FrancophonIA/ELRC3.0 huggingface dataset:
English: Together, these immunomodulatory effects of daclizumab are believed to reduce CNS pathology in MS and thereby reduce the occurrence of relapses and disability progression.
Croatian: Smatra se da ovi imunomodulirajući učinci daklizumaba zajedno smanjuju patologiju SŽS-a u MS-u te time smanjuju pojavu relapsa i napredovanja onesposobljenosti.
English: # Hazard ratio for the risk of relapse.
Croatian: # Omjer hazarda za rizik od relapsa.
English: Use caution when removing the needle cover to avoid getting a needle injury.
Croatian: Budite oprezni kad skidate pokrov igle kako bi izbjegli ozljedu iglom.
English: The majority of patients had skin reactions that were mild or moderate in severity.
Croatian: Većina bolesnika imala je kožne reakcije koje su bile blage ili umjerene težine.
English: The safety of doses above 300 mg administered subcutaneously and 400 mg intravenously have not been evaluated.
Croatian: Sigurnost primjene doza iznad 300 mg primijenjenih supkutano i 400 mg intravenski nije procijenjena.
English: • The recommendation not to initiate treatment in patients with autoimmune disorders (other than multiple sclerosis);
Croatian: • preporuku da ne započinju liječenje u bolesnika s autoimunim poremećajima (osim multiple skleroze)
English: Check the medicine window.
Croatian: Provjerite prozorčić za lijek.
English: Do not try to treat any side effects yourself.
Croatian: Nemojte pokušati sami liječiti nijednu nuspojavu.
English: In MS, the body's immune system causes inflammation which damages the protective sheath (called myelin) around the nerves in the central nervous system (including the brain and spinal cord).
Croatian: U multiploj sklerozi imunološki sustav tijela uzrokuje upalu koja oštećuje zaštitnu ovojnicu (pod nazivom mijelin) oko živaca u središnjem živčanom sustavu (uključujući mozak i leđnu moždinu).
English: • 1 Zinbryta 150 mg Pen (see Figure A) Before Use - Parts of Zinbryta Pen (See Figure A):
Croatian: • 1 Zinbryta 150 mg brizgalica (vidjeti sliku A) Prije upotrebe - dijelovi Zinbryta brizgalice (vidjeti sliku A):
English: • If some areas are too difficult for you to reach, ask a carer who has been trained to help you.
Croatian: • Ako Vam je teško doprijeti do nekih područja, zamolite za pomoć njegovatelja koji je prošao obuku kako bi Vam mogao pomoći.
English: Potential adverse reactions beyond this level are expected to be consistent with the safety profile for daclizumab in MS patients.
Croatian: Očekuje se da će potencijalne nuspojave iznad te razine biti u skladu sa sigurnosnim profilom za daklizumab u bolesnika s MS-om.
English: Your doctor will tell you how long you need to keep using Zinbryta.
Croatian: Vaš liječnik će Vam reći kako dugo trebate nastaviti primjenjivati Zinbrytu.
English: Zinbryta works by stopping the body's immune system from damaging your brain and spinal cord.
Croatian: Zinbryta djeluje tako da sprečava imunološki sustav tijela da oštećuje mozak i leđnu moždinu.
English: Collect all the supplies you will need to give yourself or to receive an injection.
Croatian: Prikupite sav pribor koji trebate za samostalno davanje injekcije ili da primite injekciju.
English: Chronic administration of daclizumab at all doses increased the incidence of skin findings (compared to those observed in control animals).
Croatian: Kronična primjena daklizumaba pri svim dozama povećala je incidenciju nalaza na koži (u odnosu na one opažene kod kontrolnih životinja).
English: You should see a yellow plunger.
Croatian: Trebali biste vidjeti žuti klip.
English: The risk of Progressive Multifocal Leukoencephalopathy (PML) associated to the treatment with Zinbryta has not been established.
Croatian: Nije ustanovljen rizik od progresivne multifokalne leukoencefalopatije (PML) povezan s liječenjem Zinbrytom.
English: Hold the Zinbryta pre-filled syringe at a 45°-90° angle to the injection site (see Figure I).
Croatian: Držite Zinbryta napunjenu štrcaljku pod kutom od 45°- 90° prema mjestu injekcije (vidjeti sliku I).
English: No meaningful differences in clinical efficacy or safety were observed among the subgroups of MS patients by weight quartile in the DECIDE study.
Croatian: Nisu uočene značajne razlike u kliničkoj djelotvornosti ili sigurnosti među podskupinama bolesnika s MS-om po kvartilu tjelesne težine u ispitivanju DECIDE.
English: Do not use the pen if:
Croatian: Nemojte koristiti brizgalicu ako:
English: • Patients with 2 or more relapses in 1 year, and with 1 or more Gd-enhancing lesions on brain MRI, or
Croatian: • Bolesnici s 2 ili više relapsa u 1 godini, i s 1 ili više lezija imbibiranih gadolinijem na MR snimci mozga, ili
English: Treatment with Zinbryta can help to prevent you from getting worse, although it will not cure MS.
Croatian: Liječenje Zinbrytom može pomoći spriječiti pogoršavanje, iako neće izliječiti multiplu sklerozu.
English: All physicians who intend to prescribe Zinbryta must ensure they are familiar with the Hepatic Risk Management Guide for Physicians for this medicinal product.
Croatian: Svi liječnici koji namjeravaju propisivati Zinbrytu moraju dobro poznavati Vodič za liječnike o zbrinjavanju rizika za jetru za ovaj lijek.
English: Make sure you can see the green stripes in the injection status window (see Figure F).
Croatian: Provjerite možete li vidjeti zelene trake u prozorčiću stanja injekcije (vidjeti sliku F).
English: You will need: - a blood test before starting treatment to check your liver function and if you have hepatitis B
Croatian: Trebat ćete provesti: - testiranje krvi prije početka liječenja kako bi se provjerila funkcija jetre te ustanovilo imate li hepatitis B ili C.
English: If Zinbryta has been outside of the refrigerator for more than a total of 30 days or if you are not sure how long Zinbryta has been at room temperature, it should be discarded.
Croatian: Ako je Zinbryta bila izvan hladnjaka dulje od ukupno 30 dana ili ako niste sigurni koliko je dugo Zinbryta bila na sobnoj temperaturi, treba je baciti.
English: Race No pharmacokinetic differences were observed between Japanese and Caucasian healthy volunteers.
Croatian: Rasa Nisu opažene razlike u farmakokinetici između zdravih dobrovoljaca japanskog podrijetla i bijele rase.
English: In a clinical study, patients (n=90) on long-term treatment with Zinbryta mounted appropriate immune responses to an inactivated trivalent seasonal influenza vaccine.
Croatian: U kliničkom ispitivanju, bolesnici (n = 90) na dugotrajnom liječenju Zinbrytom razvili su odgovarajuće imunološke odgovore na inaktivirano trovalentno cjepivo protiv sezonske gripe.
English: If you need a vaccination, ask your doctor first because Zinbryta may affect how well vaccines work.
Croatian: Ako Vam je potrebno cijepljenje, najprije pitajte svog liječnika jer Zinbryta može utjecati na učinkovitost cjepiva.
English: In addition to this leaflet you will be given a Patient Card by your doctor.
Croatian: Pored ove upute o lijeku, liječnik će Vam dati Karticu za bolesnika.
English: p<0.0001 * Rates and risk reductions/endpoints are calculated over the treatment period up to 144 weeks.
Croatian: * Stope i smanjenja rizika/ishodi izračunati su tijekom razdoblja liječenja do 144 tjedna.
English: After the clicking sound has stopped, lift the pen from your injection site.
Croatian: Kada je zvuk klikanja prestao, podignite brizgalicu s mjesta injekcije.
English: Some side effects may require your doctor to interrupt your treatment and refer you to a specialist.
Croatian: Neke nuspojave zahtijevaju da liječnik prekine Vaše liječenje i uputi Vas specijalistu.
English: Influenza†
Croatian: Gripa†
English: Zinbryta contains a small amount of sodium
Croatian: Zinbryta sadrži malu količinu natrija
English: Seasonal flu vaccines (inactive vaccine) have been shown to be effective when given to patients taking Zinbryta.
Croatian: Sezonska cjepiva protiv gripe (neaktivna cjepivo) su se pokazala učinkovitima kada se daju bolesnicima koji uzimaju Zinbrytu.
English: • You do not see the green stripes in the injection status window.
Croatian: • ne vidite zelene trake u prozorčiću stanja injekcije
English: Stomach pain may also be a symptom of liver problems, see section above on liver problems.
Croatian: Bol u želucu može također biti simptom problema s jetrom, vidjeti prethodni dio o problemima s jetrom.
English: These may be signs of a serious liver problem.
Croatian: To mogu biti znakovi ozbiljnih problema s jetrom.
English: Additional supplies which are not included in the pack (See Figure B):
Croatian: Dodatni pribor koji nije uključen u pakiranje (vidjeti sliku B):
English: The majority of the treatment-emergent anti-drug antibodies responses were transient (12% [110/913]) and the remaining minority (7% [65/913]) were persistent.
Croatian: Većina odgovora s protutijelima na lijek nastalima liječenjem bila je prolazna (12% [110/913]), a preostala manjina (7% [65/913]) bila je trajna.
English: • runny nose (rhinitis)
Croatian: • curenje iz nosa (rinitis)
English: Total NK cell counts increased approximately 1.5-fold as a result of the change in CD56bright NK cells.
Croatian: Ukupni broj NK stanica povećao se približno 1,5 puta, kao rezultat promjene u broju CD56bright NK
English: As renal excretion is not a major route of elimination, no dose adjustments are considered necessary (see section 5.2).
Croatian: Budući da izlučivanje putem bubrega nije glavni put eliminacije, ne smatra se potrebnim prilagoditi dozu (vidjeti dio 5.2).
English: These symptoms may suggest problems with your liver.
Croatian: Ovi simptomi mogu ukazivati na probleme s jetrom.
English: People with relapsing MS have repeated attacks (relapses) of symptoms caused by their nerves not working properly.
Croatian: Osobe s relapsnom multiplom sklerozom imaju ponavljane napade (relapse) simptoma uzrokovanih neispravnim radom živaca.
English: • Check that the Zinbryta medicine is colourless or slightly yellow (See Figure E).
Croatian: • Provjerite da je lijek Zinbryta bezbojan ili blago žut (vidjeti sliku E).
English: Following subcutaneous administration of daclizumab, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Croatian: Nakon supkutane primjene daklizumaba, medijan vremena do postizanja maksimalne koncentracije u serumu (Tmax) kretao se u rasponu od 5 do 7 dana.
English: Zinbryta is used to treat relapsing forms of multiple sclerosis (MS) in adults who have failed to respond despite therapy with at least two MS treatment and who cannot be given other treatments.
Croatian: Zinbryta se primjenjuje za liječenje relapsnih oblika multiple skleroze (MS) u odraslih u kojih nije postignut odgovor unatoč najmanje dvije terapije protiv multiple skleroze i koji se ne mogu liječiti drugim terapijama.
English: Step 6: Inject Medicine
Croatian: 6. korak: Injiciranje lijeka
English: Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.
Croatian: Nemojte dizati brizgalicu s mjesta injiciranja sve dok ne prestane zvuk klikanja i dok ne vidite zelene kvačice u prozorčiću stanja injekcije.
English: • decreases in the amount of white blood cells (these will show up in blood tests)
Croatian: • smanjenje broja bijelih krvnih stanica (to će se pojaviti u krvnim testovima)
English: Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Zinbryta should be allowed to warm to room temperature (20°C-30°C) (about 30 minutes) prior to injection.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Jednom kad se izvadi iz hladnjaka, Zinbrytu treba ostaviti (oko 30 minuta) da se ugrije do sobne temperature (20°C-30°C) prije primjene injekcije.
English: o Make sure Zinbryta is out of the refrigerator for no longer than 30 days.
Croatian: o Pobrinite se da Zinbryta nije izvan hladnjaka dulje od 30 dana.
English: The safety and efficacy of Zinbryta in children and adolescents below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Zinbryte u djece i adolescenta u dobi ispod 18 godina nisu još ustanovljene.
English: Mean change in MSIS-29 physical score
Croatian: Srednja vrijednost promjene u fizičkoj ocjeni MSIS-29
English: Prior to treatment initiation with Zinbryta, serum transaminases (ALT and AST) and total bilirubin levels should be obtained, and patients should be screened for Hepatitis B (HBV) and C (HCV).
Croatian: Prije početka liječenja Zinbrytom potrebno je odrediti razine serumskih transaminaza (ALT i AST) i ukupnog bilirubina, a bolesnike testirati na hepatitis B (HBV) i C (HCV).
English: Do not touch or blow on this area again before giving your injection.
Croatian: Nemojte ponovno dirati ili puhati na to područje prije davanja injekcije.
English: If serious infection develops, it could be necessary to withhold treatment with Zinbryta until the infection resolves.
Croatian: Ako dođe do ozbiljnih infekcija, može biti potreban prekid liječenja Zinbrytom dok se infekcija ne riješi.
English: Do not use more than one pre-filled syringe per month.
Croatian: Nemojte koristiti više od jedne napunjene štrcaljke mjesečno.
English: Daclizumab was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Croatian: Daklizumab je otkriven u mlijeku 11/14 ženki majmuna u laktaciji na razinama koje su bile <0,122% od razina u serumu majke, bez nuspojava opaženih u mladunčadi.
English: In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Croatian: In vitro istražna ispitivanja upućuju na to da agregati mikroglije nisu posljedica izravnog učinka daklizumaba na stanice mikroglije, nego su vjerojatno posljedica povećanja lokalne bioraspoloživosti IL-2.
English: Choose an injection site and wipe the skin with an alcohol wipe.
Croatian: Odaberite mjesto za injiciranje i obrišite kožu vatom natopljenom alkoholom.
English: Daclizumab did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Croatian: Daklizumab nije utjecao na reproduktivni kapacitet ženki i mužjaka makaki majmuna (AUC u ženki i mužjaka do 85 odnosno 100 puta veći od izloženosti pri kliničkoj dozi).
English: Check the medicine window and make sure the Zinbryta medicine is colourless to slightly yellow.
Croatian: Provjerite prozorčić za lijek i provjerite je li lijek Zinbryta bezbojan do blago žut.
English: Cumulative incidences of peak ALT or AST increase (based on laboratory data) observed in clinical trials
Croatian: Tablica 2. Kumulativna incidencija porasta vršnih vrijednosti ALT ili AST (na temelju laboratorijskih podataka) opažena u kliničkim ispitivanjima
English: Zinbryta should be administered with caution to patients with previous or current depressive disorders.
Croatian: Depresija Zinbrytu treba primjenjivati s oprezom u bolesnika s prethodnim ili trenutnim depresivnim poremećajima.
English: If a woman wishes to breast-feed during treatment with Zinbryta, the benefit of breast-feeding to the child and of therapy to the woman should be considered.
Croatian: Ako žena želi dojiti tijekom liječenja Zinbrytom, treba razmotriti korist dojenja za dijete i korist terapije za ženu.
English: There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab.
Croatian: Nije bilo vidljive korelacije između razvoja protutijela na lijek ili neutralizirajućih protutijela i kliničkog odgovora, nuspojava ili farmakodinamičkog profila daklizumaba.
English: Do not try to treat any side effects yourself, but contact your doctor or nurse.
Croatian: Nemojte pokušati sami liječiti nijednu nuspojavu, nego se obratite Vašem liječniku ili medicinskoj sestri.
English: • The liquid is cloudy or contains floating particles.
Croatian: • tekućina je zamućena ili sadrži plutajuće čestice.
English: Daclizumab is produced in a mammalian cell line (NS0) by recombinant DNA technology.
Croatian: Daklizumab je proizveden tehnologijom rekombinantne DNK u staničnoj liniji sisavaca (NS0).
English: Based on the cross-study population pharmacokinetic analysis, daclizumab pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Croatian: Na temelju analize populacijske farmakokinetike između ispitivanja, na farmakokinetiku daklizumaba nisu utjecali dob (raspon: 18 do 66 godina; n=1670) niti spol (n = 567 muškaraca i 1103 žena).
English: • infections of the airways, such as coughs and colds (nasopharyngitis, upper respiratory tract infection)
Croatian: • infekcije dišnih putova, kao što su kašalj i prehlada (nazofaringitis, infekcija gornjih dišnih putova)
English: Your pen is now ready to inject.
Croatian: Brizgalica je sada spremna za injiciranje.
English: Zinbryta is injected monthly.
Croatian: Zinbryta se ubrizgava jednom mjesečno.
English: This could lock the pen.
Croatian: To bi moglo zakočiti brizgalicu.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines and herbal supplements.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzimati bilo koje druge lijekove i biljne dodatke prehrani.
English: This tells you that the injection is happening (see Figure G).
Croatian: To znači da se lijek ubrizgava (vidjeti sliku G).
English: The majority of patients with lymphadenopathy continued on treatment with Zinbryta, and the majority of cases resolved within 3 months.
Croatian: Većina bolesnika s limfadenopatijom nastavila je liječenje Zinbrytom, a većina slučajeva riješila se u roku od 3 mjeseca.
English: A dose dependent increase in incidence of microglial aggregates above background was observed in the brain and spinal cord of monkeys treated with ≥35 mg/kg, (AUC 27 times higher than the clinical dose).
Croatian: O dozi ovisno povećanje incidencije agregata mikroglije iznad pozadine opaženo je u mozgu i leđnoj moždini majmuna tretiranih s ≥35 mg/kg, (AUC 27 puta veća od kliničke doze).
English: The efficacy of Zinbryta was demonstrated in two studies (SELECT and DECIDE) in patients with RMS.
Croatian: Djelotvornost Zinbryte dokazana je u dva ispitivanja (SELECT i DECIDE) u bolesnika s relapsnim oblikom multiple skleroze (RMS).
English: Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab in milk (for details see section 5.3).
Croatian: Dostupni toksikološki podaci u makaki majmuna u laktaciji pokazali su izlučivanje daklizumaba u mlijeko (za detalje vidjeti dio 5.3).
English: You could get a needle injury or the pen may lock.
Croatian: Možete se ozlijediti iglom ili se brizgalica može zakočiti.
English: It is recommended that patients should be trained in the proper technique for self-administering subcutaneous injection using the pre-filled syringe/pre-filled pen.
Croatian: Preporučuje se obučiti bolesnike odgovarajućoj metodi za samostalno davanje supkutane injekcije pomoću napunjene štrcaljke/napunjene brizgalice.
English: Zinbryta has not been studied in patients with immunodeficiency syndromes.
Croatian: Zinbryta nije ispitivana u bolesnika sa sindromima imunodeficijencije.
English: The most common skin reactions were rash, dermatitis, and eczema.
Croatian: Najčešće kožne reakcije bile su osip, dermatitis i ekcem.
English: Sustained severe lymphopenia (< 500/mm3), was not observed in clinical studies with Zinbryta.
Croatian: Trajna teška limfopenija (< 500/mm3) nije bila opažena u kliničkim ispitivanjima Zinbryte.
English: • The management of patients receiving Zinbryta and presenting with signs and symptoms of potential hepatic injury, including treatment discontinuation, potential consideration of additional therapy, and prompt referral to a hepatologist;
Croatian: • potrebu zbrinjavanja bolesnika koji primaju Zinbrytu, a imaju znakove i simptome potencijalnog oštećenja jetre, uključujući prekid liječenja, potencijalno razmatranje dodatne terapije i brzo upućivanje hepatologu
English: • Keep the Zinbryta pre-filled syringe/pen in its original package to protect from light.
Croatian: • Čuvajte Zinbryta napunjenu štrcaljku/brizgalicu u originalnom pakiranju radi zaštite od svjetlosti.
English: The MAH shall ensure that in each EU MS where Zinbryta is marketed, all prescribers are provided with an educational package, aiming at preventing and/or minimising the risk of serious hepatic injury (potentially life threatening or fatal) and informing the patients about the unpredictability of these events and containing the following elements:
Croatian: Nositelj odobrenja pobrinut će se da svi propisivači u svakoj državi članici Europske unije u kojoj će lijek Zinbryta biti stavljen na tržište, dobiju edukacijski materijal kako bi se spriječio i/ili minimizirao rizik od ozbiljnog oštećenja jetre (koje može biti životno opasno ili imati smrtni ishod) i obavijestilo bolesnike o nepredvidljivosti tih događaja.
English: In two 9 month studies in monkeys there were no pre-neoplastic or neoplastic tissue observed.
Croatian: U dva 9-mjesečna ispitivanja u majmuna nije bila uočena pojava preneoplastičnih ili neoplastičnih tkiva.
English: Depression*
Croatian: Depresija*
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Croatian: Ključni učinci ove modulacije signalnog puta IL-2 potencijalno povezani s terapijskim učincima daklizumaba u multiploj sklerozi uključuju selektivni antagonizam odgovora aktiviranih T-stanica i ekspanziju imunoregulatornih CD56bright stanica prirodnih ubojica (NK), za koje je pokazano da selektivno smanjuju broj aktiviranih T-stanica.
English: Treatment discontinuation is recommended in patients who reach ALT or AST >3 times the ULN regardless of bilirubin levels.
Croatian: Prekid liječenja preporučuje se u bolesnika u kojih vrijednost ALT ili AST dosegne >3 puta GGN bez obzira na razine bilirubina.
English: AST or ALT ≥ 3 x ULN AND total bilirubin ≥ x 2 ULN
Croatian: AST ili ALT ≥ 3 x GGN i ukupni bilirubin ≥ x 2 GGN
English: • The contraindication in all patients with pre-existing hepatic disease or hepatic impairment;
Croatian: • kontraindikaciju u svih bolesnika s postojećom bolesti jetre ili oštećenjem jetre
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete,
English: Liver function test abnormal
Croatian: Abnormalni test funkcije jetre
English: Hold the pen over your injection site.
Croatian: Držite brizgalicu iznad mjesta za injiciranje.
English: Cases occurred early after treatment initiation, in patients having received repeated treatment courses and several months after discontinuation.
Croatian: Ti su slučajevi zabilježeni ubrzo nakon započetog liječenja u bolesnika koji su primali ponavljane cikluse terapije i nekoliko mjeseci nakon prekida liječenja.
English: Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.
Croatian: U skladu s rezultatima iz pojedinačnih ispitivanja, analiza populacijske farmakokinetike između ispitivanja pokazala je da je izloženost daklizumabu više nego proporcionalna dozi u rasponu supkutanih doza od 50 mg do 100 mg, a proporcionalna je dozi u rasponu supkutanih doza od 100 mg do 300 mg.