FrancophonIA/ELRC3.0 huggingface dataset:
English: If this happens, immediately contact your doctor or nurse, who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Croatian: Ako se to dogodi, odmah se obratite svom liječniku ili medicinskoj sestri, koji će Vas nadzirati kako bi uočili bilo kakve znakove ili simptome nuspojava i po potrebi ih liječili.
English: Check with your doctor if this may apply to you.
Croatian: Provjerite kod svog liječnika ako se ovo odnosi na Vas
English: There are no data on the effects of belimumab on human fertility.
Croatian: Nema podataka o učincima belimumaba na plodnost u ljudi.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Benlysta.
Croatian: Nema dostupnih podataka o sekundarnom prijenosu infekcije s osoba koje primaju živa cjepiva na bolesnike koji primaju lijek Benlysta.
English: • After the needle is completely inserted, release the pinched skin.
Croatian: • Nakon što iglu potpuno ubodete, otpustite nabor kože.
English: Changes in B cells (including naïve, memory and activated B cells, and plasma cells) and IgG levels occurring in patients during ongoing treatment with intravenous belimumab were followed in a long-term uncontrolled extension study.
Croatian: Promjene u B stanicama (uključujući naivne, memorijske i aktivirane B-stanice i plazma stanice) i razine IgG-a koje se pojavljuju u bolesnika tijekom liječenja intravenski primijenjenim belimumabom praćene su u dugoročnom nekontroliranom produžetku kliničkog ispitivanja.
English: You may also wish to make a note of this information in case you are asked for it in the future.
Croatian: Bilo bi dobro da i Vi zabilježite taj podatak za slučaj da ga netko zatraži od Vas u budućnosti.
English: Serum belimumab concentrations declined in a bi-exponential manner, with a distribution half-life of 1.75 days and terminal half-life 19.4 days.
Croatian: Serumske koncentracije belimumaba smanjile su se bieksponencijalno, s poluvijekom distribucije od 1,75 dana i terminalnim poluvijekom od 19,4 dana.
English: However, belimumab was detected in the milk from female monkeys administered 150 mg/kg every 2 weeks.
Croatian: Međutim, belimumab je pronađen u mlijeku ženki majmuna nakon davanja 150 mg/kg svaka 2 tjedna.
English: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Croatian: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska
English: Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered.
Croatian: Prijavljeni su slučajevi u kojima su bolesnici razvili simptome akutne preosjetljivosti nekoliko sati nakon primjene infuzije.
English: Infusion reactions and hypersensitivity
Croatian: Infuzijske reakcije i preosjetljivost
English: Although proteinuria (≥2 g/day) increased belimumab clearance and decreases in creatinine clearance decreased belimumab clearance, these effects were within the expected range of variability.
Croatian: Iako je proteinurija (>2 g/dan) povisila klirens belimumaba, a smanjenja klirensa kreatinina su smanjila klirens belimumaba, ovi učinci su bili unutar očekivanog raspona varijabilnosti.
English: Your doctor or nurse will also tell you what signs and symptoms to look out for when using Benlysta, because serious allergic reactions can occur (see ‘Allergic reactions' in section 4).
Croatian: Liječnik ili medicinska sestra također će Vam reći na koje znakove i simptome morate pripaziti tijekom liječenja lijekom Benlysta, jer se mogu javiti ozbiljne alergijske reakcije (pogledajte odlomak
English: The systemic clearance was 204 ml/day.
Croatian: Sistemski klirens iznosio je 204 ml/dan.
English: Percent of patients with no worsening by PGA
Croatian: Postotak bolesnika bez pogoršanja prema PGA
English: Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late onset reaction.
Croatian: Bolesnici bi trebali ostati pod produženim kliničkim nadzorom (nekoliko sati), i to barem nakon prve dvije infuzije lijeka, uzimajući u obzir mogućnost pojave odgođenih reakcija.
English: The healthcare professional must provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4).
Croatian: Zdravstveni radnik mora bolesniku pružiti odgovarajuću obuku o tehnici supkutanog injiciranja i educirati ga o znakovima i simptomima reakcija preosjetljivosti (vidjeti dio 4.4).
English: Reconstituted and diluted solution for infusion
Croatian: Rekonstituirana i razrijeđena otopina za infuziju
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Benlysta subcutaneous administration in one or more subsets of the paediatric population in SLE (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Benlysta za supkutanu primjenu u jednoj ili više podskupina pedijatrijske populacije za SLE (vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni).
English: No incompatibilities between Benlysta and polyvinylchloride or polyolefin bags have been observed.
Croatian: Nisu uočene inkompatibilnosti između lijeka Benlysta i polivinilkloridnih ili poliolefinskih vrećica.
English: Dosing is not based on weight (see section 5.2).
Croatian: Doziranje se ne temelji na tjelesnoj težini (vidjeti dio 5.2).
English: These are very common and may affect more than 1 in 10 people.
Croatian: One su vrlo česte i mogu se javiti u više od 1 na 10 osoba.
English: However, given the small number of subjects ≥65 years, an effect of age cannot be ruled out conclusively.
Croatian: Međutim, s obzirom na mali broj ispitanika u dobi od ≥ 65 godina, učinak dobi ne može se definitivno isključiti.
English: Of the anti-phospholipid antibodies, only anti-cardiolipin antibody was measured.
Croatian: Od antifosfolipidnih antitijela, mjerenja su rađena samo za antikardiolipinsko protutijelo.
English: The clinical status of the subject and the adverse reaction profile of Benlysta should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Croatian: Treba imati na umu kliničko stanje pojedinca i profil nuspojava lijeka Benlysta prilikom razmatranja sposobnosti bolesnika za obavljanje zadataka koji zahtijevaju prosuđivanje, motorne ili kognitivne vještine.
English: These severe reactions are more likely to happen on the day of your first or second treatment with Benlysta, but can be delayed and occur several days afterwards.
Croatian: Veća je vjerojatnost da će se takve teške reakcije javiti prvi ili drugi dan liječenja lijekom Benlysta, ali mogu biti i odgođene i javiti se nekoliko dana kasnije.
English: The MAH shall also provide a data report on a long-term controlled safety registry where all patients are followed for a minimum of 5 years, based on a protocol agreed with CHMP.
Croatian: Nositelj odobrenja će dostaviti izvještaj o podacima dugoročnog kontroliranog registra praćenja sigurnosti gdje su svi bolesnici praćeni najmanje 5 godina, prema protokolu dogovorenom s CHMP-om.
English: 5% glucose intravenous solutions are incompatible with Benlysta and must not be used.
Croatian: 5%-tne intravenske otopine glukoze nisu kompatibilne s lijekom Benlysta, te se ne smiju koristiti.
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA26
Croatian: Farmakoterapijska skupina: selektivni imunosupresivi, ATK oznaka: L04AA26 Mehanizam djelovanja
English: • If needed, firm the injection site by pulling or stretching the skin.
Croatian: • Ako je potrebno, učvrstite mjesto za injiciranje povlačenjem ili rastezanjem kože.
English: What Benlysta looks like and contents of the pack
Croatian: Kako Benlysta izgleda i sadržaj pakiranja
English: For intravenous infusion after reconstitution and dilution.
Croatian: Za intravensku infuziju nakon rekonstitucije i razrjeđivanja.
English: Effects on male and female fertility in monkeys were assessed in the 6-month repeat dose toxicology studies of belimumab at doses up to and including 50 mg/kg.
Croatian: Učinci na mušku i žensku plodnost u majmuna bili su procijenjeni u 6-mjesečnim toksikološkim ispitivanjima ponovljenih doza belimumaba, s dozama do, i uključujući, 50 mg/kg.
English: If you experience new or worsening symptoms at any time:
Croatian: Ako u bilo kojem trenutku primijetite pojavu novih ili pogoršanje postojećih simptoma:
English: Important information about the contents of Benlysta
Croatian: Važne informacije o sadržaju lijeka Benlysta
English: There is insufficient knowledge to determine whether premedication could diminish the frequency or severity of infusion reactions.
Croatian: Nema dovoljno saznanja o tome može li premedikacija smanjiti učestalost ili težinu infuzijskih reakcija.
English: • Do not expel any air bubbles from the syringe.
Croatian: • Nemojte pokušavati izbaciti zračne mjehuriće iz štrcaljke.
English: In one study in 6 to 17-year-old paediatric patients (n=53), none of the patients developed anti-belimumab antibodies.
Croatian: U jednom ispitivanju provedenom u pedijatrijskih bolesnika u dobi od 6 do 17 godina (n=53) ni u jednoga se bolesnika nisu razvila protutijela na belimumab.
English: The risk of using Benlysta in patients with active or latent tuberculosis is unknown.
Croatian: Rizik primjene lijeka Benlysta u bolesnika s aktivnom ili latentnom tuberkulozom nije poznat.
English: Medicine given before an infusion
Croatian: Lijekovi koji se primjenjuju prije infuzije
English: The syringe or pen must be protected from light, and discarded if not used within the 12 hour period.
Croatian: Štrcaljka ili brizgalica moraju biti zaštićene od svjetlosti, a ako se ne upotrijebe u roku od 12 sati, treba ih baciti.
English: • The active ingredient is belimumab.
Croatian: • Djelatna tvar je belimumab.
English: There is limited clinical experience with overdose of Benlysta.
Croatian: Postoji ograničeno kliničko iskustvo s predoziranjem lijekom Benlysta.
English: • wheezing, difficulty in breathing or shortness of breath
Croatian: • piskanje pri disanju, otežano disanje ili nedostatak zraka
English: BLISS-52 was conducted in South America, Eastern Europe, Asia, and Australia.
Croatian: Ispitivanje BLISS-52 bilo je provedeno u Južnoj Americi, istočnoj Europi, Aziji i Australiji.
English: This was consistent with the findings from the adult intravenous clinical trials.
Croatian: Ti su rezultati odgovarali nalazima iz kliničkih ispitivanja intravenske primjene u odraslih.
English: Therefore, the use of Benlysta in elderly patients is not recommended unless the benefits are expected to outweigh the risks.
Croatian: Stoga se korištenje lijeka Benlysta u starijih bolesnika ne preporučuje osim ako koristi od liječenja premašuju rizik.
English: These may include a type of medicine called an anti-histamine and a medicine to prevent a high temperature.
Croatian: Ti lijekovi mogu uključivati lijekove poznate kao antihistaminici i lijekove za sprječavanje povišene tjelesne temperature.
English: • At the request of the European Medicines Agency;
Croatian: Nadopunjeni RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
English: • memory loss
Croatian: • gubitak pamćenja
English: Following subcutaneous administration the bioavailability of belimumab was approximately 74%.
Croatian: Bioraspoloživost belimumaba nakon supkutane primjene iznosila je približno 74%.
English: Patients should be monitored for any of these new or worsening symptoms or signs, and if such symptoms/signs occur, referral to a neurologist and appropriate diagnostic measures for PML should be considered.
Croatian: Bolesnike treba nadzirati kako bi se uočila moguća pojava ili pogoršanje tih simptoma i znakova, a ako se oni pojave, treba razmotriti upućivanje bolesnika neurologu i uvođenje odgovarajućih dijagnostičkih mjera za PML.
English: The primary efficacy endpoint was the SLE Responder Index (SRI) at Week 52 as described in the adult intravenous trials.
Croatian: Primarna mjera ishoda za djelotvornost bio je indeks odgovora SLE-a (SRI) u 52. tjednu, kako je opisano u ispitivanjima intravenske primjene u odraslih.
English: In controlled clinical intravenous and subcutaneous studies, psychiatric disorders (depression, suicidal ideation and behaviour including suicides) have been reported more frequently in patients receiving Benlysta (see section 4.8).
Croatian: U kontroliranim kliničkim ispitivanjima intravenske i supkutane primjene psihijatrijski poremećaji (depresija, suicidalne misli i ponašanje, uključujući samoubojstva) prijavljeni su češće u bolesnika koji su primali lijek Benlysta (vidjeti dio 4.8).
English: Needle guard activated
Croatian: Štitnik za iglu je aktiviran
English: Patients with malignant neoplasm within the last 5 years have not been studied, with the exception of those with basal or squamous cell cancers of the skin, or cancer of the uterine cervix, that has been fully excised or adequately treated.
Croatian: Nisu provedena ispitivanja u bolesnika koji su razvili malignu neoplazmu unutar posljednjih 5 godina, uz iznimku onih s bazocelularnim ili planocelularnim karcinomom kože, ili karcinomom cerviksa uterusa, koji je bio u potpunosti odstranjen i odgovarajuće liječen.
English: The mechanism of action of belimumab could increase the risk for the development of infections, including opportunistic infections.
Croatian: Mehanizam djelovanja belimumaba mogao bi povećati rizik od razvoja infekcija, uključujući oportunističke infekcije.
English: In a substudy, a small group of patients who had previously received either tetanus, pneumococcal or influenza vaccinations were found to maintain protective titres after treatment with Benlysta.
Croatian: U jednom se podispitivanju pokazalo da je mala skupina bolesnika koji su prethodno primili cjepivo protiv tetanusa, pneumokoka ili gripe zadržala zaštitne titre nakon liječenja lijekom Benlysta.
English: Tell your doctor or nurse immediately.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru.
English: The infusion must be discontinued immediately if the patient experiences a potentially life-threatening adverse reaction (see sections 4.4 and 4.8).
Croatian: Infuzija mora biti smjesta prekinuta ako bolesnik razvije potencijalno po život opasnu nuspojavu (vidjeti dijelove 4.4 i 4.8).
English: • Do not warm the syringe in any other way.
Croatian: • Nemojte zagrijavati štrcaljku ni na koji drugi način.
English: It is recommended that the first subcutaneous injection of Benlysta should be under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary.
Croatian: Preporučuje se prvu supkutanu injekciju lijeka Benlysta primijeniti pod nadzorom zdravstvenog radnika u okruženju koje je dovoljno opremljeno za zbrinjavanje reakcija preosjetljivosti, ako to bude potrebno.
English: Data presented below are pooled from the intravenous clinical studies (10 mg/kg intravenous dose only) and the subcutaneous clinical study.
Croatian: Podaci navedeni u nastavku objedinjeni su iz kliničkih ispitivanja intravenske primjene (samo intravenska doza od 10 mg/kg) i kliničkog ispitivanja supkutane primjene.
English: Benlysta is administered by intravenous infusion.
Croatian: Benlysta se primjenjuje putem intravenske infuzije.
English: How Benlysta is used How much to use Adults (18 years of age and older)
Croatian: Kako primjenjivati lijek Benlysta Koliko lijeka primijeniti Odrasli (u dobi od 18 ili više godina)
English: Infusion or injection-related systemic reactions and hypersensitivity: Infusion or injection-related systemic reactions and hypersensitivity were generally observed on the day of administration, but acute hypersensitivity reactions may also occur several days after dosing.
Croatian: Sistemske reakcije povezane s infuzijom ili injekcijom i preosjetljivost: Sistemske reakcije povezane s primjenom infuzije ili injekcije i preosjetljivost uglavnom su zabilježene na dan primjene, no akutne reakcije preosjetljivosti mogu se javiti i nekoliko dana nakon primjene.
English: The effects of body weight and BMI on belimumab exposure after subcutaneous administration were not considered clinically meaningful.
Croatian: Učinci tjelesne težine i ITM-a na izloženost belimumabu nakon supkutane primjene nisu se smatrali klinički značajnima.
English: Severe infections, including fatal cases, have been reported in SLE patients receiving immunosuppressant therapy, including belimumab (see section 4.8).
Croatian: Teške infekcije, uključujući slučajeve sa smrtnim ishodom, prijavljene su kod bolesnika sa SLE-om koji primaju terapiju imunosupresivima, uključujući belimumab (vidjeti dio 4.8).
English: For information on infections observed in paediatric patients see Paediatric population section below.
Croatian: Za informacije o infekcijama opaženima u pedijatrijskih bolesnika vidjeti odlomak „Pedijatrijska populacija“ u nastavku.
English: On the basis of the available information, dose adjustment is not required in patients with mild, moderate or severe renal impairment.
Croatian: Na temelju dostupnih informacija, prilagodba doze nije potrebna u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega.
English: In both studies the primary efficacy endpoint was evaluated at 52 weeks.
Croatian: U oba je ispitivanja primarna mjera ishoda djelotvornosti ocijenjena u 52. tjednu.
English: • Choose an injection site (abdomen or thigh) as seen in Figure 4.
Croatian: • Odaberite mjesto za injiciranje (trbuh ili bedro), kako je prikazano na Slici 4.
English: After reconstitution with water for injections, the reconstituted solution, if not used immediately, should be protected from direct sunlight, and stored refrigerated at 2°C to 8°C.
Croatian: Nakon rekonstitucije s vodom za injekcije, rekonstituiranu otopinu, ako se ne koristi odmah, treba zaštititi od izravne sunčeve svjetlosti te čuvati u hladnjaku na temperaturi od 2°C do 8°C.
English: Patients were randomised in a 2:1 ratio to receive belimumab 200 mg or placebo subcutaneously once weekly for 52 weeks.
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 za primanje belimumaba u dozi od 200 mg ili placeba supkutano jedanput tjedno tijekom 52 tjedna.
English: The safety and efficacy of Benlysta subcutaneous administration in children and adolescents (< 18 years of age) has not been established.
Croatian: Sigurnost i djelotvornost supkutane primjene lijeka Benlysta u djece i adolescenata (< 18 godina) nisu ustanovljene.
English: • Position the pen straight over the injection site (at a 90o angle).
Croatian: • Namjestite brizgalicu ravno iznad mjesta za injiciranje (pod kutom od 90°).
English: For instructions on reconstitution, dilution, and storage of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji, razrjeđivanju i čuvanju lijeka prije primjene vidjeti dio 6.6.
English: As belimumab is a monoclonal antibody no genotoxicity studies have been conducted.
Croatian: Budući da je belimumab monoklonsko protutijelo, nisu provedena ispitivanja genotoksičnosti.
English: Paediatric population: The pharmacokinetic parameters are based on individual parameter estimates from a population pharmacokinetic analysis of 53 patients from a study in paediatric patients.
Croatian: Pedijatrijska populacija: Farmakokinetički parametri temelje se na procjenama pojedinačnih parametara iz populacijske farmakokinetičke analize koja je obuhvatila 53 bolesnika iz pedijatrijskog ispitivanja.
English: • injection site reactions, for example: rash, redness, itching or swelling of the skin where you have injected Benlysta.
Croatian: • reakcije na mjestu injiciranja, primjerice: osip, crvenilo, svrbež ili oticanje kože na mjestu injiciranja lijeka Benlysta
English: Benlysta must not be administered as an intravenous bolus.
Croatian: Benlysta se ne smije primijeniti kao intravenski bolus.
English: Thereafter the patient should continue with the new weekly schedule from that day, even if the dosing interval may be temporarily less than a week.
Croatian: Nakon toga treba nastaviti primjenjivati lijek prema novom rasporedu primjene jedanput tjedno, čak i ako je interval doziranja u tom trenutku kraći od tjedan dana.
English: • ≥4-point reduction in the SELENA-SLEDAI score, and
Croatian: • smanjenje rezultata SELENA SLEDAI za ≥ 4 boda, i
English: Any unused solution in the vials must be discarded.
Croatian: Sva neiskorištena otopina u bočicama mora se baciti.
English: If a patient is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose (see section 5.2).
Croatian: Ako se bolesnika prebacuje s intravenske na supkutanu primjenu lijeka Benlysta, prvu supkutanu injekciju treba primijeniti 1 do 4 tjedna nakon posljednje intravenske doze (vidjeti dio 5.2).
English: … purple indicator stops moving
Croatian: … ljubičasti indikator zaustavi
English: In the case of inadvertent overdose, patients should be carefully observed and supportive care administered, as appropriate.
Croatian: U slučaju nenamjernog predoziranja, bolesnici bi trebali biti pomno nadgledani, te bi po potrebi trebala biti pružena odgovarajuća suportivna njega.
English: Tell your doctor.
Croatian: Obavijestite o tome svog liječnika.
English: Age and race
Croatian: Dob i rasa
English: A risk for indirect reduction of CYP activity by belimumab cannot be excluded.
Croatian: Ne može se isključiti rizik da će belimumab neizravno smanjiti aktivnost CYP enzima.
English: • Remove the ring cap by pulling or twisting it off.
Croatian: • Da biste skinuli zatvarač s prstenom, povucite ga ili zakrenite.
English: Steadystate exposure was reached after approximately 11 weeks of subcutaneous administration.
Croatian: Izloženost u stanju dinamičke ravnoteže postignuta je nakon približno 11 tjedana supkutane primjene.
English: Two doses up to 20 mg/kg administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.
Croatian: Dvije doze do 20 mg/kg primijenjene su u razmaku od 21 dan putem intravenske infuzije bez porasta incidencije ili težine nuspojava u usporedbi s dozama od 1, 4 ili 10 mg/kg.
English: Benlysta contains belimumab (a monoclonal antibody).
Croatian: Benlysta sadrži belimumab (monoklonsko protutijelo).
English: • a history of, or current, hepatitis B or C
Croatian: • preboljenog ili aktivnog hepatitisa B ili C
English: Belimumab + Standard Therapy (n = 554) Placebo + Standard Therapy (n = 279) * P<0.05
Croatian: Belimumab + standardno liječenje (n = 554) Placebo + standardno liječenje (n = 279)
English: Benlysta is infused over a 1 hour period.
Croatian: Benlysta se primjenjuje infuzijom u trajanju od 1 sat.
English: The safety and efficacy of Benlysta in children aged below 5 years has not been established.
Croatian: Sigurnost i djelotvornost primjene lijeka Benlysta u djece mlađe od 5 godina nisu ustanovljene.
English: Tell your doctor or nurse.
Croatian: Obavijestite svog liječnika ili medicinsku sestru.
English: Besides an expected pharmacological effect i.e. reduction of B cells, animal studies in monkeys do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section
Croatian: Uz očekivani farmakološki učinak, tj. smanjenje broja B limfocita, ispitivanja na životinjama provedena na majmunima ne ukazuju na izravne ili neizravne štetne učinke na reproduktivnu toksičnost (vidjeti dio 5.3).
English: If you forget to use Benlysta
Croatian: Ako ste zaboravili primijeniti lijek Benlysta
English: Live vaccines should not be given for 30 days before, or concurrently with Benlysta, as clinical safety has not been established.
Croatian: Živa cjepiva ne smiju se primjenjivati 30 dana prije ili istodobno s lijekom Benlysta, budući da klinička sigurnost nije ustanovljena.