FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2).
Croatian: Iskustvo primjene lijeka Repatha u bolesnika s teškim oštećenjem bubrega (definiranim kao eGFR < 30 ml/min/1,73 m2) je ograničeno (vidjeti dio 5.2).
English: It is given: together with other cholesterol lowering treatments.
Croatian: Primjenjuje se: u kombinaciji s drugim liječenjima za snižavanje razina kolesterola.
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).
Croatian: • ste odrasla osoba s visokom razinom kolesterola u krvi i ustanovljenom aterosklerotskom kardiovaskularnom bolesti (srčani ili moždani udar ili problemi s krvnim žilama u povijesti bolesti).
English: The 420 mg dose should be delivered using a single cartridge with the automated mini-doser.
Croatian: Dozu od 420 mg treba primijeniti pomoću jednog uloška s automatiziranim mini-dozatorom.
English: In any above cases, use a new automated mini-doser and cartridge.
Croatian: U bilo kojem od navedenih slučajeva, upotrijebite novi automatizirani mini-dozator i uložak.
English: Pack sizes of one, two, three or multipack of six (3x2) pre-filled pens.
Croatian: Veličine pakiranja od jedne, dvije ili tri ili višestruko pakiranje od šest (3x2) napunjenih brizgalica.
English: Reductions in LDL-C and changes in other lipid parameters in 14 adolescent patients (aged ≥ 12 to < 18 years) with homozygous familial hypercholesterolaemia are comparable to those in the overall population of patients with homozygous familial hypercholesterolaemia.
Croatian: Smanjenja vrijednosti LDL-C-a i promjene u drugim lipidnim parametrima u 14 adolescentnih bolesnika (u dobi ≥ 12 do < 18 godina) s homozigotnom obiteljskom hiperkolesterolemijom su usporedive s onima u ukupnoj populaciji bolesnika s homozigotnom obiteljskom hiperkolesterolemijom.
English: Population pharmacokinetic analysis of integrated data from the Repatha clinical trials did not reveal a difference in pharmacokinetics of evolocumab in patients with mild or moderate renal impairment relative to non-renally impaired patients.
Croatian: Populacijska farmakokinetička analiza integriranih podataka iz kliničkih ispitivanja lijeka Repatha nije otkrila razliku u farmakokinetici evolokumaba u bolesnika s blagim ili umjerenim oštećenjem bubrega u odnosu na bolesnike bez oštećenja bubrega.
English: The safety profile in the homozygous familial hypercholesterolaemia population was consistent with that demonstrated in the primary hypercholesterolaemia and mixed dyslipidaemia population.
Croatian: Sigurnosni profil u populaciji s homozigotnom obiteljskom hiperkolesterolemijom je u skladu s onim dokazanim u populaciji s primarnom hiperkolesterolemijom i miješanom dislipidemijom.
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.
Croatian: Smanjenje LDL-C-a u 52. tjednu u odnosu na početne vrijednosti, u usporedbi s placebom, bilo je dosljedno pri svim osnovnim terapijama za snižavanje lipida koje su optimizirane za LDL-C i kardiovaskularni rizik.
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.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Repatha u svim podskupinama pedijatrijske populacije u liječenju miješane dislipidemije.
English: • Do not remove or rotate the cartridge top or bottom.
Croatian: • Nemojte skidati niti okretati dno ili vrh uloška.
English: Needle is inside.
Croatian: Igla je unutra.
English: Insert the cartridge bottom first.
Croatian: Prvo umetnite dno uloška.
English: • Do not touch the bottom of the cartridge after cleaning with alcohol wipe.
Croatian: • Nemojte dodirivati dno uloška nakon što ste ga očistili alkoholnom maramicom.
English: Each pack contains one, two, three or six single use SureClick pre-filled pens.
Croatian: Svako pakiranje sadrži jednu, dvije, tri ili šest SureClick napunjenih brizgalica za jednokratnu primjenu.
English: Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, The Netherlands
Croatian: Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, Nizozemska
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.
Croatian: U dvostruko slijepim kliničkim ispitivanjima, od 18 546 bolesnika liječenih lijekom Repatha, njih 7 656 (41,3%) bilo je u dobi od ≥ 65 godina, dok je njih 1500 (8,1%) bilo u dobi od ≥ 75 godina.
English: • Injection site reactions, such as bruising, redness, bleeding, pain or swelling
Croatian: • Reakcije na mjestu primjene, kao što je nastanak modrica, crvenilo, krvarenje, bol ili oticanje
English: Then, squeeze firmly until it snaps shut.
Croatian: Zatim čvrsto pritisnite dok se ne zatvore uz škljocaj.
English: The administration device contains silver oxide-zinc batteries and includes an adhesive patch made from polyester tape with an acrylate adhesive.
Croatian: Uređaj za primjenu sadrži baterije od srebrovog oksida i cinka te dolazi s prianjajućim poliesterskim flasterom s akrilnim ljepilom.
English: It is important to tell your doctor if you are breast-feeding or plan to do so.
Croatian: Važno je da obavijestite svog liječnika ako dojite ili planirate dojiti.
English: No data on the effect of evolocumab on human fertility are available.
Croatian: Podaci o učinku evolokumaba na plodnost u ljudi nisu dostupni.
English: Do not recap the pre-filled pen or put fingers into the yellow safety guard.
Croatian: Nemojte vraćati zatvarač na napunjenu brizgalicu ili stavljati prste u žuti sigurnosni štitnik.
English: Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
Croatian: Repatha je indicirana u odraslih s primarnom hiperkolesterolemijom (heterozigotna obiteljska i stečena) ili miješanom dislipidemijom, kao dodatak dijeti:
English: Carefully lift the pre-filled pen straight up out of the box.
Croatian: 1. Pažljivo izvadite napunjenu brizgalicu ravno iz kutije.
English: The Repatha Outcomes Study (FOURIER) was a randomised, event-driven, double-blind study of 27,564 subjects, aged between 40 and 86 years (mean age 62.5 years), with established atherosclerotic CV disease; 81% had a prior MI event, 19% had a prior stroke event and 13% had peripheral arterial disease.
Croatian: Ispitivanje ishoda liječenja lijekom Repatha (FOURIER) bilo je randomizirano, događajima vođeno, dvostruko-slijepo ispitivanje na 27 564 ispitanika u dobi između 40 i 86 godina (prosječna dob 62,5 godina) s ustanovljenom aterosklerotskom KV bolesti; 81% njih s prethodnim infarktom miokarda, 19% s prethodnim moždanim udarom, a 13% njih s bolesti perifernih arterija.
English: The automated mini-doser is on when the blue status light flashes.
Croatian: Automatizirani mini-dozator je upaljen kada lampica treperi plavom svjetlošću.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza „Rok valjanosti“ ili „EXP“.
English: Start button (Do not press until ready to inject)
Croatian: Dugme za injiciranje (nemojte pritiskati sve dok niste spremni injicirati)
English: Check that the name Repatha appears on the carton label.
Croatian: Provjerite da li se na kutiji nalazi ime Repatha.
English: Repatha contains sodium
Croatian: Repatha sadrži natrij
English: On a clean, well-lit, flat work surface, place:
Croatian: Na čistu i dobro osvijetljenu, ravnu radnu površinu položite:
English: 1 See section Description of selected adverse reactions
Croatian: 1 Vidjeti dio Opis odabranih nuspojava
English: • You may hear beeps indicating your injection has started.
Croatian: • Možete čuti zvučni signal koji označava početak injiciranja.
English: the grey needle cap is missing or not securely attached.
Croatian: nedostaje sivi zatvarač igle ili nije dobro pričvršćen.
English: • Hives, red itchy bumps on your skin (urticaria)
Croatian: • Koprivnjača, crvena uzdignuća kože koja svrbe (urtikarija)
English: Step 1: Prepare A Remove one Repatha pre-filled pen from the package.
Croatian: Korak 1: Priprema A Izvadite jednu Repatha napunjenu brizgalicu iz pakiranja.
English: - The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.
Croatian: - Drugi sastojci su prolin, ledena acetatna kiselina, polisorbat 80, natrijev hidroksid, voda za injekcije.
English: There are no or limited amount of data from the use of Repatha in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lijeka Repatha u trudnica ograničeni.
English: Repatha reduced both percent atheroma volume (PAV; 1.01% [95% CI 0.64, 1.38], p < 0.0001) and total atheroma volume (TAV; 4.89 mm3 [95% CI 2.53, 7.25], p < 0.0001) compared with placebo.
Croatian: Repatha je smanjila i volumen ateroma izražen u postotku (eng. percent atheroma volume, PAV) (PAV; 1,01% [95% CI 0,64, 1,38], p < 0,0001) i ukupni volumen ateroma (eng. total atheroma volume, TAV) (TAV; 4,89 mm3 [95% CI 2,53, 7,25], p < 0,0001) u usporedbi s placebom.
English: Do not leave the orange cap off for more than 5 minutes.
Croatian: Ne ostavljajte brizgalicu bez narančastog zatvarača duže od 5 minuta.
English: Multipack: 3 (3 packs of 1) cartridges and automated mini-dosers.
Croatian: Višestruko pakiranje: 3 (3 pakiranja po 1) uloška i automatizirani mini-dozatori.
English: Administration of Repatha can also be performed by an individual who has been trained to administer the product.
Croatian: Primjenu lijeka Repatha također može obavljati osoba koja je obučena za primjenu lijeka.
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.
Croatian: Učinak liječenja bio je konzistentan za sve podskupine (uključujući dob, tip bolesti, početnu vrijednost LDL-C-a, početni intenzitet terapije statinima, primjenu ezetimiba i dijabetes) i očitovao se u smanjenju rizika od infarkta miokarda, moždanog udara i koronarne revaskularizacije; nije uočena značajna razlika s obzirom na kardiovaskularni ili mortalitet bilo kojeg uzroka, no ispitivanje nije bilo osmišljeno za otkrivanje takve razlike.
English: p valueb
Croatian: p-vrijednostb
English: DO NOT: Use the Repatha pre-filled syringe if the packaging is open or damaged.
Croatian: koristiti Repatha napunjenu štrcaljku ako je pakiranje otvoreno ili oštećeno.
English: b p value < 0.001 when compared with placebo.
Croatian: b p vrijednost < 0,001 pri usporedbi s placebom.
English: An approximately 20% increase in the clearance is in part mediated by statins increasing the concentration of PCSK9 which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Croatian: Povećanje klirensa od približno 20% djelomično je posredovano statinima koji dovode do povećanja koncentracije PCSK9, što nije negativno utjecalo na farmakodinamički učinak evolokumaba na lipide.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: • If the pre-filled syringe does not release from the tray, gently press on the back of tray.
Croatian: • Ako se napunjena štrcaljka ne oslobodi iz podloška, lagano pritisnite stražnju stranu podloška.
English: The pharmacokinetics of evolocumab were influenced by body weight without having any notable effect on LDL-C lowering.
Croatian: Farmakokinetika evolokumaba je bila pod utjecajem tjelesne težine bez ikakvog značajnog učinka na sniženje razine LDL-C-a.
English: Do not press the start button until you are ready to inject.
Croatian: Nemojte pritisnuti dugme za injiciranje sve dok niste spremni za injiciranje.
English: Important: Needle is inside.
Croatian: Važno: Igla je unutra.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment, see section 4.4 for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem bubrega, vidjeti dio 4.4 za bolesnike s teškim oštećenjem bubrega (eGFR < 30 ml/min /1,73 m2).
English: No dose adjustment is necessary in patients with mild hepatic impairment, see section 4.4 for patients with moderate and severe hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem jetre, vidjeti dio 4.4 za bolesnike s umjerenim i teškim oštećenjem jetre.
English: Do not use Repatha if you are allergic to evolocumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete primjenjivati lijek Repatha Nemojte primjenjivati lijek Repatha ako ste alergični na evolokumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: 1 cartridge and automated mini-doser.
Croatian: 1 uložak i automatizirani mini-dozator.
English: DO NOT put the grey needle cap back onto the used syringe.
Croatian: NEMOJTE vraćati sivi zatvarač igle na iskorištenu štrcaljku.
English: If your doctor decides that you or a caregiver can give the injections of Repatha using the automated mini-doser, you or your caregiver should receive training on how to prepare and inject Repatha correctly.
Croatian: Ako liječnik odluči da Vi ili Vaš njegovatelj možete davati injekcije lijeka Repatha pomoću automatiziranog mini-dozatora, Vi ili Vaš njegovatelj trebate proći obuku o ispravnom načinu pripreme i injiciranja lijeka Repatha.
English: LIST OF EXCIPIENTS Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.
Croatian: POPIS POMOĆNIH TVARI Prolin, ledena acetatna kiselina, polisorbat 80, natrijev hidroksid, voda za injekcije.
English: Do not throw away (dispose of) the automated mini doser in your household waste.
Croatian: Nemojte odlagati (bacati) automatizirani mini-dozator u kućni otpad.
English: Treatment effects were sustained over 1 year as demonstrated by reduction in LDL-C from week 12 to week 52.
Croatian: Učinci liječenja su bili održani duže od godinu dana, prema predočenom smanjenju LDL-C-a od 12. do 52. tjedna.
English: The intended pharmacological effect of decreased serum LDL-C and total cholesterol were observed in these studies and was reversible upon cessation of treatment.
Croatian: Ciljani farmakološki učinak smanjenih vrijednosti LDL-C-a i ukupnog kolesterola u serumu je uočen u ovim ispitivanjima te je bio reverzibilan nakon prestanka liječenja.
English: OLE Week 144
Croatian: OLE 144. tjedan
English: Pack sizes of one cartridge/automated mini-doser or multipack of three (3x1) cartridges/automated mini-dosers.
Croatian: Veličine pakiranja od jednog uloška/automatiziranog mini-dozatora ili višestruko pakiranje od 3 (3x1) uložaka/automatiziranih mini-dozatora.
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.
Croatian: Smanjenje vrijednosti LDL-C-a i ukupnog kolesterola u serumu je bilo izraženije nego što je prethodno opaženo u liječenju samo s evolokumabom te je bilo reverzibilno nakon prestanka liječenja.
English: All patients in the study were initially treated with Repatha 420 mg once monthly, except for those receiving lipid apheresis at enrolment who began with Repatha 420 mg once every 2 weeks.
Croatian: Svi bolesnici u ispitivanju su na početku liječeni s 420 mg lijeka Repatha jedanput mjesečno, osim onih koji su prilikom uključivanja primali lipidnu aferezu te je u njih započeto liječenje s 420 mg lijeka Repatha jedanput svaka 2 tjedna.
English: What Repatha is and what it is used for
Croatian: Što je Repatha i za što se koristi
English: Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone.
Croatian: Repatha se koristi u bolesnika koji ne mogu kontrolirati razine kolesterola samo pomoću dijete za snižavanje razine kolesterola.
English: • Do not close the door if the cartridge is missing or not fully inserted.
Croatian: • Nemojte zatvoriti vratašca ako uložak nedostaje ili nije u potpunosti umetnut.
English: A healthcare provider familiar with Repatha should be able to answer your questions.
Croatian: Na Vaša pitanja može odgovoriti zdravstveni djelatnik upoznat s lijekom Repatha.
English: C PINCH your injection site to create a firm surface.
Croatian: C UHVATITE područje injiciranja kako biste stvorili čvrstu površinu.
English: Repatha is used in addition to your cholesterol lowering diet if you are:
Croatian: Repatha se koristi kao dodatak dijeti za snižavanje razine kolesterola ako:
English: If your doctor decides that you or a caregiver can give the injections of Repatha, you or your caregiver should receive training on how to prepare and inject Repatha correctly.
Croatian: Ako liječnik odluči da Vi ili Vaš njegovatelj možete davati injekcije lijeka Repatha, Vi ili Vaš njegovatelj trebate proći obuku o ispravnom načinu pripreme i injiciranja lijeka Repatha.
English: If using the pre-filled pen, place the correct (yellow) end of the pen on the skin before injecting.
Croatian: Ako koristite napunjenu brizgalicu, pazite da prije injiciranja prislonite ispravan (žuti) kraj brizgalice na kožu.
English: • 12 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).
Croatian: • imate 12 ili više godina i visoku razinu kolesterola u krvi zbog poremećaja koji se pojavljuje u Vašoj obitelji (homozigotna obiteljska hiperkolesterolemija).
English: Do not touch the grey start button
Croatian: Nemojte dirati sivo dugme za injiciranje
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A).
English: The fluid path within the administration device is made from stainless steel and non-DEHP polyvinyl chloride, with a stainless steel 29 gauge needle.
Croatian: Dio unutar uređaja za primjenu kroz koji prolazi tekućina napravljen je od nehrđajućeg čelika i polivinilklorida bez DEHP-a, s iglom od nehrđajućeg čelika promjera 29 G.
English: Apart from a reduced T-cell Dependent Antibody Response in cynomolgus monkeys immunised with keyhole limpet haemocyanin (KLH) after 3 months of treatment with evolocumab, no adverse effects were observed in hamsters (up to 3 months) and cynomolgus monkeys (up to 6 months) at exposures much higher than patients receiving evolocumab at 420 mg once monthly.
Croatian: Osim smanjenog odgovora protutijela ovisnog o T-stanicama u makaki majmuna imuniziranih hemocijaninom iz priljepka (engl. keyhole limpet haemocyanin, KLH) nakon 3 mjeseca liječenja s evolokumabom, nikakve nuspojave nisu uočene u hrčaka (do 3 mjeseca) i makaki majmuna (do 6 mjeseci) pri mnogo većoj izloženosti u odnosu na bolesnike koji su primali evolokumab u dozi od 420 mg jedanput mjesečno.
English: A substantial reduction of LDL-C was observed throughout the study, with achieved median LDL-C ranges of 0.8 to 0.9 mmol/L at each assessment; 25% of patients achieved a LDL-C concentration less than 0.5 mmol/L.
Croatian: Značajno smanjenje vrijednosti LDL-C-a opaženo je tijekom cjelokupnog trajanja ispitivanja, s postignutim medijanom vrijednosti LDL-C-a raspona od 0,8 do 0,9 mmol/l pri svakoj procjeni; 25% bolesnika postiglo je koncentraciju LDL-C-a manju od 0,5 mmol/l.
English: • Do not store the automated mini-doser and cartridge in extreme heat or cold. For example,
Croatian: • Nemojte čuvati automatizirani mini-dozator i uložak na ekstremnoj toplini ili hladnoći.
English: A single subcutaneous administration of Repatha 140 mg or 420 mg resulted in maximum suppression of circulating unbound PCSK9 by 4 hours followed by a reduction in LDL-C reaching a mean nadir in response by 14 and 21 days, respectively.
Croatian: Jednokratna supkutana primjena lijeka Repatha od 140 mg ili 420 mg rezultirala je maksimalnom supresijom cirkulirajućeg nevezanog PCSK9 unutar 4 sata, nakon čega je uslijedilo smanjivanje LDL-C-a, dosegnuvši srednje najniže vrijednosti odgovora do 14. odnosno 21. dana.
English: the expiration date on the pre-filled syringe has passed.
Croatian: rok valjanosti na napunjenoj štrcaljki je istekao.
English: avoid storing in your vehicle's glove box or boot.
Croatian: Na primjer, izbjegavajte čuvanje u pretincu automobila ili prtljažniku.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PRE-FILLED SYRINGE BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA NAPUNJENU ŠTRCALJKU
English: Pinch skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.
Croatian: Čvrsto uhvatite nabor kože između palca i ostalih prstiju, kako biste dobili oko 5 centimetara široko područje.
English: Incorrect
Croatian: Nepravilno
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.
Croatian: Sukladno tome, PRAC se složio da reakcije preosjetljivosti treba uključiti u dio 4.8 sažetka opisa svojstava lijeka, s učestalošću „često“, te u skladu s time ažurirati i uputu o lijeku.
English: Choose a different site each time you give yourself an injection.
Croatian: Svaki put kada si dajete injekciju odaberite drugo područje.
English: The automated mini-doser and cartridge are for single use only.
Croatian: Automatizirani mini-dozator i uložak su samo za jednokratnu primjenu.
English: Step 3: Inject A Hold the stretch or pinch to create a firm surface.
Croatian: Korak 3: Injiciranje A Držite kožu rastegnutom ili u naboru kako biste stvorili čvrstu površinu.
English: Less impact from body weight was seen with repeated subcutaneous evolocumab 420 mg monthly doses.
Croatian: Manji utjecaj tjelesne težine je primijećen s opetovanom supkutanom primjenom evolokumaba u dozama od 420 mg jedanput mjesečno.
English: Repatha has not been studied in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.4).
Croatian: Repatha nije ispitivana u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) (vidjeti dio 4.4).
English: With one hand, hold the cartridge barrel and clean the cartridge bottom with an alcohol wipe.
Croatian: S jednom rukom primite tijelo uloška i očistite dno uloška alkoholnom maramicom.
English: M Firmly press and release the start button.
Croatian: Čvrsto pritisnite i otpustite dugme za injiciranje.
English: Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
Croatian: Bolesnici na aferezi mogu započeti liječenje s 420 mg svaka dva tjedna kako bi bili u skladu s njihovim rasporedom afereze.
English: Time to a MACE event (composite of CV death, MI, or stroke); 3-year Kaplan-Meier
Croatian: Slika 1. Vrijeme do MACE događaja (kompozit KV smrti, infarkta miokarda ili moždanog udara); 3-godišnja Kaplan-Meierova krivulja
English: Before you use the Repatha pre-filled pen, read this important information:
Croatian: Prije primjene Repatha napunjene brizgalice, pročitajte ove važne informacije:
English: Dose frequency in non-apheresis patients could be titrated up to 420 mg once every 2 weeks based on LDL-C response and PCSK9 levels.
Croatian: Učestalost doziranja kod bolesnika bez afereze se mogla titrirati do 420 mg jedanput svaka 2 tjedna na temelju odgovora LDL-C-a i PCSK9 vrijednosti.