FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Alirokumab je također značajno smanjio sljedeće kompozitne mjere ishoda: rizik od koronarne srčane bolesti; veliki događaj koronarne bolesti srca; kardiovaskularni događaj; i kompozitni ishod smrtnosti od svih uzroka, infarkta miokarda bez smrtnog ishoda i ishemijskog moždanog udara bez smrtnog ishoda.
English: The index ACS event was a myocardial infarction in 83.2% of patients (34.6% STEMI, 48.6% NSTEMI) and an episode of unstable angina in 16.8% of patients.
Croatian: Prvi događaj akutnog koronarnog sindroma bio je infarkt miokarda u 83,2% bolesnika (34,6% STEMI, 48,6% NSTEMI) i epizoda nestabilne angine kod 16,8% bolesnika.
English: All-cause mortality in phase 3 studies was 0.6% (20 of 3182 patients) in the alirocumab group and 0.9% (17 of 1792 patients) in the control group.
Croatian: Smrtnost zbog bilo kojeg uzroka u ispitivanjima faze 3 iznosila je 0,6% (20 do 3182 bolesnika) u skupini liječenoj alirokumabom i 0,9% (17 od 1792 bolesnika) u kontrolnoj skupini.
English: • Do not put the syringe back in the refrigerator.
Croatian: • Nemojte vraćati štrcaljku u hladnjak.
English: Before you use the pen for the first time, your doctor, pharmacist or nurse will show you how to inject Praluent.
Croatian: Prije nego što prvi puta upotrijebite brizgalicu, Vaš liječnik, ljekarnik ili medicinska sestra pokazat će Vam kako injicirati Praluent.
English: After use, place the pre-filled pen/ pre-filled syringe into a puncture resistant container and discard as required by local regulations.
Croatian: Nakon primjene, odložiti napunjenu brizgalicu/napunjenu štrcaljku u neprobojan spremnik i zbrinuti u skladu s lokalnim propisima.
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.
Croatian: Nakon zasićenja vezivanja za PCSK9, daljnja povećanja koncentracije alirokumaba ne dovode do daljnjih sniženja vrijednosti LDL-C, ali je primjetno dulje trajanje učinka sniženja vrijednosti LDL-C.
English: • Do not use any area near a visible vein.
Croatian: • Nemojte injicirati lijek blizu vidljive vene.
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.
Croatian: Postoje izvješća o nekoliko pojedinaca s mutacijama PCSK9 koje smanjuju funkciju na dva alela, a koji su imali izrazito niske vrijednosti LDL-C, uz vrijednosti HDL-C i TG-a unutar normalnog raspona.
English: Limited data are available in patients with severe renal impairment (see section 5.2).
Croatian: Dostupni su ograničeni podaci o primjeni u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: Conversely, gain-of-function mutations in the PCSK9 gene have been identified in patients with increased LDL-C levels and a clinical diagnosis of familial hypercholesterolaemia.
Croatian: Nasuprot tome, mutacije gena PCSK9 koje poboljšavaju funkciju pronađene su u bolesnika s povišenim vrijednostima LDL-C i kliničkom dijagnozom obiteljske hiperkolesterolemije.
English: Praluent should be used with caution in patients with severe hepatic impairment.
Croatian: Praluent treba primjenjivati uz oprez u bolesnika s teškim oštećenjem jetrene funkcije.
English: It is given: - together with a statin (a commonly used medicine that treats high cholesterol) or other cholesterol lowering medicines, if the maximum dose of a statin does not lower levels of cholesterol sufficiently or, - alone or together with other cholesterol lowering medicines when statins are not tolerated or cannot be used.
Croatian: Daje se: - zajedno sa statinom (lijekom koji se često koristi za liječenje visokog kolesterola) ili drugim lijekovima koji snizuju vrijednosti kolesterola, ako maksimalna doza statina ne uspije dovoljno sniziti vrijednosti kolesterola, ili - samostalno ili u kombinaciji s drugim lijekovima koji snizuju vrijednosti kolesterola kada bolesnik ne podnosi statine ili ih ne može uzimati.
English: Following single-dose subcutaneous administration of 100 mg to 300 mg alirocumab, there was no meaningful difference in exposure between Japanese and Caucasian healthy subjects.
Croatian: Nakon primjene jednokratne supkutane doze alirokumaba od 100 do 300 mg nije bilo značajne razlike u izloženosti lijeku između zdravih ispitanika japanskog podrijetla i ispitanika bijele rase.
English:  Pull pen away from your skin.
Croatian: Podignite brizgalicu s kože.
English: For pre-filled pens Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
Croatian: Za napunjene brizgalice Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
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.
Croatian: Osobe s mutacijom PCSK9 koja smanjuje funkciju na samo jednom alelu imaju niže vrijednosti LDL-C, što je u korelaciji sa značajno manjom incidencijom koronarne srčane bolesti.
English: Mean changes for all other lipids/ lipoproteins were similar to the FH I and FH II studies, however statistical significance was not reached for TG, HDL-C and Apo A-1.
Croatian: Za detaljne rezultate vidjeti Tablicu 2. Srednje promjene za sve ostale lipide/lipoproteine bile su slične onima zabilježenima u ispitivanjima FH I i FH II, ali nije postignuta statistička značajnost za TG, HDL-C ni Apo A-1.
English: In the five placebo-controlled trials in patients on a maximally tolerated dose of statin (n=3752), the discontinuation rate due to musculo-skeletal adverse events was 0.4% in the alirocumab group and 0.5% in the placebo group.
Croatian: U pet placebom kontroliranih ispitivanja u bolesnika koji su primali maksimalnu podnošljivu dozu statina (n=3752), stopa prekida liječenja zbog štetnih događaja u mišićno-koštanom sustavu iznosila je 0,4% u skupini liječenoj alirokumabom i 0,5% u onoj koja je primala placebo.
English: Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.
Croatian: Nemojte primijeniti još jednu dozu bez prethodnog razgovora sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
English: Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see section 5.2).
Croatian: Nisu provedena ispitivanja u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) (vidjeti dio 5.2).
English: Manufacturer Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
Croatian: Proizvođač Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
English: • Always use the syringe as described in the “Instructions for Use”.
Croatian: • Uvijek rukujte štrcaljkom kako je opisano u 'Uputama za uporabu'.
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.
Croatian: U dva ispitivanja (LONG TERM i HIGH FH), koja su ukupno uključivala 2416 bolesnika, primjenjivala se samo doza od 150 mg jednom svaka 2 tjedna.
English: Do not use the syringe if the grey needle cap is missing or not securely attached.
Croatian: Nemojte upotrijebiti štrcaljku ako sivi zatvarač igle nedostaje ili ako on nije čvrsto pričvršćen.
English: Do not
Croatian: Nemojte
English: Where to inject Read the detailed instructions for use leaflet on where to inject.
Croatian: Gdje injicirati lijek Za informacije o tome gdje injicirati lijek pročitajte detaljne upute za uporabu.
English: In a phase 1 study, after administration of a single 75 mg subcutaneous dose, alirocumab pharmacokinetic profiles in subjects with mild and moderate hepatic impairment were similar as compared to subjects with normal hepatic function.
Croatian: Nakon primjene jednokratne supkutane doze od 75 mg u jednom ispitivanju faze 1, farmakokinetički profili alirokumaba u ispitanika s blagim i umjerenim oštećenjem jetrene funkcije bili su slični onome u ispitanika s normalnom jetrenom funkcijom.
English: • Do not put the pen back in the refrigerator.
Croatian: • Nemojte vraćati brizgalicu u hladnjak.
English: Effects of other medicinal products on alirocumab
Croatian: Učinci drugih lijekova na alirokumab
English: If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.
Croatian: Ako je potrebno dodatno sniženje vrijednosti LDL-C u bolesnika liječenih sa 75 mg jednom svaka 2 tjedna ili 300 mg jednom svaka 4 tjedna (jednom mjesečno), doza se može prilagoditi na maksimalnu dozu od 150 mg jednom svaka 2 tjedna.
English: No data are available in patients with severe hepatic impairment.
Croatian: Nema dostupnih podataka o primjeni u bolesnika s teškim oštećenjem jetrene funkcije.
English: ITT analysis - intent-to-treat population, includes all lipid data throughout the duration of the study irrespective of adherence to the study treatment.
Croatian: Apo A-1 a ITT analiza - populacija koju se namjeravalo liječiti (engl. intent-to-treat, ITT); uključuje sve podatke o lipidima prikupljene tijekom čitavog ispitivanja, neovisno o pridržavanju ispitivanog liječenja.
English: • Check that you have the correct product and the correct dose (green plunger for 75 mg/ml).
Croatian: • Provjerite imate li pravi lijek i pravu dozu (doza od 75 mg/ml dolazi u štrcaljki sa zelenim klipom).
English: cholesterol - this lowers your “bad” cholesterol levels.
Croatian: kolesterola i tako snizuje vrijednosti 'lošeg' kolesterola.
English: To administer the 300 mg dose, give two 150 mg injections consecutively at two different injection sites.
Croatian: Za primjenu doze od 300 mg, primijenite uzastopno dvije injekcije od 150 mg na dva različita mjesta injiciranja.
English: Tel: 800 131212 (domande di tipo tecnico)
Croatian: Tel: 800 13 12 12 (domande di tipo tecnico) 800536389 (altre domande)
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.
Croatian: Većina bolesnika u programu ispitivanja faze 3 uzimala je osnovnu terapiju koja modificira lipide, koja se sastojala od maksimalne podnošljive doze statina u kombinaciji s drugim terapijama koje modificiraju lipide ili bez njih, te je u njih postojao visok ili vrlo visok kardiovaskularni (KV) rizik.
English: Manufacturer Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France
Croatian: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait Francuska
English: Can be stored outside the refrigerator below 25 °C for a single period up to 30 days protected from light.
Croatian: Može se čuvati izvan hladnjaka ispod 25°C u jednokratnom razdoblju do 30 dana zaštićen od svjetlosti.
English: In general, administration of alirocumab also resulted in a statistically significant greater percent reduction in total cholesterol (Total-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), and lipoprotein (a) [Lp(a)] as compared to placebo/ ezetimibe, whether or not patients were concomitantly being treated with a statin.
Croatian: Općenito je primjena alirokumaba dovela i do statistički značajno većeg postotka sniženja vrijednosti ukupnog kolesterola, kolesterola koji isključuje kolesterol sadržan u lipoproteinima visoke gustoće (ne-HDL-C), apolipoproteina B (Apo B) i lipoproteina (a) [Lp(a)] u usporedbi s placebom/ezetimibom, neovisno o tome jesu li se bolesnici istodobno liječili statinom ili ne.
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.
Croatian: U obje je kohorte razlika u odnosu na placebo bila statistički značajna u 24. tjednu za sve lipidne parametre, osim za ApoA-1 u podskupini bolesnika koji su primali osnovnu terapiju statinima.
English: Alirocumab significantly reduced the risk for the primary composite endpoint of the time to first occurrence of Major Adverse Cardiovascular Events (MACE-plus) consisting of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization (HR 0.85, 95% CI: 0.78, 0.93; p-value=0.0003).
Croatian: Alirokumab je značajno smanjio rizik za primarnu kompozitnu mjeru ishoda vremena do prvog pojavljivanja velikog kardiovaskularnog štetnog događaja (MACE-plus) koji je uključivao smrt zbog koronarne srčane bolesti, infarkt miokarda bez smrtnog ishoda, ishemijski moždani udar s ili bez smrtnog ishoda ili nestabilnu anginu koja zahtijeva hospitalizaciju (HR 0,85; 95% CI: 0,78; 0,93; p-vrijednost = 0,0003).
English: In all clinical studies background lipid lowering therapies could not be adjusted by trial design.
Croatian: U svim kliničkim ispitivanjima, sukladno dizajnu ispitivanja, osnovne terapije za snižavanje razine lipida nisu se mogle prilagođavati.
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.
Croatian: Ispitivanje LONG TERM uključivalo je 17,7% bolesnika s heterozigotnom obiteljskom hiperkolesterolemijom, 34,6% sa šećernom bolešću tipa 2 te 68,8% s koronarnom srčanom bolešću u anamnezi.
English: • Check that you have the correct product and the correct dose (grey plunger for 150 mg/ml).
Croatian: • Provjerite imate li pravi lijek i pravu dozu (doza od 150 mg/ml dolazi u štrcaljki sa sivim klipom).
English: MONO (N=103) Ezetimibe Alirocumab Ezetimibe Alirocumab Ezetimibe Alirocumab
Croatian: COMBO I (N=311) placebo alirokumab placebo alirokumab placebo alirokumab placebo alirokumab
English: For pre-filled syringes Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France
Croatian: Za napunjene štrcaljke Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait Francuska
English: All-cause mortality, non-fatal MI, non-fatal ischemic stroke CHD Death
Croatian: Smrtnost od svih uzroka, infarkt miokarda bez smrtnog ishoda, ishemijski moždani udar bez smrtnog ishoda Smrt zbog koronarne srčane bolesti
English: Therefore, alirocumab treatment can produce reductions in these remnant lipoproteins as evidenced by its reductions in apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TG).
Croatian: Dakle, liječenje alirokumabom može dovesti do sniženja vrijednosti tih ostatnih lipoproteina, što dokazuje sniženje vrijednosti apolipoproteina B (Apo B), kolesterola koji isključuje kolesterol sadržan u lipoproteinima visoke gustoće (engl. non-high-density lipoprotein cholesterol, ne-HDL-C) i triglicerida (TG).
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.
Croatian: Postotak bolesnika koji su dostigli vrijednosti LDL-C <25 mg/dl (<0,65 mmol/l) ovisio je o početnoj vrijednosti LDL-C i o dozi alirokumaba.
English: Since monoclonal antibodies are not known to be eliminated via renal pathways, renal function is not expected to impact the pharmacokinetics of alirocumab.
Croatian: Budući da se monoklonska protutijela ne izlučuju kroz bubrege, ne očekuje se da će bubrežna funkcija utjecati na farmakokinetiku alirokumaba.
English: COMBO I study
Croatian: Ispitivanje COMBO
English: The discontinuation rate due to injection site reactions was 0.7% in the 300 mg once every 4 weeks treatment group and 0% in the placebo group.
Croatian: Stopa prekida terapije zbog reakcija na mjestu injiciranja bila je 0,7% u skupini liječenoj s 300 mg jednom svaka 4 tjedna i 0% u placebo skupini.
English: o outer side of your upper arm
Croatian: o vanjski dio nadlaktice
English: • Adults with high cholesterol levels in their blood (hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia).
Croatian: • Praluent se koristi u odraslih osoba s visokim vrijednostima kolesterola u krvi (hiperkolesterolemijom [heterozigotnom obiteljskom ili stečenom] ili miješanom dislipidemijom).
English: Maternal toxicity was not evident in pregnant monkeys at systemic exposures that were 81 times the human exposure at the 150 mg Q2W dose.
Croatian: Nije primijećena toksičnost za majku u gravidnih ženki majmuna pri sistemskim izloženostima koje su bile 81 puta veće od one koja se postiže u ljudi nakon primjene doze od 150 mg jednom svaka 2 tjedna.
English: Difference versus placebo was statistically significant at week 24 for all lipids/ lipoproteins.
Croatian: Razlika naspram placeba u 24. tjednu bila je statistički značajna za sve lipide/lipoproteine.
English: • Always use the pen as described in the “Instructions for Use”.
Croatian: • Uvijek rukujte brizgalicom kako je opisano u 'Uputama za uporabu'.
English: Do not use the syringe if it has been dropped or damaged.
Croatian: Nemojte upotrijebiti štrcaljku ako je ispala iz ruku ili je oštećena.
English: This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab.
Croatian: To dovodi do pojačanog klirensa alirokumaba posredovanog ciljnim proteinom te smanjene sistemske izloženosti alirokumabu.
English: To give the 300 mg dose, give two 150 mg injections in a row at two different injection sites.
Croatian: Kako bi se primijenila doza od 300 mg, potrebno je dati dvije uzastopne injekcije od 150 mg na dva različita mjesta injiciranja.
English: Patients in the alirocumab 300 mg every 4 weeks treatment group received alternating placebo injections to maintain blinding in regard to injection frequency.
Croatian: Bolesnici u skupini liječenoj s 300 mg alirokumaba svaka 4 tjedna primili su naizmjenično injekcije s placebom kako bi se održalo zasljepljivanje u odnosu na učestalost injiciranja.
English: Do not use the pen if the blue cap is missing or not securely attached.
Croatian: Nemojte upotrijebiti brizgalicu ako plavi zatvarač nedostaje ili ako on nije čvrsto pričvršćen.
English:  After completing all steps in “Step A: Getting ready for an injection”, pull off the blue cap
Croatian: KORAK B: Kako injicirati  Nakon što ste dovršili sve korake iz 'Koraka A: Priprema za injekciju', skinite plavi zatvarač
English: Most injection site reactions were transient and of mild intensity.
Croatian: Većina reakcija na mjestu injiciranja bila je prolazna i blaga.
English: In genetic studies in humans, PCSK9 variants with either loss-of-function or gain-of-function mutations have been identified.
Croatian: U genetskim ispitivanjima u ljudi pronađene su varijante PCSK9 s mutacijama koje smanjuju funkciju (engl. loss-of-function) ili mutacijama koje poboljšavaju funkciju (engl. gain-of-function).
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.
Croatian: U kontroliranim ispitivanjima primarne hiperkolesterolemije i miješane dislipidemije faze 3, 1158 (34,7%) bolesnika liječenih lijekom Praluent bilo je u dobi od ≥65 godina, dok je njih 241 (7,2%) bilo u dobi od ≥75 godina.
English: Local injection site reactions were reported overall at a frequency of 16.6% in the 300 mg once every 4 weeks treatment group and 7.9% in the placebo group.
Croatian: Lokalne reakcije na mjestu injiciranja sveukupno su prijavljene s učestalošću od 16,6% u skupini liječenoj s 300 mg jednom svaka 4 tjedna te 7,9% u placebo skupini.
English: The only adverse reaction identified in ODYSSEY OUTCOMES (a long-term cardiovascular outcome trial) was injection site reaction.
Croatian: OUTCOMES (dugoročno ispitivanje kardiovaskularnih ishoda) bila je reakcija na mjestu injiciranja.
English: Inject Praluent once every 2 weeks (for the 75 mg or 150 mg dose), or once every 4 weeks/monthly (for the 300 mg dose).
Croatian: Praluent injicirajte jednom svaka 2 tjedna (za doze od 75 mg ili 150 mg) ili jednom svaka 4 tjedna/jednom mjesečno (za dozu od 300 mg).
English: Body weight No dose adjustment is needed in patients based on weight.
Croatian: Nije potrebno prilagođavati dozu na temelju tjelesne težine bolesnika.
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).
Croatian: OUTCOMES), opće alergijske reakcije bile su slične u bolesnika liječenih alirokumabom i u bolesnika koji su primali placebo (7,9% alirokumab, 7,8% placebo).
English: Summary of the Phase 3 Clinical Trials Program - 75 mg and/or 150 mg every 2 weeks (Q2W) dosing regimen
Croatian: Sažetak programa kliničkih ispitivanja faze 3 - režim doziranja 75 mg i/ili 150 mg svaka 2 tjedna
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.
Croatian: Među bolesnicima koji nisu primali osnovnu terapiju statinom, postupno povećanje doze alirokumaba dovelo je d o dodatnog sniženja srednje vrijednosti LDL-C od 3%, a glavnina tog učinka primijećena je u približno 25% bolesnika koji su nakon postupnog povećanja doze postigli najmanje dodatnih 10% sniženja vrijednosti LDL-C.
English:  Insert the needle into the fold of skin with a quick dart-like motion.
Croatian: Ubodite iglu u nabor kože brzim pokretom kao kad bacate strelicu za pikado.
English: Follow these instructions every time you use a Praluent pen.
Croatian: Pridržavajte se ovih uputa svaki puta kada koristite Praluent brizgalicu.
English: The syringe components are assembled into a single-use pre-filled pen with a blue cap and a light green activation button.
Croatian: Komponente štrcaljke sastavljene su u napunjenu brizgalicu za jednokratnu uporabu s plavim zatvaračem i svjetlozelenim aktivacijskim dugmetom.
English: The pharmacokinetics of alirocumab after single subcutaneous administration of 75 mg into the abdomen, upper arm or thigh were similar.
Croatian: Farmakokinetika alirokumaba bila je slična nakon primjene jednokratne supkutane doze od 75 mg u abdomen, nadlakticu ili bedro.
English: At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C ≥50 mg/dL or 1.29 mmol/dL), alirocumab was adjusted to 150 mg Q2W.
Croatian: U drugom mjesecu, ako je bilo potrebno dodatno snižavanje razine LDL-C na temelju unaprijed određenih kriterija LDL-C (LDL-C ≥50 mg/dl ili 1,29 mmol/dl), doza alirokumaba je prilagođena na 150 mg jednom svaka dva tjedna.
English: Based on a population pharmacokinetic analysis, race had no impact on alirocumab pharmacokinetics.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, rasa ne utječe na farmakokinetiku alirokumaba.
English: o thigh o belly (except for the 5 cm area around your navel)
Croatian: o bedro o trbuh (izbjegavajući područje od 5 cm oko pupka)
English: The mean LDL-C value at baseline was 92.4 mg/dL (2.39 mmol/L).
Croatian: Srednja vrijednost LDL-C na početku bila je 92,4 mg/dl (2,39 mmol/l).
English: Mean baseline LDL-C was 151.5 mg/dL (3.90 mmol/L).
Croatian: Srednja početna vrijednost LDL-C bila je 151,5 mg/dl (3,90 mmol/l).