FrancophonIA/ELRC3.0 huggingface dataset:
English: • The other ingredients are histidine, sucrose, polysorbate 20 and water for injection.
Slovenian: • Druge sestavine so histidin, saharoza, polisorbat 20 in voda za injekcije.
English: Most patients (88.8%) were receiving high intensity statin therapy with or without other LMT at randomization.
Slovenian: Večina bolnikov (88,8 %) je ob randomizaciji prejemala visokointenzivno zdravljenje s statini, z drugimi lipolitičnimi zdravili ali brez njih.
English:  After completing all steps in “Step A: Getting ready for an injection”, pull off the needle cap.
Slovenian:  Ko ste naredili vse korake v "Korak A: Priprava za injiciranje", snemite pokrovček brizge.
English: Anti-drug antibody responses, including NAb, were low titer and did not appear to have a clinically meaningful impact on the efficacy or safety of alirocumab, except for a higher rate of injection site reactions in patients with treatment emergent ADA compared to patients who were ADA negative (7.5% vs 3.6%).
Slovenian: Odzivi s protitelesi proti zdravilu, vključno z NAb, so bili z majhnim titrom in niso klinično pomembno vplivali na učinkovitost ali varnost alirokumaba; izjema je bil večji delež reakcij na mestu injiciranja pri bolnikih, ki so se jim med zdravljenjem pojavila ADA (7,5 %), v primerjavi z ADA-negativnimi bolniki (3,6 %).
English: What Praluent is and what it is used for
Slovenian: Kaj je zdravilo Praluent in za kaj ga uporabljamo
English: If you develop a serious allergic reaction, stop using Praluent , talk to your doctor right away.
Slovenian: Če se vam pojavi resna alergijska reakcija, nehajte uporabljati zdravilo Praluent in se takoj posvetujte z zdravnikom.
English: • Pull the needle out of the skin at the same angle as it was inserted.
Slovenian: • Potegnite iglo iz kože pod istim kotom, pod katerim ste jo zabodli.
English: • Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
Slovenian: • Zdravilo Praluent je monoklonsko protitelo (tip specializirane beljakovine, namenjene temu, da se veže na ciljno spojino v telesu.).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Praluent in all subsets of the paediatric population in the treatment of mixed dyslipidaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Praluent za vse podskupine pediatrične populacije za zdravljenje mešane dislipidemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: A multicentre, double-blind, placebo-controlled trial included 18,924 adult patients (9462 alirocumab; 9462 placebo) followed for up to 5 years.
Slovenian: Multicentrično, dvojno slepo, s placebom kontrolirano preskušanje je vključevalo 18.924 odraslih bolnikov (9462 jih je prejemalo alirokumab, 9462 placebo), ki so jih spremljali do 5 let.
English: In ten phase 3 controlled trials, involving patients with primary hypercholesterolemia and mixed dyslipidaemia, the most common adverse reactions were local injection site reactions, upper respiratory tract signs and symptoms, and pruritus.
Slovenian: V desetih kontroliranih preskušanjih 3. faze, ki so vključevala bolnike s primarno hiperholesterolemijo in mešano dislipidemijo, so bili najpogostejši neželeni učinki lokalne reakcije na mestu injiciranja, znaki in simptomi obolenja zgornjih dihal in srbenje.
English: The primary efficacy endpoint in all of the phase 3 studies was the mean percent reduction from baseline in LDL-C at week 24 as compared to placebo or ezetimibe.
Slovenian: Primarni opazovani dogodek učinkovitosti v vseh študijah 3. faze je bilo povprečno odstotno znižanje h-LDL od izhodišča do 24. tedna v primerjavi s placebom ali ezetimibom.
English:  Look at the window.
Slovenian:  Preglejte okence.
English: Monotherapy or as add-on to non-statin lipid-modifying therapy
Slovenian: Monoterapija ali dodatek nestatinskim zdravilom za prilagoditev lipidov
English: In published genetic studies as well as clinical and observational trials with lipid lowering therapies an increased risk of new onset of diabetes has been associated with lower levels of LDL-C.
Slovenian: V objavljenih genetskih študijah ter kliničnih in opazovalnih študijah z zdravili za zniževanje lipidov je bilo z nizkimi koncentracijami h-LDLpovezano večje tveganje za novonastalo sladkorno bolezen.
English: At low concentrations, the elimination is predominately through saturable binding to target (PCSK9), while at higher concentrations the elimination of alirocumab is largely through a non-saturable proteolytic pathway.
Slovenian: Pri nizkih koncentracijah poteka izločanje predvsem z saturabilno vezavo na ciljno mesto (PCSK9), pri višjih koncentracijah pa v glavnem po nesaturabilni proteolitični poti.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Praluent in one or more subsets of the paediatric population in the treatment of elevated cholesterol (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Praluent za eno ali več podskupin pediatrične populacije za zdravljenje zvišanega holesterola (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Established atherosclerotic cardiovascular disease
Slovenian: Izražena aterosklerotična srčno-žilna bolezen
English: • Check the liquid is clear, colourless to pale yellow and free from particles - if not, do not use (see picture A).
Slovenian: • Preverite, da je tekočina bistra, brezbarvna do bledo rumena in da ne vsebuje delcev - v nasprotnem primeru zdravila ne uporabite (glejte sliko A).
English: Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
Slovenian: Zdravilo Praluent je indicirano pri odraslih bolnikih z izraženo aterosklerotično srčno-žilno boleznijo za zmanjšanje srčno-žilnega tveganja z znižanjem h-LDL, in sicer kot dodatek aktivnemu obvladovanju drugih dejavnikov tveganja:
English: • Check that you have the correct product and the correct dose.
Slovenian: • Prepričajte se, da imate pravo zdravilo in pravi odmerek.
English: What you need to know before you use Praluent
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Praluent
English: For detailed results see Table 2 below.
Slovenian: Za podrobne rezultate glejte preglednico 2, spodaj.
English: Alirocumab N=9462 n (%)
Slovenian: Alirokumab N=2814 n (%)
English: Elderly No dose adjustment is needed for elderly patients.
Slovenian: Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi.
English: Of these 2615 patients, 805 (30.8%) were down-titrated to 75 mg Q2W.
Slovenian: Od teh 2615 bolnikov so 805 bolnikom (30,8 %) odmerek zmanjšali na 75 mg na 2 tedna.
English: • Check that you have the correct product and the correct dose (green plunger for 75 mg/ml).
Slovenian: • Prepričajte se, da imate pravo zdravilo in pravi odmerek (zelen bat za 75 mg/ml).
English: • Clean skin in the injection area with an alcohol wipe.
Slovenian: • Kožo na mestu injiciranje očistite z alkoholnim zložencem.
English: • Check the use by date: do not use if this date has passed.
Slovenian: • Preverite datum roka uporabnosti: če je ta datum že pretekel, zdravila ne uporabite.
English: Always check the label of your syringe to make sure you have the right medicine and the right strength.
Slovenian: Vedno preverite nalepko na brizgi in se tako prepričajte, da imate pravo zdravilo in pravo jakost.
English: Monthly exposure with 300 mg every 4 weeks treatment was similar to that of 150 mg every 2 weeks.
Slovenian: Mesečna izpostavljenost je bila s 300 mg na 4 tedne podobna kot s 150 mg na 2 tedna.
English: Green Button
Slovenian: Zeleni gumb
English: Local injection site reactions
Slovenian: Lokalne reakcije na mestu injiciranja
English: For detailed storage conditions see separate package leaflet for Praluent.
Slovenian: Za podrobne pogoje shranjevanja glejte ločeno navodilo za uporabo zdravila Praluent.
English: Other medicines and Praluent Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: A multicenter, double-blind, ezetimibe-controlled, 24 week study included 248 patients with documented statin intolerance due to skeletal muscle-related symptoms.
Slovenian: Multicentrična, dvojno slepa, z ezetimibom kontrolirana 24-tedenska študija je zajela 248 bolnikov, ki so imeli dokumentirano intoleranco za statine zaradi simptomov na skeletnih mišicah.
English: • Adults with high cholesterol levels in their blood (hypercholesterolaemia, heterozygous familial and non-familial, or mixed dyslipidaemia).
Slovenian: • Odrasli z visoko koncentracijo holesterola v krvi (hiperholesterolemija, heterozigotna familiarna ali nefamiliarna, mešana dislipidemija).
English: In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2).
Slovenian: V kliničnih študijah je bilo malo bolnikov s hudo okvaro ledvic (opredeljeno kot ocenjena hitrost glomerulne filtracije < 30 ml/min/1,73 m2) (glejte poglavje 5.2).
English: • Do not pull off the cap until you are ready to inject.
Slovenian: • Ne snemite pokrovčka, dokler niste pripravljeni za injiciranje.
English: In genetic studies in humans, PCSK9 variants with either loss-of-function or gain-of-function mutations have been identified.
Slovenian: V genetskih študijah pri človeku so odkrili različice PCSK9, ki so imele bodisi mutacije z izgubo funkcije bodisi mutacije s povečanjem funkcije.
English: • Do not heat the syringe, let it warm up on its own.
Slovenian: • Brizge ne segrevajte, temveč pustite, da se ogreje sama.
English: 1 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene -coated bromobutyl rubber plunger stopper.
Slovenian: 1 ml raztopine v silikonizirani brizgi iz prozornega stekla tipa 1, opremljeni z nameščeno iglo iz nerjavnega jekla, mehkim ščitnikom igle iz stiren-butadienske gume in čepom na batu iz brombutilne gume, prevlečene z etilentetrafluoroetilenom.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vpliv alirokumaba na druga zdravila
English: How much to inject
Slovenian: Koliko zdravila morate injicirati
English: If you stop using Praluent
Slovenian: Če ste prenehali uporabljati zdravilo Praluent
English: • Always use the syringe as described in the “Instructions for Use”.
Slovenian: • Brizgo vedno uporabljajte, kot je opisano v "Navodilih za uporabo".
English: The safety profile in patients treated with a 300 mg once every 4 week (monthly) dosing regimen, was similar to the safety profile as described for the clinical studies program using a 2 week dosing regimen, except for a higher rate of local injection site reactions.
Slovenian: Varnostne značilnosti so bile pri bolnikih, zdravljenih z odmerno shemo 300 mg enkrat na 4 tedne (mesečno), podobne varnostnim značilnostim, opisanim v programu kliničnih študij z uporabo odmerne sheme na 2 tedna; edina izjema je bil večji delež lokalnih reakcij na mestu injiciranja.
English: However, maternal toxicity was noted in pregnant rats at systemic exposures estimated to be approximately 5.3 times greater than the human exposure at the 150 mg Q2W dose (based on exposure measured in non-pregnant rats during a 5-week toxicology study).
Slovenian: Vendar pa so toksične učinke za samice-matere ugotovili pri brejih podganah ob sistemskih izpostavljenostih, ki so bile ocenjene za približno 5,3-krat tolikšne kot je izpostavljenost pri človeku ob odmerku 150 mg na 2 tedna (na podlagi izpostavljenosti, izmerjene pri nebrejih podganah v 5-tedenski toksikološki študiji).
English: Effects of alirocumab on other medicinal products
Slovenian: Vpliv drugih zdravil na alirokumab
English: Favours Alirocumab Favours Placebo
Slovenian: V korist alirokumaba V korist placeba
English: After subcutaneous administration of 50 mg to 300 mg alirocumab, median times to maximum serum concentration (tmax) were 3-7 days.
Slovenian: Po subkutani uporabi od 50 do 300 mg alirokumaba je bil mediani čas do največje koncentracije v serumu (tmax) od 3 do 7 dni.
English: • This syringe can only be used for one single injection, and must be thrown away after use.
Slovenian: • Brizgo je mogoče uporabiti le za eno injiciranje in jo je treba po uporabi zavreči.
English: All-cause mortality in phase 3 studies was 0.6% (20 of 3182 patients) in the alirocumab group and 0.9% (17 of 1792 patients) in the control group.
Slovenian: Umrljivost zaradi vseh vzrokov je bila v študijah 3. faze 0,6 % (20 od 3182 bolnikov) v skupini z alirokumabom in 0,9 % (17 od 1792 bolnikov) v kontrolni skupini.
English: Table 1 - Adverse Reactions reported in patients treated with alirocumab in controlled studies and post-marketing use
Slovenian: Preglednica 1 - Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z alirokumabom, v kontroliranih študijah in med uporabo po prihodu zdravila na trg
English: After use, place the pre-filled pen/ pre-filled syringe into a puncture resistant container and discard as required by local regulations.
Slovenian: Po uporabi dajte napolnjeni injekcijski peresnik/napolnjeno injekcijsko brizgo v vsebnik za ostre odpadke in zavrzite v skladu z lokalnimi predpisi.
English: Flu-like illness
Slovenian: gripi podobna bolezen
English: Most injection site reactions were transient and of mild intensity.
Slovenian: Večina reakcij na mestu injiciranja je bila prehodnih in blagih.
English: If you forget to use Praluent
Slovenian: Če ste pozabili uporabiti zdravilo Praluent
English: Tell your doctor if you have kidney or liver disease before using this medicine, because Praluent has been studied in few patients with severe kidney disease and not in patients with severe liver disease.
Slovenian: Pred uporabo tega zdravila morate zdravniku povedati, če imate bolezen ledvic ali jeter: zdravilo Praluent je namreč raziskano le pri majhnem številu bolnikov s hudo boleznijo ledvic, pri bolnikih s hudo boleznijo jeter pa ni raziskano.
English: Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab.
Slovenian: Statini in druga zdravila za prilagoditev lipidov povečajo nastajanje PCSK9, tj. ciljne beljakovine alirokumaba.
English: Therefore, alirocumab treatment can produce reductions in these remnant lipoproteins as evidenced by its reductions in apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TG).
Slovenian: Zato lahko zdravljenje z alirokumabom zniža te preostale lipoproteine; to se kaže z znižanjem apolipoproteina B (Apo B), holesterola v lipoproteinih, ki niso velike gostote (holesterol ne-HDL), in trigliceridov (TG).
English: What Praluent looks like and contents of the pack
Slovenian: Izgled zdravila Praluent in vsebina pakiranja
English: Alirocumab is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Slovenian: Alirokumab je človeško monoklonsko protitelo IgG1, pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
English: Praluent must not be co-administered with other injectable medicinal products at the same injection site.
Slovenian: Zdravila Praluent se na istem injekcijskem mestu ne sme uporabiti skupaj z drugimi zdravili za injiciranje.
English: Do not touch the yellow safety cover.
Slovenian: Ne dotaknite se rumenega varnostnega ščitnika.
English: The LDLR also binds triglyceride-rich VLDL remnant lipoproteins and intermediate-density lipoprotein (IDL).
Slovenian: LDLR vežejo tudi s trigliceridi bogate preostale VLDL-lipoproteine in lipoproteine srednje gostote (IDLintermediate-density lipoprotein).
English: Do not use this medicine if it looks discoloured or cloudy, or if it contains visible flakes or particles.
Slovenian: Zdravila ne uporabite, če je s premenjene barve ali motno, ali če vsebuje vidne kosme ali delce.
English: The following side effects have been reported since the marketing of Praluent, but how often they occur is not known:
Slovenian: V času od prihoda zdravila Praluent na trg so poročali o naslednjih neželenih učinkih, a kako pogosto se pojavljajo, ni znano:
English: However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.
Slovenian: Kljub temu se znižanje h-LDL ohrani skozi celoten odmerni interval, če je alirokumab uporabljan na dva tedna.
English: The usual starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks.
Slovenian: Običajni začetni odmerek zdravila Praluent je 75 mg subkutano enkrat na 2 tedna.
English: It is given: - together with a statin (a commonly used medicine that treats high cholesterol) or other cholesterol lowering medicines, if the maximum dose of a statin does not lower levels of cholesterol sufficiently or, - alone or together with other cholesterol lowering medicines when statins are not tolerated or cannot be used.
Slovenian: Zdravilo se daje: - skupaj z enim od statinov (statini so pogosto uporabljana zdravila za zdravljenje visokega holesterola) ali kakšnimi drugimi zdravili za zniževanje holesterola, če največji odmerek statina koncentracije holesterola ne zniža dovolj, ali - samo ali skupaj z drugimi zdravili za zniževanje holesterola, če statinov ni mogoče uporabiti ali jih bolnik ne prenese.
English: • Do not inject Praluent with other injectable medicines at the same spot.
Slovenian: • Zdravila Praluent ne injicirajte na isto mesto skupaj z drugimi zdravili za injiciranje.
English: o thigh o belly (except for the 5 cm area around your navel)
Slovenian: o stegno o trebuh (razen v predel 5 cm okrog popka)
English: • upper respiratory tract signs or symptoms such as sore throat, running nose, sneezing
Slovenian: • znaki ali simptomi na zgornjih dihalih, na primer boleče žrelo, izcedek iz nosu, kihanje
English: • Check that you have the correct product and the correct dose (grey plunger for 150 mg/ml).
Slovenian: • Prepričajte se, da imate pravo zdravilo in pravi odmerek (siv bat za 150 mg/ml).
English: Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Slovenian: Alirokumab je biološko zdravilo, zato ni pričakovati, da bi farmakokinetično vplival na druga zdravila ali na encime citokroma P450.
English: ITT analysis - intent-to-treat population, includes all lipid data throughout the duration of the study irrespective of adherence to the study treatment.
Slovenian: Apo A‐1 a Analiza ZNZ - populacija z-namenom-zdravljenja, vključuje vse podatke o lipidih med celotnim trajanjem študije, ne glede na adherenco z raziskovanim zdravljenjem.
English: Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9).
Slovenian: Alirokumab je povsem humano monoklonsko protitelo IgG1, ki se z veliko afiniteto in specifičnostjo veže na proproteinsko konvertazo subtilizin keksin tipa 9 (PCSK9).
English: Primary hypercholesterolaemia and mixed dyslipidaemia
Slovenian: Primarna hiperholesterolemija in mešana dislipidemija
English: Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent were local injection site reactions.
Slovenian: Najpogostejši neželeni učinki, zaradi katerega so bolniki prenehali zdravljenje z zdravilom Praluent, so bile lokalne reakcije na mestu injiciranja.
English: Reproductive toxicology studies in rats and monkeys indicated that alirocumab, like other IgG antibodies, crosses the placental barrier.
Slovenian: Študije reproduktivne toksičnosti pri podganah in opicah so pokazale, da alirokumab prehaja placentno pregrado, tako kot druga protitelesa IgG.
English: CHD event defined as: major CHD event d, unstable angina requiring hospitalization, ischemia-driven coronary revascularization procedure d
Slovenian: Koronarni dogodek, opredeljen kot: pomemben koronarni dogodek d, nestabilna angina pektoris, ki je zahtevala sprejem v bolnišnico, oz. revaskularizacijski poseg, potreben zaradi ishemije.
English: How to store Praluent 6.
Slovenian: Shranjevanje zdravila Praluent 6.
English: Always check the label of your pen to make sure you have the right medicine and the right strength.
Slovenian: Vedno preverite nalepko na peresniku in se tako prepričajte, da imate pravo zdravilo in pravo jakost.
English: STEP A: Getting ready for an injection
Slovenian: KORAK A: Priprava za injiciranje
English: For detailed results see Table 2.
Slovenian: Za podrobne rezultate glejte preglednico 2.
English:  Look at the label on the pen.
Slovenian:  Poglejte nalepko peresnika.
English: Continue to follow your cholesterol-lowering diet while taking this medicine.
Slovenian: Med uporabo tega zdravila morate še naprej upoštevati dieto za znižanje holesterola.
English: The dose of Praluent can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response.
Slovenian: Odmerek zdravila Praluent je mogoče prilagoditi posamezniku glede na njegove značilnosti, npr. izhodiščno koncentracijo h-LDL, cilj zdravljenja in odziv.
English: In the five placebo-controlled trials in patients on a maximally tolerated dose of statin (n=3752), the discontinuation rate due to musculo-skeletal adverse events was 0.4% in the alirocumab group and 0.5% in the placebo group.
Slovenian: V petih s placebom kontroliranih preskušanjih pri bolnikih, ki so jemali največji tolerirani odmerek statina (n = 3752), je bil delež prekinitev zaradi neželenih mišično-skeletnih dogodkov v skupini z alirokumabom 0,4 % in v skupini s placebom 0,5 %.
English:  Push the plunger down.
Slovenian:  Potisnite bat dol.
English: The index ACS event was a myocardial infarction in 83.2% of patients (34.6% STEMI, 48.6% NSTEMI) and an episode of unstable angina in 16.8% of patients.
Slovenian: Indeksni dogodek AKS je bil pri 83,2 % bolnikov miokardni infarkt (34,6 % STEMI, 48,6 % NSTEMI) in pri 16,8 % bolnikov nestabilna angina pektoris.
English: In pre-specified analyses before possible up-titration at week 12 in the 8 studies in which patients started with the 75 mg every 2 weeks dosing regimen, mean reductions in LDL-C ranging from 44.5% to 49.2% were achieved.
Slovenian: V vnaprej opredeljenih analizah pred morebitnim povečanjem 12. teden v 8 študijah, v katerih so bolniki začeli z odmerno shemo 75 mg na 2 tedna, so bila dosežena povprečna znižanja h-LDL od 44,5 % do 49,2 %.
English: Local injection site reactions, including erythema/redness, itching, swelling, and pain/tenderness, were reported in 6.1% of patients treated with alirocumab versus 4.1% in the control group (receiving placebo injections).
Slovenian: Lokalne reakcije na mestu injiciranja (vključno z eritemom/pordelostjo, srbenjem, oteklostjo in bolečinami/občutljivostjo) so bile opisane pri 6,1 % bolnikov, ki so dobivali alirokumab, in pri 4,1 % bolnikov v kontrolni skupini (ki so dobivali injekcije placeba).
English: • Do not put the syringe back in the refrigerator.
Slovenian: • Brizge ne dajte nazaj v hladilnik.
English: (75 milligrams per ml) or 150 milligrams (150 milligrams per ml) of alirocumab.
Slovenian: 75 miligramov (75 miligramov na ml) ali 150 miligramov (150 miligramov na ml) alirokumaba.
English: Hazard ratio (95% CI) p-value
Slovenian: Razmerje ogroženosti (95% IZ) p-vrednost