natgillin/translations-raw huggingface dataset:
These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular to the important haematological toxicity (see section 4.8).
Pri vrednotenju teh podatkov je treba upoštevati vsa dejstva o varnosti zdravila; hematološka toksičnost je še posebej pomembna (glejte poglavje 4.8).
These data should be interpreted with caution
Pri interpretaciji teh podatkov je potrebna previdnost.
These data should be interpreted with caution.
Te podatke je treba tolmačiti previdno.
These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine and tacrolimus.
Ti podatki nakazujejo, da naj cinakalcet ne bivplival na farmakokinetiko tistih skupin zdravil, ki se presnavljajo s CYP3A4 in CYP3A5, kot so nekateri imunosupresivi, vključno s ciklosporinom in takrolimusom.
These data support extrapolation of this finding to all antacids because the reduction in exposure when CellCept was co- administered with magnesium and aluminium hydroxides is considerably less than when CellCept was co-administered with PPIs.
Ti podatki podpirajo ekstrapolacijo teh ugotovitev na vse antacide, saj je zmanjšanje izpostavljenosti, kadar je zdravilo CellCept sočasno uporabljeno z magnezijevimi in aluminijevi hidroksidi, občutno manjše v primerjavi s sočasno uporabo zdravila CellCept in zaviralcev protonske črpalke.
These data support extrapolation of this finding to all antacids because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium and aluminium hydroxides is considerably less than when mycophenolate mofetil was co-administered with PPIs.
Ti podatki podpirajo ekstrapolacijo teh ugotovitev na vse antacide, saj je zmanjšanje izpostavljenosti, kadar je zdravilo Myfenax sočasno uporabljeno z magnezijevimi in aluminijevi hidroksidi, občutno manjše v primerjavi s sočasno uporabo zdravila Myfenax in zaviralcev protonske črpalke.
These data support the long term safety profile of Xiapex confirming that no new safety risks were identified during the 5 year follow-up period.
Ti podatki podpirajo dolgoročni varnostni profil zdravila Xiapex in potrjujejo, da v 5-letnem obdobju spremljanja niso ugotovili novih tveganj, povezanih z varnostjo.
These data were confirmed by a post marketing observational study sponsored by the U.S. Centers for Disease Control and Prevention.
Te podatke so potrdili v postmarketinški opazovalni študiji, sponzorirani s strani Centrov za nadzor in preprečevanje bolezni (Centers for Disease Control and Prevention) v ZDA.
These decreases were not considered clinically important since Cmax of valdecoxib is comparable after IM and IV parecoxib administration.
Tega zmanjšanja niso ocenili za klinično pomembnega, ker je Cmax valdekoksiba po i.m. in i.v. vnosu parekoksiba primerljiva.
These defects can include shortened arms or legs, malformed hands or feet, eye or ear defects, and problems with internal organs.
Te okvare lahko vključujejo krajše roke ali noge, deformirane roke in stopala, okvare oči in ušes ter težave pri notranjih organih.
These deposits is can stiffen your blood vessels and make it harder for blood to be pumped around the body.
Ti depoziti lahko stiskajo vaše krvne žile in otežujejo črpanje krvi po telesu.
These descriptive texts are included in the product information.
To opisno besedilo je vključeno v informacije o zdravilu;
These differences are not considered to be clinically relevant and no dose adjustment is necessary.
Te razlike niso klinično pomembne in prilagoditev odmerka ni potrebna.
These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre- treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Te razlike so bile verjetno posledica različnih populacij bolnikov, saj so v študijah faze 2 sodelovali bolniki, ki še niso prejemali kemoterapije, in tudi bolnice s karcinomom dojke, ki so v preteklosti prejemale kemoterapijo, s predhodno obstoječimi metastazami v jetrih in/ali nenormalnimi izhodiščnimi vrednostmi testov jetrnega delovanja.
These differences were maintained with long term treatment (as per studies in the general ED population, in diabetics with EDand in men with ED following bilateral nerve-sparing radical prostatectomy and in the open-label extension trial).
Razlike so ostale enake tudi med dolgoročnim zdravljenjem (kot v študijah splošne populacije moških z ED, bolnikov s sladkorno boleznijo z ED, bolnikov z ED, ki je bila posledica radikalne prostatektomije z ohranjanjem živcev in v poskusno odprtem podaljšanem preskušanju.
These diseases include pre-cancerous lesions of the female genitals (cervix, vulva, and vagina); pre- cancerous lesions of the anus and genital warts in males and females; cervical and anal cancers.
Te bolezni vključujejo predrakave spremembe na ženskih spolovilih (maternični vrat, vulva in nožnica), predrakave spremembe na zadnjiku in bradavice na spolovilih pri moških in ženskah, rak materničnega vratu in rak zadnjika.
These diseases include:
Te bolezni so:
These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by:
Do teh bolezni pride zaradi poškodbe mrežnice (na svetlobo občutljive plasti v zadnjem delu očesa).
These dogs may be at a higher risk for adverse effects when treated with it and should therefore be treated with special caution.
Ti psi so lahko med zdravljenjem bolj izpostavljeni tveganju za pojav neželenih učinkov, zato jih je treba obravnavati posebej previdno.
These dogs may be treated with either 50, 100 or 150 mg, if it is feasible to achieve a target dose of 11–14 mg/kg bw.
Te pse je dopustno zdraviti s 50, 100 ali 150 mg, če je mogoče doseči ciljni odmerek 11 do 14 mg/kg telesne mase.
These dose adjustments have not been confirmed in clinical studies.
Prilagoditve odmerkov niso bile potrjene s kliničnimi študijami.
These doses are equivalent to 0.1 and 0.8 times, respectively, the maximum recommended human dose of 2 grams on a mg/m2 basis, and represent the maximum tolerated doses in these species.
Ti odmerki so bili enakovredni 0,1-kratnemu oziroma 0,8-kratnemu največjemu priporočenemu odmerku pri človeku, ki je 2 g, izražen v mg/m2; pomenijo pa največje odmerke, ki jih te živalske vrste prenašajo.
These doses may not be as high as those received initially.
Ti odmerki v primerjavi z začetnimi morda ne bodo tako visoki.
These doses of hydrochlorothiazide in mice and rats represent 19 and 1.5 times, respectively, the maximum recommended human dose on a mg/m2 basis. (Calculations assume an oral dose of 25 mg/day and a 60-kg patient.)
Navedeni odmerki hidroklorotiazida pri miših in podganah predstavljajo 19- oziroma 1,5-kratno vrednost najvišjega priporočenega odmerka pri ljudeh, preračunano na enoto mg/m2 (za izračun so predpostavljali, da 60-kilogramski bolniku zaužije odmerek 25 mg/dan).
These doses represent 2.7 and 2 times, respectively, the maximum recommended human dose.
Ti odmerki pomenijo 2,7-kratni oziroma 2-kratni največji priporočeni odmerek pri človeku.
These doses resulted in systemic exposures of at least 33- or 97-times higher, respectively, than the intended human exposure.
Pri teh odmerkih je prišlo do najmanj 33- oz- 97-krat večje sistemske izpostavljenosti kot pri priporočeni uporabi pri človeku.
these drugs when co-administered
Pri sočasni uporabi z okrepljenim
these drugs when co-administered
Pri sočasni uporabi z zdravilom
These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to
Te vrednosti EC50 so precej nižje od 50% razpona koncentracij, ki so toksične za celice - od 87 µM do
These effects are described in section 4, ‘Possible side effects’.
Takšni neželeni učinki so opisani v poglavju 4, “Možni neželeni učinki”.
These effects are expected following inhibition of prostaglandin synthesis.
Gre za pričakovane učinke zavrtja sinteze prostaglandinov.
These effects are mediated by endothelin binding to ETA and ETB receptors located in the endothelium and vascular smooth muscle cells.
Te učinke posreduje endotelin, ki se veže na receptorje ETA in ETB, ki se nahajajo v endotelu in gladko- mišičnih celicah obtočil.
These effects are mild and transient.
Ti učinki so bili blagi in prehodni.
These effects are more likely at the start of the treatment or after a dose increase.
Ti učinki so verjetnejši ob začetku zdravljenja ali ob povečanju odmerka.
These effects are much less likely to occur than with oral corticosteroids.
Ti učinki pa so veliko manj verjetni pri inhalacijskem zdravljenju kakor pri uporabi peroralnih kortikosteroidov.
These effects are not relevant with regard to short term administration in the preterm infant population (see section 5.3).
Ti učinki niso pomembni zaradi kratkega obdobja dajanja v skupini nedonošenčkov (glejte poglavje 5.3).
These effects are reversible after lowering the dose.
Našteti učinki minejo, če odmerek zmanjšamo.
These effects are reversible after lowering the dose.
Ti učinki po zmanjšanju odmerka prenehajo.
These effects are unlikely to be observed under clinical conditions.
Ni verjetno, da bi se ti učinki pokazali v kliničnih pogojih.
These effects are unlikely to lead to a lack of fertility.
Ni verjetno, da ti učinki vodijo do zmanjšane plodnosti.
These effects have been reversible upon discontinuation of Rapamune in most cases (see section 5.3).
Po prekinitvi zdravljenja z zdravilom Rapamune so bili ti učinki pri večini primerov reverzibilni (glejte poglavje 5.3).
These effects include chills, headache, nausea, fever, facial flushing (redness), tiredness, low blood pressure, unsteadiness, sweating, difficulty breathing, itching, shaking, cough and vomiting.
Ti učinki vključujejo mrzlico, glavobol, slabost, povišano telesno temperaturo, pordelost obraza (rdečico), utrujenost, nizek krvni tlak, nestabilnost, znojenje, težave pri dihanju, srbenje, tresenje, kašelj in bruhanje.
These effects usually resolve without treatment.
Ti učinki navadno izzvenijo brez zdravljenja.
These effects were due to the hyperprolactinemia following lurasidone treatment, affecting the estrous cycle and copulatory behaviour as well as the maintenance of corpus luteum of the female rats, resulting in a decrease in implantation and the number of live foetuses.
Ti učinki lurasidona so bili posledica hiperprolaktinemije, ki vpliva tako na estrusni cikel in paritveno vedenje kot vzdrževanje rumenega telesca pri samicah, posledično pa se zmanjša število implantacij in živih plodov.
These effects were independent of pioglitazone’s effects on glycaemia and were statistically significant different to glibenclamide.
Ti učinki niso bili odvisni od pioglitazonovih učinkov na glikemijo in so se statistično značilno razlikovali od glibenklamida.
These effects were independent of pioglitazone’s effects on glycaemia and were statistically significant different to glibenclamide.
Ti učinki niso bili odvisni od učinkov pioglitazona na glikemijo in so se statistično pomembno razlikovali od glibenklamida.
These effects were independent of pioglitazone’s effects on glycaemia and were statistically significant different to glibenclamide.
Ti učinki niso bili odvisni od učinkov pioglitazona na glikemijo in so se statistično značilno razlikovali od glibenklamida.
These effects were independent of pioglitazone’s effects on glycaemia and were statistically significantly different to glibenclamide.
Ti učinki niso bili odvisni od pioglitazonovih učinkov na glikemijo in so se statistično značilno razlikovali od glibenklamida.
These effects were independent of pioglitazone’s effects on glycaemia and were statistically significantly different to glibenclamide.
Ti učinki niso bili odvisni od učinkov pioglitazona na glikemijo in so se statistično pomembno razlikovali od glibenklamida.
These effects were independent of pioglitazone’s effects on glycaemia and were statistically significantly different to glibenclamide.
Ti učinki so bili neodvisni od učinkov pioglitazona na glikemijo in so se statistično pomembno razlikovali od glibenklamida.
These effects were mild and transient.
Ti pojavi so bili blagi in prehodni.
These effects were not considered clinically important.
Bilo je ocenjeno, da ti učinki niso klinično pomembni.
These effects were not seen at doses ≤30 mg/kg.
Teh učinkov pri odmerkih ≤ 30 mg/kg niso opazili.
These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units).
Ti učinki so bili opaženi pri bolnikih iz vseh treh plasti, opredeljenih glede na število transfuzij eritrocitov pred študijo (4 - 14 enot; 15 - 25 enot; > 25 enot).
These effects will be investigated in further studies.
Ti učinki bodo raziskani v nadaljnjih študijah.
These effects will gradually reduce over time.
Ti učinki se bodo sčasoma zmanjšali.
These effects worsen the damage to the macula.
Ti učinki namreč še bolj poškodujejo makulo.
These elevations have not been associated with signs or symptoms of hepatocellular damage.
Ta zvišanja niso bila povezana z znaki ali simptomi hepatoceličnih okvar.
These elevations have not been associated with signs or symptoms of hepatocellular damage.
Ta zvišanja nisobila povezana z znaki ali simptomi hepatoceličnih okvar.
These elevations were mainly transient and did not lead to discontinuation.
Povečanje je bilo večinoma prehodno in zaradi njega zdravljenja ni bilo treba opustiti.
These elevations were not associated with clinically relevant increase in direct bilirubin, nor were they associated with clinical evidence of hepatitis or hepatic impairment.
Teh zvišanj ni spremljalo klinično pomembno zvišanje direktnega bilirubina; prav tako jih niso spremljale klinične manifestacije hepatitisa ali okvare jeter.
These enzymes can be found in certain receptors (such as VEGF, EGF and RET receptors) on the surface of cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Te encime lahko najdemo v različnih receptorjih (kot so receptorji VEGF, EGF in RET) na površini rakavih celic, kjer aktivirajo številne procese, vključno z delitvijo celic in rastjo novih žil.
These enzymes can be found in certain receptors (such as VEGF, FGFR and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Te encime lahko najdemo v različnih receptorjih (kot so receptorji VEGF, EGF in RET) v rakavih celicah, kjer aktivirajo številne procese, vključno z delitvijo celic in rastjo novih žil.
These enzymes can be found in certain receptors (such as VEGF, MET, AXL and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer.
Ti encimi so prisotni v nekaterih receptorjih (kot so receptorji VEGF, MET, AXL in RET) v rakavih celicah, v katerih spodbujajo številne procese, vključno z delitvijo celic in rastjo novih krvnih žil, ki oskrbujejo raka.
These enzymes can be found in mast- cell tumours, where they are involved in the growth and spread of cancer cells, and the growth of blood vessels.
Ti encimi se nahajajo v mastocitnih tumorjih, kjer sodelujejo pri rasti in širjenju rakavih celic in rasti krvnih žil.
These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR’, ‘PDGFR’ and ‘KIT’.
Ti encimi se nahajajo v nekaterih receptorjih na površini celic, ki sodelujejo pri rasti in širjenju rakavih celic, kot so receptorji za žilni endotelijski rastni faktor (VEGFR), trombocitni rastni faktor (PDGFR) in receptorji za faktor matičnih celic (KIT).
These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making them resistant to the antibiotic’s action.
Ti encimi bakterijam omogočajo, da razgrajujejo betalaktamske antibiotike, kot je ceftolozan, in posledično postanejo odporne proti njihovemu delovanju.
These enzymes enable bacteria to break down beta-lactam antibiotics such as ceftazidime, making them resistant to the antibiotic’s action.
Ti encimi bakterijam omogočajo, da razgrajujejo betalaktamske antibiotike, kot je ceftazidim, in posledično postanejo odporne proti njihovemu delovanju.
These enzymes make bacteria resistant to ceftolozane by breaking down the antibiotic before it can act.
Ti encimi naredijo bakterije odporne proti ceftolozanu, ker ga razgradijo, preden lahko deluje.
These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Na osnovi ocene mg/kg znašajo ocenjene vrednosti odmerka približno 7% celotnega materinega prejetega odmerka.
These events are also known to be common disease-related complications in patients with intra-abdominal malignancies.
Znano je, da so ti dogodki pogosti zapleti, povezani z boleznijo, pri bolnikih z intraabdominalnimi malignomi.
These events are commonly associated with other antiretroviral agents and may be expected to occur when Viramune is used in combination with other agents; however, it is unlikely that these events are due to treatment with Viramune.
Ta stanja so večinoma povezana z drugimi protivirusnimi zdravili in se lahko pojavijo, kadar jemljete tablete Viramune v kombinaciji z drugimi zdravili, ni pa verjetno, da jih povzroča samo zdravljenje s tabletami Viramune.
These events can usually be managed with either a reduction of the dose or an interruption of treatment with imatinib, but can in rare cases lead to permanent discontinuation of treatment.
Ti dogodki se lahko odpravljajo bodisi z zmanjšanjem odmerka bodisi z začasno prekinitvijo zdravljenja z imatinibom v redkih primerih pa so lahko razlog za trajno prekinitev zdravljenja.
These events have been observed in patients receiving Herceptin therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin)–containing chemotherapy.
Te neželene učinke so opazili pri bolnikih, ki so prejemali zdravilo Herceptin v monoterapiji ali v kombinaciji s paklitakselom ali docetakselom, zlasti po kemoterapiji z antraciklini (doksorubicinom ali epirubicinom).
These events have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for Sivextro.
Te učinke so opazili pri uporabi drugega zdravila iz skupine oksazolidinonov, ko so ga uporabljali dlje, kot je priporočeno za zdravilo Sivextro.
These events have been related to this class of medicines but the incidence with Cimzia is not known.
Te dogodke povezujejo s to skupino zdravil, vendar pogostnost pri zdravljenju z zdravilom Cimzia ni znana.
These events have been reported in patients treated with Memantine LEK.
Pri bolnikih, zdravljenih z memantinom, so poročali o teh dogodkih.
These events have been reported in patients treated with memantine.
Pri bolnikih, zdravljenih z memantinom , so poročali o teh dogodkih.
These events have been reported in patients treated with memantine.
Pri bolnikih, zdravljenih zmemantinom, so poročali o teh dogodkih.
These events have either been assigned a frequency of “Not known,”
Pogostnost teh učinkov je označena ali kot pogostnost
These events included: Wound deepening or desiccation (decomposition) in 5 patients (2.4%) with NexoBrid and 0 with SOC as well as (partial) graft failure in 6 patients (2.9%) with NexoBrid and 2 (1.6%) with SOC (see section 4.4).
Ti dogodki so vključevali: poglobitev ali izsušitev (dekompozicija) rane pri 5 bolnikih (2,4 %) z zdravilom NexoBrid in 0 s standardno nego ter (delno) odpoved presadka pri 6 bolnikih (2,9 %) z zdravilom NexoBrid ter 2 (1,6 %) s standardno nego (glejte poglavje 4.4).
These events led to rufinamide discontinuation in 20 % of the cases.
Ti dogodki so povzročili ukinitev rufinamida pri 20 % primerov.
These events may be sight threatening.
Ti dogodki so lahko nevarni za vid.
These events may be sight threatening.
Ti učinki lahko ogrozijo vid.
These events may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage.
Pojavijo se lahko nenadoma in se lahko v primeru pljučnih tumorjev pokažejo kot huda in življenjsko ogrožajoča hemoptiza ali pljučna krvavitev.
These events required dose reduction or interruption in 1% of patients and led to discontinuation in 0.2% of patients.
Zaradi teh podaljšanj je bilo treba znižati odmerek ali prekiniti odmerjanje ceritiniba pri 1 % bolnikov, dokončna ukinitev zdravila pa je bila potrebna pri 0,2 % bolnikov.
These events required dose reduction or interruption in 1.3% of patients and led to discontinuation in 0.2% of patients.
Zaradi teh zapletov je bilo treba znižati odmerek ali prekiniti odmerjanje ceritiniba pri 1,3 % bolnikov, dokončna ukinitev zdravljenja pa je bila potrebna pri 0,2 % bolnikov.
These events required dose reduction or interruption in 1.9% of patients and led to discontinuation in 1.1% of patients.
Zaradi teh zapletov je bilo treba znižati odmerek ali prekiniti odmerjanje ceritiniba pri 1,9 % bolnikov, dokončna ukinitev zdravljenja pa je bila potrebna pri 1,1 % bolnikov.
These events were generally mild in nature.
Ti dogodki so bili na splošno blagi.
These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is unknown: swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Teh učinkov v kliničnih študijah za pljučno arterijsko hipertenzijo niso opazili, zato je pogostnost neznana: otekanje vek, bolečina v očesu, rdeče oči, srčni infarkt in kap
These exposure changes due to body weight differences are not considered clinically relevant.
Te spremembe izpostavljenosti zaradi razlik v telesni masi ne veljajo za klinično pomembne.
These factors are known to contribute to the overall anti-thrombotic effect of enoxaparin.
Znano je, da ti faktorji pripomorejo k celotnemu antitrombotičnemu učinku enoksaparina.
These factors include:
Med takšnimi dejavniki so:
These factors should be considered when fluticasone furoate/vilanterol is prescribed and treatment should be re-evaluated if pneumonia occurs.
Te dejavnike je treba upoštevati pri predpisovanju flutikazonfuroata/vilanterola; če se pojavi pljučnica, je treba zdravljenje ponovno oceniti.
These features resolve generally within 2-12 hours of the injection.
Ta stanja na splošno izzvenijo v 2–12 urah po injiciranju.
These findings are consistent with results from G-CSF and derivatives.
Ti izsledki so v skladu z rezultati za G-CSF in derivate.
These findings consisted mainly of gastrointestinal findings (i.e. vomiting, increased gastric secretion, gastric erosions, intestine inflammation) and cardiac findings (i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
Ta opažanja obsegajo predvsem gastrointestinalne težave (t.j. bruhanje, povečano izločanje želodčne kisline, želodčne erozije, vnetje črevesja) in težave s srcem (t.j. fokalne krvavitve, depoziti hemosiderina in infiltracija limfo-histiocitnih celic v desnem atriju psov, znižan krvni tlak in povišana frekvenca srca pri podganah, morskih prašičkih in psih).
These findings don’t affect hearing and are reversible.
Pojava ne prizadaneta sluha in sta reverzibilna.
These findings in rodents are caused by a non­genotoxic, specific GLP­1 receptor­mediated mechanism to which rodents are particularly sensitive.
Te učinke pri glodalcih povzroča negenotoksičen, specifičen mehanizem prek receptorjev GLP-1, za katerega so glodalci zelo občutljivi.
These findings indicate a potential risk for short stature and tooth deformities to infants and children (see section 5.3).
Ti izsledki kažejo na mogoče tveganje za nizko rast in deformacije zob pri dojenčkih in otrocih (glejte poglavje 5.3).
These findings occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased foetal weights.
Ti izsledki so se pojavili pri odmerkih, ki so povzročili metabolično acidozo z zmanjšanjem prirastka telesne mase samic četveronožcev in zmanjšanjem teže plodov.