FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
Croatian: Međutim, ti rezultati nisu pouzdani zbog ograničenja metoda koje se koriste u analizi infliksimaba i protutijela protiv infliksimaba u serumu.
English: • Do not use this medicine if it is discoloured or if there are particles present.
Croatian: • Ovaj lijek se ne smije upotrijebiti ako je došlo do promjene boje ili su prisutne čestice.
English: You may receive some vaccines during treatment with Remicade but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remicade because they may cause infections.
Croatian: Tijekom liječenja lijekom Remicade možete primiti neka cjepiva, ali ne smijete primiti živa cjepiva (cjepiva koja sadrže žive, ali oslabljene uzročnike infekcije) jer ona mogu uzrokovati infekcije.
English: In ASPIRE, more than 90% of patients had at least two evaluable X-rays.
Croatian: Više od 90% bolesnika uključenih u ASPIRE imalo je barem dvije upotrebljive rendgenske snimke zglobova.
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: Trenutno dostupni farmakokinetički podaci opisani su u dijelu 5.2, međutim nije moguće dati preporuku o doziranju u djece mlađe od 6 godina.
English: If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy.
Croatian: Ako imate umjerenu do tešku plak psorijazu, najprije ćete biti liječeni drugim lijekovima ili postupcima, kao što je fototerapija.
English: Your doctor will advise you what other medicines you must keep using while you are having Remicade.
Croatian: Liječnik će Vam savjetovati koje lijekove morate nastaviti uzimati dok primate Remicade.
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: Od 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 (vidjeti dio 4.1).
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: Za bolesnike u kojih je rezultat pretrage na HBV infekciju pozitivan preporučuje se potražiti savjet liječnika s iskustvom u liječenju hepatitisa B.
English: Significant improvements from baseline were demonstrated in DLQI (p < 0.001) and the physical and mental component scores of the SF 36 (p < 0.001 for each component comparison).
Croatian: Značajno poboljšanje u odnosu na početno stanje pokazalo se i u upitniku DLQI (p < 0,001) i u rezultatima na fizičkoj i mentalnoj komponenti upitnika SF-36 (p < 0,001 za svaku uspoređenu komponentu).
English: Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap.
Croatian: Staklena bočica (staklo tip 1) s gumenim čepom i aluminijskim prstenom zaštićenim plastičnom kapicom.
English: Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Croatian: Simptomi obuhvaćaju promjene vida, slabost u rukama ili nogama, utrnulost ili trnce u bilo kojem dijelu tijela.
English: Your doctor will test you to see if you have TB.
Croatian: Liječnik će Vas testirati da utvrdi imate li tuberkulozu.
English: Failure to respond to treatment for Crohn's disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment.
Croatian: U liječenju Crohnove bolesti, izostanak odgovora na terapiju može ukazivati na prisutnost fiksne fibrozne strikture, koja može zahtijevati kirurško liječenje.
English: If these medicines or treatments do not work well enough, you will be given Remicade to reduce the signs and symptoms of your disease.
Croatian: Ako ti lijekovi ili postupci ne djeluju dovoljno dobro, dobit ćete Remicade kako bi se umanjili znakovi i simptomi bolesti.
English: If you are 65 or older, you have a greater risk.
Croatian: Taj je rizik veći ako imate 65 ili više godina.
English: Some cases of active tuberculosis have been reported in patients treated with Remicade during and after treatment for latent tuberculosis.
Croatian: Prijavljeno je nekoliko slučajeva aktivne tuberkuloze u bolesnika liječenih lijekom Remicade tijekom i nakon liječenja latentne tuberkuloze.
English: If you received Remicade 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 Remicade, primjena BCG cjepiva (primjenjuje se za sprječavanje tuberkuloze) Vašem djetetu unutar 6 mjeseci od rođenja može dovesti do ozbiljnih komplikacija, uključujući smrt.
English: Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i bilo koje druge lijekove za liječenje Crohnove bolesti, ulceroznog kolitisa, reumatoidnog artritisa, ankilozantnog spondilitisa, psorijatičnog artritisa ili psorijaze, ili lijekove koje ste nabavili bez recepta, poput vitamina i biljnih lijekova.
English: • Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Croatian: • Obavijestite liječnika ako imate hepatitis B ili ako znate ili sumnjate da ste zaraženi virusom hepatitisa B.
English: The majority of the malignancies developed in the lung or head and neck.
Croatian: Većina zloćudnih promjena razvila se na plućima, glavi i vratu.
English: Patients taking TNF-blockers are more susceptible to serious infections.
Croatian: Bolesnici koji uzimaju blokatore TNF-a skloniji su ozbiljnim infekcijama.
English: Patients should be advised to seek immediate medical advice if they experience any delayed adverse reaction (see section 4.8).
Croatian: Bolesnike treba savjetovati da odmah potraže liječničku pomoć ako se pojavi bilo koja kasna nuspojava (vidjeti dio 4.8).
English: N/A 139
Croatian: N/P 139
English: ACR-N uses the same criteria as the ACR20, calculated by taking the lowest percent improvement in swollen joint count, tender joint count, and the median of the remaining 5 components of the ACR response.
Croatian: Za ACR-N su korišteni isti kriteriji kao i za ACR20, a rezultat je dobiven izračunavanjem najmanjeg postotka poboljšanja broja otečenih zglobova, broja osjetljivih zglobova i medijana vrijednosti preostalih pet komponenti ACR odgovora.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Croatian: Primjena terapijskih infektivnih agenasa, poput živih atenuiranih bakterija, u druge svrhe (npr. intravezikalna instilacija BCG-a za liječenje raka) mogla bi dovesti do kliničkih infekcija, uključujući diseminirane infekcije.
English: In all cases, Remicade treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Croatian: U svim je slučajevima liječenje lijekom Remicade bilo prekinuto i/ili uvedeno drugo liječenje, uz potpuno povlačenje znakova i simptoma.
English: Name doctor:
Croatian: Ime liječnika:
English: Week-14 responders (195/282) were analysed for the primary endpoint, which was time from randomisation to loss of response (see Table 7).
Croatian: Bolesnici s odgovorom u 14. tjednu (195/282) bili su uključeni u analizu primarne mjere ishoda, a to je bilo vrijeme od randomizacije do gubitka odgovora (vidjeti Tablicu 7).
English: The educational programme consists of a patient reminder card to be held by the patient.
Croatian: Edukacijski program se sastoji od kartice s podsjetnikom za bolesnika koju će dobiti bolesnik.
English: Shortened infusions at doses > 6 mg/kg have not been studied (see section 4.8).
Croatian: Nisu provedena ispitivanja s kraćim trajanjem infuzije kod doza > 6 mg/kg (vidjeti dio 4.8).
English: • More children taking Remicade developed infections as compared to adults.
Croatian: • U djece koja su primala Remicade infekcije su se više javljale u odnosu na odrasle.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF) inhibitors, ATC code: L04AB02.
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori faktora nekroze tumora alfa (TNFα), ATK oznaka: L04AB02
English: • Tell your surgeon or dentist that you are having treatment with Remicade by showing them your patient reminder card.
Croatian: • Obavijestite svog kirurga ili stomatologa da uzimate Remicade i pokažite im svoju karticu s podsjetnikom za bolesnika.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Croatian: Prospektivno prikupljeni podaci o umjereno velikom broju trudnoća s poznatim ishodom tijekom kojih je žena bila izložena infliksimabu, a koje su završile rođenjem živog djeteta, uključujući približno 1100 trudnoća tijekom kojih je žena bila izložena infliksimabu tijekom prvog tromjesečja, ne ukazuju na porast stope malformacija u novorođenčadi.
English: • Viral infections such as herpes or flu
Croatian: • virusne infekcije poput herpesa ili gripe
English: • Tell your doctor if you are going to have any operations or dental procedures.
Croatian: • Obavijestite svog liječnika ako planirate neku operaciju ili stomatološki zahvat.
English: These patients were classified as week-2 responders and were included in the primary analysis (see Table 5).
Croatian: Ti su bolesnici klasificirani kao bolesnici s odgovorom u 2. tjednu te su uključeni u primarnu analizu (vidjeti Tablicu 5).
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25 °C after removal from refrigeration.
Croatian: Dokazana je kemijska i fizikalna stabilnost razrijeđene otopine do 28 dana na temperaturi od 2°C do 8°C i tijekom dodatna 24 sata nakon vađenja iz hladnjaka na temperaturi od 25°C.
English: > 40 weeks
Croatian: > 40 tjedana
English: The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Croatian: Predviđa se za oko 40% niži medijan AUCss u pedijatrijskih bolesnika u dobi od 2 do manje od 6 godina nego u odraslih, iako je broj bolesnika na kojemu se temelji ta procjena malen.
English: • Serious lung problems (such as interstitial lung disease)
Croatian: • ozbiljne tegobe s plućima (kao što je intersticijska bolest pluća)
English: Thereafter, all subjects continued on infliximab every 6 weeks to week 96.
Croatian: Nakon toga su svi ispitanici nastavili primati infliksimab svakih 6 tjedana do ukupno 96. tjedna.
English: Patients should be tested for HBV infection before initiating treatment with Remicade.
Croatian: Bolesnici se moraju testirati na HBV infekciju prije početka liječenja lijekom Remicade.
English: Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
Croatian: Bolesnici s umjerenim ili teškim zatajenjem srca (NYHA stupanj III/IV) (vidjeti dijelove 4.4 i 4.8).
English: Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available.
Croatian: Na raspolaganju mora biti oprema za hitne intervencije kao što je adrenalin, antihistaminici, kortikosteroidi i oprema za umjetnu ventilaciju.
English: In patients treated with methotrexate alone, the incidence of serious infections was 5.2% in patients 65 years and older compared to 2.7% in patients under 65 (see section 4.4).
Croatian: U bolesnika koji su liječeni samo metotreksatom, incidencija ozbiljnih infekcija bila je 5,2% u bolesnika u dobi od 65 ili više godina u odnosu na 2,7% u bolesnika mlađih od 65 godina (vidjeti dio 4.4).
English: CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline.
Croatian: CDAI < 150 i u 30. i u 54. tjednu, bez uzimanja kortikosteroida tijekom 3 mjeseca prije 54. tjedna u bolesnika koji su primali kortikosteroide na početku ispitivanja.
English: The effect of concomitant immunomodulator therapy was more profound in episodically-treated patients than in patients given maintenance therapy.
Croatian: Učinak istodobne terapije imunomodulatora bio je intenzivniji u bolesnika liječenih epizodički nego u onih koji su primali terapiju održavanja.
English: During clinical studies of Remicade across all approved indications the incidence of lymphoma in Remicade-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Croatian: Tijekom kliničkih ispitivanja primjene lijeka Remicade u svim odobrenim indikacijama incidencija limfoma u bolesnika koji su primali Remicade bila je viša od one očekivane u općoj populaciji, ali je pojava limfoma bila rijetka.
English: EU/1/99/116/001 1 vial 100 mg EU/1/99/116/002 2 vials 100 mg EU/1/99/116/003 3 vials 100 mg EU/1/99/116/004 4 vials 100 mg EU/1/99/116/005 5 vials 100 mg
Croatian: EU/1/99/116/001 1 bočica sa 100 mg EU/1/99/116/002 2 bočice sa 100 mg EU/1/99/116/003 3 bočice sa 100 mg EU/1/99/116/004 4 bočice sa 100 mg EU/1/99/116/005 5 bočica sa 100 mg
English: Slowly add the total volume of reconstituted Remicade solution to the 250-ml infusion bottle or bag.
Croatian: Polako dodajte cijelu količinu rekonstituirane otopine lijeka Remicade u 250-mililitarsku infuzijsku bocu ili vrećicu.
English: Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/kg.
Croatian: Od tih 108 bolesnika, 27 je liječeno preporučenom dozom infliksimaba od 5 mg/kg.
English: In clinical studies, delayed hypersensitivity reactions have been reported.
Croatian: U kliničkim ispitivanjima prijavljene su reakcije kasne preosjetljivosti.
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Croatian: U ispitivanju C0168T72 najčešće nuspojave bile su infekcije gornjih dišnih puteva, faringitis, bol u abdomenu, vrućica i glavobolja.
English: The antibody incidence was 2-3 fold higher for patients treated episodically.
Croatian: Incidencija razvoja protutijela bila je 2-3 puta veća u bolesnika koji su povremeno liječeni.
English: Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNF and when administered after disease onset, it allowed eroded joints to heal.
Croatian: Infliksimab je spriječio bolest u transgeničnih miševa koji razvijaju poliartritis kao posljedicu konstitutivne ekspresije humanog TNFα, a kada je primijenjen nakon nastupa bolesti, omogućio je cijeljenje erodiranih zglobova.
English: Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury.
Croatian: Bolesnike sa znakovima ili simptomima poremećaja jetrene funkcije treba pregledati i utvrditi postoji li oštećenje jetre.
English: Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses.
Croatian: Dostupni podaci pokazuju postizanje kliničkog odgovora obično u roku od 14 tjedana liječenja, tj. nakon tri doze.
English: Clinical Remission
Croatian: Klinička remisija
English: • Fast heart beat (tachycardia) or palpitations
Croatian: • ubrzani otkucaji srca (tahikardija) ili palpitacije
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Croatian: U pažljivo odabranih odraslih bolesnika koji su dobro podnijeli najmanje 3 početne dvosatne infuzije lijeka Remicade (faza uvodnog liječenja) te su sada na terapiji održavanja, može se razmotriti primjena daljnjih infuzija tijekom najmanje jednog sata.
English: Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after birth.
Croatian: Vaše dijete ne smije primiti "živo cjepivo", kao što je BCG (primjenjuje se za sprječavanje tuberkuloze), unutar 6 mjeseci od rođenja.
English: In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Croatian: U većine bolesnika s fistulirajućim oblikom Crohnove bolesti infliksimab je pronađen u serumu tijekom 12 tjedana (raspon od 4-28 tjedana) nakon primjene protokola.
English: A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Croatian: Smanjenje znakova i simptoma bilo je definirano kao najmanje 20%-tno poboljšanje (ACR20) s obzirom na broj osjetljivih i otečenih zglobova te poboljšanje u 3 od sljedećih 5 kriterija: (1) općoj ocjeni ispitivača, (2) općoj ocjeni bolesnika, (3) mjerilu funkcije/ograničenja, (4) vizualnoj analognoj skali boli i (5) brzini sedimentacije eritrocita ili C-reaktivnog proteina.
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 antihistaminik, hidrokortizon i/ili paracetamol kako bi se spriječili blagi i prolazni učinci.
English: If you have Crohn's disease you will first be given other medicines.
Croatian: Ako imate Crohnovu bolest, najprije ćete dobiti druge lijekove.
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Croatian: Bolesnicima se prije infuzije može dati antihistaminik, hidrokortizon i/ili paracetamol te se infuzija može usporiti kako bi se smanjio rizik od reakcija vezanih uz infuziju, osobito ako je bolesnik prethodno imao reakcije vezane uz infuziju (vidjeti dio 4.4).
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/ml, respectively.
Croatian: Pri jednokratnim dozama od 3, 5 odnosno 10 mg/kg, medijan Cmax iznosio je 77, 118 odnosno 277 mikrograma/ml.
English: For intravenous use after reconstitution and dilution.
Croatian: Za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
English: All patients administered Remicade are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Croatian: Svi bolesnici koji primaju Remicade moraju biti pod nadzorom najmanje 1 - 2 sata nakon infuzije, za slučaj akutne reakcije vezane uz infuziju.
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
Croatian: • ozbiljne kožne bolesti kao što su toksična epidermalna nekroliza, Stevens-Johnsonov sindrom i akutna generalizirana egzantematozna pustuloza
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Remicade.
Croatian: Ova kartica s podsjetnikom za bolesnika sadrži važne sigurnosne informacije, kojih morate biti svjesni prije i tijekom liječenja lijekom Remicade.
English: Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Croatian: Bila je dopuštena istodobna primjena konvencionalnih lijekova u ustaljenoj dozi te je 83% bolesnika nastavilo primati najmanje jedan od tih lijekova.
English: After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
Croatian: Nakon izlaganja infliksimabu in utero, dojenčad može biti pod povećanim rizikom od razvoja infekcije, uključujući ozbiljnu diseminiranu infekciju koja može dovesti do smrtnog ishoda.
English: N/A 60
Croatian: N/P 60
English: Median (Interquartile range)
Croatian: Medijan (interkvartilni raspon)
English: No dose recommendations can be made (see section 5.2).
Croatian: Nije moguće dati preporuku o doziranju (vidjeti dio 5.2).
English: While the numbers of patients in each subgroup are too small to draw definitive conclusions about the effect of age, there was a higher number of patients in the younger age group who stepped up in dose or discontinued treatment due to inadequate efficacy.
Croatian: Iako je broj bolesnika u svakoj podskupini premalen da bi se mogli donijeti konačni zaključci o utjecaju dobi, u mlađoj je dobnoj skupini bilo više bolesnika kojima je povećana doza ili prekinuto liječenje zbog nedovoljne djelotvornosti.
English: Elevated concentrations of TNF have been found in the joints of rheumatoid arthritis patients and correlate with elevated disease activity.
Croatian: Povišene koncentracije TNFα pronađene su u zglobovima bolesnika s reumatoidnim artritisom i povezane su s pojačanom aktivnošću bolesti.
English: Placebo (week 16)
Croatian: Placebo (16. tjedan)
English: In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Croatian: U dojenčadi koja je bila izložena infliksimabu in utero prijavljen je smrtni ishod zbog diseminirane infekcije Bacillus Calmette-Guérin (BCG) nakon primjene BCG-cjepiva nakon rođenja.
English: The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from the ACT 1 and ACT 2 studies and their extensions.
Croatian: Podaci o udjelu ispitanika koji su bili podvrgnuti kolektomiji u bilo kojem trenutku unutar 54 tjedna od prve infuzije ispitivanog lijeka prikupljeni su i objedinjeni iz ispitivanja ACT 1 i ACT 2 i njihovih nastavaka.
English: In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
Croatian: U jednogodišnjem kliničkom ispitivanju u kojemu se ispitivalo ponovljeno davanje infuzije bolesnicima s Crohnovom bolešću (ispitivanje ACCENT I), incidencija reakcija nalik serumskoj bolesti iznosila je 2,4%.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Croatian: Osnovni rizik za pojavu limfoma i leukemije povećan je u bolesnika s reumatoidnim artritisom koji imaju dugotrajnu, vrlo aktivnu upalnu bolest, što otežava procjenu rizika.