natgillin/translations-raw huggingface dataset:
In addition to thalidomide, hydrolytic products N-(o- carboxybenzoyl) glutarimide and phthaloyl isoglutamine formed via non-enzymatic processes are also present in plasma and in majority in urine.
Poleg talidomida sta v plazmi in v večji meri v urinu prisotna hidrolitična produkta N-(o-karboksibenzoil) glutarimid in ftaloil izoglutamin, ki nastaneta z neencimskimi procesi.
In addition to the above adverse reactions, the following adverse reactions have been noted with the use of risperdone products and can be expected to occur with Xeplion.
Dodatno k zgoraj navedenim neželenim učinkom, so o naslednjih neželenih učinkih poročali pri uporabi risperidona, zato se lahko pojavijo tudi pri uporabi zdravila Xeplion.
In addition to the above criteria, clinician judgement must be exercised in the evaluation of the patient’s cardiovascular functions.
Poleg zgoraj navedenih kriterijev je za presojanje bolnikovih kardiovaskularnih funkcij potrebno klinično mnenje.
In addition to the above mentioned adverse reactions, hypersensitivity reactions have been reported in IOA users (frequency unknown).
Poleg zgoraj navedenih neželenih učinkov so pri uporabnicah zdravila IOA poročali tudi o preobčutljivostnih reakcijah (neznana pogostnost).
In addition to the above, except abnormal blood test results for liver function: ringing in the ears (tinnitus) only when taking the combination treatment.
Poleg zgoraj naštetega, razen nenormalnih izvidov preiskave krvi za delovanje jeter: zvonjenje v ušesih (tinitus) le med kombiniranim zdravljenjem.
In addition to the above, when capecitabine is used alone, the very common side effects which may affect more than 1 in 10 people are:
Poleg zgoraj omenjenih, se lahko, kadar se kapecitabin uporablja samostojno, zelo pogosto (pri več kot 1 bolniku od 10) pojavijo naslednji neželeni učinki:
In addition to the above, when capecitabine is used alone, very common side effects which may affect more than 1 in 10 people are:
Poleg zgoraj omenjenih, se lahko, kadar se kapecitabin uporablja samostojno, zelo pogosto (pri več kot 1 od 10 bolnikov) pojavijo naslednji neželeni učinki:
In addition to the above, when Capecitabine SUN is used alone, very common side effects which may affect more than 1 person in 10 are:
Poleg zgoraj omenjenih neželenih učinkov, se lahko pri samostojni uporabi zdravila Kapecitabin SUN zelo pogosto (pri več kot 1 bolniku od 10) pojavijo naslednji neželeni učinki:
In addition to the above:
Poleg zgoraj naštetega:
In addition to the ADRs listed above, the following adverse reactions have been observed during post- approval use of Hizentra:
Poleg zgoraj naštetih neželenih učinkov so v obdobju trženja zdravila Hizentra opazili tudi naslednje neželene učinke:
In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Po pridobitvi dovoljenja za uporabo rosiglitazona so poleg neželenih učinkov, odkritih med kliničnimi preskušanji poročali še o neželenih učinkih, ki so navedeni v preglednici 2.
In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience (frequency of these reactions is not known (cannot be estimated from the available data)):
Poleg stranskih učinkov, ki so jih opazili v kliničnih preskušanjih, so v obdobju trženja zdravila poročali o naslednjih stranskih učinkih (pogostnost teh učinkov ni znana (je ni mogoče oceniti iz razpoložljivih podatkov)):
In addition to the adverse reactions noted in the pivotal study, adverse reactions based on post-marketing experience with the medicinal product are provided after Table 3.
Poleg neželenih učinkov, opaženih v ključni študiji, so neželeni učinki, ki temeljijo na izkušnjah po začetku trženja zdravila, navedeni pod preglednico 3.
In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju s prevelikim odmerkom opazimo rahlo oteklino lokalnih limfnih vozlov.
In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process:
Poleg neželenih učinkov, opisanih v kliničnih preskušanjih, so bili po pridobitvi dovoljenja za promet s cepivom z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom opisani tudi naslednji neželeni učinki:
In addition to the adverse reactions seen in the pivotal clinical trials, there are also data from 875 patients from NCI studies/compassionate use programme (694 patients) and Phase I (181 patients) studies of nelarabine.
Razen podatkov o neželenih učinkih iz ključnih kliničnih preskušanj nelarabina, so na razpolago tudi podatki o 875 bolnikih, ki so bili vključeni v študije Nacionalnega onkološkega inštituta/program sočutne uporabe (694 bolnikov) in študije I. faze (181 bolnikov).
In addition to the anti-Xa and anti-IIa, further anticoagulant and anti-inflammatory properties have been identified in studies in healthy volunteers and patients, as well as in preclinical models.
Poleg delovanja anti-Xa in anti-IIa so v študijah pri zdravih prostovoljcih, bolnikih in v nekliničnih modelih ugotovili še dodatne antikoagulantne in protivnetne lastnosti.
In addition to the anti-Xa and anti-IIa, further anticoagulant and anti-inflammatory properties have been identified in studies in healthy volunteers and patients, as well as in preclinical models.
Razen delovanja anti-Xa in anti-IIa so v študijah pri zdravih prostovoljcih, bolnikih in v nekliničnih modelih ugotovili še dodatne antikoagulantne in protivnetne lastnosti.
In addition to the clinical signs given under section 6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Poleg kliničnih znakov, ki so opisani v poglavju 6, lahko cepljenje z 10-krat prevelikim odmerkom povzroči tudi absces na katerem od submandibularnih limfnih vozlov.
In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see table 1).
Poleg dnevnega odmerka morajo bolniki takoj po vsaki 4-urni hemodializi dobiti dodaten odmerek (glejte preglednico 1).
In addition to the daily dose, a supplementary dose should be given immediately following every 4- hour haemodialysis treatment (see Table 1).
Poleg dnevnega odmerka morajo bolniki takoj po vsaki 4-urni hemodializi dobiti dodaten odmerek (glejte preglednico 1).
In addition to the daily dose, a supplementary dose should be given immediately following every hour haemodialysis treatment (see Table 1).
Poleg dnevnega odmerka morajo bolniki takoj po vsaki 4-urni hemodializi dobiti dodaten odmerek (glejte preglednico 1).
In addition to the in-office penile modeling procedure, patients should be provided instructions on the appropriate technique to self-perform penile modeling activities at home each day for the 6-week period following the physician penile plaque modeling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
Poleg ambulantnega postopka modeliranja penisa je treba bolnikom dati navodila za ustrezno tehniko za samoizvajanje aktivnosti modeliranja penisa doma, vsak dan za obdobje 6 tednov po obisku vsakega cikla zdravljenja, na katerem zdravnik opravi modeliranje plaka penisa, v skladu s podrobnimi navodili iz navodila za uporabo.
In addition to the need for a colonoscopy with removal of polyps by the time of the initiation of the treatment (see section 4.4.), every patient should be assessed for the need of an enhanced surveillance schedule based on the patient characteristics (e.g., age and underlying disease, previous occurrence of polyps etc.).
Poleg potrebe po kolonoskopiji z odstranitvijo polipov ob začetku zdravljenja (glejte poglavje 4.4) je treba pri vsakem bolniku pretehtati potrebo po poostrenem nadzoru, odvisno od bolnikovih značilnosti (npr. starost in osnovna bolezen, predhodno pojavljanje polipov itd.).
In addition to the observed improvement in overall survival, key secondary endpoints (PSA progression, radiographic progression-free survival, and time to first skeletal-related event) favoured enzalutamide and were statistically significant after adjusting for multiple testing.
Poleg opaženega izboljšanja celokupnega preživetja so bili v korist enzalutamida tudi ključni sekundarni opazovani dogodki (napredovanje PSA, radiografsko preživetje brez napredovanja in čas do prvega z okostjem povezanega dogodka) in so bili statistično značilni po korekciji za večkratna testiranja.
In addition to the observed improvements in overall survival and rPFS, benefit was demonstrated for ZYTIGA vs. placebo treatment in all secondary endpoint measures as follows:
Poleg opaženega izboljšanja celokupnega preživetja in rPFS so vse primerjave pri sekundarnih ciljih opazovanja govorile v prid uporabe zdravila ZYTIGA v primerjavi s placebom in sicer:
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Po začetku jemanja zdravil za zdravljenje vaše infekcije s HIV se lahko poleg oportunističnih infekcij pojavijo tudi avtoimunske bolezni (stanje, ki se pojavi, ko imunski sistem napade zdravo tkivo).
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV pojavijo tudi avtoimunske bolezni (stanje, do katerega pride, ko imunski sistem napade zdravo telesno tkivo).
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Potem, ko boste začeli jemati zdravila za zdravljenje okužbe s HIV, se lahko poleg simptomov oprotunističnih okužb pojavijo tudi avtoimunske bolezni (stanje, ki se pojavi, ko imunski sistem napade zdravo tkivo).
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after your child starts taking medicines for the treatment of your child’s HIV infection.
Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV pojavijo tudi avtoimunske motnje (stanja, do katerih pride, ko imunski sistem napade zdravo tkivo).
In addition to the phase III EINSTEIN program, a prospective, non-interventional, open-label cohort study (XALIA) with central outcome adjudication including recurrent VTE, major bleeding and death has been conducted.
Poleg III. faze programa EINSTEIN je bila izvedena prospektivna, neintervencijska, odprta kohortna študija (XALIA) z oceno pojavnosti ponovnih VTE, velikih krvavitev in smrti.
In addition to the phase III ROCKET AF study, a prospective, single-arm, post-authorization, non- interventional, open-label cohort study (XANTUS) with central outcome adjudication including thromboembolic events and major bleeding has been conducted.
Poleg III. faze kliničnega preskušanja ROCKET AF je bila izvedena prospektivna, enoskupinska (“single-arm”), postavtorizacijska, neintervencijska odprta kohortna študija (XANTUS) z oceno izida varnosti in učinkovitosti zdravljenja vključno s pojavom trombemboličnih dogodkov in velikih krvavitev.
In addition to the side effects listed above, chest pain has also been reported.
Poleg zgoraj naštetih neželenih učinkov so poročali tudi o pojavu bolečine v prsnem košu.
In addition to the side effects listed below, the following may also occur with the use of Temodal powder for solution for infusion: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising (haematoma).
Poleg spodaj navedenih neželenih učinkov, se lahko pri uporabi zdravila Temodal prašek za raztopino za injiciranje pojavijo tudi naslednji neželeni učinki: bolečina, draženje, srbenje, občutek toplote, otekanje ali rdečica na mestu injiciranja; tudi modrice (hematom).
In addition to the urinary excretion, approximately 45% of the dose was recovered in the faeces as the unchanged febuxostat (12%), the acyl glucuronide of the active substance (1%), its known oxidative metabolites and their conjugates (25%), and other unknown metabolites (7%).
Približno 45 % odmerka se je izločilo z blatom, 12 % v obliki nespremenjenega febuksostata, 1 % v obliki acil- glukuronida, 25 % v obliki znanih oksidativnih presnovkov in njihovih konjugatov in 7 % v obliki drugih neznanih presnovkov.
In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Poleg običajne samokontrole glukoze v krvi in/ali urinu, ki jo izvaja bolnik, mora bolnikovo glukozo v krvi redno nadzirati tudi zdravnik, da določi za bolnika najmanjši učinkoviti odmerek.
In addition to these three components, 0.9% (w/v) sodium chloride solution for injection will also be required for the reconstitution of the doxorubicin HCl.
Poleg teh treh sestavin bo za rekonstitucijo doksorubicinijevega klorida potreben tudi natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje.
In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Poleg teh navodil boste prejeli tudi opozorilno kartico za bolnika, ki vsebuje pomembne informacije v zvezi z varnostjo, za katere morate vedeti, preden začnete z zdravljenjem z zdravilom TYSABRI (izgovor taj-se-bri) in med samim zdravljenjem s tem zdravilom.
In addition to this leaflet, you will find a Patient Alert Card within the box, which contains important safety information that you need to know before you are given Ranexa and during treatment with Ranexa.
Poleg teh navodil boste našli kartico z opozorili za bolnika, ki vključuje pomembne varnostne informacije, s katerimi morate biti seznanjeni preden boste prejeli zdravilo Ranexa in ves čas zdravljenja z zdravilom Ranexa.
In addition VFEND has been associated with phototoxicity, including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Poleg tega je bilo zdravilo VFEND povezano s fototoksičnostjo, vključno z reakcijami, kot so efelide, lentigo ter aktinična keratoza, in psevdoporfirijo.
In addition voriconazole has been associated with phototoxicity, including reactions such as ephelides, lentigo and actinic keratosis and pseudoporphyria.
Poleg tega je bil vorikonazol povezan s fototoksičnostjo in psevdoporfirijo, vključno z reakcijami, kot so efelide, lentigo ter aktinična keratoza.
In addition voriconazole has been associated with phototoxicity, including reactions such as ephelides, lentigo and actinic keratosis and pseudoporphyria.
Poleg tega je bil vorikonazol povezan s fototoksičnostjo, vključno z reakcijami, kot so efelide, lentigo ter aktinična keratoza, in psevdoporfirijo.
In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was co- administered with a booster dose of Synflorix during the second year of life in children primed with 3 doses of Synflorix, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C).
Poleg tega so za en pnevmokokni serotip (18 C) opažali nižjo geometrijsko sredino koncentracije (GMC - geometric mean concentration) protiteles in nižjo geometrijsko sredino titrov na opsonofagocitnem preizkusu (OPA GMT - opsonophagocytic assay geometric mean titre), če je bilo cepivo proti meningokokom seroloških skupin A, C, W-135 in Y (konjugat TT) uporabljeno sočasno z obnovitvenim odmerkom cepiva Synflorix v drugem letu življenja pri otrocih, ki so primarno dobili 3 odmerke cepiva Synflorix.
In addition you will need a disposal unit for used syringes and needles.
Potrebovali boste tudi posodo za odstranjevanje uporabljenih brizg in igel.
In addition, 1 patient from the pre-authorisation phase was hospitalized due to hypertensive crisis.
Poleg tega je bil 1 bolnik, v obdobju pred izdajo dovoljenja za promet, hospitaliziran zaradi hipertenzivne krize.
In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Poleg tega je bilo v obdobju po začetku trženja zdravila 101 dojenčkov, mlajših od 12 mesecev, vključenih v varnostno študijo.
In addition, 2 patients had an overdose of maximum 600 mg twice daily (b.i.d.) up to eight days.
Poleg tega sta 2 bolnika dobivala prevelik odmerek največ 600 mg dvakrat na dan do osem dni.
In addition, 24% of sunitinib patients had received somatostatin analogs compared with 22% of placebo patients.
Poleg tega je 24 % s sunitinibom zdravljenih bolnikov prejemalo analoge somatostatina, v primerjavi z 22 % bolnikov iz skupine s placebom.
In addition, 475 immunocompromised patients (including 18 children, of these 10 oseltamivir and 8 placebo) received oseltamivir or placebo for the prophylaxis of influenza.
Poleg tega je 475 imunsko ogroženih bolnikov (vključno z 18 otroki, od tega jih je 10 prejelo zdravilo Ebilfumin in 8 placebo) prejelo zdravilo Ebilfumin ali placebo za preprečevanje gripe.
In addition, 475 immunocompromised patients (including 18 children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of influenza.
Poleg tega je 475 imunsko ogroženih bolnikov (vključno z 18 otroki, od tega jih je 10 prejelo zdravilo Tamiflu in 8 placebo) prejelo zdravilo Tamiflu ali placebo za preprečevanje gripe.
In addition, 81% of these bleeding episodes required only a single treatment with Advate.
Poleg tega je bila za 81 % teh krvavitev potrebna le ena terapija z zdravilom Advate.
In addition, 84% of physicians and 100% of parents/caregivers regarded glycopyrrolate as worthwhile compared with 41% and 56%, respectively, for placebo (p≤0.014).
Poleg tega je 84 % zdravnikov in 100 % staršev/negovalcev menilo, da je glikopirolat koristen, medtem ko je bilo pri placebu tega mnenja 41 % zdravnikov in 56 % staršev/skrbnikov (p ≤ 0,014).
In addition, 89.4% of the bleeding episodes resolved following 1 to 2 treatments with NovoEight.
Poleg tega se je 89,4 % krvavitev ustavilo po 1 ali 2 terapijah z zdravilom NovoEight.
In addition, 95.2% of the bleeding episodes resolved following 1 to 2 treatments with NovoEight.
Poleg tega se je 95,2 % krvavitev ustavilo po 1 ali 2 terapijah z zdravilom NovoEight.
In addition, a barrier method such as a condom should be used until she has completed 7 days of uninterrupted white tablet- taking.
Poleg tega naj uporablja tudi pregradno metodo kontracepcije, na primer kondom, dokler ne zaključi 7-dnevnega obdobja neprekinjenega jemanja belih tablet.
In addition, a delayed-type allergic skin reaction (cheilitis) after longer-term dermal exposure (mouthwash) has been reported.
Poleg tega so poročali o zakasnelih alergijskih kožnih reakcijah (heilitis) po daljši dermalni izpostavljenosti (ustna voda).
In addition, a double-blind, placebo-controlled cardiovascular outcome study (ELIXA) enrolled 6,068 type 2 diabetes patients with previous acute coronary syndrome (3,034 randomised to lixisenatide, including 198 patients ≥75 years of age and 655 patients with moderate renal impairment).
Poleg tega je dvojno slepa, s placebom kontrolirana študija srčno-žilnih izidov (ELIXA) zajela 6.068 bolnikov s sladkorno boleznijo tipa 2 in predhodnim akutnim koronarnim sindromom (3.034 bolnikov randomiziranih na liksisenatid, vključno z 198 bolniki, starimi ≥75 let in 655 bolniki z zmerno okvaro ledvic).
In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, lamivudine and tenofovir.
Poleg tega je s tenofovirjem izbrana substitucija K70E reverzne transkriptaze HIV-1 povzročila zmanjšano občutljivost za abakavir, emtricitabin, lamivudin in tenofovir.
In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir and lamivudine.
Poleg tega je bila s tenofovirjem izbrana substitucija K70E pri reverzni transkriptazi HIV-1, kar je povzročilo nizko raven zmanjšane občutljivosti za abakavir, emtricitabin, tenofovir in lamivudin.
In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected clinically by tenofovir disoproxil fumarate and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Poleg tega je klinično izbrana substitucija K70E reverzne transkriptaze HIV-1 z dizoproksiltenofovirijevim fumaratom povzročila zmanjšano občutljivost na abakavir, emtricitabin, tenofovir in lamivudin.
In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards.
Poleg tega so pri večini bolnikov, vključenih v glavno študijo, opravljali sledenje do 24 mesecev po koncu študije.
In addition, a pharmacokinetic-pharmacodynamic (efficacy) analysis was performed in one efficacy trial for primary generalised tonic clonic seizures.
Poleg tega je bila v enem preskušanju učinkovitosti pri primarnih generaliziranih napadih s tonično-kloničnimi krči izvedena farmakokinetično-farmakodinamična (učinkovitostna) analiza.
In addition, a prospective randomized cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event.
Poleg tega pa je bila izvedena tudi prospektivna randomizirana študija izidov kardiovaskularne varnosti, v katero je bilo vključenih 5.380 bolnikov z velikim osnovnim kardiovaskularnim tveganjem za ovrednotenje učinka alogliptina v primerjavi s placebom (kot dodatek k standardnemu zdravljenju) na pomembne neželene kardiovaskularne dogodke (MACE, “major adverse cardiovascular events”), vključno s časom do prvega pojava katerega koli dogodka, sestavljenega iz kardiovaskularne smrti, neusodnega miokardnega infarkta in neusodne možganske kapi pri bolnikih z nedavnim (15 do 90 dni) akutnim koronarnim dogodkom.
In addition, a prospective randomized cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event.
Poleg tega pa je bila izvedena tudi prospektivna randomizirana študija izidov kardiovaskularne varnosti, v katero je bilo vključenih 5.380 bolnikov z velikim osnovnim kardiovaskularnim tveganjem, za ovrednotenje učinka alogliptina v primerjavi s placebom (kot dodatek k standardnemu zdravljenju) na pomembne neželene kardiovaskularne dogodke (MACE, “major adverse cardiovascular events”), vključno s časom do prvega pojava katerega koli dogodka, sestavljenega iz kardiovaskularne smrti, neusodnega miokardnega infarkta in neusodne možganske kapi pri bolnikih z nedavnim (15 do 90 dni) akutnim koronarnim dogodkom.