natgillin/translations-raw huggingface dataset:
In study MenACWY-TT-014, the induction of immune memory was assessed one month after the administration of a fifth of the dose of ACWY-PS vaccine (10 µg of each polysaccharide) to children in the third year of life previously primed in the study MenACWY-TT-013 with Nimenrix or a licensed MenC-CRM vaccine at the age of 12 to 14 months.
U ispitivanju MenACWY-TT-014, indukcija imunološkog pamćenja je procijenjena jedan mjesec nakon primjene petine doze cjepiva ACWY-PS (10 µg svakog polisaharida) u djece u trećoj godini života, koja su prethodno u ispitivanju MenACWY-TT-013 u dobi od 12 do 14 mjeseci primila osnovno cijepljenje cjepivom Nimenrix ili odobrenim cjepivom MenC-CRM.
In study MenACWY-TT-021 conducted in subjects aged 4.5-34 years, the immunogenicity of Nimenrix administered between 30 and 42 months after vaccination with a ACWY-PS vaccine was compared to the immunogenicity of Nimenrix administered to age-matched subjects who had not been vaccinated with any meningococcal vaccine in the preceding 10 years.
U ispitivanju MenACWY-TT-021 provedenom na ispitanicima u dobi od 4,5 do 34 godine, imunogenost cjepiva Nimenrix danog između 30 i 42 mjeseca nakon cijepljenja cjepivom ACWY-PS je uspoređena s imunogenosti cjepiva Nimenrix danog ispitanicima iste dobi koji tijekom prethodnih deset godina nisu bili cijepljeni bilo kojim meningokoknim cjepivom.
In study MenACWY-TT-028, the persistence of the immune response was evaluated by hSBA 1 year after vaccination in children 6-10 years of age primed in study MenACWY-TT-027 (Table 10) (see section 4.4).
U ispitivanju MenACWY-TT-028, postojanost imunološkog odgovora je procijenjena pomoću hSBA jednu godinu nakon cijepljenja u djece u dobi od 6 do 10 godina koja su primarno cijepljena u ispitivanju MenACWY-TT-027 (Tablica 10) (vidjeti dio 4.4).
In study MenACWY-TT-039, serum bactericidal activity was also measured using human serum as the source of complement (hSBA) as a secondary endpoint (Table 2).
U ispitivanju MenACWY-TT-039, kao sekundarna mjera ishoda također je mjerena baktericidna aktivnost u serumu primjenom humanog seruma kao izvora komplementa (hSBA) (Tablica 2).
In study MenACWY-TT-043, the persistence of the immune response was evaluated 5 years after vaccination in adolescents primed in study MenACWY-TT-036 (Table 12).
U ispitivanju MenACWY-TT-043 postojanost imunološkog odgovora je procijenjena 5 godine nakon cijepljenja adolescenata koji su primarno cijepljeni u ispitivanju MenACWY-TT-036 (Tablica 12).
In study MenACWY-TT-088, the persistence of the immune response was evaluated by rSBA and hSBA up to 44 months after vaccination in children 2-10 years of age primed in study MenACWY- TT-081 (Table 9).
U ispitivanju MenACWY-TT-088 ocjenjivana je postojanost imunološkog odgovora uz pomoć rSBA i hSBA do 44 mjeseca nakon cijepljenja u djece u dobi od 2 do 10 godina koja su primarno cijepljena u ispitivanju MenACWY-TT-081 (Tablica 9).
In study MMY-3010 induction treatment withbortezomib combined with thalidomide and dexamethasone [BzTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
U ispitivanju MMY-3010 uvodno liječenje bortezomibom u kombinaciji s talidomidom i deksametazonom [BzTDx, n=130] bilo je uspoređeno s liječenjem talidomidom-deksametazonom [TDx, n=127].
In study MMY-3010 induction treatment withVELCADE combined with thalidomide and dexamethasone [VcTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
U ispitivanju MMY-3010 uvodno liječenje VELCADEom u kombinaciji s talidomidom i deksametazonom [VcTDx, n = 130] bilo je uspoređeno s liječenjem talidomidom-deksametazonom [TDx, n = 127].
In study MMY2002, 106 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
U ispitivanju MMY2002, 106 bolesnika s relapsnim i refraktornim multiplim mijelomom primalo je DARZALEX u dozi od 16 mg/kg do progresije bolesti.
In study MO16432, Herceptin (8 mg/kg loading dose, followed by 6 mg/kg maintenance every 3 weeks) was administered concurrently with 10 cycles of neoadjuvant chemotherapy
U ispitivanju MO16432, Herceptin (udarna doza od 8 mg/kg, zatim doza održavanja od 6 mg/kg svaka 3 tjedna) je davan istodobno s 10 ciklusa neoadjuvantne kemoterapije
In study MO16432, Herceptin (8 mg/kg loading dose, followed by 6 mg/kg maintenance every 3 weeks) was administered concurrently with 10 cycles of neoadjuvant chemotherapy
U ispitivanju MO16432, Herceptin (udarna doza od 8 mg/kg, zatim doza održavanja od 6 mg/kg svaka 3 tjedna) je davan istodobno s 10 ciklusa neoadjuvantne kemoterapije,
In study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomised to four different treatments:
U ispitivanju MV17150 bolesnici koji nisu odgovorili na ranije liječenje pegiliranim interferonom alfa-2b i ribavirinom, randomizirani su u četiri različite terapijske grupe:
In study PX 171 009 the incidence of venous thromboembolic events was 15.3% in the KRd arm and 9.0% in the Rd arm.
U ispitivanju PX-171-009, incidencija događaja venske tromboembolije bila je 15,3% u KRd skupini te 9,0% u Rd skupini.
In Study SC-I, abatacept administered subcutaneously (SC) was non-inferior relative to intravenous (IV) infusions of abatacept with respect to ACR 20 responses up to 6 months of treatment.
U Ispitivanju SC-I abatacept primijenjen supkutano (s.c.) nije bio inferioran u odnosu na intravenske (i.v.) infuzije abatacepta u pogledu odgovora ACR20 u razdoblju do 6 mjeseci liječenja.
In Study SC-I, abatacept was given subcutaneously to patients after a single loading dose of intravenous abatacept and then every week thereafter.
U Ispitivanju SC-I abatacept je bolesnicima primijenjen supkutano nakon jedne udarne intravenske doze abatacepta, a nakon toga svakog tjedna.
In Study SC-I, the goal was to demonstrate non-inferiority of the efficacy and comparability of the safety of abatacept subcutaneous relative to intravenous administration in subjects with moderate to severely active RA and experiencing inadequate response to MTX.
U Ispitivanju SC-I cilj je bio dokazati neinferiornost u pogledu djelotvornosti te usporedivu sigurnost abatacepta primijenjenog supkutano u odnosu na intravensku primjenu u ispitanika s umjerenim do teškim oblikom aktivnog reumatoidnog artritisa koji nisu dovoljno dobro odgovorili na MTX.
In study SC-I, the mean decrease in HAQ-DI from baseline to week 24 was 0.6 on both the subcutaneous and intravenous arms.
U ispitivanju SC-I srednje smanjenje HAQ-DI rezultata nakon 24 tjedna u odnosu na početnu vrijednost iznosilo je 0,6 i u skupini liječenoj supkutanom formulacijom i u onoj liječenoj intravenskom formulacijom.
In study SC-II, inhibition of structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde modified mean total Sharp score (mTSS).
U ispitivanju SC-II radiološki se ocjenjivala inhibicija strukturnih oštećenja zglobova izražena kao promjena srednjeg ukupnog rezultata na van der Heijdeovoj modifikaciji Sharpove bodovne skale (engl. modified mean total Sharp score, mTSS) u odnosu na početnu vrijednost.
In study SC-II, mean decrease in HAQ-DI from baseline to week 24 was significantly greater for patients treated with tocilizumab subcutaneous every other week (0.4) versus placebo (0.3).
U ispitivanju SC-II je srednje smanjenje vrijednosti HAQ-DI nakon 24 tjedna u odnosu na početnu vrijednost bilo značajno veće u bolesnika liječenih supkutanom formulacijom tocilizumaba jedanput svaka dva tjedna (0,4) nego u bolesnika koji su primali placebo (0,3).
In Study SC-II, structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde-modified Total Sharp Score (mTSS) and its components.
U ispitivanju SC-II, strukturno oštećenje zglobova ocijenjeno je radiografski i izraženo kao promjena ukupne ocjene na po van der Heijdeu modificiranoj Sharpovoj bodovnoj skali (engl. modified Total Sharp Score, mTSS) i njezinim komponentama u odnosu na početnu vrijednost.
In study SC-III, abatacept SC was evaluated in combination with methotrexate (MTX), or as abatacept monotherapy, and compared to MTX monotherapy in induction of remission following
U ispitivanju SC-III ocjenjivao se abatacept za supkutanu primjenu u kombinaciji s metotreksatom (MTX) ili u monoterapiji u usporedbi s monoterapijom
In study SC-III, abatacept SC was evaluated in combination with methotrexate, or as abatacept monotherapy, and compared to MTX monotherapy in induction of remission following 12 months of treatment, and the possible maintenance of drug-free remission after complete drug withdrawal, in adult MTX-naive patients with highly active early rheumatoid arthritis (mean DAS28-CRP of 5.4; mean symptom duration less than 6.7 months) with poor prognostic factors for rapidly progressive disease (e.g. anti- citrullinated protein antibodies [ACPA+], as measured by anti-CCP2 assay, and/or RF+, baseline joint erosions).
U ispitivanju SC-III ocjenjivao se abatacept za supkutanu primjenu u kombinaciji s metotreksatom (MTX) ili u monoterapiji u usporedbi s monoterapijom MTX-om s obzirom na indukciju remisije nakon 12 mjeseci liječenja te moguće održavanje remisije bez liječenja nakon potpunog prekida terapije u odraslih bolesnika s izrazito aktivnim ranim oblikom reumatoidnog artritisa (srednja vrijednost indeksa DAS28-CRP: 5,4; srednja vrijednost trajanja simptoma: manje od 6,7 mjeseci) koji prethodno nisu bili liječeni MTX-om i koji su imali loše prognostičke faktore za brzo progredirajuću bolest (npr. antitijela na citrulinirane proteine [engl. anti-citrullinated protein antibodies, ACPA+], koja su se određivala anti-CCP2 testom, i/ili pozitivan nalaz RF-a, erozije zglobova na početku ispitivanja).
In Study SC-III, similar immunogenicity rates were seen in patients on treatment for the abatacept+MTX, and abatacept monotherapy groups (2.9% (3/103) and 5.0% (5/101), respectively) during the double-blind 12 month period.
U ispitivanju SC-III su tijekom dvostruko slijepog 12-mjesečnog razdoblja primijećene slične stope imunogenosti u bolesnika koji su primali abatacept + MTX i onih koji su se liječili monoterapijom abataceptom (2,9% [3/103] naspram 5,0% [5/101]).
In Study SC-III, structural joint damage was assessed by MRI.
U ispitivanju SC-III, strukturno oštećenje zglobova ocjenjivalo se oslikavanjem magnetskom rezonancijom (engl. magnetic resonance imagining, MRI).
In study TAX 316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, periferni edem je i dalje bio prisutanu 19 bolesnika od 119 bolesnika s perifernim edemom u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika s perifernim edemom u FAC skupini.
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
U studiji TAX 316, 26 bolesnika (3,5%) u TAC skupini te 17 bolesnika (2,3%) u FAC skupini doživjelo je kongestivno zatajernje srca (CHF).
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736 FAC patients.
U studiji TAX 316 alopecija koja je i dalje bila prisutna tijekom praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika u TAC skupini i 645 od 736 bolesnika u FAC skupini.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736 FAC patients.
U studiji TAX 316, alopecija koja je i dalje bila prisutna tijekom praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika u TAC skupini i 645 od736 bolesnika u FAC skupini.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736FAC patients.
U studiji TAX 316 alopecija koja je i dalje bila prisutna tijekom praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika u TAC skupini i 645 od 736 bolesnika u FAC
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 TAC patients and 645 FAC patients.
U studiji TAX 316, alopecija koja je i dalje bila prisutna tijekom praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika u TAC skupini i 645 od 736 bolesnika u FAC skupini.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, od 119 bolesnika koji su imali periferni edem na kraju kemoterapije, u 19 bolesnika periferni edem je i dalje bio prisutan tijekom praćenja nakon kemoterapije u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika u FAC skupini.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, periferni edem je i dalje bio prisutan u 19 bolesnika od 119 bolesnika s perifernim edemom u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika s perifernim edemom u FAC skupini.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, periferni edem je i dalje bio prisutanu 19 bolesnika od 119 bolesnika s perifernim edemom u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika s perifernim edemom u FAC skupini.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in theTAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, od 119 bolesnika koji su imali periferni edem na kraju kemoterapije, u 19 bolesnika periferni edem je i dalje bio prisutan tijekom praćenja nakon kemoterapije u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika u FAC skupini.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, periferni edem je i dalje bio prisutan u 19 bolesnika od 119 bolesnika s perifernim edemom u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika s perifernim edemom u FAC skupini.
In study TAX316, peripheral oedema was observed to be ongoing in19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, periferni edem je i dalje bio prisutan u 19 bolesnika od 119 bolesnika s perifernim edemom u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika s perifernim edemom u FAC skupini.
In study TT01, 23 patients were entered and received treatment with Savene.
U ispitivanje TT01 uključena su 23 pacijenta koji su primili terapiju lijekom Savene.
In study TT02, 57 patients entered the study and received the first dose of Savene.
U ispitivanjeTT02 uključeno je 57 pacijenata koji su primili prvu dozu lijeka Savene.
In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at Weeks 0 and 2, 160 mg Humira at Week 0 followed by 80 mg at Week 2, or 80 mg Humira at Week 0 followed by 40 mg at Week 2.
U ispitivanju UC-I, 390 bolesnika koji nikad nisu primali terapiju antagonistima TNF-a randomizirani su tako da primaju ili placebo u nultom tjednu i u drugom tjednu, lijek Humira u dozi od 160 mg u nultom tjednu i 80 mg u drugom tjednu ili lijek Humira u dozi 80 mg u nultom tjednu i 40 mg u drugom tjednu.
In study V59P13E1, the persistence of immune responses against serogroups A, C, W135 and Y was assessed at 21 months, 3 years and 5 years post primary vaccination among subjects aged 11-18 years at the time of vaccination.
U ispitivanju V59P13E1, postojanost imunoloških odgovora protiv serogrupa A, C, W135 i Y procijenjena je 21 mjesec, 3 godine i 5 godina nakon prvog cijepljenja u ispitanika koji su u vrijeme cijepljenja imali između 11 i 18 godina.
In study V59P6E1, at one year post vaccination, the percentage of Menveo recipients with hSBA
U ispitivanju V59P6E1, godinu dana nakon cijepljenja, postotak primatelja cjepiva Menveo s hSBA
In Study V87P11 MN results against homologous A/H5N1/turkey/Turkey/1/05 indicate a seroprotection and seroconversion rate of 68% (59-75) and 81% (74-87), respectively.
Rezultati MN analize u Studiji V87P11 na homologni virus A/H5N1/turkey/Turkey/1/05 upućuju na stopu seroprotekcije i serokonverzije od 68% (59-75) odnosno 81% (74-87).
In Study V87P11 MN results against homologous A/H5N1/turkey/Turkey/1/05 indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively.
Rezultati MN analize u Studiji V87P11 na homologni virus A/H5N1/turkey/Turkey/1/05 upućuju na stopu seroprotekcije i serokonverzije od 85% (79-90), odnosno 93% (89-96).
In Study VI,
Mental Component Summary, MCS).
In Study VI, statistically significant improvement in the ACR 20 response in abatacept plus methotrexate-treated patients versus methotrexate plus placebo-treated patients was observed at 29 days, and was maintained through the duration of the study.
U Ispitivanju VI je tijekom 29 dana opaženo statistički značajno poboljšanje odgovora ACR20 u bolesnika koji su primali abatacept i metotreksat u odnosu na bolesnike koji su primali placebo, i to je poboljšanje ostalo značajno tijekom cjelokupnog trajanja ispitivanja.
In Study VI, the mean change in TSS at 12 months was significantly lower in patients treated with abatacept plus methotrexate compared to those treated with methotrexate plus placebo.
U Ispitivanju VI, prosječna vrijednost promjene TSS-a nakon 12 mjeseci bila je značajno manja u bolesnika liječenih abataceptom i metotreksatom u odnosu na one koji su primali metotreksat i placebo.
In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score < 2.6) versus the methotrexate plus placebo group (23%) at year 1.
U Ispitivanju VI, u koje su uključeni samo odrasli bolesnici, nakon godinu dana liječenja je remisiju prema indeksu DAS28-CRP (rezultat < 2,6) postigao značajno veći udio bolesnika u skupini abatacept i metotreksat (41%) u usporedbi s bolesnicima u skupini metotreksat i placebo (23%).
In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score < 2.6) versus the methotrexate plus placebo group (23%) at year 1.
U Ispitivanju VI, u koje su uključeni samo odrasli bolesnici, nakon godinu dana liječenja je remisiju prema indeksu DAS28-CRP (rezultat < 2,6) postigao značajno veći udio bolesnika u skupini abatacept plus metotreksat (41%) u usporedbi s bolesnicima u skupini metotreksat i placebo (23%).
In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ml.
U ispitivanju WV16240 primarni pokazatelji djelotvornosti bili su HBeAg serokonverzija i HBV-DNK manje od 105 kopija/ml.
In study WV16241, the primary efficacy endpoints were ALT normalisation and HBV- DNA below 2 x 104 copies/ml.
U ispitivanju WV16241 primarni pokazatelji djelotvornosti bili su normalizacija ALT-a i HBV-DNK manja od 2 x 104 kopija/ml.
In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum phosphorus ≥1.94 mmol/L following a 2-4 week phosphate binder washout period, were randomized and treated with either Velphoro, at a starting dose of 1,000 mg/day (N=707), or active-control (sevelamer carbonate, N=348) for 24 weeks.
U ispitivanju­05A 1055 bolesnika na hemodijalizi (n=968) ili peritonealnoj dijalizi (n=87) s razinom fosfora u serumu ≥1,94 mmol/l, nakon perioda ispiranja vezača fosfata od 2–4 tjedna, randomizirano je i liječeno lijekom Velphoro u početnoj dozi od 1000 mg/dan (n=707), ili aktivnom kontrolom (sevelamerkarbonat, n=348) u trajanju od 24 tjedna.
In subcutaneous carcinogenicity studies in rats and mice, no increases in tumour incidences were observed.
U istraživanjima supkutane kancerogenosti u štakora i miševa nije opažen porast incidencije tumora.
In subgroup analyses, a reduced survival benefit of pembrolizumab compared to docetaxel was observed for patients who were never-smokers or patients with tumours harbouring EGFR activating mutations who received at least platinum-based chemotherapy and a tyrosine kinase inhibitor; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data.
U analizama podskupina primijećen je smanjen povoljan učinak pembrolizumaba na preživljenje u usporedbi s docetakselom u bolesnika koji nikada nisu pušili ili bolesnika koji su imali tumore s aktivirajućim mutacijama gena EGFR i koji su primili najmanje kemoterapiju utemeljenu na platini i inhibitor tirozin kinaze; međutim, zbog malog se broja bolesnika iz tih podataka ne mogu izvući definitivni zaključci.
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 104 (3.05% per year) of edoxaban 30 mg dose reduced subjects and 166 (4.85% per year) of warfarin dose reduced subjects had a major bleeding event [HR (95% CI): 0.63 (0.50, 0.81)].
U analizi podskupina, od ispitanika u terapijskoj skupini liječenoj dozom od 60 mg kojima je doza snižena na 30 mg u ispitivanju ENGAGE AF-TIMI 48 zbog tjelesne težine ≤ 60 kg, umjerenog oštećenja funkcije bubrega ili istovremene primjene inhibitora P-gp, njih 104 (3,05% godišnje) kojima je doza edoksabana snižena na 30 mg i njih 166 (4,85% godišnje) kojima je snižena doza varfarina imalo je veliko krvarenje [HR (95% CI): 0,63 (0,50, 0,81)].
In subjects 60 years of age or older who were receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone for at least 2 weeks prior to enrollment, and 6 weeks or more following vaccination, the safety profile was generally comparable to that seen in the Adverse Event Monitoring Substudy of the SPS (see sections 4.3 and 5.1).
U ispitanika u dobi od 60 godina ili starijih koji su bili primali kroničnu terapiju/ terapiju održavanja sistemskim kortikosteroidima u dnevnoj dozi koja je odgovarala 5 do 20 mg prednizona tijekom najmanje 2 tjedna prije uključenja i 6 ili više tjedana nakon cijepljenja, sigurnosni profil općenito je bio usporediv s onim opaženim u Podispitivanju praćenja štetnih događaja u sklopu ispitivanja SPS (vidjeti dijelove 4.3 i 5.1).
In subjects > 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain (10.3%).
U osoba starijih od 64 godine, najčešće prijavljene nuspojave nakon cijepljenja bile su: bol na mjestu injiciranja (58,0%), bolovi u mišićima (19,7%), umor (13,5%), glavobolja (12,4%) i bol u zglobovima (10,3%).
In subjects taking vardenafil 10 mg orodispersible tablets with a high fat meal no effect on vardenafil AUC and tmax was observed, while vardenafil Cmax was reduced by 35% in the fed condition.
U ispitanika koji uzimaju Vivanza 10 mg raspadljive tablete za usta s obrokom bogatim mastima nije bio primijećen učinak na AUC i tmax vardenafila, dok je Cmax vardenafila bila smanjena za 35% kod uzimanja na pun želudac.