FrancophonIA/ELRC3.0 huggingface dataset:
English: DESCARTES was an international, multicentre, double-blind, randomised, placebo-controlled, 52-week study in 901 patients with hyperlipidaemia who received diet alone, atorvastatin, or a combination of atorvastatin and ezetimibe.
Croatian: DESCARTES je bilo međunarodno, multicentrično, dvostruko-slijepo, randomizirano, placebom kontrolirano ispitivanje u trajanju od 52 tjedna na 901 bolesniku s hiperlipidemijom koji su ili bili samo na posebnoj prehrani ili su primali atorvastatin ili kombinaciju atorvastatina i ezetimiba.
English: • Outer area of upper arm (only if someone else is giving the injection)
Croatian: • Vanjsko područje nadlaktice (samo ako Vam netko drugi daje injekciju)
English: DO NOT choose an area where the skin is tender, bruised, red, or hard.
Croatian: NEMOJTE odabrati područje gdje je koža osjetljiva, s modricama, crvena ili tvrda.
English: PUSH DOWN
Croatian: POTISNITE PREMA DOLJE
English: • Do not use if the medicine is cloudy or discoloured or contains flakes or particles.
Croatian: • Nemojte koristiti ako je lijek zamućen ili je promijenio boju, ili sadrži pahuljice ili čestice.
English: Important Before you use a single use Repatha pre-filled syringe, read this important information:
Croatian: Prije primjene Repatha napunjene štrcaljke za jednokratnu primjenu, pročitajte ove važne informacije:
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za supkutanu primjenu.
English: INFORMATION IN BRAILLE Repatha 140 syringe
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Repatha 140 štrcaljka
English: NonHDLC
Croatian: Non-HDLC
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Repatha 140 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 140 mg evolokumaba u 1 ml otopine.
English: In combination with rosuvastatin for 3 months, no adverse effects were observed in cynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly.
Croatian: U kombinaciji s rosuvastatinom tijekom 3 mjeseca, nisu uočene nuspojave u makaki majmuna pri mnogo većoj izloženosti u odnosu na bolesnike koji su primali evolokumab u dozi od 420 mg jedanput mjesečno.
English: NAME OF THE MEDICINAL PRODUCT Repatha 140 mg solution for injection in pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen Repatha 420 mg solution for injection in cartridge
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki Repatha 140 mg otopina za injekciju u napunjenoj brizgalici Repatha 420 mg otopina za injekciju u ulošku
English: Each cartridge contains 420 mg of evolocumab in 3.5 mL
Croatian: Jedan uložak sadrži 420 mg evolokumaba u 3,5 ml otopine
English: OLE Week 24
Croatian: OLE 24. tjedan
English: • Do not touch the start button until you place the loaded automated mini-doser and cartridge onto your skin and are ready to inject.
Croatian: • Nemojte dodirivati dugme za injiciranje sve dok ne postavite napunjeni automatizirani mini-dozator i uložak na kožu i niste spremni za injiciranje.
English: N (n) = Number of evaluable patients (N) and patients with observed LDL values at specific schedule visit (n) in the HoFH final analysis set.
Croatian: Legenda: OLE = otvoreni produžetak ispitivanja, N (n) = broj procjenjivih bolesnika (N) i bolesnika s uočenim LDL vrijednostima mjerenim pri specifičnim zakazanim posjetima (n) u setu konačne analize za homozigotnu obiteljsku hiperkolesterolemiju.
English: Do not reuse the pre-filled pen.
Croatian: Nemojte ponovno upotrebljavati iskorištenu napunjenu brizgalicu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AUTOMATED MINI-DOSER (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA AUTOMATIZIRANI MINI-DOZATOR (bez plavog okvira)
English: Repatha 140 mg solution for injection in pre-filled syringe Keep in the original carton in order to protect from light.
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki Čuvati u originalnoj kutiji radi zaštite od svjetlosti.
English: Repatha 420 mg once monthly significantly reduced LDL-C from baseline at 52 weeks compared with placebo (p < 0.001).
Croatian: Repatha u dozi od 420 mg jedanput mjesečno je značajno smanjila LDL-C u 52. tjednu u odnosu na početne vrijednosti u usporedbi s placebom (p < 0,001).
English: Study Dose regimen
Croatian: Ispitivanje Režim doziranja
English: Always hold the pre-filled syringe by the syringe barrel.
Croatian: Uvijek držite napunjenu štrcaljku za tijelo štrcaljke.
English: This increased clearance is in part mediated by statins increasing the concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Croatian: Proprotein Convertase Subtilisin/Kexin Type 9, PCSK9) što nije nepovoljno utjecalo na farmakodinamički učinak evolokumaba na lipide.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan uložak sadrži 420 mg evolokumaba u 3,5 ml otopine (120 mg/ml).
English: The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex, see section 4.4).
Croatian: Pokrov igle napunjene štrcaljke napravljen je od suhe prirodne gume (derivat lateksa, vidjeti dio 4.4).
English: No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipidlowering drugs other than statins and ezetimibe have been conducted.
Croatian: Osim za statine i ezetimib, nisu provedena druga ispitivanja farmakokinetičkih i farmakodinamičkih interakcija između lijeka Repatha i lijekova za snižavanje lipida.
English: Clinical efficacy in primary hypercholesterolaemia and mixed dyslipidaemia
Croatian: Klinička djelotvornost u liječenju primarne hiperkolesterolemije i miješane dislipidemije
English: To remove:
Croatian: NAPOMENA:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 420 mg injection evolocumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Repatha 420 mg injekcija evolokumab s.c.
English: Needle cover
Croatian: Pokrov igle
English: You should stay on your cholesterol lowering diet while taking this medicine.
Croatian: Trebate se pridržavati dijete za snižavanje razine kolesterola tijekom primjene ovog lijeka.
English: It is okay to hear a pumping sound start and stop during injection.
Croatian: Tijekom injekcije normalno je čuti početak i kraj zvuka pumpanja.
English: Repatha significantly reduced LDL-C from baseline at week 12 and week 48 compared with control (nominal p < 0.001).
Croatian: Repatha je značajno smanjila LDL-C u odnosu na početne vrijednosti u 12. tjednu i 48. tjednu u usporedbi s kontrolom (nominalna p vrijednost < 0,001).
English: • The Repatha pre-filled syringe is to be stored in the refrigerator (2ºC to 8ºC).
Croatian: • Repatha napunjena štrcaljka treba biti čuvana u hladnjaku (2°C to 8°C).
English: • Keep the Repatha pre-filled syringe out of the sight and reach of children.
Croatian: • Čuvajte Repatha napunjenu brizgalicu izvan pogleda i dohvata djece.
English: Storing your automated mini-doser and cartridge
Croatian: Čuvanje Vašeg automatiziranog mini-dozatora i uloška
English: Step 2: Get ready A Pull the orange cap straight off, only when you are ready to inject.
Croatian: Korak 2: Pripremite se A Kada ste spremni za injiciranje, povucite ravno narančasti zatvarač.
English: Changes in other lipid parameters (TC, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a treatment effect of Repatha administration in patients with homozygous familial hypercholesterolaemia.
Croatian: Promjene u drugim lipidnim parametrima (TC, non-HDL-C, TC/HDL-C i ApoB/ApoA1) također su pokazale učinak primjene lijeka Repatha u bolesnika s homozigotnom obiteljskom hiperkolesterolemijom.
English: • Do not use the pre-filled pen if any part appears cracked or broken.
Croatian: • Nemojte koristiti napunjenu brizgalicu ako bilo koji dio izgleda napuknuto ili oštećeno.
English: The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex, see section 4.4).
Croatian: Pokrov igle napunjene brizgalice napravljen je od suhe prirodne gume (derivat lateksa, vidjeti dio 4.4).
English: DO NOT recycle the syringe or the sharps disposal container or throw it into household rubbish.
Croatian: NEMOJTE reciklirati štrcaljke niti spremnik za odlaganje oštrog otpada ili ih bacati u kućni otpad
English: MARKETING AUTHORISATION NUMBER(S) Repatha 140 mg solution for injection in pre-filled syringe EU/1/15/1016/001 - 1 pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen EU/1/15/1016/002 - 1 pre-filled pen EU/1/15/1016/003 - 2 pre-filled pens EU/1/15/1016/004 - 3 pre-filled pens EU/1/15/1016/005 - 6 (3x2) pre-filled pens (multipack)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki EU/1/15/1016/001 - 1 napunjena štrcaljka
English: How to use Repatha
Croatian: Kako primjenjivati lijek Repatha
English: Skin adhesive
Croatian: Metoda s rastegnutom kožom
English: Repatha 140 mg solution for injection in pre-filled syringe The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki Pokrov igle staklene napunjene štrcaljke je napravljen od suhe prirodne gume (derivat lateksa) koja može uzrokovati alergijske reakcije.
English: Do not recycle the pre-filled pen or sharps disposal container or throw them into household rubbish.
Croatian: Nemojte reciklirati napunjenu brizgalicu niti spremnik za odlaganje oštrog otpada ili ih bacati u kućni otpad.
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group (p < 0.001).
Croatian: Repatha je značajno smanjila početne vrijednosti LDL-C-a do srednje vrijednosti u 10. i 12. tjednu, u usporedbi s placebom za skupine koje su primale rosuvastatin i simvastatin, te u usporedbi s placebom i ezetimibom za skupinu koja je primala atorvastatin (p < 0,001).
English: P Discard the used automated mini-doser in a sharps container.
Croatian: P Bacite iskorišteni automatizirani mini-dozator u spremnik za odlaganje oštrog otpada.
English: OLE Week 48 (n = 187)
Croatian: OLE 48. tjedan (n = 187)
English: OLE Week 36 (n = 187)
Croatian: OLE 36. tjedan (n = 187)
English: • Cotton ball or gauze pad
Croatian: • Pamučnu vatu ili komad gaze
English: Influenza-like illness
Croatian: • Simptomi nalik gripi
English: • Do not remove the used cartridge from the automated mini-doser.
Croatian: • Nemojte uklanjati iskorišteni uložak iz automatiziranog mini-dozatora.
English: Flashing Light beep-beep-beep
Croatian: Trepereća svjetlost bip-bip-bip
English: Make sure the medicine in the cartridge is clear and colourless to slightly yellow.
Croatian: Provjerite da je lijek u ulošku bistar i bezbojan do blago žućkaste boje.
English: OLE Week 96 (n = 180)
Croatian: OLE 96. tjedan (n = 180)
English: Immediately place the cap in the sharps disposal container.
Croatian: Odmah bacite zatvarač u spremnik za odlaganje oštrog otpada.
English: Upper arm Belly
Croatian: Nadlaktica Trbuh
English: Repatha was effective in all subgroups relative to placebo and ezetimibe, with no notable differences observed between subgroups, such as age, race, gender, region, body-mass index, National Cholesterol Education Program risk, current smoking status, baseline coronary heart disease (CHD) risk factors, family history of premature CHD, glucose tolerance status, (i.e. diabetes mellitus type 2, metabolic syndrome, or neither), hypertension, statin dose and intensity, unbound baseline PCSK9, baseline LDL-C and baseline TG.
Croatian: National Cholesterol Education Program, NCEP), trenutni pušački status, čimbenike rizika za razvoj koronarne bolesti srca (KBS) na početku ispitivanja, obiteljsku anamnezu preuranjene KBS, toleranciju glukoze, (tj. šećernu bolest tipa 2, metabolički sindrom, ili ništa od navedenog), hipertenziju, dozu i intenzitet statina, te također u odnosu na vrijednosti nevezanog PCSK9, LDL-C-a i TG-a na početku ispitivanja.
English: D Clean your injection site.
Croatian: D Očistite područje injiciranja.
English: Beep-beep-beep
Croatian: bip-bip-bip
English: beep-beep-beep
Croatian: Bip-bip-bip
English: Effect on atherosclerotic disease burden
Croatian: Učinci na aterosklerotsku bolest
English: • Do not freeze the automated mini-doser and cartridge.
Croatian: • Nemojte zamrzavati automatizirani mini-dozator i uložak.
English: Instructions for use: Repatha single use pre-filled syringe
Croatian: Upute za primjenu: Repatha napunjena štrcaljka za jednokratnu primjenu
English: Proline
Croatian: Prolin
English: Repatha was compared to placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group.
Croatian: Repatha je bila učinkovita u svim podskupinama u odnosu na placebo i ezetimib.
English: Changes in other lipid parameters (TC, ApoB, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a sustained effect of long-term Repatha administration in patients with homozygous familial hypercholesterolaemia.
Croatian: Promjene ostalih lipidnih parametara (TC, ApoB, non-HDL-C, TC/HDL-C i ApoB/ApoA1) su također pokazale održani učinak dugotrajne primjene lijeka Repatha u bolesnika s homozigotnom obiteljskom hiperkolesterolemijom.
English: Repatha 420 mg once monthly significantly reduced LDL-C from baseline at week 12 and week 52 compared with control (nominal p < 0.001).
Croatian: Repatha primijenjena u dozi od 420 mg jedanput mjesečno, značajno je smanjila LDL-C u odnosu na početnu vrijednost u 12. tjednu i 52. tjednu u usporedbi s kontrolom (nominalna p vrijednost < 0,001).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Oštećenje funkcije bubrega
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a) and increased HDL-C from baseline to mean of weeks 10 and 12 as compared to placebo for the rosuvastatin and simvastatin groups (p < 0.05) and significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), compared with placebo and ezetimibe for the atorvastatin group (p < 0.001) (see tables 2 and 3).
Croatian: Repatha je značajno smanjila početne vrijednosti TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a, VLDL-C-a, TG-a i Lp(a)-a i povećala početnu vrijednost HDL-C-a do srednje vrijednosti u 10. i 12. tjednu u usporedbi s placebom za skupine koje su primale rosuvastatin i simvastatin (p < 0,05), te značajno smanjila vrijednosti TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a i Lp (a)-a u usporedbi s placebom i ezetimibom za skupinu koja je primala atorvastatin (p < 0,001) (vidjeti Tablice 2 i 3).
English: • Do not use if the expiration date on the cartridge has passed.
Croatian: • Nemojte koristiti ako je rok valjanosti na ulošku istekao.
English: Discard the used pre-filled pen and the orange cap in a sharps disposal container.
Croatian: Bacite iskorištenu brizgalicu i narančasti zatvarač u spremnik za odlaganje oštrog otpada.
English: • Moderate physical activities can be performed during the injection process, such as walking, reaching and bending.
Croatian: • Tijekom injiciranja može se provoditi umjerena fizička aktivnost,
English: Single use
Croatian: Za jednokratnu primjenu
English: • The medicine in the pre-filled syringe is clear and colourless to slightly yellow.
Croatian: • da je lijek u napunjenoj štrcaljki bistar i bezbojan do blago žućkaste boje.
English: DO NOT: twist or bend the grey needle cap.
Croatian: NEMOJTE: okretati ili savijati sivi zatvarač igle.
English: Repatha 140 mg solution for injection in pre-filled pen The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj brizgalici Pokrov igle napunjene brizgalice je napravljen od suhe prirodne gume (derivat lateksa) koja može uzrokovati alergijske reakcije.
English: Turn tray over
Croatian: Okrenite podložak
English: Hypercholesterolaemia and mixed dyslipidaemia
Croatian: Hiperkolesterolemija i miješana dislipidemija
English: F Inspect the cartridge.
Croatian: F Pregledajte uložak.
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 from baseline to week 52 in OSLER and to week 48 in OSLER-2 compared with control (nominal p < 0.001).
Croatian: Repatha je značajno smanjila TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG i Lp(a) te povećala HDL-C i ApoA1 u odnosu na početne vrijednosti do 52. tjedna u OSLER i 48. tjedna u OSLER-2 ispitivanju, u usporedbi s kontrolom (nominalna p vrijednost < 0,001).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 140 mg injection evolocumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Repatha 140 mg injekcija evolokumab s.c.
English: Changes in other lipid parameters (TC, ApoB, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a sustained effect of long-term Repatha administration in patients with severe familial hypercholesterolaemia (non-HoFH).
Croatian: Promjene u ostalim lipidnim parametrima (TC, ApoB, non-HDL-C, TC/HDL-C i ApoB/ApoA1) su također pokazale održani učinak dugoročne primjene lijeka Repatha u bolesnika s teškom obiteljskom hiperkolesterolemijom (bez homozigotne obiteljske hiperkolesterolemije).
English: Repatha 140 mg solution for injection in pre-filled syringe 3 years.
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki 3 godine
English: Do not shake the pre-filled pen.
Croatian: Nemojte tresti napunjenu brizgalicu.
English: • Do not use the pre-filled pen if the orange cap is missing or not securely attached.
Croatian: • Nemojte koristiti napunjenu brizgalicu ako nedostaje narančasti zatvarač ili ako nije dobro pričvršćen.
English: Do not remove the orange cap from the pre-filled pen yet.
Croatian: Nemojte uklanjati narančasti zatvarač s napunjene brizgalice.
English: The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Croatian: Pokrov igle staklene napunjene štrcaljke je napravljen od suhe prirodne gume (derivat lateksa) koja može uzrokovati alergijske reakcije.
English: Keep the used syringe and sharps container out of the sight and reach of children.
Croatian: Čuvajte iskorištenu štrcaljku i spremnik za odlaganje oštrog otpada daleko od pogleda i dohvata djece.
English: • Do not inject into areas where the skin is tender, bruised, red or hard.
Croatian: • Nemojte injicirati u područje gdje je koža osjetljiva, s modricama, crvena ili tvrda.
English: Battery strip
Croatian: Trakica baterije
English: Repatha 420 mg solution for injection in cartridge
Croatian: Repatha 420 mg otopina za injekciju u ulošku
English: Grey start button
Croatian: Sivo dugme za injiciranje
English: Following repeat subcutaneous administration of 140 mg every 2 weeks, the 12-week trough concentrations were 147% higher and 70% lower in patients of 69 kg and 93 kg respectively, than that of the typical 81 kg subject.
Croatian: više odnosno 70% niže u bolesnika od 69 kg odnosno 93 kg, u odnosu na one u ispitanika uobičajene težine od 81 kg.
English: Effect of Repatha on LDL-C in patients with homozygous familial hypercholesterolaemia - mean percent change from baseline to OLE week 216 (and associated 95% CI)
Croatian: Učinak lijeka Repatha na vrijednosti LDL-C-a u bolesnika s homozigotnom obiteljskom hiperkolesterolemijom - srednja vrijednost postotka promjene od početne vrijednosti do 216. tjedna OLE-a (i povezani 95% CI)
English: Repatha 140 mg solution for injection in pre-filled syringe The 140 mg dose should be delivered using a single pre-filled syringe.
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj brizgalici Dozu od 140 mg treba primijeniti pomoću jedne napunjene brizgalice.
English: Do not inject the solution if it contains particles, or is cloudy or discoloured.
Croatian: Nemojte primjenjivati otopinu ako sadrži čestice, ako je mutna ili promijenjene boje.
English: The needle cover of the glass pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Croatian: Pokrov igle staklene napunjene brizgalice je napravljen od suhe prirodne gume (derivat lateksa) koja može uzrokovati alergijske reakcije.
English: Repatha 140 mg solution for injection in pre-filled pen Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 140 mg evolokumaba u 1 ml otopine.
English: Keep the pre-filled pen and the sharps disposal container out of the sight and reach of children.
Croatian: Čuvajte napunjenu brizgalicu i spremnik za odlaganje oštrog otpada izvan pogleda i dohvata djece.
English: E Remove the pre-filled syringe from the tray.
Croatian: Izvadite napunjenu štrcaljku iz podloška.
English: Part of the Repatha pre-filled pen may be broken even if you cannot see the break.
Croatian: Dio brizgalice može biti oštećen iako možda ne vidite oštećenje.
English: Squeeze tight snap
Croatian: Narančasti zatvarač pričvršćen
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON AUTOMATED MINI-DOSER (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA VIŠESTRUKOG PAKIRANJA AUTOMATIZIRANOG MINI-DOZATORA (uključujući plavi okvir)
English: Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Croatian: Jedna SureClick napunjena brizgalica sadrži 140 mg evolokumaba u 1 ml otopine.
English: Before administration, the solution should be inspected.
Croatian: Otopinu treba provjeriti prije primjene.
English: Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25ºC) before injection.
Croatian: Napunjena štrcaljka se može držati izvan hladnjaka prije injiciranja kako bi dosegnula sobnu temperaturu (do 25°C).
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: Nemojte primjenjivati injekciju na područjima gdje je koža osjetljiva, s modricama, crvena ili tvrda.
English: DO NOT: Try to warm the Repatha pre-filled syringe by using a heat source such as hot water or microwave.
Croatian: NEMOJTE: pokušavati ugrijati Repatha napunjenu štrcaljku korištenjem izvora topline kao što su vruća voda ili mikrovalna pećnica. izlagati Repatha napunjenu štrcaljku izravnoj sunčevoj svjetlosti. tresti Repatha napunjenu štrcaljku.
English: Maximal response was generally achieved within 1 to 2 weeks after dosing with 140 mg every 2 weeks and 420 mg once monthly.
Croatian: 2 tjedna nakon primjene doze od 140 mg svaka 2 tjedna, te doze od 420 mg jedanput mjesečno.
English: • Do not use the pre-filled pen if the expiration date has passed.
Croatian: • Nemojte koristiti napunjenu brizgalicu ako je istekao rok valjanosti.
English: After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved.
Croatian: Ako klinički značajan odgovor nije postignut nakon 12 tjedana liječenja, učestalost primjene doze se može povećati na 420 mg jedanput svaka 2 tjedna.
English: Your pre-filled pen may be left outside the refrigerator to reach room temperature (up to 25ºC) before injection.
Croatian: Napunjena brizgalica se može držati izvan hladnjaka prije injiciranja kako bi dosegnula sobnu temperaturu (do 25°C).
English: • Do not touch the skin adhesive.
Croatian: • Nemojte dodirivati prianjajuću površinu.