FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these
Croatian: • Vodič za zdravstvene radnike treba sadržavati sljedeće ključne elemente: o Relevantne informacije o sigurnosnim pitanjima adresiranima u dodatnim mjerama minimizacije rizika (npr. ozbiljnost, težina, učestalost, vrijeme do nastupa, reverzibilnost štetnih događaja, ako je primjenjivo) o Detalje o populaciji u visokom riziku za sigurnosna pitanja adresirana u dodatnim mjerama minimizacije rizika (npr. kontraindikacije, čimbenici rizika, povećani rizik uslijed interakcija s određenim lijekovima) o Detalje o tome kako miminizirati sigurnosna pitanja adresirana u dodatnim mjerama minimizacije rizika kroz odgovarajuće praćenje i upravljanje (tj. što uraditi, što ne uraditi i tko će najvjerojatnije biti pogođen sukladno različitom tijeku događanja, npr. kada treba ograničiti ili prekinuti propisivanje/ingestiju, kako uzimati lijek, kako povisiti/sniziti dozu prema laboratorijskim parametrima, znakovima i simptomima) o Ključne poruke kako provoditi savjetovanje bolesnika o Upute za zbrinjavanje mogućih štetnih događaja o Informacije o BSRBR, ARTIS, RABBIT i BIOADABASER i registrima za ulcerozni kolitis i važnosti doprinošenju istim
English: In the 10 mg twice daily tofacitinib monotherapy group the rate was 1.6 patients with events per 100 patient-years, the rate was 0 events per 100 patient-years for the placebo group, and the rate was 1.9 patients with events per 100 patient-years for the MTX group.
Croatian: U skupini koja je primala tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno stopa je bila 1,6 bolesnika s događajem na 100 bolesnik-godina, za placebo je stopa bila 0 događaja na 100 bolesnik-godina, a za skupinu koja je primala MTX stopa je bila 1,9 bolesnika s događajem na 100 bolesnik-godina.
English: Table 7 provides information regarding the pertinent study design and population characteristics.
Croatian: Informacije vezane uz primjereni dizajn ispitivanja i karakteristike populacije navedene su u Tablici 7.
English: o Contact details of the prescriber
Croatian: o Podatke za kontaktiranje propisivača
English: • The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.
Croatian: • Preporučena doza je 10 mg primijenjena dva puta dnevno tijekom 8 tjedana, nakon koje slijedi doza od 5 mg primijenjena dva puta dnevno.
English: 30 prolonged-release tablets 90 prolonged-release tablets 2 silica gel desiccants
Croatian: 30 tableta s produljenim oslobađanjem 90 tableta s produljenim oslobađanjem 2 sredstva za sušenje u obliku silika gela
English: For patients receiving tofacitinib 5 mg twice daily, dosing should be interrupted.
Croatian: U bolesnika koji uzimaju 5 mg tofacitiniba dva puta dnevno, doziranje treba privremeno prekinuti.
English: Background treatment
Croatian: Osnovno liječenje
English: Patients who completed 8 weeks in 1 of the induction studies and achieved clinical response were re-randomised into OCTAVE Sustain; 179 out of 593 (30.2%) patients were in remission at baseline of OCTAVE Sustain.
Croatian: Ispitivanje održavanja (ispitivanje OCTAVE Sustain) Bolesnici koji su završili sudjelovanje od 8 tjedana u jednom od ispitivanja uvodnog liječenja i postigli klinički odgovor, bili su ponovno randomizirani u ispitivanje OCTAVE Sustain; na početku ispitivanja u remisiji je bilo 179 od 593 (30,2 %) bolesnika.
English: Prolonged-release tablets
Croatian: Tablete s produljenim oslobađanjem
English: • The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening and maintenance of the patient o Vaccination course to be completed before treatment o A specific reference to the fact that the patient has been informed and understands that tofacitinib is contraindicated during pregnancy and breast-feeding and women of childbearing potential should use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose o That the benefit risk of tofacitinib should be discussed with the patient, and the patient alert card should be given to and discussed with the patient o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
Croatian: • Lista za propisivača treba sadržavati sljedeće ključne poruke: o Popis pretraga koje treba provoditi tijekom inicijalnog probira i tijekom liječenja bolesnika o Shemu cijepljenja koja mora biti dovršena prije početka liječenja o Specifičnu napomenu da je bolesnik obaviješten i razumije kako je uzimanje tofacitiniba kontraindicirano tijekom trudnoće i dojenja te da žene reproduktivne dobi trebaju koristiti učinkovitu kontracepciju tijekom liječenja tofacitinibom i do najmanje 4 tjedna nakon primjene zadnje doze o Da je s bolesnikom potrebno razgovarati o omjeru koristi i rizika uzimanja tofacitiniba, kao i o kartici s upozorenjima za bolesnika, te da mu je potrebno uručiti karticu s upozorenjima za bolesnika o Odgovarajuće komorbiditete uz koje se savjetuje oprez kod primjene lijeka XELJANZ i stanja u kojima se XELJANZ ne smije primijeniti o Listu konkomitantnih lijekova koji nisu kompatibilni s liječenjem lijekom XELJANZ o Potrebu rasprave s bolesnikom o rizicima povezanim s primjenom lijeka XELJANZ, osobito u pogledu infekcija, herpes zostera, tuberkuloze (TBC) i drugih oportunističkih infekcija, maligniteta, gastrointestinalne perforacije, intersticijske bolesti pluća i poremećaja u vrijednostima laboratorijskih testova o Potrebu praćenja bilo kakvih znakova i simptoma te poremećaja vrijednosti laboratorijskih testova za ranu identifikaciju gore navedenih rizika.
English: Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or
Croatian: Klinički odgovor bio je definiran kao smanjenje početne vrijednosti Mayo rezultata za ≥ 3 boda i ≥ 30 % uz popratno smanjenje podrezultata rektalnog krvarenja za ≥ 1 bod ili apsolutni podrezultat rektalnog krvarenja od 0 ili 1.
English: - The other ingredients are sorbitol (E420) (see section 2), hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520) and black iron oxide (E172).
Croatian: - Drugi sastojci su sorbitol (E420) (pogledajte dio 2), hidroksietilceluloza, kopovidon, magnezijev stearat, celulozaacetat, hidroksipropilceluloza (E463), hipromeloza (E464), titanijev dioksid (E171), triacetin (E1518), željezov oksid, crveni (E172), šelak (E904), amonijev hidroksid (E527), propilenglikol (E1520) i željezov oksid, crni (E172).
English: • hives (itching or skin rash)
Croatian: • koprivnjaču (svrbež ili osip na koži)
English: In clinical trials, tofacitinib was administered without regard to meal.
Croatian: U kliničkim je ispitivanjima tofacitinib primjenjivan neovisno o hrani.
English: XELJANZ is not recommended for use with medicines that depress the immune system, including so-called targeted biologic (antibody) therapies, such as those that inhibit tumour necrosis factor and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus.
Croatian: Ne preporučuje se primjena lijeka XELJANZ s lijekovima koji potiskuju imunološki sustav, uključujući tzv. ciljne biološke lijekove (protutijela), poput onih koji koče čimbenik nekroze tumora i snažne kemijske imunosupresivne lijekove, uključujući azatioprin, merkaptopurin, ciklosporin i takrolimus.
English: The recommended dose is 10 mg given orally twice daily for induction for 8 weeks and 5 mg given twice daily for maintenance.
Croatian: Preporučena doza je 10 mg i uzima se peroralno dva puta dnevno za uvodno liječenje tijekom 8 tjedana, dok se 5 mg uzima dva puta dnevno za održavanje.
English: XELJANZ 11 mg prolonged-release tablets can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.
Croatian: XELJANZ 11 mg tablete s produljenim oslobađanjem se također mogu uzimati same, u slučaju da liječenje metotreksatom ne podnosite ili Vam se ne preporučuje.
English: Table 7: Phase 3 clinical trials of tofacitinib 5 mg and 10 mg twice daily doses in patients with RA
Croatian: Tablica 7: Klinička ispitivanja faze 3 tofacitiniba u dozama od 5 mg i 10 mg dva puta dnevno u bolesnika s RA
English: The recommended dose is 5 mg administered twice daily.
Croatian: Preporučena doza je 5 mg primijenjeno dva puta dnevno.
English: Lymphoma was observed in 3 of 8 adult monkeys at 6 or 3 times the clinical tofacitinib exposure level (unbound AUC in humans at a dose of 5 mg or 10 mg twice daily), and 0 of 14 juvenile monkeys at 5 or 2.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Croatian: Limfom je nađen kod 3 od 8 odraslih majmuna pri razini izloženosti tofacitinibu 6 ili 3 puta većoj od kliničkih (AUC za nevezani lijek u ljudi uz dozu od 5 mg ili 10 mg dvaput dnevno) te kod 0 od 14 mladih majmuna uz razinu izloženosti 5 ili 2,5 puta veću od razine izloženosti uz dozu od 5 mg ili 10 mg dva puta dnevno u kliničkoj primjeni.
English: Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo in physical component summary (PCS) and mental component summary (MCS) scores, and in all 8 domains of the SF-36 in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2).
Croatian: Primjena 10 mg tofacitiniba dva puta dnevno dovela je do većeg poboljšanja rezultata profila fizičkog zdravlja (engl. physical component summary, PCS) i profila duševnog zdravlja (engl. mental component summary, MCS) u odnosu na početne vrijednosti u usporedbi s placebom te u pogledu svih 8 područja upitnika SF-36 u ispitivanjima uvodnog liječenja (OCTAVE Induction 1, OCTAVE Induction 2).
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2.
Croatian: Breast Cancer Resistance Protein, BCRP), OATP1B1/1B3 ili OCT1/2.
English: Rare ≥1/10,000 to
Croatian: Manje često ≥ 1/1000 i
English: Corticosteroid-free remission among patients taking corticosteroids at baselinea,g
Croatian: Remisija bez kortikosteroida među bolesnicima koji su uzimali kortikosteroide prije početka terapije a,g
English: Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
Croatian: Povišena vrijednost lipoproteina niske gustoće Povećanje tjelesne težine
English: Inadequate response to at least one conventional synthetic DMARD (csDMARD) due to lack of efficacy and/or intolerability.
Croatian: Neadekvatan odgovor na najmanje jedan konvencionalni sintetski DMARD (csDMARD) zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
English: XELJANZ is used together with methotrexate when previous rheumatoid arthritis treatment was not sufficient or was not well tolerated.
Croatian: XELJANZ se koristi u kombinaciji s metotreksatom kad Vam prethodno liječenje za reumatoidni artritis nije bilo dostatno ili ga niste dobro podnosili.
English: Printing ink shellac (E904) ammomium hydroxide (E527) propylene glycol (E1520) black iron oxide (E172)
Croatian: Tinta za označavanje šelak (E904) amonijev hidroksid (E527) propilenglikol (E1520) željezov oksid, crni (E172)
English: If you suffer from rheumatoid arthritis, your doctor may switch your tablets from XELJANZ 5 mg film-coated tablets twice daily to XELJANZ 11 mg prolonged-release tablets once daily.
Croatian: Ako bolujete od reumatoidnog artritisa, liječnik može zamijeniti liječenje XELJANZ 5 mg filmom obloženim tabletama, koje uzimate dva puta dnevno, s liječenjem XELJANZ 11 mg tabletama s produljenim oslobađanjem, koje ćete uzimati jednom dnevno.
English: Tofacitinib has been shown to be teratogenic in rats and rabbits, and to affect parturition and peri/postnatal development (see section 5.3).
Croatian: Dokazano je da je tofacitinib teratogen u štakora i kunića te da utječe na okot i peri-/postnatalni razvoj (vidjeti dio
English: In the long-term safety all exposure population, the overall rates of serious infections were 2.4 and 3.0 patients with events per 100 patient-years for 5 mg and 10 mg twice daily tofacitinib groups, respectively.
Croatian: U ispitivanjima dugoročne sigurnosti za cjelokupnu izloženu populaciju, ukupne stope ozbiljnih infekcija bile su 2,4 i 3,0 bolesnika s događajem na 100 bolesnik-godina za skupine koje su primale 5 mg, odnosno 10 mg tofacitiniba dnevno.
English: Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability.
Croatian: Neadekvatan odgovor na najmanje jedan inhibitor TNF-a (TNFi) zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
English: Lymphocytes In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm occurred in
Croatian: U kontroliranim kliničkim ispitivanjima RA-a potvrđeno je smanjenje ALC-a ispod 500 stanica/mm
English: Dose adjustment in hepatic impairment for different strength tablets
Croatian: Prilagodba doze kod oštećenja jetre za tablete različitih jačina
English: As a precautionary measure, the use of tofacitinib during breast-feeding is contraindicated (see section 4.3).
Croatian: Kao mjera opreza, primjena tofacitiniba je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: At baseline, 79.9% and 56.2% of patients had enthesitis and dactylitis, respectively.
Croatian: Prije početka terapije 79,9% odnosno 56,2% bolesnika imalo je entezitis i daktilitis.
English: No dose adjustment required.
Croatian: Prilagodba doze nije potrebna.
English: Treatment with tofacitinib has been associated with decreases in haemoglobin levels.
Croatian: Liječenje tofacitinibom bilo je povezano sa smanjenjem razine hemoglobina.
English: Potential for other medicinal products to influence the pharmacokinetics (PK) of tofacitinib
Croatian: Slika 1 Utjecaj drugih lijekova na farmakokinetiku (PK) tofacitiniba
English: Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE Induction 2) baseline Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or rectal bleeding subscore of 0 or 1.
Croatian: Mayo rezultata u ispitivanju uvodnog liječenja (OCTAVE Induction 1, OCTAVE Induction 2) za ≥ 3 boda i ≥ 30% uz popratno smanjenje podrezultata rektalnog krvarenja za ≥ 1 bod ili podrezultat rektalnog krvarenja 0 ili 1.
English: Coadministration with ketoconazole (strong CYP3A4 inhibitor), fluconazole (moderate CYP3A4 and potent CYP2C19 inhibitor), tacrolimus (mild CYP3A4 inhibitor) and ciclosporine (moderate CYP3A4 inhibitor) increased tofacitinib AUC, while rifampicin (potent CYP inducer) decreased tofacitinib AUC.
Croatian: Istodobna primjena ketokonazola (snažni inhibitor CYP3A4), flukonazola (umjereni inhibitor CYP3A4 i snažni inhibitor CYP2C19), takrolimusa (blagi inhibitor CYP3A4) i ciklosporina (umjereni inhibitor CYP3A4) povećala je AUC tofacitiniba, dok je rifampicin (snažni CYP induktor) smanjio AUC tofacitiniba.
English: The most common serious infections reported with tofacitinib were pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis.
Croatian: Najčešće ozbiljne infekcije prijavljene uz tofacitinib bile su pneumonija, celulitis, herpes zoster, infekcija urinarnog trakta, divertikulitis i apendicitis.
English: Month 6:
Croatian: 6. mjesec:
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Croatian: - Drugi sastojci su mikrokristalična celuloza, laktoza hidrat (pogledajte dio 2.), umrežena karmelozanatrij, magnezijev stearat, hipromeloza (E464), titanijev dioksid (E171), makrogol, triacetin (E1518), bojila FD&C Blue #2/Indigo Carmine Aluminum Lake (E132) i FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
English: Exposure in monkeys at the no observed adverse effect level (NOAEL) for the lymphomas was approximately 1 or 0.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Croatian: Razina izloženosti pri kojoj nisu opaženi štetni učinci (NOAEL) za limfome u majmuna bila je približno 1 ili 0,5 puta veća od razine izloženosti uz dozu od 5 mg ili 10 mg dva puta dnevno u kliničkoj primjeni.
English: Table 17: Proportion of patients meeting efficacy endpoints at week 52 (OCTAVE sustain) Central endoscopy read
Croatian: Tablica 17: Udio bolesnika koji su ostvarili ishode djelotvornosti u 52. tjednu (ispitivanje OCTAVE Sustain) Centralno očitani endoskopski nalazi
English: In the RA long-term safety population, the pattern and incidence of confirmed decreases in ANC remained consistent with what was seen in the controlled clinical studies (see section 4.4).
Croatian: U populaciji s RA-om u ispitivanju dugoročne sigurnosti, obrazac i incidencija potvrđenog smanjenja ABN-a ostali su dosljedni onima zabilježenima u kontroliranim kliničkim ispitivanjima (vidjeti dio
English: In the 6-month and 24-month, controlled clinical studies, the rate of serious infections in the 5 mg twice daily tofacitinib monotherapy group was 1.7 patients with events per 100 patient-years.
Croatian: U 6-mjesečnim i 24-mjesečnim kontroliranim kliničkim ispitivanjima, stopa ozbiljnih infekcija u skupini koja je primala tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno bila je 1,7 bolesnika s događajem na 100 bolesnik-godina.
English: Patients treated with tofacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Croatian: Čimbenike rizika (npr. hipertenzija, hiperlipidemija) u bolesnika liječenih tofacitinibom treba liječiti u sklopu uobičajene standardne skrbi.
English: Film coat cellulose acetate hydroxypropyl cellulose (E463) hypromellose (E464) titamium dioxide (E171) triacetin (E1518) red iron oxide (E172)
Croatian: Film-ovojnica celulozaacetat hidroksipropilceluloza (E463) hipromeloza (E464) titanijev dioksid (E171) triacetin (E1518) željezov oksid, crveni (E172)
English: -0.35c,*
Croatian: 3. mjesec c,*
English: Table 18: Proportion of patients meeting primary and key secondary efficacy endpoints at week 52 by TNF inhibitor therapy subgroup (OCTAVE sustain, central endoscopy read)
Croatian: Tablica 18: Udio bolesnika koji su ostvarili primarne i ključne sekundarne ishode djelotvornosti u 52. tjednu u podskupini liječenoj inhibitorom TNF-a (ispitivanje OCTAVE Sustain, centralno očitani endoskopski nalazi)
English: Table 15: Proportion of patients meeting efficacy endpoints at week 8 (OCTAVE induction study 1 and OCTAVE induction study 2) OCTAVE induction study 1 Central endoscopy read
Croatian: Tablica 15: Udio bolesnika koji su ostvarili ishode djelotvornosti u 8. tjednu (ispitivanja uvodnog liječenja OCTAVE Induction 1 i OCTAVE Induction 2) Ispitivanje uvodnog liječenja OCTAVE Induction 1 Centralno očitani endoskopski nalazi
English: 80.7% and 49.2% of patients had enthesitis and dactylitis, respectively.
Croatian: Prije početka terapije 80,7% odnosno 49,2% bolesnika imalo je entezitis i daktilitis.
English: T uberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Croatian: Tuberkuloza Divertikulitis Pijelonefritis Celulitis Herpes simplex Virusni gastroenteritis Virusna infekcija
English: Rheumatoid arthritis • The recommended dose is 5 mg twice a day.
Croatian: Reumatoidni artritis • Preporučena doza je 5 mg primijenjena dva puta dnevno.
English: Sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baselinee,f
Croatian: Održana remisija bez kortikosteroida u 24. i 52. tjednu među bolesnicima u remisiji prije početka terapije e,f
English: Improvement of endoscopic appearance of the mucosa
Croatian: Poboljšanje endoskopskog izgleda sluznice
English: Furthermore, at month 12 of study OCTAVE Open, 74% (48/65) of patients who achieved remission at the end of study OCTAVE Sustain on either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily remained in remission while receiving tofacitinib 5 mg twice daily.
Croatian: Osim toga je 74 % (48/65) bolesnika, koji su postigli remisiju na kraju ispitivanja OCTAVE Sustain uz primjenu 5 mg tofacitiniba dva puta dnevno ili 10 mg tofacitiniba dva puta dnevno, ostalo u remisiji u 12. mjesecu ispitivanja OCTAVE
English: How to store XELJANZ
Croatian: Kako čuvati XELJANZ
English: Sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baselined
Croatian: Održana remisija bez kortikosteroida u 24. i 52. tjednu među bolesnicima u remisiji prije početka terapije
English: Tofacitinib 11 mg prolonged-release tablets once daily has demonstrated pharmacokinetic equivalence (AUC and Cmax) to tofacitinib 5 mg film-coated tablets twice daily.
Croatian: Tofacitinib tablete s produljenim oslobađanjem od 11 mg primijenjene jednom dnevno pokazale su se farmakokinetički ekvivalentnima (AUC i Cmax) tofacitinib filmom obloženim tabletama od 5 mg primijenjenim dva puta dnevno.
English: Lymphomas have been observed in patients treated with tofacitinib.
Croatian: Limfomi su zabilježeni u bolesnika liječenih tofacitinibom.
English: Meningitis cryptococcal Mycobacteriu m avium complex infection
Croatian: Tuberkuloza središnjeg živčanog sustava Kriptokokni meningitis Infekcija kompleksom Mycobacteriu m avium
English: Additional monitoring tests
Croatian: Dodatne pretrage tijekom praćenja
English: It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm
Croatian: Ne preporučuje se započeti ili nastaviti liječenje tofacitinibom u bolesnika čiji je dokazani broj limfocita manji od 750 stanica/mm
English: It is recommended not to initiate dosing in patients with haemoglobin less than 9 g/dL.
Croatian: Preporuča se ne započinjati doziranje u bolesnika u kojih je razina hemoglobina manja od 9 g/dl.