natgillin/translations-raw huggingface dataset:
In addition, a reduction in corticosteroid dose of 5 mg daily, although modest, was considered clinically relevant, given the complications of long-term corticosteroid treatment.
Poleg tega je bilo zmanjšanje odmerka kortikosteroidov za 5 mg na dan, čeprav majhno, ocenjeno za klinično pomembno glede na zaplete pri dolgotrajnem zdravljenju s kortikosteroidi.
In addition, a screw cap (ethylene vinyl acetate / LDPE) with syringe-port capability is provided.
Priložena je tudi navojna zaporka (iz etilen vinil acetata in LDPE) z nastavkom, ki omogoča namestitev brizge.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine- responsive patients.
Dodatno je slikovna študija s fotonsko emisijsko računalniško tomografijo (Single Photon Emission Computed Tomography – SPECT) pri bolnikih s shizofrenijo razkrila, da so imeli bolniki, ki so se odzivali na olanzapin, nižjo zasedenost striatnih D2 receptorjev kot bolniki, ki so se odzivali na nekatere druge antipsihotike in risperidon, medtem ko je bila primerljiva z bolniki, ki so se odzivali na klozapin.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Dodatno je slikovna študija s fotonsko emisijsko računalniško tomografijo (Single Photon Emission Computed Tomography – SPECT) pri bolnikih s shizofrenijo razkrila, da so imeli bolniki, ki so se odzivali na olanzapin, nižjo zasedenost striatnih D2 receptorjev kot bolniki, ki so se odzivali na nekatere druge antipsihotike in risperidon, medtem ko je bila primerljiva z bolniki, ki so se odzivali na klozapin.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Dodatno je SPECT (Single Photon Emission Computed Tomography) slikovna študija pri bolnikih s shizofrenijo razkrila, da so imeli bolniki, ki so se odzivali na olanzapin, nižjo zasedenost striatnih D2 receptorjev kot bolniki, ki so se odzivali na nekatere druge antipsihotike in risperidon, medtem ko je bila primerljiva z bolniki, ki so se odzivali na klozapin.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Slikovna raziskava SPECT (Single Photon Emission Computed Tomography) je pri bolnikih s shizofrenijo razkrila, da je bila zasedenost striatnih receptorjev D2 pri bolnikih, ki so se odzivali na olanzapin, manjša kot pri bolnikih, ki so se odzivali na nekatere druge antipsihotike in na risperidon, medtem ko je bila primerljiva z bolniki, ki so se odzivali na klozapin.
In addition, a statistically significant reduction was found in the incidence of hip fractures (1.1 % vs.
Statistično značilno zmanjšanje je bilo ugotovljeno tudi za pojavnost zlomov kolka (1,1 % v primerjavi z
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Razen tega analiza podskupin glede na starost nakazuje, da so koristi klopidogrela pri bolnikih, starejših od 75 let, manjše od tistih, ki so jih opazili pri bolnikih ≤75 let.
In addition, a third study is ongoing in 5,623 patients where previous treatment with another disease-modifying therapy had failed (glatiramer acetate, beta-interferon or fingolimod).
Poleg tega trenutno poteka še tretja študija, ki vključuje 5 623 bolnikov, pri katerih zdravljenje z drugim zdravilom za spreminjanje poteka bolezni (glatiramer acetatom, interferonom-beta ali fingolimodom) ni bilo uspešno.
In addition, a total of 169 cases have been associated with an antidepressant and 27 cases with antipsychotics, 48,5% and 55,5% respectively, reported lack of efficacy while receiving orlistat 60 mg in association with antidepressants, antipsychotics and lithium.
Dodatno je bilo skupaj 169 primerov, povezanih z antidepresivi, in 27 primerov, povezanih z antipsihotiki, o pomanjkanju učinkovitosti so poročali pri 48,5 % primerov, ko so prejemali orlistat 60 mg skupaj z antidepresivi in 55,5 % primerov, ko so prejemali orlistat skupaj z antipsihotiki in litijem.
In addition, a variety of adverse effects have been reported with marketed use of either Merck PRP- OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine in infants and children through 71 months of age.
Poleg tega so bili med obdobjem tržne uporabe Merckovih cepiv PRP - OMPC oz. (rekombinantnega) cepiva proti hepatitisu B pri dojenčkih in otrocih do 71. meseca starosti zabeležni različni neželeni učinki.
In addition, after three years the risk of new spine fractures was lower in patients who received Prolia.
Prav tako je bilo po treh letih tveganje za nove zlome hrbtenice manjše pri bolnikih, ki so jemali zdravilo Prolia.
In addition, aggressive behaviour was observed.
Dodatno se je opazilo tudi agresivno vedenje.
In addition, all patients in this study received exemestane.
Poleg tega so vsi bolniki v tej študiji prejemali eksemestan.
In addition, all patients should receive adequate iron supplementation (e.g.
Poleg tega naj vsi bolniki med zdravljenjem z zdravilom Retacrit prejemajo ustrezne nadomestke železa (npr.
In addition, although in the defibrotide studies in VOD there have been no reports of hypersensitivity, cases of hypersensitivity including anaphylaxis were reported from a previously marketed formulation of defibrotide, consequently hypersensitivity is included as an ADR
V študijah VOB z defibrotidom ni bilo nobenih poročil o preobčutljivosti, vendar so o primerih preobčutljivosti, vključno z anafilakso, poročali pri pripravku defibrotida, ki je bil predhodno na trgu, zato je preobčutljivost vključena kot neželeni učinek.
In addition, although the risk for ONJ may be well known for the prescribers, further awareness on such risk is needed for the patients.
Zdravniki, ki zdravilo predpisujejo, verjetno dobro poznajo tveganje za osteonekrozo čeljustnic, dodatno pa je treba poskrbeti, da se bodo tega tveganja v večji meri zavedali tudi bolniki.
In addition, an increased incidence of significant elevations of ALT was observed in patients treated with tolvaptan [4.4% (42/958)] compared to those receiving placebo [1.0% (5/484)].
Pri bolnikih, zdravljenih s tolvaptanom [4,4 % (42/958)], so opazili tudi večjo incidenco pomembnih povečanj ALT v primerjavi s tistimi, ki so prejemali placebo [1,0 % (5/484)].
In addition, an increased incidence of significant elevations of ALT was observed in patients treated with tolvaptan [4.4% (42/958)] compared to those receiving placebo [1.0% (5/484)].
Pri bolnikih, zdravljenih s tolvaptanom [4,4 % (42/958)], so opazili tudi večjo incidenco pomembnih povečanj ALT, v primerjavi s tistimi, ki so prejemali placebo [1,0 % (5/484)].
In addition, an updated RMP should be submitted
Poleg tega je treba posodobljen RMP predložiti tudi:
In addition, an updated RMP should be submitted
Poleg tega je treba predložiti posodobljen načrt obvladovanja tveganja:
In addition, an updated RMP should be submitted;
Poleg tega je treba posodobljen RMP predložiti:
In addition, any prescriber of Uptravi will also have to register first with the company that markets Uptravi before being able to prescribe it.
Poleg tega se bo moral vsakdo, ki bo želel predpisovati zdravilo Uptravi, pred začetkom predpisovanja registrirati pri družbi, ki ga trži.
In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY (see Tables 1A, 1B, and section 4.4).
Poleg tega je med zdravljenjem z zdravilom YERVOY treba ovrednotiti kateri koli znak ali simptom imunsko pogojenih neželenih učinkov, vključno z drisko in s kolitisom (glejte tabeli 1A in 1B ter poglavje 4.4).
In addition, apremilast demonstrated a treatment benefit across multiple manifestations of psoriasis including pruritus, nail disease, scalp involvement and quality of life measures.
Poleg tega je apremilast pokazal koristnost zdravljenja pri številnih manifestacijah psoriaze, vključno s pruritusom, boleznijo nohtov, prizadetostjo lasišča in merilih kvalitete življenja.
In addition, around 65% of patients given Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.
Poleg tega je približno 65 % bolnikov, ki so prejemali zdravilo Feraccru, doseglo normalne ravni hemoglobina, v primerjavi z 10 % bolnikov, ki so prejemali placebo.
In addition, as with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Poleg tega se lahko pri nekaterih bolnikih, kot pri vseh zdravilih, ki vsebujejo beljakovino, pojavijo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Omnitrope).
In addition, at Week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1, or a PASI- 50 response in ESTEEM 2, were permitted to use topical psoriasis therapies and/or phototherapy in addition to apremilast 30 mg BID treatment.
Poleg tega so smeli preiskovanci, ki do 32. tedna niso dosegli odziva PASI-75 v študiji ESTEEM 1 ali odziva PASI-50 v študiji ESTEEM 2, uporabljati poleg zdravljenja z apremilastom 30 mg dvakrat na dan lokalna zdravila za psoriazo in/ali fototerapijo.
In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme’ (a programme through which doctors can request a medicine for one of their patients before it is authorised).
Poleg tega so zdravilo ATryn uporabili pri petih bolnikih, ki so zdravilo prejeli med kirurškim posegom v okviru „programa sočutne uporabe zdravila“ (programa, ki zdravnikom omogoča, da za katerega od svojih bolnikov zahtevajo zdravilo, preden je to v celoti odobreno).
In addition, based on surface area (mg/m2) dose ratios resulted in approximately 0.6 to 22 times and 1.0 to 29 times in males and females, respectively, the clinical dose of 20 mg.
Poleg tega so glede na površino (mg/m2) razmerja odmerkov v primerjavi s kliničnim odmerkom 20 mg pri samcih približno 0,6- do 22-kratna, pri samicah pa 1,0- do 29-kratna.
In addition, before starting to use this medicine, tell your doctor if you:
Prav tako pred začetkom uporabe tega zdravila obvestite zdravnika, če:
In addition, before starting to use this medicine, tell your doctor if you: have been told by a doctor that pregnancy would be dangerous for you.
Poleg tega morate pred začetkom uporabe tega zdravila zdravnika obvestiti: če vam je kakšen zdravnik kdaj rekel, da bi bila nosečnost za vas nevarna.
In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Forxiga.
Poleg tega so pri bolnikih, ki so prejemali zdravilo Forxiga, zabeležili koristno zmanjšanje telesne mase in znižanje krvnega tlaka.
In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Jardiance.
Poleg tega so pri bolnikih, ki so prejemali zdravilo Jardiance, zabeležili ugodno zmanjšanje telesne mase in krvnega tlaka.
In addition, beneficial reductions in weight and blood pressure were seen.
Poleg tega so zabeležili koristno zmanjšanje telesne mase in znižanje krvnega tlaka.
In addition, between one and two thirds of the patients in the five main trials showed a reduction in the number of white blood cells containing the Philadelphia chromosome.
Poleg tega je bilo v petih glavnih študijah pri eni do dveh tretjinah bolnikov opaziti padec števila belih krvnih celic s kromosomom Philadelphia.
In addition, by inhibiting protein synthesis and cell division, Oncaspar can disturb the mechanism of action of other substances which require cell division for their effect, e.g. methotrexate.
Poleg tega lahko zdravilo Oncaspar, z inhibicijo sinteze beljakovin in celične delitve, moti mehanizem delovanja drugih učinkovin, ki za svoj učinek potrebujejo celično delitev, kot je npr. metotreksat.
In addition, carfilzomib administration resulted in inhibition of the latent membrane protein 2 (LMP2) and multicatalytic endopeptidase complex-like 1 (MECL1) subunits of the immunoproteasome ranging from 26% to 32% and 41% to 49%, respectively, at 20 mg/m2.
Poleg tega je karfilzomib v odmerku 20 mg/m2 zavrl imunoproteasomski podenoti, in sicer latentni membranski protein 2 (LMP2) za 26 do 32 % in multikatalitičnemu endopeptidaznemu kompleksu podobno (MECL1) podenoto za 41 do 49 %.
In addition, caution is warranted when using telavancin to treat patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
Poleg tega je previdnost potrebna pri uporabi telavancina za zdravljenje bolnikov s kongenitalnim sindromom dolgega intervala QT, znanim podaljšanjem intervala QTc, nekompenzirano odpovedjo srca ali hudo hipertrofijo levega prekata.
In addition, children and adolescents have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Poleg tega so zdravili otroke in mladostnike v dveh študijah prve faze (pri bolnikih s KML ali Ph+ akutno levkemijo) in eni študiji druge faze.
In addition, children have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Poleg tega so zdravili otroke v dveh študijah prve faze (pri bolnikih s KML ali z akutno Ph+ levkemijo) in eni študiji druge faze.
In addition, clinical tolerance was good in all patients.
Klinično prenašanje je bilo dobro pri vseh bolnikih.
In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Dodatno pa ima klomipramin tudi antiholinergični učinek zaradi antagonizma holinergičnih muskarinskih receptorjev.
In addition, co-administration of Aptivus with low dose ritonavir, and medicinal products that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide, propafenone and metoprolol given in heart failure (see section 4.5).
Tudi sočasna uporaba zdravila Aptivus ob hkratnem jemanju z majhnimi odmerki ritonavirja in zdravil, katerih očistek je zelo odvisen od CYP2D6, na primer antiaritmikov flekainida, propafenona in metoprolola za zdravljenje srčnega popuščanja (glejte poglavje 4.5).
In addition, compared with free cytarabine, the formulation increases the biological half-life by a factor of 27 to 71 depending upon the route of administration and the compartment sampled.
Poleg tega ta farmacevtska oblika v primerjavi s prostim citarabinom poveča biološki razpolovni čas za faktor 27 do 71, odvisno od načina uporabe in prostora, iz katerega so jemali vzorce.
In addition, concomitant use of pazopanib and other statins should be undertaken with caution as there are insufficient data available to assess their impact on ALT levels.
Poleg tega je treba pazopanib skupaj z drugimi statini uporabljati previdno, ker ni dovolj podatkov za oceno njihovega vpliva na raven ALT.
In addition, Day+100 survival rate was improved in the Defitelio group with 38.2% (39/102) of the patients surviving versus 25.0% (8/32) in the historical control group (p=0.034).
Poleg tega se je po 100. dnevu izboljšal delež preživetja v skupini z zdravilom Defitelio, v kateri je preživelo 38,2 % bolnikov (39/102), v primerjavi z zgodovinsko kontrolno skupino z deležem 25,0 % (8/32) (p = 0,034).
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Poleg tega so ugotovili, da docetaksel deluje na nekatere, ne pa na vse celične linije z močno izraţenim p- glikoproteinom, ki ga kodira gen za odpornost proti več zdravilom.
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Poleg tega so ugotovili, da docetaksel deluje na nekatere, ne pa na vse celične linije z močno izraženim p- glikoproteinom, ki ga kodira gen za odpornost proti več zdravilom.
In addition, doctors may perform ECG continuously during
Enako opazovanje bolnika, ki se zahteva ob prvem odmerku, bo morda
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of IntronA with ribavirin.
Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila IntronA in ribavirina imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Pegasys with ribavirin.
Dodatno imajo lahko suha usta pri dolgotrajnem kombiniranem jemanju zdravila Pegasys in ribavirina škodljiv vpliv na zobe in membrane ust.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Viraferon with ribavirin.
Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila Viraferon in ribavirina imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
In addition, dry mouth that could have a damaging effect on teeth and membranes of the mouth has been reported during long-term treatment with this medicine in combination therapy with an alpha interferon.
Poleg tega so med dolgotrajnim zdravljenjem s kombinacijo tega zdravila in interferona alfa-2b poročali o suhih ustih, ki imajo lahko škodljiv vpliv na zobe in ustno sluznico.
In addition, due to an increased risk of venous thromboembolic events associated with carfilzomib, females should avoid the use of hormonal contraceptives that are associated with a risk of thrombosis during treatment with carfilzomib (see section 4.4 and 4.8).
Poleg tega ženske zaradi večjega tveganja za venske tromboembolične dogodke, ki so povezani z uporabo karfilzomiba, med zdravljenjem s karfilzomibom ne smejo uporabljati hormonskih kontraceptivov, ki so povezani z večjim tveganjem za trombozo (glejte poglavje 4.4 in 4.8).
In addition, due to the possibility of up-titration if medically necessary to control the msSBP, no conclusion can be drawn on the appropriate posology of aliskiren in patients aged 6 to 17 years.
Poleg tega zaradi možnosti zviševanja odmerkov, ki je bilo potrebno za obvladovanje srednje vrednosti sistoličnega krvnega tlaka v sedečem položaju, ni mogoče podati zaključkov o primernosti odmerjanja aliskirena pri bolnikih v starosti 6 do17 let.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Poleg tega med trajanjem pandemije viri, potrebni za poglobljeno vrednotenje periodičnih poročil o varnosti zdravila v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti „Rules Governing Medicinal Product in the European Union – Volume 9a“ morda ne bodo zadostovali za hitro identifikacijo novih varnostnih izsledkov.
In addition, during a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Poleg tega med trajanjem pandemije, viri, potrebni za poglobljeno vrednotenje rednih posodobljenih poročil o varnosti zdravila v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti (”Rules Governing Medicinal Product in the European Union”– Volume 9a), morda ne bodo zadostovali za hitro identifikacijo novih varnostnih izsledkov.
In addition, during each 28-day cycle, the patient also receives cancer treatment with lenalidomide and dexamethasone.
Poleg tega bo med vsakim 28-dnevnim ciklom bolnik prejel tudi zdravila za zdravljenje raka, ki vsebujejo lenalidomid in deksametazon.
In addition, efficacy against uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated.
Poleg tega so dokazali učinkovitost proti manj pogostima rotavirusnima genotipoma G8P4 (hud gastroenteritis) in G12P6 (gastroenteritis katerekoli jakosti).
In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Poleg tega so poročali o povišanih vrednostih jetrnih encimov v primeru prevelikega odmerjanja z intravensko danim topotekanom.
In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2–1,680 mg/m2.
Dodatno so endomiokardno biopsijo opravili tudi pri 8 bolnikih s solidnimi tumorji s kumulativnimi odmerki antraciklinov od 509 do 1.680 mg/m2.
In addition, exploratory analysis showed that the impact of covariates (i.e., renal function, race and age) on the pharmacokinetics of total trastuzumab and DM1 was limited and was not clinically relevant.
Poleg tega je eksplorativna analiza pokazala, da je bil vpliv sospremenljivk (tj. delovanja ledvic, rase in starosti) na farmakokinetiko celokupnega trastuzumaba in DM1 majhen in ni bil klinično pomemben.
In addition, female partners of male patients treated with CellCept are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of CellCept.
Dodatno se partnerkam bolnikov, ki jemljejo zdravilo CellCept, priporoča, da uporabljajo zelo učinkovito kontracepcijo med zdravljenjem in v celotnih 90 dneh po zadnjem odmerku zdravila CellCept.
In addition, female partners of male patients treated with mycophenolate are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of mycophenolate.
Dodatno se partnerkam bolnikov, ki jemljejo mofetilmikofenolat, priporoča, da uporabljajo zelo učinkovito kontracepcijo med zdravljenjem in v celotnih 90 dneh po zadnjem odmerku mofetilmikofenolata.
In addition, female partners of male patients treated with mycophenolate mofetil are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of Myclausen.
Dodatno se partnerkam bolnikov, ki jemljejo zdravilo Myclausen, priporoča, da uporabljajo zelo učinkovito kontracepcijo med zdravljenjem in v celotnih 90 dneh po zadnjem odmerku zdravila Myclausen.
In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Poleg tega so v nadzoru sezonskih trivalentnih cepiv v obdobju trženja zdravila v vseh starostnih skupinah in sezonskih trivalentnih cepiv z adjuvansom MF59, katerih sestava je bila podobna cepivu Focetria (površinski antigen, inaktivirano cepivo, z adjuvansom MF59C.1), ki so bila odobrena za uporabo pri starostnikih nad 65 let, so poročali o naslednjih neželenih učinkih:
In addition, further to a signal work-up for diabetes insipidus, four out of five literature reports lead to a possible association with temozolomide therapy, therefore the product information should be updated accordingly.
Dodatno so pri obravnavanju znakov diabetesa insipidusa štiri literaturna poročila od petih kazala na možno povezavo z zdravljenjem s temozolomidom, zato je treba informacije o zdravilu ustrezno posodobiti.