natgillin/translations-raw huggingface dataset:
However in-use stability has been demonstrated for 3 hours at 20 - 24oC.
Stabilnost po pripravi je sicer dokazana za 3 ure pri 20 – 24°C.
However it cannot be excluded that patients with liver impairment may experience higher-grade AEs and SAEs compared with the overall population.
Kljub temu ne moremo izključiti možnosti, da se pri bolnikih z boleznijo jeter lahko pojavijo višje stopnje neželenih učinkov in resnih neželenih učinkov v primerjavi s splošno populacijo.
However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).
Vendar je treba poudariti, da so bolniki v tej študiji prejemali višje odmerke od priporočenega (do 10 mg dvakrat na dan).
However ketoconazole may be an inhibitor of BCRP at the intestinal level at clinically relevant concentrations.
Vendar je lahko ketokonazol v klinično pomembnih koncentracijah zaviralec BCRP na črevesni ravni.
However lactic acidosis, sometimes fatal, has been reported in pregnant women who received the combination of didanosine and stavudine with or without other anti-retroviral treatment (see sections
Vendar je bila pri nosečnicah, ki so dobivale kombinacijo didanozina in stavudina – z drugimi protiretrovirusnimi zdravili ali brez njih – opisana laktacidoza, ki je bila včasih usodna (glejte poglavji
However mortality in affected rabbits is reduced by administering the product.
Kljub temu pa je smrtnost prizadetih kuncev zmanjšana v primeru dajanja tega zdravila.
However no clear relationship between increased post-baseline bedaquiline MICs and microbiologic outcomes was observed in the phase 2 trials where bedaquiline was given for 24 weeks, followed by continuation of the background regimen.
V klinični študiji faze 2, kjer so bedakilin odmerjali 24 tednov in nato nadaljevali z osnovno shemo, niso opazili jasne povezave med zvečanjem MIK bedakilina glede na izhodišče in izidi mikrobioloških preiskav.
However no pharmacodynamics effects from defibrotide have been identified in vivo.
Nobenih farmakodinamičnih učinkov defibrotida pa niso ugotovili in vivo.
However no testicular changes were observed in dog studies of up to 39 weeks duration at an exposure 35–fold that seen in humans based on AUC.
Pri študijah na psih, ki so trajale do 39 tednov, pri izpostavljenosti, ki je bila na osnovi vrednosti AUC 35-krat večja od izpostavljenosti pri človeku, sprememb na modih niso opazili.
However once the pack is opened use within 30 days.
Vendar ga morate po odprtju porabiti v 30 dneh.
However patients should be advised that their ability to drive and operate machines may be compromised due to their Parkinson’s disease symptoms.
Vseeno je treba bolnikom pojasniti, da je lahko njihova sposobnost vožnje in upravljanja s stroji zaradi simptomov Parkinsonove bolezni zmanjšana.
However patients with hepatic impairment such as bilirubin > 1.5 times the upper limit of normal and/or aminotransferase > 3.0times the upper limit of normal (hepatic metastases absent) or > 5.0 times the upper limit of normal (hepatic metastases present) have not been specifically studied.
Vendar pa bolnikov z okvarjenim delovanjem jeter, ki se kaže kot bilirubin > 1,5-kratnik zgornje meje normalnih vrednosti in/ali aminotransferaza > 3,0-kratnik zgornje meje normalnih vrednosti (brez zasevkov v jetrih) ali > 5,0-kratnik zgornje meje normalnih vrednosti (z zasevki v jetrih), niso posebej preučevali.
However PET is not widely available throughout Europe.
Vendar PET ni širše dostopen v Evropi.
However Possia was not more effective than clopidogrel in reducing the risk of stroke.
Vendar zdravilo Possia v primerjavi s klopidogrelom ni bilo učinkovitejše pri zmanjševanju tveganja kapi.
However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline.
Kljub temu pa se osebam, ki so jemale levetiracetam med dolgotrajno, odprto, sledilno študijo v povprečju niso poslabšale njihove vedenjske in emocionalne funkcije; natančneje, rezultati meritev agresivnega obnašanja niso bili slabši od začetnih vrednosti.
However the administration may be repeated, depending on the epidemiological situation in different areas.
Dajanje se lahko ponovi glede na epidemiološko stanje na različnih območjih.
However the anterolateral thigh may be used in very young subjects if preferred.
Pri zelo mladih osebah pa se lahko, po presoji, vseeno injicira v anterolateralni predel stegna.
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between + 2°C and + 8°C or at room temperature (below 25°C).
Vendar je osnovna raztopina dokazano kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2°C in 8°C ali pri sobni temperaturi (do 25°C).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Sicer pa je s preizkusom dokazano, da se kemična in fizična obstojnost pripravljene raztopine ohrani 8 ur, če je shranjena med 2°C in 8°C ali na sobni temperaturi (manj kot 25°C)
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Vendar je dokazano, da je osnovna raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2°C in 8°C ali pri sobni temperaturi (do 25°C).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25C).
Vendar je dokazano, da je osnovna raztopina kemijsko in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2°C in 8°C ali pri sobni temperaturi (do 25°C).
However the following side effects are seen in between 1 and 10 patients in 1,000: venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), decreased therapeutic response (lack of effectiveness of treatment) and pyrexia (fever).
Vendar so bili pri 1 do 10 bolnikih od 1 000 opaženi naslednji neželeni učinki: venski tromboembolični dogodki (težave s krvnimi strdki v venah), izpuščaji, pruritus (srbenje), urtikarija (srbeči izpuščaji), manjši terapevtski odziv (pomanjkanje učinkovitosti zdravljenja) in pireksija (povišana telesna temperatura).
However the frequency of this adverse reaction is unknown since radiation treatment information including radiation dosage information is not routinely collected in spontaneous safety reports.
Pogostnost teh neželenih učinkov ni znana, ker se v spontanih varnostnih poročilih podatkov o zdravljenju z obsevanjem, vključno z odmerkom, rutinsko ne zbira.
However the incidence rates were balanced between Xarelto and placebo for the components of fatal bleeding events, hypotension requiring treatment with intravenous inotropic agents and surgical intervention for ongoing bleeding.
Vendar pa je bila incidenca uravnotežena med zdravilom Xarelto in placebom za izid sestavljen iz krvavitve s smrtnim izidom, hipotenzijo, ki jo je bilo treba zdraviti z intravenskimi inotropnimi učinkovinami in kirurškim posegom zaradi trajajoče krvavitve.
However the largest benefit was observed in a predefined exploratory analysis in patients with EGFR activating mutations (n= 49) demonstrating a substantial PFS benefit (HR=0.10, 95% CI, 0.04 to 0.25; p<0.0001) and an overall survival HR of 0.83 (95% CI, 0.34 to 2.02).
Največjo korist pa so opazili pri bolnikih z EGFR- aktivirajočimi mutacijami (n = 49), za katere je bila eksplorativna analiza določena vnaprej, in pri katerih je bila korist v smislu preživentja brez napredovanja bolezni precejšnja (razmerje ogroženosti = 0,10, 95-% interval zaupanja: 0,04-0,25; p <0,0001), razmerje ogroženosti za celokupno preživetje pa 0,83 (95-% interval zaupanja: 0,34-2,02).
However the OHSS will only occur if hCG is also administered (see section 2, OHSS).
OHSS se lahko pojavi samo, če se uporabi tudi hCG (glejte poglavje 2, OHSS).
However the potential absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally excluded (see section 5.2).
Vendar pa možne absorpcije in akumulacije sevelamera v dolgotrajnem kroničnem zdravljenju (> eno leto) ni mogoče čisto izključiti (glejte poglavje 5.2).
However the product should not be used in cats with persisting articular cartilage lesions, as these lesions may worsen during treatment with fluoroquinolones.
Zdravilo se ne sme uporabiti pri mačkah s trdovratnimi lezijami sklepnega hrustanca, ker se lahko stanje lezij poslabša med zdravljenjem s fluorokinoloni.
However the relevance for clinical protection is unknown.
Vendar pa pomen za klinično zaščito ni znan.
However the T cells in Zalmoxis can sometimes attack the patient’s body, causing graft-versus-host disease.
Vendar pa lahko celice T v zdravilu Zalmoxis včasih napadejo bolnikovo telo in povzročijo reakcijo presadka proti gostitelju.
However the vaccine has also been shown to be safe in a field study including animals of 2 months of age.
Vendar se je cepivo tudi v terenskem poskusu na žrebetih starih 2 meseca pokazalo za varno.
However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
V končnem izidu je bila opazna velika variabilnost, t.j. pri nekaterih bolniki je nevropatija izginila, drugi pa so imeli stalne simptome.
However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
V končnem izidu je bila opazna velika variabilnost, t.j. pri nekaterih bolnikih je nevropatija izginila, drugi bolniki pa so imeli stalne simptome.
However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
V končnem izidu je bila opazna velika variabilnost, t.j. pri nekaterih bolnikih je nevropatija izginila, drugi pa so imeli stalne simptome.
However there was a wide variability in final outcome, i.e. in some patients theneuropathy resolved and some patients had persistent symptoms.
V končnem izidu je bila opazna velika variabilnost, t.j. pri nekaterih bolnikih je nevropatija izginila, drugi pa so imeli stalne simptome.
However there was no significant difference during the maintenance phase.
V vzdrževalni fazi med zdraviloma ni bilo značilne razlike.
However there were uncertainties about the effects of Zinforo in patients with certain very severe infections.
Kljub temu pa so bili učinki zdravila Zinforo pri bolnikih z določenimi zelo resnimi okužbami negotovi.
However these have no growth-inhibiting effects.
Vendar pa te ne vplivajo negativno na rast.
However they are evocative of a risk of male fertility impairment after 6 months of treatment with SIKLOS.In view of available data, the PRAC considers that the changes to the product information proposed by the MAH should be amended.
Ob upoštevanju razpoložljivih podatkov je PRAC mnenja, da je treba informacije o zdravilu, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, spremeniti.
However this will only occur if hCG is administered (see in section 2. under “Ovarian Hyper- Stimulation Syndrome”).
Vendar pa se to lahko pojavi samo, če se uporabi hCG (glejte poglavje 2 „Sindrom hiperstimulacije jajčnikov“).
However this will only occur if hCG is administered (see section ‘Warnings and precautions’).
Vendar pa se le ta pojavi samo, če se daje hCG (glejte poglavje „Opozorila in previdnostni ukrepi“).
However two of the randomized patients discontinued the study before receiving any study treatment
Dva izmed randomiziranih bolnikov sta bila iz študije izključena, preden sta prejela katero koli zdravljenje, uporabljeno v študiji.
However vision disorders most commonly observed were diplopia, photopsia, blurred vision, visual impairment, and vitreous floaters and were in most cases mild in severity.
Najpogosteje opažene motnje vida so bile diplopija, fotopsija, zamegljen vid, okvara vida in motnjave v steklovini, in so bile v večini primerov blage.
However with a longer follow-up, the difference in overall survival in favour of lenalidomide / low dose dexamethasone tends to decrease.
Vendar pa pri daljšem spremljanju razlika v celokupnem preživetju v korist lenalidomida/deksametazona v manjšem odmerku kaže tendenco zmanjševanja.
However you should be cautious as confusion and sleepiness have been seen.
Ker so pri bolnikih opazili pojave zmedenosti in zaspanosti, morate biti pri uporabi zdravila MabCampath previdni.
However, 1,611 patients (804 bosentan- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo- controlled study (study AC-052-301/302 [ENABLE 1 & 2]).
Je pa v s placebom nadzorovani študiji (študija AC-052-301/302 [ENABLE 1 & 2]) s povprečnim trajanjem zdravljenja 1,5 let sodelovalo 1611 bolnikov (804 bolniki so jemali bosentan, 807 bolnikov je prejemalo placebo) s hudim kroničnim srčnim popuščanjem (CHF – Chronic Heart Failure).
However, 1,611 patients (804 bosentan- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo-controlled study (study AC-052-301/302 [ENABLE 1 & 2]).
Je pa v s placebom nadzorovani študiji (študija AC-052-301/302 [ENABLE 1 & 2]) s povprečnim trajanjem zdravljenja 1,5 let sodelovalo 1611 bolnikov (804 bolniki so jemali bosentan, 807 bolnikov je prejemalo placebo) s hudim kroničnim srčnim popuščanjem (CHF – Chronic Heart Failure).
However, 3 (serotypes 1, 5 and 6A) of the 6 additional serotypes showed lower IgG GMC and OPA GMT when compared with children who had received at least one previous vaccination with Prevenar 13.
Vendar pa je pri 3 (serotipi 1, 5 in 6A) izmed 6 dodatnih serotipov prišlo do nižje ravni IgG GMC in OPA GMT v primerjavi z otroki, pri katerih je bilo opravljeno najmanj eno predhodno cepljenje s cepivom Prevenar 13.
However, a further update to the SmPC might be needed, if final study results become available in 2014.”
Vendar pa bo morda treba povzetek glavnih značilnosti zdravila dodatno spremeniti po razpoložljivosti končnih rezultatov študije v letu 2014.«
However, a greater treatment effect was seen in Parkinson’s disease patients with moderate dementia.
Boljši terapevtski učinek so opazili pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli zmerno demenco.
However, a greater treatment effect was seen in Parkinson’s disease patients with moderate dementia.
Vendar pa so boljši terapevtski učinek opazili pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli zmerno demenco.
However, a large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor fetal/neonatal toxicity associated with emtricitabine.
Vendar pa velika količina podatkov o nosečnicah (več kot 1.000 izidov izpostavljenih nosečnosti) ne kaže na malformacijsko ali feto/neonatalno toksičnost, povezano z emtricitabinom.
However, a large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor fetal/neonatal toxicity associated with emtricitabine.
Vendar pa večje število podatkov o uporabi emtricitabina pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) ne kaže na njegovo malformacijsko ali feto/neonatalno toksičnost.
However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.
Vendar povezave z uporabo zdravila Protopic na podlagi dosedanjih ugotovitev niso niti potrdili niti ovrgli.
However, a link to Protopic ointment treatment has not been shown.
Vendar ni dokazano, da bi bilo to povezano z zdravljenjem z zdravilom Protopic.
However, a minority of patients (about 15%) who were switched from enzyme replacement to Cerdelga, did not respond optimally after treatment for one year.
Vendar pa se manjši del bolnikov (približno 15 %), ki je z encimskega nadomestnega zdravljenja prešel na zdravilo Cerdelga, po enoletnem zdravljenju ni optimalno odzival.
However, a moderate amount of data in pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil fumarate.
Vendar pa manjše število podatkov pri nosečnicah (med 300 in 1.000 izpostavljenih nosečnosti) ne kaže na malformacije ali feto/neonatalno toksičnost, povezane z emtricitabinom in dizoproksiltenofovirijevim fumaratom.
However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator, even if with reduced efficiency.
Vseeno pa interval > 1 ure po izpostavljenosti ne izključuje dajanja in uspešnega delovanja kelatorja, četudi z zmanjšano učinkovitostjo.
However, a return to higher doses is not recommended.
Uporaba višjih odmerkov od 800 mg/dan pri teh bolnikih ni priporočljiva.
However, a second vaccine that acts in a different way is able to make antibodies that can be measured easily.
Na preprost način pa je mogoče meriti nastanek protiteles, ki jih sproži drugo cepivo z drugačnim delovanjem.
However, a signal towards a higher rate of decreased appetite and/or food intake was observed in the adefovir arm as compared to the placebo arm.
Vendar je bilo opaženo nakazovanje višje stopnje zmanjšanega teka in/ali vnosa hrane v skupini, ki je prejemala adefovir, v primerjavi s skupino, ki je prejemala placebo.
However, a significant treatment benefit for maraviroc compared to placebo + OBT was still demonstrated (see Table 6).
Kljub temu je bila dokazana bistvena terapevtska korist zdravila CELSENTRI v primerjavi s placebom + OOT (glejte preglednico 6).
However, a study in Parkinson’s patients confirmed that after treatment discontinuation there was no significant change in levodopa pharmacokinetics or in patient response to levodopa compared to pretreatment levels.
Toda študija pri Parkinsonovih bolnikih je potrdila, da v primerjavi z vrednostmi pred zdravljenjem, po prekinitvi zdravljenja ni bilo pomembnih sprememb v farmakokinetiki levodope ali v odzivu bolnika na levodopo.
However, a trend of lower anti-HPV GMTs was observed in the concomitant group.
V skupini, ki je bila sočasno cepljena z obema cepivoma, pa so opazili, da so se geometrijski srednji titri anti-HPV protiteles nagibali k nižjim vrednostim.
However, abacavir HSRs have been reported at a lower frequency in patients who do not carry this
Pri bolnikih, ki niso prenašalci tega alela, so redkeje poročali o HSR na abakavir.
However, abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis and Crohn’s disease.
Imunske bolezni, kot sta psoriaza in psoriatični artritis, so povezane z nenormalno regulacijo IL-12 in IL-23.
However, adding Corlentor to amlodipine did not provide an additional benefit.
Kot dodatek amlodipinu pa zdravilo Corlentor ni pokazalo dodatnih koristnih učinkov.
However, adding it to amlodipine did not provide an additional benefit.
Kot dodatek amlodipinu to zdravilo ni pokazalo dodatnih koristnih učinkov.
However, adding Procoralan to amlodipine did not provide an additional benefit.
Kot dodatek amlodipinu pa zdravilo Procoralan ni pokazalo dodatnih koristnih učinkov.
However, addition of an alternative immunosuppressive agent to the corticosteroid regimen may be considered.
Razmisliti je treba o dodatnem zdravljenju z drugim imunosupresivom, poleg zdravljenja s kortikosteroidi.
However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two drugs.
Vendar je med sočasno uporabo teh dveh zdravil priporočljivo ustrezno spremljati toksične učinke metotreksata.
However, adjustment
uporabi bo morda potrebno
However, administration of tenofovir disoproxil fumarate with a light meal did not have a significant effect on the pharmacokinetics of tenofovir.
Vendar pa jemanje dizoproksiltenofovirijevega fumarata z lažjim obrokom ni imelo bistvenega vpliva na farmakokinetiko tenofovirja.
However, administration of tylosin concomitantly with Velactis in cows did not show any changes of Velactis pharmacokinetic properties.
Vendar pa dajanje tilozina sočasno z zdravilom Velactis pri kravah ni povzročilo nobenih sprememb v farmakokinetičnih lastnostih kabergolina.
However, adverse reactions may occur, which may influence the ability to drive and use machines (see section 4.8).
Vendar pa se lahko pojavijo neželeni učinki, ki lahko vplivajo na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
However, Aerivio Spiromax should not be used to relieve an attack of breathlessness or wheezing.
Vendar pa zdravila Airexar Spiromax ne smete uporabljati za lajšanje napadov zasoplosti in piskajočega dihanja.
However, after combination of carbidopa with levodopa, the absorption of levodopa is similar between the older people and the young people, but the AUC is still 1.5 fold greater in the older people due to decreased DDC activity and lower clearance by aging.
Vendar pa je pri kombinaciji karbidope z levodopo absorpcija levodope pri starejših in pri mlajših podobna, med tem ko je vrednost AUC pri starejših še vedno 1,5-krat večja zaradi starostno pogojenega zmanjšanega delovanja DDK in nižjega očistka.
However, after sodium pertechnetate (99mTc), Ph.Eur is added, adequate shielding of the final preparation must be maintained.
Eur., pa je treba ves čas uporabljati ustrezen ščit pred sevanjem končnega pripravka.
However, after subcutaneous administration of Omnitrope 5 mg/ml powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Po subkutani uporabi zdravila Omnitrope prašek in vehikel za raztopino za injiciranje traja razpolovna doba 3 ure.
However, among surviving mothers with evaluable litters, maternal toxicity was limited to marginal reductions in body weight over the course of gestation days 21 to 29; and associated developmental toxicity in these litters was limited to fetal body weight decrements of 7%, and a low incidence of delayed ossification of the fetal hyoid.
Toda med preživelimi samicami z ocenljivimi legli, je bila maternalna toksičnost omejena na mejno zmanjšanje telesne mase od 21. do 29. dne gestacije; spremljajoči razvojni toksični učinki pri teh leglih so bili omejeni na 7 % zmanjšanje telesne mase plodov in majhno incidenco zapoznele osifikacije plodove hioidne kosti.
However, an adverse effect on the pregnancy can not be excluded as rat and rabbit studies have shown increased embryo/foetal lethality, (see section 5.3).
Vendar pa škodljivega učinka na nosečnost ni mogoče izključiti, ker so študije na podganah in kuncih pokazale povečano smrtnost zarodkov oziroma plodov (glejte poglavje 5.3).
However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).
Pri povečanju odmerka na največji odmerek 20 mg je potrebna previdnost; pri tem je treba upoštevati dejstvo, kako ga bolnik prenaša (glejte poglavji 4.4 in 4.8).
However, an increased number of serious adverse events were reported in elderly patients treated with Vectibix in combination with FOLFIRI (45% versus 37%) or FOLFOX (52% versus 37%) chemotherapy compared to chemotherapy alone (see section 4.4).
Vendar pa je bilo pri starejših bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo FOLFIRI opisanih več resnih neželenih učinkov (45 %) kot pri tistih, ki so prejemali samo kemoterapijo (37 %); pri starejših bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo FOLFOX je bilo ravno tako opisanih več resnih neželenih učinkov (52 %) kot pri tistih, ki so prejemali samo kemoterapijo (37 %) (glejte poglavje 4.4).