natgillin/translations-raw huggingface dataset:
No metabolic effects of ingested insulin glargine on the breastfed newborn/infant are anticipated since insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract.
Ne očekuju se metabolički učinci progutanog inzulina glargina u dojene novorođenčadi/dojenčadi jer se inzulin glargin, s obzirom da je peptid, u ljudskom probavnom sustavu probavlja u aminokiseline.
No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes).
Nije primijećena metabolizam avibaktama u preparatima ljudske jetre (mikrosomi i hepatociti).
No metabolites of telbivudine were detected following administration of 14C-telbivudine in humans.
Nakon primjene 14C-telbivudina u ljudi nisu nađeni metaboliti telbivudina.
No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines.
Za HPV cjepiva nije određena minimalna razina protutijela povezanih sa zaštitom od CIN-a stupnja 2 ili 3 ili od perzistentne infekcije cjepnim HPV tipovima.
No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines.
Za HPV cjepiva nije određena minimalna razina protutijela povezanih sa zaštitom od CIN-a stupnja 2 ili 3 ili od perzistentne infekcije cjepnim tipovima HPV-a.
No more doses can be delivered after this and IONSYS will be removed by your doctor or nurse.
Nakon toga se ne može isporučiti nijedna doza, a IONSYS će ukloniti liječnik ili medicinska sestra.
No more than 2 doses should be given within 24 hours.
Tijekom 24 sata ne smiju se dati više od dvije doze.
No more than 3 attempts per affected joint are recommended to disrupt a cord.
Ne preporučuje se više od 3 pokušaja raskidanja tračka po zahvaćenom zglobu.
No more than 4 patches should be used at the same time.
Ne smije se primijeniti više od 4 flastera odjednom.
No more than two courses of Eurartesim may be given within a 12 month period (see sections 4.4 and 5.3).
U razdoblju od 12 mjeseci ne smije se dati više od dvije kure Eurartesima (vidjeti dijelove 4.4 i 5.3).
No mutation
Bez mutacije
No natural rubber latex has to date been detected in the removable needle cap.
U zatvaraču igle koji se može skinuti do danas nije detektirana prirodna lateks guma.
No Nausea (Likert Scale) p-value c
Bez mučnine (Likertova ljestvica) p-vrijednost c
No Nausea (Likert Scale) p-valuec
Bez mučnine (Likertova ljestvica) p-vrijednost c
No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.
Na štrcaljku za usta ne smije se pričvrstiti igla, intravenska cjevčica niti bilo koja druga naprava za parenteralnu primjenu.
No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.
Na štrcaljku za usta ne smiju biti spojeni ni igla, ni intravenska kanila niti bilo koje drugo pomagalo za parenteralnu primjenu.
No needles are involved in the preparation of EVICEL for administration.
Za pripravu lijeka EVICEL za primjenu ne koriste se igle.
No needles are involved in the preparation of EVICEL for administration.
Za pripremu lijeka EVICEL za primjenu ne koriste se igle.
No needles are involved in the preparation of EVICEL for administration.
Za pripremu lijeka EVICEL za primjenu nisu potrebne igle.
No needles are supplied with the product.
Igle nisu priložene u pakiranju lijeka.
No neutropenia at baseline
Bez neutropenije na početku
No new ADRs have been added and no ADRs have been removed, other than “anorexia” which has been re-classified as “decreased appetite”.
Nisu dodane nove nuspojave, niti su uklonjene postojeće, osim "anoreksije" koja je prekvalificirana kao "smanjen apetit".
No new adverse drug reactions were identified with the addition of Incruse to FF/VI in these studies.
U tim ispitivanjima nisu identificirane nove nuspojave kod dodavanja lijeka Incruse kombinaciji FF/VI.
No New ENF*
Bez novog ENF
No new events of progressions to AP/BC were reported on-treatment since the 2-year analysis.
Nije bilo zabilježenih novih događaja progresije do ubrzane faze/blastične krize tijekom liječenja od vremena analize provedene nakon 2 godine.
No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
. Nisu identificirane nove sigurnosne bojazni za dojenčad mlađu od 12 mjeseci koja boluje od epilepsije.
No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
Nisu pronađene nikakve nove sigurnosne mjere za levetiracetam u dojenčadi mlađoj od 12 mjeseci starosti s epilepsijom.
No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to <2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
Nisu identificirani novi sigurnosni signali u analizama podataka nakon 48 tjedana iz ispitivanja APV29005 ili APV20002, u kojima su 54 ispitanika u dobi od 4 tjedna do < 2 godine primala fosamprenavir/ritonavir dvaput na dan uz osnovnu terapiju nukleozidnim inhibitorima reverzne transkriptaze, dok je njih 5 primilo samo jednokratnu dozu fosamprenavira s ritonavirom ili bez njega.
No new safety concerns were observed when Bortezomib Accord was added to the standard pediatric pre B cell ALL chemotherapy backbone.
Nisu zabilježena nova sigurnosna pitanja kada je Bortezomib Accord bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
No new safety concerns were observed when VELCADE was added to the standard pediatric pre B cell ALL chemotherapy backbone.
Nisu zabilježena nova sigurnosna pitanja kada je VELCADE bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
No new safety concerns were raised in either treatment group.
Ni u jednoj liječenoj skupini nije bila ugrožena sigurnost.
No new safety findings were identified in the 192 week analysis of the treatment- naïve subjects in which the mean treatment duration of PREZISTA/ritonavir 800/100 mg once daily was 162.5 weeks.
U 192 tjednoj analizi nije bilo novih sigurnosnih nalaza u prethodno neliječenih ispitanika, a u kojih je srednja vrijednost trajanja liječenja lijekom PREZISTA/ritonavir od 800/100 mg jednaput na dan bila 162,5 tjedna.
No new safety findings were identified.
Nisu identificirani novi sigurnosni podaci.
No new safety findings were observed.
Nisu primijećeni novi podaci u vezi sigurnosti.
No new safety signals have been identified in patients exposed to 0.05 mg/kg/day of Revestive for up to 30 months in a long-term open-label extension study.
Kod bolesnika koji su do 30 mjeseci u dugotrajnom otvorenom produžetku ispitivanja bili izloženi dozi lijeka Revestive od 0,05 mg/kg/dan nisu ustanovljeni novi sigurnosni signali.
No new unexpected safety signals were observed in this trial.
U ovom ispitivanju nisu opaženi novi neočekivani sigurnosni signali.
No non-clinical studies to evaluate the potential of dinutuximab to cause carcinogenicity, genotoxicity, or developmental and reproductive toxicity have been conducted.
Nisu provedena neklinička ispitivanja za procjenu potencijala dinutuksimaba za izazivanje kancerogenosti, genotoksičnosti ili razvojne i reproduktivne toksičnosti.
No non-specific tissue cross-reactivity was demonstrated when canakinumab was applied to normal human tissues.
Nije se pokazala nikakva nespecifična križna reaktivnost tkiva kada se kanakinumab primjenjivao na normalna ljudska tkiva.
No non-specific tissue cross-reactivity was observed when secukinumab was applied to normal human tissue.
Nije bila uočena nespecifična križna reaktivnost tkiva kada se sekukinumab primijenio na normalno ljudsko tkivo.
No NOTEL (No Observed Toxic Effect Level) could be established in the preclinical studies with the exception of a 7-day administration of 0.1 µg/kg in monkeys.
No Observed Toxic Effect Level; razina bez utvrđenih toksičnih učinaka) nije utvrđen u pretkliničkim ispitivanjima, s iznimkom 7-dnevne primjene 0,1 µg/kg kod majmuna.
No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
Reproduktivna ispitivanja na gravidnim štakorima i kunićima nisu ukazala na teratogeni potencijal (vidjeti dio 5.3).
No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
Reproduktivna ispitivanja na gravidnim ženkama štakora i kunića nisu ukazala na teratogeni potencijal (vidi dio 5.3).
No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
Reproduktivna ispitivanja na gravidnim ženkama štakora i kunića nisu ukazala na teratogeni potencijal (vidjeti dio 5.3).
No of
Broj
No of patients included in the analysis No. (%) of patients with event
Broj bolesnika uključenih u analizu
No of patients with post baseline value
Broj pacijenata s naknadnim vrijednostima
No of positive
Broj pozitivnih
No of positive nodes
Broj pozitivnih limfnih čvorova
No or minimal fibrosis or portal fibrosis
Bolesnici s prethodnim relapsoma
No oral antipsychotic supplementation was allowed.
Nije bilo dozvoljeno dodavanje oralnih antipsihotika.
No other adverse effects other than those mentioned under “Adverse reactions” have been observed after administration of a 10-fold overdose of the vaccine.
Nakon primjene deseterostruke propisane doze nisu zapažene druge nuspojave osim onih navedenih u odjeljku 6 (Nuspojave).
No other adverse reactions except those mentioned in section ‘Adverse Reactions’ were observed.
Nisu primijećene druge nuspojave osim onih već spomenutih u odjeljku ‘Nuspojave’.
No other adverse reactions except those mentioned in section ‘Adverse Reactions’ were observed.
Nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku ’Nuspojave’.
No other clinically significant drug interaction has been reported during follitropin alfa therapy.
Ne postoje izvješća ni o jednoj drugoj klinički značajnoj interakciji s lijekovima za vrijeme primjene folitropina alfa.
No other formal DDI studies with olaratumab and medicinal products commonly used in cancer patients, including those with STS (e.g. antiemetics, analgesics, anti-diarrheal drugs, oral contraceptives, etc.), have been performed.
Nisu provedena druga formalna ispitivanja interakcija između olaratumaba i lijekova koji se često koriste u bolesnika oboljelih od raka, uključujući one sa sarkomom mekog tkiva (npr. antiemetici, analgetici, antidijaroici, oralni kontraceptivi itd.).
No other liquids, including grapefruit juice, should be used for dilution.
Za razrjeđivanje se ne smiju koristiti nikakve druge tekućine, što uključuje i sok od grejpa.
No other medicinal products should be added to the prepared irrigation solution.
Drugi lijekovi ne smiju se dodavati u pripremljenu otopinu irigata.
No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection.
Niti jedan drugi lijek ne smije se ubrizgati putem namijenjenim ubrizgavanju lijeka Rapilysin, ni istodobno, ni prije, ni nakon ubrizgavanja lijeka Rapilysin.
No other medicines should be injected through the line reserved for Rapilysin, either at the same time, or before or after Rapilysin injection.
Niti jedan drugi lijek ne smije se ubrizgavati intravenskim putem namijenjenim ubrizgavanju lijeka Rapilysin, ni istodobno, ni prije, ni nakon ubrizgavanja lijeka Rapilysin.
No other medicines should be injected through the line reserved for Rapilysin, neither at the same time, nor prior to, nor following Rapilysin injection.
Niti jedan drugi lijek ne smije se ubrizgavati kroz intravenski put namijenjen ubrizgavanju lijeka Rapilysin, ni istodobno, ni prije, ni nakon ubrizgavanja lijeka Rapilysin.
No other metabolites were identifiable.
Nisu pronaĎeni nikakvi drugi metaboliti.
No other patient tested positive for anti-siltuximab antibodies and this results in an incidence rate of 0.2% for the 411 evaluable patients.
Niti jedan drugi bolesnik nije imao pozitivan rezulat na anti-siltuksimab protutijela, a to je rezultiralo incidencijom od 0,2% za 411 procijenjenih bolesnika.
No other preparations may be added to the Zutectra solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins.
Otopini lijeka Zutectra ne smiju se dodavati drugi preparati jer bi promjena koncentracije elektrolita ili pH vrijednosti mogla prouzročiti precipitaciju ili denaturaciju proteina.
No other significant clinically relevant interactions with CYPP450s were observed.
Druge klinički značajne interakcije s enzimima skupine CYPP450 nisu primijećene.
No other solutions should be used for reconstitution (see section 6.2).
Za rekonstituciju se ne smiju se upotrebljavati druge otopine (vidjeti dio 6.2).
No other treatment­related tumours have been found.
Nisu nađeni nikakvi drugi tumori povezani s liječenjem.
No overall clinically relevant adverse impact in paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on neurocognitive and developmental assessment.
Nije uočen ukupni klinički značajan štetan utjecaj na pedijatrijske bolesnike u dobi od 6 do 17 godina nakon liječenja aliskirenom u trajanju do jedne godine temeljem neurokognitivne i razvojne procjene.
No overall clinically relevant adverse impact on paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on neurocognitive and developmental assessment.
Nije uočen ukupni klinički značajan štetan utjecaj na pedijatrijske bolesnike u dobi od 6 do 17 godina nakon liječenja aliskirenom u trajanju do jedne godine temeljem neurokognitivne i razvojne procjene.
No overall differences in effectiveness were observed between patients over 65 years and younger adult patients.
Sveukupno nije primijećena razlika u učinkovitosti između bolesnika starijih od 65 godina i mlađih odraslih bolesnika.
No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients.
Općenito, nisu primijećene razlike u djelotvornosti ili sigurnosti primjene kod bolesnika od 65 godina i starijih koji su primali STELARU u usporedbi s mlađim bolesnicima, međutim broj bolesnika od 65 godina i starijih nije dostatan kako bi se utvrdilo jesu li na liječenje odgovorili različito od mlađih bolesnika.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Ukupno nisu uočene razlike u sigurnosti i učinkovitosti između starijih i mlađih bolesnika.
No overall differences in safety of Zurampic were observed in patients with mild or moderate renal impairment (eCrCL of 30-89 mL/min) compared to patients with normal renal function (see sections 4.2 and 5.2).
Nisu zamijećene sveukupne razlike u sigurnosti lijeka Zurampic u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega (eCrCL od 30 do 89 ml/min) u usporedbi s bolesnicima s normalnom funkcijom bubrega (vidjeti dijelove 4.2 i 5.2).
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Sveukupne razlike u sigurnosti i djelotvornosti nisu uočene između ispitanika starijih od 65 godina u odnosu na mlade odrasle (> 18 godina) ispitanike koji primaju citotoksičnu kemoterapije te kliničkim iskustvom nije identificirana razlika u odgovorima između starijih i mlađih odraslih bolesnika.
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Ukupne razlike u sigurnosti ili učinkovitosti nisu zabilježene u ispitanika starijih od 65 godina u usporedbi s mladim odraslim ispitanicima (> 18 godina starosti) koji su primali citotoksičnu kemoterapiju, a kliničko iskustvo nije utvrdilo razlike u odgovorima između starijih i mlađih odraslih bolesnika.
No overall differences in safety or effectiveness were observed between these older patients and younger patients.
Nije primijećena sveukupna razlika u sigurnosti primjene ili djelotvornosti između ovih bolesnika starije dobi i mlađih bolesnika.
No overall differences in safety or effectiveness were observed between these patients and younger patients therefore there is no need for dose adjustment in elderly patients.
Sveukupno, nisu primijećene razlike u sigurnosti ili učinkovitosti između tih bolesnika i mlađih bolesnika, stoga nije potrebno podešavati dozu u starijih bolesnika.
No overall differences in safety or effectiveness were observed between women aged >65 years and younger women, but greater sensitivity of some older individuals cannot be ruled out.
Ukupne razlike u sigurnosti i djelotvornosti nisu uočene u žena dobi > 65 godina i mlađih žena, no ne može se isključiti veća osjetljivost nekih starijih bolesnica.
No overall differences in safety or efficacy were observed between these patients and younger patients
Sveukupno, nisu uočene razlike u sigurnosti ili djelotvornosti između tih i mlađih bolesnika.
No overall differences in safety or efficacy were observed in elderly patients (≥ 65 years of age) treated with Vectibix monotherapy.
Kod starijih bolesnika (dob ≥ 65 godina) liječenih lijekom Vectibix u monoterapiji nisu opažene ukupne razlike u sigurnosti ili djelotvornosti.
No overall differences in safety or efficacy were reported between elderly ( ≥65 years) and younger patients (< 65 years).
Sveukupno nisu prijavljene razlike u sigurnosti i djelotvornosti između starijih osoba ( ≥65 godina) i mlađih bolesnika (< 65 godina).
No overall differences in safety or efficacy were reported between elderly patients (≥ 65 years) and younger patients (< 65 years).
Sveukupno nisu prijavljene razlike u sigurnosti ili djelotvornosti između starijih bolesnika (≥65 godina) i mlađih bolesnika (<65 godina).
No overall differences in safety were observed between the geriatric patients and younger patients; therefore, no dosage adjustment is recommended for geriatric patients.
Nisu primijećene opće razlike u sigurnosti između bolesnika starije dobi i mlađih bolesnika te se stoga ne preporučuje prilagođavati doziranje za starije bolesnike.
No overall differences were observed in the safety profile of elderly patients ≥ 65 years of age and younger adult patients < 65 years of age in the clinical studies.
U kliničkim ispitivanjima nisu opažene sveukupne razlike u sigurnosnom profilu između starijih bolesnika u dobi ≥ 65 godina i mlađih odraslih bolesnika u dobi < 65 godina.
No overall survival benefit has been observed.
Nije uočeno da bi liječenje povećavalo ukupno preživljenje.
No paediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
Nisu bile potrebne specifične pedijatrijske doze za postizanje željene razine IgG u serumu.
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Levodopa/Carbidopa/Entacapone Orion therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Nisu objavljena posebna ispitivanja farmakokinetike levodope i karbidope kod bolesnika s bubrežnom insuficijencijom, pa se stoga terapija Levodopa/Carbidopa/Entacapone Orionom mora oprezno primjenjivati kod bolesnika s teškim bubrežnim oštećenjem, uključujući bolesnike na dijalizi (vidjeti dio 5.2).
No particular studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment are reported, however, it is advised that Levodopa/Carbidopa/Entacapone Orion should be administered cautiously to patients with mild or moderate hepatic impairment.
Nisu objavljena posebna ispitivanja farmakokinetike karbidope i levodope kod bolesnika s oštećenjem jetre, međutim, savjetuje se oprezna primjena Levodopa/Carbidopa/Entacapone Oriona kod bolesnika s blagim ili umjerenim oštećenjem jetre.
No patient developed grade 4 thrombocytopenia.
Trombocitopenija stupnja nije nastupila niti u jednog bolesnika.
No patient developed HAHA to Gazyvaro during or following Gazyvaro treatment.
Nijedan bolesnik nije razvio HAHA na Gazyvaro tijekom ili nakon liječenja lijekom Gazyvaro.
No patient had a QTcF >480 msec.
Niti jedan bolesnik nije imao QTcF >480 msek.
No patient had an absolute QTcF >500 msec while on the study medicinal product.
Niti jedan bolesnik nije imao QTcF >500 msek tijekom primjene ispitivanog lijeka.
No patient required new dialysis with Soliris.
Niti jednom bolesniku nije bilo potrebno novo liječenje dijalizom uz Soliris.
No patient taking HMG-CoA reductase inhibitors experienced grade 3/4 CK elevations, as opposed to 6 (9.0%) patients not taking HMG-CoA reductase inhibitors.
Nijedan bolesnik koji je uzimao inhibitore HMG-CoA reduktaze nije imao povišenja CPK stupnja 3/4, za razliku od 6 (9,0%) bolesnika koji nisu uzimali inhibitore HMG-CoA reduktaze.
No patients discontinued from the study due to a TEAE in the SBR arm.
Nijedan bolesnik nije isključen iz ispitivanja zbog TEAE u SBR skupini.
No patients discontinued from the study due to a TEAE in the SBR arm.
Nijedan pacijent u skupini koja je ostala na početnom režimu liječenja nije prekinuo sudjelovanje u ispitivanju zbog štetnih događaja koji su se pojavili uz liječenje.
No patients discontinued rilpivirine due to adverse reactions.
Nijedan bolesnik nije prekinuo liječenje rilpivirinom zbog nuspojava.
No patients discontinued study drug because of ADRs during the blinded study treatment phase.
Nijedan bolesnik nije prestao uzimati ispitivani lijek zbog nuspojava na lijek tijekom faze slijepog ispitivanja liječenja.
No patients discontinued study drug due to ADRs.
Nijedan bolesnik nije prestao uzimati ispitivani lijek zbog nuspojava na lijek.
No patients had a maximum QTcF ≥480 msec.
Niti jedan bolesnik nije imao maksimalnu vrijednost QTcF ≥ 480 msek.
No patients had a QTc interval >500 msec.
Niti jedan bolesnik nije imao QTc-interval > 500 msek.
No patients of ≥ 65 years of age were included in clinical trials.
Bolesnici ≥ 65 godina nisu bili uključeni u klinička ispitivanja.
No patients with genotype 1 HCV had on-treatment virologic failure.
Nijedan bolesnik s infekcijom HCV-om genotipa 1 nije imao virološki neuspjeh tijekom liječenja.
No patients with genotype 5 HCV infection were enrolled.
Nije bio uključen nijedan bolesnik s genotipom 5 HCV-a.
No patients with NYHA III/IV were included in the study.
U ispitivanje nije bio uključen niti jedan bolesnik sa NYHA stupnjem III/IV.
No patients with severe hepatic impairment were included in clinical studies of idelalisib.
U klinička ispitivanja idelalisiba nisu bili uključeni pacijenti s teškim oštećenjem funkcije jetre.
No pattern of abnormal haematological or coagulation parameters has been observed in patients in general, or preceding the development of ICH.
U bolesnika liječenih Aptivusom nije uočen poseban obrazac poremećaja hematoloških ili koagulacijskih parametara, niti općenito niti prije pojave ICH.
No pattern of birth defects suggestive of a common etiology was seen.
Biljni pripravci koji sadrže gospinu travu ne smiju se kombinirati s lopinavirom ni ritonavirom.