FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Croatian: • Bolesnici s teškim oblikom reumatoidnog artritisa i drugim upalnim bolestima, koji već dugo vremena boluju od te bolesti, mogu imati veći rizik od prosječnog za razvoj limfoma.
English: The small number of patients positive for antibodies to golimumab limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures.
Croatian: Mali broj bolesnika s pozitivnim nalazom antitijela na golimumab ograničava mogućnost donošenja konačnih zaključaka o povezanosti nastanka protutijela na golimumab i kliničke djelotvornosti, ili mjera sigurnosti.
English: Key results are shown in Table 6 and described below.
Croatian: Ključni rezultati prikazani su u tablici 6 i opisani niže.
English: • On rare occasions, people treated with TNF blockers have developed lupus.
Croatian: • U rijetkim slučajevima su osobe liječene TNF blokatorima razvile lupus.
English: ACR 70 Week 14 4% 14% p = 0.008
Croatian: ACR 70 14. tjedan 4% 14% p = 0,008
English: • Keep this card with you for 6 months after the last Simponi dose, since side effects may occur a long time after your last dose of Simponi.
Croatian: • Nosite ovu karticu sa sobom još 6 mjeseci nakon posljednje doze lijeka Simponi jer se nuspojave mogu javiti i dugo vremena nakon primanja zadnje doze lijeka.
English: Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate.
Croatian: Bolesnike treba savjetovati da na odgovarajući način izbjegavaju izlaganje potencijalnim čimbenicima rizika za razvoj infekcije.
English: Keep Simponi pre-filled pen and all medicines out of the sight and reach of children.
Croatian: Napunjenu brizgalicu s lijekom Simponi i sve druge lijekove čuvajte izvan pogleda i dohvata djece.
English: • Wash your hands thoroughly with soap and warm water.
Croatian: • Dobro operite ruke sapunom i toplom vodom.
English: • Tell your doctor or pharmacist if you are taking any other medicines that affect your immune system.
Croatian: • Obavijestite svog liječnika ili ljekarnika ako uzimate neke druge lijekove koji djeluju na imunološki sustav.
English: If you have lived in or travelled to an area where infections caused by specific type of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis), are common, tell your doctor straight away.
Croatian: Ako ste živjeli ili putovali u područja u kojima su česte infekcije uzrokovane specifičnom vrstom gljivica koje mogu zahvatiti pluća ili druge dijelove tijela (histoplazmoza, kokcidioidomikoza ili blastomikoza), odmah o tome obavijestite svog liječnika.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors, ATC code: L04AB06
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori faktora nekroze tumora alfa (TNF-α), ATK oznaka: L04AB06
English: Hold firmly.
Croatian: Čvrsto držite taj nabor.
English: • If you use Simponi or other TNF blockers, your risk for developing lymphoma or another cancer may increase.
Croatian: • Ako se liječite lijekom Simponi ili drugim TNF blokatorima, možete imati povećan rizik za razvoj limfoma ili drugih vrsta raka.
English: • Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles
Croatian: • karcinomi, uključujući rak kože i nekancerogene izrasline ili kvržice, uključujući madeže
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Croatian: Postoji povećan rizik od pojave limfoma i leukemije u bolesnika s reumatoidnim artritisom koji imaju dugotrajnu, vrlo aktivnu upalnu bolest, što otežava procjenu rizika.
English: In case you have received Simponi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Croatian: U slučaju da ste primali Simponi za vrijeme trudnoće, važno je da o tome obavijestite liječnika Vašeg novorođenčeta/dojenčeta prije nego primi neko cjepivo.
English: • Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
Croatian: • imunološki poremećaji koji mogu zahvatiti pluća, kožu i limfne čvorove (najčešće se pokazuju kao sarkoidoza)
English: • If you have mild heart failure and you are being treated with Simponi, you must be closely monitored by your doctor.
Croatian: • Ako imate blagi stupanj zatajenja srca i liječite se lijekom Simponi, liječnik Vas mora pažljivo nadzirati.
English: In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment be instituted immediately.
Croatian: U slučaju predoziranja preporučuje se praćenje bolesnika kako bi se uočili eventualni znakovi ili simptomi nuspojava te odmah započelo odgovarajuće simptomatsko liječenje.
English: Among the children who tested positive for antibodies to golimumab, 39% (25/65) had neutralising antibodies.
Croatian: Među djecom koja su bila pozitivna na protutijela na golimumab, njih 39% (25/65) imalo je neutralizirajuća protutijela.
English: The baseline median number of active joints was 12, and median CRP was 0.17 mg/dL.
Croatian: Medijan broja aktivnih zglobova na početku ispitivanja iznosio je 12, a medijan CRP-a 0,17 mg/dl.
English: What Simponi is and what it is used for What you need to know before you use Simponi How to use Simponi
Croatian: Što je Simponi i za što se koristi Što morate znati prije nego počnete primjenjivati Simponi
English: • Children weighing less than 40 kg: The recommended dose of Simponi for children weighing less than 40 kg depends on their weight and height.
Croatian: • Djeca tjelesne težine manje od 40 kg: Preporučena doza lijeka Simponi za djecu tjelesne težine manje od 40 kg ovisi o njihovoj tjelesnoj težini i visini.
English: Because of the nature of the adverse events seen with this combination therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents.
Croatian: Zbog prirode štetnih događaja primijećenih kod primjene te kombinirane terapije, slična toksičnost mogla bi se javiti i kod istodobne primjene anakinre i drugih TNF-blokatora.
English: • You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle.
Croatian: • Možda ćete primijetiti mjehurić zraka u napunjenoj štrcaljki ili kapljicu tekućine na vrhu igle.
English: Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
Croatian: Neke od tih ozbiljnih infekcija nastupile su u bolesnika koji su istodobno liječeni imunosupresivima, što, uz osnovnu bolest, može povećati njihovu sklonost infekcijama.
English: Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse events, including infection.
Croatian: Potreban je oprez i kontinuirani nadzor bolesnika kod prelaska s jednog biološkog lijeka na drugi jer preklapanje bioloških aktivnosti može dodatno povećati rizik od štetnih događaja, uključujući infekciju.
English: • Chronic inflammatory condition of the lungs
Croatian: • kronična upalna stanja pluća
English: Part 1 of the study consisted of a 16-week open-label phase in which 173 enrolled children received Simponi 30 mg/m
Croatian: Prvi dio ispitivanja sastojao se od 16-tjedne otvorene faze u kojoj je 173 uključene djece primalo Simponi u dozi od 30 mg/m
English: Effect of weight on pharmacokinetics
Croatian: Utjecaj težine na farmakokinetiku lijeka
English: GO-AFTER Active RA, previously treated with one or more anti-TNF agent(s)
Croatian: GO-AFTER Aktivni RA, prethodno liječen jednim ili više TNF-blokatora
English: There are no adequate data on the use of golimumab in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni golimumaba u trudnica.
English: It will lock, and you will not receive the dose.
Croatian: Štitnik će se zaključati i nećete primiti dozu.
English: Do not warm the pre-filled syringe in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Nemojte zagrijavati napunjenu štrcaljku niti na jedan drugi način (na primjer, u mikrovalnoj pećnici ili u vrućoj vodi).
English: Prepare for your injection
Croatian: Pripremite se za injekciju
English: If multiple injections are required, the injections should be administered at different sites on the body.
Croatian: Ako je potreban veći broj injekcija, treba ih primjenjivati na različitim mjestima na tijelu.
English: • Treatment with TNF blockers such as Simponi may result in reactivation of HBV in patients who carry this virus, which can be life-threatening in some cases.
Croatian: • Liječenje TNF blokatorima, kao što je Simponi, može izazvati ponovnu aktivaciju virusa hepatitisa B u bolesnika koji nose taj virus, što u nekim slučajevima može ugroziti život.
English: 70 to < 75 0.15 0.15 0.2 75 to < 85 0.15 0.15 0.2 85 to < 95 0.15 0.2
Croatian: 70 do < 75 0,15 0,15 0,2 75 do < 85 0,15 0,15 0,2 85 do < 95 0,15 0,2
English: Simponi contains sorbitol (E420).
Croatian: Simponi sadrži sorbitol (E420).
English: It is important that you tell your baby's doctors and other health care professionals about your Simponi use before the baby receives any vaccine (for more information see section on vaccination).
Croatian: Važno je da kažete liječniku Vašeg djeteta i drugim zdravstvenim radnicima da ste primali Simponi prije nego što Vaše dijete primi neko cjepivo (za više informacija, vidjeti dio o cijepljenju).
English: If you have hearing problem, count 15 seconds from the time you first press the button and then lift the pre-filled pen from the injection site.
Croatian: Ako imate problem sa sluhom i ne čujete drugi "klik", brojite 15 sekundi od trenutka kad ste prvi put pritisnuli gumb, a zatim podignite napunjenu brizgalicu s mjesta injekcije.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Simponi.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Simponi.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: Bolesnicima s pozitivnim rezultatom pretrage na HBV infekciju preporučuje se savjetovanje s liječnikom koji ima iskustva u liječenju hepatitisa B.
English: • signs of immune system disorders called: lupus (rare).
Croatian: • znakovi poremećaja imunološkog sustava kao što su: lupus (rijetko).
English: No mutagenicity studies, animal fertility studies nor long-term carcinogenic studies have been conducted with golimumab.
Croatian: Nisu provedena istraživanja mutagenosti, istraživanja plodnosti na životinjama, niti dugoročna istraživanja kancerogenosti golimumaba.
English: Inject Simponi
Croatian: Injicirajte Simponi
English: Your doctor will decide if you should receive Simponi.
Croatian: Liječnik će odlučiti trebate li uzimati Simponi.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including golimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Croatian: Reaktivacija hepatitisa B dogodila se u bolesnika koji su primali antagonist TNF-a uključujući golimumab, a kronični su nositelji tog virusa (tj. pozitivni su na površinski antigen).
English: Table 6 Key efficacy outcomes from GO-AHEAD at week 16 Improvements in signs and symptoms
Croatian: Tablica 6 Ključni ishodi djelotvornosti u ispitivanju GO-AHEAD u 16. tjednu Poboljšanja znakova i simptoma
English: Tell your doctor straight away if you notice any of the above symptoms.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju gore navedenu nuspojavu.
English: If you received Simponi while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately six months after the last dose you received during pregnancy.
Croatian: Ako ste primili Simponi za vrijeme trudnoće, Vaše dijete može imati povećani rizik od dobivanja takve infekcije do šest mjeseci nakon posljednje doze koju ste primili za vrijeme trudnoće.
English: Physical function and health-related quality of life Physical function and disability were assessed as a separate endpoint in GO-FORWARD and GO-AFTER using the disability index of the HAQ DI.
Croatian: Fizička funkcija i zdravstveni aspekt kvalitete života Fizička funkcija i stupanj invalidnosti procijenjeni su kao poseban ishod iz ispitivanja GO-FORWARD i GO-AFTER pomoću indeksa invalidnosti iz upitnika HAQ DI.
English: • The yellow indicator is connected to the plunger of the pre-filled pen.
Croatian: • Žuti indikator je povezan s klipom napunjene brizgalice.
English: 1.1 Prior to Simponi treatment:
Croatian: 1.1 Prije liječenja lijekom Simponi:
English: The orange needle guard will extend and lock.
Croatian: Narančasti štitnik igle će se izvući i zaključati.
English: Patients taking TNF-blockers are more susceptible to serious infections.
Croatian: Bolesnici koji uzimaju TNF-blokatore skloniji su ozbiljnim infekcijama.
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Croatian: Ako dobijete vrućicu koja ne prolazi, ako vrlo lako dobivate modrice ili krvarite, ili ste vrlo blijedi, odmah se javite liječniku.
English: If you have used or been given too much Simponi (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away.
Croatian: Ako ste primili ili uzeli više lijeka Simponi nego što ste trebali (bilo da ste ubrizgali previše lijeka odjednom, ili ste ga primijenili prečesto), odmah se javite svom liječniku ili ljekarniku.
English: c 0-10 cm)
Croatian: 10 cm)
English: 105 to < 115 0.15 0.2 0.25 0.25 115 to < 125 0.2
Croatian: 105 do < 115 0,15 0,2 0,25 0,25 115 do < 125 0,2
English: CARTON FOR MULTIPACK COMPRISING 3 PACKS (INCLUDING BLUE BOX)
Croatian: KUTIJA ZA VIŠESTRUKO PAKIRANJE KOJE SE SASTOJI OD 3 PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Simponi works by blocking the action of a protein called ‘tumour necrosis factor alpha' (TNF-α).
Croatian: Simponi djeluje tako što sprječava djelovanje proteina koji se zove "faktor nekroze tumora alfa" (TNF-α).
English: Week 14 Week 24
Croatian: 14. tjedan 24. tjedan
English: It is important that you tell your baby's doctors and other health care professionals about your Simponi use so they can decide when your baby should receive any vaccine.
Croatian: Važno je da kažete liječniku Vašeg djeteta i drugim zdravstvenim radnicima da ste primali Simponi, tako da mogu odlučiti kada bi Vaše dijete moglo primiti bilo koje cjepivo.
English: Malignancies other than lymphoma
Croatian: Druge zloćudne bolesti osim limfoma
English: Tell your doctor if you develop symptoms of a disease called lupus.
Croatian: Odmah obavijestite svog liječnika ako Vam se pojave simptomi bolesti koja se zove lupus.
English: The majority of the injection site reactions were mild and moderate and the most frequent manifestation was injection site erythema.
Croatian: Većina reakcija na mjestu injekcije bila je blaga ili umjerena, a najčešće su se manifestirale kao eritem na mjestu primjene injekcije.
English: • You can also use the lower stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
Croatian: • Možete odabrati i donji dio trbuha ispod pupka, osim približno 5 cm neposredno ispod pupka.
English: • 1 Sharps container (See Step 3)
Croatian: • 1 spremnik za oštri otpad (pogledajte 3. korak)
English: ACR 50 Week 14 10% 35%*
Croatian: ACR 50 14. tjedan 10% 35%*
English: Use the space above to record your prescribed dose.
Croatian: Na predviđeno mjesto iznad zapišite dozu koja Vam je propisana.
English: Lymphoma and leukaemia
Croatian: Limfom i leukemija
English: If any changes in the appearance of the skin or growths on the skin occur during or after therapy, tell your doctor.
Croatian: Ako se tijekom ili nakon liječenja pojave promjene u izgledu kože ili izrasline na koži, obavijestite o tome svog liječnika.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated.
Croatian: Liječenje se uvodi i provodi pod nadzorom liječnika specijalista s iskustvom u dijagnosticiranju i liječenju bolesti za koje je Simponi indiciran.
English: • Back of upper arms (if a caregiver is giving you the injection) Choose a different site within your preferred area for each injection.
Croatian: • stražnji dio nadlaktice (ako Vam injekciju daje njegovatelj) Svaku injekciju primijenite u drugo mjesto unutar odabranog područja.
English: • Bronchitis
Croatian: • bronhitis
English: Patients were assessed for UC disease activity by partial Mayo score every 4 weeks (loss of response was confirmed by endoscopy).
Croatian: U bolesnika se aktivnost ulceroznog kolitisa ocjenjivala svaka 4 tjedna djelomičnim Mayo rezultatom (gubitak odgovora potvrđen je endoskopijom).
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab.
Croatian: Bolesnike se mora pažljivo pratiti zbog infekcija, uključujući i tuberkulozu, prije, tijekom i nakon liječenja golimumabom.
English: • Do not touch the needle guard activation clips (as indicated by asterisks * in figure 1) to prevent prematurely covering the needle with the needle guard.
Croatian: • Nemojte dodirivati nastavke za aktiviranje štitnika igle (označene zvjezdicama * na slici 1) kako ne bi došlo do preranog prekrivanja igle štitnikom.
English: • Do not rub your skin.
Croatian: • Nemojte trljati kožu.
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible.
Croatian: Za dijagnozu i primjenu empirijske antimikotičke terapije u ovih bolesnika treba, ako je moguće, potražiti savjet liječnika koji je stručnjak u pružanju zdravstvene skrbi bolesnicima s invazivnim gljivičnim infekcijama.
English: In a single and swift motion, insert the needle through the skin as far as it will go (see figure 6).
Croatian: Jednim brzim pokretom ubodite iglu u kožu koliko duboko ide (vidjeti sliku 6).
English: • High blood pressure
Croatian: • povišeni krvni tlak
English: Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn.
Croatian: Zbog inhibicije TNF-a golimumab primijenjen u trudnoći može utjecati na normalni imunološki odgovor novorođenčeta.
English: • heart failure (rare).
Croatian: • zatajenje srca (rijetko).
English: In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account (see section 2).
Croatian: U bolesnika s rijetkim nasljednim poremećajem nepodnošenja fruktoze treba uzeti u obzir aditivni učinak istodobno primijenjenih lijekova koji sadrže sorbitol (ili fruktozu) te unos sorbitola (ili fruktoze) prehranom (vidjeti dio 2.).
English: • Some patients treated with golimumab have developed certain kinds of skin cancer.
Croatian: • U nekih bolesnika liječenih golimumabom razvile su se određene vrste raka kože.
English: The combination of golimumab and abatacept is not recommended.
Croatian: Ne preporučuje se kombinirana primjena golimumaba i abatacepta.
English: Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
Croatian: Golimumab je humano monoklonsko protutijelo koje s velikim afinitetom tvori stabilne komplekse kako s topljivim tako i s transmembranskim bioaktivnim oblicima humanog TNF-α, što sprječava vezanje TNF-α za njegove receptore.
English: If you are not sure what to do, talk to your doctor or pharmacist.
Croatian: Ako niste sigurni što učiniti, obratite se svom liječniku ili ljekarniku.
English: However, population pharmacokinetic analysis indicated that concomitant use of NSAIDs, oral corticosteroids or sulfasalazine did not influence the apparent clearance of golimumab.
Croatian: Međutim, analiza populacijske farmakokinetike pokazala je da istodobna primjena nesteroidnih antireumatika, oralnih kortikosteroida ili sulfasalazina ne utječe na prividni klirens golimumaba.
English: At week 16, 87% of children were ACR Ped 30 responders, and 79%, 66%, and 36% of children were ACR Ped 50, ACR Ped 70, and ACR Ped 90 responders, respectively.
Croatian: U 16. tjednu je 87% djece postiglo odgovor ACR Ped 30, njih 79% odgovor ACR Ped 50, 66% odgovor ACR Ped 70, a 36% odgovor ACR Ped 90.
English: • A reminder to patients to show the Patient Reminder Card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Simponi.
Croatian: • Podsjetnik bolesnicima da Karticu s podsjetnikom za bolesnika pokažu svim zdravstvenim radnicima koji ih liječe, uključujući i u hitnim slučajevima, te obavijest zdravstvenim radnicima da bolesnik primjenjuje Simponi.
English: In addition to the primary endpoint(s), additional assessments of the impact of Simponi treatment on the signs and symptoms of arthritis, radiographic response, physical function and health-related quality of life were performed.
Croatian: Uz primarne ishode, obavljene su i dodatne procjene utjecaja liječenja lijekom Simponi na znakove i simptome artritisa, radiološki vidljiv odgovor, fizičku funkciju i zdravstveni aspekt kvalitete života.
English: Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine.
Croatian: Gotovo su svi ti bolesnici uzimali i lijekove koji se zovu azatioprin ili 6-merkaptopurin.
English: Distribution Following a single IV administration, the mean volume of distribution was 115  19 mL/kg.
Croatian: Nakon jednokratne intravenske primjene srednji volumen distribucije iznosio je 115 ± 19 ml/kg.
English: Gently, press the plunger until it stops.
Croatian: Nježno potiskujte klip sve dok se ne zaustavi.
English: There is limited safety experience of golimumab treatment in patients who have undergone surgical procedures, including arthroplasty.
Croatian: Ograničena su iskustva o sigurnosti primjene golimumaba u bolesnika podvrgnutih kirurškim postupcima, uključujući artroplastiku.
English: Liver enzyme elevations
Croatian: Povišene razine jetrenih enzima
English: Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Liječenje golimumabom treba prekinuti ukoliko bolesnik razvije novu ozbiljnu infekciju ili sepsu te treba uvesti odgovarajuću antimikrobnu ili antimikotičku terapiju sve dok infekcija ne bude pod kontrolom.
English: 95 to < 105 0.15 0.2
Croatian: 95 do < 105 0,15 0,2
English: • Inflamed eye (conjunctivitis)
Croatian: • upala oka (konjunktivitis)
English: Some of these infections have been fatal.
Croatian: Neke od tih infekcija imale su smrtni ishod.
English: • Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or are heavy smokers may be at increased risk for cancer with Simponi treatment.
Croatian: • Bolesnici s teškom trajnom astmom, kroničnom opstruktivnom bolešću pluća (KOPB) i teški pušači mogu imati povećan rizik za nastanak raka tijekom liječenja lijekom Simponi.