FrancophonIA/ELRC3.0 huggingface dataset:
English: Continue with injection site and dose preparation immediately.
Croatian: Odmah nastavite s pripremom mjesta za ubrizgavanje i pripremom doze.
English: • Wash your hands thoroughly
Croatian: • Temeljito operite ruke
English: Follow this instruction guide carefully, and soon you will develop a routine for injecting confidently.
Croatian: Pažljivo slijedite ove upute i ubrzo ćete steći rutinu i sigurnost pri ubrizgavanju.
English: Table 25 Maintenance regimen
Croatian: Tablica 25 Režim održavanja
English: • new onset or worsening of psoriasis;
Croatian: • nova pojava ili pogoršanje psorijaze;
English: Be careful not to squirt the liquid medication into your eye.
Croatian: Pazite da si ne špricnete lijek u oko.
English: This includes any possible side effects not listed in this leaflet (See section 4).
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi (pogledajte dio 4).
English: • The new injection site should be given at least 3 cm from the last injection site.
Croatian: • Novo mjesto ubrizgavanja treba biti udaljeno barem 3 cm od mjesta na kojem je dana prethodna injekcija.
English: Ped ACR 30 response (n/N)
Croatian: Pedijatrijski odgovor ACR 30 (n/N)
English: The Patient Reminder Cards should contain the following key elements:
Croatian: Kartica s podsjetnikom za bolesnika mora sadržavati sljedeće ključne elemente:
English: Imraldi contains sodium and sorbitol
Croatian: Imraldi sadrži natrij i sorbitol
English: DO NOT use the same site that was used for the last injection.
Croatian: NE koristite isto mjesto kao za prethodnu injekciju.
English: • Use a different injection site every time:
Croatian: • Svaki put odaberite drugo mjesto za ubrizgavanje:
English: You will set the volume to the prescribed dose in step 4 (Dose Preparation).
Croatian: Volumen ćete na propisanu dozu postaviti u koraku 4 (Priprema doze).
English: DO NOT over-tighten.
Croatian: NEMOJTE previše zategnuti.
English: Choose an injection site on your body.
Croatian: Odaberite mjesto ubrizgavanja na tijelu.
English: Double-Blind Response at Week 12
Croatian: Dvostruko slijepo Odgovor u 12. tjednu
English: Monoclonal antibodies are proteins that attach to a specific target.
Croatian: Monoklonska protutijela su proteini koji se vežu na specifičnu ciljnu tvar.
English: Your doctor may prescribe another strength of Imraldi if your child needs a different dose.
Croatian: Liječnik može propisati drugu dozu lijeka Imraldi ako vaše dijete treba drugačiju dozu.
English: In RA study III, these improvements were maintained throughout 52 weeks.
Croatian: U ispitivanju RA III , to se poboljšanje održalo 52 tjedna.
English: Your doctor may decide to stop treatment.
Croatian: Vaš liječnik možda odluči prekinuti terapiju.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of these medications.
Croatian: Istodobne stabilne doze aminosalicilata, kortikosteroida i/ili imunomodulatorskih lijekova bile su dozvoljene te je 80 % bolesnika nastavilo uzimati barem jedan od ovih lijekova.
English: Significant response was first observed at week 2 and maintained through 24 weeks (Table 13).
Croatian: To se poboljšanje prvi put uočilo u drugom tjednu i održalo se 24 tjedna (Tablica 13).
English: • allergic reactions (including seasonal allergy);
Croatian: • alergijske reakcije (uključujući sezonsku alergiju);
English: You and your doctor should pay special attention to signs of infection while you are being treated with Imraldi.
Croatian: I Vi i Vaš liječnik morate obratiti posebnu pažnju na znakove infekcije dok se liječite lijekom Imraldi.
English: What Imraldi contains
Croatian: Što Imraldi sadrži
English: Imraldi can also be given alone.
Croatian: Imraldi se može primjenjivati i sam.
English: Prior to launch of Imraldi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Imraldi u promet, svaki nositelj odobrenja za stavljanje lijeka u promet (MAH) u svakoj zemlji članici mora s nacionalnim regulatornim tijelom dogovoriti sadržaj i format edukacijskog programa, uključujući modalitete distribucije i druge aspekte programa.
English: Failure to perform the following steps as described may cause contamination which may lead to infection of your child.
Croatian: Ako sljedeće korake ne provedete kako je opisano, može doći do onečišćenja i posljedično infekcije Vašeg djeteta.
English: ASDASc,d,e
Croatian: c,d,e
English: • Look at the expiry date on the box to be used.
Croatian: • Provjerite rok valjanosti na kutiji koju ćete koristiti.
English: • With the free hand, gently grasp the cleaned area of skin and hold firmly.
Croatian: • Slobodnom rukom nježno primite očišćene dijelove kože i čvrsto ih držite
English: • If you see remaining air bubbles or air gaps in the liquid medication in the syringe, you may repeat this process up to 3 times.
Croatian: • Ako vidite zaostale mjehuriće zraka ili zračne praznine u tekućini u štrcaljki, možete ponoviti ovaj postupak do 3 puta.
English: Contact your doctor, nurse or pharmacist.
Croatian: Nazovite svog liječnika, medicinsku sestru ili ljekarnika.
English: • opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered);
Croatian: • oportunističke infekcije (uključujući tuberkulozu i druge infekcije do kojih dolazi kod slabljenja otpornosti na bolest);
English: The educational program consists of a Patient Reminder Card.
Croatian: Edukacijski program sastoji se od kartice s podsjetnikom za bolesnika.
English: • You will set the volume to the prescribed dose in a later step.
Croatian: • Volumen za propisanu dozu postavit ćete u kasnijem koraku.
English: If the remaining volume is less than the prescribed dose volume, DO NOT use the syringe and contact your healthcare provider.
Croatian: Ako je preostali volumen manji od propisanog, NE koristite štrcaljku i obratite se svom zdravstvenom radniku.
English: When you push the pre-filled pen firmly onto your skin, the injection will start automatically.
Croatian: Kada napunjenu brizgalicu čvrsto pritisnete na kožu ubrizgavanje će započeti automatski.
English: Table 19 Maintenance regimen
Croatian: Tablica 19 Režim održavanja
English: NOTE:
Croatian: NAPOMENA:
English: If you don't know the amount, STOP HERE and contact your doctor for further instruction.
Croatian: Ako ne znate, STANITE i obratite se liječniku za daljnje upute.
English: 3) Choosing and preparing an injection site
Croatian: 3) Odabir i priprema mjesta ubrizgavanja
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM1 with an IC50 of 0.1-0.2 nM).
Croatian: Adalimumab također modulira biološke odgovore koje inducira ili regulira TNF, uključujući promjene u razinama adhezijskih molekula koje su odgovorne za migraciju leukocita (ELAM-1, VCAM-1 i ICAM-1 s IC50 od 0,1-0,2 nM).
English: The following instructions explain how to inject Imraldi.
Croatian: U sljedećim uputama objašnjeno je kako ubrizgati lijek Imraldi.
English: Placebo/MTXAdalimumab/MTX (95% Confidence Interval b)
Croatian: Placebo/MTXAdalimumab/MTX (95 % interval pouzdanosti b)
English: Again, SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose, this is important to get the proper dose and important in order to prevent air bubbles or air gaps in the liquid medication.
Croatian: Ponovno, POLAKO izvucite bijeli klip štrcaljke do 0,1 ml preko propisane doze, ovo je važno za pravilno doziranje i važno radi toga da se spriječi ulaz mjehurića zraka ili zračnih praznina u tekućinu.
English: Results from the overall UC-II study population are shown in Table 28.
Croatian: Rezultati za ukupnu populaciju iz ispitivanja UC-II prikazani su u Tablici 28.
English: 4) Dose Preparation
Croatian: 4) Priprema doze
English: Clinical remission (defined as Mayo score ≤2 with no subscore >1) was assessed at week 8.
Croatian: Klinička remisija (definirana kao Mayo rezultat ≤ 2 bez podrezultata > 1) ocjenjivala se u osmom tjednu.
English: • increased sweating;
Croatian: • povećano znojenje;
English: This step is important to get the proper dose.
Croatian: Ovaj je korak važan za pravilno doziranje.
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Croatian: Zvjezdica (*) u stupcu 'Klasifikacija organskih sustava' znači da se detaljnije informacije mogu pronaći u dijelovima 4.3, 4.4 i 4.8.
English: • multiple sclerosis;
Croatian: • multipla skleroza;
English: The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 % respectively.
Croatian: Odgovarajući udio bolesnika bez radiološke progresije iznosio je 31,3 %, 23,7 % odnosno 36,7 %.
English: This injection should not be mixed in the same syringe or vial with any other medicine.
Croatian: Ovu injekciju ne smijete miješati u istoj štrcaljki ili bočici s drugim lijekovima.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: • Set up the following items on a clean surface, DO NOT take them out of their individual packaging yet.
Croatian: • Na čistu radnu površinu postavite sljedeći pribor, no još ga NEMOJTE vaditi iz njihovih pojedinačnih pakiranja.
English: • difficulty sleeping;
Croatian: • otežano spavanje;
English: DO NOT use if the liquid is not clear or not free of particles.
Croatian: NEMOJTE koristiti ako tekućina nije bistra ili ako sadrži čestice.
English: Place the greenbase straight (90 degrees) on your skin, and push the entire pre-filled pen down firmly to start the injection.
Croatian: Stavite zelenu bazu uspravno (pod kutem od 90 stupnjeva) na kožu, čvrsto pritisnite cijelu napunjenu brizgalicu prema dolje kako bi započelo ubrizgavanje.
English: General handling: DO NOT dispose of any waste items until after the injection is completed.
Croatian: Općenito rukovanje: NE bacajte dijelove pribora u otpad sve dok ne dovršite ubrizgavanje.
English: Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Croatian: Gnojni hidradenitis (koji se ponekad naziva inverznim aknama) je kronična i često bolna upalna bolest kože.
English: • Using a piece of gauze, apply pressure over the injection site for 10 seconds.
Croatian: • Koristeći se komadom gaze, na 10 sekundi pritisnite mjesto ubrizgavanja.
English: Pull the syringe away from your skin.
Croatian: Povucite štrcaljku iz kože.
English: • In some patients the body may fail to produce enough of the blood cells to fight off infections or help you to stop bleeding.
Croatian: • U nekih bolesnika postoji mogućnost da tijelo ne uspije proizvesti dovoljne količine krvnih stanica koje pomažu u borbi protiv infekcija ili zaustavljanju krvarenja.
English: After proper training in injection technique, patients may self-inject with Imraldi if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Nakon odgovarajuće poduke o tehnici ubrizgavanja injekcija, bolesnici mogu sami sebi davati injekcije lijeka Imraldi ako njihov liječnik procijeni da je to moguće provesti, uz medicinsko praćenje po potrebi.
English: A large number (approximately 2,100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1,500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Croatian: Prospektivno prikupljeni podaci o velikom broju trudnoća izloženih adalimumabu (približno 2100) koje su završile živorođenjem s poznatim ishodom, uključujući više od 1500 trudnoća izloženih tijekom prvog tromjesečja, ne ukazuju na povećanu stopu malformacija u novorođenčeta.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet o primjeni ovog lijeka.
English: • Choose a site on your thigh or abdomen (except the area around the navel).
Croatian: • Odaberite mjesto na bedru ili trbuhu (osim područja oko pupka).
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defense against infection and cancer.
Croatian: Antagonisti TNF-a, kao što je adalimumab, djeluju na imunološki sustav te njihova primjena može utjecati na obranu tijela od infekcija i raka.
English: The syringe or pen must be protected from light, and discarded if not used within the 28-day period.
Croatian: Štrcaljku ili brizgalicu mora se zaštiti od svjetlosti i zbrinuti ako se ne iskoristi unutar 28 dana.
English: In CD study III, at week 4, 58 % (499/854) of patients were in clinical response and were assessed in the primary analysis.
Croatian: U 4. tjednu ispitivanja CD III 58 % bolesnika (499/854) imalo je klinički odgovor i bilo je uvršteno u primarnu analizu.
English: • night sweats;
Croatian: • noćno znojenje;
English: • With one quick, short motion, push needle all the way into skin.
Croatian: • Jednim brzim kratkim pokretom gurnite iglu do kraja u kožu.
English: For instructions for use, refer to section 7.
Croatian: Za upute za primjenu pogledajte dio 7.
English: • If you are over 65 years you may be more susceptible to infections while taking Imraldi.
Croatian: • Ako ste stariji od 65 godina, možete biti podložniji infekcijama za vrijeme primjene lijeka Imraldi.
English: Hold the pen against your skin until the yellow indicator fills the medication window and stops moving.
Croatian: Brizgalicu držite pritisnutu na kožu sve dok žuti indikator ne ispuni prozorčić za prikaz lijeka i prestane se pomicati.
English: Alternatively, if a patient has stopped Imraldi and signs and symptoms of disease recur, Imraldi may be re-administered.
Croatian: Alternativno, ako je bolesnik prestao uzimati lijek Imraldi, a znakovi i simptomi bolesti su se opet pojavili, Imraldi se može ponovno primijeniti.
English: >32 weeks
Croatian: > 32 tjedna
English: • tuberculosis
Croatian: • tuberkuloza
English: • Check to see that the fluid remaining in the syringe is at least the prescribed dose volume.
Croatian: • Provjerite da je količina preostale tekućine u štrcaljki barem jednaka volumenu propisane doze.
English: • high blood pressure;
Croatian: • visok krvni tlak;
English: This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Croatian: Ta upala može dovesti do slabljenja vida i/ili prisutnosti plutajućih čestica u oku (crnih točkica ili tankih niti koje se kreću vidnim poljem).
English: The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab:
Croatian: Gore opisani simptomi mogu biti znakovi dolje nabrojenih nuspojava, uočenih pri primjeni adalimumaba:
English: • Let go of the skin in your hand.
Croatian: • Pustite kožu iz ruke kojom ju držite.
English: • severe rash, hives or other signs of allergic reaction;
Croatian: • težak osip, koprivnjaču ili druge znakove alergijske reakcije;
English: Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis.
Croatian: Tuberkuloza se može razviti tijekom liječenja čak i ako ste primili preventivnu terapiju za tuberkulozu.
English: c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Croatian: c Rezultat za aktivnost ankilozantnog spondilitisa d Djelomična egzacerbacija definirala se kao ASDAS rezultat ≥ 1,3, ali < 2,1 pri dva uzastopna posjeta.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Croatian: Adalimumab je rekombinantno humano monoklonsko protutijelo, proizvedeno u stanicama jajnika kineskog hrčka.
English: Then lift your thumb to let the needle retract into the body of the syringe.
Croatian: Zatim maknite palac i omogućite da se igla uvuče u tijelo štrcaljke.
English: Check with your doctor before you receive any vaccines.
Croatian: Provjerite sa svojim liječnikom prije nego primite bilo kakvo cjepivo.
English: This could bend or damage the needle.
Croatian: Tako možete saviti ili oštetiti iglu.
English: Never reuse a vial and other components.
Croatian: Nikada nemojte ponovno koristiti istu bočicu ili druge komponente.
English: • On rare occasions, treatment with Imraldi could result in lupus-like syndrome.
Croatian: • U rijetkim slučajevima liječenje lijekom Imraldi može dovesti do pojave sindroma sličnog lupusu.
English: Analysis Treatment
Croatian: Analiza liječenja
English: What Imraldi is and what it is used for
Croatian: Što je Imraldi i za što se koristi
English: • reactivation of hepatitis B;
Croatian: • reaktivacija hepatitisa B;
English: DO NOT put these items into regular household waste.
Croatian: NE bacajte taj pribor u obični kućanski otpad.
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1 % to 1 % of the maternal serum level.
Croatian: Ograničeni podaci iz objavljene literature ukazuju na to da se adalimumab izlučuje u majčino mlijeko u vrlo maloj koncentraciji te da koncentracije adalimumaba u majčinom mlijeku iznose 0,1% do 1% razine u serumu majke.
English: By attaching to TNFα, Imraldi decreases the process of inflammation in these diseases.
Croatian: Vezivanjem za TNFα Imraldi smanjuje upalni proces pri tim bolestima.
English: You may first be given other medicines.
Croatian: Moguće da će Vam prvo biti propisani drugi lijekovi.
English: • Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Croatian: • Držite pakiranje štrcaljke i POLAKO izvucite bijeli klip štrcaljke do 0,1 ml preko propisane doze (primjerice, ako je propisana doza 0,5 ml, izvucite bijeli klip štrcaljke do 0,6 ml).
English: Clinical response * p value for Standard Dose versus Low Dose comparison
Croatian: Klinički odgovor * p vrijednost za standardnu dozu u usporedbi s niskom dozom.
English: Patients in clinical response (decrease in CDAI ≥70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Croatian: Bolesnici s kliničkim odgovorom (smanjenje CDAI rezultata od ≥ 70) u 4. tjednu stratificirani su i analizirani odvojeno od bolesnika bez kliničkog odgovora u 4. tjednu.
English: This is important to get the proper dose.
Croatian: Ovo je važno za pravilno doziranje.
English: • swollen face, hands, feet;
Croatian: • otečeno lice, ruke ili stopala;
English: • raised liver enzymes.
Croatian: • povišena razina enzima jetre.
English: If retreatment with Imraldi is indicated, the above guidance on dose and treatment duration should be followed.
Croatian: Ako je indicirano ponovno liječenje lijekom Imraldi, potrebno je pridržavati se gore navedenih smjernica za doziranje i trajanje liječenja.
English: Induction of clinical remission (defined as CDAI <150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Croatian: Indukcija kliničke remisije (definirana kao CDAI < 150) ispitivala se u dva ispitivanja, CD I (CLASSIC I) i CD II (GAIN).
English: • cancer, including cancer of the lymph system (lymphoma) and melanoma (a type of skin cancer);
Croatian: • rak, uključujući rak limfnog sustava (limfom) i melanom (vrsta raka kože);
English: If active tuberculosis is diagnosed, Imraldi therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Imraldi (vidjeti dio 4.3).
English: • There have been very rare cases of certain kinds of cancer in children and adults taking Imraldi or other TNFα blockers.
Croatian: • Vrlo se rijetko javljaju slučajevi određenih vrsta raka u djece i odraslih bolesnika liječenih lijekom Imraldi ili nekim drugim TNFα blokatorom.
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Croatian: Dužim razdobljem liječenja adalimumabom u dozi 40 mg tjedno tijekom 96 tjedana nisu utvrđeni novi nalazi koji bi se odnosili na sigurnost primjene.
English: Choose an injection site & clean skin
Croatian: Odaberite mjesto ubrizgavanja i očistite kožu
English: Side effects may occur up to 4 months or more after the last Imraldi injection.
Croatian: Nuspojave se mogu javiti do 4 mjeseca ili više nakon ubrizgavanja zadnje doze lijeka Imraldi.
English: You should continue to inject Imraldi for as long as your doctor has told you.
Croatian: Nastavite injicirati lijek Imraldi onoliko dugo koliko Vam kaže liječnik.
English: • serious infections (including blood poisoning and influenza);
Croatian: • ozbiljne infekcije (uključujući trovanje krvi i gripu);
English: Your abdomen (except the area around the navel) or thighs are best.
Croatian: Najbolja mjesta su na trbuhu (osim područja oko pupka) i na bedrima.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Imraldi, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira latentna tuberkuloza, prije početka liječenja lijekom Imraldi mora se započeti odgovarajuća profilaksa tuberkuloze, u skladu s lokalnim preporukama.
English: P value*
Croatian: P vrijednost*
English: The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤10.
Croatian: Primarni ishod ispitivanja bio je klinička remisija u 26. tjednu, definirana kao PCDAI rezultat ≤ 10.
English: The needle might be dirty or damaged.
Croatian: Igla može biti onečišćena ili oštećena.
English: • abnormal muscle breakdown;
Croatian: • abnormalno raspadanje mišića;
English: • impotence;
Croatian: • impotencija;
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Croatian: Doziranje adalimumaba u ovih bolesnika određeno je na temelju farmakokinetičkih modela i simulacija (vidjeti dio 5.2).
English: These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Croatian: Ove infekcije nisu uvijek bile prepoznate u bolesnika koji su primali antagoniste TNF-a, što je rezultiralo kašnjenjem s primjerenim liječenjem i ponekad dovelo do smrtnog ishoda.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Croatian: • imunološki poremećaji koji mogu zahvatiti pluća, kožu i limfne čvorove (najčešće kao stanje koje se naziva sarkoidoza);
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Imraldi injection.
Croatian: • Trebate razmotriti korištenje odgovarajuće kontracepcije kako biste spriječili trudnoću te biste je trebali nastaviti koristiti najmanje 5 mjeseci nakon posljednje injekcije lijeka Imraldi.