FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Xeljanz are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Xeljanz kontinuirano se prate.
English: An overview of Xeljanz and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Xeljanz i zašto je odobren u EU-u
English: The most common side effects with Xeljanz (seen in between 1 and 10 patients in 100) are headache, infection and inflammation of the nose and throat, diarrhoea, nausea (feeling sick), joint pain and hypertension (high blood pressure).
Croatian: Najčešće nuspojave lijeka Xeljanz (uočene u 1 do 10 na 100 bolesnika) jesu glavobolja, infekcija i upala nosa i grla, proljev, mučnina, bol u zglobovima i hipertenzija (povišeni krvni tlak).
English: Xeljanz is used together with methotrexate after treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
Croatian: Xeljanz se uzima zajedno s metotreksatom kada liječenje jednim ili više lijekova poznatih kao antireumatski lijekovi koji mijenjaju tijek bolesti (DMARD) nije dovoljno dobro djelovalo ili je dovelo do teško podnošljivih nuspojava.
English: Xeljanz must also not be used in patients with severely reduced liver function or in pregnant and breastfeeding women.
Croatian: Xeljanz se također ne smije primjenjivati u bolesnika sa znatno smanjenom funkcijom jetre ili u trudnica i dojilja.
English: The most common serious side effects seen with Xeljanz are serious infections such as pneumonia (infection of the lungs), cellulitis (infection of the deep skin tissue), herpes zoster (shingles), urinary tract infection, diverticulitis (infection affecting the intestines) and appendicitis (infection of the appendix) as well as opportunistic infections that can occur in patients with weakened immune systems.
Croatian: Najčešće ozbiljne nuspojave zabilježene pri primjeni lijeka Xeljanz jesu ozbiljne infekcije kao što su pneumonija (infekcija pluća), celulitis (infekcija potkožnog tkiva), herpes zoster, infekcija mokraćnog sustava, divertikulitis (infekcija koja zahvaća crijeva) i apendicitis (infekcija slijepog crijeva) te oportunističke infekcije koje se mogu javiti u bolesnika s oslabljenim imunosnim sustavom.
English: Several studies have shown that Xeljanz is effective at treating rheumatoid arthritis, psoriatic arthritis and ulcerative colitis in patients who had previously tried other treatments.
Croatian: Nekoliko je ispitivanja pokazalo da je lijek Xeljanz učinkovit u liječenju reumatoidnog artritisa, psorijatičnog artritisa i ulceroznog kolitisa u bolesnika koji su prethodno pokušali primijeniti druga liječenja.
English: For more information about using Xeljanz, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Xeljanz pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: These enzymes play an important role in the process of inflammation that occur in rheumatoid and psoriatic arthritis, and ulcerative colitis.
Croatian: Ti enzimi imaju važnu ulogu u procesu upale koja se javlja u slučaju reumatoidnog i psorijatičnog artritisa te ulceroznog kolitisa.
English: Six studies in over 4,200 patients with rheumatoid arthritis have shown that Xeljanz is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage.
Croatian: U šest ispitivanja provedenih u više od 4 200 bolesnika s reumatoidnim artritisom pokazalo se da Xeljanz učinkovito smanjuje bol i oticanje zglobova, poboljšava pokretljivost zglobova i usporava njihovo daljnje oštećivanje.
English: Similarly, in the second study Xeljanz was more effective than placebo at improving symptoms (50% of Xeljanz-treated patients versus 24% of those given placebo) and ability to perform everyday activities.
Croatian: Slično tome, u drugom ispitivanju lijek Xeljanz bio je učinkovitiji od placeba u ublažavanju simptoma (u 50 % bolesnika liječenih lijekom Xeljanz nasuprot 24 % bolesnika koji su primali placebo) i sposobnosti obavljanja svakodnevnih aktivnosti.
English: Xeljanz is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints, and psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints).
Croatian: Xeljanz je lijek za liječenje odraslih osoba s umjerenim do teškim reumatoidnim artritisom, bolešću koja uzrokuje upalu zglobova, i psorijatičnim artritisom (crvene ljuskave lezije na koži i upala zglobova).
English: Xeljanz is also used to treat adults with moderate to severe ulcerative colitis, a disease causing inflammation and ulcers in the lining of the gut, after treatment with other medicines has not worked well, has stopped working or has led to troublesome side effects.
Croatian: Xeljanz se također primjenjuje za liječenje odraslih osoba s umjerenim do teškim ulceroznim kolitisom, bolešću koja uzrokuje upalu i čireve na stijenci crijeva, te nakon neuspješnog liječenja drugim lijekovima, liječenja koje je prestalo djelovati ili je dovelo do teško podnošljivih nuspojava.
English: In the first study symptoms improved substantially in 50 and 52% respectively of patients taking Xeljanz and adalimumab for 3 months, compared with 33% of those receiving placebo; patients given Xeljanz or adalimumab also showed a greater improvement in their ability to perform everyday activities.
Croatian: U prvom ispitivanju zabilježeno je znatno smanjenje simptoma u 50 % bolesnika koji su tijekom tri mjeseca primali lijek Xeljanz i u 52 % bolesnika koji su tijekom tri mjeseca primali adalimumab, u usporedbi s 33 % u bolesnika koji su primali placebo; u bolesnika koji su primali lijek Xeljanz ili adalimumab također je zabilježeno veće poboljšanje sposobnosti obavljanja svakodnevnih aktivnosti.
English: What benefits of Xeljanz have been shown in studies?
Croatian: Koje su koristi lijeka Xeljanz dokazane u ispitivanjima?
English: How does Xeljanz work?
Croatian: Kako djeluje Xeljanz?
English: In the first study in 614 patients with ulcerative colitis, 18% of patients treated with Xeljanz 10 mg twice a day had mild or no symptoms after 8 weeks of treatment compared with 8% of patients who received placebo.
Croatian: U prvom ispitivanju provedenom u 614 bolesnika s ulceroznim kolitisom, u 18 % bolesnika liječenih dozom lijeka Xeljanz od 10 mg dvaput na dan zabilježeni su blagi simptomi ili izostanak simptoma nakon osam tjedana liječenja, u usporedbi s 8 % bolesnika koji su primali placebo.
English: In patients with rheumatoid arthritis, Xeljanz can also be taken alone by patients who cannot take or are intolerant to methotrexate.
Croatian: U bolesnika s reumatoidnim artritisom koji ne mogu uzimati metotreksat ili ga ne podnose lijek Xeljanz može se primjenjivati i kao samostalna terapija.
English: How is Xeljanz used?
Croatian: Kako se Xeljanz koristi?
English: In one of the studies, where Xeljanz was taken alone, Xeljanz was more effective than methotrexate at slowing down joint damage and reducing symptoms.
Croatian: U jednom od tih ispitivanja, u kojemu se primjenjivao kao samostalna terapija, lijek Xeljanz bio je učinkovitiji od metotreksata u usporavanju oštećenja zglobova i ublažavanju simptoma.
English: In another study, Xeljanz taken alone was more effective than placebo (a dummy treatment) at reducing symptoms, such as pain and swelling.
Croatian: U drugom ispitivanju lijek Xeljanz primjenjivao se kao samostalna terapija i bio je učinkovitiji od placeba (prividno liječenje) u ublažavanju simptoma kao što su bol i oticanje.
English: The first study compared Xeljanz with adalimumab (an injected medicine for psoriatic arthritis) and placebo in 422 patients.
Croatian: U prvom ispitivanju provedenom u 422 bolesnika lijek Xeljanz uspoređen je s adalimumabom (lijek za liječenje psorijatičnog artritisa koji se primjenjuje ubrizgavanjem) i placebom.
English: Similarly, in a second study with 547 patients, after 8 weeks of treatment 17% of patients treated with Xeljanz had mild or no symptoms compared with 4% of placebo-treated patients.
Croatian: Slično tome, u drugom ispitivanju provedenom u 547 bolesnika, nakon osam tjedana liječenja zabilježeni su blagi simptomi ili izostanak simptoma u 17 % bolesnika liječenih lijekom Xeljanz, u usporedbi s 4 % bolesnika koji su primali placebo.
English: In a third study with 593 patients, 34% of patients treated with Xeljanz 5 mg twice a day had mild or no symptoms after a year of treatment compared with 11% of patients receiving placebo.
Croatian: U trećem ispitivanju provedenom u 593 bolesnika, nakon jedne godine liječenja zabilježeni su blagi simptomi ili izostanak simptoma u 34 % bolesnika liječenih dozom lijeka Xeljanz od 5 mg dvaput na dan, u usporedbi s 11 % bolesnika koji su primali placebo.
English: Xeljanz, in combination with methotrexate, was shown to be effective at improving symptoms of psoriatic arthritis in 3 main studies.
Croatian: U trima glavnim ispitivanjima lijek Xeljanz u kombinaciji s metotreksatom pokazao se učinkovitim u ublažavanju simptoma psorijatičnog artritisa.
English: Xeljanz was more effective than placebo at reducing the symptoms of ulcerative colitis in three main studies.
Croatian: U trima glavnim ispitivanjima lijek Xeljanz bio je učinkovitiji od placeba u ublažavanju simptoma ulceroznog kolitisa.
English: The second study compared Xeljanz with placebo in 395 patients.
Croatian: U drugom ispitivanju provedenom u 395 bolesnika lijek Xeljanz uspoređen je s placebom.
English: Date of first authorisation: 11 May 2016
Croatian: Datum prvog odobrenja: 11.svibanj 2016.
English: Follow the directions given to you by your doctor.
Croatian: Pridržavajte se uputa koje Vam je dao Vaš liječnik.
English: Please contact your doctor immediately:
Croatian: Odmah se javite svom liječniku:
English: It is not known whether they respond differently from younger subjects.
Croatian: Nije poznato odgovaraju li te osobe drugačije od mlađih ispitanika.
English: The required dose is determined using the following formulae:
Croatian: Potrebna doza određuje se prema sljedećoj formuli:
English: This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Croatian: To možete učiniti tako da bočice ostavite na sobnoj temperaturi približno jedan sat ili tako da ih držite u ruci nekoliko minuta.
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Croatian: To je osobito važno kod promjene laboratorija i/ili reagensa koji se koriste u testu.
English: - Reconstitution and withdrawal must be carried out under aseptic conditions.
Croatian: - Rekonstitucija i izvlačenje moraju se provesti u aseptičnim uvjetima.
English: • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: • Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • if you notice that the medicine stops working properly
Croatian: • ako primijetite da je lijek prestao pravilno djelovati
English: DO NOT expose the vials to direct heat.
Croatian: NEMOJTE izlagati bočice izravnoj toplini.
English: • Inhibitors: the medicine stops working properly (continuous bleeding).
Croatian: • Inhibitori: lijek je prestao pravilno djelovati (neprekidno krvarenje).
English: Your doctor will calculate the dose of IDELVION you need.
Croatian: Vaš liječnik će izračunati dozu lijeka IDELVION koja Vam je potrebna.
English: The amount of IDELVION you need to take and the duration of treatment depend on:
Croatian: Količina lijeka IDELVION koju morate primijeniti i trajanje liječenja ovise o:
English: Let blood flow back to the end of the tube.
Croatian: Pustite da krv poteče prema kraju cjevčice.
English: All 85 bleeding episodes were successfully treated with 1 or 2 doses of IDELVION.
Croatian: Svih 85 epizoda krvarenja su uspješno bila liječena s 1 ili 2 doze lijeka IDELVION.
English: 50 - 80 (initial level)
Croatian: 50 - 80 (početna doza)
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at 2-25 °C).
Croatian: Nakon rekonstitucije kemijska i fizička stabilnost dokazane su tijekom 8 sati na temperaturi od 225°C.
English: In each of these situations, the benefit of treatment with IDELVION should be weighed against the risk of these complications.
Croatian: U svakoj od tih situacija se korist liječenja lijekom IDELVION mora odvagnuti u odnosu na rizik od navedenih komplikacija.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta lijek se mora odmah upotrijebiti.
English: No investigations on carcinogenicity and reproductive toxicology have been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti i reproduktivne toksičnosti.
English: Including uncomplicated tooth extraction
Croatian: Uključujući nekomplicirano vađenje zuba
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using IDELVION.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite IDELVION.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Croatian: Treba spomenuti da ABR nije usporediv između koncentrata različitih faktora i između različitih kliničkih ispitivanja.
English: General Instructions
Croatian: Opće upute
English: Of the 106 bleeding episodes, the majority (94; 88.7%) was treated with single injection, 103; 97.2% were treated with 1-2 injections.
Croatian: Od 106 epizoda krvarenja, većina (94; 88,7%) je bila liječena s jednom injekcijom, 103; 97,2% su bili liječeni sa 1-2 injekcije.
English: • IDELVION must not be mixed with other medicines or solvents except those mentioned in section 6.
Croatian: • IDELVION se ne smije miješati s drugim lijekovima ili otapalima osim onih navedenih u dijelu 6.
English: Check yourself for any side effects that might happen straight away.
Croatian: Pripazite na sve nuspojave koje bi se mogle odmah pojaviti.
English: Frequencies have been evaluated according to 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), not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja 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), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Factor IX is involved in blood clotting.
Croatian: Faktor IX sudjeluje u zgrušavanju krvi.
English: Immune tolerance induction
Croatian: Indukcija imunološke tolerancije
English: Currently available information support extension of treatment intervals for some patients though potentially associated with an increased risk for bleeding compared to a once weekly regimen.
Croatian: Trenutno dostupni podaci podupiru produljenje intervala liječenja za neke bolesnike iako su potencijalno povezani s povećanim rizikom od krvarenja u usporedbi s režimom primjene jednom tjedno.
English: Clinical studies investigating safety and efficacy of longer treatment intervals than once weekly are ongoing.
Croatian: Klinička ispitivanja sigurnosti i djelotvornosti intervala u liječenju koji su duži od primjenejednom tjedno su u tijeku.
English: If you have any side effects that might be related to the administration of IDELVION, the injection should be stopped (see also sections 2 and 4).
Croatian: Ako nastupi bilo koja nuspojava koja bi mogla biti povezana s primjenom lijeka IDELVION, injekcija se mora prekinuti (pogledajte i djelove 2 i 4).
English: Without opening the vials, warm the IDELVION powder and the liquid to room or body temperature.
Croatian: Prije nego što otvorite bočice, zagrijte IDELVION prašak i tekućinu na sobnu ili tjelesnu temperaturu.
English: Frequency of doses (hours) / Duration of therapy (days)
Croatian: Učestalost doziranja (sati) / trajanje terapije (dani)
English: Single dose may be sufficient for a majority of minor surgeries.
Croatian: Jedna bi doza mogla biti dovoljna kod većine manjih kirurških zahvata.
English: • if you notice symptoms of allergic reactions (see below)
Croatian: • ako primijetite simptome alergijskih reakcija (pogledajte u nastavku)
English: Albumin is a natural, inert carrier protein in plasma with a half-life of approximately 20 days.
Croatian: Albumin je prirodan, inertan prijenosni protein u plazmi, čiji poluvijek iznosi približno 20 dana.
English: IDELVION can be used for all age groups.
Croatian: IDELVION se može koristiti u svim dobnim skupinama.
English: Single dose should be sufficient for majority of bleeds.
Croatian: Jedna bi doza trebala biti dovoljna kod većine krvarenja.
English: • the site and intensity of the bleeding
Croatian: • mjestu i jačini krvarenja
English: You should be monitored carefully for the development of inhibitors.
Croatian: Trebat će Vas pažljivo nadzirati zbog mogućeg razvoja inhibitora.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Količina koju treba primijeniti i učestalost primjene uvijek se moraju uskladiti s kliničkom učinkovitošću u pojedinom slučaju.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeat dose toxicity, genotoxicity, thrombogenicity and local tolerability.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jednokratne i ponovljenih doza, genotoksičnosti, trombogenosti i lokalne podnošljivosti.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents except those mentioned in section 6.1.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima, sredstvima za razrjeđivanje ni otapalima osim onih navedenih u dijelu 6.1.
English: Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96% of all treated bleeding episodes.
Croatian: Hemostatska djelotvornost pri rezoluciji krvarenja ocijenjena je izvrsnom ili dobrom u 96% svih epizoda krvarenja.
English: The product contains traces of hamster proteins (see also “Do not use IDELVION”).
Croatian: Ovaj lijek sadrži proteine hrčka u tragovima (pogledajte odlomak “Nemojte primjenjivati IDELVION”).
English: • The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
Croatian: • Prašak se mora pomiješati s otapalom (tekućinom) i izvući iz bočice u aseptičnim uvjetima.
English: Allow the vials to dry before opening the Mix2Vial package (which contains the filter transfer device), then follow the instructions given below.
Croatian: Pričekajte da se bočice osuše prije nego što otvorite Mix2Vial pakiranje (koje sadrži uređaj za prijenos filtera), a zatim slijedite upute u nastavku.
English: After a bleeding episode during prophylaxis, patients should maintain their prophylaxis regimen as closely as possible, with 2 doses of IDELVION being administered at least 24 hours apart but longer as deemed suitable for the patient.
Croatian: Nakon epizode krvarenja tijekom profilakse bolesnici trebaju održavati svoj režim profilakse što je više moguće, s 2 doze lijeka IDELVION primijenjene u razmaku od najmanje 24 sata ali i duže ako se tako smatra prikladnijim za bolesnika.
English: Other medicines and IDELVION
Croatian: Drugi lijekovi i IDELVION
English: Your treatment should be started and monitored by a doctor who is experienced in the treatment of blood clotting disorders.
Croatian: Vaše liječenje mora započeti i nadzirati liječnik koji ima iskustva s liječenjem poremećaja zgrušavanja krvi.
English: • During pregnancy and breast-feeding, IDELVION should be given only if it is clearly needed.
Croatian: • Tijekom trudnoće i dojenja IDELVION se smije primjenjivati samo ako je to uistinu potrebno.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Croatian: Stoga u bolesnika s alergijskim reakcijama treba ispitati moguću prisutnost inhibitora.
English: The use of high purity factor IX is rarely associated with such adverse reactions.
Croatian: Primjena faktora IX visoke čistoće rijetko se povezuje s takvim nuspojavama.
English: Your doctor should inform you of the early signs of hypersensitivity reactions.
Croatian: Liječnik bi Vas trebao upozoriti na rane znakove reakcija preosjetljivosti.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Croatian: U takvim se slučajevima preporučuje kontaktirati specijalizirani centar za liječenje hemofilije.
English: Make sure that you only pull away the blister package and not the Mix2Vial set.
Croatian: Pazite da povučete samo blister pakiranje, a ne i set Mix2Vial.
English: The safety and efficacy in the perioperative setting was evaluated in two pivotal Phase 3 studies (Study 3001 and 3002) and the on-going Phase 3 safety extension study (Study 3003).
Croatian: Sigurnost i djelotvornost kod perioperativnoe primjene procijenjene su u dva pivotalna ispitivanja faze 3 (Ispitivanje 3001 i 3002) te tijekom nastavka ispitivanja sigurnosti primjene, u ispitivanju faze 3 koje još uvijek trake (Ispitivanje 3003).
English: There is no information on the effects of factor IX on fertility.
Croatian: Nema podataka o učincima faktora IX na plodnost.
English: From those subjects, 8 (38%) experienced at least one bleeding during the 14 day-prophylaxis, while they had no bleeding events during once weekly prophylaxis.
Croatian: Od tih bolesnika, njih 8 (38%) je iskusilo barem jedno krvarenje tijekom 14-dnevne profilakse, a nisu imali niti jedan događaj krvarenja tijekom profilakse provođene primjenom lijeka jednom tjedno.
English: The perprotocol efficacy analysis includes 15 surgeries performed in 12 patients between 8 and 51 years of age undergoing major or minor surgical, dental or other surgical invasive procedures.
Croatian: Analiza djelotvornosti po realiziranom protokolu uključila je 15 kirurških zahvata izvedenih u 12 ispitanika između 8. i 51. godine života podvrgnutih većim ili manjim kirurškim, stomatološkim ili drugim kirurškim invazivnim postupcima.
English: Previously untreated patients The safety and efficacy of IDELVION in previously untreated patients have not yet been established.
Croatian: Prethodno neliječeni bolesnici Sigurnost i djelotvornost lijeka IDELVION u prethodno neliječenih bolesnika još nisu ustanovljene.
English: Clinical studies of IDELVION did not include subjects aged 65 and over.
Croatian: U klinička ispitivanja lijeka IDELVION nisu bili uključeni ispitanici u dobi od 65 ili više godina.
English: The following side effects occurred uncommonly (may affect up to 1 in 100 people):
Croatian: Sljedeće su se nuspojave javile manje česte (mogu se javiti u do 1 na 100 osoba):
English: Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin.
Croatian: Aktivirani faktor IX, u kombinaciji s aktiviranim faktorom VIII, aktivira faktor X, što naposljetku dovodi do pretvaranja protrombina u trombin.
English: (initial level)
Croatian: (početna doza)
English: Take care not to get any blood in the syringe containing the product.
Croatian: Pripazite da krv ne uđe u štrcaljku u kojoj se nalazi lijek.
English: Repeat PK assessment for up to 30 weeks demonstrated a stable pharmacokinetic profile and incremental recovery was consistent over time.
Croatian: Ponovljene farmakokinetičke procjene koje su se provodile tijekom razdoblja do 30 tjedana pokazale su stabilan farmakokinetički profil, a prirast po jedinici doze bio je postojan kroz vrijeme.