FrancophonIA/ELRC3.0 huggingface dataset:
English: Improvements in health-related quality of life and physical function were also maintained through 2 years of therapy.
Croatian: Poboljšanja u kvaliteti života povezanoj sa zdravljem i fizičkoj funkciji također su održani tijekom 2 godine liječenja.
English: The youngest children (4 years of age) had reduced clearance (increased clearance when normalised by weight) compared with older children (12 years of age) and adults.
Croatian: Najmlađa djeca (starosti 4 godine) imala su smanjeni klirens (povišeni klirens kada je normaliziran prema tjelesnoj težini) u usporedbi sa starijom djecom (u dobi od 12 godina) i odraslima.
English: It blocks the activity of another protein in the body that causes inflammation.
Croatian: Koči aktivnost druge bjelančevine koja u tijelu uzrokuje upalu.
English: Responses of Patients with Psoriasis in Studies 2, 3 And 4
Croatian: Odgovori bolesnika sa psorijazom u ispitivanjima 2, 3 i 4
English: The clinical impact of this is unknown, however, infants may be at increased risk of infection.
Croatian: Klinički utjecaj je nepoznat, no dojenčad može imati povećan rizik od infekcija.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB01
Croatian: Farmakoterapijska skupina: imunosupresivi, inhibitori čimbenika nekroze tumora alfa (TNF-α), ATK oznaka: L04AB01
English: The Patient's Alert Card should contain the following key elements for patients treated with LIFMIOR:
Croatian: Kartica s upozorenjima za bolesnika treba sadržavati sljedeće ključne elemente za bolesnike koji se liječe lijekom LIFMIOR:
English: You may now lift the pen from your skin (see Diagram 7).
Croatian: Sada možete podići brizgalicu s kože (vidjeti sliku 7).
English: This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Croatian: To uključuje izvještaje reaktivacije hepatitisa B u bolesnika koji su bili anti-HBc pozitivni, ali HBsAg negativni.
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of LIFMIOR.
Croatian: Ovi simptomi mogu upućivati na moguće životno opasne poremećaje krvi koji zahtijevaju prekid liječenja LIFMIORom.
English: Check the expiry date (month/year) on the pen.
Croatian: Provjerite datum isteka roka valjanosti (mjesec/godina) na brizgalici.
English: Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation*
Croatian: Alergijske reakcije (vidjeti Poremećaji kože i potkožnog tkiva), nastanak autoprotutijela*
English: Needle safety shield disappears inside the pen
Croatian: Sigurnosni štitnik za iglu nestaje unutar brizgalice
English: Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Croatian: Ispitivanje 4 procijenilo je 142 bolesnika i imalo je slične kriterije uključivanja kao i ispitivanja 2 i 3.
English: Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age.
Croatian: Procjene klirensa i volumena u bolesnika starosti 65 do 87 godina bile su slične procjenama u bolesnika mlađih od 65 godina.
English: This study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy.
Croatian: Ovo ispitivanje nije pokazalo ni povećane rizike od manjih urođenih mana, prijevremenog poroda, mrtvorođenja ili infekcija u prvoj godini života za dojenčad čije su majke bile izložene etanerceptu tijekom trudnoće.
English: The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression.
Croatian: Ostali slučajevi bile su različite vrste zloćudnih bolesti, uključujući rijetke zloćudne bolesti tipično povezane s imunosupresijom.
English: Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Croatian: Među bolesnicima koji su završili puna 24 mjeseca terapije u ispitivanju stopa ne-progresije je bila 78%, 70% odnosno 61%.
English: Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of LIFMIOR following its long-term use in patients with JIA.
Croatian: Nadalje, nisu provedena ni ispitivanja kojima bi se procijenili učinci prekida primjene ili smanjenja preporučene doze LIFMIORa nakon dugotrajne primjene u bolesnika s JIA.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: Za bolesnike koji su pozitivni na HBV infekciju preporučuje se konzultacija s liječnikom s iskustvom u liječenju hepatitisa B.
English: Lightly pinching the skin around the injection site between the thumb and index finger of your free hand may make the injection easier and more comfortable.
Croatian: Lagano uhvatite nabor kože oko mjesta ubrizgavanja između palca i kažiprsta slobodne ruke - to može olakšati ubrizgavanje i učiniti ga ugodnijim.
English: • The pre-filled syringe is for single-use administration only.
Croatian: • Napunjena štrcaljka je samo za jednokratnu primjenu.
English: Alcoholic hepatitis
Croatian: Alkoholni hepatitis
English: • For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Croatian: • Kod sljedećih oblika juvenilnog idiopatskog artritisa kad liječenje metotreksatom nije dovoljno dobro djelovalo ili nije bilo pogodno:
English: • Remove the protective cover from the syringe tip by breaking the white cap along the perforation.
Croatian: • Uklonite zaštitni pokrov s vrha štrcaljke tako što ćete slomiti bijeli poklopac duž perforacijske crte.
English: The modified TSS at 12 months is presented in the table below.
Croatian: Modificirani TSS nakon 12 mjeseci prikazan je u donjoj tablici.
English: This will help to reduce foaming (lots of bubbles) (see Diagram 8).
Croatian: Tako će se smanjiti stvaranje pjene (puno mjehurića) (vidjeti sliku 8).
English: • Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen
Croatian: • vodič za obuku koji olakšava osposobljavanje bolesnika za sigurnu primjenu napunjene brizgalice
English: PASI 75, n (%)
Croatian: PASI 75, n (%) PASI 50, n (%)
English: On pressing the centre of the button, you will hear a click.
Croatian: Kad pritisnete sredinu gumba, začut ćete “klik”.
English: A total of 401 patients were enrolled from which 203 were treated with LIFMIOR.
Croatian: Uključen je ukupno 401 bolesnik od čega su 203 liječena LIFMIORom.
English: If the date has passed, do not use the pen and contact your pharmacist for assistance.
Croatian: Ako je datum prošao, nemojte koristiti brizgalicu i obratite se ljekarniku za pomoć.
English: If someone else is giving you the injection, the outer area of the upper arms may also be used.
Croatian: Ako Vam netko drugi daje injekciju, može se koristiti i vanjska strana nadlaktice.
English: • if the child has, or is at risk of developing a serious blood infection called sepsis.
Croatian: • ako dijete ima ili je u opasnosti od razvoja ozbiljne infekcije krvi zvane sepsa.
English: Malignant melanoma (see section 4.4), lymphoma, leukaemia
Croatian: Maligni melanom (vidjeti dio 4.4), limfom, leukemija
English: Carefully dispose of any LIFMIOR solution that has not been injected within 6 hours.
Croatian: Pažljivo zbrinite preostalu otopinu LIFMIORa koja nije bila ubrizgana u roku od 6 sati.
English: If you are self injecting, you should not use the outer area of the upper arms.
Croatian: Ako sami sebi ubrizgavate otopinu, ne smijete upotrijebiti vanjsku stranu nadlaktice.
English: Toxic epidermal necrolysis
Croatian: Toksična epidermalna nekroliza
English: Package leaflet: information for the user
Croatian: Uputa o lijeku: Informacije za korisnika
English: Patients with complete ankylosis of the spine were not included in the study.
Croatian: Bolesnici s potpunom ankilozom kralježnice nisu bili uključeni u ispitivanje.
English: • if the child has an infection of any kind.
Croatian: • ako dijete ima bilo kakvu infekciju.
English: Place your other hand on the longer portion of the container.
Croatian: Drugom rukom uhvatite dulji dio spremnika.
English: The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Croatian: Središnji volumen raspodjele etanercepta iznosi 7,6 l, dok je volumen raspodjele u stanju dinamičke ravnoteže 10,4 l.
English: Before starting treatment with LIFMIOR, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Croatian: Prije početka terapije LIFMIORom svi bolesnici moraju proći pregled s obzirom na aktivnu i inaktivnu (‘latentnu') tuberkulozu.
English: Step 4: Disposing of the used MYCLIC pen
Croatian: Korak 4: Odlaganje uporabljene brizgalice MYCLIC
English: If LIFMIOR has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Croatian: Ako LIFMIOR nema učinka na Vašu bolest ni nakon 12 tjedana, liječnik Vam može reći da prestanete uzimati ovaj lijek.
English: • Once the seal has been broken, remove the short, wide end of the plastic container.
Croatian: • Nakon što prelomite spoj, izvucite kratki široki kraj iz plastičnog spremnika.
English: Patients should be evaluated for infections before, during, and after treatment with LIFMIOR, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Croatian: Bolesnike treba ocijeniti s obzirom na moguće infekcije prije, za vrijeme i nakon liječenja LIFMIORom, vodeći računa o tome da srednja vrijednost poluvremena eliminacije etanercepta iznosi otprilike 70 sati (raspon od 7 do 300 sati).
English: a. One MYCLIC pre-filled pen and one alcohol swab (take these from the carton of pens you keep in your refrigerator).
Croatian: Jednu napunjenu brizgalicu MYCLIC i jedan jastučić natopljen alkoholom (izvadite ih iz kutije s brizgalicama koju držite u hladnjaku).
English: LIFMIOR treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Croatian: Liječenje LIFMIORom dovelo je do poboljšanja fizičke funkcije tijekom dvostruko slijepog razdoblja, pri čemu je ovo poboljšanje održano i tijekom dugotrajnog izlaganja do 2 godine.
English: In a long-term psoriasis study in which patients received 50 mg twice weekly for 96 weeks, the incidence of antibodies observed at each assessment point was up to approximately 9%.
Croatian: U dugotrajnim ispitivanjima s psorijazom u kojima su bolesnici primali 50 mg dva puta tjedno tijekom 96 tjedana, incidencija protutijela uočenih u svakoj točki ocjenjivanja bila je do otprilike 9%.
English: • Wegener's granulomatosis: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Croatian: • Wegenerova granulomatoza: LIFMIOR se ne preporučuje za liječenje Wegenerove granulomatoze, rijetke upalne bolesti.
English: Start again with another dose tray.
Croatian: Počnite ponovno s drugim podloškom za dozu.
English: Placing the needle on the syringe
Croatian: Postavljanje igle na štrcaljku
English: The dosage of LIFMIOR is based on body weight for paediatric patients.
Croatian: Doza LIFMIORa temelji se na tjelesnoj težini pedijatrijskih bolesnika.
English: Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Croatian: Proporcionalnost doze nije bila službeno ocijenjena, ali nema vidljivog zasićenja klirensa u postojećem rasponu doziranja.
English: Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Croatian: Bolesnici sa teškim reumatoidnim artritisom, koji boluju duže vrijeme, mogu imati veći rizik razvoja limfoma od prosjeka.
English: In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških medicinskih proizvoda, zaštitni znak i broj serije primijenjenog proizvoda treba uredno evidentirati (ili navesti) u bolesničkom kartonu.
English: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis.
Croatian: LIFMIOR se ne preporučuje za liječenje Wegenerove granulomatoze.
English: LIFMIOR works by reducing the inflammation associated with certain diseases.
Croatian: LIFMIOR smanjuje upalu povezanu s određenim bolestima.
English: It is recommended that you record the date that LIFMIOR is removed from the refrigerator and the date after which LIFMIOR should be discarded (no more than 4 weeks following the removal from the refrigerator).
Croatian: Preporučuje se zabilježiti datum kada je LIFMIOR izvađen iz hladnjaka i datum nakon kojega LIFMIOR treba baciti (do 4 tjedna od vađenja iz hladnjaka).
English: The needle will remain protected inside the pen until the pen is activated.
Croatian: Igla će ostati zaštićena unutar brizgalice sve do aktivacije brizgalice.
English: Thrombocytopenia, anaemia, leukopenia, neutropenia
Croatian: Trombocitopenija, anemija, leukopenija, neutropenija
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving LIFMIOR.
Croatian: Nisu dostupni podaci o sekundarnom prijenosu infekcija putem živih cjepiva u bolesnika koji primaju LIFMIOR.
English: Linearity
Croatian: Linearnost
English: In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
Croatian: U prvom dijelu ispitivanja 51 od 69 (74%) bolesnika pokazalo je klinički odgovor i ušlo je u drugi dio ispitivanja.
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of LIFMIOR during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Croatian: Važno je da prije cijepljenja djeteta obavijestite pedijatra i druge zdravstvene radnike o uporabi LIFMIORa tijekom trudnoće (za više informacija vidjeti dio 2, ''Cijepljenje'').
English: PsARC Month 3
Croatian: PsARC 3. mjesec b
English: In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score.
Croatian: U ovom ispitivanju strukturalno oštećenje zglobova procijenjeno je radiološki te prikazano kao promjena ukupne ocjene na Sharpovoj ljestvici (Total Sharp Score - TSS) i njenim dijelovima, ocjene erozije i ocjena suženja zglobnog prostora (Joint Space Narrowing score - JSN).
English: • To open the plastic container, hold the short, wide end in one hand.
Croatian: • Da biste otvorili taj plastični spremnik, jednom rukom uhvatite kratki, široki kraj.
English: Time
Croatian: Vrijeme
English: Talk to your doctor before taking LIFMIOR.
Croatian: Obratite se svom liječniku prije nego uzmete LIFMIOR.
English: No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed.
Croatian: Nije zabilježena promjena u stopi spontanih pobačaja, mrtvorođenčadi ili manjih malformacija.
English: The needle cover contains dry natural rubber (latex) (see section 4.4).
Croatian: Pokrov za iglu sadrži suhu prirodnu gumu (lateks) (vidjeti dio 4.4).
English: Be careful not to push down on the plunger.
Croatian: Pazite da ne potisnete klip.
English: Some patients receiving LIFMIOR have developed skin cancers.
Croatian: Neki od bolesnika koji su primali LIFMIOR razvili su rak kože.
English: In evaluating patients for infections, the patient's risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered.
Croatian: Pri ocjeni podložnosti bolesnika infekcijama treba razmotriti rizik za razvoj oportunističke infekcije (npr. izlaganje endemskim mikozama).
English: After preparing the LIFMIOR solution, immediate use is recommended (up to a maximum of 6 hours).
Croatian: Nakon pripreme otopine LIFMIORa, preporučuje se odmah je primijeniti (unutar najviše 6 sati).
English: LIFMIOR treatment may increase mortality in patients with established sepsis.
Croatian: Liječenje LIFMIORom može povećati smrtnost bolesnika s dokazanom sepsom.
English: These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy.
Croatian: Takve bolesnike je potrebno kontrolirati s obzirom na znakove i simptome aktivne HBV infekcije tijekom terapije i nekoliko tjedana nakon završetka terapije.
English: At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
Croatian: Na kraju dvostruko slijepog ispitivanja bolesnici su mogli ući u dugoročni otvoreni produžetak ispitivanja ukupnog trajanja do 2 godine.
English: While neutropenic, one patient developed cellulitis that resolved after hospitalisation (see sections 4.4 and 4.5).
Croatian: Tijekom neutropenije u jednog se bolesnika razvio celulitis koji se nakon hospitalizacije povukao (vidjeti dijelove 4.4 i 4.5).
English: Similar results were obtained in the 2 smaller ankylosing spondylitis trials.
Croatian: Slični rezultati postignuti su u dva manja ispitivanja s ankilozantnim spondilitisom.
English: Radiographic progression at 12 months was significantly less in the LIFMIOR group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Croatian: Radiološka progresija nakon 12 mjeseci bila je značajno manja u skupini s LIFMIORom nego u skupini s metotreksatom, dok je kombinacija bila značajno bolja od obje monoterapije u smislu usporavanja radiološke progresije (vidjeti sljedeću sliku).
English: Patients who develop a new infection while undergoing treatment with LIFMIOR should be monitored closely.
Croatian: Bolesnike u kojih se razviju nove infekcije za vrijeme liječenja LIFMIORom mora se pažljivo nadgledati.
English: Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
Croatian: Bez promjena ili gotovo bez promjena na koži definirano kao 0 ili 1 na ljestvici od 0 do 5.
English: TNF-antagonists, such as LIFMIOR, affect the immune system and their use may affect the body's defenses against infection and cancer.
Croatian: Antagonisti TNF-a, kao što je LIFMIOR, utječu na imunološki sustav i njihova primjena može imati učinak na obranu organizma protiv infekcija i raka.
English: The clinical significance of this interaction is unknown.
Croatian: Klinički značaj navedene interakcije nije poznat.
English: Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Croatian: U svih je bolesnika potrebno provesti odgovarajuće testove probira, tj. tuberkulinski kožni test i rendgen toraksa (mogu se primijeniti lokalne preporuke).
English: 24a n = 193 wk 12
Croatian: 24a n = 193 tj. 12
English: LIFMIOR can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: LIFMIOR se može davati kao monoterapija u slučaju nepodnošljivosti metotreksata ili kada je nastavak liječenja metotreksatom neodgovarajući.
English: The side effects and their frequencies seen in children and adolescents are similar to those described above.
Croatian: Nuspojave opažene u djece i adolescenata i njihova učestalost slične su ovima opisanima gore.
English: The clinical significance of this is unknown.
Croatian: Klinički značaj ovog zapažanja nije poznat.
English: Compared to placebo, treatment with LIFMIOR resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Croatian: U usporedbi s placebom, liječenje lijekom LIFMIOR rezultiralo je u statistički značajnom poboljšanju u ASAS 40, ASAS 20 i ASAS 5/6.
English: Uncommon ≥ 1/1,000 to < 1/100
Croatian: Manje često ≥ 1/1000 i < 1/100
English: The use of LIFMIOR in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Croatian: Primjena LIFMIORa u kombinaciji s drugom sistemskom terapijom ili fototerapijom za liječenje psorijaze nije ispitana.
English: Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of LIFMIOR (10 mg, 25 mg or 50 mg).
Croatian: Liječnik će odrediti točnu dozu za dijete i propisat će odgovarajuću jačinu LIFMIORa (10 mg, 25 mg ili 50 mg).
English: No dose adjustment is required.
Croatian: Nije potrebna prilagodba doze.
English: In addition, one study found more birth defects when the mother had received LIFMIOR in pregnancy, compared with mothers who had not received LIFMIOR or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Croatian: Nadalje, jedno ispitivanje je zabilježilo više urođenih mana u slučaju kada je majka tijekom trudnoće primila LIFMIOR u usporedbi s majkama koje nisu primile LIFMIOR ili druge slične lijekove (antagoniste TNF-a), iako nije zabilježeno o kojem se tipu prijavljenih urođenih mana radi.
English: However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Croatian: Međutim, pojava je bila rijetka, a period praćenja bolesnika liječenih placebom bio je kraći nego u bolesnika liječenih antagonistima TNF-a.
English: Another study found no increased risk of birth defects when the mother had received LIFMIOR in pregnancy.
Croatian: Drugo ispitivanje nije zabilježilo povećani rizik od urođenih mana kada je majka primala LIFMIOR tijekom trudnoće.
English: Autoimmune hepatitis*
Croatian: Autoimuni hepatitis*
English: Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Croatian: Nastavak terapije treba pažljivo razmotriti u bolesnika bez odgovora u ovom vremenskom razdoblju.
English: Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Croatian: Simulacija doziranja upućuje na zaključak da će starija djeca (u dobi od 10-17 godina) imati serumske razine slične onima u odraslih, dok će mlađa djeca imati znatno niže razine.
English: The 10 mg LIFMIOR dose had consistently less effect on structural damage than the 25 mg dose.
Croatian: Doza od 10 mg LIFMIORa imala je znatno manji učinak na strukturalno oštećenje u usporedbi s dozom od 25 mg.
English: Name and address of the manufacturers responsible for batch release Wyeth Pharmaceuticals
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet Wyeth Pharmaceuticals
English: This combination has not demonstrated increased clinical benefit.
Croatian: Nije dokazano da ova kombinacija povećava kliničku korist.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP,) koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • This medicine has been prescribed for you or a child in your care.
Croatian: • Ovaj je lijek propisan Vama ili djetetu za koje skrbite.