FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Mulpleo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Mulpleo pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: An overview of Mulpleo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Mulpleo i zašto je odobren u EU-u
English: The second study involving 215 adults found that 65% of patients who took Mulpleo did not require platelet transfusion before their procedure, compared with 29% of patients who received placebo.
Croatian: U drugom ispitivanju na 215 odraslih osoba pokazalo se da 65 % bolesnika koji su primali Mulpleo nije trebalo transfuziju trombocita prije zahvata, u usporedbi s 29 % bolesnika koji su primali placebo.
English: Unwanted effects that occurred in studies are thought to result from patients' medical condition and the nature of the invasive procedure for which Mulpleo was used.
Croatian: Smatra se da su nuspojave iz ispitivanja posljedica zdravstvenog stanja bolesnika i prirode invazivnog zahvata tijekom kojeg se upotrebljavao Mulpleo.
English: Mulpleo contains the active substance lusutrombopag.
Croatian: Mulpleo sadrži djelatnu tvar lusutrombopag.
English: The first study, involving 96 adults, found that 79% of patients who took Mulpleo did not require a transfusion of platelets before their procedure, compared with 13% of patients who received placebo (a dummy treatment).
Croatian: U prvom ispitivanju na 96 odraslih osoba pokazalo se da 79 % bolesnika koji su primali Mulpleo nije trebalo transfuziju trombocita prije zahvata, u usporedbi s 13 % bolesnika koji su primili placebo (prividno liječenje).
English: Mulpleo is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to longstanding liver disease.
Croatian: Mulpleo je lijek za sprječavanje prekomjernog krvarenja u odraslih osoba s trombocitopenijom uzrokovanom kroničnom bolešću jetre.
English: Mulpleo1 (lusutrombopag)
Croatian: (lusutrombopag)
English: In two main studies involving adults with low levels of platelets due to long-standing liver disease, Mulpleo increased platelet count before an invasive procedure and reduced the need for transfusions.
Croatian: U dvama glavnim ispitivanjima koja su obuhvaćala odrasle osobe s niskim brojem trombocita uzrokovanim dugotrajnom bolešću jetre, lijek Mulpleo povećao je broj trombocita prije invazivnog zahvata te je smanjio potrebu za transfuzijom.
English: What benefits of Mulpleo have been shown in studies?
Croatian: Koje su koristi od lijeka Mulpleo utvrđene u ispitivanjima?
English: Studies have found that Mulpleo increases platelet count, thereby lowering the risk of excessive bleeding during or after an invasive procedure and reducing the need for transfusing platelets.
Croatian: U ispitivanjima je utvrđeno da Mulpleo povećava broj trombocita, pri čemu se smanjuje rizik od prekomjernog krvarenja tijekom invazivnog zahvata ili nakon njega te se smanjuje potreba za transfuzijom trombocita.
English: Unwanted effects that occurred in studies involving patients taking Mulpleo were headache, nausea (feeling sick), portal vein thrombosis (a blockage in the blood vessel that carries blood from the intestines to the liver) and rash.
Croatian: Nuspojave koje su u ispitivanjima nastupile kod bolesnika koji su primali Mulpleo bile su glavobolja, mučnina (slabost), tromboza portalne vene (začepljenje krvne žile koja prenosi krv od crijeva do jetre) i osip.
English: How is Mulpleo used?
Croatian: Kako se Mulpleo primjenjuje?
English: The active substance in Mulpleo, lusutrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count.
Croatian: Djelatna tvar lijeka Mulpleo, lusutrombopag, veže se na iste receptore kao i trombopoetin, čime se povećava broj tromobocita.
English: For more information on the side effects and restrictions of Mulpleo, see the package leaflet.
Croatian: Više informacija o nuspojavama i ograničenjima pri primjeni lijeka Mulpleo potražite u uputi o lijeku.
English: How does Mulpleo work?
Croatian: Kako djeluje Mulpleo
English: This generally takes 30 minutes.
Croatian: Za to je obično potrebno 30 minuta.
English: Wash your hands well with soap and water.
Croatian: Dobro operite ruke sapunom i vodom.
English: Elderly patients (≥65 years old)
Croatian: Stariji bolesnici (≥ 65 godina)
English: Date of first authorisation: 8 January 2018
Croatian: Datum prvog odobrenja: 08. siječnja 2018.
English: Long-term safety
Croatian: Dugoročna sigurnost
English: Important!
Croatian: Važno!
English: Gender, Race
Croatian: Spol, rasa
English: This creates a firmer surface.
Croatian: Tako ćete stvoriti čvršću površinu.
English: Total duration of treatment: 104 - 112 weeks
Croatian: Ukupno trajanje liječenja: 104 - 112 tjedana
English: This should be done gradually, under the direct supervision of your doctor.
Croatian: To je potrebno učiniti postepeno, pod izravnim nadzorom Vašeg liječnika.
English: • through clothing
Croatian: • kroz odjeću
English: Individual day and night time scores were similar.
Croatian: Pojedinačni rezultati za dnevne i noćne simptome bili su slični.
English: Go straight on to the next steps, without delay.
Croatian: Odmah prijeđite na sljedeći korak, bez odgađanja.
English: Such reactions may happen within hours or days after the injection.
Croatian: Takve reakcije mogu se javiti unutar nekoliko sati ili dana nakon injekcije.
English: • if you have a parasitic infection or if you live in an area where parasitic infections are common or you are travelling to such a region.
Croatian: • ako imate parazitsku infekciju ili ako živite u području gdje su parazitske infekcije česte ili putujete u takva područja.
English: However, no data are available in patients over 75 years of age.
Croatian: Međutim, nema dostupnih podataka za bolesnike starije od 75 godina.
English: Södertälje Sweden
Croatian: Södertälje Švedska
English: Efficacy and safety were consistent with the predecessor trials.
Croatian: Djelotvornost i sigurnost bile su u skladu s onima iz prethodnih ispitivanja.
English: Most antibodies were neutralising and persistent.
Croatian: Većina protutijela bila je neutralizirajuća i perzistentna.
English: Not known (the frequency cannot be determined from the available data):
Croatian: Nepoznato (učestalost se ne može odrediti iz dostupnih podataka)
English: It may contain small white particles.
Croatian: Može sadržavati male bijele čestice.
English: Results shown based on last available data for each variable.
Croatian: Navedeni podaci temelje se na posljednjim dostupnim podacima za svaku varijablu.
English: Seek medical attention immediately if you think you may be having an allergic reaction.
Croatian: Odmah potražite liječničku pomoć ako mislite da biste mogli imati alergijsku reakciju.
English: No dedicated animal studies have been conducted.
Croatian: Nisu provedena posebna ispitivanja na životinjama.
English: • fever (high temperature)
Croatian: • vrućica (visoka tjelesna temperatura)
English: Open the carton.
Croatian: Otvorite kutiju.
English: If the green plunger does not fill the viewing window, you may not have received the full dose.
Croatian: Ako zeleni klip nije ispunio cijeli prozorčić za provjeru, možda niste primili punu dozu.
English: It is important that you talk to your doctor about how to recognise early symptoms of serious allergic reactions and how to manage these reactions if they occur.
Croatian: Važno je da razgovarate sa svojim liječnikom o tome kako prepoznati rane simptome ozbiljnih alergijskih reakcija i kako zbrinuti te reakcije ako se pojave.
English: The first 3 injections are every 4 weeks.
Croatian: Prve 3 injekcije daju se svaka 4 tjedna.
English: Its administration to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Croatian: Njegovu primjenu kod trudnica treba razmotriti samo ako je očekivana korist za majku veća od bilo kojeg mogućeg rizika za plod.
English: For each injection, choose a different site that is at least 3 cm away from where you last injected.
Croatian: Za svaku injekciju odaberite mjesto koje je najmanje 3 cm udaljeno od mjesta u koje ste prethodno injicirali lijek.
English: No data are available for children aged 6 to 11 years old.
Croatian: Nema dostupnih podataka za djecu u dobi od 6 do 11 godina.
English: Parasitic (Helminth) Infection
Croatian: Parazitska (helmintska) infekcija
English: If your response to the treatment allows it, your doctor may try to reduce the dose of some of these medicines, especially ones called ‘corticosteroids'.
Croatian: Ako Vaš odgovor na liječenje dozvoljava, Vaš će liječnik pokušati smanjiti dozu nekih od tih lijekova, posebice onih koji se nazivaju „kortikosteroidi“.
English: Serious allergic reactions
Croatian: Ozbiljne alergijske reakcije
English: Common (these may affect up to 1 in 10 people)
Croatian: Česte (mogu se javiti u do 1 na 10 osoba)
English: You will hear a click.
Croatian: Čut ćete 'klik'.
English: The most commonly reported adverse reactions during treatment are headache (8%) and pharyngitis (3%).
Croatian: Najčešće prijavljene nuspojave tijekom liječenja su glavobolja (8%) i faringitis (3%).
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: Do not:
Croatian: Nemojte:
English: • it has been frozen
Croatian: • ako je bila zamrznuta
English: It may contain particles.
Croatian: Može sadržavati čestice.
English: Difference
Croatian: Razlika
English: Currently available data in children 12 to less than 18 years old are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci o primjeni kod djece u dobi od 12 do manje od 18 godina opisani su u dijelovima 4.8, 5.1 i 5.2, ali nije moguće dati preporuku o doziranju.
English: You will hear a second ‘click'.
Croatian: Čut ćete još jedan 'klik'.
English: This medicine may weaken your ability to fight certain types of parasitic infections,
Croatian: Ovaj lijek može oslabiti sposobnost tijela da se bori protiv određenih vrsta parazitskih infekcija.
English: Do not use Fasenra if you are pregnant unless your doctor tells you otherwise.
Croatian: Nemojte primati lijek Fasenra ako ste trudni, osim ako Vam liječnik ne kaže drugačije.
English: These reactions may occur within hours of administration, but in some instances have a delayed onset (i.e. days).
Croatian: Te se reakcije mogu javiti unutar nekoliko sati nakon primjene, ali u nekim slučajevima nastupaju kasnije (tj. nakon nekoliko dana).
English: Do not inject:
Croatian: Nemojte injicirati:
English: This is to make sure you inject all of the medication.
Croatian: Tako ćete biti sigurni da ste injicirali sav lijek.
English: MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW United Kingdom
Croatian: MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW Ujedinjeno Kraljevstvo
English: Nijmegen, 6545CG Netherlands
Croatian: Nijmegen, 6545CG Nizozemska
English: Let it air dry.
Croatian: Pričekajte da se osuši na zraku.
English: This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Croatian: Ove informacije ne zamjenjuju razgovor sa zdravstvenim radnikom o Vašoj bolesti ili njezinu liječenju.
English: The recommended dose is an injection of 30 mg.
Croatian: Preporučena doza je injekcija od 30 mg.
English: If needed, cover the injection site with a small bandage.
Croatian: Po potrebi prekrijte mjesto injiciranja malim flasterom.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeated dose toxicity studies in monkeys.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije ili toksičnosti ponovljenih doza na majmunima.
English: Children and adolescents The safety and benefits of this medicine are not known in children below the age of 18.
Croatian: Djeca i adolescenti Sigurnost i koristi primjene ovog lijeka kod djece mlađe od 18 godina nisu poznate.
English: • if you have any symptoms of an allergic reaction (see section 4).
Croatian: • ako imate bilo koji simptom alergijske reakcije (pogledajte dio 4).
English: You do not need to do anything about it.
Croatian: Ne morate ga ukloniti.
English: • the security seal on the carton has been broken
Croatian: • ako je sigurnosna naljepnica na kutiji potrgana
English: Number of patients (n) varies slightly due to the number of patients for whom data were available for each variable.
Croatian: Broj bolesnika (n) neznatno se razlikuje zbog broja bolesnika za koje su bili dostupni podaci za svaku pojedinu varijablu.
English: • into scars or damaged skin
Croatian: • u ožiljke ili oštećenu kožu
English: Other medicines for asthma
Croatian: Drugi lijekovi za astmu
English: There is no evidence of IL-5Rα expression on hepatocytes.
Croatian: Nema dokaza ekspresije IL-5Rα na hepatocitima.
English: • into the 5 cm area around your belly-button
Croatian: • u područje unutar 5 cm oko pupka
English: For examples of the associated manifestations reported and a description of the time to onset, see section 4.4.
Croatian: Za primjere prijavljenih manifestacija povezanih s lijekom i opis vremena do nastupa vidjeti dio 4.4.
English: n= number of patients with data at timepoint.
Croatian: n = broj bolesnika za koje su bili dostupni podaci u navedenoj vremenskoj točki.
English: If your asthma symptoms get worse while receiving injections of Fasenra, call your doctor.
Croatian: Ako Vam se simptomi astme pogoršaju dok primate injekcije lijeka Fasenra, javite se svom liječniku.
English: For example, do not warm it in a microwave or hot water, or put it near other heat sources.
Croatian: Primjerice, nemojte je zagrijavati u mikrovalnoj pećnici ili vrućoj vodi niti stavljati blizu drugih izvora topline.
English: The overall adverse event profile was similar to the asthma trials described above.
Croatian: Sveukupan profil štetnih događaja bio je sličan kao i u gore opisanim ispitivanjima kod astme.
English: It is unknown whether benralizumab or its metabolites are excreted in human or animal milk.
Croatian: Nije poznato izlučuju li se benralizumab ili njegovi metaboliti u ljudsko ili životinjsko mlijeko.
English: It is preferable to avoid the use of Fasenra during pregnancy.
Croatian: Poželjno je izbjegavati primjenu lijeka Fasenra tijekom trudnoće.
English: • it has been dropped or damaged
Croatian: • ako je pao ili se oštetio
English: Do not touch the cleaned area before injecting.
Croatian: Nemojte dodirivati očišćeno mjesto prije injiciranja.
English: The liquid should be clear and colourless to yellow.
Croatian: Tekućina treba biti bistra i bezbojna do žuta.
English: It is not known whether Fasenra could harm your unborn baby.
Croatian: Nije poznato može li Fasenra naškoditi nerođenom djetetu.
English: Benralizumab has not been studied in children (5 to 11 years old) (see section 4.2).
Croatian: Benralizumab se nije ispitivao kod djece (u dobi od 5 do 11 godina) (vidjeti dio 4.2).
English: The frequency, type and severity of adverse reactions in the adolescent population were observed to be similar to those seen in adults.
Croatian: Primijećeno je da su učestalost, vrsta i težina nuspojava u adolescentnoj populaciji bile slične onima opaženima kod odraslih.
English: Rate a.
Croatian: Stopa a.
English: Check the viewing window to make sure all the liquid has been injected.
Croatian: Pregledajte prozorčić za provjeru kako biste bili sigurni da ste injicirali svu tekućinu.
English: Hold down firmly for 15 seconds.
Croatian: Držite brizgalicu čvrsto pritisnutom tijekom 15 sekundi.
English: The recommended injection site is the front of your thigh.
Croatian: Preporučeno mjesto za injiciranje je prednja strana bedra.
English: However, in the offspring of monkeys dosed while pregnant, there was a reduction in eosinophils.
Croatian: Međutim, u mladunaca ženki majmuna kojima je davan lijek za vrijeme trudnoće, primijećeno je smanjenje eozinofila.
English: Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Croatian: Bolesnike treba uputiti da se obrate liječniku za savjet ako im je astma i dalje nekontrolirana ili ako se pogorša nakon početka liječenja.
English: Insert the needle at an angle of 45 degrees.
Croatian: Ubodite iglu pod kutom od 45 stupnjeva.
English: Risk to the breast-fed child cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops.
Croatian: Nježno pritisnite kožu pamučnom vatom ili gazom dok krvarenje ne prestane.
English: Animal toxicology and/or pharmacology
Croatian: Toksikologija i/ili farmakologija kod životinja
English: • if your asthma remains uncontrolled or worsens during treatment with this medicine.
Croatian: • ako Vam je astma i dalje nekontrolirana ili ako se pogorša tijekom liječenja ovim lijekom.
English: Overall, in patients who were anti-drug antibody positive in the predecessor trials, titres remained stable or declined in the second year of treatment.
Croatian: Sveukupno su kod bolesnika koji su bili pozitivni na protutijela na lijek u prethodnim ispitivanjima titri ostali stabilni ili su se smanjili u drugoj godini liječenja.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from using Fasenra taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka o tome hoće li se prekinuti dojenje ili trajno/privremeno obustaviti liječenje lijekom Fasenra, uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za ženu.
English: Paediatric population The safety and efficacy of Fasenra in children aged 6 to 18 years have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost lijeka Fasenra kod djece u dobi od 6 do 18 godina nisu ustanovljene.
English: Do not expose to heat.
Croatian: Ne izlagati toplini.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines before using Fasenra.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove prije nego što primite lijek Fasenra.
English: Keep Fasenra and all medicines out of the sight and reach of children.
Croatian: Čuvajte lijek Fasenra i sve druge lijekove izvan pogleda i dohvata djece.
English: • if you have had an allergic reaction to an injection or medicine in the past (see section 4 for symptoms of an allergic reaction).
Croatian: • ako ste u prošlosti možda imali alergijsku reakciju na neku injekciju ili lijek (pogledajte dio 4 za simptome alergijske reakcije).
English: The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils.
Croatian: Receptor IL-5 specifično se eksprimira na površini eozinofila i bazofila.
English: Do not touch the needle, or let it touch any surface.
Croatian: Nemojte dodirivati iglu niti dopustiti da dođe u dodir s bilo kojom drugom površinom.
English: Anaphylactic reactions have been reported.
Croatian: Prijavljene su anafilaktičke reakcije.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Croatian: Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Monoclonal antibodies, such as benralizumab, are transported across the placenta linearly as pregnancy progresses; therefore, potential exposure to a fetus is likely to be greater during the second and third trimester of pregnancy.
Croatian: Monoklonska protutijela poput benralizumaba linearno se prenose kroz posteljicu kako trudnoća odmiče; stoga će potencijalna izloženost ploda vjerojatno biti veća tijekom drugog i trećeg tromjesečja trudnoće.
English: If you are taking medicines called ‘oral corticosteroids', using Fasenra may also allow you to reduce the daily dose or stop the oral corticosteroids you need to control your asthma.
Croatian: Ako uzimate lijekove koji se zovu ‘oralni kortikosteroidi', korištenje lijeka Fasenra također može pomoći smanjiti dnevnu dozu ili prekinuti uzimanje kortikosteroida koji su Vam potrebni da biste astmu držali pod kontrolom.
English: After Use
Croatian: Nakon uporabe
English: You must look out for signs of these reactions (such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of your face, tongue or mouth) while you are taking Fasenra.
Croatian: Morate pripaziti na znakove tih reakcija (kao što su koprivnjača, osip, dišne tegobe, nesvjestica, omaglica, ošamućenost i/ili oticanje lica, jezika ili usta) dok se liječite lijekom Fasenra.
English: Before Use
Croatian: Prije uporabe
English: Patients were permitted to enter a second extension trial after a minimum of 8 weeks in Trial 4 without completing the 56-week extension period.
Croatian: 4. Bolesnici su mogli ući u drugi produžetak ispitivanja nakon najmanje 8 tjedana sudjelovanja u Ispitivanju 4, a da nisu dovršili 56-tjedno razdoblje produžetka.
English: Patients with known helminth infections were excluded from participation in clinical trials.
Croatian: Bolesnici s poznatim infekcijama helmintima nisu bili uključeni u klinička ispitivanja.
English: d. EOT for Trial 4 was Week 48 (the last timepoint for adults and adolescent data).
Croatian: d. Kraj liječenja u Ispitivanju 4 bio je 48. tjedan (zadnja vremenska točka u kojoj su se prikupljali podaci za odrasle i adolescente).
English: Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms.
Croatian: Lijek Fasenra može smanjiti broj napadaja astme koji se pojavljuju, pomoći Vam da lakše dišete i smanjiti Vaše simptome astme.
English: Following subcutaneous administration, the elimination half-life was approximately 15.5 days.
Croatian: Poluvrijeme eliminacije nakon supkutane primjene iznosilo je približno 15,5 dana.
English: After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary.
Croatian: Nakon odgovarajuće obuke o tehnici supkutanog injiciranja i edukacije o znakovima i simptomima reakcija preosjetljivosti (vidjeti dio 4.4), bolesnici bez anafilaksije u povijesti bolesti ili njihovi njegovatelji mogu sami injicirati lijek Fasenra ako liječnik utvrdi da je to prikladno, uz medicinsko praćenje prema potrebi.
English: Eosinophils may be involved in the immunological response to some helminth infections.
Croatian: Eozinofili mogu sudjelovati u imunom odgovoru na neke infekcije helmintima.
English: Eosinophil depletion does not produce chronic systemic alterations of proinflammatory cytokines.
Croatian: Deplecija eozinofila ne dovodi do kroničnih sistemskih promjena proupalnih citokina.
English: Exacerbation rate requiring hospitalisation/emergency room visit
Croatian: Stopa egzacerbacija koje su zahtijevale hospitalizaciju/posjet hitnoj službi
English: Its colour may vary from colourless to yellow.
Croatian: Njegova se boja može kretati u rasponu od bezbojne do žute.