FrancophonIA/ELRC3.0 huggingface dataset:
English: Before you use the syringe for the first time, your doctor, pharmacist or nurse will show you how to inject Praluent.
Slovenian: Preden boste prvič uporabili brizgo, vam bo zdravnik, farmacevt ali medicinska sestra pokazal, kako injicirati zdravilo Praluent.
English: The LONG TERM study included 17.7% heFH patients, 34.6% with type 2 diabetes mellitus, and 68.6% with a history of coronary heart disease.
Slovenian: Študija LONG TERM je zajela 17,7 % bolnikov s heFH, 34,6 % bolnikov s sladkorno boleznijo tipa 2 in 68,6 % bolnikov z anamnezo koronarne srčne bolezni.
English: The majority of patients in the phase 3 program were taking background lipid-modifying therapy consisting of a maximally tolerated dose of statin, with or without other lipidmodifying therapies, and were at high or very high cardiovascular (CV) risk.
Slovenian: Večina bolnikov v programu 3. faze je jemala osnovno zdravljenje za prilagoditev lipidov, ki je obsegalo največji tolerirani odmerek statina z drugimi zdravili za prilagoditev lipidov ali brez njih, in so imeli veliko ali zelo veliko kardiovaskularno (KV) tveganje.
English:  Look at the label on the syringe.
Slovenian:  Poglejte nalepko brizge.
English: After removal from the refrigerator, Praluent must be used within 30 days or discarded.
Slovenian: Po odstranitvi iz hladilnika morate zdravilo Praluent v 30 dneh porabiti ali zavreči.
English: Clinical efficacy and safety in primary hypercholesterolaemia and mixed dyslipidaemia
Slovenian: Klinična učinkovitost in varnost pri primarni hiperholesterolemiji in mešani dislipidemiji
English: No data are available in patients with severe hepatic impairment.
Slovenian: Podatkov o bolnikih s hudo okvaro jeter ni.
English: Two studies (LONG TERM and HIGH FH), involving a total of 2416 patients, were performed with a 150 mg every 2 weeks (Q2W) dose only.
Slovenian: Dve študiji (LONG TERM in HIGH FH), ki sta skupaj zajeli 2416 bolnikov, sta bili izvedeni samo z odmerkom 150 mg na 2 tedna.
English: In the cardiovascular outcomes controlled study, 2505 patients (26.5%) treated with Praluent were ≥65 years of age and 493 patients (5.2%) treated with Praluent were ≥75 years of age.
Slovenian: V kontrolirani študiji srčno-žilnih izidov je bilo 2505 bolnikov (26,5 %), zdravljenih z zdravilom Praluent starih ≥ 65 let ter 493 bolnikov (5,2 %), zdravljenih z zdravilom Praluent starih ≥ 75 let.
English: COMBO I study
Slovenian: Študija COMBO I
English: No difference was seen in the incidence of pruritus.
Slovenian: Pojavnost srbenja se ni razlikovala.
English: Individuals with single allele PCSK9 loss-of-function mutation have lower levels of LDL-C, which correlated with a significantly lower incidence of coronary heart disease.
Slovenian: Osebe z enoalelsko mutacijo PCSK9 z izgubo funkcije imajo nižjo koncentracijo h-LDL, to pa korelira z bistveno manjšo pojavnostjo (incidenco) koronarne bolezni srca.
English: Each pre-filled pen or pre-filled syringe is for single use only.
Slovenian: Vsak napolnjen injekcijski peresnik in vsaka napolnjena injekcijska brizga je samo za enkratno uporabo.
English: • Do not remove the pen until the entire window has turned yellow.
Slovenian: • Ne odstranite peresnika, dokler okence ni rumeno.
English: Do not expose syringe to direct sunlight.
Slovenian: Peresnika ne izpostavljajte neposredni sončni svetlobi.
English: Manufacturer Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
Slovenian: Izdelovalec Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
English: Praluent can be stored outside the refrigerator (below 25 °C) protected from light for a single period not exceeding 30 days.
Slovenian: Zdravilo Praluent lahko shranjujete izven hladilnika (pri temperaturi do 25 °C) zaščiteno pred svetlobo za enkratno obdobje, ki ne sme biti daljše od 30 dni.
English: LDL-C values <25 mg/dL (<0.65 mmol/L)
Slovenian: Vrednosti h-LDL < 25 mg/dl (< 0,65 mmol/l)
English: Alirocumab also significantly reduced the following composite endpoints: risk of CHD event; major CHD event; cardiovascular event; and the composite of all-cause mortality, non-fatal MI, and non-fatal ischemic stroke.
Slovenian: Alirokumab je tudi značilno zmanjšal naslednje sestavljene izide: tveganje za koronarni dogodek, pomemben koronarni dogodek, srčno-žilni dogodek ter sestavljeni dogodek umrljivosti zaradi vseh vzrokov, MI brez smrtnega izida in ishemične možganske kapi brez smrtnega izida.
English: Patients in the alirocumab 300 mg every 4 weeks treatment group received alternating placebo injections to maintain blinding in regard to injection frequency.
Slovenian: Bolniki v skupini, zdravljeni s 300 mg alirokumaba na 4 tedne, so izmenično prejemali injekcije placeba za ohranitev slepitve o pogostnosti injekcij.
English: Alirocumab also results in reductions in lipoprotein (a) [Lp(a)], which is a form of LDL that is bound to apolipoprotein (a).
Slovenian: Alirokumab zniža tudi lipoprotein (a) [Lp(a)], tj. H-LDL, vezan na apolipoprotein (a).
English: A slightly greater than dose proportional increase was observed, with a 2.1- to 2.7-fold increase in total alirocumab concentrations for a 2-fold increase in dose from 75 mg to 150 mg Q2W.
Slovenian: Opažali so porast, ki je bil rahlo večji od sorazmernega odmerku, z 2,1- do 2,7-kratnim zvišanjem celotne koncentracije alirokumaba ob 2-kratnem povečanju odmerka s 75 mg na 150 mg na 2 tedna.
English: Reduction in LDL-C was seen across age, gender, body mass index (BMI), race, baseline LDL-C levels, patients with heFH and non-heFH, patients with mixed dyslipidaemia, and diabetic patients.
Slovenian: Znižanje h-LDL so ugotovili ne glede na starost, spol, indeks telesne mase (ITM), raso, izhodiščno koncentracijo h-LDL, pri bolnikih s heFH in ne-heFH, bolnikih z mešano dislipidemijo in pri sladkornih bolnikih.
English: Follow these instructions every time you use a Praluent syringe.
Slovenian: Ta navodila upoštevajte vsakič, ko uporabljate brizgo zdravila Praluent.
English: • Inject all of the solution by slowly and steadily pushing down the plunger.
Slovenian: • Počasi in enakomerno potiskajte bat dol, da boste injicirali vso raztopino.
English: Read the package leaflet and the detailed instructions for use leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo in podrobna navodila za uporabo.
English: • Check the use by date and do not use if this date has passed.
Slovenian: • Preverite datum roka uporabnosti; če je ta datum že pretekel, zdravila ne uporabite.
English: • Use your thumb and first finger to pinch a fold of skin at the injection site.
Slovenian: • S palcem in kazalcem stisnite kožo na mestu injiciranja v gubo.
English: Where to inject Read the detailed instructions for use leaflet on where to inject.
Slovenian: Kam injicirati Preberite podrobnejša navodila za uporabo kam lahko injicirate
English: MONO (N=103) Ezetimibe Alirocumab Ezetimibe Alirocumab Ezetimibe Alirocumab
Slovenian: COMBO I (N = 311) Placebo Alirokumab Placebo Alirokumab Placebo Alirokumab Placebo Alirokumab
English:  Pull pen away from your skin.
Slovenian:  Potegnite peresnik od kože.
English: If you use more Praluent than you should If you use more Praluent than you should, talk to your doctor, pharmacist or nurse.
Slovenian: Če ste uporabili večji odmerek zdravila Praluent, kot bi smeli Če ste uporabili večji odmerek zdravila Praluent, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: In in vitro assays, alirocumab did not induce Fc-mediated effector function activity (antibody-dependent cell-mediated toxicity and complement-dependent cytotoxicity) either in the presence or absence of PCSK9 and no soluble immune complexes capable of binding complement proteins were observed for alirocumab when bound to PCSK9.
Slovenian: V preizkusih in vitro alirokumab ni sprožil z Fc-posredovane efektorske funkcijske aktivnosti (od protiteles odvisne celično posredovane toksičnosti in od komplementa odvisne citotoksičnosti) ne v prisotnosti ne v odsotnosti PCSK9; če je bil alirokumab vezan na PCSK9, pa niso opazili topnih imunskih kompleksov, ki bi lahko vezali beljakovine komplementa.
English: Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Slovenian: Zdravilo Praluent je indicirano pri odraslih bolnikih s primarno hiperholesterolemijo (heterozigotno familiarno ali nefamiliarno) ali mešano dislipidemijo kot dodatek dieti: - v kombinaciji s statinom ali s statinom skupaj z drugimi hipolipemiki pri bolnikih, ki ciljnega holesterola LDL (h-LDL) ne morejo doseči z največjim toleriranim odmerkom statina, ali - samo ali v kombinaciji z drugimi hipolipemiki pri bolnikih, ki statinov ne prenesejo ali so ti pri njih kontraindicirani.
English: There were no adverse effects on surrogate markers of fertility (e.g. estrous cyclicity, testicular volume, ejaculate volume, sperm motility, or total sperm count per ejaculate) in monkeys, and no alirocumab-related anatomic pathology or histopathology findings in reproductive tissues in any rat or monkey toxicology study.
Slovenian: Pri opicah niso ugotovili nobenih neželenih učinkov na nadomestne označevalce plodnosti (npr. cikličnost estrusa, volumen mod, količino ejakulata, gibljivost semenčic in celotno število semenčic na ejakulat) in v nobeni toksikološki študiji na podganah ali opicah niso v reproduktivnih tkivih odkrili z alirokumabom povezanih anatomskih patoloških ali histopatoloških sprememb.
English: Do not use the syringe if the grey needle cap is missing or not securely attached.
Slovenian: Ne uporabite brizge, če sivi pokrovček igle manjka ali ni trdno nameščen.
English: • Do not put the blue cap back on.
Slovenian: • Modrega pokrovčka ne nameščajte nazaj.
English: Since monoclonal antibodies are not known to be eliminated via renal pathways, renal function is not expected to impact the pharmacokinetics of alirocumab.
Slovenian: Ni znano, da bi se monoklonska protitelesa izločala po ledvičnih poteh, zato ni pričakovati, da bi delovanje ledvic vplivalo na farmakokinetiko alirokumaba.
English: • Do not rub the skin after the injection.
Slovenian: • Po injiciranju kože ne drgnite.
English: The percentage of patients who reached LDL-C values <25 mg/dL (<0.65 mmol/L) depended both on the baseline LDL-C and the dose of alirocumab.
Slovenian: Odstotek bolnikov, ki so dosegli h-LDL < 25 mg/dl (< 0,65 mmol/l), je bil odvisen tako od izhodiščnega h-LDL kot od odmerka alirokumaba.
English: Can be stored outside the refrigerator below 25 °C for a single period up to 30 days protected from light.
Slovenian: Lahko shranjujete izven hladilnika pri temperaturi do 25 °C za enkratno obdobje do največ 30 dni zaščiteno pred svetlobo.
English: Upon saturation of PCSK9 binding, further increases in alirocumab concentrations do not result in a further LDL-C reduction, however an extended duration of the LDL-C lowering effect is observed.
Slovenian: Po nasičenju vezave na PCSK9 dodatna zvišanja koncentracije alirokumaba ne povzročijo dodatnega znižanja h-LDL, opazno pa je podaljšano delovanje učinka na znižanje h-LDL.
English: Although adverse consequences of very low LDL-C were not identified in alirocumab trials, the long-term effects of very low levels of LDL-C are unknown.
Slovenian: V preskušanjih alirokumaba sicer niso ugotovili neželenih posledic zelo nizkega h-LDL, toda dolgotrajni učinki zelo nizkega h-LDL niso znani.
English: CHOICE I study
Slovenian: Študija CHOICE I
English: In the 2 studies in which patients were started and maintained on 150 mg every 2 weeks, the achieved mean reduction of LDL-C at week 12 was 62.6%.
Slovenian: V 2 študijah, v katerih so bolniki začeli in vzdrževali zdravljenje s 150 mg na 2 tedna, je bilo doseženo povprečno znižanje h-LDL 12. teden 62,6 %.
English: In the cardiovascular outcomes study (ODYSSEY OUTCOMES), general allergic reactions were similar in alirocumab-treated patients and placebo-treated patients (7.9% alirocumab, 7.8% placebo).
Slovenian: V študiji srčno-žilnih izidov (ODYSSEY OUTCOMES) je bil delež splošnih alergijskih reakcij podoben med bolniki, zdravljenimi z alirokumabom, in bolniki, ki so prejemali placebo (7,9 % z alirokumabom, 7,8 % s placebom).
English: Compared to alirocumab monotherapy, the exposure to alirocumab is about 40%, 15%, and 35% lower when used concomitantly with statins, ezetimibe, and fenofibrate, respectively.
Slovenian: V primerjavi z monoterapijo z alirokumabom je izpostavljenost alirokumabu med sočasno uporabo s statini nižja za približno 40 %, z ezetimibom za približno 15 % in s fenofibratom za približno 35 %.
English: The pharmacodynamic effect of alirocumab in lowering LDL-C is indirect, and mediated through the binding to PCSK9.
Slovenian: Farmakodinamični vpliv alirokumaba na znižanje h-LDL je posreden in poteka preko vezave na PCSK9.
English: In all clinical studies background lipid lowering therapies could not be adjusted by trial design.
Slovenian: V vseh kliničnih študijah ni bilo mogoče z zasnovo študije izvesti prilagoditve glede na osnovno zdravljenje za znižanje lipidov..
English: Your doctor will tell you which dose is right for you and how often to inject (75 mg or 150 mg once every 2 weeks, or 300 mg once every 4 weeks/monthly).
Slovenian: Zdravnik vam bo povedal, kateri odmerek je pravi za vas in kako pogosto si ga injicirajte (75 mg ali 150 mg enkrat na 2 tedna ali 300 mg enkrat na 4 tedne/mesečno).
English: Praluent blocks a protein called PCSK9.
Slovenian: Zdravilo Praluent blokira beljakovino PCSK9.
English: Manufacturer Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France
Slovenian: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait Francija
English: Blue cap
Slovenian: Modri pokrovček
English: • Ask your doctor, pharmacist or nurse how to throw away the container.
Slovenian: • Zdravnika, farmacevta ali medicinsko sestro vprašajte, kako zavreči vsebnik.
English: Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.
Slovenian: Ne dajte si še enega odmerka, ne da bi se posvetovali z zdravnikom, farmacevtom ali medicinsko sestro.
English: Patients had experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of those statins, with or without other LMT.
Slovenian: Bolnike, ki so v obdobju od 4 do 52 tednov pred randomizacijo doživeli akutni koronarni sindrom (AKS), so zdravili z lipolitičnimi zdravili z intenzivno uporabo statinov (opredeljeno kot 40 ali 80 mg atorvastatina ali 20 ali 40 mg rosuvastatina) oz. največjim toleriranim odmerkom teh statinov, z drugimi lipolitičnimi zdravili ali brez njih.
English: For pre-filled pens Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
Slovenian: Napolnjeni injekcijski peresniki Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
English: In patients not on a background statin, up-titration of alirocumab resulted in an additional 3% mean reduction in LDL-C, with the majority of the effect seen in approximately 25% of patients who achieved at least an additional 10% LDL-C lowering after up-titration.
Slovenian: Med bolniki, ki niso prejemali osnovnega zdravljenja s statinom, je povečanje odmerka alirokumaba doseglo dodatno 3 % povprečno znižanje h-LDL; večina tega učinka se je pojavila pri približno 25 % bolnikov, ki so dosegli vsaj dodatno 10 % znižanje h-LDL po povečanju odmerka.
English: In the phase 3 primary hypercholesterolemia and mixed dyslipidaemia controlled studies, 1158 patients (34.7%) treated with Praluent were ≥65 years of age and 241 patients (7.2%) treated with Praluent were ≥75 years of age.
Slovenian: V kontroliranih študijah 3. faze za primarno hiperholesterolemijo in mešano dislipidemijo je bilo 1158 bolnikov (34,7 %), zdravljenih z zdravilom Praluent, starih ≥ 65 let, 241 bolnikov (7,2 %) zdravljenih z zdravilom Praluent, pa je bilo starih ≥ 75 let.
English: Hazard ratios were calculated posthoc; for all CV events, HR=0.91 (95% CI, 0.62 to 1.34); for MACE-plus, HR=0.52 (95% CI, 0.31 to 0.90).
Slovenian: Razmerja ogroženosti so bila izračunana post hoc; za vse KV dogodke je bilo ROg = 0,91 (95 % IZ 0,62 do 1,34), za MACE-plus je bilo ROg = 0,52 (95 % IZ 0,31 do 0,90).
English:  After completing all steps in “Step A: Getting ready for an injection”, pull off the blue cap
Slovenian: KORAK B: Kako injicirati  Ko ste naredili vse korake v "Korak A: Priprava za injiciranje", snemite modri pokrovček
English: A few individuals have been reported, who carry PCSK9 loss-of-function mutations in two alleles and have profoundly low LDL-C levels, with HDL-C and TG levels in the normal range.
Slovenian: Opisanih je bilo nekaj nosilcev mutacije PCSK9 z izgubo funkcije na dveh alelih; te osebe imajo skrajno nizko koncentracijo h-LDL, koncentracijo HDL in TG pa v normalnem območju.
English: For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section
Slovenian: Za rezultate študij o vplivu na h-LDL, srčno-žilne dogodke in o proučevanih populacijah glejte poglavje 5.1.
English: Do not get rid of any air bubbles in the syringe before the injection.
Slovenian: Pred injiciranjem ne odstranjujte zračnih mehurčkov iz brizge.
English: Based on a population pharmacokinetic analysis, race had no impact on alirocumab pharmacokinetics.
Slovenian: Na podlagi populacijske farmakokinetične analize rasa ne vpliva na farmakokinetiko alirokumaba.
English: Do not use the pen if the blue cap is missing or not securely attached.
Slovenian: Ne uporabite peresnika, če modri pokrovček manjka ali ni trdno nameščen.
English: Secondary Endpoints
Slovenian: Končna točka
English: Store in a refrigerator (2°C to 8°C).
Slovenian: Shranjujte v hladilniku (2 °C do 8°C).
English: If needed, individual pre-filled syringes may be kept outside the refrigerator below 25°C for a maximum of 30 days.
Slovenian: Če je potrebno, lahko posamezne napolnjene injekcijske peresnike shranjujete izven hladilnika pri temperaturi do 25°C za največ 30 dni.
English: • if you are allergic to alirocumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Praluent • če ste alergični na alirokumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Animal studies do not indicate direct or indirect harmful effects with respect to maintenance of pregnancy or embryo-fetal development; maternal toxicity was noted in rats, but not in monkeys at doses in excess of the human dose, and a weaker secondary immune response to antigen challenge was observed in the offspring of monkeys (see section 5.3).
Slovenian: Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov glede ohranitve nosečnosti ali embrio-fetalnega razvoja; toksičnost za samice matere je bila ugotovljena pri podganah, ne pa pri opicah ob odmerkih, ki so presegali odmerek za človeka.
English: Hypersensitivity, hypersensitivity vasculitis
Slovenian: Bolezni imunskega sistema preobčutljivost, preobčutljivostni vaskulitis
English: Solution for injection (injection)
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje (injekcija).
English: In pre-specified final analyses of the LONG TERM study, treatment-emergent CV events confirmed by adjudication occurred in 72 of 1550 (4.6%) patients in the alirocumab group and in 40 of 788 (5.1%) patients in the placebo group; MACE-plus confirmed by adjudication were reported in 27 of 1550 (1.7%) patients in the alirocumab group and 26 of 788 (3.3%) patients in the placebo group.
Slovenian: V vnaprej opredeljenih končnih analizah študije LONG TERM so se med zdravljenjem nastali KV dogodki, potrjeni s presojo, pojavili pri 72 od 1550 (4,6 %) bolnikov v skupini z alirokumabom in pri 40 od 788 (5,1 %) bolnikov v skupini s placebom; s presojo potrjeni MACE-plus so se pojavili pri 27 od 1550 (1,7 %) bolnikov v skupini z alirokumabom in pri 26 od 788 (3,3 %) bolnikov v skupini s placebom.
English: Neutralising antibody (NAb) responses were observed in 0.5% of patients treated with alirocumab and in <0.1% of patients treated with placebo.
Slovenian: Odzive z nevtralizacijskimi protitelesi (NAb - neutralising antibodies) so opazili pri 0,5 % bolnikov, ki so prejemali alirokumab, in pri < 0,1 % bolnikov, ki so prejemali placebo.
English: In studies using the criteriabased up-titration regimen, a majority of patients achieved the pre-defined target LDL-C (based on their level of CV risk) on the 75 mg Q2W dose, and a majority of patients maintained treatment on the 75 mg Q2W dose.
Slovenian: V študijah, v katerih so povečevanje odmerka izvajali na podlagi meril, je večina bolnikov dosegla vnaprej opredeljeni ciljni h-LDL (na podlagi svojega KV tveganja) z odmerkom 75 mg na 2 tedna in večina bolnikov je tudi vzdrževala zdravljenje z odmerkom 75 mg na 2 tedna.
English:  Let the syringe warm up at room temperature for 30 to 40 minutes.
Slovenian:  Brizgo za 30 do 40 minut pustite na sobni temperaturi, da se ogreje.
English: • You can stand or sit to give yourself an injection.
Slovenian: • Zdravilo si lahko injicirate stoje ali sede.
English: Body weight was identified as one significant covariate in the final population PK model impacting alirocumab pharmacokinetics.
Slovenian: Telesna masa se je v končnem populacijskem farmakokinetičnem modelu izkazala kot pomembna sospremenljivka, ki vpliva na farmakokinetiko alirokumaba.
English: Do not use the syringe if it has been dropped or damaged.
Slovenian: Ne uporabite brizge, če je kam padla ali če je poškodovana.
English: PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver.
Slovenian: PCSK9 se veže na receptorje za lipoproteine majhne gostote (LDLR - low-density lipoprotein receptors) na površini jetrnih celic in pospeši razgradnjo LDLR v jetrih.
English: Patients on 75 mg Q2W who had two consecutive LDL-C values below 15 mg/dL (0.39 mmol/L) were switched to placebo in a blinded fashion.
Slovenian: Bolniki, ki so prejemali 75 mg na 2 tedna in so imeli dve zaporedni vrednosti h-LDL pod 15 mg/dl (0,39 mmol/l), so zaslepljeno prešli na placebo.
English: In a multicenter, double-blind, placebo-controlled, 14 week study, 13 patients with heterozygous familial hypercholesterolaemia (heFH) due to gain-of-function mutations in the PCSK9 gene were randomised to receive either alirocumab 150 mg Q2W or placebo.
Slovenian: V multicentrični dvojno slepi s placebom kontrolirani 14-tedenski študiji so 13 bolnikov s heterozigotno familiarno hiperholesterolemijo (heFH) zaradi mutacije gena PCSK9 s povečanjem funkcije randomizirali na prejemanje ali alirokumaba 150 mg na 2 tedna ali placeba.
English: • Use a 45° angle if you can only pinch 2 cm of skin.
Slovenian: • Če lahko v gubo stisnete le 2 cm kože, zabodite pod kotom 45 stopinj.
English: In both cohorts, the difference vs placebo was statistically significant at week 24 for all lipid parameters, except for Apo A-1 in the subgroup of patients on background statin.
Slovenian: V obeh kohortah so se po 24 tednih v primerjavi s placebom značilno razlikovali vsi lipidni parametric, razen Apo A-1 v podskupini bolnikov, ki so prejemali statin.
English: No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the phase 3 program.
Slovenian: Med obema odmerkoma (75 mg in 150 mg), uporabljenima v programu 3. faze, niso opazili razlik v varnostnih značilnostih.
English: Every 4 week dosing study
Slovenian: Študija uporabe na 4 tedne
English: Excipients: histidine, sucrose, polysorbate 20, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: histidin, saharoza, polisorbat 20, voda za injekcije.