FrancophonIA/ELRC3.0 huggingface dataset:
English: If you do not notice that you have missed a dose until it is already time for your next dose, then just inject this next dose as planned.
Croatian: Ako primijetite da ste propustili dozu tek kad je već vrijeme za sljedeću, jednostavno injicirajte sljedeću dozu kako ste i planirali.
English: • if you are HIV positive or have low immunoglobulin levels
Croatian: • ako ste HIV pozitivni ili imate nisku razinu imunoglobulina
English: Depression can affect up to 1 in 10 people, suicidal thoughts and suicide attempts can affect up to 1 in 100 people.
Croatian: Depresija se može javiti u do 1 na 10 osoba, dok se samoubilačke misli i pokušaji samoubojstva mogu javiti u do 1 na 100 osoba.
English: This medicine is not intended for use in children younger than 5 years of age.
Croatian: Ovaj lijek nije namijenjen za primjenu u djece mlađe od 5 godina.
English: You may hear a second “click" a few seconds before the purple indicator stops moving.
Croatian: Možda ćete čuti drugi 'klik' nekoliko sekundi prije nego što se ljubičasti indikator zaustavi. (Slika 10)
English: • nose, throat or stomach infection
Croatian: • infekcije nosa, grla ili želuca
English: • Find a comfortable, well-lit and clean surface and place the following supplies within reach:
Croatian: • Pronađite udobnu, dobro osvijetljenu i čistu površinu i na nju položite sljedeći pribor, tako da Vam bude nadohvat ruke:
English: If you get any of the following symptoms of an infection:
Croatian: Ako dobijete neke od sljedećih simptoma infekcije:
English: Take a dose on the new day (even if it is less than a week since your last dose).
Croatian: Primijenite dozu na željeni dan (čak i ako je od posljednje doze prošlo manje od tjedan dana).
English: It is normal to see one or more air bubbles in the solution.
Croatian: Normalno je da u otopini bude jedan ili više zračnih mjehurića.
English: Reconstitution is typically complete within 10 to 15 minutes after the water has been added, but it may take up to 30 minutes.
Croatian: Rekonstitucija je najčešće završena unutar 10 do 15 minuta nakon dodavanja vode, no može potrajati i do 30 minuta.
English: Tell your doctor immediately if you have any of these symptoms, or similar problems that have lasted over several days.
Croatian: Odmah obavijestite svog liječnika ako imate bilo koji od tih simptoma ili slične tegobe koje traju nekoliko dana.
English: Allow the skin to air dry.
Croatian: Pričekajte da se koža osuši na zraku.
English: • Do not use if dropped onto a hard surface.
Croatian: • Nemojte je upotrijebiti ako je pala na tvrdu površinu.
English: No new safety signals were observed in the paediatric population 12 years of age and above (n=43).
Croatian: Nisu opaženi novi sigurnosni signali u pedijatrijskoj populaciji u dobi od 12 ili više godina (n=43).
English: Benlysta is not compatible with 5% glucose.
Croatian: Benlysta nije kompatibilna s 5% glukozom.
English: Intravenous infusion in adults
Croatian: Intravenska infuzija u odraslih
English: • low white blood cell count (can be seen in blood tests)
Croatian: • sniženi broj bijelih krvnih stanica (vidi se u nalazima krvnih pretraga)
English: • no worsening (<0.30 point increase) in Physician's Global Assessment score (PGA)
Croatian: • bez pogoršanja (porast bodova za < 0,30) rezultata PGA (Physician's Global Assessment score).
English: Because of its mechanism of action, belimumab may interfere with the response to immunisations.
Croatian: Zbog svog mehanizma djelovanja, belimumab može interferirati s odgovorom na imunizacije.
English: Reconstitution and dilution must be carried out under aseptic conditions.
Croatian: Rekonstitucija i razrjeđivanje moraju biti provedeni u aseptičkim uvjetima.
English: • high temperature or fever
Croatian: • povišena tjelesna temperatura ili vrućica
English: The study was not powered for any statistical comparisons and all data are descriptive.
Croatian: Ispitivanje nije imalo statističku snagu ni za kakvu statističku usporedbu te su svi podaci opisni.
English: The needle will automatically rise up into the needle guard.
Croatian: Igla će se automatski uvući u štitnik igle.
English: No treatment-related changes were noted in the male and female reproductive organs of sexually mature animals.
Croatian: Nisu uočene promjene vezane uz liječenje na muškim i ženskim reproduktivnim organima spolno zrelih životinja.
English: It is not necessary to inject two doses on the same day.
Croatian: Nije potrebno injicirati dvije doze isti dan.
English: The majority did not necessitate drug discontinuation.
Croatian: Većina ih nije zahtijevala prekid primjene lijeka.
English: In particular tell your doctor if you are being treated with medicines that affect your immune system:
Croatian: Osobito je važno da kažete liječniku ako se liječite lijekovima koji utječu na imunološki sustav, kao što su:
English: Gently swirl the vial for 60 seconds.
Croatian: Nježno vrtite bočicu tijekom 60 sekundi.
English: If you feel depressed, have thoughts about harming yourself or other distressing thoughts, or if you are depressed and notice that you feel worse or develop new symptoms:
Croatian: Ako se osjećate depresivno, razmišljate o tome da si naudite ili imate druge uznemirujuće misli, odnosno ako ste depresivni i primijetite da se osjećate gore ili da imate nove simptome:
English: Protect the reconstituted solution from sunlight.
Croatian: Zaštitite rekonstituiranu otopinu od sunčeve svjetlosti.
English: • if you are planning to have a vaccination or have had a vaccination within the last 30 days.
Croatian: • ako se planirate cijepiti ili ste cijepljeni u zadnjih 30 dana.
English: Maximum serum concentrations of belimumab were generally observed at, or shortly after, the end of the infusion.
Croatian: Maksimalne serumske koncentracije belimumaba su općenito bile zamijećene na kraju ili ubrzo nakon infuzije.
English: You may hear a first “click” at the start of the injection.
Croatian: Možda ćete na početku injekcije čuti prvi 'klik'.
English: • if you are allergic to belimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na belimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Do not perform the injection if you do not have all the supplies listed.
Croatian: • Nemojte injicirati lijek ako nemate sav navedeni pribor.
English: The infusion rate may be slowed or interrupted if the patient develops an infusion reaction.
Croatian: Brzina infuzije se može smanjiti ili privremeno prekinuti ako bolesnik razvije infuzijsku reakciju.
English: You are usually given Benlysta on the first day of treatment then again 14 and 28 days later.
Croatian: Uobičajeno je da se Benlysta primjenjuje na prvi dan liječenja, te ponovno 14 i 28 dana kasnije.
English: • Do not let the needle touch any surface.
Croatian: • Nemojte dopustiti da igla dodiruje bilo kakvu površinu.
English: * All patients received standard therapy
Croatian: *Svi su bolesnici primali standardnu terapiju
English: Do not sell separately.
Croatian: Ne smije se prodavati zasebno.
English: • If you become pregnant while being treated with Benlysta, tell your doctor.
Croatian: • Ako zatrudnite za vrijeme liječenja lijekom Benlysta, obavijestite svog liječnika.
English: Continue to hold the pen down until the purple indicator has stopped moving.
Croatian: Držite brizgalicu pritisnutom sve dok se ljubičasti indikator ne prestane pomicati.
English: No carcinogenicity studies or fertility studies (male or female) have been performed.
Croatian: Nisu provedena ispitivanja karcinogenosti niti plodnosti (muške ili ženske).
English: Contact your doctor or go to a hospital straight away.
Croatian: Odmah se obratite svom liječniku ili otiđite u bolnicu.
English: Response, n (%)
Croatian: Odgovor, n (%)
English: Read the information ‘Increased risk of brain infection' in section 4 of this leaflet.
Croatian: Pročitajte informacije u odlomku 'Povećan rizik od infekcije mozga' u dijelu 4. ove upute.
English: You will be checked closely and if you do have any reactions these will be treated.
Croatian: Pažljivo će Vas se pratiti, a bilo kakva reakcija će biti liječena.
English: Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available.
Croatian: Stoga Benlysta treba biti primijenjena u okruženju u kojem je odmah dostupna oprema za zbrinjavanje takvih reakcija.
English: Do not give Benlysta as a subcutaneous injection to children or adolescents younger than 18 years of age.
Croatian: Nemojte dati lijek Benlysta za potkožnu injekciju djeci ni adolescentima mlađima od 18 godina.
English: There are insufficient data to draw conclusions regarding response to other vaccines.
Croatian: Nema dovoljno podataka za donošenje zaključka o odgovoru na druga cjepiva.
English: Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza i reproduktivne toksičnosti.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: The maximum serum concentration was 313 µg/ml (range: 173-573 µg/ml) based on simulating the concentration time profile using the typical parameter values of the population pharmacokinetic model.
Croatian: Maksimalna serumska koncentracija je iznosila 313 µg/ml (raspon: 173-573 µg/ml) temeljeno na simulaciji vremenskog profila koncentracije koristeći tipične parametarske vrijednosti populacijskog farmakokinetičkog modela.
English: Some infections can be severe and can uncommonly cause death.
Croatian: Neke infekcije mogu biti teške i mogu manje često uzrokovati smrt.
English: It is not known if belimumab could be an indirect modulator of such cytokines.
Croatian: Nije poznato bi li belimumab mogao biti neizravan modulator takvih citokina.
English: Other possible side effects: Very common side effects
Croatian: Ostale moguće nuspojave: Vrlo česte nuspojave
English: • if you have, or have had, hepatitis B or C
Croatian: • ako imate ili ste preboljeli hepatitis B ili C
English: Keeping hold of the syringe, slowly move your thumb back, allowing the plunger to rise up (Figure 9).
Croatian: Držeći štrcaljku na mjestu, polako pomaknite palac prema gore da bi se klip vratio nazad (Slika 9).
English: It is not necessary to administer two doses on the same day.
Croatian: Nije potrebno primijeniti dvije doze isti dan.
English: Elderly: Benlysta has been studied in a limited number of elderly patients.
Croatian: Starije osobe: Benlysta je ispitivana na ograničenom broju starijih bolesnika.
English: It can affect almost any organ in the body, and is thought to involve a type of white blood cells called B cells.
Croatian: Može zahvatiti bilo koji organ u tijelu, a smatra se da je posredovan tipom bijelih krvnih stanica koje se zovu B limfociti.
English: • Keep refrigerated until 30 minutes before use.
Croatian: • Čuvati u hladnjaku do 30 minuta prije primjene.
English: Few patients with ADA reported serious/severe AEs.
Croatian: Nekoliko bolesnika s ADA prijavilo je ozbiljne/teške nuspojave.
English: If a dose is missed, it should be administered as soon as possible.
Croatian: Ako se propusti doza, treba je primijeniti što je prije moguće.
English: There may be a small amount of blood at the injection site.
Croatian: Na mjestu injiciranja može se pojaviti mala količina krvi.
English: You will be given Benlysta as well as your usual treatment for lupus.
Croatian: Lijek Benlysta ćete primiti uz Vašu uobičajenu terapiju za lupus.
English: Physicians should be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., cognitive, neurological or psychiatric symptoms or signs).
Croatian: Liječnici moraju osobito pripaziti na simptome koji ukazuju na PML, a koje bolesnici možda ne primjećuju (npr. kognitivne, neurološke ili psihijatrijske simptome ili znakove).
English: Tell your doctor if you are taking any other medicines, if you have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).
Croatian: Učinci na mušku i žensku plodnost nisu formalno procjenjivani u ispitivanjima na životinjama (vidjeti dio 5.3).
English: No formal studies have been conducted.
Croatian: Formalna ispitivanja nisu provedena.
English: Contents of the pack and other information What Benlysta contains
Croatian: Sadržaj pakiranja i druge informacije Što Benlysta sadrži
English: It is recommended that you make a note of this information in case you are asked for it in the future.
Croatian: Preporučuje se da taj podatak zabilježite za slučaj da ga netko zatraži od Vas u budućnosti.
English: Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Croatian: Lijek Benlysta ne smije se koristiti tijekom trudnoće osim ako potencijalna korist ne opravdava potencijalni rizik za fetus.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Croatian: Ako se sumnja na PML, treba obustaviti daljnju primjenu lijeka sve dok se PML ne isključi.
English: This will insert the needle and start the injection.
Croatian: Tako ćete ubosti iglu i započeti injekciju.
English: Your doctor or nurse will show you or your caregiver how to inject Benlysta.
Croatian: Liječnik ili medicinska sestra pokazat će Vama ili Vašem njegovatelju kako injicirati lijek Benlysta.
English: • pain in hands or feet
Croatian: • bolovi u šakama i stopalima
English: • hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl)
Croatian: • hipogamaglobulinemije (IgG <400 mg/dl) ili nedostatka IgA (IgA <10 mg/dl)
English: The two studies were similar in design except that BLISS-76 was a 76-week study and BLISS-52 was a 52-week study.
Croatian: Ta dva ispitivanja bila su sličnog dizajna, osim što je BLISS-76 bilo 76-tjedno ispitivanje, dok je ispitivanje BLISS-52 trajalo 52 tjedna.
English: Due to overlap in signs and symptoms, it is not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases.
Croatian: Uslijed preklapanja znakova i simptoma, u svim slučajevima nije moguće razlikovati reakcije preosjetljivosti od infuzijskih reakcija.
English: All patients received standard therapy.
Croatian: Svi su bolesnici primali standardnu terapiju.
English: If you use more Benlysta than you should
Croatian: Ako primijenite više lijeka Benlysta nego što ste trebali
English: They can occasionally be severe (uncommon, affecting up to 1 in 100 people), and could be life-threatening.
Croatian: Takve reakcije ponekad mogu biti teške (manje često; javljaju se u do 1 na 100 osoba), a mogu biti i opasne po život.
English: Then add the required volume of the reconstituted Benlysta solution into the infusion bag or bottle.
Croatian: Nakon toga dodajte potreban volumen rekonstituirane otopine lijeka Benlysta u infuzijsku vrećicu ili bocu.
English: • Hold the syringe in one hand.
Croatian: • Jednom rukom uhvatite štrcaljku.
English: • Hold the pen comfortably so that you can view the inspection window.
Croatian: • Uhvatite brizgalicu tako da Vam udobno leži u ruci i da možete vidjeti prozorčić za provjeru.
English: • severe active lupus nephritis (see section 5.1)
Croatian: • teškog aktivnog lupusnog nefritisa (vidjeti dio 5.1)
English: Supplies you need for the injection
Croatian: Pribor koji Vam je potreban za injekciju
English: Some infections were severe or fatal.
Croatian: Neke su infekcije bile teške ili su imale smrtni ishod.
English: Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage.
Croatian: Lupus je bolest u kojoj vlastiti imunološki sistem (sistem koji se brine za obranu od infekcija) napada stanice i tkiva vlastitog tijela, uzrokujući upalu i oštećenje organa.
English: Gently invert the bag or bottle to mix the solution.
Croatian: Nježno okrenite vrećicu ili bocu kako biste promiješali otopinu.
English: Remove the ring cap.
Croatian: Skinite zatvarač s prstenom.
English: An informal assessment of menstrual cycling in females demonstrated no belimumab-related changes.
Croatian: Neformalno ispitivanje menstrualnog ciklusa u ženki pokazalo je da nema promjena vezanih uz primjenu belimumaba.
English: Adverse reactions reported in association with cases of overdose have been consistent with those expected for belimumab.
Croatian: Prijavljene nuspojave povezane sa slučajevima predoziranja su u skladu s onima očekivanima za belimumab.
English: Discontinuation of treatment with Benlysta should be considered if there is no improvement in disease control after 6 months of treatment.
Croatian: Treba razmotriti prekid liječenja lijekom Benlysta ako nema poboljšanja u kontroli bolesti nakon 6 mjeseci liječenja.
English: See ‘Important information about the contents of Benlysta' in section 2 for further information.
Croatian: Pogledajte odlomak 'Važne informacije o sadržaju lijeka Benlysta' u dijelu 2. za više informacija.
English: You may see a drop of liquid at the end of the needle.
Croatian: Možda ćete vidjeti kapljicu tekućine na vrhu igle.
English: Limited data suggest that Benlysta does not significantly affect the ability to maintain a protective immune response to immunisations received prior to administration of Benlysta.
Croatian: Prema ograničenim podacima, Benlysta ne utječe značajno na sposobnost održavanja zaštitnog imunog odgovora na imunizacije primljene prije primjene lijeka Benlysta.
English: The SLE Responder Index measures improvement in SLE disease activity, without worsening in any organ system, or in the patient's overall condition.
Croatian: Indeks odgovora SLE-a mjeri poboljšanje vezano uz aktivnost bolesti, bez pogoršanja u bilo kojem organskom sustavu ili u općem stanju bolesnika.
English: If you feel depressed or have thoughts of harming yourself or committing suicide, you may find it helpful to tell a relative or close friend and ask them to read this leaflet.
Croatian: Ako ste depresivni ili razmišljate o tome da si naudite ili počinite samoubojstvo, moglo bi Vam pomoći da o tome razgovarate s članom obitelji ili bliskim prijateljem te da ih zamolite da pročitaju ovu uputu.
English: A nurse or doctor will give you Benlysta through a drip in your vein (intravenous infusion) over one hour.
Croatian: Medicinska sestra ili liječnik dat će Vam lijek Benlysta kroz venski put (intravenska infuzija) u trajanju od sat vremena.
English: Depression and suicide
Croatian: Depresija i samoubojstvo
English: This is to avoid the skin becoming hardened.
Croatian: Tako ćete izbjeći otvrdnuće kože.
English: Infusion reactions occurred more frequently during the first two infusions and tended to decrease with subsequent infusions (see section 4.8).
Croatian: Infuzijske reakcije su se pojavljivale češće tijekom prve dvije infuzije i imale su tendenciju rjeđeg pojavljivanja u sljedećim infuzijama (vidjeti dio 4.8).
English: • bacterial infections (see ‘Infections' above)
Croatian: • bakterijske infekcije (pogledajte odlomak 'Infekcije' u prethodnom tekstu)
English: The systemic clearance was 215 ml/day (range: 69-622 ml/day).
Croatian: Sistemski klirens iznosio je 215 ml/dan (raspon: 69-622 ml/dan).
English: After use - needle is covered by needle guard
Croatian: Nakon uporabe - štitnik za iglu prekriva iglu
English: If you experience these symptoms, particularly if you get two or more of them together:
Croatian: Ako primijetite navedene simptome, a osobito ako se istodobno pojave dva simptoma ili više njih:
English: • Obligation to complete post-authorisation measures
Croatian: • Obaveza provođenja mjera nakon davanja odobrenja
English: Pregnancy Benlysta is not usually recommended if you are pregnant.
Croatian: Trudnoća Benlysta se obično ne preporučuje u trudnoći.
English: It is unknown whether Benlysta is excreted in human milk or is absorbed systemically after ingestion.
Croatian: Nije poznato izlučuje li se Benlysta u majčino mlijeko u ljudi i apsorbira li se sistemski nakon ingestije.
English: Percent of patients with no worsening by BILAG index
Croatian: Postotak bolesnika bez pogoršanja prema BILAG indeksu
English: The frequency given is the highest seen with either formulation.
Croatian: Navedena je najveća učestalost zabilježena kod bilo koje od dviju formulacija.
English: The response for the individual components of the endpoint were consistent with that of the SRI (Table 3).
Croatian: Stopa odgovora za pojedinačne komponente mjere ishoda odgovarala je stopi SRI odgovora (Tablica 3).
English: Patient median age was 37 years (range: 18 to 77 years), and the majority (94%) were female.
Croatian: 37 godina (raspon: 18 - 77 godina), a većina je bolesnika (94%) bila ženskog spola.
English: Assay sensitivity for neutralising antibodies and non-specific anti-drug antibody (ADA) is limited by the presence of active drug in the collected samples.
Croatian: Osjetljivost testa na neutralizirajuća antitijela i nespecifična antitijela na lijek (ADA - anti-drug antibody) ograničena je prisutnošću aktivnog lijeka u prikupljenim uzorcima.
English: Other medicines and Benlysta
Croatian: Drugi lijekovi i Benlysta
English: In one study in paediatric patients (6 to 17 years of age) the pharmacodynamic response was consistent with the adult data.
Croatian: U jednom ispitivanju provedenom u pedijatrijskih bolesnika (u dobi od 6 do 17 godina) farmakodinamički je odgovor bio u skladu s podacima zabilježenima u odraslih.
English: BMI-dependent changes in exposure did not lead to corresponding changes in efficacy.
Croatian: Promjene u izloženosti ovisne o ITM-u nisu dovele do odgovarajućih promjena u djelotvornosti.
English: • When the injection is complete, lift the pen from the injection site.
Croatian: • Kad injekcija završi, podignite brizgalicu s mjesta injiciranja.
English: Prepare for the injection
Croatian: Pripremite se za injekciju
English: Belimumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Croatian: Belimumab je protein za koji je očekivani metabolički put razgradnja na male peptide i pojedine aminokiseline putem široko rasprostranjenih proteolitičkih enzima.
English: The recommended injection sites are the abdomen or thigh.
Croatian: Preporučena mjesta za injiciranje su abdomen ili bedro.
English: IgG1 molecules such as belimumab are catabolised by widely distributed proteolytic enzymes, which are not restricted to hepatic tissue and changes in hepatic function are unlikely to have any effect on the elimination of belimumab.
Croatian: IgG1 molekule, kao što je belimumab, se kataboliziraju putem široko rasprostranjenih proteolitičkih enzima, koji nisu ograničeni samo na jetreno tkivo, te je malo vjerojatno da će promjene u funkciji jetre imati ikakvog učinka na eliminaciju belimumaba.
English: Depression and suicidality
Croatian: Depresija i suicidalnost
English: Because maternal antibodies (IgG) are excreted in breast milk, it is recommended that a decision should be made whether to discontinue breast-feeding or to discontinue Benlysta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: S obzirom da se majčina protutijela (IgG) izlučuju u majčino mlijeko, potrebno je odlučiti hoće li se prekinuti dojenje ili terapija lijekom Benlysta, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Percent of patients with reduction in SELENASLEDAI ≥4
Croatian: Postotak bolesnika sa smanjenjem SELENASLEDAI ≥4