natgillin/translations-raw huggingface dataset:
Study VII (WA19926), a 2 year study with the planned primary analysis at week 52 evaluated 1162 MTX-naïve adult patients with moderate to severe, active early RA (mean disease duration ≤ 6 months).
Študija VII (WA19926) je bila dveletna študija z načrtovano primarno analizo v 52. tednu; ocenila je 1162 odraslih bolnikov z zmernim do hudim, aktivnim, zgodnjim revmatoidnim artritisom (povprečno trajanje bolezni ≤ 6 mesecev), ki se še niso zdravili z metotreksatom.
Study Week
teden študije
Study with various dosing regimen
Študija z različnimi režimi odmerjanja
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule
Študija WO16229: uvajalni odmerek 8 mg/kg, sledil je odmerek 6 mg/kg po 3-tedenskem režimu.
study, NCT number NCT01532089) (due date: Q4 2018)
4. četrtletje 2018
Stuffy nose
poln nos
Stuffy nose
zamašen nos
Stuffy nose
zamašen nos,
Sub-populations
Podskupine
Subacute cutaneous lupus erythematosu s (see section 4.4).
subakutni kožni eritematozni lupus (glejte poglavje 4.4).
Subarachnoid haemorrhage
ubarahnoidna krvavitev
SUBCUTANEOUS
PODKOŽJA
Subcutaneous
subkutana
Subcutaneous
ubkutana
Subcutaneous
ubkutana ali
subcutaneous
ubkutano
Subcutaneous
uporaba
Subcutaneous
Za subkutano
Subcutaneous
Za subkutano uporabo
Subcutaneous (SC) use
subkutana (s.c.) uporaba
Subcutaneous (SC) use.
subkutana (s.c.) uporaba
Subcutaneous absorption at the 90 mg dose is comparable when injected into abdomen, thigh or arm.
Absorpcija odmerka 90 mg po subkutanem dajanju je primerljiva pri injiciranju v abdomen, stegno ali nadlaket.
Subcutaneous administration could lead to a suboptimal response to the vaccine (see section 4.4).
Subkutano dajanje lahko povzroči manj kot optimalen odziv na cepivo (glejte poglavje 4.4).
Subcutaneous administration of 100 micrograms of parathyroid hormone into the abdomen produces a rapid increase in plasma parathyroid hormone levels and achieves a peak at 1 to 2 hours after dosing.
Podkožno dajanje 100 g obščitničnega hormona v trebuh povzroči hitro zvišanje plazemskih ravni obščitničnega hormona tako, da dosežejo najvišjo koncentracijo 1 do 2 uri po odmerjanju.
Subcutaneous administration of Draxxin to cattle causes very commonly transient pain reactions and local swellings at the injection site that can persist for up to 30 days.
Pri govedu podkožno dajanje Draxxina pogosto povzroči trenutno bolečino in lokalno oteklino na mestu vbrizgavaja, ki lahko vztraja tudi do 30 dni.
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen.
Zdravilo subkutano injiciramo v nadlakti, stegna, zadnjico ali trebuh (glejte poglavje 6.6).
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen.
Zdravilo subkutano injiciramo v nadlakti, stegna, zadnjico ali trebuh.
Subcutaneous administration.
Subkutana uporaba
Subcutaneous and
ubkutana in
Subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Podkožno in intramuskularno dajanje živali dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije in sicer pri manj kot 10 % goved.
Subcutaneous anticoagulant (i.e.: LMWH, fondaparinux): Discontinue subcutaneous anticoagulant and start Lixiana at the time of the next scheduled subcutaneous anticoagulant dose.
Subkutani antikoagulant (n.pr.: heparin z majhno molekulsko maso (LMWH), fondaparinuks): ukinite subkutani antikoagulant in začnite dajati zdravilo Lixiana ob času naslednjega načrtovanega odmerka subkutanega antikoagulanta.
Subcutaneous haematoma
Ne (N=13090)
Subcutaneous haematoma
podkožni hematom
Subcutaneous haematoma (bleeding under the skin causing a swelling)
Podkožni hematom (podkožna krvavitev, ki povzroča oteklino)
Subcutaneous hormonal implant
Podkožni hormonski vsadek
Subcutaneous infusion for home treatment should be commenced and initially monitored by a healthcare professional experienced in the guidance of patients for home treatment.
Subkutano infundiranje za zdravljenje na domu naj uvede in na začetku zdravstveni delavec z izkušnjami pri usposabljanju bolnikov za zdravljenje na domu.
Subcutaneous injection
Subkutana injekcija
Subcutaneous injection
ubkutana uporaba
Subcutaneous injection in the neck or intramuscular injection in the breast of one dose of 0.25 ml.
En odmerek po 0,25 ml subkutano na vratu ali intramuskularno v prsni predel
Subcutaneous injection in the neck or intramuscular injection in the breast of the chicken.
Subkutano na vratu ali intramuskularno v prsni predel.
Subcutaneous injection technique
Način subkutanega injiciranja
Subcutaneous injections
Podkožne injekcije
Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats.
Subkutane injekcije zdravila Relistor v odmerku 150 mg/kg/dan so pri podganah zmanjšale plodnost.
Subcutaneous injections:
Podkožne injekcije
Subcutaneous or
Subkutana ali
Subcutaneous or
Subkutana ali intravenska
Subcutaneous or
Subkutana ali intravenska uporaba
Subcutaneous or
Subkutano ali
Subcutaneous or
ubkutana ali
Subcutaneous or
ubkutana uporaba
Subcutaneous or
uporaba
Subcutaneous or
Za subkutano ali
Subcutaneous or dermal bleedingf, Bruising g
podkožne ali kožne krvavitvef, podpludbe g
Subcutaneous or dermal bleedingh, Rash, Pruritus
podkožne ali kožne krvavitveh, izpuščaj, srbenje
Subcutaneous or in ovo route.
Cepivo se injicira ali subkutano ali in ovo.
Subcutaneous or intramuscular use
ubkutana ali intramuskularna uporaba
Subcutaneous or intravenous injection
podkožno ali intravensko
Subcutaneous or intravenous injection, Intramuscular use
podkožno ali intravensko; intramuskularna uporaba
Subcutaneous or intravenous use
intravensko uporabo
Subcutaneous or intravenous use
Subkutana ali
Subcutaneous or intravenous use
Subkutana intravensk
Subcutaneous or intravenous use
Subkutano ali intravenozno
Subcutaneous or intravenous use
ubkutana ali intravenska uporaba
Subcutaneous or intravenous use
ubkutana uporaba
Subcutaneous or intravenous use
ubkutano ali intravensko
Subcutaneous or intravenous use
ubkutano ali intravenskoo
Subcutaneous or intravenous use
Za intravensko in subkutano uporabo
Subcutaneous or intravenous use
za subkutano ali intravensko uporabo
Subcutaneous or intravenous use
Za subkutano in intravensko uporabo
Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use Subcutaneous or intravenous use
Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba Subkutana ali intravenska uporaba
Subcutaneous or intravenous use, Intramuscular use
ubkutana ali intravenska uporaba; intramuskularna uporaba
Subcutaneous or intravenous use.
Subkutana ali intravenska uporaba
Subcutaneous peginterferon beta-1a resulted in approximately 4-, 9-, and 13-fold higher exposure (AUC168h) values and approximately 2-, 3.5- and 5-fold higher Cmax, following single doses of 63 (6 MIU),
Subkutano dajanje peginterferona beta-1a je povzročilo za približno 4-, 9- in 13-krat večje vrednosti izpostavljenosti (AUC168h) in za približno 2-, 3,5- in 5-krat večjo vrednost Cmax po uporabi enkratnega odmerka 63 (6 milijonov i.e.), 125 (12 milijonov i.e.) oz.
Subcutaneous reconstitution:
Subkutana rekonstitucija:
Subcutaneous regimens of 140 mg every 2 weeks and 420 mg once monthly were equivalent in average LDL-C lowering (mean of weeks 10 and 12) resulting in -72 to -57% from baseline compared with placebo.
Shemi podkožne uporabe 140 mg vsaka 2 tedna in 420 mg enkrat na mesec sta bili enakovredni, kar zadeva povprečno znižanje LDL-H (povprečje 10. in 12. tedna), in sta dosegli znižanje od -72 do - 57 % v primerjavi s placebom.
Subcutaneous route
Subkutano
Subcutaneous route
Subkutano dajanje.
SUBCUTANEOUS TISSUE
KOŽE IN
subcutaneous tissue disorders
Bolezni kože in podkožja
Subcutaneous use
i.e./0,4
Subcutaneous use
i.e./0,6
Subcutaneous use
i.e./0,8
Subcutaneous use
i.e./1,0
Subcutaneous use
injiciranje
Subcutaneous use
intravensko uporabo Za subkutano uporabo
Subcutaneous use
metilnaltreksonijev bromid subkutana uporaba
Subcutaneous use
obščitnični hormon subkutana uporaba
Subcutaneous use
peresniki
Subcutaneous use
Pot uporabe
Subcutaneous use
Subkutalna uporaba
Subcutaneous use
Subkutan a uporaba
Subcutaneous use
Subkutan o dajanje
Subcutaneous use
Subkutana
Subcutaneous use
Subkutana ali
Subcutaneous use
Subkutana aplikacija
Subcutaneous use
Subkutana injekcija
Subcutaneous use
Subkutana intravensk
Subcutaneous use
Subkutana uporaba e
Subcutaneous use
Subkutana uporaba.
Subcutaneous use
Subkutano dajanje.
Subcutaneous use
ubkutana
Subcutaneous use
ubkutana uporaba
subcutaneous use
ubkutana uporaba subkutana uporaba
Subcutaneous use
uporaba
Subcutaneous use
uporaba Subkutana uporaba
Subcutaneous use
uporabo
Subcutaneous use
za subkutano
Subcutaneous use
Za subkutano ali
Subcutaneous use
Za subkutano uporabo Za subkutano ali
Subcutaneous use
Za subkutano uporabo.
Subcutaneous use (cattle), intramuscular use (pigs)
Subkutano (govedo) Intramuskularno (prašiči)
Subcutaneous use (cattle), intramuscular use (pigs, sheep)
Subkutana uporaba (govedo), intramuskularna uporaba (prašiči, ovce)
Subcutaneous use (cattle), intramuscular use (pigs, sheep)
Subkutana uporaba, intramuskularna uporaba (prašiči, ovce)
Subcutaneous use and intravenous use.
Za intravensko in subkutano uporabo.
Subcutaneous use Clinical efficacy
Subkutana uporaba Klinična učinkovitost
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins.In case of intravenous administration, the solution should be injected over approx.
Pri bolnikih, ki niso na dializi, dajemo prednost subkutanemu dajanju, saj se tako izognemo punkciji perifernih ven.
Subcutaneous use Once weekly
Subkutana uporaba Enkrat na teden
Subcutaneous use or intravenous use
intravensko uporabo
Subcutaneous use(cattle), intramuscular use (pigs)
Subkutano (govedo) Intramuskularno (prašiči)
Subcutaneous use, in-ovo use
Subkutana uporaba, in-ovo uporaba
Subcutaneous use, intramuscular use
Intramuskularna uporaba Subkutana uporaba
Subcutaneous use, intramuscular use
intramuskularno
Subcutaneous use, intramuscular use
Subkutano, intramuskularno
Subcutaneous use, intramuscular use or intravenous use
Podkožna, intravenska in intramuskularna
Subcutaneous use.
Subkutano
Subcutaneous use.
Subkutano dajanje
Subcutaneous use.
Subkutano.
Subcutaneous use.
Za subkutano dajanje.
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Podkožno, intramuskularno in intravensko dajanje živali dobro prenašajo; v kliničnih raziskavah so pri manj kot 10 % goveda zasledili samo blago in prehodno oteklino na mestu podkožne injekcije.
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Podkožno, intramuskularno in intravensko dajanje živali dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10 % goveda.
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Subkutano, intramuskularno in intravensko dajanje živali dobro prenašajo; opazili so le rahlo, prehodno oteklino na mestu injiciranja po subkutanem dajanju pri manj kot 10 % goveda, zdravljenega v okviru kliničnih študij.
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Subkutano, intramuskularno in intravensko uporabo živali dobro prenašajo; opazili so le rahlo, prehodno oteklino na mestu injiciranja po subkutanem dajanju pri manj kot 10 % goveda, zdravljenega v okviru kliničnih študij.
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Živali podkožno, intramuskularno in intravensko injiciranje dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije in sicer pri manj kot 10 % goved.
Subcutaneous, intramuscular or intravenous use
Podkožno, intramuskularno ali intravensko dajanje
Subcutaneous, intramuscular, intravenous use
ubkutana, intramuskularna, intravenska uporaba
SUBCUTANEOUSLY (See section 4.4)
SUBKUTANO. (glejte poglavje 4.4)
Subcutaneoususe
ubkutana in
Subdural haematoma#
omotičnost
Subdural haematoma#
ubduralni hematom#
Subdural haemorrhage
ubduralna krvavitev
Subgroup analyses
Analiza podatkov po podskupinah
Subgroup analyses suggested that the route and type of concomitant estrogen (transdermal oestradiol, oral conjugated equine estrogen (CEE), oral non-CEE) can influence patient response.
Analiza podskupin je nakazala, da lahko na odziv bolnic vpliva način uporabe in vrsta estrogena (transdermalni estradiol, peroralni konjugirani konjski estrogen (CEE), drugi peroralni estrogeni kot CEE).
Subgroup analyses testing for heterogeneity of once vs twice daily demonstrated no significant effect of sex, age, or viral load at randomisation.
Analize podskupin za testiranje heterogenosti med enkrat in dvakrat na dan niso pokazale značilnih vplivov spola, starost ali virusne obremenitve ob randomizaciji.
Subgroup analysis also showed that 29% of obese women (BMI ≥ 30) and 43% of normal weight women (BMI < 30) showed a marked or better improvement.
V analizi podskupin se je pokazala tudi razlika med prekomerno prehranjenimi ženskami (BMI  30), kjer je prišlo do izboljšanja pri 29 % in tistimi z normalno telesno maso (BMI < 30), kjer je prišlo do izboljšanja pri 43 % žensk.
Subgroup analysis results by historical KRAS mutational status showed a treatment effect for OS in favour of regorafenib over placebo for patients with KRAS wild-type tumours whereas a numerically lower effect was reported in patients with KRAS mutant tumours; the treatment effect for PFS favouring regorafenib was observed regardless of KRAS mutational status.
Izsledki analize podskupin z mutacijo gena KRAS v anamnezi so pokazali terapevtski učinek za celokupno preživetje v korist regorafeniba v primerjavi s placebom za bolnike s tumorji z divjim tipom gena KRAS, medtem ko so poročali o numerično manjšem učinku pri bolnikih s tumorji z mutacijo gena KRAS; terapevtski učinek za preživetje brez napredovanja bolezni je bil v korist regorafeniba ne glede na status mutacije gena KRAS.
Subgroup survival analyses showed a consistent survival benefit for treatment with ZYTIGA (see Figure 5).
Rezultati analize preživetja po podskupinah dosledno kažejo boljše preživetje pri zdravljenju z zdravilom ZYTIGA (glejte Sliko 5).
Subgroup survival analysis showed a consistent survival benefit for treatment with Xofigo, independent of total alkaline phosphatase (ALP), use of bisphosphonates at baseline and prior use of docetaxel.
Analiza preživetja po podskupinah je pokazala dosledno korist zdravljenja z zdravilom Xofigo za preživetje, ne glede na celokupno vrednost alkalne fosfataze, sočasno uporabo difosfonatov na začetku zdravljenja in predhodno uporabo docetaksela.
Subgroups of patients with higher disease activity were defined by relapse and MRI criteria as reported below, with the following efficacy results:
Podskupine bolnikov z večjo aktivnostjo bolezni so bile opredeljene po kriterijih recidiva in MRS kot sledi in z naslednjimi rezultati glede na učinkovitost:
Subje ct incide nce
Pogostnost
Subject
Preiskovanec
Subject did not progress or die [n (%)]
Pri preskušancu bolezen ni napredovala ali ni umrl [n (%)]
Subject evaluations of injection site pain based on a visual analogue scale tended to lessen in frequency and intensity over time in all Phase 2 and 3 studies.
V vseh študijah faze II in III se je pogostnost in intenzivnost bolečine na mestu injiciranja, ki so jo ocenjevali z vizualno analogno skalo (VAS), sčasoma zmanjšala.
Subject Incidence
Pogostnost
Subject not known to have died [n (%)]
Preskušanec, za katerega ne vemo, da je umrl [n (%)]
Subject observed to have died [n (%)]
Preskušanec, za katerega vemo, da je umrl [n (%)]
Subject observed to have progressed or died [n
Pri preskušancu je bolezen napredovala ali je umrl [n (%)]
Subject to medical prescription.
Predpisovanje in izdaja zdravila je le na recept.
Subject/parent global assessment of overall well-being (VAS 0-10 cm)
Splošna ocena počutja s strani bolnika ali staršev (VAS 0-10 cm)
Subjective improvement in health-related quality of life measurements
Subjektivno izboljšanje mer zdravstvene kakovosti življenja
Subjects
Preizkušanci
Subjects (%) achieving: HbA1c < 7%
Preiskovanci (%), ki so dosegli: HbA1c < 7
Subjects (%) with plasma HIV-1 RNA
Bolniki (%) s plazemsko HIV-1 RNA
Subjects (%) with plasma HIV-1 RNA
Preiskovanci (%) s plazemsko HIV-1
Subjects (N)
Osebe (n)
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faze pa so bili obravnavani kot neodzivni bolniki.
Subjects achieved a mean CFA-72h of 84.08 with Enzepi and of 85.33 with comparator.
Preskušanci so dosegli povprečni koeficient CFA–72h 84,08 pri zdravilu Enzepi in 85,33 pri primerjalnem zdravilu.
Subjects also received a daily oral dose of 3 mg/kg/day cyclosporine and 2 g/day of mycophenolate mofetil starting three days before administration of alipogene tiparvovec through week 12.
Preskušanci so prejemali tudi dnevni peroralni odmerek 3 mg/kg/dan ciklosporina in 2 g/dan mofetilmikofenolata , kar se je začelo tri dni pred injiciranjem alipogentiparvoveka in trajalo do 12. tedna.
Subjects applied up to two sachets of Zyclara 3.75% cream or vehicle daily to the skin of the attached area (either entire face or balding scalp, but not both) for two 2-week treatment cycles separated by a 2-week no-treatment cycle.
Bolniki so dnevno nanašali do dve vrečici zdravila Zyclara 3,75% krema ali vehikla na površino prizadetega predela (bodisi celoten obraz bodisi neporaščeno lasišče, vendar ne oboje) v dveh 2-tedenskih ciklusih zdravljenja, med katerima je bilo 2- tedensko obdobje premora brez zdravljenja.
Subjects continued taking their current dose of MTX from the day of randomization.
Bolniki so od dneva randomizacije nadaljevali zdravljenje z MTX v trenutnem odmerku.
Subjects had a median Cumulative Illness Rating Scale (CIRS) score of 8.
Osebe so imele mediani rezultat skupne ocene bolezni (CIRS, Cumulative Illness Rating Scale) 8.
Subjects had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic HCV infection pre-transplantation.
Osebe so imele pri presejanju HCV RNA ≥ 104 i.e./ml in dokumentirano dokazano kronično okužbo s HCV pred presaditvijo.
Subjects had received 1 to 3 prior lines of therapy (median of 2), including prior treatment with bortezomib (66%), thalidomide (44%) and lenalidomide (20%).
Preiskovanci so predhodno dobivali od 1 do 3 linije zdravljenja (mediano 2), vključno s predhodnim zdravljenjem z bortezomibom (66 %), talidomidom (44 %) in lenalidomidom (20 %).
Subjects in both edoxaban treatment groups had their dose halved if one or more of the following clinical factors were present: moderate renal impairment (CrCL 30 – 50 mL/min), low body weight ( 60 kg) or concomitant use of specific P-gp inhibitors (verapamil, quinidine, dronedarone).
Preiskovancem v obeh skupinah zdravljenja z edoksabanom so odmerek prepolovili, če je bil prisoten eden ali več od naslednjih kliničnih dejavnikov: zmerna okvara ledvic (CrCL 30 – 50 ml/min), majhna telesna masa ( 60 kg) ali sočasna uporaba specifičnih inhibitorjev P-gp (verapamil, kinidin, dronedaron).
Subjects must have been naïve to tenofovir disoproxil fumarate, but could have received interferon based regimens (> 6 months prior to screening) or any other non-tenofovir disoproxil fumarate containing oral anti-HBV nucleoside/nucleotide therapy (> 16 weeks prior to screening).
Bolniki so morali biti predhodno še nezdravljeni z dizoproksiltenofovirijevim fumaratom, lahko pa so prejemali režime na osnovi interferona (> 6 mesecev pred presejanjem) ali katero koli drugo peroralno nukleozidno/nukleotidno zdravilo proti virusu HBV, ki ni vsebovalo dizoproksiltenofovirijevega fumarata (> 16 tednov pred presejanjem).
Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Imunski odziv proti A/Indonesia/5/2005
Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
Imunski odziv proti A/Vietnam/1194/2004
Subjects on chronic/maintenance systemic corticosteroids
Osebe na kroničnem/vzdrževalnem zdravljenju s sistemskimi kortikosteroidi
Subjects on on demand therapy prior to entry either entered the individualised prophylaxis arm or were randomised to the weekly prophylaxis or on demand arms.
Osebe, ki so bile pred vstopom v študijo zdravljene na zahtevo, so bile dodeljene bodisi v individualiziran profilaktični krak bodisi randomizirane v krak s tedensko profilakso ali krak z zdravljenjem po potrebi.
Subjects previously vaccinated with a 3-dose regimen of quadrivalent HPV types 6, 11, 16, and 18 vaccine (Gardasil or Silgard), hereafter referred to as qHPV vaccine, may receive 3 doses of Gardasil 9 (see section 5.1).
Osebe, predhodno cepljene s 3 odmerki štirivalentnega cepiva proti HPV s tipi 6, 11, 16 in 18 (cepivo Gardasil ali Silgard), v nadaljevanju qHPV (quadrivalent HPV) cepivo, lahko prejmejo 3 odmerke cepiva Gardasil 9 (glejte poglavje 5.1).
Subjects previously vaccinated with a plain polysaccharide meningococcal vaccine and vaccinated with Nimenrix 30 to 42 months later had lower Geometric Mean Titres (GMTs) measured with rabbit complement serum bactericidal assay (rSBA) than subjects who had not been vaccinated with any meningococcal vaccine in the preceding 10 years (see section 5.1).
Osebe, predhodno cepljene z navadnim polisaharidnim meningokoknim cepivom, od 30 do 42 mesecev pozneje pa s cepivom Nimenrix, so imele nižje geometrične sredine titrov (GMT – Geometric Mean Titre), določene s presusom baktericidnosti v serumu s kunčjim komplementom (rSBA - rabbit complement Serum Bactericidal Assay), kot osebe, ki v zadnjih 10 letih niso prejele nobenega cepiva proti meningokokom (glejte poglavje 5.1).
Subjects randomized
Naključno razvrščeni bolniki