FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 July 2015
Croatian: Datum prvog odobrenja: 17. srpnja 2015.
English: If you use more Repatha than you should
Croatian: Ako primijenite više lijeka Repatha nego što ste trebali
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
English: Name and address of the manufacturer of the biological active substance Immunex Rhode Island Corporation 40 Technology Way
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Immunex Rhode Island Corporation 40 Technology Way
English: “Click”
Croatian: „Klik“
English: You will hear a click.
Croatian: Čut ćete „klik“.
English: • It is normal to see a few drops of fluid on your skin after you remove the used automated mini doser.
Croatian: • Normalno je vidjeti nekoliko kapi tekućine na koži nakon što uklonite automatizirani mini-dozator.
English: Important: After you load the automated mini-doser, proceed to the next step without delay.
Croatian: Važno: Nakon što napunite automatizirani mini-dozator, nastavite sa sljedećim korakom bez odgode.
English: Hazard ratioa (95% CI)
Croatian: Omjer hazardaa (95% CI)
English: • Do not place the loaded automated mini-doser on your body if the red status light flashes for more than 5 seconds.
Croatian: • Nemojte postavljati napunjeni automatizirani mini-dozator na tijelo ako crvena svjetlost treperi dulje od 5 sekundi.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Insert the needle into the skin using a 45 to 90 degree angle.
Croatian: Uvedite iglu u kožu pod kutom od 45 do 90 stupnjeva.
English: Coronary revascularisation
Croatian: Koronarna revaskularizacija
English: • You can only press the start button once.
Croatian: • Dugme za injiciranje možete pritisnuti samo jedanput.
English: Take Repatha as soon as you can after the missed dose.
Croatian: Primijenite lijek Repatha čim prije nakon propuštene doze.
English: Rare: may affect up to 1 in 1,000 people • Swelling of the face, mouth, tongue, or throat (angioedema)
Croatian: Rijetke nuspojave: mogu se javiti u do 1 na 1000 osoba • Oticanje lica, usta, jezika ili grla (angioedem)
English: For instructions on administration, see section 6.6 and the ‘Instructions for Use' provided in the carton.
Croatian: Za upute o primjeni vidjeti dio 6.6 i "Upute za primjenu" dostupne u kutiji.
English: B Remove the air bubble / gap.
Croatian: B Uklonite mjehurić zraka/prazninu.
English: F Inspect medicine and syringe.
Croatian: F Provjerite lijek i štrcaljku.
English: Elderly patients (age ≥ 65 years) No dose adjustment is necessary in elderly patients.
Croatian: Stariji bolesnici (u dobi ≥ 65 godina) Nije potrebna prilagodba doze u starijih bolesnika.
English: In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Croatian: U slučaju predoziranja, bolesnika treba liječiti simptomatski i po potrebi primijeniti odgovarajuće potporne mjere.
English: Patients at Risk
Croatian: Bolesnici izloženi riziku
English: Type BF Applied Part
Croatian: Primijenjeni dio tipa BF
English: For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Croatian: Za rezultate ispitivanja s obzirom na učinke na LDL-C, kardiovaskularne događaje i ispitivane populacije vidjeti dio 5.1.
English: Inform your doctor if you are trying to get pregnant, think you may be pregnant or become pregnant taking Repatha.
Croatian: Obavijestite svog liječnika ako pokušavate zatrudnjeti, mislite da biste mogli biti trudni ili zatrudnjeti tijekom primjene lijeka Repatha.
English: Do not put fingers into the yellow safety guard.
Croatian: Nemojte stavljati prste u žuti sigurnosni štitnik.
English: If you notice an air bubble/gap:
Croatian: Ako primijetite mjehurić zraka/prazninu:
English: • The automated mini-doser contains batteries, electronics, and a needle.
Croatian: • Automatizirani mini-dozator sadrži baterije, elektroničke dijelove i iglu.
English: If the automated mini-doser is attached to your body, carefully remove it.
Croatian: Ako je automatizirani mini-dozator pričvršećn na Vaše tijelo, oprezno ga uklonite.
English: Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab.
Croatian: Repatha se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje evolokumabom.
English: During injection, keep the automated mini-doser a minimum of 10 cm (4 inches) away from other electronics such as mobile phones.
Croatian: Tijekom injiciranja, držite automatizirani mini-dozator udaljen najmanje 10 cm od ostalih elektroničkih uređaja, poput mobitela.
English: At the end of the first year (week 52 in OSLER and week 48 in OSLER-2), patients entered the all Repatha period in which all patients received open-label Repatha for either another 4 years (OSLER) or 2 years (OSLER-2).
Croatian: Na kraju prve godine (52. tjedan u OSLER i 48. tjedan u OSLER-2), bolesnici su ušli u Repatha razdoblje u kojem su svi bolesnici otvoreno (open-label) uzimali lijek Repatha ili još 4 godine (OSLER) ili 2 godine (OSLER-2).
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Croatian: Očekuje se da će njegov metabolizam i eliminacija slijediti puteve klirensa imunoglobulina, što rezultira degradacijom do malih peptida i pojedinačnih aminokiselina.
English: Check that:
Croatian: Provjerite:
English: L When the blue light flashes, the automated mini-doser is ready.
Croatian: L Kada treperi plava svjetlost, automatizirani mini-dozator je spreman.
English: Needle inside (under cover)
Croatian: Igla je unutra (ispod pokrova)
English: B Open the carton and peel away the white paper cover.
Croatian: B Otvorite kutiju i uklonite bijeli papirnati pokrov.
English: Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Check to see that the used plunger completely fills the medicine window, and the green solid light turns off, letting you know all medicine has been injected.
Croatian: Provjerite da li iskorišteni klip u potpunosti ispunjava prozorčić lijeka, te je li zelena stalna svjetlost ugašena, što Vam pokazuje da je sav lijek injiciran.
English: The mutagenic potential of evolocumab has not been evaluated.
Croatian: Mutageni potencijal evolokumaba nije ispitan.
English: GRH0465 v1
Croatian: GRH0621HR v1
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Croatian: Ako ima krvi, pritisnite pamučnu vatu ili komad gaze na mjesto injiciranja.
English: What Repatha contains - The active substance is evolocumab.
Croatian: Što Repatha sadrži - Djelatna tvar je evolokumab.
English: 4.5 Interaction with other medicinal products and other forms of interaction No formal drug-drug interaction studies have been conducted for Repatha.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcija lijekova za lijek Repatha.
English: Talk to your doctor, pharmacist or nurse before using Repatha if you have: - liver disease, - severe kidney problems.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek Repatha ako imate: - bolest jetre, - teških problema s bubrezima.
English: There is no specific treatment for Repatha overdose.
Croatian: Ne postoji specifično liječenje predoziranja lijekom Repatha.
English: Repatha is a medicine that lowers levels of 'bad' cholesterol, a type of fat, in the blood.
Croatian: Repatha je lijek koji snižava razine „lošeg“ kolesterola, oblika masti, u krvi.
English: No overall differences in safety or efficacy were observed between these patients and younger patients.
Croatian: Sveukupno, nisu uočene razlike u sigurnosti ili djelotvornosti između tih i mlađih bolesnika.
English: This can dry out the medicine.
Croatian: Tako se lijek može isušiti.
English: A flashing green light and a click signals the injection has started.
Croatian: Trepereća zelena svjetlost i „klik“ označavaju da je započelo injiciranje.
English: Evolocumab was estimated to have an effective half-life of 11 to 17 days.
Croatian: Efektivni poluvijek evolokumaba je procijenjen na 11 do 17 dana.
English: Window turns yellow when the injection is done
Croatian: Prozorčić postaje žut kada je injiciranje završeno.
English: This resulted in similar time course and extent of absolute LDL-C lowering.
Croatian: To je rezultiralo sličnim vremenskim tijekom i opsegom apsolutnog snižavanja LDL-C-a.
English: Let your skin dry before injecting.
Croatian: Pustite da se koža osuši prije injiciranja.
English: d The treatment effect on stroke was driven by a reduction in risk of ischaemic stroke; there was no effect on haemorrhagic or undetermined stroke.
Croatian: d Učinak liječenja na moždani udar bio je posljedica smanjenja rizika od ishemijskog moždanog udara; nije bilo učinka na hemoragijski ili nespecificirani moždani udar.
English: Important: To attach the automated mini-doser securely, it is important to use a firm and flat skin surface.
Croatian: Važno: Kako biste sigurno pričvrstili automatizirani mini-dozator, važno je koristiti čvrstu i ravnu površinu na koži.
English: DO NOT use any medicine that is left in the used syringe.
Croatian: NEMOJTE koristiti lijek koji je zaostao u iskorištenoj štrcaljki.
English: Important: If medication leaks from the loaded automated mini-doser contact your doctor or pharmacist.
Croatian: Važno: Ako lijek curi iz napunjenog automatiziranog mini-dozatora obratite se svom liječniku ili ljekarniku.
English: Other medicines and Repatha
Croatian: Drugi lijekovi i Repatha
English: Do not stretch for thigh Important: Adjust your body posture to avoid skin folds and bulges.
Croatian: Nemojte rastezati kožu na bedru Važno: Prilagodite držanje tijela kako biste izbjegli nabore ili izbočine na koži.
English: After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks.
Croatian: Nakon 12 tjedana, Vaš liječnik može odlučiti povećati dozu na 420 mg svaka dva tjedna.
English: B Firmly PUSH down the pre-filled pen onto the skin until it stops moving.
Croatian: B Čvrsto POTISNITE napunjenu brizgalicu prema dolje na kožu, dok se ne prestane micati.
English: Freeze the Repatha pre-filled syringe or use one that has been frozen.
Croatian: zamrzavati Repatha napunjenu štrcaljku ili koristiti neku koja je bila zamrznuta.
English: D Keep PUSHING down on the skin.
Croatian: D Nastavite POTISKIVATI brizgalicu na kožu.
English: Cardiovascular risk reduction in adults with established atherosclerotic cardiovascular disease
Croatian: Smanjenje kardiovaskularnog rizika u odraslih s ustanovljenom aterosklerotskom kardiovaskularnom bolesti
English: of solution (120 mg/mL).
Croatian: (120 mg/ml).
English: If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Croatian: Ako želite koristiti isto područje injiciranja, pobrinite se da ne injicirate u isto mjesto koje ste koristili za prethodnu injekciju.
English: The study did not investigate the correlation between atherosclerotic disease regression and cardiovascular events.
Croatian: Ispitivanjem nije istražena korelacija između regresije aterosklerotske bolesti i kardiovaskularnih događaja.
English: For single use only.
Croatian: Isključivo za jednokratnu primjenu.
English: Effect of Repatha on major cardiovascular events
Croatian: Učinak lijeka Repatha na velike kardiovaskularne događaje
English: Common: may affect up to 1 in 10 people
Croatian: Česte nuspojave: mogu se javiti u do 1 na 10 osoba
English: A total of 1,324 patients enrolled in OSLER.
Croatian: Ukupno je 1 324 bolesnika uključeno u OSLER ispitivanje.
English: The review of all reported hypersensitivity reactions revealed a clear evidence of different clinical presentations of hypersensitivity associated with evolocumab.
Croatian: Ocjena svih prijavljenih reakcija preosjetljivosti otkrila je jasne dokaze različitih kliničkih prikaza preosjetljivosti povezane s evolokumabom.
English: • Gently tap the syringe barrel with your fingers until the air bubble/gap rises to the top of the syringe.
Croatian: • lagano lupkajte po tijelu štrcaljke s prstima sve dok se mjehurić zraka/praznina ne podignu do vrha štrcaljke.
English: By attaching to, and mopping up PCSK9, the medicine increases the amount of cholesterol entering the liver and so lowers the level of cholesterol in the blood.
Croatian: Vezanjem i uklanjanjem PCSK9, ovaj lijek povećava količinu kolesterola koja ulazi u jetru i time smanjuje razinu kolesterola u krvi.
English: (treatment in the absence of a statin)
Croatian: (liječenje u odsutnosti statina)
English: Therefore, close monitoring may be warranted in these patients.
Croatian: Stoga je potrebno pozorno praćenje takvih bolesnika.
English: Solution for injection (injection) (automated mini-doser).
Croatian: Otopina za injekciju (injekcija) (automatizirani mini-dozator).
English: Step 1: Prepare A Remove the Repatha pre-filled syringe carton from the refrigerator and wait 30 minutes.
Croatian: Korak 1: Priprema A Izvadite kutiju Repatha napunjene štrcaljke iz hladnjaka i pričekajte 30 minuta.
English: LDL-C reduction of approximately 55% to 75% was achieved with Repatha as early as week 1 and maintained during long-term therapy.
Croatian: Smanjenje LDL-C-a od oko 55% do 75% ostvareno je primjenom lijeka Repatha već u prvom tjednu, te se održalo tijekom dugotrajne terapije.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for evolocumab, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za evolokumab, znanstveni zaključci CHMP-a su sljedeći:
English: In clinical studies, 0.3% of patients (48 out of 17,992 patients) treated with at least one dose of Repatha tested positive for binding antibody development.
Croatian: U kliničkim ispitivanjima, 0,3% bolesnika (48 od 17 992 bolesnika) liječenih najmanje jednom dozom lijeka Repatha bilo je pozitivno na razvoj veznih protutijela.
English: Hazard Ratio, 0.80 (95% CI, 0.73, 0.88) P<0.0001
Croatian: Omjer hazarda, 0,80 (95% CI, 0,73; 0,88) P<0,0001
English: What Repatha looks like and contents of the pack
Croatian: Kako Repatha izgleda i sadržaj pakiranja
English: The long-term safety of sustained very low levels of LDL-C (i.e. < 0.65 mmol/L [< 25 mg/dL]) has not yet been established.
Croatian: Dugoročna sigurnost, koja se tiče održanih vrlo niskih vrijednosti LDL-C-a (tj. < 0,65 mmol/l [< 25 mg/dl]) još nije ustanovljena.
English: Do not leave the grey needle cap off for more than 5 minutes.
Croatian: Ne ostavljajte sivi zatvarač igle skinut duže od 5 minuta.
English: b 2-sided log-rank test stratified by randomisation stratification factors collected via IVRS.
Croatian: b Dvostrani log-rang test stratificiran faktorima stratificiranja randomizacije prikupljenima pomoću IVRS-a.
English: Treatment in the absence of a statin
Croatian: Liječenje u odsutnosti statina
English: If your doctor has prescribed Repatha along with another cholesterol lowering medicine, follow your doctor's instructions on how to take these medicines together.
Croatian: Ako Vam je liječnik propisao lijek Repatha zajedno s drugim lijekom za snižavanje razine kolesterola, slijedite liječničke upute o tome kako se ti lijekovi primjenjuju zajedno.
English: Automated mini-doser Plastic cover
Croatian: Automatizirani mini-dozator Plastični pokrov
English: Additional environmental conditions
Croatian: Dodatni okolišni uvjeti
English: Make sure clothing does not get in the way of the loaded automated mini-doser, and you can see the blue light at all times.
Croatian: Pazite da odjeća ne smeta napunjenom automatiziranom mini-dozatoru, i da u svakom trenutku možete vidjeti plavu svjetlost.
English: Increasing liver LDLR levels results in associated reductions in serum LDL-cholesterol (LDL-C).
Croatian: Povećanje jetrenih LDLR vrijednosti posljedično dovodi do povezanih smanjenja serumskog LDL-kolesterola (LDL-C).
English: Put the original package with any unused pre-filled pens back in the refrigerator.
Croatian: 2. Vratite originalno pakiranje s neiskorištenim napunjenim brizgalicama natrag u hladnjak.
English: Solution for injection (injection) (SureClick).
Croatian: Otopina za injekciju (injekcija) (SureClick).
English: C When done, RELEASE your thumb, and gently lift the syringe off skin.
Croatian: C Kada ste gotovi, OTPUSTITE palac i lagano odvojite štrcaljku od kože.
English: The relative risk of the MACE composite (CV death, MI, or stroke) was significantly reduced by 20%.
Croatian: Relativni rizik od MACE kompozitnog ishoda (KV smrt, infarkt miokarda ili moždani udar) bio je značajno smanjen za 20%.
English: • Do not insert the cartridge more than 5 minutes before injection.
Croatian: • Nemojte umetati uložak više od 5 minuta prije injiciranja.
English: The loaded automated mini-doser will lay flat on your body.
Croatian: Napunjeni automatizirani mini-dozator će prilijegati na Vaše tijelo.
English: • Do not touch or contaminate the needle cover area.
Croatian: • Nemojte dodirivati ili onečistiti područje pokrova igle.
English: K To securely attach the automated mini-doser, prepare and clean an injection site that is less likely to have body hair, or you can trim the area.
Croatian: Kako biste sigurno pričvrstili automatizirani mini-dozator, pripremite i očistite mjesto za injiciranje koje je najmanje prekriveno dlakama, ili možete ukloniti dlake s tog područja.
English: You may notice an air bubble/gap in the Repatha pre-filled syringe.
Croatian: Možda ćete primijetiti mjehurić zraka/prazninu u Repatha napunjenoj štrcaljki.
English: In clinical studies with repeated subcutaneous dosing over 12 weeks, dose proportional increases in exposure were observed with dose regimens of 140 mg and greater.
Croatian: U kliničkim ispitivanjima s opetovanom supkutanom primjenom tijekom 12 tjedana, uočeno je povećanje u izloženosti proporcionalno s dozom, uz režime doza od 140 mg i više.
English: Repatha is intended for patient self-administration after proper training.
Croatian: Repatha je namijenjena za samoprimjenu od strane bolesnika nakon odgovarajuće obuke.
English: The presence of anti-evolocumab binding antibodies did not impact the pharmacokinetic profile, clinical response, or safety of Repatha.
Croatian: Prisutnost anti-evolokumab veznih protutijela nije utjecala na farmakokinetički profil, klinički odgovor ili sigurnost lijeka Repatha.
English: Hold the loaded automated mini-doser with the blue light visible, and place it on your skin.
Croatian: Uzmite napunjeni automatizirani mini-dozator s vidljivom plavom svjetlošću i postavite ga na kožu.
English: B Using slow and constant pressure, PUSH the plunger rod all the way down until the syringe is empty.
Croatian: B Koristeći polagani i postojani pritisak, POTISNITE klip sve do kraja, dok štrcaljka ne bude prazna.
English: Use a firm and flat skin surface.
Croatian: Koristite čvrstu i ravnu površinu kože.
English: • Talk with your healthcare provider about proper disposal.
Croatian: • Razgovarajte sa zdravstvenim djelatnikom o pravilnom odlaganju.
English: Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency in table 1 below using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Croatian: Nuspojave zabilježene u ključnim, kontroliranim kliničkim ispitivanjima te spontanim prijavljivanjem prikazane su prema klasifikaciji organskih sustava i učestalosti u Tablici 1 na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1 000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1 000) i vrlo rijetko (< 1/10 000).
English: If you also receive apheresis, a procedure similar to dialysis where cholesterol and other fats are removed from the blood, your doctor may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
Croatian: Ako također primate aferezu, postupak sličan dijalizi kojim se kolesterol i druge masti uklanjaju iz krvi, Vaš liječnik može odlučiti da započnete s dozom od 420 mg svaka dva tjedna kako bi se liječenje podudaralo s aferezom.
English: Repatha must not be administered intravenously or intramuscularly.
Croatian: Repatha se ne smije primjenjivati intravenski ili intramuskularno.
English: The pharmacokinetic interaction between statins and evolocumab was evaluated in the Repatha clinical trials.
Croatian: Farmakokinetička interakcija između statina i evolokumaba je procijenjena u kliničkim ispitivanjima lijeka Repatha.
English: It is recommended that 12 and 13 year olds are supervised by an adult when they are using the automated mini-doser.
Croatian: Preporučuje se da 12- ili 13-godišnjake prilikom korištenja automatiziranog mini-dozatora nadzire odrasla osoba.
English: • You may hear a pumping sound.
Croatian: • Možete čuti zvuk pumpanja.
English: • Place the tray on your hand.
Croatian: • Položite podložak na svoju ruku.
English: No statin dose adjustments are necessary when used in combination with Repatha.
Croatian: Nije potrebna prilagodba doze statina kada se primjenjuju u kombinaciji s lijekom Repatha.
English: NOTE: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Croatian: Kada maknete napunjenu brizgalicu s kože, igla će automatski biti pokrivena.
English: See the detailed “Instructions for Use” at the end of this leaflet for instructions about how to store, prepare, and use your Repatha automated mini-doser at home.
Croatian: Pogledajte detaljne "Upute za primjenu" na kraju ove upute o načinu pohrane, pripreme i korištenja Vašeg Repatha automatiziranog mini-dozatora kod kuće.
English: However, baseline PCSK9 levels and the degree and time course of PCSK9 neutralisation were found to be similar between patients with mild or moderate hepatic impairment and healthy volunteers.
Croatian: Međutim, početne razine PCSK9 te stupanj i vremenski tijek neutralizacije PCSK9 bili su podjednaki između bolesnika s blagim ili umjerenim oštećenjem jetre i zdravim dobrovoljcima.
English: B Gather all materials needed for your injection.
Croatian: B Prikupite svu opremu potrebnu za injiciranje.
English: The exposure to evolocumab was found to be approximately 40-50% lower compared to healthy subjects.
Croatian: Utvrđeno je da je izloženost evolokumabu bila niža u odnosu na zdrave ispitanike za oko 40-50%.
English: Step 2: Get ready A Carefully pull the grey needle cap straight out and away from your body.
Croatian: Korak 2: Pripremite se A Pažljivo povucite sivi zatvarač s igle ravno i dalje od Vašeg tijela.
English: What Repatha is and how it works
Croatian: Što je Repatha i kako djeluje
English: No time dependent changes were observed in serum concentrations over a period of 124 weeks.
Croatian: Tijekom razdoblja od 124 tjedna nisu opažene nikakve promjene serumskih koncentracija ovisne o vremenu.