natgillin/translations-raw huggingface dataset:
Sirolimus administered concomitantly (5 mg), and at 2 hours (5 mg) and 4 hours (10 mg) after CsA (300 mg), resulted in increased sirolimus AUC by approximately 183%, 141% and 80%, respectively.
Uporaba sirolimusa sočasno s CsA (5 mg), 2 uri (5 mg) ali 4 ure (10 mg) po dajanju CsA (300 mg), zveča AUC sirolimusa za približno 183 %, 141 % oziroma 80 %.
Sirolimus AUC0-∞ ↑ 11-fold
sirolimus AUC0-∞ ↑ 11-krat
sirolimus AUC0-∞ ↑ 712%
sirolimus AUC0-∞ ↑ 712
sirolimus Cmax ↑ 384%
sirolimus Cmax ↑ 384
Sirolimus Cmax ↑ 6.6-fold
sirolimus Cmax ↑ 6,6-krat
Sirolimus Cmax  6.6-fold Sirolimus AUC0-  11-fold
sirolimus Cmax  6,6-krat sirolimus AUC0-  11-krat
Sirolimus Cmax  6.6-fold Sirolimus AUC0-  11-fold
sirolimus Cmax  6,6-krat sirolimus AUC0- 11-krat
Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively.
Cmax, tmax in AUC sirolimusa se povečajo: Cmax za 1,4-krat, tmax za 1,3-krat in AUC za 1,6-krat.
Sirolimus concentrations were measured in concentration-controlled studies of paediatric renal-transplant patients who were also receiving ciclosporin and corticosteroids.
Koncentracije sirolimusa so bile merjene v študijah kontroliranih koncentracij pri pediatričnih bolnikih po presaditvi ledvic, ki so prejemali tudi ciklosporin in kortikosteroide.
Sirolimus concentrations, following the administration of Rapamune tablets (5 mg) to healthy subjects as single doses are dose proportional between 5 and 40 mg.
Pri zdravih prostovoljcih so koncentracije sirolimusa po enkratnem odmerku zdravila Rapamune tablete (5 mg) odvisne od odmerka v razponu od 5 do 40 mg.
Sirolimus did not affect the pharmacokinetics of either diltiazem or its metabolites desacetyldiltiazem and desmethyldiltiazem.
Sirolimus ne vpliva na farmakokinetiko diltiazema niti njegovih metabolitov, deacetildiltiazema in demetildiltiazema.
Sirolimus has been administered concurrently with the following agents in clinical studies: tacrolimus, ciclosporin, azathioprine, mycophenolate mofetil, corticosteroids and cytotoxic antibodies.
V kliničnih študijah so sirolimus uporabljali sočasno z naslednjimi zdravili: takrolimus, ciklosporin, azatioprin, mikofenolat mofetil, kortikosteroidi in citotoksična protitelesa.
Sirolimus in combination with other immunosuppressive agents has not been extensively investigated.
Kombinacije z drugimi zaviralci imunske odzivnosti niso bile natančneje raziskane.
Sirolimus is also a substrate for the multidrug efflux pump, P-glycoprotein (P-gp) located in the small intestine.
Je tudi substrat za P-glikoprotein (P-gp), iztočno črpalko za več zdravil, ki se nahaja v tankem črevesu.
Sirolimus is extensively metabolised by O-demethylation and/or hydroxylation.
V veliki meri se presnavlja z O-demetilacijo in/ali hidroksilacijo.
Sirolimus is extensively metabolised by the CYP3A4 isozyme in the intestinal wall and liver.
Sirolimus se v veliki meri presnavlja s pomočjo izoencima CYP3A4 v črevesni steni in v jetrih.
Sirolimus is the major component in human whole blood and contributes to greater than 90% of the immunosuppressive activity.
Med njimi v polni krvi pri človeku prevladuje sirolimus, ki prispeva več kot 90 % k zaviranju imunske odzivnosti.
Sirolimus levels should be monitored and appropriate dose reductions of both medicinal products should be considered.
Nivo sirolimusa je treba spremljati in po potrebi ustrezno zmanjšati odmerka obeh zdravil.
Sirolimus levels should be monitored, and appropriate dose reductions of both medicinal products should be considered.
Nivo sirolimusa je treba spremljati in po potrebi ustrezno zmanjšati odmerka obeh zdravil.
Sirolimus tablets contain 214.4 mg of sucrose and 86.4 mg of lactose.
Tablete sirolimusa vsebujejo 214,4 mg saharoze in 86,4 mg laktoze.
Sirolimus tablets contain 215.7 mg of sucrose and 86.4 mg of lactose.
Tablete sirolimusa vsebujejo 215,7 mg saharoze in 86,4 mg laktoze.
Sirolimus tablets contain 215.8 mg of sucrose and 86.4 mg of lactose.
Tablete sirolimusa vsebujejo 215,8 mg saharoze in 86,4 mg laktoze.
Sirolimus trough concentration data in 35 renal transplant patients above 65 years of age were similar to those in the adult population (n=822) from 18 to 65 years of age.
Najnižje krvne koncentracije sirolimusa v stanju dinamičnega ravnovesja pri 35 bolnikih s presajeno ledvico, starejših od 65 let, so bile podobne kot pri skupini 822 odraslih bolnikov, starih od 18 do 65 let.
Sirolimus trough concentrations should be monitored at least 3 to 4 days after a loading dose(s).
Najnižje koncentracije sirolimusa je treba spremljati vsaj 3 do 4 dni po enem ali več polnitvenih odmerkih.
Sirolimus was not mutagenic in the in vitro bacterial reverse mutation assays, the Chinese Hamster Ovary cell chromosomal aberration assay, the mouse lymphoma cell forward mutation assay, or the in vivo mouse micronucleus assay.
Sirolimus se ni izkazal za mutagenega pri in vitro bakterijskem testu reverznih mutacij, testu kromosomskih aberacij v ovarijskih celicah kitajskega hrčka, testu mutacije celic mišjega limfoma, niti v in vivo mikronukleusnem testu pri miših.
sirolimus, with close
Natančno je treba spremljati
SIRS, capillary leak syndrome (signs and symptoms of cytokine release, e.g., tachypnea, tachycardia, hypotension, pulmonary oedema) were reported as an adverse event in 5% (6/115) of paediatric patients (5 ALL, 1 AML) (see section 4.4).
O sindromu SIRS, sindromu kapilarnih razpok (znaki in simptomi izločanja citokinov, npr. tahipneja, tahikardija, hipotenzija, pljučni edem) kot o neželenem učinku so poročali pri 5 % (6/115) pediatričnih bolnikov (5 ALL, 1 AML) (glejte poglavje 4.4).
SIRTURO 100 mg tablets
SIRTURO 100 mg tablete bedakilin
SIRTURO contains lactose monohydrate
Zdravilo SIRTURO vsebuje laktozo monohidrat
SIRTURO contains “lactose” (a type of sugar).
Zdravilo SIRTURO vsebuje "laktozo" (vrsto sladkorja).
Sirturo has been given ‘conditional approval’.
Zdravilo Sirturo je pridobilo „pogojno dovoljenje za promet“.
SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Zdravilo SIRTURO je indicirano za uporabo kot del ustrezne kombinirane sheme zdravljenja pljučne tuberkuloze, odporne proti več zdravilom (MDR-TB - multidrug-resistant tuberculosis), pri odraslih bolnikih, kadar se učinkovite sheme zdravljenja zaradi odpornosti ali prenosljivosti ne da drugače sestaviti.
SIRTURO must always be taken together with other medicines for treating tuberculosis.
Zdravilo SIRTURO morate vedno jemati skupaj z drugimi zdravili za zdravljenje tuberkuloze.
SIRTURO should be used in combination with at least three medicinal products to which the patient’s isolate has been shown to be susceptible in vitro.
Zdravilo SIRTURO je treba uporabljati v kombinaciji z najmanj tremi zdravili na katere je bolnikov izolat in vitro dokazano občutljiv.
SIRTURO with alcohol
Zdravilo SIRTURO skupaj z alkoholom
Sit or lie in a comfortable position so you are relaxed.
Udobno sedite ali lezite tako, da boste v sproščenem položaju in da boste zlahka videli tisti del trebuha, v katerega boste injicirali zdravilo.
Sitagliptin 100 mg
itagliptin 100 mg
Sitagliptin 100 mg + metformin and sulfonylurea (N = 378)
itagliptin 100 mg + metformin in sulfonilsečnina (n = 378)
Sitagliptin 100 mg + metformin and sulphonylurea (N = 378)
itagliptin 100 mg + metformin in sulfonilsečnina (n = 378)
Sitagliptin 100 mg once daily (n=315)
Insulin glargin+ enkrat na dan (n=262)
Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
(dvakrat na dan) : sitagliptin 50 mg + metformin 500 mg
Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z glimepiridom in metforminom (n = 115)
Sitagliptin 100 mg once daily added to ongoing insulin + metformin therapy  (N=223)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z insulinom in metforminom (n = 223)
Sitagliptin 100 mg once daily added to ongoing metformin therapy (N=453)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z metforminom (n = 453)
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy# (N=152)
(dvakrat na dan) : sitagliptin 50 mg + metformin 1.000 mg
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy¶ (N=152)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju s pioglitazonom in metforminom¶ (n = 152)
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy¶ (N=152)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju s pioglitazonom in metforminom¶ (n= 152)
Sitagliptin 100 mg once daily added to ongoing pioglitazone therapy (N=163)
obstoječemu zdravljenju s pioglitazonom in metforminom#
Sitagliptin 100 mg once daily§ (N= 193)
Sitagliptin 100 mg enkrat na dan§ (N = 193)
Sitagliptin 100 mg once daily (N= 229)
Sitagliptin 100 mg enkrat na dan (N = 229)
Sitagliptin 50 mg + metformin 1,000 mg
(dvakrat na dan) : sitagliptin 50 mg + metformin 1.000 mg
Sitagliptin 50 mg + metformin 1,000 mg (N=178)
(dvakrat na dan) : sitagliptin 50 mg + metformin 1.000 mg
Sitagliptin 50 mg + metformin 500 mg
(dvakrat na dan) : sitagliptin 50 mg + metformin 500 mg
Sitagliptin 50 mg + metformin 500 mg (N=183)
(dvakrat na dan) : sitagliptin 50 mg + metformin 500 mg
Sitagliptin is renally excreted.
Sitagliptin se izloča preko ledvic.
Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
Sitagliptinijev fosfat je peroralno aktiven, močan in zelo selektiven zaviralec encima dipeptidil- peptidaze 4 (DPP-4) in se uporablja za zdravljenje sladkorne bolezni tipa 2.
Sitagliptin was modestly removed by haemodialysis (13.5 % over a 3- to 4-hour haemodialysis session starting hours post-dose).
Sitagliptin se je zmerno odstranil s hemodializo (13,5 % pri 3- do 4-urni hemodializi, ki se začne 4 ure po odmerku).
site conditions
aplikacije
SITE CONDITIONS
MESTU APLIKACIJE
site erythema, injection site pain, fatigue, rigors, pyrexia, influenza-like illness, asthenia, malaise, irritability
vnetje na mestu injiciranja, reakcija na mestu injiciranja, eritem na mestu injiciranja, bolečina na mestu injiciranja, utrujenost, mrzlica, pireksija, gripi podobna bolezen, astenija, bolehnost, razdražljivost
site haematoma
puerperija in
Site of administration
Mesto injiciranja
Site of the pump implantation
Mesto vsaditve črpalke
Site unknown2
Neznano mesto2
Site-directed mutagenesis of the Y93H substitution in both genotype 1a and 1b as well as the Q30R and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Usmerjena mutageneza substitucije Y93H v obeh genotipih 1a in 1b ter substitucija Q30R in L31M v genotipu 1a je doprinesla visoke ravni zmanjšane dovzetnosti za ledipasvir (večkratna sprememba EC50 je bila v razponu od 544-krat do 1,677-krat).
Site-directed NNRTI mutant virus
Na NNRTI odporen virus z mutacijo na enem mestu
Sites in East Asia administered a reduced dose of docetaxel at 60 mg/m2 every 21 days.
V centrih v Vzhodni Aziji so dajali manjši odmerek docetaksela 60 mg/m2 vsakih 21 dni.
Sites responsible for Batch Release in the EEA:-
Odgovoren za sproščanje serije v EGP:
Sivextro 200 mg powder for concentrate tedizolid phosphate
Sivextro 200 mg prašek za koncentrat tedizolid fosfat
Sivextro contains sodium
Zdravilo Sivextro vsebuje natrij
Sivextro is a white to off-white powder for concentrate for solution for infusion in a glass vial.
Zdravilo Sivextro je bel do skoraj bel prašek za koncentrat za raztopino za infundiranje v stekleni viali.
Sivextro is an antibiotic that contains the active substance tedizolid phosphate.
Zdravilo Sivextro je antibiotik, ki vsebuje zdravilno učinkovino tedizolid fosfat.
Sivextro is an oval, yellow film-coated tablet imprinted with ‘TZD’ on one side and ‘200’ on the other side.
Zdravilo Sivextro je v obliki ovalnih, rumenih filmsko obloženih tablet z vtisnjenima oznakama "TZD" na eni in "200" na drugi strani.
Sivextro may have a minor influence on the ability to drive and use machines as it may cause dizziness, fatigue or, uncommonly, somnolence (see section 4.8).
Zdravilo Sivextro ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji, saj lahko povzroči omotico, utrujenost ali, občasno, zaspanost (glejte poglavje 4.8).
Sivextro’s safety profile is comparable to that of linezolid and was considered acceptable.
Varnostni profil zdravila Sivextro je podoben varnostnemu profilu linezolida in je bil ocenjen za sprejemljivega.
Six hours after treatment, the concentration of tylvalosin in the gastrointestinal tract mucosa has a mean concentration of 133 ng/g and in the gastrointestinal contents of 1,040 ng/g.
Šest ur po zdravljenju je povprečna koncentracija tilvalozina v sluznici prebavil 133 ng/g, v vsebini prebavil pa 1040 ng/g.
Six hundred and seven (607) subjects had radiographic progression or died: 271 (50%) in the abiraterone acetate group and 336 (62%) in the placebo group.
Šeststosedem (607) preiskovancev je imelo radiografsko potrjeno napredovanje bolezni ali umrlo: od tega jih je bilo 271 (50%) v skupini, ki je prejemala abirateronacetat in 336 (62%) v skupini, ki je prejemala placebo.
Six months after the first dose, the seroprotection rate was as follows:
Dvanajst mesecev po prvem odmerku je bil delež serološke zaščite naslednji:
Six months seizure freedom
Šest mesecev brez epileptičnega napada
Six of 143 (4%) adult patients with CLD receiving eltrombopag experienced TEEs (all of the portal venous system) and two of 145 (1%) subjects in the placebo group experienced TEEs (one in the portal venous system and one myocardial infarction).
Trombembolični dogodki so se pojavili pri šestih od 143 (4 %) odraslih bolnikov s kronično boleznijo jeter, ki so prejemali eltrombopag (vsi dogodki so bili v portalnem venskem sistemu), in pri dveh od 145 (1 %) preiskovancev v skupini s placebom (en dogodek v portalnem venskem sistemu in en miokardni infarkt).
Six of 20 (30%) women on REYATAZ/ritonavir 300/100 mg and 13 of 21 (62%) women on REYATAZ/ritonavir 400/100 mg experienced grades 3 to 4 hyperbilirubinaemia.
Pri 6 od 20 bolnic (30%), ki so prejemale zdravilo REYATAZ/ritonavir v odmerku 300/100 mg, in 13 od 21 bolnic (62%), ki so prejemale zdravilo REYATAZ/ritonavir v odmerku 400/100 mg, so poročali o pojavu hiperbilirubinemije stopnje 3 do 4.
Six of the 11 patients with available data continued to make motor development gains beyond Week 52 (with individual patient treatment durations ranging from 58 to 168 weeks; mean follow-up period of
Šest izmed 11 bolnikov, za katere so na voljo podatki, je motorično napredovalo tudi po 52. tednu (s trajanjem zdravljenja pri posameznih bolnikih v razponu med 58 in 168 tednov; povprečno obdobje sledenja 121 tednov); vključno s
Six of these 11 (55 %) patients had mean indinavir plasma concentrations 8 hours post- dose (Cmin) below assay threshold of reliable quantification.
Šest preiskovank med temi 11 (55 %) je imelo povprečno plazemsko koncentracijo indinavirja 8 ur po odmerku (cmin) nižjo od praga zanesljive kvantitativne določitve pri testu.
Six open-label studies evaluated Oncaspar in relapse/refractory haematological diseases.
Šest odprtih študij je vrednotilo zdravilo Oncaspar pri recidivnih/neodzivnih hematoloških boleznih.
Six patients (1 in the 12-week, 5 in the 24-week treatment group) with HCV RNA < LLOQ at last measurement prior to transplant, were transplanted prior to SVR12 and were excluded from SVR12 and relapse analyses.
Pri šestih bolnikih (1 v 12-tedenski, 5 v 24-tedenski skupini zdravljenja) z vrednostjo RNA HCV < LLOQ ob zadnjem merjenju pred presaditvijo so opravili presaditev pred SVR12 in so jih izključili iz analiz SVR12 ter relapsa.
Six treatment cycles, each of 28 day duration, followed by maintenance once every two months for two years or until disease progression (whichever occurs first).
Šest 28-dnevnih ciklusov zdravljenja, ki jim sledi vzdrževalna uporaba enkrat na dva meseca v obdobju dveh let ali do napredovanja bolezni (kar se zgodi prej).
Six treatment cycles, each of 28 day duration, followed by maintenance once every two months for two years or until disease progression (whichever occurs first).
Šest 28-dnevnih ciklusov zdravljenja, ki jim sledi vzdrževalno zdravljenje enkrat na dva meseca v obdobju dveh let ali do napredovanja bolezni (kar se zgodi prej).
Six treatment cycles, each of 28 day duration.
Šest ciklusov zdravljenja, od katerih vsak traja 28 dni.
Six weeks after the eighth injection (fourth treatment cycle) of Xiapex
Šest tednov po osmi injekciji (četrti cikel zdravljenja) zdravila Xiapex je
Six years after vaccination, 84%, 87%, 97% and 48% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 89%, 86%, 100% and 82% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Šest let po cepljenju je bilo 84 %, 87 %, 97 % oziroma 48 % oseb seropozitivnih po metodi cLIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18, ter 89 %, 86 %, 100 % oziroma 82 % oseb seropozitivnih po metodi IgG LIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18.
Six-hundred and sixty two patients eligible for the 38-week Double-blind, Active-controlled Phase were randomly assigned in a 2:2:1 ratio to double-blind treatment to one of 3 treatment groups: 1) Abilify Maintena 2) the stabilisation dose of oral aripiprazole 10-30 mg, or 3) aripiprazole Long- Acting Injectable 50 mg/25 mg.
662 bolnikov, ki so bili primerni za vključitev v 38-tedensko dvojno slepo aktivno nadzorovano fazo, so bili v razmerju 2 : 2 : 1 randozimirano porazdeljeni v eno od treh spodaj navedenih preiskovanih skupin, v kateri so prejemali dvojno slepo zdravljenje: 1) zdravilo Abilify Maintena; 2) stabilizacijski odmerek peroralnega aripiprazola v 10–30 mg; ali 3) dolgodelujoči parantertalni aripiprazol 50 mg/25 mg.
Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2 % (95 % CI:-7.8 8.2).
73,0 % bolnikov, ki so se zdravili z levetiracetamom, in 72,8 % bolnikov, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem (CR) je bilo šest mesecev brez napadov; prilagojena absolutna razlika med zdravljenjema je bila 0,2 % (95-% CI: 7,8-8,2).
Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95% CI: -7.8 8.2).
73,0 % bolnikov, ki so se zdravili z levetiracetamom, in 72,8 % bolnikov, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem (CR) je bilo šest mesecev brez napadov; prilagojena absolutna razlika med zdravljenjema je bila 0,2 % (95 % CI: 7,8–8,2).
Sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of the A/Vietnam/1203/2004 vaccine or were sham vaccinated.
Šestnajst dihurjev je bilo razdeljenih v dve skupini, cepljeni pa so bili na 0. in 21. dan z odmerkom 7,5 µg cepiva A/Vietnam/1203/2004 ali z lažnim cepivom.
Sixteen males (55%) and 13 females (45%) were included with a mean age of 30.7 years, ranging from 18 to 55 years.
Vključenih je bilo 16 moških (55 %) in 13 žensk (45 %) s povprečno starostjo 30,7 leta, tj. od 18 do 55 let.
Sixteen of 30 subjects (53%) harboured Q148 virus at baseline.
Šestnajst od 30 preiskovancev (53 %) je imelo izhodiščno virus Q148.
Sixteen of 434 ART-naïve patients who received fosamprenavir 700mg/ritonavir 100mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
48. tednu virusni neodziv pojavil pri 16 od 434 bolnikov, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, pri čemer so določili genotip 14 izolatov.
Sixty-eight percent (21/31) of antibody- positive patients had neutralising antibodies in vitro.
Oseminšestdeset odstotkov (21/31) bolnikov s pozitivnim izvidom na protitelesa je imelo nevtralizirajoča protitelesa in vitro.
Sixty-eight percent (68%) of patients had an ECOG performance status score of 0 and 32% patients had ECOG performance status 1.
Oseminšestdeset odstotkov (68 %) bolnikov je imelo oceno stanja zmogljivosti po ECOG 0 in 32 % bolnikov je imelo oceno stanja zmogljivosti po ECOG 1.
Sixty-five patients entered a follow-up SBS study for up to an additional 28 weeks of treatment.
Petinšestdeset bolnikov se je vključilo v spremljevalno študijo SKČ, ki je obsegala do 28 dodatnih tednov zdravljenja.
Sixty-five percent of patients studied in a SCN trial program with filgrastim administration, were under 18 years of age.
V kliničnih preskušanjih je bilo 65% bolnikov, ki so se zdravili zaradi hude kronične nevtropenije, mlajših od 18 let.
Sixty-five percent of patients studied in a SCN trial program, were under 18 years of age.
V kliničnih preskušanjih je bilo 65 % bolnikov, ki so se zdravili zaradi hude kronične nevtropenije, mlajših od 18 let.
Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
65% bolnikov, ki so sodelovali v raziskovalnem programu za bolnike s hudo kronično nevtropenijo, je bilo mlajših od 18 let.
Sixty-four percent of patients were men and 98% were white.
98 % bolnikov belcev.
Sixty-one patients completed the study (35 patients received the recommended 400/100 mg twice-daily dose throughout the study).
Študijo je dokončalo 61 bolnikov (35 bolnikov je ves čas študije dobivalo priporočeni odmerek 400/100 mg dvakrat na dan).
Sixty-one patients were treated at the starting dose of 300 mg/m2/day.
Enainšestdeset bolnikov so zdravili z začetnim odmerkom 300 mg/m2/dan.
Sixty-one patients with cardiac iron overload, previously treated with deferoxamine, were randomized to continue deferoxamine (average dose 43 mg/kg/day; N=31) or to switch to Ferriprox (average dose 92 mg/kg/day N=29).
Naključno so izbrali 61 pacientov s presežno količino kardialnega železa, ki so se prej zdravili z deferoksaminom, da so nadaljevali z deferoksaminom (povprečen odmerek 43 mg/kg/dan; N=31) ali pa prešli na Ferriprox (povprečen odmerek 92 mg/kg/dan; N = 29).
Sixty-six percent of placebo patients received post-study therapy compared to 30 % of pazopanib patients.
Po študiji je zdravljenje prejemalo 66 % bolnikov, ki so dobivali placebo, in 30 % tistih, ki so dobivali pazopanib.
Sixty-three patients received a starting dose of 50 mg sunitinib orally, once daily for 4 consecutive weeks followed by a 2-week rest period, to comprise a complete cycle of 6 weeks (schedule 4/2).
Triinšestdeset bolnikov je prejemalo začetni odmerek 50 mg sunitiniba peroralno enkrat na dan 4 tedne zapored, čemur je sledil 2-tedenski premor, tako da je celotni ciklus trajal 6 tednov (shema 4/2).
Sixty-three percent of Q4- and 81% of Q2- treated patients met the composite endpoint at Month 24; the difference was not statistically significant based on the 95% CI (-0.357, 0.058).
Triinšestdeset odstotkov Q4- in 81 % od Q2-zdravljenih bolnikov je doseglo sestavljeno končno točko v 24. mesecu; razlika na osnovi 95 % IZ (-0.357, 0.958) ni bila statistično značilna.
size
pakiranja
Size 2 hard capsule (6.4x18.0 mm) with an opaque blue cap and opaque white body with “A1001” printed in black containing white to pale brown powder.
Trda kapsula velikosti 2 (6,4 x 18,0 mm) z n prozornim modrim pokrovčkom in neprozornim belim telesom s črno oznako „A1001“, ki vsebuje bel do bledo rjav prašek.
Size “00” hard capsules with caramel body and cap.
Trup in pokrovček karamelne barve, trde kapsule velikosti „00”.
Size “3” hard capsules with orange body and cap.
Oranžen trup in pokrovček, trde kapsule velikosti ”3”.
Size: % mean TBSA
Velikost: % povprečje CPT
sJIA Patients
Bolniki s sJIA
sJIA Patients < 30 kg
Bolniki s sJIA < 30 kg
sJIA Patients:
Bolniki s sJIA:
SJS and TEN have been reported.
Poročali so o SJS in TEN.