FrancophonIA/ELRC3.0 huggingface dataset:
English: Three trials of which one trial was a dedicated surgery trial included in total 15 major and 26 minor surgery procedures (patients aged 13 to 56 years).
Croatian: Od ukupno tri ispitivanja, jedno je bilo posvećeno ispitivanju primjene kod kirurških zahvata, u koje je uključeno ukupno 15 većih i 26 manjih kirurških zahvata (bolesnici u dobi od 13 do 56 godina).
English: Novo Nordisk A/S Brennum Park 25K DK-3400 Hillerød Denmark
Croatian: Novo Nordisk A/S Brennum Park 25K DK-3400 Hillerød Danska
English: Keep out of the sight and reach of children
Croatian: DJECE Čuvati izvan pogleda i dohvata djece
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with recombinant factor IX products and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Reakcije preosjetljivosti ili alergijske reakcije (koje mogu uključivati angioedem, pečenje i peckanje na mjestu infuzije, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) primijećene su rijetko kod lijekova koji sadrže rekombinantni faktor IX, a u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: If sudden and severe allergic reactions (e.g. anaphylactic reactions) occur, the injection must be stopped immediately.
Croatian: U slučaju pojave iznenadnih i teških alergijskih reakcija (npr. anafilaktička reakcija) primjena injekcije se mora odmah prekinuti.
English: The long-term safety of Refixia in children below 12 years has not yet been established.
Croatian: Sigurnost dugotrajne primjene lijeka Refixia u djece mlađe od 12 godina nije još ustanovljena.
English: • The active substance is nonacog beta pegol (pegylated human coagulation factor IX (rDNA)).
Croatian: • Djelatna tvar je nonakog beta pegol (pegilirani humani koagulacijski faktor IX (rDNK)).
English: Kidney disorder (nephrotic syndrome)
Croatian: Poremećaj bubrega (nefrotski sindrom)
English: • In case you only need part of the entire vial, use the scale on the syringe to see how much reconstituted solution you withdraw, as instructed by your doctor or nurse.
Croatian: • Ako trebate samo dio sadržaja bočice, pomoću skale na štrcaljki odredite koliko pripremljene otopine ćete uvući, u skladu s uputama koje ste dobili od liječnika ili medicinske sestre.
English: Your doctor will do a blood test to check if you have developed inhibitors (neutralising antibodies) against Refixia.
Croatian: Vaš će liječnik napraviti pretragu krvi kako bi provjerio da li ste razvili inhibitore (neutralizirajuća protutijela) na lijek Refixia.
English: Please record on the carton the date Refixia is removed from the refrigerator and placed at room temperature.
Croatian: Zabilježite na kutiji datum kada je lijek Refixia izvađen iz hladnjaka i stavljen na sobnu temperaturu.
English: Volume of distribution (Vss) (ml/kg)
Croatian: Volumen distribucije (Vss) (ml/kg)
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Croatian: U literaturi su prijavljeni slučajevi koji pokazuju korelaciju između pojave inhibitora faktora IX i alergijskih reakcija.
English: Refixia can be used only in adolescents (12 years and above).
Croatian: Refixia se može primjenjivati samo u adolescenata (12 i više godina starosti).
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Croatian: Budući da se hemofilija B rijetko javlja u žena, iskustva s primjenom faktora IX tijekom trudnoće i dojenja nisu dostupna.
English: • Refixia is provided as a powder and solvent for solution for injection (500 IU, 1000 IU or
Croatian: • Refixia je dostupna kao prašak i otapalo za otopinu za injekciju (500 IU, 1000 IU ili 2000 IU
English: Use of a reference laboratory is recommended when a chromogenic assay or a qualified one-stage clotting assay is not available locally.
Croatian: Preporučuje se upotreba referentnog laboratorija kada kromogeni test ili kvalificirani jednostupanjski test zgrušavanja krvi nije dostupan lokalno.
English: The success rate and dose needed for treatment of the bleeding episodes were independent of the localisation of the bleed.
Croatian: Stopa uspjeha i doza potrebna za liječenje epizoda krvarenja nisu ovisile o mjestu krvarenja.
English: Based on modelled data using observed terminal half-lives (1549 days) in rat tissue distribution studies, the 40 kDa polyethylene-glycol (PEG) moiety will reach steady state levels in all human tissues within 1-2 years of treatment.
Croatian: Na temelju modeliranih podataka, koristeći primijećena terminalna poluvremena (15-49 dana) u ispitivanjima distribucije u tkivima štakora, polietilenglikolni dio (PEG) od 40 kDa dostić će stanje dinamičke ravnoteže u svim ljudskim tkivima tijekom 1-2 godine liječenja.
English: Stop the injection and contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, shortness of breath, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, and/or dizziness.
Croatian: Odmah prekinite primjenu injekcije i obratite se svom liječniku ili hitnoj medicinskoj službi ako imate znakove alergijske reakcije, kao što su osip, koprivnjača, urtike, svrbež na velikim površinama kože, crvenilo i/ili oticanje usana, jezika, lica ili šaka, poteškoće pri gutanju ili disanju, nedostatak zraka, piskanje pri disanju, stezanje u prsnom košu, blijeda i hladna koža, ubrzani otkucaji srca i/ili omaglica.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also section 4.4).
Croatian: U nekim slučajevima te su reakcije napredovale do teške anafilaksije i njihov je nastanak bio vremenski usko povezan s razvojem inhibitora faktora IX (vidjeti i dio 4.4).
English: The mean total consumption of Refixia during and after surgery was 241 IU/kg (range: 81-460 IU/kg).
Croatian: Srednja vrijednost ukupne potrošnje lijeka Refixia tijekom i nakon kirurškog zahvata bila je 241 IU/kg (raspon: 81-460 IU/kg).
English: Non-interventional post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study deriving from a registry of Haemophilia patients according to an agreed protocol.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): kako bi se ispitali mogući učinci nakupljanja PEG-a u koroidnom spletu mozga i drugim tkivima/organima, nositelj odobrenja treba provesti i predati rezultate neintervencijskog ispitivanja sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet koji proizlaze iz registra bolesnika oboljelih od hemofilije u skladu s dogovorenim planom ispitivanja.
English: As expected, body weight adjusted clearance in paediatric and adolescent patients was higher compared to adults.
Croatian: Kako je i očekivano, klirens prilagođen prema tjelesnoj težini veći je u pedijatrijskih i adolescentnih bolesnika u usporedbi s odraslima.
English: Do not use Refixia:
Croatian: Nemojte primjenjivati lijek Refixia:
English: In the post-surgery period Day 1 to 6 and Day 7 to 13, the median number of additional 40 IU/kg doses administered was 2.0 and 1.5, respectively.
Croatian: U razdoblju nakon operacije, od 1. do 6. dana i od 7. do 13. dana, medijan dodatno primijenjenih doza od 40 IU/kg bio je 2,0 odnosno 1,5.
English: The potency (International Units) is determined using the European Pharmacopeia one-stage clotting test.
Croatian: Potentnost (internacionalne jedinice) se određuje jednostupanjskim testom zgrušavanja krvi prema Europskoj farmakopeji.
English: The success rate for treatment of bleeding episodes was also independent of whether the bleed was traumatic or spontaneous of nature.
Croatian: Stopa uspjeha liječenja epizoda krvarenja nije ovisila ni o tome je li bila riječ o traumatskom ili spontanom krvarenju.
English: Due to the interference of polyethylene glycol (PEG) in the one-stage clotting assay with various aPTT reagents, it is recommended to use a chromogenic assay (e.g. Rox Factor IX or Biophen) when monitoring is needed.
Croatian: Zbog interferencije polietilenglikola (PEG) u jednostupanjskom testu zgrušavanja krvi s različitim aPTT reagensima, preporučuje se primijeniti kromogeni test (npr. Rox faktor IX ili Biophen) kada je potrebno praćenje.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Croatian: Stoga u bolesnika koji razviju alergijske reakcije treba provjeriti jesu li prisutni inhibitori.
English: Incorrect technique can introduce germs that can infect the blood.
Croatian: Nepravilnom tehnikom u krvotok se mogu unijeti mikroorganizmi, koji mogu uzrokovati infekciju krvi.
English: The completed clinical trial programme included one phase 1 trial and four phase 3 multicentre, noncontrolled trials.
Croatian: Kompletan program kliničkog ispitivanja uključivao je jedno ispitivanje faze 1 i četiri multicentrična,
English: This new expiry date should never exceed the one initially mentioned on the outer carton.
Croatian: Taj novi rok valjanosti ne smije biti nakon onog prvobitno navedenog na kutiji.
English: The patients received 1 pre-operative injection of 80 IU/kg on the day of surgery, and post-operatively, injections of 40 IU/kg.
Croatian: Bolesnici su primili 1 prijeoperacijsku injekciju od 80 IU/kg na dan operacije i, nakon operacije, injekcije od 40 IU/kg.
English: * Factor IX trough levels = factor IX activity measured prior to next weekly dose (5 to 10 days post dosing) at steady state.
Croatian: * Najniže koncentracije faktora IX = aktivnost faktora IX izmjerena prije sljedeće tjedne doze (5 do 10 dana nakon doziranja) u stanju dinamičke ravnoteže.
English: In a repeat dose toxicity study in monkeys, mild and transient body tremors were seen 3 hours post dosing and abated within 1 hour.
Croatian: U ispitivanju toksičnosti ponovljenih doza na majmunima, blagi i prolazni tremor primijećen je 3 sata nakon doziranja, a smanjenje unutar 1 sata.
English: For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja na sobnoj temperaturi i uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
English: Table 1 Treatment of bleeding episodes with Refixia
Croatian: Tablica 1 Liječenje epizoda krvarenja lijekom Refixia
English: Fifty-four of the patients across all age-groups were treated with a weekly prophylactic dose of 40 IU/kg where 23 (43%) of these patients had no bleeding episodes.
Croatian: Pedeset i četiri bolesnika svih dobnih skupina liječeno je dozom od 40 IU/kg jednom tjedno u svrhu profilakse, a 23 (43%) tih bolesnika nije imalo epizode krvarenja.
English: These body tremors were seen at doses of Refixia (3,750 IU/kg), which were more than 90 times higher than the recommended dose for humans (40 IU/kg).
Croatian: Ti tremori primijećeni su kod doza lijeka Refixia (3750 IU/kg), koje su ˃90 puta više od preporučenih doza (40 IU/kg) u ljudi.
English: Mean steady state factor IX trough levels above 15% were observed for all age groups, see section 5.2 for details.
Croatian: Srednja vrijednost najniže koncentracije faktora IX u stanju dinamičke ravnoteže od preko 15% zabilježena je u svih dobnih skupina, vidjeti dio 5.2 za detalje.
English: The product contains traces of hamster proteins.
Croatian: Ovaj lijek sadrži proteine hrčka u tragovima.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles, or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija B je spolno vezan nasljedni poremećaj koagulacije krvi uslijed smanjenih razina faktora IX, a uzrokuje obilno krvarenje u zglobove, mišiće ili unutarnje organe, koje može nastati spontano ili kao posljedica slučajne ili kirurške traume.
English: If you have such antibodies, you may be at an increased risk of sudden and severe allergic reactions (e.g. anaphylactic reaction) during future treatment with factor IX.
Croatian: Ako imate takva protutijela, možete imati povećani rizik od pojave iznenadnih i teških alergijskih reakcija (npr. anafilaktičke reakcije) tijekom budućeg liječenja faktorom IX.
English: Do not use the equipment if you suspect it is contaminated.
Croatian: Nemojte koristiti pribor ako sumnjate da je onečišćen.
English: The overall success rate (defined as excellent or good) for treatment of bleeds was 93% (551 out of 591).
Croatian: Ukupna stopa uspjeha (koja se definira kao izvrsna ili dobra) u liječenju krvarenja bila je 93% (551 od 591).
English: If you have a central venous access device (CVAD), you may develop infections or blood clots at the site of the catheter.
Croatian: Ako imate centralni venski kateter (engl. central venous access device, CVAD), na mjestu postavljenog katetera mogu se razviti infekcije ili krvni ugrušci.
English: Haemostatic effect of Refixia during surgery was confirmed with a success rate of 100% in the 15 major surgeries in the trials.
Croatian: Hemostatski učinak lijeka Refixia potvrđen je tijekom kirurških zahvata sa stopom uspjeha od 100% u
English: The use of high purity factor IX products like Refixia is rarely associated with such adverse reactions.
Croatian: Primjena lijekova koji sadrže faktor IX visoke čistoće kao što je Refixia rijetko je povezana s takvim nuspojavama.
English: Keep reconstituted Refixia solution out of direct light.
Croatian: Pripremljenu otopinu lijeka Refixia držite podalje od izravne svjetlosti.
English: The use of Refixia in children below 12 years is not indicated (see section 4.2 for information on paediatric use).
Croatian: Refixia nije indicirana za primjenu u djece mlađe od 12 godina (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Pharmacokinetics were investigated in 16 adult and adolescent patients of which 6 were normal weight (BMI 18.5-24.9 kg/m2) and 10 were overweight (BMI 25-29.9 kg/m2).
Croatian: Farmakokinetika je ispitivana u 16 odraslih i adolescentnih bolesnika, od kojih je 6 bilo normalne tjelesne težine (ITM 18,5-24,9 kg/m2), a 10 ih je imalo prekomjernu tjelesnu težinu (ITM 25
English: • Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Croatian: • Obrišite gumeni čep sterilnim alkoholnim tupferom i pričekajte nekoliko sekundi da se osuši na zraku prije uporabe kako biste bili sigurni da je broj mikroorganizama sveden na najmanju moguću mjeru.
English: In case of residual FIX activity levels, there is a risk of interference when performing the Nijmegen modified Bethesda assay for inhibitor testing.
Croatian: U slučaju rezidualne aktivnosti faktora IX, postoji rizik od interferencije prilikom provođenja Nijmegen modificiranog Bethesda testa za otkrivanje inhibitora.
English: After repeated treatment with human coagulation factor IX (rDNA) products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Croatian: Inhibitori Nakon ponovljenog liječenja lijekovima koji sadrže humani koagulacijski faktor IX (rDNK), bolesnike je potrebno nadzirati zbog mogućeg razvoja neutralizirajućih protutijela (inhibitora), a čija se količina određuje u Bethesda jedinicama (BU) korištenjem odgovarajućeg biološkog testiranja.
English: By replacement therapy the plasma levels of factor IX are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Croatian: Nadomjesnom terapijom povećavaju se razine faktora IX u plazmi, čime se omogućuje privremena korekcija nedostatka faktora te korekcija sklonosti krvarenju.
English: • Remove the plastic cap from the vial.
Croatian: • Uklonite plastični zatvarač s bočice.
English: • The powder is white to off-white and the solvent is clear and colourless.
Croatian: • Prašak je bijel do bjelkast, a otapalo je bistro i bezbojno.
English: A total of 115 previously treated male patients with moderate or severe haemophilia B have been exposed to Refixia for a total of 170 patient years in the completed clinical trials.
Croatian: U završenim kliničkim ispitivanjima ukupno 115 prethodno liječenih muških bolesnika s umjerenom ili teškom hemofilijom B izloženo je lijeku Refixia ukupno 170 bolesnik-godina.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Croatian: Napomena, GSK-ovi za različite koncentrate faktora ili iz različitih kliničkih ispitivanja nisu međusobno usporedivi.
English: When comparing the 10 IU/kg and 40 IU/kg treatments, the annualised bleeding rate for patients in the 40 IU/kg arm was found to be 49% lower than the bleeding rate (95% CI: 5%;73%) for patients in the 10 IU/kg arm (p<0.05).
Croatian: Prilikom usporedbe bolesnika koji su primali 10 IU/kg i 40 IU/kg, stopa krvarenja na godišnjoj razini bolesnika koji su se nalazili u skupini na 40 IU/kg bila je za 49% niža od stope krvarenja (95%CI: 5%;73%) bolesnika u skupini na 10 IU/kg (p<0,05).
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban centralni venski kateter (engl. central venous access device, CVAD), treba uzeti u obzir rizik od mogućih komplikacija povezanih s centralnim venskim kateterom uključujući lokalne infekcije, bakterijemiju te trombozu na mjestu uvođenja katetera.
English: Your doctor may also do a blood test to check if you have developed factor IX inhibitors (neutralising antibodies) against your medicine, as inhibitors may develop together with allergic reactions.
Croatian: Vaš će liječnik možda napraviti i pretragu krvi kako bi provjerio da li ste razvili inhibitore faktora IX (neutralizirajuća protutijela) na lijek jer se inhibitori mogu razviti zajedno s alergijskim reakcijama.
English: Area under the curve (AUC)0-168h (IU*hours/ml)
Croatian: Površina ispod krivulje(AUC)0-168h (IU*sati/ml)
English: Of the 597 treated bleeds observed in 79 (75%) of the 105 patients, 521 (87%) of the bleeds were resolved with 1 injection and 60 (10%) of the bleeds were resolved with 2 injections of Refixia.
Croatian: (75%) od 105 bolesnika, 521 (87%) krvarenje riješeno je 1 injekcijom, a 60 (10%) krvarenja riješeno je s 2 injekcije lijeka Refixia.
English: After storage at room temperature the medicine must not be put back in the refrigerator.
Croatian: Nakon čuvanja na sobnoj temperaturi lijek se ne smije ponovno čuvati u hladnjaku.
English: Area under the curve (AUC)inf (IU*hours/ml)
Croatian: Površina ispod krivulje (AUC)inf (IU*sati/ml)
English: Novo Nordisk A/S Hagedornsvej 1 DK-2820 Gentofte Denmark
Croatian: Novo Nordisk A/S Hagedornsvej 1 DK-2820 Gentofte Danska
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Croatian: Primjena lijekova koji sadrže faktor IX niske čistoće povezana je sa slučajevima infarkta miokarda, diseminirane intravaskularne koagulacije, venske tromboze i plućne embolije.
English: In this pivotal trial in adolescent and adult patients, there were 70 breakthrough bleeding episodes for 16 out of 29 patients in the 40 IU/kg prophylaxis arm.
Croatian: U ovom pivotalnom ispitivanju u adolescenata i odraslih bolesnika bilo je 70 epizoda probojnog krvarenja kod 16 od 29 bolesnika u skupini profilakse s 40 IU/kg.
English: If you use more Refixia than you should If you use more Refixia than you should, contact your doctor.
Croatian: Ako primijenite više lijeka Refixia nego što ste trebali, obratite se svom liječniku.
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Croatian: Zbog mogućeg rizika od trombotskih komplikacija, potrebno je započeti klinički nadzor uz odgovarajuće biološko testiranje kako bi se uočili rani znakovi trombotske i potrošne koagulopatije kad se ovaj lijek primjenjuje u bolesnika s bolešću jetre, bolesnika nakon kirurškog zahvata, novorođenčadi ili u bolesnika u kojih postoji rizik od trombotskih pojava ili diseminirane intravaskularne koagulacije (DIK).
English: All patients assessed in the steady state pharmacokinetic session had factor IX activity levels above 0.24 IU/ml at 168 hours post dosing with a weekly dose of 40 IU/kg.
Croatian: Svi bolesnici procijenjeni u farmakokinetičkoj sesiji u stanju dinamičke ravnoteže imali su razine aktivnosti faktora IX iznad 0,24 IU/ml 168 sati nakon doziranja 40 IU/kg jednom tjedno.
English: For treatment of bleeds in paediatrics, the overall success rate (defined as excellent or good) was 93% (39 out of 42 bleeds), where 36 (86 %) of the bleeds were resolved with 1 injection, and 5 (12%) of the bleeds were resolved with 2 injections of Refixia.
Croatian: U liječenju krvarenja kod pedijatrijske populacije ukupna stopa uspjeha (definirana kao izvrsna ili dobra) bila je 93% (39 od 42 krvarenja), gdje je 36 (86%) krvarenja riješeno s 1 injekcijom, a 5 (12%) krvarenja riješeno je s 2 injekcije lijeka Refixia.
English: In distribution and excretion studies in mice and rats, the 40 kDa polyethylene-glycol (PEG) moiety of Refixia was shown to be widely distributed to and eliminated from organs, and excreted via plasma in urine (44-56%) and faeces (28-50%).
Croatian: (PEG) od 40 kDa, dio lijeka Refixia, široko distribuiran i da se eliminira iz organa te izlučuje putem plazme u urinu (44-56%) i stolicom (28-50%).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva pruritus*
English: Refixia is given as an injection into a vein.
Croatian: Refixia se primjenjuje injekcijom u venu.
English: Excipient with known effect Less than 1 mmol sodium (23 mg) per vial.
Croatian: Pomoćna tvar s poznatim učinkom Manje od 1 mmol (23 mg) natrija po bočici.
English: Recommended dose IU/kg body weight
Croatian: Preporučena doza u IU/kg tjelesne težine
English: Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator.
Croatian: Kad se jednom izvadi iz hladnjaka, lijek se ne smije ponovno vraćati u hladnjak.
English: ≥18 years N=6
Croatian: ≥18 godina N=6
English: If you are in doubt contact your doctor.
Croatian: Ako imate nedoumica, obratite se svom liječniku.
English: Adjustments of doses and administration intervals may be considered based on achieved FIX levels and individual bleeding tendency.
Croatian: Prilagodba doza i intervali primjene mogu se razmotriti na temelju postignutih razina faktora IX i individualne sklonosti krvarenju.
English: Refixia is not indicated for use in children (below 12 years).
Croatian: Refixia nije indicirana za primjenu u djece (mlađe od 12 godina).