FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Mean Percent Change from Baseline in LDL-C and Other Lipids/ Lipoproteins in PlaceboControlled and Ezetimibe-Controlled Studies - 75 mg and/or 150 mg Q2W Dosing Regimen
Croatian: Tablica 2: Srednja vrijednost postotka promjene vrijednosti LDL-C i drugih lipida/lipoproteina u odnosu na početnu vrijednost u placebom i ezetimibom kontroliranim ispitivanjima - režim doziranja 75 mg i/ili 150 mg svaka 2 tjedna
English: Gender Based on a population pharmacokinetic analysis, gender has no impact on alirocumab pharmacokinetics.
Croatian: Spol Prema populacijskoj farmakokinetičkoj analizi, spol ne utječe na farmakokinetiku alirokumaba.
English: In the 2 studies in which patients were started and maintained on 150 mg every 2 weeks, the achieved mean reduction of LDL-C at week 12 was 62.6%.
Croatian: U dvama ispitivanjima u kojima su bolesnici započeli i nastavili liječenje dozom od 150 mg jednom svaka 2 tjedna, postignuta srednja vrijednost sniženje LDL-C u 12. tjednu iznosila je 62,6%.
English: Monotherapy or as add-on to non-statin lipid-modifying therapy
Croatian: Monoterapija ili kao dodatak terapiji koja modificira lipide, a koja ne uključuje statine
English: In pre-specified analyses before possible up-titration at week 12 in the 8 studies in which patients started with the 75 mg every 2 weeks dosing regimen, mean reductions in LDL-C ranging from 44.5% to 49.2% were achieved.
Croatian: Prema unaprijed određenim analizama provedenima prije mogućeg postupnog povećanja doze u 12. tjednu u 8 ispitivanja u kojima su bolesnici započeli liječenje dozom od 75 mg jednom svaka 2 tjedna, postignute su srednje vrijednosti sniženja LDL-C u rasponu od 44,5% do 49,2%.
English: • The active substance is alirocumab.
Croatian: • Djelatna tvar je alirokumab.
English: This is because there is no experience of using the medicine in these age groups.
Croatian: Naime, nema iskustva s njegovom primjenom u tim dobnim skupinama.
English: In the cardiovascular outcomes study (ODYSSEY OUTCOMES), injection site reactions also occurred more frequently in alirocumab-treated patients than in placebo-treated patients (3.8% alirocumab versus 2.1% placebo).
Croatian: OUTCOMES), reakcije na mjestu primjene su se također pojavljivale češće u bolesnika liječenih alirokumabom nego u bolesnika koji su primali placebo (3,8% alirokumab nasuprot 2,1% placebo).
English: • the Praluent syringe
Croatian: • Praluent štrcaljka
English: Your doctor will tell you which dose is right for you and how often to inject (75 mg or 150 mg once every 2 weeks, or 300 mg once every 4 weeks/monthly).
Croatian: Liječnik će Vam reći koja je doza primjerena za Vas i koliko često se injicira (75 mg ili 150 mg jednom svaka 2 tjedna ili 300 mg jednom svaka 4 tjedna/jednom mjesečno).
English: In the ODYSSEY OUTCOMES trial, 5.5% of patients treated with alirocumab 75 mg and/or 150 mg every 2 weeks (Q2W) had anti-drug antibodies (ADA) detected after initiating treatment compared with 1.6% of patients treated with placebo, most of these were transient responses.
Croatian: OUTCOMES, 5,5% bolesnika liječenih sa 75 mg i/ili 150 mg alirokumaba svaka 2 tjedna imalo je protutijela na lijek nakon početka liječenja u usporedbi s 1,6% bolesnika koji su primali placebo, od kojih je većina imala prolazne odgovore.
English: • Throw away syringe and cap into a puncture-resistant container immediately after use.
Croatian: • Bacite brizgalicu i zatvarač u neprobojan spremnik odmah nakon uporabe.
English:  Let the syringe warm up at room temperature for 30 to 40 minutes.
Croatian: Pričekajte 30 do 40 minuta da se štrcaljka ugrije na sobnu temperaturu.
English: In a multicenter, double-blind, placebo-controlled, 14 week study, 13 patients with heterozygous familial hypercholesterolaemia (heFH) due to gain-of-function mutations in the PCSK9 gene were randomised to receive either alirocumab 150 mg Q2W or placebo.
Croatian: U multicentričnom, dvostruko slijepom, placebom kontroliranom, 14-tjednom ispitivanju provedenom u 13 bolesnika s heterozigotnom obiteljskom hiperkolesterolemijom nastalom zbog mutacija gena PCSK9 koje poboljšavaju funkciju, bolesnici su bili randomizirani za primanje alirokumaba u dozi od 150 mg jednom svaka 2 tjedna ili placeba.
English: Follow these instructions every time you use a Praluent syringe.
Croatian: Pridržavajte se ovih uputa svaki puta kada koristite Praluent štrcaljku.
English: Do not use the pen if it has been dropped or damaged.
Croatian: Nemojte upotrijebiti brizgalicu ako je ispala iz ruku ili je oštećena.
English: Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.
Croatian: U bolesnika kojima je potrebno veće sniženje vrijednosti LDL-C (>60%), liječenje može započeti dozom od 150 mg jednom svaka 2 tjedna ili 300 mg jednom svaka 4 tjedna ( jednom mjesečno), primijenjeno supkutano.
English: 1 pre-filled syringe 2 pre-filled syringes 6 pre-filled syringes
Croatian: 1 napunjena brizgalica 2 napunjene brizgalice 6 napunjenih brizgalica
English: What Praluent is used for
Croatian: Za što se Praluent koristi
English: Store unused syringes in the refrigerator at 2°C to 8°C.
Croatian: Neupotrijebljene brizgalice čuvajte u hladnjaku na temperaturi od 2°C do 8°C.
English: Compared to alirocumab monotherapy, the exposure to alirocumab is about 40%, 15%, and 35% lower when used concomitantly with statins, ezetimibe, and fenofibrate, respectively.
Croatian: U usporedbi s monoterapijom alirokumabom, izloženost alirokumabu pri njegovoj istodobnoj primjeni sa statinima, ezetimibom i fenofibratom smanjuje se za 40%, 15% odnosno 35%.
English: Immunogenicity/ Anti-drug-antibodies (ADA)
Croatian: Imunogenost/protutijela na lijek
English: A concentration-dependent reduction in free PCSK9 and LDL-C is observed until target saturation is achieved.
Croatian: Primjetno je o koncentraciji ovisno smanjenje udjela nevezanog PCSK9 i LDLC do postizanja ciljne zasićenosti.
English: At week 8, the mean reduction in LDL-C from baseline with all patients treated with alirocumab was 72.4%.
Croatian: U 8. tjednu srednja vrijednost sniženja LDL-C u odnosu na početnu vrijednost u svih bolesnika liječenih alirokumabom iznosila je 72,4%.
English: No dose adjustment is needed for patients with mild or moderate hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije.
English: • Ask your doctor, pharmacist or nurse how to throw away the container.
Croatian: • Pitajte svog liječnika, ljekarnika ili medicinsku sestru kako zbrinuti spremnik.
English: • Do not pull off the cap until you are ready to inject.
Croatian: • Zatvarač skinite tek kada ste spremni injicirati lijek.
English: Following discontinuation of alirocumab, no rebound in LDL-C was observed, and LDL-C levels gradually returned to baseline levels.
Croatian: Nakon prekida primjene alirokumaba nije primijećen nagli skok vrijednosti LDL-C, već su se vrijednosti LDL-C postupno vratile na početne vrijednosti.
English: 1, 2, or 6 pre-filled syringes.
Croatian: 1, 2 ili 6 napunjenih štrcaljki.
English: Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred (may affect up to 1 in 1,000 people).
Croatian: Ponekad su se javljale ozbiljne alergijske reakcije kao što su preosjetljivost (otežano disanje), numularni ekcem (crvenkaste točkice na koži ponekad praćene mjehurićima na koži) i hipersenzitivni vaskulitis (specifičan oblik reakcije preosjetljivosti koju prate simptomi poput proljeva, osipa ili ljubičastih točkica na koži) (mogu se javiti u do 1 na 1000 osoba).
English: A multicenter, double-blind, ezetimibe-controlled 2 year study included 707 patients categorised as very high CV risk and not at their pre-defined target LDL-C on a maximally tolerated dose of statin.
Croatian: Multicentrično, dvostruko slijepo, ezetimibom kontrolirano, 2-godišnje ispitivanje uključivalo je 707 bolesnika koji su bili kategorizirani kao bolesnici s vrlo visokim KV rizikom i koji nisu postigli unaprijed određenu ciljnu vrijednost LDL-C uz maksimalnu podnošljivu dozu statina.
English: In pre-specified final analyses of the LONG TERM study, treatment-emergent CV events confirmed by adjudication occurred in 72 of 1550 (4.6%) patients in the alirocumab group and in 40 of 788 (5.1%) patients in the placebo group; MACE-plus confirmed by adjudication were reported in 27 of 1550 (1.7%) patients in the alirocumab group and 26 of 788 (3.3%) patients in the placebo group.
Croatian: Prema unaprijed određenim konačnim analizama podataka iz ispitivanja LONG TERM, neovisno potvrđeni KV događaji koji su se javili tijekom liječenja zabilježeni su u 72 od 1550 (4,6%) bolesnika u skupini liječenoj alirokumabom te u 40 od 788 (5,1%) bolesnika u skupini koja je primala placebo; neovisno potvrđeni MACE-plus događaji bili su prijavljeni u 27 od 1550 (1,7%) bolesnika liječenih alirokumabom te 26 od 788 (3,3%) onih koji su primali placebo.
English: Excipients: histidine, sucrose, polysorbate 20, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: histidin, saharoza, polisorbat 20, voda za injekcije.
English: Blue cap
Croatian: Plavi zatvarač
English: • Check the use by date: do not use if this date has passed.
Croatian: • Provjerite rok valjanosti: nemojte primijeniti lijek ako mu je istekao rok valjanosti.
English: Patients received either alirocumab 300 mg Q4W, alirocumab 75 mg Q2W, or placebo in addition to their existing lipid-modifying therapy (statin, non-statin therapy or diet alone).
Croatian: Bolesnici su primili alirokumab 300 mg svaka 4 tjedna, alirokumab75 mg svaka 2 tjedna ili placebo kao dodatak na svoju već postojeću terapiju koja modificira lipide (statini, nestatinska terapija ili samo dijeta).
English: A multicenter, double-blind, placebo-controlled, 48 week study included 540 patients on a maximally tolerated dose of a statin, with or without other lipid-modifying therapy (308 in the alirocumab 300 mg Q4W group, 76 in the alirocumab 75 mg Q2W group, and 156 in the placebo group), and 252 patients not treated with a statin (144 in the alirocumab 300 mg Q4W group, 37 in the alirocumab 75 mg Q2W group, and 71 in the placebo group).
Croatian: Multicentrično, dvostruko slijepo, placebom kontrolirano, 48-tjedno ispitivanje uključilo je 540 bolesnika na maksimalno podnošljivoj dozi statina, s nekom drugom terapijom koja modificira lipide ili bez nje (308 u skupini s 300 mg alirokumaba svaka 4 tjedna, 76 u skupini sa 75 mg alirokumaba svaka 2 tjedna te 156 u placebo skupini) i 252 bolesnika koji nisu liječeni statinom (144 u skupini s 300 mg alirokumaba svaka 4 tjedna, 37 u skupini sa 75 mg alirokumaba svaka 2 tjedna te 71 u placebo skupini).
English: Body weight was identified as one significant covariate in the final population PK model impacting alirocumab pharmacokinetics.
Croatian: U konačnom populacijskom farmakokinetičkom modelu tjelesna je težina identificirana kao jedna od značajnih kovarijanti koje utječu na farmakokinetiku alirokumaba.
English: The syringe components are assembled into a single-use pre-filled pen with a blue cap and a dark grey activation button.
Croatian: Komponente štrcaljke sastavljene su u napunjenu brizgalicu za jednokratnu uporabu s plavim zatvaračem i tamnosivim aktivacijskim dugmetom.
English: In pre-specified analyses of pooled phase 3 studies, treatment-emergent CV events confirmed by adjudication, consisting of coronary heart disease (CHD) death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalisation, congestive heart failure hospitalisation, and revascularisation, were reported in 110 (3.5%) patients in the alirocumab group and 53 (3.0%) patients in the control group (placebo or active control) with HR=1.08 (95% CI, 0.78 to 1.50).
Croatian: Prema unaprijed određenim analizama objedinjenih podataka iz ispitivanja faze 3, neovisno potvrđeni KV događaji koji su se javili tijekom liječenja, a uključivali su smrt zbog koronarne srčane bolesti, infarkt miokarda, ishemijski moždani udar, nestabilnu anginu koja je zahtijevala hospitalizaciju, hospitalizaciju uslijed kongestivnog zatajenja srca i revaskularizaciju, prijavljeni su u 110 (3,5%) bolesnika u skupini liječenoj alirokumabom te 53 (3,0%) bolesnika u kontrolnoj skupini (placebo ili aktivni kontrolni lijek), uz HR=1,08 (95% CI: 0,78 - 1,50).
English: Without Background Statin
Croatian: Bez osnovne terapije statinima
English: Read all of the instructions carefully before using the Praluent syringe.
Croatian: Pažljivo pročitajte cijele upute prije nego što upotrijebite Praluent brizgalicu.
English:  Push and immediately release the grey button with your thumb.
Croatian: Pritisnite sivo dugme palcem i odmah ga otpustite.
English: • Use a 45° angle if you can only pinch 2 cm of skin.
Croatian: • Ako možete uhvatiti nabor kože od samo 2 cm, ubodite iglu pod kutom od 45º.
English: Patients on 75 mg Q2W who had two consecutive LDL-C values below 15 mg/dL (0.39 mmol/L) were switched to placebo in a blinded fashion.
Croatian: Bolesnici na dozi od 75 mg jednom svaka dva tjedna koji su imali dvije uzastopne vrijednosti LDL-C ispod 15 mg/dl (0,39 mmol/l) prebačeni su na placebo na slijepi način.
English: Based on a population pharmacokinetic analysis, the median apparent half-life of alirocumab at steady state was 17 to 20 days in patients receiving alirocumab as monotherapy at subcutaneous doses of either 75 mg Q2W or 150 mg Q2W.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, medijan prividnog poluvijeka alirokumaba u stanju dinamičke ravnoteže iznosio je 17 do 20 dana u bolesnika koji su primali monoterapiju alirokumabom u supkutanim dozama od 75 mg jednom svaka 2 tjedna ili 150 mg jednom svaka 2 tjedna.
English: In studies using the criteriabased up-titration regimen, a majority of patients achieved the pre-defined target LDL-C (based on their level of CV risk) on the 75 mg Q2W dose, and a majority of patients maintained treatment on the 75 mg Q2W dose.
Croatian: U ispitivanjima u kojima se primjenjivao režim postupnog povećanja doze na temelju zadanih kriterija, većina bolesnika postigla je unaprijed određenu ciljnu vrijednost LDL-C (određenu na temelju njihove vrijednosti KV rizika) uz dozu od 75 mg jednom svaka 2 tjedna te je većina bolesnika nastavila liječenje dozom od 75 mg jednom svaka 2 tjedna.
English: Neutralising antibody (NAb) responses were observed in 0.5% of patients treated with alirocumab and in <0.1% of patients treated with placebo.
Croatian: Odgovori neutralizirajućim protutijelima bili su zabilježeni u 0,5% bolesnika liječenih alirokumabom i u <0,1% bolesnika koji su primali placebo.
English: It is available in pack size of 1, 2 or 6 pre-filled pens.
Croatian: Dostupna je u pakiranjima od 1, 2 ili 6 napunjenih brizgalica.
English: Reduction in LDL-C was seen across age, gender, body mass index (BMI), race, baseline LDL-C levels, patients with heFH and non-heFH, patients with mixed dyslipidaemia, and diabetic patients.
Croatian: Sniženje vrijednosti LDL-C primijećeno je kod svih dobnih skupina, oba spola, svih indeksa tjelesne mase (ITM), rasa, početnih vrijednosti LDL-C, bolesnika s heterozigotnom obiteljskom i stečenom hiperkolesterolemijom, bolesnika s miješanom dislipidemijom te bolesnika sa šećernom bolešću.
English: Talk to your doctor, pharmacist or nurse about all your medical conditions, including allergies, before using Praluent.
Croatian: Prije nego što primijenite Praluent, razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom o svim medicinskim stanjima koja imate, uključujući alergije.
English: LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.
Croatian: LDLR je primarni receptor koji odstranjuje cirkulirajući LDL i stoga pad vrijednosti LDLR-a uzrokovan djelovanjem PCSK9 dovodi do viših vrijednosti LDL-C u krvi.
English: Praluent is not recommended during pregnancy or breast-feeding.
Croatian: Ne preporučuje se primjena lijeka Praluent u trudnica i dojilja.
English: Difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C, Apo B, and Lp(a).
Croatian: Razlika naspram ezetimiba u 24. tjednu bila je statistički značajna za LDL-C, ukupni kolesterol, ne-HDL.K, Apo B i Lp(a).
English:  Push and immediately release the green button with your thumb.
Croatian: Pritisnite zeleno dugme palcem i odmah ga otpustite.
English: Tel. aus dem Ausland: +49 69 305 21 131
Croatian: Tel.: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131
English: Keep the pen or syringe in the outer carton in order to protect from light.
Croatian: Čuvati brizgalicu ili štrcaljku u vanjskom pakiranju radi zaštite od svjetlosti.
English: • Take the syringe out of the packaging by holding the syringe body.
Croatian: Prije nego što počnete • Izvadite štrcaljku iz pakiranja držeći je za tijelo.
English: Each single-use syringe contains either 75 milligrams
Croatian: Jedna brizgalica za jednokratnu uporabu sadrži 75 miligrama
English: Upper respiratory tract signs and symptoms*
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja znakovi i simptomi gornjih dišnih putova*
English: The patient may either self-inject Praluent, or a caregiver may administer Praluent, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
Croatian: Nakon što ga zdravstveni radnik pouči pravilnoj tehnici supkutanog injiciranja, bolesnik može Praluent primjenjivati samostalno ili mu ga može injicirati njegov skrbnik.
English: If needed, individual pre-filled syringes may be kept outside the refrigerator below 25°C for a maximum of 30 days.
Croatian: Ako je potrebno, pojedinačne napunjene brizgalice mogu se čuvati izvan hladnjaka ispod 25°C najviše 30 dana.
English: The absolute bioavailability of alirocumab after subcutaneous administration was about 85% as determined by population pharmacokinetic analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, apsolutna bioraspoloživost alirokumaba nakon supkutane primjene iznosila je približno 85%.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva pruritus urtikarija numularni ekcem
English: Major adverse cardiovascular events (“MACEplus”, i.e.: CHD death, myocardial infarction, ischemic stroke, and unstable angina requiring hospitalisation) confirmed by adjudication were reported in 52 of 3182 (1.6%) patients in the alirocumab group and 33 of 1792 (1.8%) patients in the control group (placebo or active control); HR=0.81 (95% CI, 0.52 to 1.25).
Croatian: Neovisno potvrđeni veliki kardiovaskularni štetni događaji (engl. major cardiovascular adverse events, MACE) („MACE-plus“, tj. smrt zbog koronarne srčane bolesti, infarkt miokarda, ishemijski moždani udar i nestabilna angina koja zahtijeva hospitalizaciju) bili su prijavljeni u 52 od 3182 (1,6%) bolesnika u skupini liječenoj alirokumabom te 33 od 1792 (1,8%) bolesnika u kontrolnoj skupini (placebo ili aktivni kontrolni lijek); HR=0,81 (95% CI: 0,52 - 1,25).
English: However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.
Croatian: Međutim, kada se alirokumab primjenjuje svaka dva tjedna, sniženje vrijednosti LDL-C održano je tijekom intervala doziranja.
English: Eight studies were performed with a dose of 75 mg Q2W, and criteria-based up-titration to 150 mg Q2W at week 12 in patients who did not achieve their pre-defined target LDL-C based on their level of CV risk at week 8.
Croatian: U osam se ispitivanja ocjenjivala doza od 75 mg jednom svaka 2 tjedna, koja se u 12. tjednu postupno povećala u skladu sa zadanim kriterijima na 150 mg jednom svaka 2 tjedna u bolesnika koji nisu postigli unaprijed određenu ciljnu vrijednost LDL-C utvrđenu na temelju njihove razine KV rizika u 8. tjednu.
English: Week24 LDL-C (ITT)
Croatian: 24. tjedan LDL-C (ITT)a
English: The syringe is equipped with a dark grey polypropylene plunger rod.
Croatian: Štrcaljka je opremljena tamnosivim polipropilenskim potisnikom klipa.
English: Do not freeze the syringe.
Croatian: Nemojte zamrzavati štrcaljku.
English: In a pool of ten placebo-controlled and active-controlled trials of patients treated with alirocumab 75 mg and/or 150 mg Q2W as well as in a separate clinical study of patients treated with alirocumab 75 mg Q2W or 300 mg every 4 weeks (including some patients with dose adjustment to 150 mg Q2W), the incidence of detecting ADA and NAb was similar to the results from the ODYSSEY OUTCOMES trial described above.
Croatian: U skupini od deset ispitivanja kontroliranih placebom i aktivno kontroliranih ispitivanja s bolesnicima liječenim alirokumabom u dozi od 75 mg i/ili 150 mg svaka 2 tjedna, kao i u odvojenom kliničkom ispitivanju bolesnika liječenih alirokumabom 75 mg svaka 2 tjedna ili 300 mg svaka 4 tjedna (uključujući i neke bolesnike s prilagodbom doze do 150 mg svaka 2 tjedna), učestalost razvoja protutijela na lijek i neutralizirajućih protutijela bila je slična rezultatima iz gore opisanog ispitivanja ODYSSEY
English: • the Praluent pen
Croatian: • Praluent brizgalica
English: The difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C and Apo B.
Croatian: Razlika naspram ezetimiba u 24. tjednu bila je statistički značajna za LDL-C, ukupni kolesterol, ne-HDL-C i Apo B.
English: How to use Praluent
Croatian: Kako primjenjivati Praluent
English: • Do not put the grey needle cap back on.
Croatian: • Nemojte vraćati sivi zatvarač igle na štrcaljku.
English: If needed, individual pre-filled pens may be kept outside the refrigerator below 25°C for a maximum of 30 days.
Croatian: Ako je potrebno, pojedinačne napunjene štrcaljke mogu se čuvati izvan hladnjaka ispod 25°C najviše 30 dana.
English: Difference versus ezetimibe was statistically significant at week 24 for all lipids/ lipoproteins except for TG, and Apo A-1.
Croatian: Razlika naspram ezetimiba u 24. tjednu bila je statistički značajna za sve lipide/lipoproteine osim za TG-a i Apo A-1.
English: If you use more Praluent than you should If you use more Praluent than you should, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijenite više lijeka Praluent nego što ste trebali, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: The parts of the Praluent syringe are shown in this picture.
Croatian: Upute za uporabu Dijelovi Praluent brizgalice prikazani su na slici u nastavku.
English: Keep the syringe in the outer carton in order to protect from light.
Croatian: Čuvati štrcaljku u vanjskom pakiranju radi zaštite od svjetlosti.
English:  Check if the window has turned yellow, before removing the pen.
Croatian: Provjerite je li štrcaljka prazna prije nego što uklonite iglu.
English: A multicenter, double-blind, ezetimibe-controlled, 24 week study included 103 patients with a moderate CV risk, not taking statins or other lipid-modifying therapies, and a baseline LDL-C between 100 mg/dL (2.59 mmol/L) to 190 mg/dL (4.91 mmol/L).
Croatian: Ovo multicentrično, dvostruko slijepo, ezetimibom kontrolirano, 24-tjedno ispitivanje uključivalo je 103 bolesnika s umjerenim KV rizikom koji nisu uzimali statine ni druge terapije koje modificiraju lipide, a imali su početnu vrijednost LDL-C između 100 mg/dl (2,59 mmol/l) i 190 mg/dl (4,91 mmol/l).
English: • Use a 90º angle if you can pinch 5 cm of skin.
Croatian: • Ako možete uhvatiti nabor kože od 5 cm, ubodite iglu pod kutom od 90º.