FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not warm the syringe using heat sources such as hot water or a microwave.
Croatian: Nemojte grijati štrcaljku pomoću izvora topline kao što su vruća voda ili mikrovalna pećnica.
English: The physician should ensure appropriate follow-up of patients for any systemic injection reaction and localised injection site reaction after the initial subcutaneous injection is administered.
Croatian: Liječnik mora osigurati odgovarajuće praćenje bolesnika za bilo koje sistemske reakcije kao i za lokalizirane reakcije na mjestu injekcije nakon početnog davanja supkutane injekcije.
English: A damaged pen may not function properly.
Croatian: Oštećena brizgalicu možda neće pravilno raditi.
English: The subcutaneous administration of Remsima to New Zealand White rabbits was well tolerated at the actual concentration to be used in humans.
Croatian: Supkutana primjena lijeka Remsima na novozelandskim bijelim kunićima bila je dobro tolerirana pri koncentracijama koje se sada primjenjuju kod ljudi.
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remsima.
Croatian: • Vaš liječnik će Vam dati i karticu s upozorenjima za bolesnika, koja sadrži važne sigurnosne informacije kojih morate biti svjesni prije i tijekom liječenja lijekom Remsima.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remsima in the infusion bag only.
Croatian: Čuvanje dulje od 24 sata na temperaturi od 2°C do 8°C se odnosi samo na pripremu lijeka Remsima u infuzijskoj vrećici.
English: It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed.
Croatian: Važno je provjeriti navode na pakiranju lijeka kako bi se osiguralo da se bolesniku daje prava formulacija (intravenska ili supkutana) kao što mu je propisano.
English: b. Using your other hand, gently pinch a fold of skin you cleaned.
Croatian: b. Drugom rukom nježno uhvatite u nabor kožu koju ste očistili.
English: If you forget or miss your Remsima infusion
Croatian: Ako ste zaboravili ili propustili infuziju lijeka Remsima
English: a. Look at the pen and confirm that the olive green plunger rod is filling the window completely.
Croatian: Pogledajte brizgalicu i potvrdite da je maslinastozeleni klip u potpunosti ispunio prozorčić.
English: One serious infusion reaction (<1%) occurred in a patient on infliximab monotherapy.
Croatian: Nastupila je jedna ozbiljna reakcija na infuziju (< 1%) u bolesnika koji je primao monoterapiju infliksimabom.
English: In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Croatian: U svim je slučajevima liječenje lijekom infliksimab bilo prekinuto i/ili uvedeno drugo liječenje, uz potpuno povlačenje znakova i simptoma.
English: Remsima should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Croatian: Remsima se smije primjenjivati u djece samo ako se liječe od Crohnove bolesti ili ulceroznog kolitisa.
English: 6 weeks after your 1st dose
Croatian: 6 tjedana nakon 1. doze
English: c. When your sharps disposal container is almost full, it should be disposed of in accordance with local requirements.
Croatian: c. Kad je Vaš spremnik za oštre predmete gotovo napunjen, treba ga zbrinuti u skladu s lokalnim propisima.
English: Inspect the syringe.
Croatian: Provjerite štrcaljku.
English: Do not touch the needle cover.
Croatian: Nemojte doticati pokrov igle.
English: Therefore, subcutaneous use of Remsima is recommended for use only in adults.
Croatian: Stoga se supkutana primjena lijeka Remsima preporučuje samo za odrasle osobe.
English: a. Press the pen firmly against the skin.
Croatian: Pritisnite brizgalicu čvrsto na kožu.
English: 5 years at 2°C - 8°C.
Croatian: Pet godina na temperaturi 2°C-8°C.
English: • Tell your doctor before you are given Remsima if you have or have ever had a problem that affects your nervous system.
Croatian: • Obavijestite svog liječnika prije nego što počnete primati lijek Remsima ako imate ili ste imali neki problem koji je zahvaćao Vaš živčani sustav.
English: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Remsima treatment again.
Croatian: • Obavijestite svog liječnika ako ste se u prošlosti već liječili lijekovima koji sadrže infliksimab i sada ponovno započinjete liječenje lijekom Remsima.
English: • If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
Croatian: • U slučaju ponovne aktivacije hepatitisa B liječnik će možda morati prekinuti liječenje i dati Vam lijekove za učinkovitu antivirusnu terapiju s potpornim liječenjem.
English: Remsima infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Croatian: Infuziju lijeka Remsima moraju davati osposobljeni zdravstveni radnici koji su obučeni prepoznati bilo koji problem u vezi s infuzijom.
English: Placebo (Week 16)
Croatian: Placebo (16. tjedan
English: It is used in adults for the following inflammatory disease:
Croatian: Koristi se u odraslih osoba za sljedeću upalnu bolest:
English: Myocardial ischaemia/myocardial infarction
Croatian: ishemija miokarda/infarkt miokarda
English: The primary endpoint of the study was the treatment difference of the change from baseline of DAS28 (CRP) at Week 22.
Croatian: Primarna mjera ishoda u ispitivanja bila je razlika u liječenju u promjeni od početne točke DAS28 (CRP) u 22. tjednu.
English: b. If you do not have an approved sharps disposal container, you may use a household container that is:
Croatian: b. Ako ne posjedujete odobreni spremnik za oštre predmete, možete koristiti drugi kućni spremnik koji: • je proizveden od tvrde plastike,
English: 2 weeks after your 1st dose
Croatian: 2 tjedna nakon 1. doze
English: The mean terminal half-life ranged from 11.3 days to 13.7 days for 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects.
Croatian: Srednja vrijednost terminalnog poluvijeka kretala se u rasponu od 11,3 do 13,7 dana za 120, 180 i 240 mg infliksimaba primijenjenog supkutano u zdravih ispitanika.
English: b. Push the plunger down slowly and as far as it will go until the syringe is empty.
Croatian: b. Gurajte klip polagano prema dolje sve do kraja, odnosno dok se štrcaljka ne isprazni.
English: If you forget or miss an appointment to receive Remsima, make another appointment as soon as possible.
Croatian: Ako ste zaboravili ili propustili doći na infuziju lijeka Remsima, dogovorite novi pregled što je prije moguće.
English: The following information is intended for healthcare professionals only: Patients treated with Remsima should be given the patient reminder card.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Bolesnici koji se liječe lijekom Remsima moraju dobiti karticu s podsjetnikom za bolesnika
English: Placebo (Week 24)
Croatian: Placebo (24. tjedan
English: For more information about the safety of infliximab in elderly patients, see sections 4.4 and 4.8.
Croatian: Za više podataka o sigurnosti primjene infliksimaba u starijih bolesnika, vidjeti dijelove 4.4 i 4.8.
English: a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
Croatian: Pripremite čistu, ravnu, dobro osvijetljenu površinu kao što je stol ili pult.
English: Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Croatian: Do sada dostupni farmakokinetički podaci opisani su u dijelu 5.2, ali ne mogu se dati preporuke za doziranje u djece mlađe od 6 godina.
English: Elevations of ALT ≥5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Croatian: ≥ 5 puta iznad gornje granice normale (GGN) (vidjeti Tablicu 2).
English: There is no specific treatment for Remsima overdose.
Croatian: Ne postoji specifično liječenje za predoziranje lijekom Remsima.
English: Do not warm the pen using heat sources such as hot water or a microwave.
Croatian: Nemojte grijati brizgalicu pomoću izvora topline kao što su vruća voda ili mikrovalna pećnica.
English: If you received Remsima while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Croatian: Ako ste tijekom trudnoće primali lijek Remsima, primjena BCG cjepiva (primjenjuje se za sprječavanje tuberkuloze) Vašem djetetu unutar 6 mjeseci od rođenja može dovesti do ozbiljnih komplikacija, uključujući smrt.
English: The estimate of treatment difference was 0.27 with corresponding lower limit of the two-sided 95% confidence interval [CI] of 0.02 (95% CI: 0.02, 0.52), which was greater than the pre-specified non-inferiority margin of -0.6 indicating non-inferiority of Remsima subcutaneous formulation to Remsima intravenous formulation.
Croatian: Procjena razlike liječenja bila je 0,27 s odgovarajućom donjom granicom dvostranog 95 %-tnog intervala pouzdanosti [CI] od 0,02 (95 % CI: 0,02, 0,52), koji je bio veći od prethodno specificirane margine neinferiornosti od -0,6, što pokazuje neinferiornost supkutane formulacije u odnosu na intravensku formulaciju lijeka Remsima.
English: Systemic injection reaction/ localised injection site reaction/ hypersensitivity
Croatian: Sistemske reakcije na injekciju/lokalizirane reakcije na mjestu primjene/preosjetljivost
English: Do not dilute the reconstituted Remsima solution with any other diluent.
Croatian: Ne razrjeđujte rekonstituiranu otopinu lijeka Remsima niti s jednom drugom otopinom.
English: However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that non-live vaccinations received during treatment with anti-TNF therapies, including infliximab may elicit a lower immune response than in patients not receiving anti-TNF therapy.
Croatian: Međutim, ispitivanja iz objavljene literature kod različitih indikacija (npr. reumatoidni artritis, psorijaza, Crohnova bolest) ukazuju na to da neživa cjepiva primljena tijekom liječenja anti-TNF lijekovima, uključujući infliksimab, mogu dovesti do slabijeg imunološkog odgovora nego u bolesnika koji ne primaju anti-TNF terapiju.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
English: ACCENT I (Week-2 responders) % of Patients
Croatian: ACCENT I (bolesnici s odgovorom u 2. tjednu) % bolesnika
English: • The abdomen except for the 5 cm around the belly button (navel).
Croatian: • trbuh (abdomen) osim u područje 5 cm oko pupka,
English: If you feel tired, dizzy, or unwell after having Remsima, do not drive or use any tools or machines.
Croatian: Ako se nakon primjene lijeka Remsima osjećate umorno, imate omaglicu ili se osjećate loše, nemojte voziti ni rukovati alatima i strojevima.
English: Sorbitol 45 mg per 1 mL
Croatian: Sorbitol 45 mg u 1 ml.
English: Hypersensitivity to the active substance, to other murine proteins or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, druge mišje proteine ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Remsima.
Croatian: Ova kartica s podsjetnikom za bolesnika sadrži važne sigurnosne informacije, kojih morate biti svjesni prije i tijekom liječenja lijekom Remsima.
English: Single intravenous doses up to 20 mg/kg have been administered without toxic effects and repeated doses of Remsima subcutaneous formulation up to 240 mg have been administered without toxic effects.
Croatian: Primjena jednokratnih intravenskih doza do 20 mg/kg nije izazvala toksične učinke, a ponovljene doze supkutane formulacije lijeka Remsima do 240 mg nisu izazvale toksične učinke.
English: They are administered 2 weeks apart via intravenous infusion.
Croatian: Doze se daju u razmacima od 2 tjedna putem intravenske infuzije.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C - 8°C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Croatian: Međutim, ako se otopina pripremila u sterilnim uvjetima, može se čuvati u hladnjaku na temperaturi od 2°C do 8°C do 28 dana i tijekom dodatna 24 sata nakon vađenja iz hladnjaka na temperaturi od 25°C.
English: It is important that you tell your baby's doctors and other health care professionals about your Remsima use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Croatian: Važno je obavijestiti liječnike Vašeg djeteta i druge zdravstvene radnike o Vašem primanju lijeka Remsima, tako da mogu odlučiti kada Vaše dijete treba primiti bilo koje cjepivo, uključujući živa cjepiva kao što je BCG (primjenjuje se za sprječavanje tuberkuloze).
English: You may receive some vaccines during treatment with Remsima but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remsima because they may cause infections.
Croatian: Tijekom liječenja lijekom Remsima možete primiti neka cjepiva, ali ne smijete primiti živa cjepiva (cjepiva koja sadrže žive, ali oslabljene uzročnike infekcije) jer ona mogu uzrokovati infekcije.
English: Infliximab has not been studied in these patient populations.
Croatian: Infliksimab nije ispitivana u ovim populacijama bolesnika.
English: The safety population consisted of 168 patients in the Remsima subcutaneous group and 175 patients in the Remsima intravenous group.
Croatian: Populacija za ispitivanje sigurnosti primjene sastojala se od 168 bolesnika u grupi liječenoj lijekom Remsima supkutano i 175 bolesnika u grupi liječenoj lijekom Remsima intravenski.
English: Tell your doctor straight away if you notice any of the above.
Croatian: Odmah obavijestite svog liječnika ako primijetite nešto od gore navedenog.
English: Forty six percent of patients continued on stable doses of methotrexate (≤25 mg/week).
Croatian: Četrdeset i šest posto bolesnika nastavilo je primati ustaljene doze metotreksata (≤ 25 mg na tjedan).
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC
Croatian: Postotak bolesnika koji su postigli kliničku remisiju bez kortikosteroida u 26. tjednu, SONIC
English: The requirements for submission of PSURs 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: popis) predviđenom člankom 107 .c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Croatian: * Infliksimab je kimerično ljudsko-mišje monoklonsko protutijelo IgG1 proizvedeno u mišjim hibridoma stanicama tehnologijom rekombinantne DNK.
English: From experience with intravenous infliximab, if the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last administration.
Croatian: Iz iskustva s intravenskim infliksimabom, ako se ponovno pojave znakovi i simptomi bolesti, infliksimab se može ponovno primijeniti unutar 16 tjedana od zadnje primjene.
English: • The doctor will decide your dose and how often you will be given Remsima.
Croatian: • Liječnik će odrediti koju dozu lijeka Remsima ćete primati i koliko često.
English: The required total volume of reconstituted Remsima solution has to be calculated.
Croatian: Morate izračunati ukupni potrebni volumen rekonstituirane otopine lijeka Remsima.
English: All randomised patients
Croatian: Svi randomizirani bolesnici
English: Methotrexate was given concomitantly.
Croatian: Metotreksat se davao usporedno.
English: Endophthalmitis
Croatian: endoftalmitis
English: • Some patients receiving infliximab via injection under the skin have experienced local injection site reactions.
Croatian: • Neki bolesnici koji su primili infliksimab putem injekcije pod kožu doživjeli su lokalne reakcije na mjestu injekcije.
English: In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Croatian: U slučaju predoziranja, bolesnika treba liječiti simptomatski i sukladno potrebi primijeniti potporne mjere.
English: The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.
Croatian: Uobičajena preporučena doza lijeka Remsima primijenjena supkutanom injekcijom je 120 mg jednom svaka 2 tjedna bez obzira na tjelesnu težinu.
English: • Tell your surgeon or dentist that you are having treatment with Remsima by showing them your patient reminder card.
Croatian: • Obavijestite svog kirurga ili stomatologa da uzimate Remsima i pokažite im svoju karticu s podsjetnikom za bolesnika.
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have also been reported, some in close temporal association with infusion of infliximab.
Croatian: Prijavljeni su i događaji (neki sa smrtnim ishodom) ishemije/infarkta miokarda i aritmije, od kojih su neki bili vremenski usko povezani s infuzijom infliksimaba.
English: Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
Croatian: S obzirom da otopina za infuziju ne sadržava konzervanse, preporučuje se početi s primjenom što prije, a svakako u roku od 3 sata nakon rekonstitucije i razrjeđivanja.
English: During clinical studies of infliximab across all approved indications the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Croatian: Tijekom kliničkih ispitivanja primjene lijeka infliksimab u svim odobrenim indikacijama incidencija limfoma u bolesnika koji su primali infliksimab bila je viša od one očekivane u općoj populaciji, ali je pojava limfoma bila rijetka.
English: ACCENT II (Week-14 responders)
Croatian: ACCENT II (bolesnici s odgovorom u 14. tjednu)
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Croatian: Sljedeće nuspojave prijavljene su češće u djece s Crohnovom bolešću uključene u kliničko ispitivanje REACH (vidjeti dio 5.1) nego u odraslih bolesnika s Crohnovom bolešću: anemija (10,7%), krv u stolici (9,7%), leukopenija (8,7%), navale crvenila (8,7%), virusne infekcije (7,8%), neutropenija (6,8%), bakterijske infekcije (5,8%) i alergijske reakcije dišnog sustava (5,8%).
English: Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i bilo koje druge lijekove za liječenje reumatoidnog artritisa ili lijekove koje ste nabavili bez recepta, poput vitamina i biljnih lijekova.
English: While using Remsima you should not receive live vaccines.
Croatian: Dok uzimate Remsima ne smijete primati živa cjepiva.
English: Do not inject into skin that is within 5 cm of your belly button (navel), or is tender, damaged, bruised, or scarred.
Croatian: Nemojte davati injekciju u kožu unutar 5 cm od pupka ili kožu koja je osjetljiva, oštećena, ima modricu ili ožiljak.
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Remsima.
Croatian: • Ako liječnik misli da kod Vas postoji rizik od razvoja TBC-a, prije nego primite lijek Remsima možda ćete dobiti lijekove za liječenje TBC-a.
English: • If you received Remsima while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Croatian: • Ako ste primali lijek Remsima za vrijeme trudnoće, kod Vašeg djeteta također može postojati veći rizik za razvoj infekcije kod primjene živih cjepiva u razdoblju do šest mjeseci nakon rođenja.
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE
Croatian: Učinci na ACRn, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu, ASPIRE
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test:
Croatian: Zamolite liječnika da ovdje zabilježi vrstu i datum posljednjeg testiranja na tuberkulozu (TBC):
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji je opisan u Modulu 1.8.2
English: a. Remove the needle from the skin at the same angle it was inserted.
Croatian: Izvucite iglu iz kože pod istim kutom pod kojim ste ju uveli u kožu.
English: a. Leave the syringe at room temperature for 30 minutes to allow it to naturally warm up.
Croatian: Ostavite štrcaljku na sobnoj temperaturi 30 minuta kako biste omogućili da se zagrije.
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB.
Croatian: Slučajevi tuberkuloze prijavljeni su u bolesnika liječenih infliksimabom, čak i u bolesnika koji su već bili liječeni lijekovima protiv TBC-a.
English: The mean scores for DAS28 (CRP) and DAS28 (ESR) gradually decreased from baseline at each time point until Week 54 in each treatment arm (see Table 5 and Table 6, respectively).
Croatian: Srednja vrijednost rezultata za DAS28 (CRP) i DAS28 (ESR) se u odnosu na početnu točku postepeno smanjila u svakoj vremenskoj točki do 54. tjedna, u svakoj ispitnoj skupini (vidjeti Tablicu 5 odnosno Tablicu 6).
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system
Croatian: • odstupanja u vrijednostima proteina koji je prisutan u krvi, a zove se faktor komplementa i dio je imunološkog sustava
English: Note: Rotate the injection site each time you give an injection.
Croatian: Napomena: mijenjajte mjesto primjene svaki puta kada dajete injekciju.
English: Tachycardia, palpitation
Croatian: tahikardija, palpitacije
English: Always keep the medicinal product out of the sight and reach of children.
Croatian: Uvijek čuvajte lijek izvan pogleda i dohvata djece.
English: Acute reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following administration of infliximab.
Croatian: Akutne reakcije, uključujući anafilaktičke reakcije, mogu se razviti tijekom (u roku od nekoliko sekundi) ili unutar nekoliko sati nakon primjene infliksimaba.
English: c. Ensure you have the following supplies:
Croatian: c. Provjerite imate li sljedeće:
English: ≥90% improvement
Croatian: Poboljšanje ≥ 90%
English: All systemic injection reactions were mild to moderate.
Croatian: Sve sistemske reakcije na injekciju bile su blage do umjerene.