameznikih z očistkom kreatinina &gt; 80 mL/min, 50 – 80 mL/min oziroma 30 – 49 mL/min.
GH &lt; 2.5 μg/l
rastni hormon &lt; 2,5 μg/l
GH &lt; 2.5 μg/l and IGF-1 ≤ULN
rastni hormon &lt; 2,5 μg/l in IGF-1 ≤ZMN
GH &lt; 2.5 μg/l and normalised IGF-1*
rastni hormon &lt; 2,5 μg/l in normalizacija IGF-1
Gingival hyperplasia (≥ 1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥ 1/100 to &lt; 1/10), pancreatitis (≥ 1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do &lt; 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) in atrofija črevesne sluznice.
Gingival hyperplasia (≥ 1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥ 1/100 to &lt; 1/10), pancreatitis, (≥ 1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do &lt; 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) in atrofija črevesne sluznice.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do &lt; 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do &lt; 1/10), pancreatitis (≥ 1/100 do &lt; 1/10) in atrofija črevesne sluznice.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do &lt; 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) in atrofija črevesne sluznice.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do &lt; 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) in atrofija črevesne sluznice.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥1/100 to &lt; 1/10), pancreatitis, (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do &lt; 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) in atrofija črevesne sluznice.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegaloviruscolitis, (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingivalna hiperplazija (≥ 1/100 do &lt; 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) in atrofija črevesne sluznice.
GIOTRIF has not been studied in patients with eGFR &lt; 15 mL/min/1.73m² or on dialysis.
Zdravila GIOTRIF niso preučevali pri bolnikih z eGFR &lt; 15 ml/min/1,73m² in pri tistih, ki so na dializi.
GIOTRIF treatment in patients with eGFR &lt; 15 mL/min/1.73m² or on dialysis is not recommended.
Zdravila GIOTRIF ne priporočamo bolnikom z eGFR &lt; 15 ml/min/1,73 m² in tistim, ki so na dializi.
Given the available clinical and kinetic data, no dose adjustment is necessary (see section 5.2), but close clinical surveillance is recommended in patients with a body weight &lt; 50 kg (see section 4.4).
Glede na dosegljive klinične in kinetične podatke odmerka ni treba prilagajati (glejte poglavje 5.2), toda priporočamo natančno klinično spremljanje pri bolnikih s telesno maso &lt; 50 kg (glejte poglavje 4.4).
Given the available clinical and kinetic data, no dose adjustment is necessary (see section 5.2), but close clinical surveillance is recommended in patients with a body weight &lt; 50 kg (see section 4.4).
Glede na dosegljive klinične in kinetične podatke odmerka ni treba prilagajati (glejte poglavje 5.2), toda priporočamo natančno klinično spremljanjepri bolnikih s telesno maso &lt; 50 kg (glejte poglavje 4.4).
Glaxo Wellcome GmbH &amp; Co. KG
Glaxo Wellcome GmbH &amp; Co, KG
Glimepiride has a very low distribution volume (approximately 8.8 litres) which is roughly equal to the albumin distribution space, high protein binding ( &gt; 99%), and a low clearance (approximately 48 ml/min).
Glimepirid ima zelo nizek volumen porazdelitve (približno 8,8 litrov), kar je približno enako površini porazdelitve albumina, visoko vezavo na beljakovine (99 %) in nizek očistek (približno 48 ml/min).
Grade 2 ( &lt; 75, ≥50x109/l)
Stopnja 2 ( &lt; 75, ≥50x109/l)
Grade 2 ( &gt; 2.5 to 5.0 times upper limit of normal (ULN)) ALT elevations occurred in &lt; 8% of patients treated with this medicinal product.
Povečanje ALT 2. stopnje ( &gt; 2,5- do 5,0-kratna zgornja meja normalne vrednosti (ULN)) se je pojavilo pri &lt; 8% bolnikov, zdravljenih s tem zdravilom.
Grade 2 with creatinine &gt; 1.5 to ≤ 3 times upper limit of normal (ULN)
2. stopnja s kreatininom &gt; 1,5- do ≤ 3-krat nad zgornjo normalno mejo (ZNM)
Grade 3 &amp; 4 ( &lt; 50x109/l)
Stopnja 3 in 4 ( &lt; 50x109/l)
Grade 3 &amp; 4 n (%)
3. in 4. stopnja n (%)
Grade 3 ( &lt; 1, ≥0.5x109/l)
Stopnja 3 ( &lt; 1, ≥0,5x109/l)
Grade 3 ( &gt; 5.0 to 20.0 times ULN) elevations occurred in &lt; 4% of patients treated with GIOTRIF (see section 4.4).
3. stopnje ( &gt; 5,0- do 20,0-kratna ULN) se je pojavilo pri &lt; 4% bolnikov, zdravljenih z zdravilom GIOTRIF (glejte poglavje 4.4).
Grade 3 and 4 cases were reported in 0.8% (14/1728) and &lt; 0.1% (1/1728) of patients respectively.
O primerih stopnje 3 so poročali pri 0,8 % (14/1.728) bolnikov, o primerih stopnje 4 pa pri &lt; 0,1 % bolnikov (1/1.728).
Grade 3 or higher pneumonia occurred more frequently among elderly patients treated with IMBRUVICA (13% of patients age ≥ 65 versus 7% of patients &lt; 65 years of age).
Pri starejših bolnikih, ki so prejemali zdravilo IMBRUVICA, se je pogosteje pojavila pljučnica stopnje 3 ali več (13% bolnikov, starih ≥ 65 v primerjavi s 7% bolnikov &lt; 65 let).
Grade 4 ( &lt; 0.5x109/l)
Stopnja 4 ( &lt; 0,5x109/l)