FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average post-baseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20-Week 24 to Week 49 - 52 intervals).
Croatian: Udio bolesnika kojima je bilo potrebno liječenje akutnog napada gihta (ispitivanja APEX i FACT) bio je brojčano manji u skupinama kod kojih je nakon početka liječenja postignuta prosječna razina urata u serumu <6,0 mg/dl, <5,0 mg/dl ili <4,0 mg/dl, u usporedbi sa skupinom kod koje je nakon početka liječenja postignuta prosječna razina urata u serumu ≥6,0 mg/dl tijekom posljednja 32 tjedna liječenja (u intervalima od 20. - 24. tjedna do 49. - 52. tjedna).
English: How to take Febuxostat Krka
Croatian: Kako uzimati Febuxostat Krka
English: Overall, 346 patients with haematological malignancies undergoing chemotherapy and at intermediate
Croatian: Ukupno je bilo uključeno 346 bolesnika s hematološkim zloćudnim bolestima koji su podvrgnuti kemoterapiji i imaju srednje visoki/visoki rizik od nastajanja sindroma tumorske lize.
English: Following multiple doses of 80 mg of febuxostat in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, the Cmax and AUC of febuxostat and its metabolites did not change significantly compared to subjects with normal hepatic function.
Croatian: Nakon višekratnih doza od 80 mg febuksostata u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre, Cmax i AUC febuksostata i njegovih metabolita nije bio značajno promijenjen u odnosu na ispitanike s urednom funkcijom jetre.
English: The FACT study showed the statistically significant superiority of both febuxostat 80 mg and febuxostat 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 μmol/L).
Croatian: Ispitivanje FACT pokazalo je statistički značajnu superiornost liječenja, kako febuksostatom 80 mg tako i febuksostatom 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg, s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357 µmol/l).
English: How to store Febuxostat Krka
Croatian: Kako čuvati Febuxostat Krka
English: Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet pojavile su se rijetke ozbiljne reakcije preosjetljivosti na febuksostat, uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i anafilaktičku reakciju/šok.
English: hepatitis (up to liver failure), raising of the white-cells count in the blood (leukocytosis, with or without eosinophilia) - reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis) - nervousness - feeling thirsty - ringing in the ears - blurred vision, change in vision - hair loss - mouth ulceration - inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting - increased sweating - weight decrease, increased appetite, uncontrolled loss of appetite (anorexia) - muscle and/or joint stiffness - abnormally low blood cell counts (white or red blood cells or platelets) - urgent need to urinate - changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis) - inflammation of the liver (hepatitis) - yellowing of the skin (jaundice) - liver damage - increased level of creatine phosphokinase in blood (an indicator of muscle damage) - sudden cardiac death.
Croatian: nekroza i odvajanje gornjeg sloja kože i sluznica sa stvaranjem mjehura, što rezultira ljuštenjem i mogućom sepsom (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza) - nervoza - osjećaj žeđi - zvonjava u ušima - zamagljen vid, promjene vida - opadanje kose - ulceracije u ustima - upala gušterače: česti simptomi su bol u trbuhu, mučnina i povraćanje - pojačano znojenje - smanjenje tjelesne težine, pojačani apetit, nekontrolirani gubitak apetita (anoreksija) - ukočenost mišića i/ili zglobova - abnormalno nizak broj krvnih stanica (bijelih ili crvenih krvnih stanica ili krvnih pločica) - osjećaj hitnosti mokrenja - promjena ili smanjenje količine mokraće zbog upale bubrega (tubulointersticijski nefritis) - upala jetre (hepatitis) - žuta boja kože (žutica) - oštećenje jetre - povišena razina kreatin fosfokinaze u krvi (pokazatelj oštećenja mišića) - iznenadna srčana smrt.
English: A total of 1,086 patients were enrolled: febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145).
Croatian: Ukupno je bilo uključeno 1086 bolesnika: dobivali su febuksostat 80 mg jednom dnevno (n=649), febuksostat 120 mg jednom dnevno (n=292) i alopurinol 300/100 mg jednom dnevno (n=145).
English: Seven hundred sixty (760) patients were randomized: febuxostat 80 mg QD (n=256), febuxostat 120 mg QD (n=251), or allopurinol 300 mg QD (n=253).
Croatian: Sedamsto šezdeset (760) bolesnika je randomizirano te su primali: febuksostat 80 mg jednom dnevno (n=256), febuksostat 120 mg jednom dnevno (n=251), ili alopurinol 300 mg jednom dnevno (n=253).
English: For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100 mg QD.
Croatian: U ispitanika s oštećenom funkcijom bubrega koji su randomizirani u skupinu liječenu alopurinolom, najviša doza bila je 100 mg jednom dnevno.
English: The recommended oral dose of Febuxostat Krka is 80 mg once daily without regard to food.
Croatian: Preporučena peroralna doza lijeka Febuxostat Krka je 80 mg jednom dnevno, neovisno o unosu hrane.
English: Dyspnoea, bronchitis, upper respiratory tract infection, cough
Croatian: Manje često Dispneja, bronhitis, infekcija gornjega dišnog sustava, kašalj
English: Febuxostat Krka works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
Croatian: Krka djeluje dovoljno brzo da se ponovno mjerenje mokraćne kiseline u serumu može provesti nakon 2 tjedna.
English: Patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome treated with febuxostat should be under cardiac monitoring as clinically appropriate.
Croatian: Prevencija i liječenje hiperuricemije u bolesnika koji imaju rizik od nastajanja STL-a Bolesnicima liječenim febuksostatom koji su podvrgnuti kemoterapiji zbog hematoloških zloćudnih bolesti i imaju srednje visoki do visoki rizik od nastajanja sindroma tumorske lize treba pažljivo pratiti rad srca kako je klinički prikladno.
English: Febuxostat Krka 80 mg film-coated tablets Febuxostat Krka 120 mg film-coated tablets febuxostat
Croatian: Krka 80 mg filmom obložene tablete Febuxostat Krka 120 mg filmom obložene tablete febuksostat
English: Febuxostat Krka is available as either an 80 mg tablet or a 120 mg tablet.
Croatian: Dostupne su tablete lijeka Febuxostat Krka od 80 mg ili 120 mg.
English: Gout flares during the last 4 weeks of the study (Weeks 24-28) were observed in 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) and 20% (placebo) of subjects.
Croatian: Tijekom posljednja 4 tjedna ispitivanja (24.-28. tjedan) primijećeni su akutni napadi gihta u 15% (febuksostat 80 mg, 120 mg), 14% (alopurinol 300 mg) i 20% (placebo) ispitanika.
English: Two thousand and two hundred-sixty nine (2269) patients were randomized: febuxostat 40 mg QD (n=757), febuxostat 80 mg QD (n=756), or allopurinol 300/200 mg QD (n=756).
Croatian: Bilo je randomizirano 2269 bolesnika: febuksostat 40 mg jednom dnevno (n=757), febuksostat 80 mg jednom dnevno (n=756) ili alopurinol 300 mg/200 mg jednom dnevno (n=756).
English: Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet su prikupljene rijetke prijave ozbiljnih alergijskih reakcija/reakcija preosjetljivosti, uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i akutnu anafilaktičku reakciju/šok.
English: Febuxostat can be co-administered with naproxen with no dose adjustment of febuxostat or naproxen being necessary.
Croatian: Febuksostat se može primjenjivati istodobno s naproksenom, bez potrebe prilagodbe doze febuksostata ili naproksena.
English: Gout flares during the last 4 weeks of the study (Weeks 49-52) were observed in 6-8% (febuxostat 80 mg, 120 mg) and 11% (allopurinol 300 mg) of subjects.
Croatian: Tijekom posljednja 4 tjedna ispitivanja (49.-52. tjedan) primijećeni su akutni napadi gihta u 6 do 8% (febuksostat 80 mg, 120 mg) i 11% (alopurinol 300 mg) ispitanika.
English: If you stop taking Febuxostat Krka your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys.
Croatian: Ako prestanete uzimati Febuxostat Krka, razina mokraćne kiseline može početi rasti i simptomi
English: In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA < 6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively.
Croatian: Udio bolesnika koji su postigli primarni ishod djelotvornosti (razina mokraćne kiseline u serumu <6,0 mg/dl na završnoj kontroli) u CONFIRMS ispitivanju, a kojima je početna razina mokraćne kiseline u serumu bila ≥10 mg/dl bio je 27% (66/249) kod bolesnika liječenih febuksostatom od 40 mg jednom dnevno, 49% (125/254) kod liječenih febuksostatom od 80 mg jednom dnevno te 31% (72/230) kod bolesnika liječenih alopurinolom 300 mg/200 mg jednom dnevno.
English: Possible symptoms of allergic reactions might be: - rash including severe forms (e.g. blisters, nodules, itchy, exfoliative rash), itchiness - swelling of limbs or face - difficulties in breathing - fever with enlarged lymph nodes - but also serious life threatening allergic conditions with cardiac and circulatory arrest.
Croatian: svrbež - oticanje udova ili lica - poteškoće s disanjem - vrućica s povećanim limfnim čvorovima - ali i ozbiljna alergijska stanja opasna po život sa srčanim i cirkulatornim zastojem.
English: Febuxostat Krka is indicated in adults.
Croatian: Krka je indiciran u odraslih.
English: Febuxostat Krka 120 mg tablets febuxostat
Croatian: Krka 120 mg tablete febuksostat
English: Febuxostat Krka 80 mg tablets febuxostat
Croatian: Krka 80 mg tablete febuksostat
English: Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat Krka every day.
Croatian: S vremenom će se, ako nastavite uzimati Febuxostat Krka svaki dan, napadaji gihta pojavljivati rjeđe i biti manje bolni.
English: In this subgroup febuxostat achieved the primary efficacy endpoint (sUA < 6.0 mg/dL at the last 3 visits) in 41% (80 mg QD), 48% (120 mg QD), and 66% (240 mg QD) of patients compared to 9% in the allopurinol 300 mg/100 mg QD and 0 % in the placebo groups.
Croatian: U ovoj podskupini febuksostat je postigao primarni ishod djelotvornosti (razina mokraćne kiseline u serumu <6,0 mg/dl prilikom zadnje 3 kontrole) u 41% (80 mg jednom dnevno), 48% (120 mg jednom dnevno) i 66% (240 mg jednom dnevno) bolesnika, u usporedbi s 9% u skupini koja je primala alopurinol 300 mg/100 mg jednom dnevno i 0% u skupini koja je primala placebo.
English: An analysis in patients with gout and renal impairment was prospectively defined in the CONFIRMS study, and showed that febuxostat was significantly more efficacious in lowering serum urate levels to < 6 mg/dL compared to allopurinol 300 mg/200 mg in patients who had gout with mild to moderate renal impairment (65% of patients studied).
Croatian: U CONFIRMS ispitivanju je prospektivno analizirana skupina bolesnika s gihtom i oštećenom funkcijom bubrega, te je pokazano da je u bolesnika s gihtom i blago do umjereno oštećenom funkcijom bubrega (65% promatranih ispitanika), febuksostat značajno djelotvorniji u sniženju razine serumskih urata na <6,0 mg/dl u odnosu na alopurinol 300 mg/200 mg.
English: Gout: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Croatian: Giht: preporučeno doziranje u bolesnika s blagim oštećenjem funkcije jetre je 80 mg.
English: No dose adjustment was required for enrolled patients on the basis of hepatic function.
Croatian: U ispitanika uključenih u ispitivanje nije bila potrebna prilagodba doze prema funkciji jetre.
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Croatian: Major Adverse Cardiovascular Events, MACE) bila je slična u bolesnika liječenih febuksostatom i bolesnika liječenih alopurinolom (HR 1,03; 95% CI 0,87-1,23), ali je u bolesnika liječenih febuksostatom primijećena viša stopa kardiovaskularne smrti (4,3% u odnosu na 3,2% bolesnika; HR 1,34; 95% CI 1,03-1,73).
English: Iron oxide, yellow (E172)
Croatian: Ovojnica tablete poli(vinilni alkohol) makrogol 3350 titanijev dioksid (E171) talk željezov oksid, žuti (E172)
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience
Croatian: Tablica 1: Nuspojave u fazi 3 dugoročnih produžetaka ispitivanja i nakon stavljanja lijeka u promet Poremećaji krvi i limfnog sustava Rijetko
English: Modelling and simulation analysis of data from a pre-clinical study in rats indicates that, in case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose (see section 4.4 and 5.3).
Croatian: Analiza podataka iz modeliranja i simulacije u nekliničkom ispitivanju na štakorima ukazuje da je, u slučaju istodobne primjene s febuksostatom, dozu merkaptopurina/azatioprina potrebno smanjiti na 20% ili niže od prethodno propisane doze (vidjeti dijelove 4.4 i 5.3).
English: The reccomended oral dose of Febuxostat Krka is 120 mg once daily without regard to food.
Croatian: Sindrom tumorske lize: preporučena peroralna doza lijeka Febuxostat Krka je 120 mg jednom dnevno, neovisno o unosu hrane.
English: Febuxostat Krka 80 mg film-coated tablets febuxostat
Croatian: Krka 80 mg filmom obložene tablete febuksostat
English: Febuxostat Krka 120 mg film-coated tablets febuxostat
Croatian: Krka 120 mg filmom obložene tablete febuksostat
English: Febuxostat Krka contains lactose and sodium
Croatian: Krka sadrži laktozu i natrij
English: IJ
Croatian: Dob
English: Febuxostat Krka 120 mg film-coated tablets
Croatian: Krka 120 mg filmom obložene tablete
English: España KRKA Farmacéutica, S.L.
Croatian: KRKA Pharma Dublin, Ltd.
English: Febuxostat Krka 80 mg film-coated tablets
Croatian: Krka 80 mg filmom obložene tablete
English: Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy Febuxostat Krka is available as a 120 mg tablet.
Croatian: Prevencija i liječenje visokih razina mokraćne kiseline kod bolesnika koji su podvrgnuti kemoterapiji za rak
English: Mean (±SEM) Serum Uric Acid Level (mg/dL)
Croatian: Primarni ishod u podskupini bolesnika s mokraćnom kiselinom u serumu ≥10 mg/dl
English: Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria
Croatian: Zatajenje bubrega, nefrolitijaza, hematurija, polakizurija, proteinurija
English: Gout flares
Croatian: Napadi gihta
English: Tablet core
Croatian: Peroralna primjena.
English: Following an 80 mg oral dose of
Croatian: Nakon peroralno primijenjene doze od 80 mg febuksostata označenog s
English: Febuxostat Krka works by reducing uric acid levels.
Croatian: Krka djeluje tako da smanjuje razinu mokraćne kiseline.
English: Iron oxide, red (E172)
Croatian: Ovojnica tablete poli(vinilni alkohol) makrogol 3350 titanijev dioksid (E171) talk željezov oksid, crveni (E172)
English: KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658
Croatian: KRKA - FARMA d.o.o. Tel: + 385 1 6312 100
English: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Croatian: Preporučeno doziranje u bolesnika s blagim oštećenjem funkcije jetre je 80 mg.
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina lijeka, puteva primjene, nositelja odobrenja u državama članicama
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Ukkel
Croatian: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Ukkel
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophem 110
Croatian: Luksemburg NV AstraZeneca SA Rue Egide Van Ophem 110
English: AstraZeneca S.p.A. Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy
Croatian: Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy
English: 2719 EE Zoetermeer The Netherlands cream; hydrophilic cutaneous use
Croatian: Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands krema; hidrofilna
English: EMLA 5% w/w Cream lidocaine prilocaine
Croatian: EMLA 5% w/w Cream lidokain prilokain
English: Emla krém 5% lidocaine prilocaine
Croatian: Emla krém 5% lidokain prilokain
English: Emla Cream 5% lidocaine prilocaine
Croatian: Emla Cream 5% lidokain prilokain
English: The Netherlands AstraZeneca B.V. Louis Pasteurlaan 5
Croatian: AstraZeneca B.V.
English: This summary was last updated in 10-2017.
Croatian: Sažetak je posljednji put ažuriran: 10.2017.
English: In addition, 81% of these bleeding episodes required only a single treatment with Advate.
Croatian: Osim toga, 81 % tih epizoda krvarenja zahtijevalo je samo jedan tretman lijekom Advate.
English: Hypersensitivity (allergic) reactions have been reported and may in some cases become severe.
Croatian: Zabilježene su reakcije preosjetljivosti (alergijske reakcije) koje u nekim slučajevima mogu postati ozbiljne.
English: The full EPAR for Advate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni (EPAR) lijeka Advate nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Advate octocog alfa
Croatian: Advate oktokog alfa
English: Other information about Advate
Croatian: Ostale informacije o lijeku Advate
English: The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Advate u promet koje vrijedi na prostoru Europske unije od 2. ožujka 2004.
English: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Croatian: Oktokog alfa proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: tvori se od stanica u koje je uveden gen (DNK) koji im omogućuje da ga proizvode.
English: The additional studies confirmed Advate's effectiveness, including in children under 6 years of age.
Croatian: Dodatnim ispitivanjima potvrđena je djelotvornost lijeka Advate i u djece mlađe od 6 godina.
English: Advate is similar to another medicine approved in the EU called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine.
Croatian: Lijek Advate sličan je drugom lijeku odobrenom u EU-u pod nazivom Recombinate, ali se proizvodi na drugačiji način, tako da u njemu ne postoje proteini ljudskog ili životinjskog podrijetla.
English: Advate is intended for either short-term or long-term use.
Croatian: Lijek Advate predviđen je za kratkotrajnu ili dugotrajnu primjenu.
English: What measures are being taken to ensure the safe and effective use of Advate?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Advate?
English: This is a summary of the European public assessment report (EPAR) for Advate.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Advate.
English: What is Advate and what is it used for?
Croatian: Što je Advate i za što se koristi?
English: Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever).
Croatian: Česte nuspojave lijeka Advate (javljaju se u 1 do 10 na 100 bolesnika) jesu glavobolja i pireksija (vrućica).
English: What are the risks associated with Advate?
Croatian: Koji su rizici povezani s lijekom Advate?
English: Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years.
Croatian: U tri dodatna ispitivanja proučavana je uporaba lijeka u sprečavanju krvarenja i tijekom kirurškog zahvata u bolesnika s teškom ili umjereno teškom hemofilijom A, uključujući ispitivanje na 53 djece mlađe od 6 godina.
English: Why is Advate approved?
Croatian: Zašto je lijek Advate odobren?
English: It is not intended to provide practical advice on how to use Advate.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Advate.
English: The dose and duration of treatment depend on whether Advate is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Croatian: Doza i trajanje liječenja ovise o tome primjenjuje li se lijek Advate za liječenje ili sprečavanje krvarenja ili tijekom kirurškog zahvata, kao i o razinama faktora VIII u bolesnika, o stupnju hemofilije, jačini i mjestu krvarenja te stanju i tjelesnoj težini bolesnika.
English: The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.
Croatian: Podatci o induciranoj imunotoleranciji u bolesnika s inhibitorima smatrani su nedostatnima kako bi se lijek odobrio posebno za tu primjenu.
English: The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from ‘none' to ‘excellent' in 107 patients, all of whom received Advate.
Croatian: Ispitivanjem se razmatrao broj epizoda krvarenja te je djelotvornost lijeka Advate u zaustavljanju krvarenja ocijenjena na ljestvici od „nikakva” do „izvrsna” u 107 bolesnika koji su svi primali lijek Advate.
English: It contains the active substance octocog alfa (human coagulation factor VIII).
Croatian: Lijek sadržava djelatnu tvar oktokog alfa (ljudski koagulacijski faktor VIII).
English: Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Croatian: Lijek Advate ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na ljudski koagulacijski faktor VIII, protein miša ili hrčka ili bilo koji drugi sastojak lijeka.