FrancophonIA/ELRC3.0 huggingface dataset:
English: Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment.
Croatian: Budući da se humani imunoglobulini izlučuju u majčino mlijeko, žene ne smiju dojiti najmanje 6 mjeseci nakon liječenja lijekom Remicade.
English: Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Croatian: Jednokratne intravenske infuzije od 1, 3, 5, 10 ili 20 mg/kg infliksimaba proizvele su povećanja proporcionalna dozi maksimalne koncentracije u serumu (Cmax) i područja ispod krivulje koncentracija-vrijeme (AUC).
English: Other paediatric indications
Croatian: Ostale pedijatrijske indikacije
English: If these medicines do not work well enough, you will be given Remicade which you will take in combination with another medicine called methotrexate to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete Remicade, koji ćete koristiti u kombinaciji s drugim lijekom koji se zove metotreksat kako bi se:
English: Lung disease or heavy smoking
Croatian: Bolest pluća ili teški pušači
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remicade 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 Remicade u infuzijskoj vrećici.
English: It is important that you tell your baby's doctors and other healthcare professionals about your Remicade 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 pedijatra Vašeg djeteta i druge zdravstvene radnike o Vašem primanju lijeka Remicade, 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: In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
Croatian: U ovom je ispitivanju 66% bolesnika (686 od 1040) primilo barem jednu infuziju u skraćenom trajanju od 90 minuta ili manje, a 44% bolesnika (454 od 1040) barem jednu infuziju u skraćenom trajanju od 60 minuta ili manje.
English: Warnings and precautions Talk to your doctor before or during treatment with Remicade if you have:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije ili za vrijeme liječenja lijekom Remicade u sljedećim situacijama:
English: The elimination pathways for infliximab have not been characterised.
Croatian: Putevi eliminacije infliksimaba nisu opisani.
English: The usual dose is 5 mg for every kg of body weight.
Croatian: Uobičajena doza je 5 mg po svakom kilogramu tjelesne težine.
English: Remove flip-top from the vial and wipe the top with a 70% alcohol swab.
Croatian: Skinite poklopac s bočice i obrišite vrh vatom natopljenom 70%-tnim alkoholom.
English: Remicade should only be used during pregnancy if your doctor feels it is necessary for you.
Croatian: Remicade se tijekom trudnoće smije primjenjivati samo ako Vaš liječnik smatra da je to neophodno za Vas.
English: Use of live vaccines can result in clinical infections, including disseminated infections.
Croatian: Primjena živih cjepiva može dovesti do kliničkih infekcija, uključujući diseminirane infekcije.
English: Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Croatian: Rano prepoznavanje atipične kliničke slike teške infekcije kao i tipične kliničke slike rijetke i neuobičajene infekcije od ključne je važnosti kako bi se smanjilo kašnjenje s dijagnozom i liječenjem.
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: • Temporary loss of sight during or within 2 hours of infusion
Croatian: • privremeni gubitak vida tijekom ili unutar 2 sata od infuzije
English: Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo.
Croatian: Terapija održavanja infliksimabom svakih 8 tjedana značajno je smanjila broj hospitalizacija i operacija vezanih uz bolest u odnosu na placebo.
English: • Children and adults taking Remicade may have an increased risk of developing lymphoma or another cancer.
Croatian: • Djeca i odrasli koji uzimaju Remicade mogu imati povećan rizik za razvoj limfoma ili neke druge vrste raka.
English: Crohn's disease (6 to 17 years)
Croatian: Crohnova bolest (6 do 17 godina)
English: In this situation, do not return to refrigerated storage again.
Croatian: U takvoj situaciji, nemojte ponovno vraćati lijek u hladnjak radi čuvanja.
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: Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Croatian: Uporabite isključivo pribor za infuziju s "in-line", sterilnim, nepirogenim filtrom male sposobnosti vezanja proteina (veličina pora 1,2 mikrometra ili manje).
English: Remicade infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Croatian: Infuziju lijeka Remicade moraju davati osposobljeni zdravstveni radnici koji su obučeni prepoznati bilo koji problem u vezi s infuzijom.
English: If your baby has continual fevers or infections, contact your baby's doctor immediately.
Croatian: Ako Vaše dijete ima učestale vrućice ili infekcije, odmah se obratite pedijatru svog djeteta.
English: Before reconstitution: 3 years at 2 °C - 8 °C.
Croatian: Prije rekonstitucije: 3 godine na temperaturi 2°C-8°C.
English: In P01522, improvement in signs and symptoms was also observed as early as week 2.
Croatian: I u ispitivanju P01522, poboljšanje znakova i simptoma bolesti opaženo je već u 2. tjednu.
English: Patients who did not respond to infliximab at week 8 (n = 15) received no further medicinal product and returned for safety follow-up.
Croatian: Bolesnici koji nisu odgovorili na infliksimab u 8. tjednu (n = 15) nisu dalje primali lijek i praćeni su radi ocjene sigurnosti primjene.
English: 2 weeks after your 1
Croatian: 2 tjedna nakon 1. doze
English: Similar trends in the achievement of corticosteroid-free clinical remission were observed at week 50.
Croatian: Slični trendovi u postizanju kliničke remisije bez kortikosteroida opaženi su i u 50. tjednu.
English: • Difficult or painful breathing, chest pain
Croatian: • otežano ili bolno disanje, bol u prsnom košu
English: • Pain in the joints, muscles or back
Croatian: • bol u zglobovima, mišićima ili leđima
English: Discuss the use of contraception during this time with your doctor.
Croatian: Razgovarajte sa svojim liječnikom o uporabi kontracepcije tijekom tog razdoblja.
English: Keep this card with you for 4 months after your dose of Remicade, or in case of pregnancy for at least 6 months after the birth of your baby.
Croatian: Nosite ovu karticu sa sobom još 4 mjeseca nakon posljednje doze lijeka Remicade ili, u slučaju trudnoće, još najmanje 6 mjeseci nakon poroda.
English: • Talk to you doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Croatian: • Obavijestite liječnika ako ste nedavno primili ili trebate primiti liječenje terapijskim infektivnim agensom (poput unosa BCG-a koji se koristi za liječenje raka).
English: While using Remicade you should not receive live vaccines.
Croatian: Dok uzimate Remicade ne smijete primati živa cjepiva.
English: • Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Remicade.
Croatian: • Obavijestite svog liječnika ako imate ili ste imali neki problem koji je zahvaćao Vaš živčani sustav prije nego počnete primati Remicade.
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Croatian: Ta provjera treba obuhvatiti detaljnu anamnezu s podacima o obolijevanju od tuberkuloze ili mogućem prijašnjem kontaktu s tuberkulozom i prijašnjoj i/ili sadašnjoj imunosupresivnoj terapiji.
English: Remicade should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: Remicade treba davati uz oprez bolesnicima s blagim zatajenjem srca (NYHA stupanj I/II).
English: • Cancer in children and adults
Croatian: • rak u djece i odraslih
English: Upon removal from refrigerated storage, Remicade must not be returned to refrigerated storage.
Croatian: Nakon što se izvadi iz hladnjaka, Remicade se ne smije vratiti u hladnjak radi čuvanja.
English: Periodic screening should continue in women treated with Remicade, including those over 60 years of age.
Croatian: Potrebno je nastaviti s periodičkim probirnim pregledima žena liječenih lijekom Remicade, uključujući i one starije od 60 godina.
English: N/A 53.0
Croatian: N/P 53,0
English: There was no difference between groups in the number of late responders thereafter.
Croatian: Nakon toga se skupine nisu razlikovale s obzirom na broj bolesnika koji su imali kasni odgovor.
English: Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
Croatian: Bolesnici kojima je interval između doza skraćen na manje od 8 tjedana mogu biti izloženi povećanom riziku od nuspojava.
English: For preparation and administration instructions, see section 6.6.
Croatian: Za upute o pripremi i primjeni vidjeti dio 6.6.
English: • The doctor will decide your dose and how often you will be given Remicade.
Croatian: • Liječnik će odrediti koju dozu lijeka Remicade ćete primati i koliko često.
English: In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed versus baseline.
Croatian: Uz to, opaženo je statistički i klinički značajno poboljšanje u kvaliteti života i u visini kao i značajno smanjenje primjene kortikosteroida u odnosu na početak liječenja.
English: However some patients may experience serious side effects and may require treatment.
Croatian: Međutim, u nekih bolesnika nuspojave mogu biti teške i zahtijevati liječenje.
English: • Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
Croatian: • Bolesnici s teškim oblikom reumatoidnog artritisa, koji već dugo vremena boluju od te bolesti, mogu imati veći rizik za razvoj limfoma.
English: Infliximab should only be used during pregnancy if clearly needed.
Croatian: Infliksimab se u trudnoći smije primjenjivati samo ako je neophodno.
English: In ASSERT, improvement in signs and symptoms was observed as early as week 2.
Croatian: U ispitivanju ASSERT, poboljšanje znakova i simptoma opaženo je već u 2. tjednu.
English: If you have had a break in your Remicade treatment of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Croatian: Ako je prekid u liječenju lijekom Remicade trajao dulje od 16 tjedana, povećan je rizik od pojave alergijskih reakcija kod ponovnog početka liječenja.
English: Remicade should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Croatian: Remicade se smije primjenjivati u djece samo ako se liječe od Crohnove bolesti ili ulceroznog kolitisa.
English: 38 weeks
Croatian: 38 tjedana
English: • Provision to record the type, date, and result of TB screenings
Croatian: • napomenu da je potrebno evidentirati vrstu, datum i rezultat probira na TBC
English: Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer.
Croatian: Trenutno dostupni podaci ne upućuju na to da liječenje infliksimabom utječe na rizik od razvoja displazije ili raka debelog crijeva.
English: Patients who responded at week 4 were followed to week 12.
Croatian: Bolesnici koji su odgovorili na liječenje nakon 4 tjedna praćeni su do 12. tjedna.
English: • You have tuberculosis (TB) or another serious infection such as pneumonia or sepsis.
Croatian: • Ako imate tuberkulozu (TBC) ili neku drugu ozbiljnu infekciju kao što je upala pluća ili sepsa.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Croatian: TNF alfa sudjeluje u upalnim procesima u organizmu, pa se njegovom blokadom može smanjiti upala u tijelu.
English: • Lack of interest or emotion
Croatian: • manjak motivacije i emocija
English: N/A 49.4
Croatian: N/P 49,4
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Croatian: Ako se sumnja na latentnu tuberkulozu, treba potražiti savjet liječnika s iskustvom u liječenju tuberkuloze.
English: Isolated cases of liver failure resulting in liver transplantation or death have occurred.
Croatian: Zabilježeni su i izolirani slučajevi zatajenja jetre koji su rezultirali transplantacijom jetre ili smrću.
English: Due to its inhibition of TNF, infliximab administered during pregnancy could affect normal immune responses in the newborn.
Croatian: Budući da inhibira TNFα, primjena infliksimaba tijekom trudnoće može utjecati na normalan imunološki odgovor novorođenčeta.
English: Ulcerative colitis (6 to 17 years)
Croatian: Ulcerozni kolitis (6 do 17 godina)
English: Furthermore, a reduction in corticosteroid use and improvements in quality of life were observed.
Croatian: Osim toga, zabilježeno je smanjenje primjene kortikosteroida te poboljšanje kvalitete života.
English: If response was lost during maintenance treatment, crossing over to a higher dose (10 mg/kg) and/or shorter dosing interval (q8 weeks) was allowed.
Croatian: Ako se tijekom terapije održavanja odgovor na terapiju izgubio, dopustio se prelazak na veću dozu (10 mg/kg) i/ili kraći interval između dvije doze (8 tjedana).
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 reactions, 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 nuspojava, uključujući infekciju.
English: If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued.
Croatian: Pojavi li se kod skraćene infuzije reakcija vezana uz infuziju, može se razmotriti sporija brzina za buduće infuzije, ako se terapija nastavlja.
English: These medicines may cause side effects.
Croatian: Ti lijekovi mogu uzrokovati nuspojave.
English: • Small red or purple spots caused by bleeding under the skin
Croatian: • male crvene ili ljubičaste točkice uzrokovane krvarenjem ispod kože
English: • Inflammation in the eye that may cause changes in the vision, including blindness
Croatian: • upala oka koja može uzrokovati promjene vida, uključujući sljepoću
English: Rheumatoid arthritis The usual dose is 3 mg for every kg of body weight.
Croatian: Reumatoidni artritis Uobičajena doza je 3 mg po svakom kilogramu tjelesne težine.
English: The concomitant use of infliximab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Croatian: Istodobna primjena infliksimaba s drugim biološkim lijekovima se ne preporučuje zbog mogućeg povećanog rizika od infekcije i drugih mogućih farmakoloških interakcija.
English: Elevations of ALT ≥ 5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Croatian: Opažen je povišen ALT ≥ 5 puta iznad gornje granice normale (GGN) (vidjeti Tablicu 2).
English: • Tuberculosis
Croatian: • tuberkuloza
English: Remicade should be administered intravenously over a 2 hour period.
Croatian: Remicade se primjenjuje intravenski tijekom razdoblja od 2 sata.
English: N/A 4.4% N/A 1.5%
Croatian: N/P 4,4% N/P 1,5%
English: Re-administration across indications
Croatian: Ponovna primjena u svim indikacijama
English: After the first year of the study, 78 patients continued into an open-label extension to week 98.
Croatian: Nakon prve godine ispitivanja, 78 bolesnika nastavilo je sudjelovati u otvorenoj fazi ispitivanja do 98. tjedna.
English: The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže (medijan Vd od 3,0 do 4,1 litre) nije ovisio o veličini primijenjene doze i pokazao je da se infliksimab pretežito distribuira unutar vaskularnog odjeljka.
English: * ITT-analysis where subjects with missing data were included as non-responders.
Croatian: * ITT-analiza, analiza svih bolesnika koje se namjeravalo liječiti; ispitanici za koje su nedostajali podaci bili uključeni kao oni u kojih nije nastupio odgovor.
English: Key results are presented in Table 10.
Croatian: Najvažniji rezultati prikazani su u Tablici 10.
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 Remicade.
Croatian: • Vaš liječnik će Vam dati i karticu s podsjetnikom za bolesnika, koja sadrži važne sigurnosne informacije kojih morate biti svjesni prije i tijekom liječenja lijekom Remicade.
English: Before starting treatment with Remicade, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Croatian: Prije početka liječenja lijekom Remicade sve bolesnike treba provjeriti na aktivnu i neaktivnu ("latentnu") tuberkulozu.
English: Experimental data show that TNF is essential for the clearing of intracellular infections.
Croatian: Eksperimentalni podaci pokazuju da je TNFα neophodan za uklanjanje unutarstanične infekcije.
English: HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Croatian: Health Assessment Questionnaire); veće vrijednosti označavaju manji stupanj onesposobljenosti.
English: • Tell your doctor if you have any heart problems, such as mild heart failure.
Croatian: • Obavijestite svog liječnika ako imate nekih problema sa srcem, npr. blagi stupanj zatajenja srca.
English: The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
Croatian: Djelotvornost lijeka Remicade tijekom 54. tjedna ispitivala se u ispitivanju ACT 1.
English: • Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Croatian: • pogoršanje bolesti koja se zove dermatomiozitis (očituje se kao osip kože praćen slabošću mišića)
English: Studies in mice deficient in TNF demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters.
Croatian: Istraživanja na miševima s deficijencijom TNFα nisu pokazala povećanu pojavu tumora nakon izloženosti poznatim tumorskim inicijatorima i/ili promotorima.
English: • Some patients receiving Remicade have developed symptoms of an immune system disorder called lupus.
Croatian: • U nekih bolesnika koji primaju Remicade razvili su se simptomi poremećaja imunološkog sustava koji se zove lupus.
English: • Swelling of small blood vessels (vasculitis)
Croatian: • oticanje malih krvnih žila (vaskulitis)
English: Specific studies of Remicade in elderly patients have not been conducted.
Croatian: Nisu provedena posebna ispitivanja lijeka Remicade u starijih bolesnika.
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: Instructions for use and handling - reconstitution, dilution and administration
Croatian: Upute za uporabu i rukovanje - rekonstitucija, razrjeđivanje i primjena otopine
English: Remicade and Orencia should not be used together.
Croatian: Remicade i Orencia ne smiju se istodobno uzimati.
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 Remicade, 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 Remicade, mogu dovesti do slabijeg imunološkog odgovora nego u bolesnika koji ne primaju anti-TNF terapiju.
English: For more information see section on vaccination.
Croatian: Za dodatne informacije vidjeti dio o cijepljenju.
English: • Feeling forgetful, irritable, confused, nervous
Croatian: • zaboravljivost, razdražljivost, zbunjenost, nervoza
English: For more information about the safety of Remicade in elderly patients (see sections 4.4 and 4.8).
Croatian: Za više podataka o sigurnosti primjene lijeka Remicade u starijih bolesnika (vidjeti dijelove 4.4 i 4.8).
English: After the first year of the study, 53 patients continued into an open-label extension to week 102.
Croatian: Nakon prve godine ispitivanja, 53 bolesnika nastavilo je sudjelovati u otvorenoj fazi ispitivanja do 102. tjedna.
English: In vivo, infliximab rapidly forms stable complexes with human TNF, a process that parallels the loss of TNF bioactivity.
Croatian: In vivo, infliksimab brzo stvara stabilne komplekse s humanim TNFα, što se događa usporedno s gubitkom bioaktivnosti TNFα.
English: Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection.
Croatian: Invazivne gljivične infekcije manifestiraju se prije kao diseminirane nego lokalizirane bolesti, a testovi na antigene i protutijela mogu u nekih bolesnika biti negativni unatoč postojanju aktivne infekcije.
English: Patients should be closely monitored and Remicade must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Croatian: Bolesnike treba pomno nadzirati, a primjena lijeka ne smije se nastaviti u onih bolesnika u kojih se pojave novi ili pogoršaju postojeći simptomi zatajenja srca (vidjeti dijelove 4.3 i 4.8).
English: • Tell your doctor if you have had treatment with Remicade in the past and are now starting Remicade treatment again.
Croatian: • Obavijestite svog liječnika ako ste se u prošlosti već liječili lijekom Remicade i sada ponovno započinjete liječenje lijekom Remicade.
English: Remicade works by selectively attaching to TNF alpha and blocking its action.
Croatian: Remicade djeluje tako što se selektivno vezuje za TNF alfa i onemogućuje njegovo djelovanje.
English: AZA was given at a dose of 2.5 mg/kg daily.
Croatian: AZA se davao u dozi od 2,5 mg/kg na dan.
English: An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion.
Croatian: Reakcija vezana uz infuziju u kliničkim je ispitivanjima definirana kao svaki štetan događaj koji nastupi tijekom davanja infuzije ili u roku od jednog sata nakon infuzije.