FrancophonIA/ELRC3.0 huggingface dataset:
English: However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
Croatian: Međutim, ograničeni podaci o sigurnosti primjene lijeka dobiveni iz registra bolesnika sugeriraju da je sigurnosni profil u djece između 2 i 3 godine starosti sličan onome koji je zabilježen u odraslih i djece u dobi od 4 godine ili više, kada se svaki tjedan dozira supkutano 0,8 mg/kg (vidjeti dio 5.1).
English: LIFMIOR powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Croatian: Prije primjene LIFMIOR prašak za otopinu mora se rekonstituirati u 1 ml otapala (vidjeti dio 6.6).
English: Worsening of cardiac failure congestive (see section 4.4)
Croatian: Pogoršanje kongestivnog srčanog zatajenja (vidjeti dio 4.4)
English: After removal of the needle cap, you will see a purple needle safety shield extending slightly from the end of the pen.
Croatian: Nakon uklanjanja zatvarača igle, vidjet ćete ljubičasti sigurnosni štitnik igle kako se proteže malo s kraja brizgalice.
English: • Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years
Croatian: • Poliartikularni artritis (s pozitivnim ili negativnim reumatoidnim faktorom) i produljeni oligoartritis u bolesnika od navršene 2 godine života.
English: Compared to placebo, patients with rheumatic diseases treated with LIFMIOR had a significantly higher incidence of injection site reactions (36% vs. 9%).
Croatian: U usporedbi s bolesnicima koji su primali placebo, u bolesnika s reumatskim bolestima koji su primali LIFMIOR uočena je značajno veća incidencija reakcija na mjestu primjene injekcije (36% naspram 9%).
English: Do not touch the needle or allow it to touch any surface.
Croatian: Nemojte dirati iglu i pazite da ne dodirne neku drugu površinu.
English: Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Croatian: Ispitivanje 2 je procijenilo 652 bolesnika s kroničnom plak psorijazom koristeći iste kriterije uključivanja kao u ispitivanju 1, uz dodatak minimalnog PASI indeksa 10 na probiru.
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 18).
Croatian: • Brzim, kratkim pokretom ubodite iglom kroz kožu pod kutom između 45° i 90° (vidjeti sliku 18).
English: For children, remove only the portion of liquid as directed by your child's doctor.
Croatian: Za djecu izvucite samo dio otopine prema uputi djetetovog liječnika.
English: Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available.
Croatian: Odgovarajući podaci o liječenju bolesnika zaraženih HBV-om kombinacijom antivirusne terapije i antagonista TNF-a nisu dostupni.
English: Two large clinical trials evaluating the use of LIFMIOR in the treatment of CHF were terminated early due to lack of efficacy.
Croatian: Dva velika klinička ispitivanja primjene LIFMIORa u liječenju kongestivnog zatajenja srca prekinuta su ranije uslijed nedostatne djelotvornosti.
English: In a study of 49 adult patients with rheumatoid arthritis treated with LIFMIOR, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Croatian: U ispitivanju koje je provedeno u 49 odraslih bolesnika s reumatoidnim artritisom liječenih LIFMIORom nije bilo dokaza o smanjenju preosjetljivosti odgođenog tipa, smanjenju razine imunoglobulina ni promjeni ukupnog broja populacije izvršnih stanica.
English: Compared to placebo, treatment with LIFMIOR resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Croatian: Liječenje LIFMIORom, u usporedbi s placebom, dovelo je do značajnog poboljšanja ASAS 20, ASAS 50 i ASAS 70 već nakon 2 tjedna nakon početka terapije.
English: Name and address of the manufacturers of the biological active substance Boehringer Ingelheim Pharma KG
Croatian: Nazivi i adrese proizvođača biološke djelatne tvari Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65
English: These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Croatian: Te infekcije uzrokovane su bakterijama, mikobakterijama, gljivicama, virusima i parazitima (uključujući protozoe).
English: LIFMIOR should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.
Croatian: LIFMIOR se obično ne bi smio primjenjivati u djece s poliartikularnim artritisom ili produljenim oligoartritisom mlađe od 2 godine, kao ni u djece s artritisom povezanim s entezitisom ili psorijatičnim artritisom mlađe od 12 godina niti u djece s psorijazom mlađe od 6 godina.
English: In this situation, the benefit/risk balance of LIFMIOR therapy should be very carefully considered.
Croatian: U navedenoj situaciji nužno je vrlo pomno razmotriti omjer koristi i rizika terapije LIFMIORom.
English: Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Croatian: Etanercept također može utjecati na biološku aktivnost kontroliranu dodatnim molekulama koje seuključuju kasnije (npr. citokini, adhezijske molekule ili proteinaze), a koje inducira ili nadzire TNF.
English: In the postmarketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi leukemije u bolesnika koji su liječeni antagonistima TNF-a.
English: Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Croatian: U znatnom dijelu patologije zgloba u reumatoidnom artritisu i ankilozantnom spondilitisu te patologije kože u plak psorijazi posreduju proupalne molekule povezane u mrežu koju kontrolira TNF.
English: In a double blind, placebo controlled, randomised clinical study in adult patients with psoriatic arthritis 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Croatian: U dvostruko slijepom, placebom kontroliranom, randomiziranom kliničkom ispitivanju u odraslih bolesnika s psorijatičnim artritisom, 184 bolesnika je također primilo polivalentno pneumokokno polisaharidno cjepivo u 4. tjednu.
English: These reactions were generally transient and did not recur with treatment.
Croatian: Te su reakcije općenito bile prolazne naravi te se nisu ponavljale.
English: Tell the doctor or pharmacist if the child is taking, has recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the child's doctor.
Croatian: Obavijestite svog liječnika ili ljekarnika ako dijete uzima, nedavno je uzelo ili bi moglo uzeti bilo koje druge lijekove (uključujući anakinru, abatacept ili sulfasalazin), čak i one koje nije propisao liječnik.
English: Summary of the safety profile
Croatian: Sažetak sigurnosnog profila lijeka
English: ACR Responsesa ACR 20
Croatian: ACR odgovori ACR 20 ACR 50 ACR 70
English: LIFMIOR should be discarded if not used within four weeks after removal from the refrigerator.
Croatian: LIFMIOR treba baciti ako se ne upotrijebi u roku od četiri tjedna nakon što je izvađen iz hladnjaka.
English: Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
Croatian: Vaskulitis (uključujući vaskulitis s pozitivnim antineutrofilnim citoplazmatskim protutijelima)
English: This injection should not be mixed with any other medicine.
Croatian: Ovu injekciju se ne smije miješati niti s jednim drugim lijekom.
English: Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
Croatian: Ozbiljne infekcije (uključujući pneumoniju, celulitis, bakterijski artritis, sepsu i parazitarnu infekciju)*
English: Histiocytosis haematophagic (macrophage activation syndrome)*
Croatian: Hematofagična histiocitoza (sindrom aktivacije makrofaga)*
English: The safety and efficacy of LIFMIOR in patients with immunosuppression have not been evaluated.
Croatian: Sigurnost primjene i djelotvornost LIFMIORa u bolesnika s imunosupresijom nisu ispitane.
English: Your doctor will determine if LIFMIOR is an appropriate treatment.
Croatian: Liječnik će odrediti je li liječenje LIFMIORom primjereno za Vas.
English: Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: 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: Unutar klasifikacije organskih sustava nuspojave su navedene prema učestalosti (broj bolesnika u kojih se očekuje pojava navedene reakcije), sukladno sljedećim kategorijama: 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: The efficacy of LIFMIOR was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (<3 years duration) who had never received treatment with methotrexate.
Croatian: Djelotvornost LIFMIORa uspoređena je s metotreksatom u randomiziranom, aktivno kontroliranom ispitivanju s radiološkom ocjenom na slijepo kao primarnom mjerom ishoda, u 632 odrasla bolesnika s aktivnim reumatoidnim artritisom (<3 godine trajanja) koji nikada nisu bili liječeni metotreksatom.
English: Concurrent treatment with abatacept
Croatian: Istodobno liječenje abataceptom
English: In a group of 2,711 plaque psoriasis patients treated with LIFMIOR in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
Croatian: U skupini od 2711 bolesnika s plak psorijazom liječenih LIFMIORom u dvostruko slijepom, otvorenom ispitivanju u trajanju do 2,5 godine zabilježeno je 30 zloćudnih bolesti i 43 nemelanomska raka kože.
English: Tell the doctor if the child develops any abdominal cramps and pain, diarrhoea, weight loss or blood in the stool.
Croatian: Obavijestite svojeg liječnika ako dijete razvije bilo kakve bolove ili grčeve u trbuhu, proljev, izgubi na težini ili uočite krv u stolici.
English: If you stop using LIFMIOR
Croatian: Ako prestanete primjenjivati LIFMIOR
English: Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
Croatian: Aksijalni spondiloartritis bez radioloških dokaza Liječenje odraslih s teškim aksijalnim spondiloartritisom bez radioloških dokaza s objektivnim znakovima upale na koje upućuju povišene vrijednosti C-reaktivnog proteina (CRP) i/ili rezultati snimanja magnetskom rezonancijom (MR), u kojih postoji neadekvatan odgovor na nesteroidne protuupalne lijekove (NSAIL).
English: In the 2-year active-controlled study where patients were treated with either LIFMIOR alone, methotrexate alone or LIFMIOR in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
Croatian: U dvogodišnjem aktivno kontroliranom ispitivanju u kojem su bolesnici liječeni samo LIFMIORom, samo metotreksatom ili LIFMIORom u kombinaciji s metotreksatom, stope ozbiljnih infekcija bile su slične za sve liječene skupine.
English: In adults (aged 18 and over), LIFMIOR can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Croatian: U odraslih (u dobi od 18 ili više godina) LIFMIOR se može primijeniti za liječenje umjerenog ili teškog reumatoidnog artritisa, psorijatičnog artritisa, teškog aksijalnog spondiloartritisa uključujući ankilozantni spondilitis i umjerene ili teške psorijaze - u svakom od tih slučajeva, obično kada ostali široko primjenjivani načini liječenja nisu djelovali dovoljno dobro ili su za Vas neprikladni.
English: The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain.
Croatian: Primarna mjera djelotvornosti (ASAS 40) bila je 40-postotno poboljšanje u najmanje tri od četiri parametra procjene ASAS i odsutnost pogoršanja preostalog parametra.
English: • Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints
Croatian: • Znakovi ozbiljne infekcije, kao što su visoka temperatura koja može biti praćena kašljem, nedostatkom zraka, zimicom, slabošću ili toplim, crvenim, osjetljivim, bolnim područjem na koži ili zglobovima.
English: LIFMIOR should not be used if all the powder in the vial is not dissolved within 10 minutes.
Croatian: LIFMIOR se ne smije primijeniti ako se sav prašak u bočici ne otopi unutar 10 minuta.
English: Clinical improvement, including onset of action within 2 weeks with LIFMIOR 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months.
Croatian: Kliničko poboljšanje, uključujući početak djelovanja LIFMIORa u dozi od 25 mg unutar razdoblja od 2 tjedna, bilo je slično onome zabilježenom u prethodnim ispitivanjima te se održalo tijekom sljedeća 24 mjeseca.
English: For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
Croatian: Za bolesnike koji su primali 50 mg jednom tjedno tijekom ispitivanja odgovor s obzirom na djelotvornost nastavio se poboljšavati s time da je 71% bolesnika postiglo PASI 75 u 24. tjednu.
English: L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Water for injections
Croatian: L-argininklorid natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat voda za injekcije
English: The difference between LIFMIOR alone and methotrexate alone was also significant (p<0.05).
Croatian: Također je značajna razlika između LIFMIORa u monoterapiji i metotreksata u monoterapiji (p<0,05).
English: Ankylosing Spondylitis Response
Croatian: Odgovor ankilozantnog spondilitisa
English: Adult patients had serum samples tested for autoantibodies at multiple timepoints.
Croatian: Uzorci seruma odraslih bolesnika testirani su na autoprotutijela u više navrata.
English: • While holding the syringe upright, remove any air bubbles by slowly pushing on the plunger until the air is removed (see Diagram 16).
Croatian: • Držeći štrcaljku usmjerenu prema gore, uklonite mjehuriće zraka tako što ćete polako potisnuti klip sve dok ne istisnete zrak (vidjeti sliku 16).
English: There is insufficient evidence of the efficacy of LIFMIOR in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Croatian: Nema dovoljno dokaza o djelotvornosti LIFMIORa u bolesnika sa psorijatičnim artropatijama koje su slične ankilozantnom spondilitisu i artritis mutilansu, zbog malog broja ispitivanih bolesnika.
English: Autoimmune hepatitis
Croatian: Autoimuni hepatitis
English: Among patients receiving LIFMIOR, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months.
Croatian: Među bolesnicima koji su primali LIFMIOR klinički odgovor javio se općenito unutar 1 do 2 tjedna od početka liječenja, a gotovo uvijek nakon 3 mjeseca liječenja.
English: These include the alcohol swab from the LIFMIOR carton and a cotton ball or gauze.
Croatian: Pribor uključuje jastučić natopljen alkoholom iz kutije LIFMIORa i komadić vate ili gaze.
English: LIFMIOR is administered by subcutaneous injection.
Croatian: LIFMIOR se primjenjuje supkutanom injekcijom.
English: • Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Croatian: • Teška psorijaza u bolesnika u dobi od navršenih 6 godina života koji nisu prikladno odgovorili na (ili ne podnose) fototerapiju ili druge sistemske terapije.
English: There is generally no applicable use of LIFMIOR in children aged below 6 years in the indication plaque psoriasis.
Croatian: U djece mlađe od 6 godina općenito nije primjerena primjena LIFMIORa u indikaciji plak psorijaze.
English: Step 1: Preparing for an LIFMIOR injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of the used MYCLIC pen
Croatian: Korak 1: Priprema za injekciju LIFMIORa Korak 2: Odabir mjesta uboda Korak 3: Ubrizgavanje otopine LIFMIORa Korak 4: Odlaganje uporabljene brizgalice MYCLIC
English: There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi intersticijske plućne bolesti (uključujući pneumonitis i plućnu fibrozu), od kojih su neki imali smrtan ishod.
English: • For enthesitis-related arthritis in patients from the age of 12 years when other widely used treatments have not worked well enough or are not suitable for them
Croatian: • Artritis povezan s entezitisom u bolesnika od navršenih 12 godina života kad drugi široko primjenjivani načini liječenja nisu djelovali dovoljno dobro ili za njih nisu bili prikladni.
English: As you lift the pen, the purple needle safety shield will automatically extend to cover the needle.
Croatian: Kad podignete brizgalicu s kože, ljubičasti sigurnosni štitnik za iglu automatski će se izvući i prekriti iglu.
English: Elevated liver enzymes
Croatian: Povišeni jetreni enzimi
English: The solvent is a clear, colourless liquid.
Croatian: Otapalo je bistra, bezbojna tekućina.
English: Opportunistic infections have been reported in association with LIFMIOR, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Croatian: Oportunističke infekcije zabilježene su u vezi s LIFMIORom, uključujući invazivne gljivične, parazitske (uključujući protozoalne), virusne (uključujući herpes zoster), bakterijske (uključujući bakterije listeriju i legionelu) i atipične mikobakterijske infekcije.
English: There is generally no applicable use of LIFMIOR in children aged below 2 years in the indication juvenile idiopathic arthritis.
Croatian: U djece mlađe od 2 godine općenito nije primjerena primjena LIFMIORa u indikaciji juvenilnog idiopatskog artritisa.
English: If you forget to inject LIFMIOR
Croatian: Ako ste zaboravili primijeniti LIFMIOR
English: Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal failure.
Croatian: Iako nakon primjene radioizotopom označenog etanercepta bolesnicima i dobrovoljcima postoji eliminacija radioaktivnosti u mokraći, nisu bile opažene povećane koncentracije etanercepta u bolesnika s akutnim zatajenjem bubrega.
English: Increased etanercept concentrations were not observed in patients with acute hepatic failure.
Croatian: Povećane koncentracije etanercepta nisu bile opažene u bolesnika s akutnim zatajenjem funkcije jetre.
English: Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Croatian: Potreban je oprez kada se razmatra liječenje antagonistima TNF-a bolesnika koji u anamnezi imaju zloćudne bolesti, kao i kada se razmatra nastavak liječenja bolesnika koji su razvili zloćudnu bolest.
English: The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
Croatian: Usporavanje oštećenja perifernih zglobova opaženo je u bolesnika s poliartikularnim simetričnim zahvaćanjem zglobova.
English: If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Croatian: Ako ste zabrinuti zbog izgleda otopine, obratite se ljekarniku za pomoć.
English: This injection should not be mixed in the same syringe or vial with any other medicine.
Croatian: Ovu injekciju se ne smije miješati u istoj štrcaljki ili bočici niti s jednim drugim lijekom.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
Croatian: Bolesnicima tjelesne težine od 62,5 kg ili veće može se dati fiksna doza iz napunjene štrcaljke ili napunjene brizgalice.
English: The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Croatian: U najveće od navedenih ispitivanja (n= 277) bili su uključeni bolesnici u dobi od 18 do 70 godina koji su imali aktivni ankilozantni spondilitis definiran bodovima na vizualnoj analognoj skali (VAS)  30 za prosječno trajanje i intenzitet jutarnje ukočenosti i uz VAS bodove 30 za najmanje 2 od sljedeća 3 parametra: opća procjena bolesnika, prosječne vrijednosti VAS za noćnu bol u leđima i ukupnu bol u leđima, prosječno 10 pitanja u Bathovom funkcionalnom indeksu ankilozantnog spondilitisa (Bath Ankylosing Spondylits Functional Index (BASFI)).
English: Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy).
Croatian: Osim toga, rijetko je bilo prijava perifernih demijelinizirajućih polineuropatija (uključujući Guillan-Barréov sindrom, kroničnu upalnu demijelinizirajuću polineuropatiju, demijelinizirajuću polineuropatiju i multifokalnu motoričku neuropatiju).
English: In part 2, patients with a clinical response at day 90 were randomised to remain on LIFMIOR or receive placebo for four months and assessed for disease flare.
Croatian: U drugom dijelu bolesnici s kliničkim odgovorom 90. dana randomizirani su da i dalje primaju LIFMIOR ili placebo kroz četiri mjeseca i zatim je procijenjeno pogoršanje bolesti.