FrancophonIA/ELRC3.0 huggingface dataset:
English: A small subset of microglial aggregates were associated with microhaemorrhage but with no evident functional sequelae in monkeys.
Croatian: Mali podskup agregata mikroglije bio je povezan s mikrokrvarenjem, ali bez evidentnih funkcionalnih posljedica u majmuna.
English: Firmly press and hold down the pen on your injection site.
Croatian: Čvrsto pritisnite i držite brizgalicu na mjestu davanja injekcije.
English: A pre-filled syringe of Zinbryta is contained within a spring-powered pen injector called Zinbryta Pen.
Croatian: Napunjena štrcaljka Zinbryte ugrađena je u injekcijsku brizgalicu s oprugom, pod nazivom Zinbryta Pen.
English: Low level of a type of white blood cells (called lymphocytes): Zinbryta could reduce your level of these white blood cells so you will have a blood test every 3 months.
Croatian: Zinbryta može smanjiti razinu tih bijelih krvnih stanica pa ćete morati testirati krv svaka 3 mjeseca.
English: Back of Upper Arm
Croatian: Stražnji dio nadlaktice ruke
English: • the syringe/pen is cracked or broken.
Croatian: • štrcaljka/brizgalica napuknuta ili slomljena.
English: Patients should be informed about the risk of hepatic injury, the need for periodic monitoring and warned about signs or symptoms suggestive of hepatic dysfunction.
Croatian: Bolesnike treba upoznati s rizikom od oštećenja jetre i potrebom za periodičnim praćenjem te upozoriti na znakove ili simptome koji ukazuju na disfunkciju jetre.
English: If a patient develops severe depression, and/or suicidal ideation, discontinuation of Zinbryta should be considered (see section 4.8).
Croatian: Ako bolesnik razvije tešku depresiju i/ili suicidalne ideje, treba uzeti u obzir trajni prekid primjene Zinbryte (vidjeti dio 4.8).
English: What Zinbryta contains
Croatian: Što Zinbryta sadrži
English: When you have any medical treatment, even if it is not for your MS, show the Patient Card to the doctor, pharmacist or nurse.
Croatian: Kad primate bilo kakvu terapiju, čak i ako to nije za multiplu sklerozu, pokažite Karticu za bolesnika liječniku,
English: Ask your doctor, pharmacist, or nurse for instructions on throwing away used syringes.
Croatian: Pitajte svog liječnika, ljekarnika ili medicinsku sestru za upute o bacanju iskorištenih štrcaljki.
English: In clinical studies, the pharmacodynamic effects of Zinbryta 150 mg administered subcutaneously every 4 weeks were consistent with modulation of IL-2 signalling as evidenced by the rapid and sustained saturation of the target CD25 receptors on circulating T-cells and a sustained approximately 2-fold increase in serum IL-2 concentration.
Croatian: U kliničkim ispitivanjima, farmakodinamički učinci Zinbryte 150 mg primijenjene supkutano svaka 4 tjedna bili su u skladu s modulacijom IL-2 signaliziranja kao što pokazuje brzo i održano zasićenje ciljnih CD25 receptora na cirkulirajućim T-stanicama i održano, približno dvostruko povišenje serumske koncentracije IL-2.
English: Zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable (see section 4.4).
Croatian: Zinbryta je indicirana za liječenje odraslih bolesnika s relapsnim oblicima multiple skleroze (RMS) koji su imali nezadovoljavajući odgovor na najmanje dvije terapije koje modificiraju tijek bolesti te za koje je liječenje nekom drugom terapijom koja modificira tijek bolesti kontraindicirano ili iz drugih razloga neprikladno (vidjeti dio 4.4).
English: Figure 1: Percentage of patients relapse-free (DECIDE study)
Croatian: Slika 1: Postotak bolesnika bez relapsa (ispitivanje DECIDE)
English: The exact metabolic pathway for daclizumab has not been characterised.
Croatian: Biotransformacija Točan metabolički put daklizumaba nije razjašnjen.
English: At week 96, Zinbryta demonstrated a statistically significant reduction in the number of new or newly enlarging T2 hyperintense lesions, the number of new T1 Gd-enhancing lesions and the mean number of new T1 hypointense lesions.
Croatian: U 96. tjednu, Zinbryta je pokazala statistički značajno smanjenje broja novih ili novoprogredirajućih hiperintenzivnih lezija na T2-mjerenoj snimci, broj novih lezija imbibiranih gadolinijem na T1-mjerenoj snimci i srednji broj novih hipointenzivnih lezija na T1-mjerenoj snimci.
English: The safety of immunisation with live viral vaccines during treatment with Zinbryta has not been studied.
Croatian: Sigurnost imunizacije živim virusnim cjepivima za vrijeme liječenja Zinbrytom nije ispitana.
English: You should see green stripes.
Croatian: Trebali biste vidjeti zelene trake.
English: • Prescriber name, signature and date.
Croatian: • ime i prezime liječnika koji je propisao lijek, potpis i datum.
English: Zinbryta will be prescribed to you by a doctor experienced in the treatment of MS.
Croatian: Zinbrytu će Vam propisati liječnik s iskustvom u liječenju multiple skleroze.
English: Do not inject into an area of your body where the skin is irritated, red, bruised, tattooed, infected, or scarred.
Croatian: Nemojte injicirati u područja tijela gdje je koža nadražena, osjetljiva, crvena, s modricama, tetovirana, zaražena ili s ožiljcima.
English: Pull the pen cap straight off and set it aside (See Figure E).
Croatian: Povucite zatvarač ravno prema gore i odložite ga sa strane (vidjeti sliku E).
English: Giving the Injection
Croatian: Davanje injekcije
English: Step 3: Check the Zinbryta Pen (Figure C) a.
Croatian: 3. korak: Provjerite Zinbryta brizgalicu (slika C) a.
English: Autoimmune haemolytic anaemia has been reported in patients treated with Zinbryta which resolved with standard treatment and discontinuation of Zinbryta.
Croatian: Autoimuna hemolitična anemija zabilježena je u bolesnika liječenih Zinbrytom, a povukla se uz standardno liječenje i prestanak primjene Zinbryte.
English: If you forget to take Zinbryta
Croatian: Ako ste zaboravili primijeniti Zinbrytu
English: For patients who test positive for HBV or HCV infection, consultation with a physician with expertise in the treatment of HBV or HCV is recommended.
Croatian: Bolesnicima s pozitivnim testom na infekciju virusima hepatitisa B ili C preporučuje se savjetovanje s liječnikom specijalistom za liječenje HBV-a ili HCV-a.
English: Daclizumab is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Croatian: Ne očekuje se da se daklizumab eliminira putem bubrega ili metabolizira jetrenim enzimima (vidjeti dio 4.2).
English: What Zinbryta is and what it is used for
Croatian: Što je Zinbryta i za što se koristi
English: *Observed with a ≥2% higher incidence than placebo †Observed with a ≥2% higher incidence than interferon beta-1a (intramuscular)
Croatian: * Opaženo s incidencijom ≥2% višom nego s placebom † Opaženo s incidencijom ≥2% višom nego s interferonom beta-1a (intramuskularno)
English: Although the effect on disability progression was mainly seen in patients with baseline EDSS < 3.5, evidence of efficacy was shown in patients with relapsing secondary progressive MS (SPMS) as defined by baseline EDSS ≥ 3.5 and at least one of the three: confirmed 24 week worsening of EDSS, or ≥ 20% decline on Timed 25-foot Walk (T25FW), or, ≥ 20% decline on 9-Hole Peg Test (9HPT).
Croatian: Iako je učinak na progresiju onesposobljenosti uglavnom opažen kod bolesnika s početnom vrijednosti EDSS < 3,5, dokazana je djelotvornost u bolesnika s relapsnom sekundarno progresivnom MS (SPMS), koja je definirana početnom vrijednosti EDSS ≥ 3,5 i barem jednim od sljedeća tri: potvrđeno pogoršanje EDSS-a tijekom 24 tjedna, ili ≥ 20% smanjenje u testu hoda na određenu udaljenost (engl.
English: Cases of hepatic injury have occurred in patients taking Zinbryta with other hepatotoxic drugs, although the role of these medicinal products is uncertain.
Croatian: U bolesnika koji su primjenjivali Zinbrytu s drugim hepatotoksičnim lijekovima zabilježeni su slučajevi oštećenja jetre, iako uloga tih lijekova nije jasna.
English: In the DECIDE study subgroup analysis, there was a statistically significant reduction observed compared to interferon beta-1a (intramuscular) on ARR and the number of new or newly enlarging T2 hyperintense lesions across subgroups (gender, age, prior MS DMT therapy, and disease activity levels).
Croatian: U analizi podskupina u ispitivanju DECIDE postojalo je statistički značajno smanjenje u usporedbi s interferonom beta-1a (intramuskularno) za godišnju stopu relapsa i broj novih ili novoprogredirajućih hiperintenzivnih lezija na T2-mjerenoj snimci za sve podskupine (spol, dob, prethodno liječenje MS-a terapijom koja modificira tijek bolesti i razine aktivnosti bolesti).
English: Step 7: Remove the pre-filled syringe from your injection site
Croatian: 7. korak: Uklonite napunjenu štrcaljku s mjesta injekcije
English: • The recommendation not to initiate Zinbryta in patients with ALT or AST ≥ 2 times the ULN, and to discontinue treatment in patients with ALT or AST > 3 times the ULN;
Croatian: • preporuku da ne započnu liječenje Zinbrytom u bolesnika s vrijednostima ALT ili AST ≥ 2 puta GGN, te da prekinu terapiju u bolesnika s vrijednostima ALT ili AST > 3 puta GGN
English: Step 4: Choose and clean your injection site a.
Croatian: 4. korak: Odaberite i očistite mjesto za injiciranje a.
English: • If a refrigerator is not available, Zinbryta syringes/pens can be stored at room temperature (up to 30oC) in the original pack for up to 30 days.
Croatian: • Ako hladnjak nije dostupan, Zinbryta štrcaljke/brizgalice se mogu čuvati na sobnoj temperaturi (do 30°C) u originalnom pakiranju do 30 dana.
English: As data on use of Zinbryta during pregnancy are limited, the risk to the baby and benefit to the mother should be taken into consideration.
Croatian: Trudnoća i dojenje Budući da su podaci o primjeni Zinbryte tijekom trudnoće ograničeni, treba uzeti u obzir rizik za dijete i korist za majku.
English: • sore throat, tonsillitis (pharyngitis, laryngitis)
Croatian: • grlobolja, upala krajnika (faringitis, laringitis)
English: You will be given a Patient Card with further information about the things to watch out for while taking Zinbryta.
Croatian: Dobit ćete Karticu za bolesnika s više informacija o stvarima na koje trebate paziti dok primjenjujete
English: When observed during Zinbryta clinical studies, lymphopenia was mostly mild to moderate (≥ 500/mm3).
Croatian: Limfopenija opažena tijekom kliničkih ispitivanja Zinbryte bila je uglavnom blaga do umjerena (≥ 500/mm3).
English: Choose an injection site in your thigh, abdomen, or the back of your upper arm (See highlighted areas in Figure D).
Croatian: Odaberite mjesto za injiciranje na bedru, trbuhu ili stražnjoj strani nadlaktice (vidjeti označena područja na slici D).
English: Zinbryta is provided with the needle pre-attached.
Croatian: Zinbryta se isporučuje s već pričvršćenom iglom.
English: The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month.
Croatian: Preporučena doza Zinbryte je 150 mg koja se daje supkutanom injekcijom jedanput na mjesec.
English: Mean number of new T1 Gdenhancing lesions between 8 and 24 weeks (on monthly MRI scans)
Croatian: Srednji broj novih lezija imbibiranih gadolinijem na T1-mjerenoj snimci između 8 i 24 tjedana (na mjesečnom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK INNER CARTON (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KARTONSKA KUTIJA VIŠESTRUKOG PAKIRANJA (bez plavog okvira)
English: • alcohol wipe
Croatian: • vata natopljena alkoholom
English: If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), it is recommended to promptly measure serum transaminases, discontinue treatment with Zinbryta, as appropriate, and promptly refer the patient to a hepatologist.
Croatian: Ako bolesnik razvije kliničke znakove ili simptome koji upućuju na disfunkciju jetre (npr. neobjašnjiva mučnina, povraćanje, bol u abdomenu, umor, anoreksija, ili žutica i/ili tamni urin), preporučuje se odmah izmjeriti serumske transaminaze, prekinuti liječenje Zinbrytom i bolesnika bez odlaganja uputiti hepatologu.
English: Percentage of relapse-free patients
Croatian: Postotak bolesnika bez relapsa
English: Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to daclizumab or to any of the excipients (see section 6.1).
Croatian: Zinbryta je kontraindicirana u bolesnika s anamnezom teške preosjetljivosti (npr. anafilaksija ili anafilaktoidna rekcija) na daklizumab ili na neku od pomoćnih tvari (vidjeti dio 6.1).
English: Let the injection site dry on its own before injecting the dose.
Croatian: Pustite da se mjesto injiciranja samo osuši prije injiciranja doze.
English: Zinbryta is for subcutaneous use.
Croatian: Zinbryta je namijenjena za supkutanu primjenu.
English: • the solution is any other colour than colourless to slightly yellow.
Croatian: • otopina bilo koje druge boje osim bezbojne do blago žute.
English: If a dose is missed and it is more than 2 weeks from the missed dose, patients should skip the missed dose, wait until their next scheduled dose, and then remain on their original monthly dosing schedule.
Croatian: Ako je doza propuštena i prošlo je više od 2 tjedna od propuštene doze, bolesnici trebaju preskočiti propuštenu dozu, pričekati njihovu sljedeću dozu, a zatim nastaviti s izvornim mjesečnim rasporedom doziranja.
English: Before you prepare your injection, take the syringe out of the fridge and let it warm to room temperature.
Croatian: Priprema za injiciranje Napomena: Prije pripreme injekcije, izvadite štrcaljku iz hladnjaka i pustite da se ugrije na sobnu temperaturu.
English: There is limited data on concomitant use of Zinbryta with MS symptomatic therapies.
Croatian: Ograničeni su podaci o primjeni Zinbryte istodobno sa simptomatskim terapijama multiple skleroze.
English: It is not known whether Zinbryta passes into breast milk.
Croatian: Nije poznato da li se Zinbryta izlučuje u majčino mlijeko.
English: Zinbryta pre-filled syringe is for subcutaneous injection (injection into skin).
Croatian: Zinbryta napunjena štrcaljka namijenjena je za supkutanu injekciju (injekciju pod kožu).
English: Upper respiratory tract infection†
Croatian: Infekcija gornjih dišnih putova†
English: In patients with neutralising antibodies, daclizumab clearance was increased on average by 19% (see section 5.2).
Croatian: U bolesnika s neutralizirajućim protutijelima, klirens daklizumaba bio je povišen u prosjeku za 19% (vidjeti dio 5.2).
English: Step 9: Disposing of used Zinbryta Pens
Croatian: 9. korak: Odlaganje iskorištenih Zinbryta brizgalica
English: The incidence of discontinuation due to medicine related hepatic disorders was 5% in Zinbryta-treated patients and 4% in interferon beta-1a (intramuscular).
Croatian: Incidencija prekida liječenja zbog jetrenih poremećaja povezanih s lijekom iznosila je 5% u bolesnika liječenih Zinbrytom i 4% u bolesnika liječenih interferonom beta-1a (intramuskularno).
English: The active substance in Zinbryta is daclizumab.
Croatian: Djelatna tvar Zinbryte je daklizumab.
English: Step 1: Collect your supplies and wash your hands Use a well-lit, clean, flat surface to work on, like a table.
Croatian: Koristite dobro osvijetljenu, čistu i ravnu površinu za rad, poput stola.
English: Total lymphocyte counts <0.8x109 cells/L ([Common Terminology Criteria for Adverse
Croatian: Ukupni broj limfocita <0,8x109 stanica/L
English: If you do develop liver problems your MS doctor may stop your treatment with Zinbryta and refer you to a liver specialist (see section 4, Possible side effects).
Croatian: Vas liječi protiv multiple skleroze može Vam prekinuti liječenje Zinbrytom i uputiti Vas specijalistu za jetru (vidjeti dio 4. Moguće nuspojave)
English: If you do not not undergo your scheduled blood tests your doctor may decide to stop treatment with Zinbryta.
Croatian: Ako se ne pridržavate rasporeda krvnih pretraga, liječnik Vam može odlučiti prekinuti liječenje Zinbrytom.
English: Table 4: SELECT study clinical and MRI results (at 52 weeks) Placebo
Croatian: Tablica 4: Klinički i MR rezultati ispitivanja SELECT (u 52. tjednu)
English: It is not known whether Zinbryta is secreted in human milk.
Croatian: Nije poznato izlučuje li se Zinbryta u ljudsko mlijeko.
English: Pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield containing 1 mL of solution.
Croatian: Napunjena štrcaljka napravljena od stakla (tip 1) s gumenim čepom i termoplastičnim krutim štitnikom igle koja sadrži 1 ml otopine.
English: • The importance of monitoring the liver function (AST, ALT and total bilirubin levels) at least monthly (or more frequently as clinically indicated) as close as possible before each treatment administration, and for up to six months after the last dose;
Croatian: • važnost praćenja funkcije jetre (razine AST-a, ALT-a i ukupnog bilirubina) najmanje jednom mjesečno (ili češće ako je klinički indicirano) što bliže prije svake primjene lijeka, te do šest mjeseci nakon zadnje doze
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C for up to 30 days.
Croatian: • Ako bude potrebno, Zinbryta se može čuvati u zatvorenoj originalnoj kutiji bez rashlađivanja na temperaturi do 30°C do 30 dana.
English: The colitis improved with discontinuation of Zinbryta and standard treatment.
Croatian: Kolitis se poboljšao nakon prekida liječenja Zinbrytom i primjene standardnog liječenja.
English: Baseline characteristics Mean age (years) Mean disease duration (years) Mean number of relapses within 12 months prior to study Median EDSS score Percent with EDSS ≥ 3.5
Croatian: Srednja vrijednost broja relapsa unutar 12 mjeseci prije ispitivanja Medijan EDSS ocjene Postotak s EDSS ≥ 3,5
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OUTER CARTON (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KARTONSKA KUTIJA VIŠESTRUKOG PAKIRANJA (s plavim okvirom)
English: Do not use external heat sources such as hot water to warm Zinbryta pre-filled syringe.
Croatian: Nemojte koristiti vanjske izvore topline kao što je vruća voda da zagrijete Zinbryta napunjenu štrcaljku.
English: Table 1: Adverse reactions reported for Zinbryta 150mg System Organ Class
Croatian: Tablica 1: Nuspojave prijavljene za Zinbrytu od 150 mg Klasifikacija organskih sustava
English: In case a dose is missed and it is within 2 weeks of the missed dose, patients should be instructed to inject without delay their missed dose and then remain on their original monthly dosing schedule.
Croatian: Ako je doza propuštena i nisu još prošla 2 tjedna od propuštene doze, bolesnike treba uputiti da bez odgađanja injiciraju propuštenu dozu čim se sjete, a zatim nastave s izvornim mjesečnim rasporedom doziranja.
English: • your skin or the whites of the eyes turn yellow Increased tiredness, dark urine and skin or whites of the eyes turning yellow also may be symptoms of liver problems, see section above on liver problems.
Croatian: Povećan umor, tamna mokraća i žuta boja kože ili bjeloočnica mogu također biti simptomi problema s jetrom, vidjeti prethodni dio o problemima s jetrom.
English: • inflamed or enlarged lymph nodes (lymphadenopathy, lymphadenitis)
Croatian: • upaljeni ili povećani limfni čvorovi (limfadenopatija, limfadenitis)
English: • Very common (≥ 1/10)
Croatian: • vrlo često (≥ 1/10)
English: Elimination As an IgG1 monoclonal antibody, daclizumab is not expected to undergo renal elimination.
Croatian: Eliminacija Budući da je IgG1 monoklonsko protutijelo, za daklizumab se ne očekuje eliminacija putem bubrega.
English: Marketing Authorisation Holder Biogen Idec Ltd.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Biogen Idec Ltd.
English: • The importance of the liver function monitoring, at least monthly during treatment (or more frequently as clinically indicated), and for up to 6 months after the last dose;
Croatian: • navesti važnost praćenja funkcije jetre najmanje jednom mjesečno tijekom liječenja (ili češće ako je klinički indicirano) te do 6 mjeseci nakon zadnje doze
English: • increased tiredness
Croatian: • povećan umor
English: 1.0 point improvement p=0.0008
Croatian: pogoršanje od 3,0 boda poboljšanje od 1,0 bod p=0,0008
English: If you remove the cap, do not re-cap the pen.
Croatian: Ako zatvarač ipak skinete, nemojte ga vraćati na brizgalicu.
English: The Card informs patients of the risk of serious hepatic injury, and its possible symptoms, so that they are aware of situations in which they should contact a healthcare professional in a timely manner.
Croatian: Kartica obavještava bolesnika o riziku od ozbiljnog oštećenja jetre i mogućim simptomima, kako bi znao u kojoj se situaciji treba pravodobno obratiti zdravstvenom radniku.
English: Total exposure (subject-years) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
Croatian: > 5 x GGN > 10 x GGN > 20 x GGN
English: Parts of the Zinbryta pre-filled syringe (See Figure C)
Croatian: Dijelovi Zinbryta napunjene štrcaljke (vidjeti sliku C)
English: Pre-existing hepatic disease or hepatic impairment (see section 4.4).
Croatian: Postojeća bolest jetre ili oštećenje jetre (vidjeti dio 4.4).
English: Percentage of patients with clinically meaningful worsening in MSIS-29
Croatian: Postotak bolesnika s klinički značajnim pogoršanjem u fizičkoj ocjeni MSIS-29 (≥7,5 bodova)
English: In the active-controlled study (the DECIDE study), 919 patients received Zinbryta (150 mg, every 4 weeks) and 922 patients received interferon beta-1a intramuscular, (30 microgram weekly) for a minimum of 2 years and up to 3 years.
Croatian: U aktivno kontroliranom ispitivanju (ispitivanje DECIDE), 919 bolesnika je primalo Zinbrytu (150 mg, svaka 4 tjedna) i 922 bolesnika je primalo interferon beta-1a intramuskularno (30 mikrograma tjedno) najmanje 2 godine, a najviše 3 godine.
English: • The need to provide the patient with the Patient Card and the Acknowledgment Form, discuss their content before starting Zinbryta treatment, informing patients of the risk of hepatic injury, the need for periodic monitoring and the signs or symptoms suggestive of hepatic dysfunction.
Croatian: • potrebu da bolesnik prije nego što započne liječenje Zinbrytom dobije Karticu za bolesnika i Obrazac potvrde o upoznatosti s rizicima, da bolesnicima objasne sadržaj tih dokumenata koji bolesnike upoznaju s rizikom od oštećenja jetre, potrebom za periodičnim praćenjem i znakovima ili simptomima koji ukazuju na disfunkciju jetre.
English: Caution is recommended when administering medicinal products of known hepatotoxic potential including non-prescription products and herbal supplements concomitantly with Zinbryta (see section 4.4).
Croatian: Preporučuje se oprez kada se lijekovi poznatog hepatotoksičnog potencijala, uključujući bezreceptne lijekove i biljne pripravke, primjenjuju istodobno s lijekom Zinbryta (vidjeti dio 4.4).
English: The SELECT study was double-blind, randomised, placebo-controlled, with either Zinbryta 150 mg (n=208), or 300 mg (n=209) versus placebo (n=204) every 4 weeks for 52 weeks.
Croatian: SELECT je bilo dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje sa Zinbrytom od 150 mg (n = 208) ili 300 mg (n = 209) u odnosu na placebo (n = 204) primijenjene svaka 4 tjedna tijekom 52 tjedana.
English: LIST OF EXCIPIENTS Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
Croatian: Natrijev sukcinat, sukcinatna kiselina, natrijev klorid, polisorbat 80, voda za injekcije
English: In clinical studies, Zinbryta increased the incidence of depression [5% vs 1% (placebo); 8% vs 6% (interferon beta-1a (intramuscular))]; the incidence of serious reactions of depression was <1% with Zinbryta.
Croatian: U kliničkim ispitivanjima Zinbryta je povećala incidenciju depresije [5% naspram 1% (placebo); 8% naspram 6% (interferon beta-1a (intramuskularno)]; incidencija ozbiljnih nuspojava depresije bila je <1% sa Zinbrytom.