FrancophonIA/ELRC3.0 huggingface dataset:
English: Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the green button again.
Croatian: Napomena - ako ne možete pokrenuti ubrizgavanje kako je opisano, čvršće pritisnite brizgalicu na kožu, zatim ponovo pritisnite zeleni gumb.
English: For adult patients, withdraw the entire volume.
Croatian: Za odrasle bolesnike izvucite cijeli sadržaj bočice.
English: • The needle will remain in the long part of the package.
Croatian: • Igla će ostati u dugačkom dijelu pakiranja.
English: LIFMIORa
Croatian: LIFMIOR
English: b: Values for Disease Activity Score (DAS) are means.
Croatian: Vrijednosti za bodove za aktivnost bolesti (Disease Activity Score (DAS)) su srednje vrijednosti.
English: Do NOT remove the white collar that remains on the syringe.
Croatian: NEMOJTE ukloniti bijeli vrat koji ostaje na štrcaljki.
English: The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease.
Croatian: Odgovarajuća doza i učestalost doziranja za dijete ili adolescenta ovisi o tjelesnoj težini i bolesti.
English: In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
Croatian: U nekim slučajevima određene gljivične i druge oportunističke infekcije nisu prepoznate, što je rezultiralo kašnjenjem odgovarajućeg liječenja, a katkad i smrću.
English: This benefit was maintained in Year 2 of this study.
Croatian: Ovaj učinak bio je održan i u drugoj godini ovog ispitivanja.
English: LIFMIOR N=103 to 105*
Croatian: LIFMIOR N=103 do 105*
English: If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose.
Croatian: Ako se ne sjetite sve do dana kada je na redu sljedeća doza, nemojte primijeniti dvostruku dozu (dvije doze u jednom danu) kako biste nadoknadili zaboravljenu dozu.
English: Store in a refrigerator (2° - 8°C).
Croatian: Čuvati u hladnjaku (2C - 8C).
English: Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Croatian: Bolesnici su prethodno bili liječeni s NSAIL (86%), DMARD (80%) ili kortikosteroidima (24%).
English: Check with the doctor or pharmacist if you are not sure.
Croatian: Provjerite s liječnikom ili ljekarnikom ako niste sigurni.
English: On hearing the second ‘click' (or, if you do not hear a second ‘click', after 10 seconds have passed), your injection will be complete (see Diagram 6).
Croatian: Kad začujete drugi “klik” (ili, ako ne začujete drugi “klik”, nakon što protekne 10 sekundi), ubrizgavanje je završilo (vidjeti sliku 6).
English: Assemble the additional supplies you will need for your injection.
Croatian: Prikupite dodatni pribor koji će Vam biti potreban za injekciju.
English: Very Rare
Croatian: Vrlo rijetko
English: With the other hand, hold the syringe like a pencil.
Croatian: Drugom rukom pridržite štrcaljku poput olovke.
English: Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses.
Croatian: Bolesnici koji su uzimali DMARD, NSAIL ili kortikosteroide mogli su ih nastaviti uzimati u stabilnoj dozi.
English: What LIFMIOR looks like and contents of the pack
Croatian: Kako LIFMIOR izgleda i sadržaj pakiranja
English: Date of first authorisation: 13 February 2017 Date of last renewal: {DD month YYYY}
Croatian: Datum prvog odobrenja: 13. veljače 2017.
English: • Infections/monitoring: Tell your doctor of any recent travel outside the European region.
Croatian: • Infekcije/praćenje: obavijestite svog liječnika o svim nedavnim putovanjima izvan Europe.
English: ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.
Croatian: ASAS 50 i 70 odgovori uključivali su iste kriterije s 50%-tnim, odnosno 70%-tnim poboljšanjem.
English: Responses observed during the open-label period were similar to those observed in the double-blind period.
Croatian: Odgovori zabilježeni tijekom otvorenog razdoblja bili su slični onima u dvostruko slijepom razdoblju.
English: Gather the items that you will need for your injection, and place them on the chosen surface:
Croatian: Prikupite pribor koji će Vam biti potreban za injekciju i postavite ga na odabranu površinu:
English: What LIFMIOR is and what it is used for
Croatian: Što je LIFMIOR i za što se koristi
English: If you received LIFMIOR during pregnancy, your baby may have a higher risk of getting an infection.
Croatian: Ako primite LIFMIOR tijekom trudnoće, Vaše dijete može imati veći rizik za dobivanje infekcije.
English: Serious haematological, neurological and autoimmune reactions have also been reported.
Croatian: Prijavljene su i ozbiljne hematološke, neurološke i autoimune reakcije.
English: Information in this leaflet is organised under the following 7 sections:
Croatian: Informacije u ovoj uputi organizirane su u sljedećih 7 dijelova:
English: An analysis of clinical trial data did not reveal any baseline disease characteristics that would assist clinicians in selecting the most appropriate dosing option (intermittent or continuous).
Croatian: Analiza podataka kliničkih ispitivanja nije otkrila nijednu osnovnu značajku bolesti koja bi pomogla kliničarima u odabiru najprikladnijeg doziranja (intermitentnog ili kontinuiranog).
English: Serious infections affect fewer than 1 in 100 patients treated with LIFMIOR.
Croatian: Ozbiljne infekcije zahvaćaju manje od 1 na 100 bolesnika liječenih LIFMIORom.
English: Do not attempt to administer an injection until you are sure that you understand how to use the MYCLIC pen properly.
Croatian: Nemojte pokušavati primijeniti injekciju dok niste sigurni da razumijete kako se ispravno upotrebljava MYCLIC brizgalica.
English: Hold the pen at a right angle (90º) to the injection site.
Croatian: Postavite brizgalicu pod pravim kutom (90º) na mjesto ubrizgavanja.
English: • Very rare (may affect up to 1 in 10,000 people): failure of the bone marrow to produce crucial blood cells.
Croatian: • Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba): Zatajenje funkcije koštane srži koja proizvodi ključne krvne stanice.
English: Continue to hold the pen firmly against your skin until you hear a second click, or until 10 seconds after the first click (whichever happens first).
Croatian: Nastavite držati brizgalicu čvrsto pritisnutu na kožu sve dok ne začujete drugi “klik” ili tijekom 10 sekundi nakon prvog “klika”(štogod bude prije).
English: Significant improvement was also observed for the ASAS partial remission and BASDAI 50.
Croatian: Značajno poboljšanje također je uočeno za djelomičnu remisiju ASAS-a i BASDAI 50.
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of LIFMIOR is generally not recommended.
Croatian: Primjena živih cjepiva dojenčadi 16 tjedana nakon majčine zadnje doze LIFMIORa obično se ne preporučuje.
English: • Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Croatian: • Znakovi raka: rak može zahvatiti bilo koji dio tijela uključujući kožu i krv, a mogući znakovi ovise o vrsti i lokaciji raka.
English: Starting from one of the top corners, pull back the paper cover from the top and sides of the tray.
Croatian: Počevši od jednog od gornjih kuteva, povucite papirnati pokrov s vrha i sa strane posude.
English: • The dose tray should contain the items listed below.
Croatian: • Podložak za dozu mora sadržavati dolje navedene predmete.
English: What LIFMIOR contains
Croatian: Što LIFMIOR sadrži
English: The other ingredients in LIFMIOR are:
Croatian: Drugi sastojci u LIFMIORu su:
English: Long-term experience with LIFMIOR was generally comparable to the original 48-week study and did not reveal any new safety findings.
Croatian: Dugoročno iskustvo s LIFMIORom bilo je općenito usporedivo s originalnim ispitivanjem od 48 tjedana i nije otkrilo nijednu novu činjenicu o sigurnosti primjene.
English: The recommended injection site is the middle of the front of the thighs.
Croatian: Preporučeno mjesto za injekciju je prednja strana sredine natkoljenice.
English: The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified.
Croatian: Vrste velikih urođenih mana bile su u skladu s onima koje su najčešće prijavljivane u općoj populaciji i nije utvrđen nikakav osobit obrazac abnormalnosti.
English: If you prefer, you may alternatively use the stomach area, but make sure you choose a site at least 5 cm away from the belly button (navel).
Croatian: Ako želite, možete naizmjence koristiti područje trbuha, ali pazite da odaberete područje koje je najmanje 5 cm udaljeno od pupka.
English: Patients were also required to have an inadequate response or intolerance to two or more NSAIDs.
Croatian: Bolesnici su također morali imati neodgovarajući odgovor ili intoleranciju na dva ili više nesteroidna protupalna lijeka.
English: Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1).
Croatian: Kontinuirana terapija dulja od 24 tjedna može biti prikladna za nekih odraslih bolesnika (vidjeti dio 5.1).
English: Inspection window will have turned purple
Croatian: Prozorčić za provjeru postat će ljubičast
English: Sepsis or risk of sepsis.
Croatian: Sepsa ili rizik od sepse.
English: Rates of serious adverse events and serious infections did not increase with long-term exposure.
Croatian: Stope ozbiljnih nuspojava i ozbiljnih infekcija nisu se povećale s dugotrajnom izloženosti.
English: Injection site reactions usually occurred in the first month.
Croatian: Reakcije na mjestu primjene injekcije obično su se pojavljivale tijekom prvog mjeseca.
English: a. p = 0.0001.
Croatian: p = 0,0001.
English: • Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with LIFMIOR.
Croatian: • Vaš liječnik će Vam također uručiti Karticu s upozorenjima za bolesnika koja sadrži važne informacije o sigurnosti o kojima morate voditi računa prije i za vrijeme liječenja LIFMIORom.
English: Injection advice:
Croatian: Savjet za ubrizgavanje:
English: Do NOT remove the grey stopper or aluminium ring around the top of the vial.
Croatian: NE uklanjajte sivi čep i aluminijski prsten oko vrha bočice.
English: Invasive fungal infections accounted for more than half of the fatalities amongst patients who developed opportunistic infections.
Croatian: Invazivne gljivične infekcije činile su više od polovice smrtnih slučajeva među bolesnicima u kojih su se razvile oportunističke infekcije.
English: Whilst waiting for the solution in the pen to reach room temperature, read Step 2 (below), and choose an injection site.
Croatian: Dok čekate da otopina dosegne sobnu temperaturu, pročitajte korak 2 (niže dolje) i odaberite mjesto za primjenu injekcije.
English: PASI 50 14 58* 70 74* 77 9 PASI 75 4 34* 44 49* 59 3
Croatian: PASI 50 14 58* 70 74* 77 9 64* 77* 9 69* 83 PASI 75 4 34* 44 49* 59 3 34* 49* 2 38* 71 DSGA
English: No formal clinical trials have been conducted in children aged 2 to 3 years.
Croatian: Nisu provedena službena klinička ispitivanja u djece u dobi od 2 do 3 godine.
English: However, it cannot be excluded that the combination of LIFMIOR with methotrexate could be associated with an increase in the rate of infections.
Croatian: Međutim, ne može se isključiti mogućnost da je kombinacija LIFMIORa s metotreksatom povezana s porastom stope infekcija.
English: (If not, don't use the dose tray and consult your pharmacist).
Croatian: (Ako ne, nemojte koristiti podložak za dozu i obratite se svom ljekarniku).
English: • The needle has been placed in a plastic container to keep it sterile.
Croatian: • Igla se nalazi u plastičnom spremniku kako bi bila sterilna.
English: Your doctor or nurse will tell you how to inject LIFMIOR.
Croatian: Vaš liječnik ili medicinska sestra pokazat će Vam kako injicirati LIFMIOR.
English: There appears to be no correlation between antibody development and clinical response or adverse events.
Croatian: Izgleda da nema korelacije između razvoja protutijela i kliničkog odgovora ili nuspojava.
English: Hampshire, PO9 2NG United Kingdom
Croatian: Hampshire, PO9 2NG Ujedinjeno Kraljevstvo
English: The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Croatian: Zabilježene stope i incidencije u ovim kliničkim ispitivanjima slične su očekivanim za ispitivanu populaciju.
English: UNIQUE IDENTIFIER-2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom.
English: In postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Croatian: Prema iskustvima nakon stavljanja lijeka u promet približno polovica od svih izvješća o slučajevima oportunističkih infekcija diljem svijeta bile su invazivne gljivične infekcije.
English: For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment.
Croatian: Za sve gore navedene indikacije, dostupni podaci upućuju da se klinički odgovor najčešće postiže unutar 12 tjedana terapije.
English: The exposure-adjusted rate was 0.06 events per 100 patient-years.
Croatian: Stopa prilagođena izloženosti iznosila je 0,06 događaja u 100 bolesnik-godina.
English: Children and adults taking LIFMIOR may have an increased risk of developing lymphoma or another cancer.
Croatian: Djeca i odrasli liječeni LIFMIORom mogu imati povećani rizik razvoja limfoma ili nekog drugog raka.
English: LIFMIOR has not been studied in children aged less than 2 years.
Croatian: LIFMIOR nije ispitan u djece mlađe od 2 godine.
English: From a microbiological point of view, the reconstituted medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituiran lijek treba se odmah primijeniti.
English: Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby.
Croatian: Vaš liječnik će Vam pomoći odlučiti nadmašuju li koristi liječenja mogući rizik za Vaše dijete.
English: If you feel that the effect of LIFMIOR is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je djelovanje LIFMIORa prejako ili preslabo, obratite se svom liječniku ili ljekarniku.
English: • Instructional materials to share with patients
Croatian: • materijale s uputama koji se dijele bolesnicima
English: Treatment with LIFMIOR should continue until remission is achieved, for up to 24 weeks.
Croatian: Liječenje LIFMIORom se mora nastaviti dok se ne postigne remisija, najdulje do 24 tjedna.
English: There is no apparent pharmacokinetic difference between males and females.
Croatian: Nema vidljive razlike u farmakokinetici između muškaraca i žena.
English: Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Croatian: Etanercept se sastoji od 934 aminokiseline i ima prividnu molekularnu masu od otprilike 150 kilodaltona.
English: LIFMIOR is also prescribed for the treatment of the following diseases in children and adolescents
Croatian: LIFMIOR se propisuje i za liječenje sljedećih bolesti u djece i adolescenata:
English: When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
Croatian: Kada uklonite pokrov s igle, na vršku igle može se pojaviti kapljica tekućine; to je normalno.
English: The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
Croatian: Liječnik će vam dati detaljne upute za pripremu i određivanje odgovarajuće doze.
English: If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at temperatures of up to 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i ne bi smjeli biti dulji od 6 sati na temperaturi do 25C, osim ako je lijek rekonstituiran u kontroliranim i validiranim aseptičkim uvjetima.
English: Do NOT use any other syringe.
Croatian: NE upotrebljavajte neku drugu štrcaljku.
English: After cleaning, do not touch the stopper with your hands or allow it to touch any surface.
Croatian: Nakon čišćenja, ne dodirujte čep rukama i nemojte dopustiti da dodiruje druge površine.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of LIFMIOR, and in accordance with local recommendations.
Croatian: Ako je postavljena dijagnoza inaktivne (‘latentne') tuberkuloze, mora se započeti liječenje latentne tuberkuloze antituberkuloticima prije početka primjene LIFMIORa, u skladu s lokalnim preporukama.
English: Other medicines and LIFMIOR
Croatian: Drugi lijekovi i LIFMIOR
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Croatian: Ovaj pregled mora uključivati detaljnu anamnezu s osobnom anamnezom tuberkuloze ili mogućeg prethodnog kontakta s tuberkulozom te prethodnu i/ili tekuću imunosupresivnu terapiju.
English: The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja u odraslih osoba, kao i iskustvu nakon stavljanja lijeka u promet.
English: The pen's inspection window should now be completely purple, confirming that the dose has been injected correctly (see Diagram 8).
Croatian: Prozorčić za provjeru na brizgalici sada bi trebao biti potpuno ljubičast, što potvrđuje da je doza ispravno ubrizgana (vidjeti sliku 8).
English: If the window is not completely purple, contact your nurse or pharmacist for assistance, since the pen may not have injected the LIFMIOR solution completely.
Croatian: Ako prozorčić nije potpuno ljubičast, obratite se medicinskoj sestri ili ljekarniku za pomoć, budući da se iz brizgalice možda nije u potpunosti ubrizgala otopina LIFMIORa.
English: Inject slowly, at an angle of 45° to 90° to the skin.
Croatian: Ubrizgavajte sporo, pod kutom od 45° do 90° u odnosu na kožu.
English: Posology and administration are the same as for adults 18-64 years of age.
Croatian: Doziranje i način primjene jednaki su kao i u odraslih osoba starosti 18-64 godine.
English: Waiting until the solution reaches room temperature may make the injection more comfortable for you.
Croatian: Ako pričekate da otopina dosegne sobnu temperaturu, injekcija Vam može biti ugodnija.
English: Placebo N=106 to 109*
Croatian: Placebo N=106 do 109*
English: Reactions at the injection site (these do not occur as often after the first month of treatment).
Croatian: Reakcije na mjestu primjene injekcije (nakon prvog mjeseca liječenja više se ne pojavljuju tako često).
English: Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose.
Croatian: Etanercept se sporo apsorbira s mjesta supkutane injekcije pri čemu maksimalnu koncentraciju nakon jednokratne doze doseže u roku od otprilike 48 sati.
English: LIFMIOR should only be used during pregnancy if clearly needed.
Croatian: LIFMIOR se tijekom trudnoće smije primjenjivati samo ako je to posve neophodno.
English: The use of LIFMIOR is not expected to affect the ability to drive or use machines.
Croatian: Ne očekuje se da će primjena LIFMIORa utjecati na sposobnost upravljanja vozilima ili strojevima.
English: If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Croatian: Ako zaboravite primijeniti dozu, trebate je primijeniti čim se sjetite, osim u slučaju kad je sljedeća predviđena doza sljedeći dan, u tom slučaju trebate preskočiti propuštenu dozu.
English: Both TNFRs exist naturally in membrane-bound and soluble forms.
Croatian: Oba TNFR-a prirodno postoje vezani za membranu i u topljivu obliku.
English: Do not try to use the pen again, and do not try to use another pen without agreement from your nurse or pharmacist.
Croatian: Nemojte pokušati ponovno uporabiti tu brizgalicu, i nemojte uporabiti drugu brizgalicu ako se niste tako dogovorili s medicinskom sestrom ili ljekarnikom.
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Croatian: Utjecaj uznapredovale dobi ispitan je u populacijskoj farmakokinetičkoj analizi serumskih koncentracija etanercepta.
English: Hepatitis B reactivation, listeria
Croatian: Reaktivacija hepatitisa B, listeria
English: See section 4.4.
Croatian: Vidjeti dio 4.4.
English: To avoid damaging the needle inside the pen, do not bend the white needle cap while you are removing it, and do not re-attach it once it has been removed.
Croatian: Da izbjegnete oštećenje igle unutar brizgalice, nemojte savijati bijeli zatvarač igle dok ga uklanjate i nemojte ga vraćati na iglu nakon što ste ga jednom uklonili.
English: If you have used more LIFMIOR than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately.
Croatian: Ako ste primijenili više LIFMIORa nego što ste trebali (bilo da ste primijenili odjednom previše ili ste ga primjenjivali prečesto), odmah se savjetujte s liječnikom ili ljekarnikom.
English: The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies.
Croatian: Učinci etanercepta na ishode trudnoća ispitivani su u dva opservacijska kohortna ispitivanja.
English: LIFMIOR contains no antibacterial preservative, and therefore solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution.
Croatian: LIFMIOR ne sadrži antibakterijski konzervans pa stoga otopinu pripravljenu s vodom za injekcije treba primijeniti što prije, u roku od 6 sati nakon rekonstitucije.
English: Etanercept is cleared slowly from the body.
Croatian: Etanercept se sporo uklanja iz tijela.
English: The effect of LIFMIOR on radiographic progression was maintained in patients who continued on treatment during the second year.
Croatian: Učinak LIFMIORa na radiološku progresiju održan je u bolesnika koji su nastavili s liječenjem tijekom druge godine.
English: Worsening of hepatitis C
Croatian: Pogoršanje hepatitisa C
English: Instructions for use and handling
Croatian: Upute za uporabu i rukovanje
English: Worsening of symptoms of dermatomyositis
Croatian: Pogoršanje simptoma dermatomiozitis
English: This section is divided into the following sub-sections:
Croatian: Ovaj dio podijeljen je na sljedeće pododjeljke:
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using LIFMIOR.
Croatian: Prije stavljanja lijeka u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti konačni edukacijski materijal s regulatornim tijelom u toj državi članici, koji obuhvaća informacije koje su pružene svim zdravstvenim radnicima od kojih se očekuje da propisuju lijek, a koje se odnose na ispravnu i sigurnu primjenu napunjenih brizgalica i Karticu s upozorenjima za bolesnika, koja se daje bolesnicima koji koriste LIFMIOR.