natgillin/translations-raw huggingface dataset:
The data in Table 1 is based on the controlled Studies (I−IX,CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period.
Podatki v tabeli 1 temeljijo na kontroliranih študijah (I-IX, CLASSIC I, GAIN in CHARM) (opisanih v poglavju 5.1), ki zajemajo 3271 bolnikov, ki so med kontroliranim obdobjem dobivali Trudexo, in 1809 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
The data in Table 1 is based on the controlled Studies (I−IX,CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period.
Podatki v tabeli 1 temeljijo na kontroliranih študijah (I−IX, CLASSIC I, GAIN in CHARM) (opisanih v poglavju 5.1), ki zajemajo 3271 bolnikov, ki so med kontroliranim obdobjem dobivali Trudexo, in 1809 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
The data in Table 2 below describes adverse reactions from clinical trials in patients treated with Vimizim.
Podatki v preglednici 2 opisujejo neželene učinke iz kliničnih preskušanj z bolniki, zdravljenimi z zdravilom Vimizim.
The data in the table below describe adverse reactions reported from clinical studies in patients with mCRC who received panitumumab as a single agent or in combination with chemotherapy (n = 2,588) and spontaneous reporting.
Spodnja tabela opisuje neželene učinke, zabeležene v kliničnih študijah pri bolnikih z mKRR, ki so dobivali panitumumab kot edino zdravilo ali v kombinaciji s kemoterapijo (n = 2.588), in iz spontanih poročil v obdobju trženja zdravila.
The data indicate that the 99mTc-depreotide displays high-affinity binding to somatostatin receptors.
Podatki kažejo, da ima 99mTc- depreotid visoko vezalno afiniteto za somatostatinske receptorje.
The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 17).
Podatki kažejo, da je skrajšanje zdravljenja na 16 tednov povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 17).
The data indicates that between 3.9% to 18.9% of patients reported too much whitening, with between 0% to 9.3% of patients indicating that they were bothered by too much whitening.
Podatki kažejo, da je o čezmerno beli koži poročalo od 3,9 % do 18,9 % bolnikov, pri čemer je od 0 % do 9,3 % bolnikov navedlo, da jih je preveč bela koža motila.
The data lock point (DLP) for the next PSUR would be 31 August 2016.
Zaključeno obdobje za zbiranje podatkov (DLP) za naslednji PSUR naj bi bil 31. avgust 2016
the data lock points
zbiranja podatkov
The data on 52 patients were considered as the main evidence from the study as these patients were identified as having an unmet medical need, because other tyrosine kinase inhibitors were not considered appropriate treatment options for them due to disease resistance or the risk of severe side effects.
Podatke o 52 bolnikih so upoštevali kot glavni dokaz iz študije, saj so bili ti bolniki opredeljeni kot bolniki, katerih zdravstvene potrebe večinoma niso izpolnjene, ker se drugi zaviralci tirozinske kinaze ne štejejo za primerno možnost zdravljenja zanje zaradi odpornosti bolezni ali zaradi tveganja resnih neželenih učinkov.
The data on the 40 patients showed that 55% of patients (22 out of 40) responded to treatment.
Podatki o 40 bolnikih so pokazali, da se je 55 % (22 od 40) bolnikov odzvalo na zdravljenje.
The data presented below refer to a lower dose of the fixed-dose combination containing these two actives, a dose and strength which is not available for Aerivio Spiromax.
Podatki, predstavljeni v nadaljevanju, se nanašajo na manjši odmerek fiksne kombinacije odmerka, ki vsebuje ti dve zdravilni učinkovini; odmerek in jakost, v kateri zdravilo Airexar Spiromax ni na voljo.
The data presented were insufficient to support the use of Altargo in the treatment of infected dermatitis.
Predloženi podatki niso bili zadostni za utemeljitev uporabe zdravila Altargo pri zdravljenju infekcijskega dermatitisa.
The data provided on immune tolerance induction in patients with inhibitors showed, that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Podatki o indukciji imunske tolerance pri bolnikih z zaviralci kažejo, da je visok odmerek za nekatere bolnike koristen in je zaviralce možno odstraniti, vendar pa podatkov ni bilo dovolj, da bi izrecno odobrili zdravilo za to uporabo.
The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.
Podatkov o indukciji imunske tolerance pri bolnikih z zaviralci ni bilo dovolj, da bi izrecno odobrili zdravilo za to uporabo.
The data reflect the percentage of patients whose test results were considered positive for antibodies to Cimzia in an ELISA, and are highly dependent on the sensitivity and specificity of the assay.
Podatki kažejo odstotek bolnikov, pri katerih so bili rezultati testa ELISA na protitelesa proti zdravilu Cimzia pozitivni, in so v veliki meri odvisni od občutljivosti in specifičnosti testa.
The data sources used to determine adverse reaction frequency descriptors included two phase III clinical studies (PURSUIT and ESPRIT).
Vir podatkov za ugotovitev pogostnosti neželenih učinkov sta dve klinični študiji III. faze (PURSUIT in ESPRIT).
The data suggest that Cosentyx does not suppress the humoral immune response to the meningococcal or influenza vaccines.
Podatki kažejo, da zdravilo Cosentyx ne zavira humoralnega imunskega odziva na meningokokno cepivo oziroma cepivo proti gripi.
The data to be collected shall be agreed with the CHMP.
Podatki se zbirajo v dogovoru s CHMP.
The data to support the use of Pylobactell comes from two main studies of the use of antibiotics to treat H. pylori infection, where it was used as a test.
Podatki v prid uporabi zdravila Pylobactell izhajajo iz dveh glavnih študij uporabe antibiotikov za zdravljenje okužbe s H. pylori, kjer je bilo zdravilo Pylobactell uporabljeno kot test.
the date at which the medicine was taken out from the refrigerator will be put on the outer carton
Na zunanjo ovojnino zabeležite datum, ko ste zdravilo vzeli iz hladilnika.
the date of administration,
datum infuzije zdravila,
the date of administration,
datum uporabe,
The date should be added as soon as the inhaler has been removed from the tray.
Ta datum morate zapisati, takoj ko inhalator vzamete iz embalaže
The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%.
Delež serološke zaščite pri otrocih, ki so prejeli dva polovična (0,25 ml) odmerka, je bil 180. dan 100 %.
The day 8 responses in this placebo controlled study were fully in line with those seen in VIKING-3 (not placebo controlled), including by baseline integrase resistance categories.
8. dan v tej s placebom kontrolirani študiji so bili popolnoma skladni s tistimi v študiji VIKING-3 (nekontrolirani s placebom), vključno z izhodiščnimi kategorijami odpornosti na integrazo.
The day after the last infusion a drainage of ascites until stop of spontaneous flow is performed.
Na dan po zadnji infuziji opravite drenažo, da ascites spontano preneha teči.
The day of weekly administration can be changed if necessary as long as the next dose is administered at least one day (24 hours) later.
Dan tedenskega dajanja se po potrebi lahko zamenja, pri čemer pa mora biti naslednji odmerek dan vsaj en dan (24 ur) kasneje.
The day you apply your first patch will be Day 1.
Dan, ko namestite prvi obliž, je dan 1.
The days of the week are printed on the blister strip - this will help you remember to take your capsule.
Na pretisnem traku so natisnjene okrajšave imen dni v tednu - tako se boste vsak dan lažje spomnili, da morate vzeti kapsulo.
The deacetylation is mediated by carboxyl- esterases (i.e. carboxylesterase 1b/c and 2) and may also be mediated by other hydrolytic enzymes.
Deacetilacija poteka s karboksilesterazami (in sicer s karboksilesterazama 1b/c in 2), lahko pa poteka tudi z drugimi hidrolitičnimi encimi.
The debrided area must be covered immediately by temporary or permanent skin substitutes or dressings to prevent desiccation and/or formation of pseudoeschar and/or infection.
Očiščen predel morate takoj prekriti z začasnim kožnim nadomestkom ali stalnim kožnim presadkom ali oblogo, da se ne osuši in/ali ne nastanejo psevdoeshare in/ali okužbe.
The decision for an individual patient on the use of the product at home for patients with VWD and with haemophilia A should be made by the treating physician who should ensure that appropriate training is provided and the use is reviewed at intervals.
Odločitev o tem, ali sme posamezni bolnik uporabljati zdravilo za bolnike s VWB in hemofilijo A doma, mora sprejeti lečeči zdravnik, ki mora tudi poskrbeti za ustrezno izobraževanje ter uporabo v določenih časovnih presledkih tudi preverjati.
The decision of whether a patient is suitable for home-treatment / self-administration is made by the treating doctor, who should ensure appropriate training is provided (e.g. regarding reconstitution, use of transfer device or filter, assembly of intravenous tubing, infusion techniques, maintenance of a treatment diary, identification of adverse reactions and measures to be taken in case such reactions occur) and the use is reviewed at regular intervals.
Odločitev o tem, ali je bolnik primeren za zdravljenje doma/samoinfundiranje, bo sprejel lečeči zdravnik, ki mora zagotoviti ustrezno usposabljanje (npr. glede rekonstitucije, uporabe pripomočka za prenos ali filtra, priprave intravenskih cevk, tehnik infundiranja, vodenja dnevnika zdravljenja, identifikacije neželenih učinkov in ukrepov, ki so potrebni pri pojavu takih reakcij) in pregled uporabe v rednih časovnih intervalih.
The decision on initiating self-administration of Firazyr should only be taken by a physician experienced in the diagnosis and treatment of hereditary angioedema (see section 4.4).
Za uvedbo samoinjiciranja zdravila Firazyr se lahko odloči samo zdravnik z izkušnjami na področju diagnosticiranja in zdravljenja hereditarnega angioedema (glejte poglavje 4.4).
The decision on whether to reduce the dose for either or both treatments should be based on the prescriber’s assessment of individual patient safety or tolerability.
Odločitev za zmanjšanje odmerka enega ali obeh zdravil mora temeljiti na zdravnikovi oceni varnosti in prenašanja pri posameznem bolniku.
The decision to continue or discontinue treatment should be based on all aspects of the patient’s disease status rather than on neutralising activity status alone.
Pri odločitvi o nadaljevanju ali prenehanju zdravljenja je treba upoštevati celoten status bolezni, ne le prisotnost nevtralizacijske aktivnosti.
The decision to continue Xolair following the 16-week timepoint, or on subsequent occasions, should be based on whether a marked improvement in overall asthma control is seen (see section 5.1, Physician’s overall assessment of treatment effectiveness).
Odločitev za nadaljevanje zdravljenja z zdravilom Xolair po 16- tedenskem obdobju ali pri nadaljnjih presojah mora temeljiti na izrazitem izboljšanju celotnega obvladovanja astme (glejte poglavje 5.1, Zdravnikova celotna ocena učinkovitosti zdravljenja).
The decision to discontinue RoActemra in sJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.
O ukinitvi zdravila RoActemra zaradi nenormalnih laboratorijskih vrednosti je treba pri sJIA presojati za vsakega bolnika posebej.
The decision to initiate triple oral therapy should include consideration of the alternative to switch the patient to insulin.
Odločitev o uvedbi peroralnega zdravljenja s tremi zdravili mora vključevati tudi premislek o alternativi – zdravljenju z insulinom.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Odločitev, da se predpiše selektivni zaviralec COX-2, mora temeljiti na oceni vseh tveganj za vsakega posameznega bolnika (glejte poglavji 4.3 in 4.4).
The decision to prescribe EVRA should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs (see sections 4.3 and 4.4).
Ob odločitvi za predpisovanje zdravila EVRA je treba upoštevati obstoječe dejavnike tveganja za vsako posamično žensko, zlasti za vensko trombembolijo (VTE), in kakšno je tveganje za VTE z zdravilom EVRA v primerjavi s tveganjem pri drugih kombiniranih hormonskih kontraceptivih (CHC, combined hormonal contraceptives (glejte poglavji 4.3 in 4.4).
The decision to prescribe IOA should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with IOA compares with other CHCs (see sections 4.3 and 4.4).
Pri odločitvi, da predpišete zdravilo IOA, je treba upoštevati trenutne dejavnike tveganja pri posameznici, zlasti za vensko trombembolijo (VTE) in kakšno je tveganje za VTE pri zdravilu IOA v primerjavi z drugimi kombiniranimi hormonskimi kontraceptivi (CHC – combined hormonal contraceptives) (glejte poglavji 4.3 in 4.4).
The decision to prescribe Zoely should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Zoely compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Pri odločitvi, da predpišete zdravilo Zoely, je treba upoštevati trenutne dejavnike tveganja pri posameznici, zlasti za vensko trombembolijo (VTE) in kakšno je tveganje za VTE pri zdravilu Zoely v primerjavi z drugimi kombiniranimi hormonskimi kontraceptivi (CHC – combined hormonal contraceptives) (glejte poglavji 4.3 in 4.4).
The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Odločitev o ponovni uvedbi zdravljenja z aksitinibom po kirurškem posegu mora temeljiti na klinični presoji ustreznosti celjenja rane.
The decision to stop using Humira should be discussed with your child’s doctor.
O odločitvi, da bi prenehali uporabljati zdravilo Humira, se morate posvetovati z otrokovim zdravnikom.
The decision to stop using ORENCIA should be discussed with your doctor.
O prekinitvi zdravljenja z zdravilom ORENCIA se morate posvetovati s svojim zdravnikom.
The decision to stop using Zerit should be discussed with your doctor.
O prenehanju jemanja zdravila Zerit se morate posvetovati s svojim zdravnikom.
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient’s underlying risk factors (see sections 4.4, 4.5 and 4.8).
O uvajanju zaščitnih ukrepov proti trombozi se morate odločiti po skrbni oceni dejavnikov tveganja pri posameznem bolniku (glejte poglavja 4.4, 4.5 in 4.8).
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient’s underlying risk factors.
Odločitev o uporabi antitrombotičnih profilaktičnih ukrepov je treba sprejeti po temeljiti oceni obstoječih dejavnikov tveganja pri posameznem bolniku.
The decision to take therapeutic measures for TFR should be made after careful clinical assessment of the individual patient (see section 4.2).
Odločitev za terapevtsko ukrepanje proti reakciji izbruha tumorja mora temeljiti na skrbni klinični oceni posameznega bolnika (glejte poglavje 4.2).
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2 – 3 months.
Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov moramo upoštevati, da nastopi učinek zdravljenja čez 2–3 mesece.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov je treba upoštevati, da nastopi učinek zdravljenja čez 2-3 mesece.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov moramo upoštevati, da nastopi učinek zdravljenja čez 2–3 mesece.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Pri odločitvi glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov je treba upoštevati, da začne zdravljenje učinkovati šele po 2–3 mesecih.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Pri odločitvi za preprečevanje z okostjem povezanih dogodkov pri bolnikih z zasevki v kosteh je treba upoštevati, da začne zdravljenje učinkovati šele po 2-3 mesecih.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2–3 months.
Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov moramo upoštevati, da nastopi učinek zdravljenja čez 2–3 mesece.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2–3 months.
Pri odločitvi glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov je treba upoštevati, da začne zdravljenje učinkovati šele po 2-3 mesecih.
The decision to treat this type of infection with Cubicin should be based on the likelihood that the medicine will work against the infection and on advice from an expert; bacteraemia (infection of the blood) caused by S. aureus, associated with either of the two infections above, in adults.
Podlaga za odločitev o zdravljenju te vrste okužbe z zdravilom Cubicin mora biti verjetnost, da bo to delovalo proti okužbi, ter nasvet strokovnjaka; bakteremije (okužbe krvi), ki jo povzroča bakterija S. aureus in je povezana s katero od zgoraj omenjenih okužb, pri odraslih.
The decision to use dolutegravir in the presence of integrase class resistance should take into account that the activity of dolutegravir is considerably compromised for viral strains harbouring Q148+2 secondary mutations from G140A/C/S, E138A/K/T, L74I (see section 5.1).
Pri odločanju za uporabo dolutegravirja ob prisotni odpornosti na zdravila iz skupine zaviralcev integraze je treba upoštevati, da je delovanje dolutegravirja pri virusnih sevih, ki vsebujejo Q148 + 2 sekundarni mutaciji G140A/C/S, E138A/K/T, L74I precej zmanjšano (glejte poglavje 5.1).
The decision to use Mycamine should take into account a potential risk for the development of liver tumours.
Pri odločitvi o uporabi zdravila Mycamine je treba upoštevati morebitno tveganje za razvoj tumorjev jeter.
The decision whether to breast-feed during Ilaris therapy should therefore only be taken after a thorough benefit-risk evaluation.
Za dojenje v času zdravljenja z zdravilom Ilaris se je zato smiselno odločiti šele po temeljitem razmisleku o razmerju med tveganji in koristmi.
The decline in 6MWT distance from Baseline to Week 72 was significantly reduced compared with placebo in study PIPF-006 (p<0.001, rank ANCOVA).
V študiji PIPF–006 je bil padec razdalje pri šestminutnem testu hoje v 72. tednu glede na izhodiščno vrednost pomembno zmanjšan v primerjavi s placebom (p < 0,001, rang ANCOVA).
The decline in distance walked during a 6MWT from Baseline to Week 52 was significantly reduced in patients receiving Esbriet compared with patients receiving placebo in PIPF-016 (p=0.036, rank ANCOVA); 26% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance compared to 36% of patients receiving placebo.
V študiji PIPF–016 se je razdalja, prehojena v šestminutnem testu hoje v 52. tednu, glede na izhodiščno vrednost značilno manj zmanjšala pri bolnikih, ki so dobivali zdravilo Esbriet, v primerjavi z bolniki, ki so dobivali placebo (p = 0,036, rang ANCOVA); pri 26 % bolnikov, ki so dobivali zdravilo Esbriet, se je razdalja v šestminutnem testu hoje zmanjšala za ≥ 50 m v primerjavi s 36 % bolnikov, ki so dobivali placebo.
The decline in heart rate usually starts within one hour of the first dose, and is steepest within 6 hours.
Srčna frekvenca se začne zniževati v eni uri po prejemu prvega odmerka in se najhitreje znižuje prvih 6 ur.
The decrease from baseline in HbA1c was –0.41% in the nateglinide plus metformin group and –0.57% in the gliclazide plus metformin group (difference 0.17%, [95% CI –0.03, 0.36]).
HbA1c se je zmanjšal od izhodišča za – 0,41 % v skupini z nateglinidom plus metforminom in za –0,57 % v skupini z gliklazidom plus metforminom (razlika 0,17 %, 95-odstotni interval zaupanja –0,03, 0,36).
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg.
Zmanjšanje krvnega tlaka je odvisno od odmerka pri enkratnih dnevnih odmerkih in s tendenco doseganja platoja pri odmerkih večjih od 300 mg.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg.
Znižanje krvnega tlaka je odvisno od dnevnega odmerka in s platojem pri odmerkih, večjih od 300 mg.
The decrease in HbA1c observed in patients with a baseline ≥10.0% was greater.
Pri bolnikih z izhodiščno vrednostjo HbA1c ≥ 10,0% so opažali večje znižanje vrednosti HbA1c.
The decrease in non-renal clearance in the patients of the study was estimated to give a 20% increase in the AUC of lacosamide.
Ocenjujejo, da je zmanjšanje neledvičnega očistka pri bolnikih v študiji povzročilo 20 % povečanje AUC lakozamida.
The decrease in serum proteins caused by Oncaspar can increase the toxicity of other medicinal products that are protein bound.
Znižanje ravni serumskih beljakovin, ki jih povzroči zdravilo Oncaspar, lahko poveča toksičnost drugih zdravil, ki se vežejo na beljakovine.
the decreased exposure by increasing the
nadomestiti s zvečanjem odmerka drugih
The decreased in AUCt, AUC∞ and Cmax of fenofibric acid (point estimate) is of 30.94%, 10.9% and 68.71% respectively.
Znižanje vrednosti AUCt, AUC∞ in Cmax fenofibratne kisline (ocenjena vrednost) znaša 30,94 %, 10,9 % in 68,71 %.
The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.
Do zmanjšanja koncentracij belih krvničk (WBC – white blood cell) in nevtrofilcev je prišlo predvsem v prvih šestih tednih zdravljenja, zatem pa so vrednosti ostale relativno stabilne.
The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.
Do zmanjšanja koncentracij belih krvničk (WBC- white blood cell) in nevtrofilcev je prišlo predvsem v prvih šestih tednih zdravljenja, zatem pa so vrednosti ostale relativno stabilne.
The definition of major bleeding events (MBEs) followed the recommendations of the International Society on Thrombosis and Haemostasis.
Velike krvavitve so bile opredeljene v skladu s priporočili mednarodnega združenja za trombozo in hemostazo (International Society on Thrombosis and Haemostasis).
The definition of MBEs followed the recommendations of the International Society on Thrombosis and Haemostasis as described under RE-COVER and RE-COVER II.
Velike krvavitve so bile opredeljene v skladu s priporočili mednarodnega združenja za trombozo in hemostazo (International Society on Thrombosis and Haemostasis), kot je opisano pri RE-COVER in RE-COVER II.