natgillin/translations-raw huggingface dataset:
On the basis of the scientific conclusions for evolocumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing evolocumab is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za evolokumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) evolokumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Repatha must not be administered intravenously or intramuscularly.
Zdravila Repatha se ne sme dajati intravensko ali intramuskularno.
• The single use automated mini-doser for subcutaneous injection is intended only for use with the cartridge.
• Avtomatski odmernik za subkutano injiciranje za enkratno uporabo je namenjen le za uporabo z vložkom.
Changes in unbound PCSK9 and serum lipoproteins were reversible upon discontinuation of Repatha.
Spremembe nevezanega PCSK9 in lipoproteinov v serumu so bile po prenehanju uporabe zdravila Repatha reverzibilne.
No overall differences in safety or efficacy were observed between these patients and younger patients.
V celoti med temi bolniki in mlajšimi bolniki niso ugotovili razlik v varnosti in učinkovitosti.
d The treatment effect on stroke was driven by a reduction in risk of ischaemic stroke; there was no effect on haemorrhagic or undetermined stroke.
d Učinek zdravljenja na možgansko kap je bil posledica zmanjšanja tveganja za ishemično možgansko kap; vpliva na hemoragično ali nedoločeno možgansko kap ni bilo.
The loaded automated mini-doser will lay flat on your body.
Napolnjeni avtomatski odmernik bo ležal plosko na telesu.
A total of 1,324 patients enrolled in OSLER.
Študija OSLER je zajela skupno 1.324 bolnikov.
45 minutes.
Počakajte 45 minut.
Hazard Ratio, 0.80 (95% CI, 0.73, 0.88) P<0.0001
Razmerje ogroženosti, 0,80 (95 % IZ, 0,73, 0,88) p<0,0001
Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Za rezultate študije glede učinka na holesterol LDL, srčno-žilne dogodke in o preiskovanih bolnikih glejte poglavje 5.1.
Do not stretch for thigh Important: Adjust your body posture to avoid skin folds and bulges.
Ne raztezajte kože na stegnu Pomembno: Prilagodite telesno držo tako, da ne bo kožnih gub ali izboklin.
After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks.
Zdravnik se lahko po 12 tednih odloči za povečanje odmerka na 420 mg na vsaka dva tedna.
A total of 3,681 patients enrolled in OSLER-2.
Študija OSLER-2 je zajela skupno 3.681 bolnikov.
Important: You must push all the way down but do not touch the grey start button until you are ready to inject.
Pomembno: Potisniti morate do konca dol, vendar se ne dotikajte sivega sprožilnega gumba, dokler niste pripravljeni na injiciranje.
The relative risk of the MACE composite (CV death, MI, or stroke) was significantly reduced by 20%.
Relativno tveganje za sestavljen dogodek MACE (srčno-žilna smrt, miokardni infarkt ali možganska kap) je bilo značilno znižano za 20 %.
• You hear several beeps.
• Slišite več piskov.
During injection, keep the automated mini-doser a minimum of 10 cm (4 inches) away from other electronics such as mobile phones.
Med injiciranjem mora biti avtomatski odmernik vsaj 10 cm odmaknjen od kakršne koli elektronske naprave, na primer od mobilnega telefona.
Insert the cartridge bottom first.
Najprej vstavite dno vložka.
Do not touch the grey start button
Ne dotikajte se sivega sprožilnega gumba
• Alcohol wipes.
• alkoholne zložence.
Step 2: Get ready A Carefully pull the grey needle cap straight out and away from your body.
2. korak: Pripravite se A Previdno potegnite sivi pokrovček igle naravnost z brizge in proč od telesa.
Combination with a statin and statin with other lipid-lowering therapies
Kombinacija s statinom in s statinom z drugimi zdravili za zniževanje lipidov
No data on the effect of evolocumab on human fertility are available.
Podatkov o vplivu evolokumaba na plodnost pri človeku ni.
Component of a multi-pack, can't be sold separately.
Del skupnega pakiranja, ni za ločeno prodajo.
Take Repatha as soon as you can after the missed dose.
Zdravilo Repatha uporabite čim prej po izpuščenem odmerku.
Step 3: Inject J Peel away both green pull tabs to show the adhesive.
3. korak: Injiciranje J Odlepite oba zelena potezna jezička, da se pokaže lepilo.
• Place the tray on your hand.
• Položite pretisni omot na roko.
Automated mini-doser Plastic cover
Avtomatski odmernik Plastično prekritje
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.
Poskrbite, da oblačila ne bodo ovirala napolnjenega avtomatskega odmernika in da boste ves čas videli modro lučko.
b p value < 0.001 when compared with placebo.
b vrednost p < 0,001 v primerjavi s placebom.
Stretch skin firmly by moving your thumb and fingers in the opposite direction, creating an area about 2 inches (5 centimetres) wide.
Kožo čvrsto raztegnite tako, da palec in prste razmaknete v nasprotni smeri in tako ustvarite približno 5 centimetrov širok predel.
Let your skin dry before injecting.
Pustite, da se koža pred injiciranjem osuši.
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.
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.
Important: Needle is inside.
Pomembno: Znotraj je igla.
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.
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.
Repatha is intended for patient self-administration after proper training.
Zdravilo Repatha je namenjeno za samoinjiciranje, potem ko bolnik opravi ustrezno usposabljanje.
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.
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.
• You may hear a pumping sound.
• Morda boste slišali zvok črpanja.
What Repatha is and how it works
Kaj je zdravilo Repatha in kako deluje
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).
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).
Hazard ratioa (95% CI)
Razmerje ogroženostia (95 % IZ)
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).
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).
• It is important that you do not try to give yourself the injection unless you have received training from your healthcare provider.
• Pomembno je, da si zdravila ne poskušate injicirati sami, dokler vas tega ne nauči zdravstveni delavec.
• Talk with your healthcare provider about proper disposal.
• Z zdravstvenim delavcem se posvetujte o pravilnem odlaganju.
• Do not let the automated mini-doser get wet from water or any other liquids.
• Pazite, da se avtomatski odmernik ne zmoči z vodo ali katero koli drugo tekočino.
What Repatha is and what it is used for What you need to know before you use Repatha How to use Repatha
Kaj je zdravilo Repatha in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Repatha Kako uporabljati zdravilo Repatha Možni neželeni učinki
C When done, RELEASE your thumb, and gently lift the syringe off skin.
C Ko ste opravili, ODMAKNITE palec in brizgo previdno dvignite od kože.
Repatha (N = 13,784) n (%)
Zdravilo Repatha (N = 13.784) n (%)
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.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Repatha za vse podskupine pediatrične populacije za zdravljenje mešane dislipidemije.
The automated mini-doser is on when the blue status light flashes.
Avtomatski odmernik je vklopljen, ko modra lučka stanja utripa.
Stop using the loaded automated mini-doser.
Nehajte uporabljati napolnjeni avtomatski odmernik.
B Using slow and constant pressure, PUSH the plunger rod all the way down until the syringe is empty.
B S počasnim in enakomernim pritiskom POTISNITE bat brizge do konca noter, dokler brizga ni prazna.
Therefore, no dose adjustments are necessary based on body weight.
Zato odmerka ni treba prilagoditi glede na telesno maso.
Other medicines and Repatha
Druga zdravila in zdravilo Repatha
B Gather all materials needed for your injection.
B Pripravite ves material, potreben za injiciranje.
• Joint pain (arthralgia)
• Bolečine v sklepih (artralgija)
Troubleshooting What to do if the loaded automated mini-doser status light continuously flashes red and you hear beeps.
Kaj storiti, če lučka stanja na napolnjenem avtomatskem odmerniku nenehno rdeče utripa in slišite piske.
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.
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.
• Injection site reactions, such as bruising, redness, bleeding, pain or swelling
• Reakcije na mestu injiciranja, kot na primer podplutba, pordelost, krvavitev, bolečina ali zatekanje
• 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).
• odrasla oseba z visokim holesterolom v krvi in potrjeno aterosklerotično srčno-žilno boleznijo (zgodovina srčnega infarkta, možganske kapi ali težav s krvnimi žilami).
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.
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).
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.
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.
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.
Če morate uporabiti isto mesto za injiciranje, se prepričajte, da ne boste injicirali na isti točki kot prejšnjič.
Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone.
Zdravilo Repatha uporabljamo pri bolnikih, ki koncentracije holesterola ne morejo uravnati samo z dieto za zniževanje holesterola.
Hospitalisation for unstable anginae a Based on a Cox model stratified by the randomisation stratification factors collected via IVRS.
Hospitalizacija zaradi nestabilne angine pectorise a Na osnovi Cox modela, stratificirano z randomiziranimi faktorji stratifikacije, pridobljenimi iz IVRS.
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.
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.
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.
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.
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.
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").
Repatha is given as an injection under the skin (subcutaneous).
Zdravilo Repatha se daje z injiciranjem pod kožo (subkutano).
Warning: Do not modify the device.
Opozorilo: Ne posegajte v pripomoček.
NOTE: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
OPOMBA: Ko boste napolnjeni injekcijski peresnik odmaknili od kože, bo samodejno prekril iglo.
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.
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.
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri do 1 od 100 oseb
OLE Week 144
Odprto podaljšanje 144. teden
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.
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.
Solution for injection (injection) (SureClick).
Raztopina za injiciranje (injekcija) (SureClick).
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.
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.
(HMD) (combined rosuvastatin, simvastatin, & atorvastatin groups)
(HMD) (združeni podatki skupin z rosuvastatinom, simvastatinom in atorvastatinom)
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.
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.
Press down firmly
Čvrsto pritisnite dol
Do not use Repatha if you are allergic to evolocumab or any of the other ingredients of this medicine (listed in section 6).
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).
Evolocumab is designed to attach to a substance called PCSK9 that affects the liver's ability to take in cholesterol.
Evolokumab je zasnovan za vezavo na snov, ki jo imenujemo PCSK9 in vpliva na sposobnost jeter, da sprejemajo holesterol.
Sterilised using ethylene oxide
Sterilizirano z uporabo etilenoksida.
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.
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.
Do not leave the grey needle cap off for more than 5 minutes.
Brizge s snetim sivim pokrovčkom ne puščajte več kot 5 minut.
Reductions in serum LDL-C and total cholesterol were more pronounced than observed previously with evolocumab alone, and were reversible upon cessation of treatment.
Znižanji LDL-H in celokupnega holesterola sta bili izrazitejši kot predhodno s samim evolokumabom in sta bili po prenehanju zdravljenja reverzibilni.
DO NOT: Use the Repatha pre-filled syringe if the packaging is open or damaged.
NE UPORABLJAJTE napolnjene injekcijske brizge zdravila Repatha, če je pakiranje odprto ali poškodovano.
Talk to your doctor, pharmacist or nurse before using Repatha if you have: - liver disease, - severe kidney problems.
Pred začetkom uporabe zdravila Repatha se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate: - bolezen jeter, - hude težave z ledvicami.
Hold the loaded automated mini-doser with the blue light visible, and place it on your skin.
Primite napolnjeni avtomatski odmernik tako, da boste videli modro lučko, in ga položite na kožo.
Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Pred uvedbo zdravila Repatha je treba izključiti druge vzroke hiperlipidemije ali mešane dislipidemije (npr. nefrotski sindrom, hipotiroidizem).
• Moderate physical activities can be performed during the injection process, such as walking, reaching and bending.
• Med postopkom injiciranja lahko izvajate zmerne telesne dejavnosti, na primer hodite, segate po stvareh ali se sklanjate.
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.
Bolnike s pozitivnim serumskim izvidom za ne-nevtralizacijska protitelesa so dodatno testirali za nevtralizacijska protitelesa; noben bolnik ni imel pozitivnega izvida za nevtralizacijska protitelesa.
Before starting Repatha, you should be on a diet to lower your cholesterol.
Pred začetkom jemanja zdravila Repatha morate biti na dieti za zniževanje holesterola.
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.
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.
VLDLC
VLDLH
This could damage the syringe.
S tem lahko poškodujete brizgo.
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.
Z vezavo na PCSK9 zdravilo onemogoči to beljakovino, s tem poveča količino holesterola, ki vstopa v jetra, in tako zniža holesterol v krvi.
C Gather all materials needed for your injection.
C Pripravite ves material, potreben za injiciranje.
M Firmly press and release the start button.
M Čvrsto pritisnite sprožilni gumb in ga izpustite.
The presence of anti-evolocumab binding antibodies did not impact the pharmacokinetic profile, clinical response, or safety of Repatha.
Prisotnost ne-nevtralizacijskih protiteles proti evolokumabu ni vplivala na farmakokinetične značilnosti, klinični odziv ali varnost zdravila Repatha.
Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see section 5.2).
Uporaba pri bolnikih s hudo okvaro jeter (Child-Pugh C) ni raziskana (glejte poglavje 5.2).
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.
Pri bolnikih z zmerno okvaro jeter so ugotovili manjšo celokupno izpostavljenost evolokumabu, kar lahko zmanjša učinek na znižanje LDL-H.
Grey start button
Sivi sprožilni gumb
Syringe label with expiration date
Nalepka na brizgi z datumom izteka roka uporabnosti
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]).
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]).
• Do not touch the skin adhesive.
• Ne dotikajte se lepila za kožo.
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:
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:
alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.
samo ali skupaj z drugimi zdravili za zniževanje holesterola, če statini ne delujejo dobro ali jih ni mogoče uporabiti.
The pre-filled cartridge is assembled with a telescopic screw device component.
Napolnjeni vložek je sestavljen s pomočjo teleskopskega vijačnega elementa.
Administration of Repatha can also be performed by an individual who has been trained to administer the product.
Zdravilo Repatha lahko injicira tudi oseba, ki se je usposobila za njegovo dajanje.
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.
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 %.