natgillin/translations-raw huggingface dataset:
In the open-label extension of Studies I, II, III, VI, and SC-I durable and sustained ACR 20, 50, and 70 responses have been observed through 7 years, 5 years, 5 years, 2 years, and 5years, respectively, of abatacept treatment.
Trajanje in ohranitev odzivov ACR 20, 50 in 70 so v odprtem podaljšku študije I spremljali 7 let zdravljenja z abataceptom, v odprtem podaljšku študije II 5 let zdravljenja z abataceptom, v odprtem podaljšku študije III 5 let zdravljenja z abataceptom, v odprtem podaljšku študije VI 2 leti zdravljenja z abataceptom in v odprtem podaljšku študije SC-I 5 let zdravljenja z abataceptom.
In the open-label extension, improvement in the signs and symptoms was maintained with Humira therapy through Week 156.
Pri podaljšanih študijah brez placeba se je pri zdravljenju z zdravilom Humira izboljšanje znakov in simptomov ohranjalo do 156. tedna.
In the open-label follow-up phase, the treatment effect on CDMS was still evident after 3 and 5 years (Table 3) even though the majority of patients from the placebo-group was treated with Betaferon at least from the second year onwards.
V odprti fazi nadaljevanja študije so bili učinki zdravljenja na CDMS še vedno opazni po 3 in 5 letih (preglednica 3), čeprav je bila večina bolnikov iz skupine, ki je dobivala placebo, zdravljena z zdravilom Betaferon vsaj od drugega leta naprej.
In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non- MTX- treated.
V odprti uvajalni fazi so bolnike stratificirali v dve skupini: zdravljene z metotreksatom in zdravljene brez metotreksata.
In the open-label paediatric study, sixteen patients with Fabry disease (8-16 years old; 14 males, 2 females) had been treated for one year.
V pediatrični študiji odprtega tipa je bilo eno leto zdravljenih šestnajst bolnikov (starih od 8 do 16 let; 14 moških, 2 ženski) s Fabryjevo boleznijo.
In the osteoporosis treatment study after 3 years of treatment, bazedoxifene 20 mg and raloxifene 60 mg exhibited significant reductions in serum total cholesterol, low-density lipoprotein (LDL) cholesterol and a significant increase in high-density lipoprotein (HDL) cholesterol compared to placebo.
V študiji zdravljenja osteoporoze sta po 3 letih zdravljenja bazedoksifen v odmerku 20 mg in raloksifen v odmerku 60 mg povzročila pomembno znižanje celokupnega serumskega holesterola, LDL holesterola (LDL = lipoprotein majhne gostote) in pomembno zvišanje HDL holesterola (HDL = lipoprotein velike gostote) v primerjavi s placebom.
In the osteoporosis treatment study, significantly fewer Optruma-treated patients required initiation of hypolipidaemic therapy compared to placebo.
V študiji zdravljenja osteoporoze je bila pri bolnicah, zdravljenih z zdravilom Optruma, uvedba hipolipemične terapije potrebna pri značilno manjšem številu v primerjavi s placebom.
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between Aclasta (2.6%) and placebo (2.1%).
V študijah osteoporoze (v PFT, v študiji HORIZON – študiji ponovnih zlomov (Recurrent Fracture Trial [RFT]) sta bili združeni incidenci atrijske fibrilacije primerljivi med zdravilom Aclasta (2,6 %) in placebom (2,1 %).
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
V študijah osteoporoze (v PFT, v študiji HORIZON – študiji ponovnih zlomov (Recurrent Fracture Trial [RFT]) sta bili združeni incidenci atrijske fibrilacije primerljivi med zoledronsko kislino (2,6 %) in placebom (2,1 %).
In the other cases with known evolution, pregnancy had been interrupted either voluntarily or upon medical advice.
V drugih primerih z znano evolucijo je bila nosečnost prekinjena bodisi prostovoljno ali po nasvetu zdravnikov.
In the other main study, the results were similar with 59% of patients who received Cimzia (228 out of 388) achieving 20% reductions compared with 14% of patients receiving placebo (27 out of 198).
V drugi glavni študiji so bili rezultati podobni, in sicer je do 20-odstotnega zmanjšanja prišlo pri 59 % (228 od 388) bolnikov, ki so prejemali zdravilo Cimzia, v primerjavi s 14 % (27 od 198) bolnikov, ki so prejemali placebo.
In the other patients, dose-normalised AUClast ranged from 887-3930 ngh/ml per gram of NexoBrid.
Pri ostalih bolnikih je bil razpon AUClast, normaliziran na odmerek, od 887– 3.930 ng/ml na gram zdravila NexoBrid.
In the other patients, dose-normalised Cmax ranged from 141-523 ng/ml per gram of NexoBrid.
Pri ostalih bolnikih je bil razpon Cmax, normaliziran na odmerek, od 141–523 ng/ml na gram zdravila NexoBrid.
In the other study [Bergman et al, 2004] repeated co-administration of both simvastatin 80 mg and fenofibrate 160 mg led to a reduction in the AUC of the SVA of 36% (90% CI 30%-42%).
V drugi študiji [Bergman in sod., 2004] je večkratno sočasno dajanje simvastatina 80 mg in fenofibrata 160 mg zmanjšalo vrednost AUC SVK za 36 % (90-odstotni IZ 30 %–42 %).
In the other study hypothyroidism was reported in a total of 31 (13%) sunitinib subjects and 2 (0.8%) capecitabine subjects.
V drugi študiji so o hiportiroidizmu poročali pri 31 (13 %) preskušankah, ki so prejemale sunitinib, in pri 2 (0,8 %) preskušankah, ki sta prejemali kapecitabin.
In the other study, in which patient counselling was also more intensive, the overall weight loss was greater over the study period: 8.1% with Mysimba and 4.9% with placebo.
V drugi študiji, v kateri so bili bolniki med drugim deležni intenzivnejšega svetovanja, je bilo skupno zmanjšanje telesne mase v času študije večje: 8,1-odstotno pri uporabi zdravila Mysimba in
In the other two studies, 185 patients with CAPS (including seven children aged 2-4 years) were given Ilaris every eight weeks for at least 24 weeks.
V drugih dveh študijah je 185 bolnikov z obolenji CAPS (vključno s sedmimi otroki, starimi od 2 do 4 let) vsakih osem tednov prejelo zdravilo Ilaris, kar je trajalo vsaj 24 tednov.
In the other two studies, 85% of patients had no relapses.
V drugih dveh študijah 85 % bolnikov ni imelo ponovnih zagonov.
In the overall group of patients with macular oedema related to diabetes the CHMP noted that the benefit was modest and was outweighed by the risks including the development of cataracts.
Pri splošni skupini bolnikov z makularnim edemom, povezanim s sladkorno boleznijo, je odbor CHMP izpostavil, da je korist skromna in da so tveganja, vključno z razvojem sive mrene, večja.
In the overall patient population and the two main subgroups (prior sunitinib treatment and prior cytokine treatment), there was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of PFS (see Table 2 and Figures 1, 2 and 3).
V celokupni populaciji bolnikov in v dveh najpomembnejših podskupinah (predhodno zdravljenje s sunitinibom in predhodno zdravljenje s citokinom) je bil pri primarnem opazovanem dogodku, preživetju brez napredovanja bolezni (PFS), aksitinib statistično pomembno boljši od sorafeniba (glejte Preglednico 2 in Slike 1, 2 in 3).
In the overall patient population of the study MF 4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
V celotni populaciji bolnikov v študiji MF 4411 niso opazili zmanjšanja nevretenčnih zlomov, ugotovili pa so, da je bila ibandronska kislina v dnevnih odmerkih učinkovita pri podskupini bolnikov z velikim tveganjem (T-vrednost MKG stegneničnega vratu pod -3,0), kjer se je tveganje za nevretenčne zlome zmanjšalo za 69 %.
In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
V celotni populaciji bolnikov v študiji MF4411 niso opazili zmanjšanja nevretenčnih zlomov, ugotovili pa so, da je bila ibandronska kislina enkrat na dan učinkovita pri podskupini bolnikov z visokim tveganjem (T-vrednost MKG stegneničnega vratu pod –3,0), kjer se je tveganje za nevretenčne zlome zmanjšalo za 69 %.
In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69% was observed.
V celotni populaciji bolnikov v študiji MF4411 niso opazili zmanjšanja nevretenčnih zlomov, ugotovili pa so, da je bila ibandronska kislina enkrat na dan učinkovita pri podskupini bolnikov z visokim tveganjem (T-vrednost MKG stegneničnega vratu pod –3,0), kjer se je tveganje za nevretenčne zlome zmanjšalo za 69 %.
In the overall pool of guanfacine-treated patients, somnolence occurred in 40.6% and sedation in 10.2% of guanfacine-treated patients.
V celotni združeni skupini bolnikov, zdravljenih z gvanfacinom, se je somnolenca pojavila pri 40,6 % in sedacija pri 10,2 % bolnikov, zdravljenih z gvanfacinom.
In the overall population (n = 31), 2 mg/kg twice daily resulted in a daily exposure of 8,535 ng·h/mL; AUC was 4,268 ng·h/mL (CV: 61%).
Pri celotni populaciji (n = 31) z odmerkom 2 mg/kg dvakrat dnevno je bila dnevna izpostavljenost 8,535 ng h/ml, AUC pa 4,268 ng h/ml (CV: 61 %).
In the overall population (n = 31), 2 mg/kg twice daily resulted in a daily exposure of 8,535 ng·h/mL; AUC was 4,268 ng·h/mL (CV: 61%).
Pri celotni populaciji (n = 31) z odmerkom 2 mg/kg dvakrat dnevno je bila dnevna izpostavljenost 8,535 ng h/ml, AUC pa 4,268 ng h/ml (CV: 61%).
In the overall population of 2,712 SPRYCEL treated patients, 520 (19%) experienced adverse reactions leading to treatment discontinuation.
V celotni populaciji 2.712 bolnikov, ki so se zdravili z zdravilom SPRYCEL, je bilo zaradi pojava neželenih učinkov zdravljenje treba prekiniti pri 520 (19%) bolnikih.
In the overall population of the second study (889 patients), Tarceva caused a marginal increase in how long the patients lived without their disease getting worse and in how long they survived.
Pri celokupni populaciji druge študije (889 bolnikov) so ugotovili, da je zdravilo Tarceva prispevalo k malenkostnemu podaljšanju časa do poslabšanja bolezni in časa preživetja bolnikov.
In the overall population, 86% (227/263) had documentation of response at the time of the first scan (6 weeks); 96% (253/263) had documentation of response at the time of the second scan (12 weeks).
V celotni populaciji je imelo 86 % (227/263) bolnikov dokumentiran odziv ob času prvega slikanja (6 tednov), 96 % (253/263) pa je imelo dokumentiran odziv ob času drugega slikanja (12 tednov).
In the overall SJIA program, high ALT and/or AST > 3 x upper limit of normal (ULN) were reported in 19 patients (9.5%).
V celotnem programu študij SJIA so o zvišanih vrednostih ALT in/ali AST na > 3-kratnik zgornje meje normalnih vrednosti poročali pri 19 bolnikih (9,5 %).
In the overall SJIA program, transient decreased white blood cell (WBC) counts ≤ 0.8 x LLN were reported in 33 patients (16.5%).
V celotnem programu študij SJIA so o prehodno znižanem številu levkocitov na ≤ 0,8-kratnik spodnje meje normalnih vrednosti poročali pri 33 bolnikih (16,5 %).
In the overall SJIA program, transient decreases in absolute neutrophil count (ANC) to less than 1 x 109/l were reported in 12 patients (6.0%).
V celotnem programu študij SJIA so o prehodnem znižanju absolutnega števila nevtrofilcev na manj kot 1 x 109/l poročali pri 12 bolnikih (6,0 %).
In the overall SJIA program, transient decreases in platelet counts (< LLN) were observed in 19 patients (9.5%).
V celotnem programu študij SJIA so prehodno znižanje koncentracije trombocitov (pod spodnjo mejo normalnih vrednosti) opažali pri 19 bolnikih (9,5 %).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination and gait disturbance) and/or gastrointestinal origin (vomiting and diarrhoea).
Pri prekomernem odmerjanju do 140 mg ali pri neznanih odmerkih so se pri bolnikih pokazali simptomi povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost, vrtoglavica, vznemirjenost, agresivnost, halucinacije in motnje hoje) in/ali prebavili (bruhanje in driska).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Pri prekomernem odmerjanju do 140 mg ali pri neznanih odmerkih so se pri bolnikih pokazali simptomi povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost, vrtoglavica, vznemirjenost, agresivnost, halucinacije in motnje hoje) in/ali prebavili (bruhanje in driska).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or gastrointestinal origin (vomiting and diarrhoea).
Pri prekomernem odmerjanju do 140 mg ali pri neznanih odmerkih so se pri bolnikih pokazali simptomi povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost, vrtoglavica, vznemirjenost, agresivnosti, halucinacije in motnje hoje) in/ali prebavili (bruhanje in driska).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Pri prevelikih odmerkih do 140 mg in pri neznanih odmerkih so se pri bolnikih pokazali simptomi, povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost, vrtoglavica, vznemirjenost, agresivnost, halucinacije in motnje hoje) in/ali prebavili (bruhanje in driska).
In the overdose groups, transient and self-limiting neurological signs were observed in some animals: mild tremors at 3 times the maximum exposure dose and convulsions at 5 times the maximum exposure dose.
V skupinah psov s prekomernim odmerjanjem, so pri nekaterih živalih opazili naslednje prehodne in samoomejujoče nevrološke znake: blago tresenje pri 3krat večjem odmerku od največjega priporočenega in krče pri 5krat večjem odmerku od največjega priporočenega.
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0 % and 53.3 %, respectively.
V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa 53,3 %.
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa 53,3 %.
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 28.0% and 53.3%, respectively.
V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa 53,3 %.
In the paediatric population 5 µg/kg i.v. glycopyrronium has low central bioavailability, except in the case where the blood brain barrier has been compromised (e.g. a shunt infection).
Pri pediatrični populaciji ima intravenski odmerek glikopironija v višini 5 µg/kg nizko centralno biološko razpoložljivost, razen v primeru poškodovane krvno-možganske pregrade (npr. okužba šanta).
In the paediatric studies APV20003 and APV29005, 67 PI-experienced patients were treated with fosamprenavir / ritonavir and of 22 virological failure isolates genotyped, nine patients were found with treatment-emergent protease mutations.
V študijah APV20003 in APV29005, ki so jih izvedli pri otrocih, je 67 bolnikov, ki so se predhodno že zdravili z zaviralci proteaz, prejemalo fosamprenavir / ritonavir.
In the paediatric study, the most prevalent adverse reactions in patients treated with combination therapy for up to 48 weeks with Pegasys and ribavirin were influenza-like illness (91%), headache (64%), gastrointestinal disorder (56%), , and injection-site reaction (45%).
V pediatrični študiji so bili pri bolnikih, zdravljenih s kombinacijo zdravila Pegasys in ribavirina do 48 tednov, prevladujoči neželeni učinki gripi podobna bolezen (91 %), glavobol (64 %), gastrointestinalne motnje (56 %)in reakcije na mestu injiciranja (45 %).
In the paediatric study, the most prevalent adverse reactions in patients treated with combination therapy for up to 48 weeks with Pegasys and ribavirin were influenza-like illness (91%), headache (64%), gastrointestinal disorder (56%), and injection-site reaction (45%).
V pediatrični študiji so bili pri bolnikih, zdravljenih s kombinacijo zdravila Pegasys in ribavirina do 48 tednov, prevladujoči neželeni učinki gripi podobna bolezen (91 %), glavobol (64 %), gastrointestinalne motnje (56 %)in reakcije na mestu injiciranja (45 %).
In the Paget’s disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
V preskušanjih zdravljenja Pagetove bolezni so opažali simptomatsko hipokalciemijo pri približno 1 % bolnikov, pri katerih je tudi izzvenela.
In the palonosetron 10 µg/kg, 20 µg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
V skupinah s palonosetronom 10 µg/kg, 20 µg/kg in ondansetroom je bil delež bolnikov s CR0-24h 54,2 %, 59,4 % in 58,6 %.
In the pancreatic neuroendocrine study, patients who took Afinitor lived for an average of 11 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.
V študiji nevroendokrinega tumorja pankreatičnega izvora so bolniki, ki so prejemali zdravilo Afinitor, v povprečju 11 mesecev živeli brez poslabšanja bolezni v primerjavi s 4,6 meseca pri bolnikih, ki so prejemali placebo.
In the paper by Besouw et al (2011), the authors provided description of 6 male paediatric patients (age at onset ranged 3-15 years) with cystinosis who experienced adverse effects while receiving cysteamine.
V dokumentu, ki so ga izdali Besouw in drugi (2011), so avtorji navedli opis šestih moških pediatričnih bolnikov (starost ob nastopu bolezni 3-15 let) s cistinozo, pri katerih so se pojavili škodljivi učinki pri jemanju cysteamina.
In the Partners PrEP clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 during the study.
V klinični študiji Partners PrEP niso bile zaznane nobene različice HIV–1 z izraženo K65R, K70E, M184V ali M184I v času serokonverzije pri osebah, ki so so se okužile s HIV–1 med študijo.
In the patient stratum with baseline calculated GFR above 40 mL/min, renal function was not improved overall.
V skupini bolnikov z izhodiščno izračunano GFR, večjo od 40 ml/min, se ledvična funkcija v celoti gledano ni zvečala.
In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUC was 4,410 ng·h/mL (CV: 58%).
Pri bolnikih, starejših od 2 let (n = 22) je bila dnevna izpostavljenost 8,820 ng h/ml, AUC pa 4,410 ng h/ml (CV: 58 %).
In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUC was 4,410 ng·h/mL (CV: 58%).
Pri bolnikih, starejših od 2 let (n = 22) je bila dnevna izpostavljenost 8,820 ng h/ml, AUC pa 4,410 ng h/ml (CV: 58%).
In the patients aged <20 years the increase from baseline percent predicted FEV1 was larger: 11.3% for TOBI Podhaler and 6.9% for the nebuliser solution after 3 cycles.
Pri bolnikih, ki so bili stari manj kot 20 let, je bilo po 3 ciklusih zdravljenja povečanje odstotka napovedane vrednosti FEV1 večje, in sicer 11,3 % pri uporabi zdravila TOBI Podhaler in 6,9 % pri uporabi raztopine za nebulator.
In the patients who used Regranex, 47% of the ulcers that were less than 5 cm2 in size healed.
Pri bolnikih, ki so uporabljali zdravilo Regranex, se je zacelilo 47 % razjed s površino, manjšo od 5 cm2.
In the patients with IHC-p53 positivity, a lower rate of progression to AML was observed amongst patients who achieved a transfusion independence (TI) response (11.1%) compared to a non-responder (34.8%).
Pri bolnikih s pozitivnim IHC-p53 so opazili manjši delež napredovanja v AML pri bolnikih, ki so dosegli odziv neodvisnosti od transfuzij (TI) (11,1 %), v primerjavi z neodzivnimi bolniki (34,8 %).
In the Pbo/PR arm, 2 (9%) patients had baseline bridging fibrosis and no patients had baseline cirrhosis.
V kraku Pbo/PR pa na začetku zdravljenja ciroze ni imel noben bolnik, mostno fibrozo pa sta imela 2 bolnika (9%).
In the PecFent clinical trial programme, 104 (26.1%) of patients were over 60 years of age, 67 (16.8%) over 65 years and 15 (3.8%) over 75 years.
V programu kliničnega preskušanja zdravila PecFent so bili 104 bolniki (26,1 %) starejši od 60 let, 67 bolnikov (16,8 %) je bilo starejših od 65 let in 15 (3,8 %) starejših od 75 let.
In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens:
V kliničnem preskušanju kombiniranega zdravljenja z zdravilom PegIntron je 1.530 predhodno nezdravljenih bolnikov eno leto prejemalo enega od naslednjih kombiniranih režimov zdravljenja:
In the per protocol population there was a significantly larger observed reduction in GHb in the pre-meal glulisine group compared with the regular insulin group.
V populaciji po-protokolu so v skupini, ki je uporabljala glulisin pred obrokom, ugotovili značilno večje znižanje vrednosti glikiranega hemoglobina kot v skupini, ki je uporabljala navadni insulin.
In the performed clinical studies, the additive effect of the second dose, if any, cannot be independently established.
Na podlagi opravljenih kliničnih študij ni mogoče neodvisno ugotoviti, kolikšen je prispevek uporabe drugega odmerka, če sploh je kakšen.
In the peri-parturient dairy cow, the positive effects of monensin include reduced blood ketones, increased serum glucose and reduced incidence of ketosis.
Pri kravah molznicah v obporodnem obdobju so pozitivni učinki monezina med drugim znižanje ketonov v krvi, povišanje glukoze v serumu in zmanjšanje pojavnosti ketoze.
In the period covered by this PSUR 41 cases of overdose have been reported.
V obdobju, ki ga zajema to posodobljeno poročilo o varnosti zdravila (PSUR) poročajo o 41 primerih prevelikega odmerjanja.
In the Peyronie’s disease clinical studies, at 6 weeks after the first treatment cycle of Xiapex, approximately 75% of patients had antibodies against AUX-I and approximately 55% of patients had antibodies against AUX-II.
V kliničnih študijah Peyroniejeve bolezni je imelo 6 tednov po prvem ciklu zdravljenja z zdravilom Xiapex približno 75 % bolnikov protitelesa proti AUX-I in približno 55 % bolnikov je imelo protitelesa proti AUX-II.
In the phase 1 studies, adverse events with a frequency of  5% included headache (30.9%), ecchymosis (23.0%), and pain (5.8%).
V študijah faze 1 so neželeni dogodki s pogostnostjo  5 %vključevali: glavobol (30,9 %), ekhimoze (23,0 %) in bolečine (5,8 %).
In the Phase 1/2 clinical study in patients with previously treated Ph+ leukaemias, QTcF interval changes >60 ms from baseline were observed 6 (1.1%) of 562 patients.
V klinični študiji 1./2. faze pri bolnikih s predhodno zdravljenimi Ph+ levkemijami so pri 6 (1,1 %) od 562 bolnikov opazili spremembe intervala QTcF > 60 ms v primerjavi z izhodiščem.