FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Croatian: Bolesnicima se prije infuzije može dati premedikacija npr. antihistaminik, hidrokortizon i/ili paracetamol kako bi se spriječili blagi i prolazni učinci.
English: • In case you have received Remsima while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Croatian: • U slučaju da ste primali lijek Remsima za vrijeme trudnoće, važno je da o tome obavijestite pedijatra svog djeteta prije nego što Vaše dijete primi ikakvo cjepivo.
English: c HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Croatian: c HAQ = upitnik za procjenu zdravlja (engl.Health Assessment Questionnaire); veće vrijednosti označavaju manji stupanj onesposobljenosti.
English: 178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Croatian: 580 uključenih bolesnika 178 (30,7%) je imalo težak oblik bolesti (CDAI rezultat > 300 uz istodobno uzimanje kortikosteroida i/ili imunosupresiva), što je odgovaralo populaciji definiranoj u indikaciji
English: • Use the syringe ONLY if your healthcare provider has trained you on the right way to prepare for and to give an injection.
Croatian: • Primijenite štrcaljku SAMO ako Vas je zdravstveni radnik obučio kako na pravilan način pripremiti i dati injekciju.
English: Table 1 lists the ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Croatian: U Tablici 1 navedene su nuspojave koje se temelje na iskustvu iz kliničkih ispitivanja kao i nuspojave prijavljene nakon stavljanja lijeka u promet, od kojih su neke imale smrtni ishod.
English: • Cotton ball or gauze*
Croatian: • vatu ili gazu*
English: Take your next dose on the next originally planned date and thereafter biweekly.
Croatian: Sljedeću dozu uzmite na sljedeći prvotno planirani datum, a nakon toga svaka dva tjedna.
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: 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: The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Croatian: Udio bolesnika s infekcijama u ispitivanju C0168T72 bio je sličan kao u ispitivanju Crohnove bolesti u pedijatrijskih bolesnika (REACH), ali veći nego udio u ispitivanjima ulceroznog kolitisa u odraslih (ACT 1 i
English: • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Remsima.
Croatian: • Obavijestite svog liječnika ako imate neprirodne otvore na koži (fistule) prije nego počnete primati lijek Remsima.
English: • The front of the thighs.
Croatian: • prednju stranu bedara,
English: Subcutaneous administration of Remsima is not recommended for paediatric use and no data are available on the use of Remsima administered subcutaneously in the paediatric population.
Croatian: Supkutana primjena lijeka Remsima ne preporučuje se za pedijatrijsku primjenu i nema dostupnih podataka o supkutanoj primjeni lijeka Remsima u pedijatrijskih bolesnika.
English: If patients miss an injection of Remsima subcutaneous formulation, they should be instructed to take the missed dose immediately in case this happens within 7 days from the missed dose, and then remain on their original bi-weekly dosing schedule.
Croatian: Ako bolesnici propuste dati injekciju supkutane formulacije lijeka Remsima, mora ih se uputiti da odmah uzmu propuštenu dozu ako su se unutar 7 dana sjetili da su je propustili, a zatim da nastave s prvobitnim doziranjem svaka dva tjedna.
English: Vaccine breakthrough infection (after in utero exposure to infliximab)*.
Croatian: probojna infekcija uzrokovana cjepivom (nakon izlaganja infliksimabu in utero)*
English: After single doses of 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects, the mean Cmax values were 10.0, 15.1 and 23.1 µg/mL, respectively, and for all doses infliximab could be detected in the serum for at least 12 weeks thereafter.
Croatian: Nakon jedne doze od 120, 180 i 240 mg supkutanog infliksimaba primjenjenog zdravim ispitanicima, srednje Cmax vrijednosti bile su 10,0, 15,1 i 23,1 µg/ml, i kod svih doza infliksimab se mogao detektirati u serumu najmanje 12 tjedana nakon toga.
English: For this reason, the initial intravenous administrations should take place where emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway is immediately available.
Croatian: Iz tog razloga, početna intravenska primjena smije se započeti tamo gdje je oprema za hitno liječenje odmah dostupna, npr. adrenalin, antihistaminici, kortikosteroidi i oprema za umjetnu ventilaciju.
English: vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
Croatian: podrhtavanje ili lupanje u prsnom košu, ubrzani ili usporeni otkucaji srca i oticanje stopala.
English: a. After the needle is inserted, let go of the pinched skin.
Croatian: Nakon što ste uveli iglu u kožu, pustite nabor kože.
English: • Signs of a nervous system problem (including eye problems) such as fits, tingling or numbness in any part of your body, weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
Croatian: • Znakove neuroloških problema (uključujući poremećaje oka) kao što su napadaji, trnci ili utrnulost bilo kojeg dijela tijela, slabost u rukama ili nogama, promjene vida, poput dvostruke slike ili drugi problemi s očima.
English: Systemic injection reaction and localised injection site reaction in adult patients administered with Remsima subcutaneous formulation
Croatian: Sistemske reakcije na injekciju i lokalizirane reakcije na mjestu injekcije u odraslih bolesnika kojima je dana supkutana formulacija lijeka Remsima
English: The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.
Croatian: Preporučena doza supkutane formulacije lijeka Remsima je 120 mg jednom svaka 2 tjedna.
English: a. Leave the pen at room temperature for 30 minutes to allow it to naturally warm up.
Croatian: Ostavite brizgalicu na sobnoj temperaturi 30 minuta kako biste omogućili da se zagrije.
English: Remsima may have a minor influence on the ability to drive and use machines.
Croatian: Remsima malo utječe sposobnost upravljanja vozilima i rada sa strojevima.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), lichenoid reactions, acute generalised exanthematous pustulosis (AGEP).
Croatian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem, furunkuloza, linearna IgA bulozna dermatoza (LABD), lihenoidne reakcije, akutna generalizirana egzantematozna pustuloza (AGEP)
English: Talk to your doctor before or during treatment with Remsima if you have:
Croatian: Obratite se svom liječniku prije ili za vrijeme liječenja lijekom Remsima u sljedećim situacijama:
English: ≥75% improvement
Croatian: Poboljšanje ≥ 75%
English: EGIS Praha, spol.
Croatian: EGIS Praha, spol. s r.o.
English: The medicinal product may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Croatian: Ovaj se lijek može čuvati na temperaturi do najviše 25°C tijekom razdoblja od najviše 14 dana.
English: Inspect the pen.
Croatian: Provjerite brizgalicu.
English: Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose.
Croatian: Potrebno je procijeniti prikladnost pojedinog bolesnika za samostalnu supkutanu primjenu kod kuće, a bolesnike je potrebno upozoriti da obavijeste liječnika prije primjene naredne doze ako primjete simptome alergijske reakcije.
English: The efficacy of subcutaneous infliximab in rheumatoid arthritis patients was assessed in a randomised, parallel-group pivotal Phase I/III study consisting of two parts: Part 1 to determine the optimal dose of subcutaneous infliximab and Part 2 to demonstrate non-inferiority in terms of efficacy of subcutaneous infliximab compared to intravenous infliximab treatment.
Croatian: Djelotvornost supkutane primjene infliksimaba u bolesnika s reumatoidnim artritisom procijenjena je u randomiziranom pivotalnom ispitivanju faze I/III u paralelnim skupinama koje se sastojalo od dva dijela: u 1. dijelu određivala se optimalna doza supkutane primjene infliksimaba, a u 2. dijelu se dokazivala neinferiornost u smislu djelotvornosti supkutane primjene infliksimaba u usporedbi s intravenskim liječenjem infliksimabom.
English: When switching from the maintenance therapy of infliximab intravenous formulation to the subcutaneous formulation of Remsima, the subcutaneous formulation may be administered 8 weeks after the last administration of the intravenous infusions of infliximab 3 mg/kg given every 8 weeks.
Croatian: Kad se prelazi s terapije održavanja intravenskom formulacijom infliksimaba na supkutanu formulaciju, supkutana formulacija smije se dati 8 tjedana nakon zadnjeg davanja intravenske infuzije infliksimaba 3 mg/kg svakih 8 tjedana.
English: There is insufficient information regarding the switching of patients who received the intravenous infusions of infliximab higher than 3 mg/kg every 8 weeks to the subcutaneous formulation of Remsima.
Croatian: Nema dovoljno podataka u vezi prijelaza bolesnika koji su primili intravenske infuzije infliksimaba više od 3 mg/kg svakih 8 tjedana na primjenu supkutane formulacije lijeka Remsima.
English: The safety profile of Remsima subcutaneous formulation in combination with methotrexate was evaluated in a Phase I/III parallel group study in patients with active rheumatoid arthritis.
Croatian: Sigurnosni profil supkutane formulacije lijeka Remsima u kombinaciji s metotreksatom procijenjen je u fazama I/III ispitivanja s paralelnim skupinama u bolesnika s aktivnim reumatoidnim artritisom.
English: • Rotate the injection site each time you give an injection.
Croatian: • Mijenjajte mjesto primjene svaki put kad dajete injekciju.
English: If jaundice and/or ALT elevations ≥5 times the upper limit of normal develop(s), infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Croatian: Ako se razvije žutica i/ili je koncentracija ALT ≥ 5 puta veća od gornje granice normale, liječenje infliksimabom treba prekinuti te provesti temeljite pretrage i utvrditi razlog poremećaja.
English: If you forget to use Remsima
Croatian: Ako ste zaboravili uzeti lijek Remsima
English: The required volume of reconstituted Remsima solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
Croatian: Potrebni volumen rekonstituirane otopine lijeka Remsima treba se polako dodavati u 250-mililitarsku infuzijsku bocu ili vrećicu te lagano promiješati.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remsima treatment.
Croatian: • Bolesnici s KOPB-om i bolesnici koji su teški pušači mogu imati povećan rizik za razvoj raka pri liječenju lijekom Remsima.
English: • Use the pen ONLY if your healthcare provider has trained you on the right way to prepare for and to give an injection.
Croatian: • Primijenite brizgalicu SAMO ako Vas je zdravstveni radnik obučio kako na pravilan način pripremiti i dati injekciju.
English: • Tell your doctor before you are given Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Croatian: • Prije nego što počnete primati lijek Remsima, obavijestite svog liječnika ako bolujete od bolesti pluća koja se zove kronična opstruktivna plućna bolest (KOPB) ili ste teški pušač
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Croatian: Analiza mononuklearnih stanica u lamini propriji, dobivenih biopsijom sluznice crijeva, pokazala je da je liječenje infliksimabom dovelo do smanjenja broja stanica koje mogu izraziti TNFα i interferon γ.
English: The primary endpoint in both studies was the percent of patients who achieved ≥75% improvement in PASI from baseline at week 10.
Croatian: Primarna mjera ishoda u oba ispitivanja bio je postotak bolesnika u kojih se postiglo poboljšanje vrijednosti PASI za ≥ 75% u 10. tjednu u odnosu na početno stanje.
English: Remsima SC 120 mg (N=165)
Croatian: Remsima s.c. 120 mg (N=165)
English: Patients with no deterioration/patients evaluated (%)c
Croatian: (srednja vrijednost ± SDc) Medijan (interkvartilni raspon) Bolesnici bez pogoršanja/evaluirani bolesnici (%)c
English: Remsima is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Croatian: Lijek Remsima je dostupan u staklenoj bočici koja sadrži prašak za koncentrat za otopinu za infuziju.
English: In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Croatian: U skupini 2, nakon infuzije u 36. tjednu, bolesnici koji su imali BASDAI ≥ 3 na dva uzastopna pregleda primali su dozu od 7,5 mg/kg infliksimaba svakih 6 tjedana do 96. tjedna.
English: Read carefully these instructions before using the Remsima syringe.
Croatian: Pažljivo pročitajte ove upute prije primjene Remsima brizgalice.
English: Most of these reactions were mild to moderate and resolved spontaneously without any treatment within a day.
Croatian: Većina ovih reakcija bile su blage do umjerene i povukle su se spontano u roku od jednog dana bez dodatnog liječenja.
English: Date of Remsima therapy initiation:
Croatian: Datum početka liječenja lijekom Remsima:
English: In Part 2 of this study, among 357 patients who were enrolled to receive 2 doses of Remsima 3 mg/kg intravenously at Weeks 0 and 2, 167 patients were randomised to receive Remsima 120 mg subcutaneously at Week 6 and every 2 weeks up to Week 54, while 176 patients were randomised to receive Remsima 3 mg/kg intravenously at Weeks 6, 14 and 22 and then switched to Remsima 120 mg subcutaneous at Week 30 once-every 2 weeks up to Week 54.
Croatian: U 2. dijelu ovog ispitivanja, od 357 bolesnika koji su intravenski primili dvije doze lijeka Remsima od 3 mg/kg u 0. i 2. tjednu, randomizirano je 167 bolesnika za supkutanu primjenu lijeka Remsima od 120 mg u 6. tjednu i svaka dva tjedna do 54. tjedna, dok je 176 bolesnika randomizirano za intravensku primjenu lijeka Remsima od 3 mg/kg u 6., 14. i 22. tjednu nakon čega su u 30. tjednu prebačeni na liječenje supkutanom primjenom lijeka Remsima od 120 mg svaka dva tjedna do 54.
English: Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 3 mg/kg given 2 weeks apart.
Croatian: Supkutano liječenje lijekom Remsima mora se započeti kao terapija održavanja 4 tjedna nakon zadnje primjene dvije intravenske infuzije infliksimaba 3 mg/kg dane u razmaku od dva tjedna.
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Croatian: hepatosplenički limfom T-stanica (prvenstveno u adolescenata i mlađih odraslih muškaraca s Crohnovom bolešću i ulceroznim kolitisom), karcinom
English: In this situation, do not return to refrigerated storage again.
Croatian: U takvoj situaciji, nemojte ponovno vraćati lijek u hladnjak na čuvanje.
English: • Tell your doctor before you are given Remsima if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Croatian: • Prije nego primite lijek Remsima, obavijestite svog liječnika ako ste ikad živjeli ili putovali u područja u kojima su česte infekcije histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Croatian: Djelotvornost lijeka infliksimab tijekom 54 tjedana ispitivala se u kliničkom ispitivanju ACT 1.
English: • Low blood counts, including a severely decreased number of white blood cells
Croatian: • smanjen broj krvnih stanica, uključujući značajno smanjenje broja bijelih krvnih stanica.
English: If you were using Remsima during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Remsima use before the baby receives any vaccines.
Croatian: Ako ste uzimali Remsima tijekom trudnoće, obavijestite liječnika Vašeg djeteta ili druge zdravstvene radnike koji skrbe za Vaše dijete da ste uzimali Remsima prije nego što dijete primi bilo koje cjepivo.
English: If these medicines or treatments do not work well enough, you will be given Remsima to reduce the signs and symptoms of your disease.
Croatian: Ako ti lijekovi ili postupci ne djeluju dovoljno dobro, dobit ćete lijek Remsima kako bi se umanjili znakovi i simptomi bolesti.
English: Do not touch the needle.
Croatian: Nemojte doticati iglu.
English: Side effects may also occur after your treatment with Remsima has stopped.
Croatian: Nuspojave se mogu pojaviti i nakon prestanka liječenja lijekom Remsima.
English: • If you received Remsima during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: • Ako ste primali lijek Remsima tijekom trudnoće, kod Vašeg djeteta može postojati povećan rizik od infekcije.
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Croatian: Do sada dostupni podaci opisani su u dijelovima 4.8 i 5.2, ali ne mogu se dati preporuke za doziranje.
English: The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Croatian: 0,8 godina (incidencija 5,7% [95% CI 2,65%-10,6%]).
English: Single subcutaneous injections of 120, 180 and 240 mg of infliximab yielded approximately dose proportional increases in the maximum serum concentration (Cmax) and area under the concentrationtime curve (AUC).
Croatian: Jednokratne supkutane injekcije od 120, 180 i 240 mg infliksimaba rezultirale su približno dozi proporcionalnim povećanjima maksimalne koncentracije u serumu (Cmax) i površine ispod krivulje koncentracija-vrijeme (AUC).
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 jsu i u 50. tjednu.
English: ≥50% improvement
Croatian: Poboljšanje ≥ 50%
English: Under aseptic conditions, each Remsima vial should be reconstituted with 10 mL of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Croatian: U aseptičkim uvjetima trebate rekonstituirati otopinu u svakoj bočici lijeka Remsima s 10 ml vode za injekcije, koristeći štrcaljku s iglom promjera 21 G (0,8 mm) ili užom.
English: The co-primary endpoints were the proportion of patients in clinical remission (CDAI <150) at week 30 and time to loss of response through week 54.
Croatian: Dvije primarne mjere ishoda bile su udio bolesnika u kliničkoj remisiji (CDAI < 150) u 30. tjednu i vrijeme do gubitka odgovora do 54. tjedna.
English: After use, place the pre-filled syringe/ pre-filled syringe with automatic needle guard/ pre-filled pen into a puncture resistant container and discard as required by local regulations.
Croatian: Nakon uporabe odložite štrcaljku / štrcaljku s automatskim štitnikom igle / brizgalicu u spremnik otporan na probijanje i zbrinite sukladno nacionalnim propisima.
English: In studies in healthy subjects, the mean (± standard deviation) apparent clearance of Remsima 120 mg administered subcutaneously was 19.3 ± 6.9 mL/hr.
Croatian: U ispitivanjima na zdravim ispitanicima srednja vrijednost (± standardno odstupanje) vidljivog klirensa lijeka Remsima od 120 mg primijenjenog supkutano bio je 19,3 ± 6,9 ml/sat.
English: In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Croatian: 5 mg/kg s ili bez metotreksata, protutijela su se pojavila u ukupno 15% bolesnika (protutijela su se pojavila u 4% bolesnika koji su primali metotreksat i u 26% bolesnika koji nisu početno primali metotreksat).
English: In the Phase IIIb trial in Crohn's disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Croatian: Crohnovoj bolesti, pod nazivom SONIC, bolesnici u placebo skupini primali su AZA u dozi od 2,5 mg/kg/dan kao aktivnu kontrolu uz placebo infuzije infliksimaba.
English: Children may receive some vaccines during treatment with Remsima but should not receive live vaccines while using Remsima.
Croatian: Tijekom liječenja lijekom Remsima djeca mogu primiti neka cjepiva, ali ne smiju primiti živa cjepiva za vrijeme primjene lijeka Remsima.
English: Remsima should be administered intravenously.
Croatian: Remsima se primjenjuje intravenski.
English: City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Croatian: Meath K32 YD60 Irska
English: The safety profile of Remsima subcutaneous formulation (evaluated in 168 and 175 patients for the subcutaneous infliximab group and the intravenous infliximab group, respectively) from active rheumatoid arthritis patients was overall similar to the safety profile of the intravenous formulation.
Croatian: Sigurnosni profil supkutane formulacije lijeka Remsima (procijenjeno u grupi od 168 bolesnika liječenih infliksimabom supkutano i 175 bolesnika liječenih infliksimabom intravenski) u bolesnika s aktivnim reumatoidnim artritisom bio je sveukupno sličan sigurnosnom profilu intravenske formulacije.
English: • Children and adults taking Remsima may have an increased risk of developing lymphoma or another cancer.
Croatian: • Djeca i odrasli koji uzimaju lijek Remsima mogu imati povećan rizik za razvoj limfoma ili neke druge vrste raka.
English: Tell your doctor straight away if you notice any of the following:
Croatian: Odmah obavijestite liječnika ako primijetite nešto od sljedećeg:
English: The incidence of serious infections in infliximab-treated patients 65 years and older was greater than in those under 65 years of age.
Croatian: Incidencija ozbiljnih infekcija u bolesnika u dobi od 65 ili više godina koji su liječeni lijekom infliksimab bila je veća nego u bolesnika mlađih od 65 godina.
English: Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Croatian: Remsima je indicirana za liječenje teškog, aktivnog ankilozantnog spondilitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju.
English: Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Croatian: Znakovi obuhvaćaju promjene vida, slabost u rukama ili nogama, utrnulost ili trnce u bilo kojem dijelu tijela.
English: • able to close with a tight-fitting, puncture-resistant lid, without sharps being able to come out;
Croatian: • se može čvrsto zatvoriti poklopcem otpornim na probijanje a da pri tom oštri dijelovi ne mogu ispasti iz spremnika,