FrancophonIA/ELRC3.0 huggingface dataset:
English: While firmly holding the vial adapter package connect the pre-filled solvent syringe to the vial adapter by pushing the syringe tip down onto the luer lock in the centre of the vial adapter, and turning it clockwise until the syringe is secured.
Slovenian: Čvrsto primite ovojnino nastavka viale in na nastavek viale namestite napolnjeno injekcijsko brizgo z vehiklom tako, da konico brizge potisnite na Luer Lock priključek v središču nastavka viale, nato pa brizgo zavrtite v smeri urinih kazalcev in jo tesno privijte.
English: calcium chloride dihydrate, sucrose, Tris base, Tris HCl, Tri-sodium citrate dihydrate.
Slovenian: Pomožne snovi: polisorbat 80 natrijev klorid kalcijev klorid dihidrat saharoza trometamol trometamolijev klorid trinatrijev citrat dihidrat Pred uporabo preberite priloženo navodilo!
English: Preferred MedDRA term Frequency
Slovenian: Prednostni izraz po klasifikaciji MedDRA
English: Allergic type hypersensitivity reactions are possible with OBIZUR.
Slovenian: Pri uporabi zdravila OBIZUR so možne preobčutljivostne reakcije alergičnega tipa.
English: Due date
Slovenian: Drugi podatki
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: No interactions of OBIZUR with other medicinal products have been reported.
Slovenian: O medsebojnem delovanju zdravila OBIZUR z drugimi zdravili ni poročil.
English: You should contact your doctor if you missed a dose and do not know how to compensate for this.
Slovenian: Če ste pozabili odmerek in ne veste, kako ravnati v tem primeru, se posvetujte z zdravnikom.
English: NAME OF THE MEDICINAL PRODUCT OBIZUR 500 U powder and solvent for solution for injection
Slovenian: OBIZUR 500 e. prašek in vehikel za raztopino za injiciranje
English: Baseline hFVIII activity t½ (h)
Slovenian: Izhodiščna aktivnost hFVIII
English: Use immediately or within 3 hours after reconstitution.
Slovenian: Zdravilo uporabite nemudoma, vendar najkasneje v 3 urah po rekonstituciji.
English: Obizur is a recombinant, B-domain deleted, porcine sequence Factor VIII (susoctocog alfa).
Slovenian: Zdravilo OBIZUR je rekombinanten faktor VIII brez domene B, iz prašičjega zaporedja (susoktokog alfa).
English: MARKETING AUTHORISATION HOLDER
Slovenian: Shranjevanje zdravila OBIZUR
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Rekonstituirano zdravilo pred uporabo s prostim očesom preglejte za tujke in spremembo barve.
English: OBIZUR contains approximately 500 U/ml susoctocog alfa after reconstitution.
Slovenian: Zdravilo OBIZUR po rekonstituciji vsebuje približno 500 e./ml susoktokoga alfa.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: prašek in vehikel za raztopino za injiciranje Prašek je bel.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Obizur water for injections.
Slovenian: Vehikel za zdravilo OBIZUR voda za injekcije
English: • Inspect the reconstituted OBIZUR solution for particulate matter and discoloration prior to administration.
Slovenian: • Rekonstituirano raztopino zdravila OBIZUR pred uporabo s prostim očesom preglejte za tujke in spremembo barve.
English: Pack size
Slovenian: 2 tableti
English: • if you have problems with your liver;
Slovenian: • če imate težave z jetri;
English: • decreased vitamin B12 levels in the blood
Slovenian: • znižana raven vitamina B12 v krvi
English: All RMPs should be updated accordingly via an appropriate variation to be submitted no later than one month of the European Commission decision;
Slovenian: Vse načrte za obvladovanje tveganja je treba ustrezno posodobiti prek ustrezne vloge za spremembo, ki jo je treba predložiti najpozneje en mesec po sklepu Evropske komisije.
English: • if you have had a diabetic pre-coma;
Slovenian: • če ste kadar koli v preteklosti imeli diabetično predkomo;
English: Diabetic ketoacidosis a,
Slovenian: žeja diabetična ketoacidoza a,
English: • cimetidine, a medicine used to treat stomach problems.
Slovenian: • cimetidin, zdravilo za zdravljenje želodčnih težav;
English: Lactic acidosis Vitamin B12 deficiency
Slovenian: laktacidoza pomanjkanje vitamina B12
English: • certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Slovenian: • nekatera zdravila za zdravljenje visokega krvnega tlaka (zaviralci ACE in antagonisti receptorjev angiotenzina II);
English: • if you have severely reduced kidney function;
Slovenian: • če imate hudo oslabljeno delovanje ledvic;
English: These symptoms could be a sign of “diabetic ketoacidosis”a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Slovenian: Ti simptomi so lahko znak “diabetične ketoacidoze”, težave, ki se lahko pojavi pri sladkorni bolezni zaradi povišanih ravni “ketonskih teles” v urinu ali krvi, kar je razvidno iz laboratorijskih preiskav.
English: • pain in the pelvis, or mid-back pain (when kidneys are infected)
Slovenian: • bolečina v predelu medenice ali sredine hrbta (če so okužene ledvice)
English: Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Slovenian: Metformin V prospektivni randomizirani študiji (UKDPS) je bila dokazana dolgoročna korist intenzivnega urejanja glukoze v krvi pri sladkorni bolezni tipa 2.
English: Other side effects while taking Synjardy: Very common
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo med jemanjem zdravila Synjardy: Zelo pogosti
English: What Synjardy looks like and contents of the pack
Slovenian: Izgled zdravila Synjardy in vsebina pakiranja
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Slovenian: • zdravila za zdravljenje bolečine in vnetja (nesteroidna protivnetna zdravila in ali zaviralci COX2, kot sta ibuprofen in celekoksib);
English: Table 2 Adverse reactions reported in placebo-controlled studies System organ class
Slovenian: Preglednica 2: Neželeni učinki, o katerih so poročali v s placebom nadzorovanih študijah Organski sistem
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Slovenian: Diabetična ketoacidoza, redka (pojavi se lahko pri največ 1 od 1.000 bolnikov) To so znaki diabetične ketoacidoze (glejte poglavje 2 »Opozorila in previdnostni ukrepi«): - povišane ravni “ketonskih teles” v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje - bolečine v želodcu - prekomerna žeja - hitro in globoko dihanje - zmedenost - neobičajna zaspanost ali utrujenost - sladkast zadah, sladek ali kovinski okus v ustih ali drugačen vonj urina ali znoja.
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Slovenian: Kationske snovi, ki se izločajo s tubularno sekrecijo (npr. cimetidin), lahko zaradi tekmovanja za skupne ledvične tubulne prenašalne mehanizme medsebojno delujejo z metforminom.
English: General Synjardy should not be used in patients with type 1 diabetes.
Slovenian: Zdravila Synjardy ne smejo uporabljati bolniki s sladkorno boleznijo tipa 1.
English: • abnormalities in liver function tests, inflammation of the liver (hepatitis)
Slovenian: • nenormalni izvidi testov delovanja jeter, vnetje jeter (hepatitis)
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness;
Slovenian: Tveganje za nastanek diabetične ketoacidoze lahko povečajo dolgotrajnejše stradanje, prekomerno uživanje alkohola, dehidracija, nenadno zmanjšanje odmerka insulina ali povečana potreba po insulinu zaradi večje operacije ali resne bolezni.
English: • blood tests may show increases in the amount of red blood cells in your blood (haematocrit)
Slovenian: • krvni testi lahko pokažejo povišane vrednosti rdečih krvnih celic (hematokrit)
English: Complicated urinary tract infections (including serious urinary infections, pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Slovenian: Zapletene okužbe sečil (vključno z resnimi okužbami sečil, pielonefritisom ali urosepso) so se pri bolnikih, zdravljenih z empagliflozinom, pojavile s podobno pogostnostjo kot pri placebu.
English: Taking this medicine • Swallow the tablet whole with water.
Slovenian: • Tableto pogoltnite celo z vodo.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the SGLT2 inhibitor containing products identified in Annex A remains favourable, subject to the agreed amendments to the product information and additional pharmacovigilance activities to be reflected in the RMP.
Slovenian: Posledično je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo zaviralec SGLT2 in so navedena v Prilogi A, še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu ter dodatne farmakovigilančne dejavnosti, vključene v načrt za obvladovanje tveganja.
English: • stomach ache (abdominal pain)
Slovenian: • bolečina v trebuhu (abdominalna bolečina)
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased
Slovenian: 2,c zvišana raven kreatinina v krvi/zmanjšana hitrost glomerulne filtracije zvišan hematokrit
English: Table 10 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressure Placebo empagliflozin
Slovenian: Preglednica 10: Rezultati učinkovitosti v 12. tednu v s placebom nadzorovani študiji empagliflozina pri bolnikih s sladkorno boleznijo tipa 2 in nekontroliranim krvnim tlakom placebo empagliflozin
English: • redness of the skin (erythema) or an itchy rash (hives)
Slovenian: • pordelost kože (eritem) ali srbeč izpuščaj (koprivnica)
English: Glycaemic efficacy and cardivascular outcomes have been assessed in a total of 10,366 patients with type 2 diabetes who were treated in 9 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 2950 patients received empagliflozin 10 mg and 3701 received empagliflozin 25 mg as add-on to metformin therapy.
Slovenian: Glikemično učinkovitost in srčno-žilne izide so proučevali v 9 dvojno slepih, s placebom ali zdravilno učinkovino nadzorovanih kliničnih študijah, v katerih je bilo zdravljenih skupaj 10.366 bolnikov s sladkorno boleznijo tipa 2 najmanj 24 tednov, od tega jih je 2.950 prejemalo empagliflozin 10 mg in 3.701 empagliflozin 25 mg kot dodatno zdravljenje k metforminu.
English: The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Slovenian: Evropska komisija je 15. aprila 2016 sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for postmarketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Slovenian: Za kanagliflozin so bile amputacije spodnjih okončin (zlasti prstov) kot neželeni učinek že vključene v informacije o zdravilu; odbor PRAC je menil tudi, da je treba zbrati dodatne informacije o amputacijah, in sicer z ustreznimi obrazci za poročila o primerih v kliničnih preskušanjih, vprašalniki za spremljanje primerov v obdobju trženja, uporabo seznamov prednostnih izrazov MedDRA za znake, ki napovedujejo amputacijo, in ustreznimi metaanalizami velikih študij, vključno s študijami kardiovaskularnih izidov.
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
Slovenian: • pomembno zmanjšanje absolutnega tveganja za kateri koli s sladkorno boleznijo povezan zaplet v skupini z metforminom (29,8 dogodka/1.000 bolnikov-let), v primerjavi s samo dieto (43,3 dogodka/1.000 bolnikov-let), p = 0,0023, in v primerjavi z obema skupinama s sulfonilsečnino ali insulinom v monoterapiji (40,1 dogodka/1.000 bolnikov-let), p = 0,0034;
English: derived from postmarketing experience see section 4.4
Slovenian: Izhaja iz izkušenj v obdobju trženja b
English: respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus
Slovenian: Povprečno zvišanje vrednosti od izhodiščne za zdravljenje z empagliflozinom 10 mg ali 25 mg v primerjavi s placebom je bilo 5,0 % oz. 5,2 % v primerjavi z 3,7 % za skupni holesterol; 4,6 % oz. 2,7 % v primerjavi z -0,5 % za HDL holesterol; 9,1 % oz. 8,7 % v primerjavi z 7,8 % za LDL holesterol; 5,4 % oz. 10,8 % v primerjavi z 12,1 % za trigliceride.
English: However, temporary interruption of treatment should be considered in patients with complicated urinary tract infections.
Slovenian: Vendar pa je treba pri bolnikih z zapleteno okužbo sečil razmisliti o začasni prekinitvi zdravljenja.
English: • genital yeast infection (thrush)
Slovenian: • glivična okužba spolovil (vaginalna kandidoza)
English: Table 7: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy
Slovenian: Preglednica 7: Rezultati učinkovitosti v 18. in 52. tednu v s placebom nadzorovani študiji z empagliflozinom kot dodatnim zdravljenjem k večkratnim dnevnim odmerkom insulina sočasno z metforminom placebo empagliflozin
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Slovenian: Z enkratno dnevno uporabo empagliflozina so bile v stanju dinamičnega ravnovesja vrednosti v plazmi AUC 1.870 nmol.h in Cmax 259 nmol/l za empagliflozin 10 mg ter AUC 4.740 nmol.h in Cmax 687 nmol/l za empagliflozin 25 mg. Sistemska izpostavljenost empagliflozinu se je večala sorazmerno z odmerkom.
English: Table 4: Efficacy results at 24 week comparing empagliflozin in combination with metformin to the individual components
Slovenian: Preglednica 4: Rezultati učinkovitosti pri 24-tedenski primerjavi empagliflozina v kombinaciji z metforminom z zdravljenjem le s posameznimi komponentami Empagliflozin 10 mg
English: • diarrhoea or stomach ache
Slovenian: • driska ali trebušne bolečine
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Slovenian: V kliničnih preskušanjih in v obdobju trženja so pri bolnikih, ki so bili zdravljeni z zaviralci SGLT2, vključno z empagliflozinom, poročali o redkih primerih diabetične ketoacidoze (DKA), vključno z življenje ogrožujočimi.
English: • loss of appetite
Slovenian: • izguba teka
English: Of these, a total of 794 patients received empagliflozin as add-on to metformin plus insulin, of which 266 patients were treated with empagliflozin 10 mg and 264 with empagliflozin 25 mg.
Slovenian: Od teh je bilo 266 ali 264 bolnikov zdravljenih z empagliflozinom 10 mg oziroma z empagliflozinom 25 mg kot dodatnim zdravljenjem k metforminu in insulinu.
English: Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Slovenian: Synjardy 5 mg/850 mg filmsko obložene tablete so rumenkasto bele, ovalne, bikonveksne tablete.
English: Table 8 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformin
Slovenian: Preglednica 8: Rezultati učinkovitosti v 18. in 78. tednu v s placebom nadzorovani študiji empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu z metforminom placebo empagliflozin 10 mg empagliflozin 25 mg
English: Table 9: Treatment effect for the primary composite endpoint, its components and mortality
Slovenian: Učinek zdravljenja na primarni sestavljeni opazovani dogodek, njegovi sestavni deli in umrljivost placebo empagliflozin
English: See subsections below for additional information Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia) Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Slovenian: Dolgotrajno zdravljenje z metforminom so povezali z zmanjšano absorpcijo vitamina B12, kar lahko zelo redko pripelje do klinično pomembnega pomanjkanja tega vitamina (npr. megaloblastne anemije).
English: PRAC noted that an increased amputation risk has only become apparent with canagliflozin so far, but one large cardiovascular outcome study (DECLARE) is still on-going for dapagliflozin and amputation events were not been systematically captured within the completed large cardiovascular outcome study conducted with empagliflozin (EMPA-REG).
Slovenian: v zaključeni veliki študiji kardiovaskularnih dogodkov z empagliflozinom (EMPA-REG) pa amputacij niso sistematično beležili.
English: HbA1c (%) at week 52 Baseline (mean) Change from baseline
Slovenian: Vrednost HbA1c (%) v 52. tednu
English: • changes to the way things taste
Slovenian: • spremembe v okušanju
English: Erythema Urticaria
Slovenian: Ledvična okvara
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo
Slovenian: Vrednost HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na glimepirid
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 14 January 2013
Slovenian: Datum prve odobritve: 11. januar 2008 Datum zadnjega podaljšanja: 14. januar 2013
English: After first reconstitution the suspension should be used immediately.
Slovenian: Po prvi rekonstituciji morate suspenzijo uporabiti takoj.
English: The reconstituted suspension should be milky and homogenous without visible precipitates.
Slovenian: Rekonstituirana suspenzija mora biti mlečna in homogena brez vidnih oborin.
English: Gemcitabine (N=430)
Slovenian: gemcitabin (N=430)
English: Instructions for use, handling and disposal
Slovenian: Navodila za uporabo, ravnanje in odstranjevanje
English: • Depression, sleep problems
Slovenian: • depresivnost, težave s spanjem
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: Some settling of the reconstituted suspension may occur.
Slovenian: Lahko se pojavi manjše usedanje rekonstituirane suspenzije.
English: 1 The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients.
Slovenian: 1 Pogostnost preobčutljivostnih reakcij je izračunana na osnovi enega primera dokazane povezave v populaciji 789 bolnikov.
English: AND ≥ 75,000
Slovenian: IN ≥ 75.000
English: Lactation (see section 4.6).
Slovenian: Dojenje (glejte poglavje 4.6).
English: Your doctor or pharmacist is responsible for disposing of any unused Abraxane correctly.
Slovenian: Vaš zdravnik ali farmacevt je odgovoren za pravilno odstranitev neuporabljenega zdravila Abraxane.
English: Patients with pre-existing neuropathy of Grade ≥ 2 or serious medical risk factors involving any of the major organ systems were excluded.
Slovenian: Bolnike s predhodno nevropatijo ≥ 2. stopnje ali resnimi medicinskimi dejavniki tveganja v zvezi s katerim koli pomembnim organskim sistemom so izključili.
English: Day 1 < 1500
Slovenian: 1. dan < 1.500
English: The safety and efficacy of Abraxane in children and adolescents aged 0-17 years has not been established.
Slovenian: Varnost in učinkovitost zdravila Abraxane pri otrocih in mladostnikih, starih 0 - 17 let, nista bili dokazani.
English: Each drug was administered on Day 1 of each 21-day cycle.
Slovenian: Vsako zdravilo so dali 1. dan vsakega 21-dnevnega cikla.
English: Based on population pharmacokinetic analysis, the total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.
Slovenian: Na podlagi populacijske farmakokinetične analize je celotni volumen porazdelitve približno 1741 l; velik volumen porazdelitve kaže na obsežno ekstravaskularno porazdelitev in/ali vezavo paklitaksela v tkivih.
English: Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients.
Slovenian: Nevtropenija je bila najbolj opazna pomembna hematološka toksičnost (o njej so poročali pri 79 % bolnikov), bila je hitro reverzibilna in odvisna od odmerka; o levkopeniji so poročali pri 71 % bolnikov.
English: Tell your doctor if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete, ste pred kratkim prejemali ali pa boste morda začeli prejemati katero koli drugo zdravilo, vključno z zeliščnimi pripravki.
English: • A disorder of the electrical conduction system of the heart (atrioventricular block)
Slovenian: • motnja električnega prevodnega sistema srca (atrioventrikularni blok)
English: Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Slovenian: Omejitev infundiranja zdravila Abraxane na 30 minut, kot je navedeno v navodilih, zmanjša možnost z infuzijo povezanih reakcij.
English: It is not known if paclitaxel is excreted in human milk.
Slovenian: Ni znano, ali se paklitaksel izloča v mleko pri človeku.
English: What you need to know before you are given Abraxane
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Abraxane
English: The majority of alopecia events occurred less than one month after initiation of Abraxane.
Slovenian: Večina primerov alopecije se je pojavila manj kot en mesec po uvedbi zdravila Abraxane.
English: Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Slovenian: Nato vialo pazljivo in počasi sučite in/ali obračajte vsaj 2 minuti, dokler se ves prašek popolnoma ne resuspendira.
English: The non-inferiority criterion was met for both PFS and OS with the upper bound of the 95% confidence interval for the associated hazard ratios being less than 1.176 (Table 13).
Slovenian: Kriterij neinferiornosti je bil izpolnjen tako za PFS kot za OS z zgornjo mejo 95-odstotnega intervala zaupanja za pridruženi razmerji tveganja, ki sta bili manjši od 1,176 (preglednica 13).
English: OR < 100,000
Slovenian: ALI < 100.000