FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Croatian: Istodobna primjena inhibitora HIV proteaze sakvinavira, koji je inhibitor CYP3A4, u stanju dinamičke ravnoteže (1200 mg tri puta na dan) sa sildenafilom (jedna doza od 100 mg) povećala je Cmax sildenafila za 140%, a AUC sildenafila za 210%.
English: Efficacy in adult patients with PAH (when used in combination with epoprostenol) A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
Croatian: Provedeno je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje s 267 bolesnika s PAH-om koji su bili stabilizirani na intravenskoj terapiji epoprostenolom.
English: How to store Mysildecard
Croatian: Kako čuvati Mysildecard
English: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively.
Croatian: Učinci liječenja na plućni krvožilni otpor, korigirani za placebo, bili su -178 dyn.s/cm5 (p=0,0051) kod primjene sildenafila u dozi od 20 mg TID, -195 dyn.s/cm5 (p=0,0017) kod primjene sildenafila u dozi od 40 mg TID te -320 dyn.s/cm5 (p < 0,0001) kod primjene sildenafila u dozi od 80 mg TID.
English: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section
Croatian: Istodobna primjena sildenafila u bolesnika koji uzimaju alfa-blokatore može u osjetljivih osoba dovesti do simptomatske hipotenzije (vidjeti dio 4.4).
English: Do not take Mysildecard: • if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Mysildecard: - ako ste alergični na sildenafil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako uzimate lijekove koji sadrže nitrate ili donore dušikova oksida poput amil nitrata.
English: Respiratory, thoracic and mediastinal disorders Common epistaxis, cough, nasal congestion
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često epistaksa, kašalj, kongestija nosa
English: Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mmHg (p = 0.01) and -5.1 mmHg (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Croatian: Učinci liječenja na srednju vrijednost plućnog arterijskog tlaka, korigirani za placebo, bili su -2,7 mmHg (p = 0,04) kod primjene sildenafila u dozi od 20 mg TID, -3,0 mmHg (p = 0,01) kod primjene sildenafila u dozi od 40 mg TID te -5,1 mmHg (p < 0,0001) kod primjene sildenafila u dozi od 80 mg TID.
English: Titanium dioxide (E171)
Croatian: Film ovojnica: hipromeloza 6 mPas titanijev dioksid (E171) triacetin
English: • currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
Croatian: (leukemiju), rak koštane srži (multipli mijelom) ili bilo kakvu bolest ili deformitet penisa - trenutno imate vrijed na želucu, poremećaj krvarenja (poput hemofilije) ili tegobe s krvarenjem iz nosa.
English: A total of 106 out of 234 (45%) subjects were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children < 7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
Croatian: CPET test se mogao provesti u ukupno 106 od 234 ispitanika (45%), koji su obuhvaćali djecu u dobi od ≥ 7 godina i razvojno sposobnu za izvođenje testa.
English: Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94%, 93% and 85% in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94% and 93% for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
Croatian: Kaplan-Meierove procjene trogodišnjeg preživljenja u bolesnika tjelesne težine > 20 kg na početku ispitivanja bile su: 94% za skupinu koja je primala nisku dozu, 93% za skupinu koja je primala srednju dozu i 85% za skupinu koja je primala visoku dozu sildenafila.
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg)
Croatian: U malom, placebom kontroliranom ispitivanju u bolesnika s dokumentiranom, ranom, dobno uvjetovanom degeneracijom makule (n = 9), sildenafil (jedna doza od 100 mg) nije pokazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, razlikovanje boja simulacijom semafora, Humphreyev perimetar i fotostres test).
English: Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels.
Croatian: Podaci od jedne dojilje pokazuju da se sildenafil i njegov aktivni metabolit
English: A total of 234 subjects aged 1 to 17 years were treated in a randomised, double-blind, multi-centre, placebo controlled parallel group, dose ranging study.
Croatian: U randomiziranom, dvostruko slijepom, multicentričnom, placebom kontroliranom ispitivanju raspona doza s paralelnim skupinama liječena su ukupno 234 ispitanika u dobi od 1 do 17 godina.
English: Most patients were WHO Functional Class II (107/277, 39%) or III (160/277, 58%) with a mean baseline 6-minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4%) or IV (9/277, 3%) at baseline.
Croatian: Većina je bolesnika imala bolest funkcionalnog stupnja II (107/277, 39%) ili III (160/277, 58%) prema klasifikaciji SZO.
English: Adverse reactions which occurred in > 1% of sildenafil-treated patients and were more frequent (> 1% difference) on sildenafil in the pivotal study or in the sildenafil combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1 /1,000 to < 1/100) and not known (cannot be estimated from the available data).
Croatian: U sljedećoj su tablici navedene nuspojave koje su nastupile u > 1% bolesnika liječenih sildenafilom i koje su se javile češće (razlika > 1%) uz primjenu sildenafila u dozama od 20, 40 ili 80 mg TID u pivotalnom ispitivanju ili u kombiniranim podacima iz oba placebom kontrolirana ispitivanja u plućnoj arterijskoj hipertenziji.
English: if you experience sudden decrease or loss of vision (frequency not known) if you have an erection, which lasts continuously for more than 4 hours.
Croatian: Ako iskusite bilo koju od sljedećih nuspojava, morate prestati uzimati Mysildecard i odmah se javiti liječniku (pogledajte i dio 2.): - ako osjetite iznenadno smanjenje ili gubitak vida (učestalost nepoznata) - ako imate erekciju koja traje neprekidno dulje od 4 sata.
English: Not known sudden hearing loss
Croatian: Poremećaji uha i labirinta često vrtoglavica nepoznato iznenadni gubitak sluha
English: Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
Croatian: Poremećaji oka često krvarenje mrežnice, oštećenje vida, zamagljen vid, fotofobija, kromatopsija, cijanopsija, iritacija oka, očna hiperemija manje često smanjena oštrina vida, diplopija, neuobičajeni osjeti u oku nepoznato nearterijska prednja ishemijska optička neuropatija*, okluzija krvnih žila mrežnice, poremećaj vidnog polja*
English: Local reactions may increase slightly following the second dose, in this case lasting up to 15 days.
Croatian: Lokalne reakcije mogu se malo pojačati nakon druge doze, što u ovom slučaju može trajati do 15 dana.
English: Local reactions at the injection site are common and normally resolve within 4 weeks.
Croatian: Lokalne reakcije u mjestu injekcije su uobičajene i normalno nestaju u roku od 4 tjedna.
English: Cattle may show a temporary increase in body temperature (no more than 2.7 °C) in the 48 hours following vaccination.
Croatian: U goveda se može manifestirati privremeno povišenje tjelesne temperature (ne veće od 2,7°C) tijekom 48 sati nakon cijepljenja.
English: The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Croatian: Europska agencija za lijekove (EMA) pregledala je dodatne informacije dostavljene u skladu s usuglašenim rasporedom o kvaliteti, sigurnosti i djelotvornosti cjepiva.
English: Protection starts three weeks after the last injection and lasts for one year.
Croatian: Zaštita započinje tri tjedna nakon posljednje injekcije i traje godinu dana.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Croatian: Cjepivo također sadrži dodatne tvari (aluminij hidroksid i saponin) za jači imunološki odgovor.
English: The vaccine is given to young animals as two injections under the skin.
Croatian: Cjepivo se daje mladim životinjama kao dvije potkožne injekcije.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Cjepiva djeluju tako da „uče” imunološki sustav (prirodnu obranu tijela) kako da se brani protiv bolesti.
English: The first injection is given from three months of age and the second injection is given three weeks later.
Croatian: Prva se injekcija daje nakon tri mjeseca starosti, a druga se injekcija daje tri tjedna nakon prve injekcije.
English: Zulvac 1+8 Bovis was initially authorised under ‘exceptional circumstances'.
Croatian: Zulvac 1+8 Bovis prvotno je odobren u „iznimnim okolnostima”.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in cattle from three months of age.
Croatian: Cjepivo se koristi za sprječavanje viremija (prisutnosti virusa u krvi) u goveda nakon tri mjeseca starosti.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Croatian: Razdoblje karencije je rok koji mora proći između primjene lijeka i klanja životinja te uporabe mesa ili mlijeka za ljudsku konzumaciju.
English: Another laboratory study in cattle looked at how long the vaccine was able to protect against bluetongue infection.
Croatian: Drugo laboratorijsko ispitivanje u goveda istražilo je koliko dugo cjepivo može štititi protiv upale plavog virusa.
English: Inactivated adjuvanted vaccine against bluetongue disease virus, serotypes 1 and 8
Croatian: Inaktivirano adjuvantno cjepivo protiv virusa bolesti plavog jezika, serotipovi 1 i 8
English: The withdrawal period for Zulvac 1 + 8 Bovis for meat and milk is zero days.
Croatian: Razdoblje karencije za Zulvac 1 + 8 Bovis za meso i mlijeko iznosi nula dana.
English: A field study was also conducted investigating the safety of the vaccine in dairy cows, including pregnant and lactating cows.
Croatian: Provedeno je i terensko ispitivanje, u kojem je istražena sigurnost cjepiva u mliječnih krava, uključujući i gravidne krave te krave u laktaciji.
English: The field study showed that the vaccine can be used safely in pregnant and lactating cows.
Croatian: Terensko ispitivanje dokazalo je da se cjepivo može sigurno koristiti u gravidnih krava i krava u laktaciji.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1+8 Bovis to convert to a normal status.
Croatian: U 2013. godini CVMP je zaključio da su dostavljeni podaci primjereni za promjenu statusa odobrenja za stavljanje u promet VMP-a Zulvac 1+8 Bovis u normalan status.
English: The studies looked at the strength of vaccine required to protect against bluetongue infection, and at the safety of the vaccine.
Croatian: Ispitivanja su istražila jačinu cjepiva potrebnog za zaštitu protiv upale plavog jezika i sigurnost cjepiva.
English: The studies showed that the vaccine is safe and that it prevents viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age.
Croatian: Ispitivanjima je utvrđeno da je cjepivo sigurno, te da sprječava viremije uzrokovane virusom plavog jezika serotipove 1 i 8 u goveda nakon tri mjeseca starosti.
English: The CVMP concluded that the benefits of Zulvac 1+8 Bovis exceed the risks for prevention of viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age and recommended that Zulvac 1+8 Bovis be given a marketing authorisation.
Croatian: CVMP je zaključio da koristi od cjepiva Zulvac 1+8 Bovis nadmašuju njegove rizike u suzbijanju viremije uzrokovane virusom plavog jezika serotipovima 1 i 8 u goveda nakon tri mjeseca starosti, te je preporučio izdavanje odobrenja za stavljanje u promet cjepiva Zulvac 1+8 Bovis.
English: Zulvac 1+8 Bovis is a vaccine that contains inactivated (killed) bluetongue serotypes 1 and 8 viruses as the active substance.
Croatian: Zulvac 1+8 Bovis je cjepivo koje sadrži inaktivirane (ubijene) serotipove 1 i 8 virusa plavog jezika kao djelatnu tvar.
English: Zulvac 1+8 Bovis was studied in calves in four main studies carried out in a laboratory.
Croatian: Zulvac 1+8 Bovis ispitivan je na govedima u četiri glavna ispitivanja provedena u laboratoriju.
English: In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly.
Croatian: U slučaju izlaganja životinja virusu plavog jezika u budućnosti njihov imunološki sustav brže proizvodi protutijela, što pomaže pri zaštiti goveda od bolesti.
English: This means that it was not possible at the time of the initial authorisation to obtain complete information about Zulvac 1+8 Bovis.
Croatian: Razlog za navedeno je nemogućnost dobivanja potpunih informacija o cjepivu Zulvac 1+8 Bovis.
English: Zulvac 1+8 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Croatian: Zulvac 1-8 Bovis sadrži viruse plavog jezika koji su inaktivirani tako da ne mogu uzrokovati bolest.
English: immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Croatian: Kada se daje govedima, imunološki sustav životinja prepoznaje viruse kao „strana tijela” i proizvodi protutijela protiv njih.
English: Zulvac 1+8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Croatian: Zulvac 1+8 Bovis primjenjuje se u goveda za zaštitu protiv bolesti plavog jezika, infekcije uzrokovane virusom plavog jezika koja se prenosi mušicama.
English: Other information about Zulvac 1+8 Bovis:
Croatian: Druge informacije o lijeku Zulvac 1+8 Bovis:
English: Zulvac 1+8 Bovis is a vaccine.
Croatian: Zulvac 1+8 Bovis je cjepivo.
English: What is the risk associated with Zulvac 1+8 Bovis?
Croatian: Koji su rizici povezani s lijekom Zulvac 1+8 Bovis?
English: What is Zulvac 1+8 Bovis?
Croatian: Što je Zulvac 1+8 Bovis?
English: Why has Zulvac 1+8 Bovis been approved?
Croatian: Zašto je Zulvac 1+8 Bovis odobren?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zulvac 1+8 Bovis on 08/03/2012.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod«prodname» Zulvac 1+8 Bovis dana 08.03.2012. Informacije o tome je li za ovaj proizvod potreban veterinarski recept možete naći na etiketi/vanjskom dijelu pakiranja.
English: The virus exists in several forms (serotypes) throughout the world; the types used in Zulvac 1+8 Bovis are serotypes 1 and 8.
Croatian: Tipovi korišteni u lijeku Zulvac 1+8 Bovis su serotipovi 1 i 8.
English: What benefit has Zulvac 1+8 Bovis shown during the studies?
Croatian: Koje koristi Zulvac 1+8 Bovis su utvrđene tijekom ispitivanja?
English: How does Zulvac 1+8 Bovis work?
Croatian: Kako Zulvac 1+8 Bovis djeluje?
English: How has Zulvac 1+8 Bovis been studied?
Croatian: Kako se Zulvac 1+8 Bovis ispitivao?
English: What is Zulvac 1+8 Bovis used for?
Croatian: Za što se Zulvac 1+8 Bovis koristi?
English: T cells must be ‘activated' before they work.
Croatian: T stanice moraju se „aktivirati” prije nego što počnu djelovati.
English: Further doses are given at the end of weeks 8 and 12.
Croatian: Dodatne se doze daju na kraju 8. i 12. tjedna.
English: Belatacept has been designed to attach to two of these molecules called CD80 and CD86.
Croatian: Belatacept se vezuje na dvije takve molekule naziva CD80 i CD86.
English: The full EPAR for Nulojix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Nulojix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This happens when certain molecules attach to receptors on the surface of the T cells.
Croatian: To se događa kada se određene molekule vežu na receptore na površini T stanica.
English: Doses are calculated using the patient's weight.
Croatian: Doze se izračunavaju na temelju tjelesne težine bolesnika.
English: In the initial phase it is given at a dose of 10 mg per kilogram body weight on day 1 (day of transplantation or the day before) and then again on days 5, 14 and 28.
Croatian: U početnoj se fazi lijek daje u dozi od 10 mg po kilogramu tjelesne težine 1. dana (na dan presađivanja ili dan prije presađivanja) i zatim ponovno 5., 14, i 28. dana.
English: The most common serious side effects of Nulojix seen in more than 2% of patients are: urinary tract infection (infection of the structures that carry urine), cytomegalovirus infection, pyrexia (fever), increased blood creatinine (a marker of kidney problems), pyelonephritis (kidney infection), diarrhoea, gastroenteritis (diarrhoea and vomiting), poor functioning of the transplanted kidney, leucopenia (low white blood cell counts), pneumonia (infection of the lungs), basal cell carcinoma (a cancer), anaemia (low red blood cell counts), dehydration.
Croatian: Najčešće ozbiljne nuspojave lijeka Nulojix zabilježene u više od 2 % bolesnika su: infekcija mokraćnih puteva (infekcija struktura kojima prolazi urin), citomegalovirusna infekcija, pireksija (vrućica), povišen kreatinin u krvi (marker problema s bubrezima), pijelonefritis (bubrežna infekcija), proljev, gastroenteritis (proljev i povraćanje), oslabljena funkcija presađenog bubrega, leukopenija (nizak broj bijelih krvnih stanica), pneumonija (upala pluća), karcinom bazalnih stanica (rak), anemija (nizak broj crvenih krvnih stanica), dehidracija.
English: It contains the active substance belatacept.
Croatian: Sadrži djelatnu tvar belatacept.
English: The studies also looked at the number of organ rejections that occurred within one year of the transplant.
Croatian: Ispitivanja su se također bavila brojem odbacivanja organa zabilježenima tijekom jedne godine nakon presađivanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nulojix on 17 June 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Nulojix na snazi u Europskoj uniji od 17. lipnja 2011.
English: After the initial phase, which lasts three months, Nulojix is given at a maintenance dose of 5 mg/kg every four weeks starting from the end of the week 16.
Croatian: Nakon početne faze koja traje tri mjeseca, lijek Nulojix daje se u dozi održavanja od 5 mg/kg svaka četiri tjedna počevši od kraja 16. tjedna.
English: This is a summary of the European public assessment report (EPAR) for Nulojix.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Nulojix.
English: Other information about Nulojix
Croatian: Ostale informacije o lijeku Nulojix
English: For more information about treatment with Nulojix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Nulojix pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What measures are being taken to ensure the safe and effective use of Nulojix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nulojix?
English: The main measures of effectiveness were the proportion of patients who survived with their transplanted kidneys intact and how well their kidneys functioned.
Croatian: Glavna mjerila učinkovitosti bila su omjer bolesnika koji su preživjeli bez ikakvih posljedica po presađene bubrege i koliko je dobra bila funkcija njihovih bubrega.
English: It is used with corticosteroids and a mycophenolic acid (other medicines used to prevent organ rejection).
Croatian: Koristi se u kombinaciji s kortikosteroidima i mikofenolnom kiselinom (drugim lijekovima koji se primjenjuju za sprečavanje odbacivanja organa).
English: This is because patients treated with Nulojix who have had no previous exposure to the virus are at higher risk of getting a type of cancer known as post-transplant lymphoproliferative disorder.
Croatian: Razlog tome je taj što bolesnici koji primaju Nulojix, a koji nisu bili izloženi virusu, imaju povećan rizik od dobivanja jedne vrste raka koji se zove posttransplantacijska limfoproliferativna bolest.
English: Although the studies showed more acute rejections after one year of treatment with Nulojix compared with cyclosporine A, this did not lead to reduced patient and organ survival after three years.
Croatian: Iako su ispitivanja pokazala više akutnih odbacivanja nakon jedne godine liječenja lijekom Nulojix u usporedbi s ciklosporinom A, to nije dovelo do smanjenja stope preživljavanja bolesnika i organa nakon tri godine.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nulojix.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Nulojix.
English: Nulojix is given as an infusion into a vein over 30 minutes.
Croatian: Nulojix se infuzijom ubrizgava u venu u trajanju od 30 minuta.
English: Nulojix must not be used in patients who have not been exposed to the Epstein-Barr virus or in whom previous exposure is uncertain.
Croatian: Nulojix se ne smije primjenjivati u bolesnika koji nisu bili izloženi Epstein-Barrovom virusu ili za koje nije sigurno jesu li mu bili izloženi.
English: Overall, the benefits of Nulojix compared well with the comparator medicine.
Croatian: Sve u svemu, koristi od lijeka Nulojix imale su dobre rezultate u odnosu na lijek za usporedbu.
English: In addition, the company that makes Nulojix will include an alert card in each medicine's pack to increase awareness of the benefits and risks with Nulojix.
Croatian: Osim toga, proizvođač lijeka Nulojix dodat će karticu s upozorenjima u svako pakiranje lijeka kako bi se povećala svijest o koristima i rizicima povezanima s lijekom Nulojix.
English: The active substance in Nulojix, belatacept, is an immunosuppressive medicine.
Croatian: Djelatna tvar u lijeku Nulojix, belatacept, jest imunosupresiv.
English: A risk management plan has been developed to ensure that Nulojix is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Nulojix.
English: Intensive Nulojix treatment with a longer initial phase of six months produced similar results to treatment with a three-month initial phase.
Croatian: Intenzivna terapija lijekom Nulojix uz dulju početnu fazu od šest mjeseci dala je slične rezultate kao i terapija s tromjesečnom početnom fazom.