FrancophonIA/ELRC3.0 huggingface dataset:
English: Component of a multi-pack, can't be sold separately.
Slovenian: Del skupnega pakiranja, ni za ločeno prodajo.
English: Take Repatha as soon as you can after the missed dose.
Slovenian: Zdravilo Repatha uporabite čim prej po izpuščenem odmerku.
English: Step 3: Inject J Peel away both green pull tabs to show the adhesive.
Slovenian: 3. korak: Injiciranje J Odlepite oba zelena potezna jezička, da se pokaže lepilo.
English: • Place the tray on your hand.
Slovenian: • Položite pretisni omot na roko.
English: Automated mini-doser Plastic cover
Slovenian: Avtomatski odmernik Plastično prekritje
English: Make sure clothing does not get in the way of the loaded automated mini-doser, and you can see the blue light at all times.
Slovenian: Poskrbite, da oblačila ne bodo ovirala napolnjenega avtomatskega odmernika in da boste ves čas videli modro lučko.
English: b p value < 0.001 when compared with placebo.
Slovenian: b vrednost p < 0,001 v primerjavi s placebom.
English: Stretch skin firmly by moving your thumb and fingers in the opposite direction, creating an area about 2 inches (5 centimetres) wide.
Slovenian: Kožo čvrsto raztegnite tako, da palec in prste razmaknete v nasprotni smeri in tako ustvarite približno 5 centimetrov širok predel.
English: Let your skin dry before injecting.
Slovenian: Pustite, da se koža pred injiciranjem osuši.
English: Of the 18,546 patients treated with Repatha in double-blind clinical studies 7,656 (41.3%) were ≥ 65 years old, while 1,500 (8.1%) were ≥ 75 years old.
Slovenian: Od 18.546 bolnikov, zdravljenih z zdravilom Repatha, v dvojno slepih kliničnih študijah je bilo 7.656 (41,3 %) starih ≥ 65 let, 1.500 (8,1 %) pa starih ≥ 75 let.
English: Important: Needle is inside.
Slovenian: Pomembno: Znotraj je igla.
English: If you also receive apheresis, a procedure similar to dialysis where cholesterol and other fats are removed from the blood, your doctor may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
Slovenian: Če se zdravite tudi z aferezo, ki je podoben postopek kot dializa, pri katerem so iz krvi odstranjeni holesterol in druge maščobe, se lahko zdravnik odloči, da bo zdravljenje začel z odmerkom 420 mg na dva tedna, da se bo ujemalo z zdravljenjem z aferezo.
English: Repatha is intended for patient self-administration after proper training.
Slovenian: Zdravilo Repatha je namenjeno za samoinjiciranje, potem ko bolnik opravi ustrezno usposabljanje.
English: Single 140 mg subcutaneous doses of Repatha were studied in 8 patients with mild hepatic impairment, 8 patients with moderate hepatic impairment and 8 healthy subjects.
Slovenian: Enkraten 140 mg subkutani odmerek zdravila Repatha so proučili pri 8 bolnikih z blago okvaro jeter, 8 bolnikih z zmerno okvaro jeter in 8 zdravih osebah.
English: • You may hear a pumping sound.
Slovenian: • Morda boste slišali zvok črpanja.
English: What Repatha is and how it works
Slovenian: Kaj je zdravilo Repatha in kako deluje
English: In the integrated clinical safety analysis set, the subject incidence of adverse events potentially associated with hypersensitivity was 4.45% in any evolocumab group and 3.95% in subjects in any control group; the relative risk ratio was 1.13 (95% CI: 1.02, 1.25).
Slovenian: V naboru združenih podatkov za analizo klinične varnosti je incidenca neželenih učinkov, potencialno povezanih s preobčutljivostjo, pri bolnikih v kateri koli skupini z evolokumabom znašala 4,45 %, pri bolnikih v kateri koli kontrolni skupini pa 3,95 %; relativno razmerje tveganj je znašalo 1,13 (95 % IZ: 1,02, 1,25).
English: Hazard ratioa (95% CI)
Slovenian: Razmerje ogroženostia (95 % IZ)
English: Repatha can help prevent heart attack, stroke, and certain heart procedures to restore blood flow to the heart due to a build-up of fatty deposits in your arteries (also known as atherosclerotic cardiovascular disease).
Slovenian: Zdravilo Repatha pomaga pri preprečevanju srčnega infarkta, možganske kapi in določenih delovanjih srca za obnovitev krvnega pretoka v srce zaradi nalaganja maščobnih usedlin v arterijah (znano tudi kot aterosklerotična srčno-žilna bolezen).
English: • It is important that you do not try to give yourself the injection unless you have received training from your healthcare provider.
Slovenian: • Pomembno je, da si zdravila ne poskušate injicirati sami, dokler vas tega ne nauči zdravstveni delavec.
English: • Talk with your healthcare provider about proper disposal.
Slovenian: • Z zdravstvenim delavcem se posvetujte o pravilnem odlaganju.
English: • Do not let the automated mini-doser get wet from water or any other liquids.
Slovenian: • Pazite, da se avtomatski odmernik ne zmoči z vodo ali katero koli drugo tekočino.
English: What Repatha is and what it is used for What you need to know before you use Repatha How to use Repatha
Slovenian: Kaj je zdravilo Repatha in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Repatha Kako uporabljati zdravilo Repatha Možni neželeni učinki
English: C When done, RELEASE your thumb, and gently lift the syringe off skin.
Slovenian: C Ko ste opravili, ODMAKNITE palec in brizgo previdno dvignite od kože.
English: Repatha (N = 13,784) n (%)
Slovenian: Zdravilo Repatha (N = 13.784) n (%)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Repatha in all subsets of the paediatric population in the treatment of mixed dyslipidaemia.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Repatha za vse podskupine pediatrične populacije za zdravljenje mešane dislipidemije.
English: The automated mini-doser is on when the blue status light flashes.
Slovenian: Avtomatski odmernik je vklopljen, ko modra lučka stanja utripa.
English: Stop using the loaded automated mini-doser.
Slovenian: Nehajte uporabljati napolnjeni avtomatski odmernik.
English: B Using slow and constant pressure, PUSH the plunger rod all the way down until the syringe is empty.
Slovenian: B S počasnim in enakomernim pritiskom POTISNITE bat brizge do konca noter, dokler brizga ni prazna.
English: Therefore, no dose adjustments are necessary based on body weight.
Slovenian: Zato odmerka ni treba prilagoditi glede na telesno maso.
English: Other medicines and Repatha
Slovenian: Druga zdravila in zdravilo Repatha
English: B Gather all materials needed for your injection.
Slovenian: B Pripravite ves material, potreben za injiciranje.
English: • Joint pain (arthralgia)
Slovenian: • Bolečine v sklepih (artralgija)
English: Troubleshooting What to do if the loaded automated mini-doser status light continuously flashes red and you hear beeps.
Slovenian: Kaj storiti, če lučka stanja na napolnjenem avtomatskem odmerniku nenehno rdeče utripa in slišite piske.
English: Check to see that the used plunger completely fills the medicine window, and the green solid light turns off, letting you know all medicine has been injected.
Slovenian: Preverite, ali je okence za zdravilo povsem napolnjeno z uporabljenim batom in ali je stalno prižgana zelena lučka ugasnila; to pomeni da je bilo celotno zdravilo injicirano.
English: • Injection site reactions, such as bruising, redness, bleeding, pain or swelling
Slovenian: • Reakcije na mestu injiciranja, kot na primer podplutba, pordelost, krvavitev, bolečina ali zatekanje
English: • an adult with a high cholesterol level in your blood and established atherosclerotic cardiovascular disease (a history of heart attack, stroke or blood vessel problems).
Slovenian: • odrasla oseba z visokim holesterolom v krvi in potrjeno aterosklerotično srčno-žilno boleznijo (zgodovina srčnega infarkta, možganske kapi ali težav s krvnimi žilami).
English: In each extension study, patients were randomised 2:1 to receive either Repatha plus standard of care (evolocumab group) or standard of care alone (control group) for the first year of the study.
Slovenian: V obeh podaljšanih študijah so bolnike za prvo leto študije v razmerju 2:1 randomizirali bodisi na prejemanje zdravila Repatha in standardno oskrbo (skupina z evolokumabom) bodisi le na standardno oskrbo (kontrolna skupina).
English: A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Repatha therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Repatha, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Slovenian: Če morate uporabiti isto mesto za injiciranje, se prepričajte, da ne boste injicirali na isti točki kot prejšnjič.
English: Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone.
Slovenian: Zdravilo Repatha uporabljamo pri bolnikih, ki koncentracije holesterola ne morejo uravnati samo z dieto za zniževanje holesterola.
English: Hospitalisation for unstable anginae a Based on a Cox model stratified by the randomisation stratification factors collected via IVRS.
Slovenian: Hospitalizacija zaradi nestabilne angine pectorise a Na osnovi Cox modela, stratificirano z randomiziranimi faktorji stratifikacije, pridobljenimi iz IVRS.
English: The effects of Repatha 420 mg once monthly on atherosclerotic disease burden, as measured by intravascular ultrasound (IVUS), were evaluated in a 78-week double-blind, randomised, placebo controlled study in 968 patients with coronary artery disease on a stable background of optimal statin therapy.
Slovenian: Učinki zdravila Repatha 420 mg enkrat na mesec na breme aterosklerotične bolezni, izmerjeno z znotrajžilnim ultrazvokom (IVUS - Intravascular ultrasound), so bili ocenjeni v 78-tedenski, dvojno slepi, randomizirani, s placebom kontrolirani študiji pri 968 bolnikih s koronarno arterijsko boleznijo na stabilnem osnovnem zdravljenju z optimalnim statinom.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Repatha in one or more subsets of the paediatric population in the treatment of elevated cholesterol.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Repatha za eno ali več podskupin pediatrične populacije za zdravljenje zvišanega holesterola.
English: LDL-C and other lipid parameters returned to baseline within 12 weeks after discontinuation of Repatha at the beginning of OSLER or OSLER-2 without evidence of rebound.
Slovenian: LDL-H in drugi lipidni parametri so se po prenehanju uporabe zdravila Repatha v 12 tednih vrnili na izhodiščne vrednosti, kot so bile na začetku študij OSLER ali OSLER-2, brez znakov preobrata ("rebound").
English: Repatha is given as an injection under the skin (subcutaneous).
Slovenian: Zdravilo Repatha se daje z injiciranjem pod kožo (subkutano).
English: Warning: Do not modify the device.
Slovenian: Opozorilo: Ne posegajte v pripomoček.
English: NOTE: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Slovenian: OPOMBA: Ko boste napolnjeni injekcijski peresnik odmaknili od kože, bo samodejno prekril iglo.
English: OSLER and OSLER-2 were two randomised, controlled, open-label extension studies to assess the long-term safety and efficacy of Repatha in patients who completed treatment in a ‘parent' study.
Slovenian: OSLER in OSLER-2 sta bili randomizirani, kontrolirani, odprti podaljšani študiji za oceno dolgoročne varnosti in učinkovitosti zdravila Repatha pri bolnikih, ki so dokončali zdravljenje v matični študiji.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri do 1 od 100 oseb
English: OLE Week 144
Slovenian: Odprto podaljšanje 144. teden
English: TAUSSIG was a multicentre, open-label, 5-year extension study to assess the long-term safety and efficacy of Repatha, as an adjunct to other lipid-lowering therapies, in patients with severe familial hypercholesterolaemia (FH), including homozygous familial hypercholesterolaemia.
Slovenian: TAUSSIG je bila multicentrična, odprta 5-letna podaljšana študija za oceno dolgoročne varnosti in učinkovitosti zdravila Repatha kot dodatka drugim zdravilom za zniževanje lipidov pri bolnikih s hudo družinsko hiperholesterolemijo (DH), vključno s homozigotno družinsko hiperholesterolemijo.
English: Solution for injection (injection) (SureClick).
Slovenian: Raztopina za injiciranje (injekcija) (SureClick).
English: Accordingly the PRAC agreed to include hypersensitivity reactions in the section 4.8 of the SmPC with a frequency common and update the PL accordingly.
Slovenian: V skladu s tem se je odbor PRAC strinjal, da se preobčutljivostne reakcije vključi v poglavje 4.8 povzetka glavnih značilnosti zdravila s pogostnostjo pogosti in da se ustrezno posodobijo navodila za uporabo.
English: (HMD) (combined rosuvastatin, simvastatin, & atorvastatin groups)
Slovenian: (HMD) (združeni podatki skupin z rosuvastatinom, simvastatinom in atorvastatinom)
English: Despite the very low levels of LDL-C achieved, no new safety issues were observed (see section 4.8); the frequencies of new onset diabetes and cognitive events were comparable in patients who achieved LDL-C levels < 0.65 mmol/L and those with higher LDL-C.
Slovenian: Kljub doseženim zelo nizkim vrednostim LDL-H niso zabeležili novih varnostnih težav (glejte poglavje 4.8); frekvenci novih pojavov sladkorne bolezni in kognitivnih dogodkov sta bili primerljivi med bolniki, ki so dosegli koncentracije LDL-H < 0,65 mmol/l, in bolniki, ki so imeli višje vrednosti LDL-H.
English: Press down firmly
Slovenian: Čvrsto pritisnite dol
English: Do not use Repatha if you are allergic to evolocumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Repatha Ne uporabljajte zdravila Repatha, če ste alergični na evolokumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Evolocumab is designed to attach to a substance called PCSK9 that affects the liver's ability to take in cholesterol.
Slovenian: Evolokumab je zasnovan za vezavo na snov, ki jo imenujemo PCSK9 in vpliva na sposobnost jeter, da sprejemajo holesterol.
English: Sterilised using ethylene oxide
Slovenian: Sterilizirano z uporabo etilenoksida.
English: In clinical studies with repeated subcutaneous dosing over 12 weeks, dose proportional increases in exposure were observed with dose regimens of 140 mg and greater.
Slovenian: V kliničnih študijah s ponavljajočo se subkutano uporabo v obdobju 12 tednov so z odmerjanjem 140 mg in več opažali z odmerkom sorazmerna povečanja izpostavljenosti.
English: Do not leave the grey needle cap off for more than 5 minutes.
Slovenian: Brizge s snetim sivim pokrovčkom ne puščajte več kot 5 minut.
English: Reductions in serum LDL-C and total cholesterol were more pronounced than observed previously with evolocumab alone, and were reversible upon cessation of treatment.
Slovenian: Znižanji LDL-H in celokupnega holesterola sta bili izrazitejši kot predhodno s samim evolokumabom in sta bili po prenehanju zdravljenja reverzibilni.
English: DO NOT: Use the Repatha pre-filled syringe if the packaging is open or damaged.
Slovenian: NE UPORABLJAJTE napolnjene injekcijske brizge zdravila Repatha, če je pakiranje odprto ali poškodovano.
English: Talk to your doctor, pharmacist or nurse before using Repatha if you have: - liver disease, - severe kidney problems.
Slovenian: Pred začetkom uporabe zdravila Repatha se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate: - bolezen jeter, - hude težave z ledvicami.
English: Hold the loaded automated mini-doser with the blue light visible, and place it on your skin.
Slovenian: Primite napolnjeni avtomatski odmernik tako, da boste videli modro lučko, in ga položite na kožo.
English: Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Slovenian: Pred uvedbo zdravila Repatha je treba izključiti druge vzroke hiperlipidemije ali mešane dislipidemije (npr. nefrotski sindrom, hipotiroidizem).
English: • Moderate physical activities can be performed during the injection process, such as walking, reaching and bending.
Slovenian: • Med postopkom injiciranja lahko izvajate zmerne telesne dejavnosti, na primer hodite, segate po stvareh ali se sklanjate.
English: The patients whose sera tested positive for binding antibodies were further evaluated for neutralising antibodies and none of the patients tested positive for neutralising antibodies.
Slovenian: Bolnike s pozitivnim serumskim izvidom za ne-nevtralizacijska protitelesa so dodatno testirali za nevtralizacijska protitelesa; noben bolnik ni imel pozitivnega izvida za nevtralizacijska protitelesa.
English: Before starting Repatha, you should be on a diet to lower your cholesterol.
Slovenian: Pred začetkom jemanja zdravila Repatha morate biti na dieti za zniževanje holesterola.
English: Reduction in LDL-C from baseline at week 52 compared with placebo was consistent across background lipidlowering therapies optimised for LDL-C and cardiovascular risk.
Slovenian: Znižanje LDL-H od izhodišča do 52. tedna je bilo v primerjavi s placebom dosledno pri vseh osnovnih zdravljenjih za znižanje lipidov, optimiziranih za LDL-H in srčno-žilno tveganje.
English: VLDLC
Slovenian: VLDLH
English: This could damage the syringe.
Slovenian: S tem lahko poškodujete brizgo.
English: By attaching to, and mopping up PCSK9, the medicine increases the amount of cholesterol entering the liver and so lowers the level of cholesterol in the blood.
Slovenian: Z vezavo na PCSK9 zdravilo onemogoči to beljakovino, s tem poveča količino holesterola, ki vstopa v jetra, in tako zniža holesterol v krvi.
English: C Gather all materials needed for your injection.
Slovenian: C Pripravite ves material, potreben za injiciranje.
English: M Firmly press and release the start button.
Slovenian: M Čvrsto pritisnite sprožilni gumb in ga izpustite.
English: The presence of anti-evolocumab binding antibodies did not impact the pharmacokinetic profile, clinical response, or safety of Repatha.
Slovenian: Prisotnost ne-nevtralizacijskih protiteles proti evolokumabu ni vplivala na farmakokinetične značilnosti, klinični odziv ali varnost zdravila Repatha.
English: Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see section 5.2).
Slovenian: Uporaba pri bolnikih s hudo okvaro jeter (Child-Pugh C) ni raziskana (glejte poglavje 5.2).
English: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL-C reduction.
Slovenian: Pri bolnikih z zmerno okvaro jeter so ugotovili manjšo celokupno izpostavljenost evolokumabu, kar lahko zmanjša učinek na znižanje LDL-H.
English: Grey start button
Slovenian: Sivi sprožilni gumb
English: Syringe label with expiration date
Slovenian: Nalepka na brizgi z datumom izteka roka uporabnosti
English: In patients with primary hypercholesterolaemia or mixed dyslipidaemia on high dose statin, the systemic exposure of evolocumab was slightly lower than in subjects on low-to-moderate dose statin (the ratio of AUClast 0.74 [90% CI 0.29; 1.9]).
Slovenian: Pri bolnikih s primarno hiperholesterolemijo ali mešano dislipidemijo, ki so prejemali visokoodmerni statin, je bila sistemska izpostavljenost evolokumabu nekoliko manjša kot pri preiskovancih, ki s prejemali nizek ali zmeren odmerek statina (razmerje AUClast 0,74 [90 % IZ 0,29, 1,9]).
English: • Do not touch the skin adhesive.
Slovenian: • Ne dotikajte se lepila za kožo.
English: Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
Slovenian: Zdravilo Repatha je indicirano pri odraslih s potrjeno aterosklerotično srčno-žilno boleznijo (miokardni infarkt, možganska kap ali periferna arterijska bolezen) za znižanje srčno-žilnega tveganja z znižanjem koncentracij holesterola LDL, kot dodatek h korekciji drugih dejavnikov tveganja:
English: alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.
Slovenian: samo ali skupaj z drugimi zdravili za zniževanje holesterola, če statini ne delujejo dobro ali jih ni mogoče uporabiti.
English: The pre-filled cartridge is assembled with a telescopic screw device component.
Slovenian: Napolnjeni vložek je sestavljen s pomočjo teleskopskega vijačnega elementa.
English: Administration of Repatha can also be performed by an individual who has been trained to administer the product.
Slovenian: Zdravilo Repatha lahko injicira tudi oseba, ki se je usposobila za njegovo dajanje.
English: In 80-85% of all primary hyperlipidaemia patients treated with either dose, Repatha demonstrated a ≥ 50% reduction in LDL-C at the mean of weeks 10 and 12.
Slovenian: Pri 80-85 % vseh bolnikov s primarno hiperlipidemijo, zdravljenih z enim ali drugim odmerkom, je zdravilo Repatha v povprečju 10. in 12. tedna znižalo LDL-H za ≥ 50 %.
English: MARKETING AUTHORISATION NUMBER(S) Repatha 140 mg solution for injection in pre-filled syringe EU/1/15/1016/001 - 1 pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen EU/1/15/1016/002 - 1 pre-filled pen EU/1/15/1016/003 - 2 pre-filled pens EU/1/15/1016/004 - 3 pre-filled pens EU/1/15/1016/005 - 6 (3x2) pre-filled pens (multipack)
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/15/1016/001 - 1 napolnjena injekcijska brizga Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/15/1016/002 - 1 napolnjen injekcijski peresnik EU/1/15/1016/003 - 2 napolnjena injekcijska peresnika EU/1/15/1016/004 - 3 napolnjeni injekcijski peresniki EU/1/15/1016/005 - 6 (3 x 2) napolnjenih injekcijskih peresnikov (skupno pakiranje) Repatha 420 mg raztopina za injiciranje v vložku
English: Available data demonstrate that there are no clinically meaningful differences between the safety profiles of patients with LDL-C levels < 0.65 mmol/L and those with higher LDL-C, see section 4.8.
Slovenian: Podatki, ki so na voljo, kažejo, da ni klinično pomembnih razlik v varnostnih značilnostih pri bolnikih s koncentracijo LDL-H < 0,65 mmol/l in bolnikih z višjim LDL-H (glejte poglavje 4.8).
English: The most commonly reported adverse reactions during pivotal trials, at the recommended doses, were nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%), and injection site reactions (2.2%).
Slovenian: V ključnih preskušanjih so med uporabo priporočenih odmerkov najpogosteje poročali o neželenih učinkih nazofaringitis (7,4 %), okužba zgornjih dihal (4,6 %), bolečina v hrbtu (4,4 %), artralgija (3,9 %), gripa (3,2 %) in reakcije na mestu injiciranja (2,2 %).
English: The treatment effect was consistent across all subgroups (including age, type of disease, baseline LDL-C, baseline statin intensity, ezetimibe use, and diabetes) and was driven by a reduction in the risk of myocardial infarction, stroke and coronary revascularisation; no significant difference was seen on cardiovascular or all-cause mortality however the study was not designed to detect such a difference.
Slovenian: Učinek zdravljenja je bil konsistenten med vsemi podskupinami (vključno s starostjo, tipom bolezni, izhodiščnim LDL-H, izhodiščno intenzivnostjo zdravljenja s statini, uporabo ezetimiba in sladkorno boleznijo) in je bil usmerjen z znižanjem tveganja za miokardni infarkt, možgansko kap in koronarno revaskularizacijo; za srčno-žilno umrljivost ali umrljivost zaradi vseh vzrokov niso opazili značilnih razlik, vendar študija ni bila načrtovana za zaznavanje te razlike.
English: Check that the name Repatha appears on the carton label.
Slovenian: Preverite ime zdravila Repatha na nalepki škatle.