FrancophonIA/ELRC3.0 huggingface dataset:
English: The results are presented in Table 3.
Croatian: Rezultati su prikazani u tablici 3.
English: Alirocumab N=9462 n (%)
Croatian: Alirokumab N=9462 n (%)
English: • Do not remove the syringe until it is completely empty.
Croatian: • Nemojte ukloniti štrcaljku dok ne bude potpuno prazna.
English: Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Croatian: Monoklonska protutijela su proteini koji prepoznaju druge jedinstvene proteine i vezuju se za njih.
English: SANOFI CHIMIE 9 Quai Jules Guesde 94403 Vitry-sur-Seine France
Croatian: SANOFI CHIMIE 9 Quai Jules Guesde 94403 Vitry-sur-Seine Francuska
English: Combination therapy with a statin
Croatian: Kombinirana terapija sa statinom
English: LONG TERM study
Croatian: Ispitivanje LONG TERM
English: HIGH FH study
Croatian: Ispitivanje HIGH FH
English: The fluctuations between Cmax and Ctrough were higher for the every 4 weeks dosage regimen.
Croatian: Fluktuacije između Cmax i Cmin bile su veće za režim doziranja svaka 4 tjedna.
English: There were no adverse effects on fetal growth or development in rats or monkeys.
Croatian: Nije bilo štetnih učinaka na rast i razvoj ploda u štakora ni majmuna.
English: Overall, 730 (7.7%) of 9451 patients switched to placebo.
Croatian: Ukupno, 730 (7,7%) od 9451 bolesnika je prešlo na placebo.
English: • Press and firmly hold the pen against your body until the yellow safety cover is no longer visible.
Croatian: • Pritisnite brizgalicu uz tijelo i držite je čvrsto pritisnutom dok žuti sigurnosni pokrov više ne bude vidljiv.
English: • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.
Croatian: • Ako vidite krv, pritisnite komad pamučne vate ili gaze na mjesto injiciranja dok krvarenje ne prestane.
English: • By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad”
Croatian: • Blokiranjem PCSK9, Praluent povećava broj receptora dostupnih za uklanjanje 'lošeg'
English: If signs or symptoms of serious allergic reactions occur, treatment with Praluent must be discontinued and appropriate symptomatic treatment initiated (see section 4.3).
Croatian: Ako se pojave znakovi ili simptomi ozbiljnih alergijskih reakcija, mora se prekinuti liječenje lijekom Praluent i uvesti odgovarajuće simptomatsko liječenje (vidjeti dio 4.3).
English: • Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
Croatian: • Praluent je monoklonsko protutijelo (jedna vrsta specijaliziranog proteina oblikovanog tako da se pričvrsti za ciljnu tvar u tijelu).
English: • “Bad” cholesterol is normally removed from your blood by binding to specific “receptors” (docking stations) in your liver.
Croatian: • 'Loš' kolesterol obično se uklanja iz krvi vezivanjem za specifične 'receptore' (mjesta spajanja ili povezivanja) u jetri.
English: On-treatment analysis - analysis restricted to the time period that patients actually received treatment.
Croatian: b Analiza liječene populacije - analiza ograničena na vremensko razdoblje u kojem su bolesnici uistinu primali liječenje.
English: Praluent has no or negligible influence on the ability to drive and use machines.
Croatian: Praluent ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Yellow safety cover Needle inside
Croatian: Žuti sigurnosni pokrov Unutra je igla
English: The following side effects have been reported since the marketing of Praluent, but how often they occur is not known:
Croatian: Sljedeće su nuspojave prijavljene nakon stavljanja u promet lijeka Praluent, ali nije poznato koliko često se javljaju:
English: • Do not rub the skin after the injection.
Croatian: • Nemojte trljati kožu nakon injekcije.
English: • The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
Croatian: • Lijek se injicira pod kožu, a možete ga primijeniti samostalno ili Vam ga može injicirati netko drugi (skrbnik).
English: There is no specific treatment for Praluent overdose.
Croatian: Nema specifičnog liječenja za predoziranje lijekom Praluent.
English: • Always read the "Instructions for Use" provided in the box.
Croatian: • Uvijek pročitajte 'Upute za uporabu' priložene u kutiji.
English: What you need to know before you use Praluent 3.
Croatian: Što morate znati prije nego počnete primjenjivati Praluent 3.
English: Praluent blocks a protein called PCSK9.
Croatian: Praluent blokira protein koji se zove PCSK9.
English: Not all presentations and pack sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti svi farmaceutski oblici i veličine pakiranja.
English: If you have questions, ask your doctor, pharmacist or nurse or call the sanofi-aventis number on the package leaflet.
Croatian: Ako imate pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri ili nazovite sanofi-aventis na broj naveden u uputi o lijeku.
English: STEP A: Getting ready for an injection
Croatian: KORAK A: Priprema za injekciju
English: Alirocumab is expected to degrade to small peptides and individual amino acids.
Croatian: Očekuje se da će se alirokumab razgraditi u malene peptide i pojedinačne aminokiseline.
English: Two studies were conducted in patients who were not concomitantly treated with a statin, including one study in patients with documented statin intolerance.
Croatian: Dva su ispitivanja provedena u bolesnika koji nisu istodobno bili liječeni statinima, uključujući jedno ispitivanje u bolesnika s dokumentiranim nepodnošenjem statina.
English: The observed cases of pruritus were typically mild and transient.
Croatian: Primijećeni slučajevi pruritusa obično su bili blagi i prolazni.
English: Human immunoglobulin G (IgG) is excreted in human milk, in particular in colostrum; the use of Praluent is not recommended in breast-feeding women during this period.
Croatian: Humani imunoglobulin G (IgG) izlučuje se u majčino mlijeko, osobito u kolostrum; stoga se primjena lijeka Praluent u dojilja ne preporučuje tijekom tog razdoblja.
English: Two elimination phases were observed for alirocumab.
Croatian: Primijećene su dvije faze eliminacije alirokumaba.
English: No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the phase 3 program.
Croatian: Nije primijećena nikakva razlika u sigurnosnom profilu između dviju doza (75 mg i 150 mg) koje su se primjenjivale u programu ispitivanja faze 3.
English: All of the studies met their primary endpoint.
Croatian: Sva su ispitivanja postigla primarnu mjeru ishoda.
English: • Inject all of the solution by slowly and steadily pushing down the plunger.
Croatian: • Injicirajte svu otopinu polako i ravnomjerno pritišćući klip prema dolje.
English: The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Croatian: Primjena lijeka Praluent ne preporučuje se tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje alirokumabom.
English: For allergic reactions that may occur while taking Praluent, see section 4.
Croatian: Za alergijske reakcije koje bi mogle nastupiti tijekom liječenja lijekom Praluent pogledajte dio 4.
English: The safety profile in ODYSSEY OUTCOMES was consistent with the overall safety profile described in the phase 3 controlled trials.
Croatian: OUTCOMES bio je konzistentan s ukupnim sigurnosnim profilom opisanim u kontroliranim ispitivanjima faze 3.
English: The distribution of body weight and age, two covariates impacting alirocumab exposure, were different among renal function categories and most likely explain the observed pharmacokinetic differences.
Croatian: Raspodjela tjelesne težine i dob, dvije kovarijante koje utječu na izloženost alirokumabu, razlikovale su se između različitih kategorija bubrežne funkcije i stoga su najvjerojatnije objašnjenje za primijećene farmakokinetičke razlike.
English: Since the effects of alirocumab on the breast-fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue Praluent during this period.
Croatian: Budući da nisu poznati učinci alirokumaba na dojenče, potrebno je donijeti odluku o tome hoće li se tijekom tog razdoblja prekinuti dojenje ili liječenje lijekom Praluent.
English: The lipid-lowering effect of alirocumab was observed within 15 days after the first dose reaching maximum effect at approximately 4 weeks.
Croatian: Hipolipemijski učinak alirokumaba primijećen je unutar 15 dana nakon primjene prve doze, a maksimalni je učinak postignut nakon približno 4 tjedna.
English: FHI and FHII (N=732)
Croatian: FHI i FHII (N=732)
English: The safety profile in patients treated with a 300 mg once every 4 week (monthly) dosing regimen, was similar to the safety profile as described for the clinical studies program using a 2 week dosing regimen, except for a higher rate of local injection site reactions.
Croatian: Sigurnosni profil u bolesnika liječenih na režimu doziranja od 300 mg jednom svaka 4 tjedna (jednom mjesečno) bio je sličan sigurnosnom profilu opisanom za program kliničkih ispitivanja s režimom doziranja svaka 2 tjedna, osim za višu stopu lokalnih reakcija na mjestu injiciranja.
English: Hazard Ratio: 0.85 95% CI (0.78, 0.93)
Croatian: Omjer hazarda: 0,85 95% CI (0,78; 0,93)
English: ALTERNATIVE study
Croatian: Ispitivanje ALTERNATIVE
English: Evaluation of Cardiovascular (CV) events
Croatian: Ocjenjivanje kardiovaskularnih (KV) događaja
English: • PCSK9 lowers the number of these receptors in the liver - this causes your “bad” cholesterol to be higher than it should.
Croatian: • PCSK9 smanjuje broj tih receptora u jetri - zbog toga vrijednosti 'lošeg' kolesterola postaju više nego što bi trebale biti.
English: • Do not remove the pen until the entire window has turned yellow.
Croatian: • Nemojte ukloniti brizgalicu dok cijeli prozorčić ne bude žut.
English: • itching (pruritus).
Croatian: • svrbež (pruritus)
English: Do not get rid of any air bubbles in the syringe before the injection.
Croatian: Nemojte uklanjati mjehuriće zraka iz štrcaljke prije injekcije.
English: • a puncture-resistant container (see Step B, 8).
Croatian: • neprobojan spremnik (pogledajte korak B, 8).
English: Alirocumab binds to PCSK9.
Croatian: Alirokumab se vezuje za PCSK9.
English: Although similar efficacy was observed in patients over 75 years, data are limited in this age group.
Croatian: Iako je slična djelotvornost primijećena i u bolesnika starijih od 75 godina, podaci o primjeni u toj dobnoj skupini su ograničeni.
English: FH I and FH II studies
Croatian: Ispitivanja FH I i FH II
English: Praluent should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Croatian: Praluent se ne smije injicirati u područja zahvaćena aktivnom kožnom bolešću ili ozljedom poput sunčanih opeklina, kožnih osipa, upale ili kožnih infekcija.
English: This did not translate into a clinically meaningful difference in LDL-C lowering.
Croatian: To nije dovelo do klinički značajne razlike u snižavanju vrijednosti LDL-C.
English: • Hold the skin like this for the whole injection.
Croatian: • Držite kožu tako tijekom cijele injekcije.
English: The pen will not work if the yellow safety cover is not depressed fully.
Croatian: Brizgalica neće raditi ako žuti sigurnosni pokrov posve ne utisnete.
English:  Look at the label on the syringe.
Croatian: Pogledajte naljepnicu na štrcaljki
English: Overall, 71.6% of patients were categorized at high or very high CV risk and not at their LDL-C target.
Croatian: Sveukupno, 71,6% bolesnika kategorizirano je s visokim ili vrlo visokim kardiovaskularnim rizikom i izvan svojih ciljnih vrijednosti LDL-C.
English: In controlled clinical studies, no safety issues were identified with more frequent dosing than the recommended every 2 week dosing schedule.
Croatian: U kontroliranim kliničkim ispitivanjima nisu primijećeni sigurnosni problemi uz doziranje koje je učestalije od preporučenog rasporeda primjene jednom svaka 2 tjedna.
English: Although no safety issues were observed in patients over 75 years of age, data are limited in this age group.
Croatian: Iako nisu primijećeni sigurnosni problemi među bolesnicima starijima od 75 godina, podaci o primjeni u toj dobnoj skupini su ograničeni.
English: LDL-C reduction was consistent regardless of concomitantly used statins and doses.
Croatian: Sniženje vrijednosti LDL-C bilo je dosljedno, neovisno o istodobno primjenjivanim statinima i dozama.
English:  Push the plunger down.
Croatian: Pritisnite klip prema dolje.
English: Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see section 5.3).
Croatian: Budući da je alirokumab rekombinantno IgG1 protutijelo, očekuje se da će proći kroz placentarnu barijeru (vidjeti dio 5.3).
English: After removal from the refrigerator, the medicinal product must be used within 30 days or discarded.
Croatian: Nakon vađenja iz hladnjaka, lijek se mora upotrijebiti unutar 30 dana ili baciti.
English: When co-administered with a statin, the median apparent half-life of alirocumab was 12 days.
Croatian: Kada se primjenjivao istodobno sa statinom, medijan prividnog poluvijeka alirokumaba iznosio je 12 dana.
English: * including mainly oropharyngeal pain, rhinorrhea, sneezing ** including erythema/redness, itching, swelling, pain/tenderness
Croatian: * uključujući pretežno orofaringealnu bol, rinoreju, kihanje ** uključujući eritem/crvenilo, svrbež, oticanje, bol/osjetljivost
English: The offspring of monkeys that received high doses of alirocumab weekly throughout pregnancy had a weaker secondary immune response to antigen challenge than did the offspring of control animals.
Croatian: Mladunčad ženki majmuna koje su primale visoke doze alirokumaba svaki tjedan tijekom graviditeta imala je slabiji sekundarni imunološki odgovor na izlaganje antigenu nego mladunčad kontrolnih životinja.
English: • a puncture-resistant container (see Step B, 6).
Croatian: • neprobojan spremnik (pogledajte korak B, 6).
English: Praluent helps lower your levels of “bad” cholesterol (also called “LDL cholesterol”).
Croatian: Praluent pomaže sniziti vrijednosti 'lošeg' kolesterola (koji se još naziva i 'LDL kolesterolom').
English: Figure 1 Primary Composite Endpoint Cumulative Incidence Over 4 Years in ODYSSEY OUTCOMES
Croatian: Slika 1 Kumulativna incidencija primarne kompozitne mjere ishoda tijekom 4 godine u ispitivanju ODYSSEY
English: Do not touch the yellow safety cover.
Croatian: Nemojte dirati žuti sigurnosni pokrov.
English: Reproductive toxicology studies in rats and monkeys indicated that alirocumab, like other IgG antibodies, crosses the placental barrier.
Croatian: Toksikološka ispitivanja učinaka na reprodukciju provedena na štakorima i majmunima ukazala su na to da alirokumab, baš kao i druga IgG protutijela, prolazi kroz placentarnu barijeru.
English: Do not stop using Praluent without talking with your doctor.
Croatian: Nemojte prestati primjenjivati Praluent bez prethodnog razgovora sa svojim liječnikom.
English: In published genetic studies as well as clinical and observational trials with lipid lowering therapies an increased risk of new onset of diabetes has been associated with lower levels of LDL-C.
Croatian: U objavljenim genetskim ispitivanjima, kao i u kliničkim i opservacijskim ispitivanjima s terapijama za snižavanje razine lipida, povećani rizik od novonastalog dijabetesa povezan je s nižim razinama LDL-C.
English: For the remaining duration of breast-feeding, exposure is expected to be low.
Croatian: Očekuje se da će izloženost tijekom preostalog razdoblja dojenja biti mala.
English: Pharmacotherapeutic group: Other lipid modifying agents, ATC code: C10AX14.
Croatian: Farmakoterapijska skupina: ostali pripravci koji modificiraju lipide, ATK oznaka: C10AX14.
English: A reduction of all-cause mortality was also observed, with only nominal statistical significance by hierarchical testing (HR 0.85, 95% CI: 0.73, 0.98).
Croatian: Uočeno je također i smanjenje smrtnosti od svih uzroka, uz samo nominalnu statističku značajnost hijerarhijskim ispitivanjem (HR 0,85, 95% CI: 0,73; 0,98).
English: For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section
Croatian: Za rezultate ispitivanja vezano uz učinke na LDL-C, kardiovaskularne događaje i ispitivane populacije vidjeti dio 5.1.
English: However, the LDLR has been shown to have a low affinity for Lp(a), therefore the exact mechanism by which alirocumab lowers Lp(a) is not fully understood.
Croatian: Međutim, pokazalo se da LDLR ima nizak afinitet prema Lp(a) pa stoga točan mehanizam kojim alirokumab snizuje vrijednost Lp(a) nije posve razjašnjen.
English: Precautions to be taken before handling Praluent should be allowed to warm to room temperature prior to use.
Croatian: Mjere opreza koje treba poduzeti prije rukovanja lijekom Prije primjene treba pričekati da se Praluent ugrije na sobnu temperaturu.
English: COMBO II study
Croatian: Ispitivanje COMBO II
English: What Praluent is and what it is used for
Croatian: Što je Praluent i za što se koristi
English: Based on a population pharmacokinetic analysis, age was associated with a small difference in alirocumab exposure at steady state, with no impact on efficacy or safety.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, dob je povezana s malom razlikom u izloženosti alirokumabu u stanju dinamičke ravnoteže, koja ne utječe ni na djelotvornost ni na sigurnost.
English: • alcohol wipes
Croatian: • tupferi natopljeni alkoholom
English: • Use your thumb and first finger to pinch a fold of skin at the injection site.
Croatian: • Palcem i kažiprstom uhvatite nabor kože na mjestu injiciranja.
English:  After completing all steps in “Step A: Getting ready for an injection”, pull off the needle cap.
Croatian: Nakon što ste dovršili sve korake iz 'Koraka A: Priprema za injekciju', skinite zatvarač igle.
English: At low concentrations, the elimination is predominately through saturable binding to target (PCSK9), while at higher concentrations the elimination of alirocumab is largely through a non-saturable proteolytic pathway.
Croatian: Pri niskim se koncentracijama eliminacija odvija prvenstveno putem saturabilnog vezivanja za ciljni protein (PCSK9), dok se pri većim koncentracijama eliminacija alirokumaba uvelike odvija nesaturabilnim proteolitičkim putem.
English: Continue to follow your cholesterol-lowering diet while taking this medicine.
Croatian: Nastavite se pridržavati dijete za snižavanje vrijednosti kolesterola tijekom liječenja ovim lijekom.
English: • Do not use if the window appears solid yellow (see picture B).
Croatian: • Nemojte primijeniti lijek ako je prozorčić posve žut (pogledajte sliku B).
English: Elderly No dose adjustment is needed for elderly patients.
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika.
English: The Kaplan-Meier estimates of the cumulative incidence of the primary endpoint for the overall patient population over time are presented in Figure 1.
Croatian: Kaplan-Meier procjena kumulativne incidencije primarne mjere ishoda za ukupnu populaciju bolesnika tijekom vremena prikazana je na Slici 1.
English: Every 4 week dosing study
Croatian: Ispitivanje doziranja svaka 4 tjedna
English: Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration).
Croatian: Vrijednosti lipida mogu se ocijeniti 4 do 8 tjedana nakon početka liječenja ili titracije doze te se sukladno nalazu može prilagoditi doza (postupno povećati ili smanjiti).
English: <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su kako slijedi: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • This syringe can only be used for one single injection, and must be thrown away after use.
Croatian: • Ova se štrcaljka može upotrijebiti samo za jednu injekciju, nakon čega se mora baciti.
English: Praluent is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Croatian: Praluent se primjenjuje kao supkutana injekcija u bedro, abdomen ili nadlakticu.
English: Established atherosclerotic cardiovascular disease
Croatian: Utvrđena aterosklerotska kardiovaskularna bolest
English: Following intravenous administration, the volume of distribution was about 0.04 to 0.05 L/kg indicating that alirocumab is distributed primarily in the circulatory system.
Croatian: Volumen distribucije nakon intravenske primjene iznosio je približno 0,04 do 0,05 l/kg, što ukazuje na to da se alirokumab prvenstveno raspodjeljuje u cirkulacijski sustav.
English: • Check that you have the correct product and the correct dose.
Croatian: • Provjerite imate li pravi lijek i pravu dozu.
English: General allergic reactions were reported more frequently in the alirocumab group (8.1% of patients) than in the control group (7.0% of patients), mainly due to a difference in the incidence of pruritus.
Croatian: Opće alergijske reakcije prijavljene su češće u skupini liječenoj alirokumabom (8,1% bolesnika) nego u kontrolnoj skupini (7,0% bolesnika), prvenstveno zbog razlike u incidenciji pruritusa.
English:  If needed pinch the skin.
Croatian: Ako je potrebno, uhvatite nabor kože.
English: Praluent must not be co-administered with other injectable medicinal products at the same injection site.
Croatian: Praluent se ne smije primijeniti istodobno s drugim lijekovima koji se primjenjuju injekcijom na istome mjestu injiciranja.
English: What you need to know before you use Praluent
Croatian: Što morate znati prije nego počnete primjenjivati Praluent
English: In animal studies, there were no adverse effects on surrogate markers of fertility (see section 5.3).
Croatian: U ispitivanjima na životinjama nisu primijećeni štetni učinci na zamjenske biljege plodnosti (vidjeti dio 5.3).
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).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke s obzirom na očuvanje trudnoće ili embriofetalni razvoj; toksičnost za majku primijećena je u štakora, ali ne i u majmuna pri dozama većima od onih preporučenih za ljude, a u mladunčadi majmuna primijećen je slabiji sekundarni imuni odgovor na izlaganje antigenu (vidjeti dio 5.3).
English: After subcutaneous administration of 50 mg to 300 mg alirocumab, median times to maximum serum concentration (tmax) were 3-7 days.
Croatian: Nakon supkutane primjene 50 mg do 300 mg alirokumaba, medijani vremena do postizanja maksimalne serumske koncentracije (tmax) iznosili su 3 - 7 dana.
English: • Do not touch the yellow safety cover.
Croatian: • Nemojte dirati žuti sigurnosni pokrov.
English: If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule.
Croatian: Ako bolesnik propusti dozu, treba primijeniti injekciju što je prije moguće i zatim nastaviti liječenje prema uobičajenom rasporedu.
English: The long-term consequences of continuing alirocumab treatment in the presence of ADA are unknown.
Croatian: Dugoročne posljedice nastavka liječenja alirokumabom u prisutnosti protutijela na lijek nisu poznate.
English: After removal from the refrigerator, Praluent must be used within 30 days or discarded.
Croatian: Nakon vađenja iz hladnjaka, Praluent se mora upotrijebiti unutar 30 dana ili baciti.
English: Always check the label of your syringe to make sure you have the right medicine and the right strength.
Croatian: Uvijek provjerite naljepnicu štrcaljke kako biste bili sigurni da imate pravi lijek i pravu jačinu.