FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternatively, if a patient has stopped Hulio and signs and symptoms of disease recur, Hulio may be re-administered.
Croatian: Alternativno, ako je bolesnik prestao uzimati lijek Hulio, a znakovi i simptomi bolesti su se opet pojavili, Hulio se može ponovno primijeniti.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
Croatian: često pogoršanje ili nova pojava psorijaze (uključujući palmoplantarnu pustuloznu psorijazu)1),
English: Talk to your doctor or pharmacist before using Hulio.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek Hulio.
English: phase
Croatian: Faza
English: • If you are over 65 years you may be more susceptible to infections while taking Hulio.
Croatian: • Ako ste stariji od 65 godina, možete biti podložniji infekcijama za vrijeme primjene lijeka Hulio.
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Croatian: Bolesnici iz ispitivanja UC-I i UC-II imali su mogućnost prijeći u otvoreni dugotrajni produžetak ispitivanja (UC-III).
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: To help you remember which day(s) of the week Hulio should be injected, it may be helpful to make a note on a calendar or in a diary.
Croatian: Da biste zapamtili koji je dan u tjednu potrebno ubrizgati Hulio, bilo bi dobro da to zabilježite u kalendaru ili u dnevniku.
English: In Study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Croatian: U ispitivanju UV II, statistički značajne razlike primijećene su samo za oštrinu vida, ali su druge komponente brojčano bile u korist adalimumaba.
English: • If the plunger is not pressed all the way the safety feature will not activate afterwards to cover the needle.
Croatian: • Ako se klip ne pritisne do kraja, neće se aktivirati sigurnosna značajka za pokrivanje igle nakon ubrizgavanja.
English: • excessive night urination;
Croatian: • prekomjerno noćno mokrenje,
English: Each pack is for single use only
Croatian: Jedno pakiranje namijenjeno je za jednokratnu uporabu
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži adalimumab u jednoj ili više podskupina pedijatrijske populacije u indikaciji ulceroznog kolitisa, vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: Tuberculosis can develop during therapy even if your child have had preventative treatment for tuberculosis.
Croatian: Tuberkuloza se može razviti tijekom liječenja čak i ako je Vaše dijete primilo preventivnu terapiju za tuberkulozu.
English: PGA-F clear/minimal and ≥2-grade improvement (%)
Croatian: PGA-F bez bolesti/minimalno i poboljšanje za ≥ 2 stupnja
English: Hulio can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Croatian: Hulio može smanjiti broj nodula i apscesa koje imate te ublažiti bol koja često prati ovu bolest.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received Hulio during pregnancy compared with mothers with the same disease who did not receive Hulio.
Croatian: • U ispitivanju provedenom u trudnica nije utvrđen povećan rizik od urođenih mana kada su majke primale lijek Hulio tijekom trudnoće u odnosu na majke s istom bolešću koje nisu primale lijek Hulio.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Hulio.
Croatian: Vi i Vaš liječnik morate obratiti posebnu pažnju na znakove infekcije dok se liječite lijekom Hulio.
English: - If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako je Vaše dijete alergično na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: After proper training, the injection can be self-administered or given by another person, for example a family member or carer.
Croatian: Nakon primjerene obuke, injekciju si možete dati sami, ili Vam je može dati druga osoba, primjerice član obitelji ili njegovatelj.
English: • worsening skin rash with muscle weakness.
Croatian: • pogoršanje kožnog osipa popraćenog mišićnom slabošću.
English: • DO NOT re-cap or touch the needle with your fingers, or let the needle touch anything.
Croatian: • NE vraćajte kapicu na iglu niti je dodirujte prstima i ne dopustite da igla dođe u doticaj s bilo čim drugim.
English: Read all of this leaflet carefully before giving your child this medicine because it contains important information for him/her.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete djetetu davati ovaj lijek jer sadrži važne podatke za dijete.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: 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); and not known (cannot be estimated from the available data).
Croatian: Sljedeći popis nuspojava temelji se na razdoblju iz kliničkih ispitivanja i nakon stavljanja lijeka u promet, a prikazane su ispod u Tablici 6 prema klasifikaciji organskih sustava i učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • Wait for the skin to dry on its own, do not blow it dry.
Croatian: • Pričekajte da se koža sama osuši, nemojte je sušiti puhanjem.
English: DO NOT pull the white plunger rod completely out of the syringe.
Croatian: NE izvlačite bijeli klip štrcaljke u potpunosti van iz štrcaljke.
English: Adalimumab n=274 confidence interval)
Croatian: Adalimumab n=274 interval pouzdanosti)
English: PGA: Clear/minimal
Croatian: PGA: bez bolesti /minimalno
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Croatian: Prividna plazmatska koncentracija adalimumaba uz koju se postiže polovica maksimalne vjerojatnosti za odgovor PedACR 50 (EC50) bila je 3 µg/ml (95% CI: 1 - 6 µg/ml).
English: What you need to know before giving your child Hulio Do not give Hulio - If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete primjenjivati lijek Hulio Nemojte primjenjivati lijek Hulio - Ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If active tuberculosis is diagnosed, Hulio therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Hulio (vidjeti dio 4.3).
English: • DO NOT over-tighten.
Croatian: • NEMOJTE previše zategnuti.
English: The second received 20 mg of adalimumab every week for 52 weeks.
Croatian: Druga je dobivala 20 mg adalimumaba svaki tjedan tijekom 52 tjedna.
English: Step 2 - Wash hands Wash your hands with soap and water.
Croatian: Korak 2 - Operite ruke Operite ruke sapunom i vodom.
English: Hidradenitis suppurativa (sometimes called ‘acne inversa') is a long-term and often painful inflammatory skin disease.
Croatian: Gnojni hidradenitis (koji se ponekad naziva „inverznim aknama“) je dugotrajna i često bolna upalna bolest kože.
English: • Wait for it to dry on its own, do not blow dry it.
Croatian: • Pričekajte da se sama osuši, nemojte je sušiti puhanjem.
English: Seek medical attention urgently if you develop any of the following signs of allergic reaction or heart failure:
Croatian: Zatražite hitnu medicinsku pomoć ako se pojave bilo koji od sljedećih znakova alergijske reakcije ili zatajenja srca:
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
Croatian: Egzacerbacija bolesti definirana je pogoršanjem od ≥ 30% od početnog stanja u ≥ 3 od 6 ključnih kriterija za pedijatrijski ACR, ≥ 2 aktivna zgloba i poboljšanje veće od 30% u najviše 1 od 6 kriterija.
English: For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: U bolesnika koji su pozitivni na infekciju virusom hepatitisa B preporučuje se potražiti savjet liječnika s iskustvom u liječenju hepatitisa B.
English: In the Viewing Window, the Orange Indicator will advance to show the progress of the injection.
Croatian: U prozorčiću će se narančasti pokazivač nastaviti pomicati kako bi se prikazalo napredovanje ubrizgavanja.
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Croatian: Klinička remisija je Mayo rezultat ≤ 2 bez podrezultata > 1.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Hulio.
Croatian: Doza istodobno primijenjenih kortikosteroida može se postupno smanjivati u skladu s kliničkom praksom, počevši dva tjedna nakon započinjanja liječenja lijekom Hulio.
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Croatian: Ove infekcije mogu biti ozbiljne i uključuju tuberkulozu, infekcije uzrokovane virusima, gljivicama, parazitima ili bakterijama, ili drugim neuobičajenim zaraznim organizmima te sepsu (otrovanje krvi).
English: If retreatment with Hulio is indicated, the above guidance on dose and treatment duration should be followed.
Croatian: Ako je indicirano ponovno liječenje lijekom Hulio, potrebno je pridržavati se gore navedenih smjernica za doziranje i trajanje liječenja.
English: Your child's doctor, nurse or other healthcare professional will show you how to prepare the injection and give it to your child.
Croatian: Liječnik Vašeg djeteta, medicinska sestra ili drugi zdravstveni djelatnik pokazat će vam kako pripremiti injekciju i dati je djetetu.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2018
Croatian: Datum prvog odobrenja: 17. rujna 2018.
English: • There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Croatian: • Vrlo se rijetko javljaju određene vrste tumora u djece i odraslih bolesnika liječenih adalimumabom ili nekim drugim TNFα blokatorom.
English: Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
Croatian: Dostupni podaci upućuju na to da se klinički odgovor obično postiže unutar 2 - 8 tjedana liječenja.
English: If you don't know this, STOP HERE and ask your child's doctor.
Croatian: Ako to ne znate, STANITE i pitajte liječnika svog djeteta.
English: Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for Standard Dose versus Low Dose comparison.
Croatian: 26. tjedan Klinička remisija Klinički odgovor 52. tjedan Klinička remisija Klinički odgovor * p vrijednost za standardnu dozu u usporedbi s niskom dozom.
English: Hulio is a biosimilar medicinal product.
Croatian: Hulio je biosličan lijek.
English: • DO NOT use the pen if it has been dropped onto a hard surface.
Croatian: • NEMOJTE upotrebljavati brizgalicu ako je pala na tvrdu površinu.
English: Hulio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hulio is indicated.
Croatian: Liječenje lijekom Hulio moraju započeti i nadzirati liječnici specijalisti s iskustvom u dijagnosticiranju i liječenju stanja za koja je Hulio indiciran.
English: Treatment with Hulio can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Croatian: Liječenje lijekom Hulio može se započeti u kombinaciji s kortikosteroidima i/ili drugim nebiološkim imunomodulatorima.
English: This inflammation leads 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 dovodi do slabljenja vida i/ili prisutnosti „letećih mušica“ u vidnom polju oka (crnih točkica ili tankih niti koje se kreću vidnim poljem).
English: Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give the injection.
Croatian: Pronađite mirno mjesto s dobro osvijetljenom, čistom i ravnom radnom površinom i pripremite sav pribor potreban za davanje injekcije.
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Croatian: Adalimumab je značajno smanjio rizik od neuspjeha liječenja za 75% u odnosu na placebo, što pokazuje omjer hazarda (HR = 0,25 [95% CI: [0,12; 0,49]).
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hulio (see section 4.4).
Croatian: Oftalmolozima se preporučuje da se posavjetuju s odgovarajućim specijalistom prije nego što započnu liječenje lijekom Hulio (vidjeti dio 4.4).
English: After proper training in injection technique, patients may self-inject with Hulio 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 Hulio ako njihov liječnik procijeni da je to moguće provesti i uz medicinsko praćenje po potrebi.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Croatian: Zabilježena je reaktivacija hepatitisa B u bolesnika koji su uzimali antagoniste TNF-a, uključujući adalimumab, i koji su bili kronični nositelji tog virusa (tj. pozitivni na površinski antigen).
English: • bleeding in the stomach;
Croatian: • krvarenje u želucu,
English: Step 7 - Inject Hulio
Croatian: Korak 7 - Ubrizgajte Hulio
English: Treatment with Hulio should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Croatian: Liječenje lijekom Hulio ne smije se započeti u bolesnika s aktivnim infekcijama, uključujući kronične ili lokalizirane infekcije, sve dok se te infekcije ne stave pod kontrolu.
English: Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive the injection.
Croatian: Pronađite mirno mjesto s dobro osvijetljenom, čistom i ravnom radnom površinom i pripremite sav pribor potreban za davanje ili primanje injekcije.
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Croatian: U ispitivanju UC-II među onima koji su uz adalimumab bili u remisiji u osmom tjednu, njih 21/41 (51%) bilo je u remisiji u 52. tjednu.
English: • Once syringe is firmly attached to the needle, remove the clear needle packaging.
Croatian: • Nakon što je štrcaljka dobro pričvršćena za iglu, uklonite prozirno pakiranje igle.
English: Side effects may occur up to 4 months or more after the last Hulio injection.
Croatian: Nuspojave se mogu pojaviti 4 mjeseca ili više nakon posljednje injekcije lijeka Hulio.
English: • increased sweating;
Croatian: • pojačano znojenje,
English: • DO NOT touch or pull back on the plunger at any time.
Croatian: • NE dodirujte niti povlačite klip u bilo kojem trenutku.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Hulio, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira latentna tuberkuloza, prije početka liječenja lijekom Hulio mora se započeti odgovarajuća profilaksa tuberkuloze, u skladu s lokalnim preporukama.
English: Hulio contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Croatian: Hulio sadrži djelatnu tvar adalimumab, lijek koji djeluje na imunološki (obrambeni) sustav Vašeg tijela.
English: Due to its inhibition of TNF, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Croatian: Zbog inhibicije faktora tumorske nekroze α (TNFα), adalimumab primijenjen u trudnoći mogao bi utjecati na normalne imune odgovore novorođenčeta.
English: Time to Treatment Failure At or After week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab Time to Treatment Failure At or After week 2 in Study UV II Primary analysis (ITT) Placebo Adalimumab
Croatian: Vrijeme do neuspjeha liječenja u 6. tjednu ili nakon njega u ispitivanju UV I Primarna analiza (ITT) Placebo Adalimumab Vrijeme do neuspjeha liječenja u 2. tjednu ili nakon njega u ispitivanju UV II Primarna analiza (ITT) Placebo Adalimumab
English: • nerve damage;
Croatian: • oštećenje živca,
English: If your doctor considers that methotrexate is inappropriate, Hulio can be given alone.
Croatian: Ako Vaš liječnik procijeni da metotreksat nije prikladan, Hulio se može davati samostalno.
English: Check with child's doctor before receiving any vaccines.
Croatian: Provjerite s liječnikom svog djeteta prije primanja bilo kakvih cjepiva.
English: If there are air bubbles in the syringe, push the plunger rod all the way back in to push the solution back into the vial.
Croatian: Ako u štrcaljki ima mjehurića zraka, pritisnite klip štrcaljke skroz do kraja da biste otopinu vratili u bočicu.
English: Each pre-filled syringe has a safety feature, this will retract and cover the needle after the plunger is released.
Croatian: Svaka napunjena štrcaljka opremljena je sigurnosnom značajkom koja uvlači i pokriva iglu nakon otpuštanja klipa.
English: Component of a multipack, can't be sold separately.
Croatian: 2 jastučića natopljena alkoholom Dio višestrukog pakiranja, ne može se prodavati zasebno.
English: Serious adverse reactions have been reported for adalimumab.
Croatian: Prijavljene su ozbiljne nuspojave za adalimumab.
English: If the needle did not retract, carefully place the used syringe into a sharps container to avoid injury.
Croatian: Ako se igla ne uvuče, pažljivo odložite iskorištenu štrcaljku u spremnik za zbrinjavanje oštrih predmeta kako ne bi došlo do ozljede.
English: • mild allergic reactions (including seasonal allergy);
Croatian: • blage alergijske reakcije (uključujući sezonsku alergiju),
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Croatian: Koncentracije adalimumaba u sinovijalnoj tekućini nekolicine bolesnika s reumatoidnim artritisom iznosile su 31 - 96% koncentracija u serumu.
English: Do not attempt to self-inject until you are sure that you understand how to prepare and administer the injection.
Croatian: Ne pokušavajte si sami dati injekciju dok niste sigurni da razumijete kako je prirediti i ubrizgati.
English: • DO NOT rub the injection site.
Croatian: • Mjesto ubrizgavanja NE trljajte.
English: The pre-filled syringe or pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Croatian: Napunjenu štrcaljku ili napunjenu brizgalicu mora se zaštiti od svjetlosti i zbrinuti ako se ne iskoristi unutar 14 dana.
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 u obliku bolesti koja se zove sarkoidoza),
English: • DO NOT touch this area again before giving the injection.
Croatian: • Prije davanja injekcije NE dodirujte ponovno to područje.
English: • serious infections
Croatian: • ozbiljne infekcije
English: Do not mix any other medicine into the same syringe or vial with the Hulio solution.
Croatian: Nemojte dodavati bilo kakav drugi lijek u istu štrcaljku ili bočicu s otopinom lijeka Hulio.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Croatian: Tijekom terapije održavanja doza kortikosteroida može se postupno smanjivati u skladu s kliničkim smjernicama.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hulio in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu profilakse tuberkuloze također treba razmotriti prije početka liječenja lijekom Hulio u bolesnika s nekoliko faktora rizika ili sa značajnim faktorima rizika od tuberkuloze unatoč negativnom nalazu na tuberkulozu i u bolesnika s latentnom ili aktivnom tuberkulozom u anamnezi u kojih se ne može utvrditi adekvatan tijek liječenja.
English: If your child has moderate or severe heart failure.
Croatian: Ako Vaše dijete boluje od umjerenog ili teškog zatajenja srca.
English: Should treatment be interrupted, Hulio may be re-introduced as appropriate.
Croatian: Ako liječenje treba privremeno prekinuti, Hulio se kasnije po potrebi može ponovno uvesti.
English: This risk may increase if your child lung function is reduced.
Croatian: Taj rizik može biti povećan ako je smanjena funkcija djetetovih pluća.
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Croatian: U otvorenom produžetku ispitivanja poboljšanje znakova i simptoma održalo se uz terapiju adalimumbabom do 156. tjedna.
English: • DO NOT twist or bend the needle cover while removing it, this may damage the needle.
Croatian: • NE zakrećite niti savijajte pokrov igle pri uklanjanju jer se time može oštetiti igla.
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
Croatian: U ispitivanjima RA I - IV sve pojedinačne komponente kriterija ACR odgovora (broj bolnih i otečenih zglobova, liječnikova i bolesnikova ocjena aktivnosti bolesti i boli, indeks onesposobljenosti (HAQ) i razine CRP-a (mg/dl)) pokazale su poboljšanje nakon 24 ili 26 tjedana u odnosu na placebo.
English: Hulio in combination with methotrexate, is indicated for:
Croatian: U kombinaciji s metotreksatom, Hulio je indiciran za:
English: Repeat this step to draw the solution back into the syringe again, pulling the plunger rod SLOWLY.
Croatian: Ponovite ovaj korak da biste otopinu ponovno uvukli u štrcaljku POLAGANIM povlačenjem klipa štrcaljke.
English: Pull the syringe away from the injection site at the same angle as inserted and release your thumb from the plunger.
Croatian: Izvucite štrcaljku s mjesta ubrizgavanja pod istim kutem pod kojim je umetnuta i maknite palac s klipa.
English: Patients treated with Hulio should be given the Patient Reminder Card.
Croatian: Bolesnicima koji se liječe lijekom Hulio treba dati Karticu s podsjetnikom za bolesnika.