FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table 7).
Croatian: Podaci prikupljeni tijekom produljenog praćenja bolesnika u ispitivanju (medijan praćenja 9 godina) potvrdili su dugoročnu korist terapije održavanja lijekom rituksimab s obzirom na PFS, EFS, TNLT i TNCT (Tablica 7).
English: • Signs of PML include: - Confusion, memory loss or problems thinking - Loss of balance or a change in the way you walk or talk - Decreased strength or weakness on one side of your body - Blurred vision or loss of vision.
Croatian: smetenost, gubitak pamćenja ili poteškoće s razmišljanjem gubitak ravnoteže ili promjenu u načinu hoda ili govora gubitak snage ili slabost na jednoj strani tijela zamagljen vid ili gubitak vida
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Croatian: Kartica sadrži važne informacije o sigurnosti za bolesnike, vezane uz potencijalno povećani rizik od infekcija, uključujući progresivnu multifokalnu leukoencefalopatiju (PML).
English: You must also do this for 12 months after your last treatment with Blitzima.
Croatian: Morate to činiti i još 12 mjeseci nakon posljednje primjene lijeka Blitzima.
English: Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported (see section 4.8).
Croatian: Prijavljene su teške kožne reakcije poput toksične epidermalne nekrolize (Lyellov sindrom) i StevensJohnsonova sindroma, neke od njih sa smrtnim ishodom (vidjeti dio 4.8).
English: Blitzima should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Croatian: Blitzima se treba primijeniti prvog dana svakog kemoterapijskog ciklusa, nakon intravenske primjene glukokortikoidne komponente kemoterapije, ako je liječenje obuhvaća.
English: Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Croatian: * Reakcije povezane s infuzijom uključivale su simptome prijavljene pri sljedećem planiranom posjetu nakon svake infuzije te nuspojave koje su se javile na dan primjene infuzije ili jedan dan nakon njezine primjene.
English: Table 15 Summary of efficacy by baseline autoantibody status Week 24
Croatian: Sažetak djelotvornosti prema početnom statusu autoantitijela 24. tjedan
English: This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Croatian: Taj sindrom može biti povezan s nekim značajkama sindroma lize tumora, primjerice hiperuricemijom, hiperkalijemijom, hipokalcijemijom, hiperfosfatemijom, akutnim zatajenjem bubrega, povišenom razinom laktat dehidrogenaze (LDH), kao i s akutnim zatajenjem dišnog sustava i smrću.
English: Your doctor may prescribe Blitzima for the treatment of:
Croatian: Liječnik Vam može propisati lijek Blitzima za liječenje sljedećih bolesti:
English: Corticosteroids will usually be given by injection before the start of Blitzima treatment.
Croatian: Obično će se prije početka liječenja lijekom Blitzima primijeniti injekcija kortikosteroida.
English: Blitzima contains the active substance “rituximab”.
Croatian: Blitzima sadrži djelatnu tvar „rituksimab“.
English: It is not known whether Blitzima has an effect on you being able to drive or use any tools or machines.
Croatian: Nije poznato utječe li Blitzima na sposobnost upravljanja vozilima ili rada s alatima i strojevima.
English: Repeated treatment courses with Blitzima are possible.
Croatian: Ciklusi liječenja lijekom Blitzima mogu se ponavljati.
English: • The active ingredient in Blitzima is called rituximab.
Croatian: • Djelatna tvar u lijeku Blitzima zove se rituksimab.
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population) Outcome†
Croatian: Tablica 12 Klinički odgovor u trenutku primarne mjere ishoda Ispitivanja 1 (ITT populacija) Ishod†
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among rituximab-treated PV patients, with a ≥ 2% absolute difference in incidence between the rituximab-treated group and the standard-dose prednisone group up to month 24.
Croatian: Nuspojave navedene u Tablici 5 predstavljaju štetne događaje čija je stopa među bolesnicima s PV-om liječenima lijekom rituksimab iznosila 5% i za koje je apsolutna razlika u incidenciji između skupine liječene lijekom rituksimab i one liječene standardnom dozom prednizona iznosila 2% do 24. mjeseca.
English: The incidence of ADRs of all grades and grade 3/4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Croatian: Incidencija nuspojava svih stupnjeva i nuspojava stupnja 3/4 bila je slična u starijih i mlađih bolesnika (< 65 godina).
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Blitzima (the last dose of methylprednisolone may be given on the same day as the first infusion of Blitzima).
Croatian: U bolesnika s granulomatozom s poliangitiisom (Wegenerova granulomatoza) ili mikroskopskim poliangitiisom se prije prve infuzije lijeka Blitzima preporučuje intravenska primjena metilprednizolona u dozi od 1000 mg na dan tijekom 1 do 3 dana (posljednja doza metilprednizolona može se dati istoga dana kao i prva infuzija lijeka Blitzima).
English: Following induction of remission with Blitzima, maintenance treatment should be initiated no sooner than 16 weeks after the last Blitzima infusion.
Croatian: Nakon primjene lijeka Blitzima za poticanje remisije, terapiju održavanja treba započeti najmanje 16 tjedana nakon posljednje infuzije lijeka Blitzima.
English: Aseptically withdraw the necessary amount of Blitzima, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Croatian: U aseptičkim uvjetima izvucite potrebnu količinu lijeka Blitzima i razrijedite do izračunate koncentracije od 1 do 4 mg/ml rituksimaba u vrećici za infuziju koja sadrži sterilnu apirogenu otopinu natrijevog klorida za injekciju od 9 mg/ml (0,9 %) ili 5 %-tnu vodenu otopinu D-glukoze.
English: Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab.
Croatian: Srednja vrijednost titara antitijela na niz antigena (Streptococcus pneumoniae, influenca tipa A, zaušnjaci, rubela, varičela) prije terapije održala se najmanje 6 mjeseci nakon liječenja rituksimabom.
English: In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Croatian: U ispitivanjima primjene rituksimaba u kombinaciji s kemoterapijom incidencija pojave srčanih aritmija stupnja 3 i 4, uglavnom supraventrikularnih aritmija kao što su tahikardija i undulacija/fibrilacija atrija, bila je veća u skupini liječenoj kombinacijom R-CHOP (14 bolesnika, 6,9 %) u usporedbi sa skupinom koja je primala CHOP (3 bolesnika, 1,5 %).
English: Although subgroups were small, rituximab maintenance treatment provided a significant benefit in terms of overall survival for both patients responding to CHOP and patients responding to R-CHOP, although longer follow-up is required to confirm this observation.
Croatian: Iako su podskupine bile male, terapija održavanja rituksimabom donijela je značajnu korist u smislu ukupnog preživljenja kako bolesnicima koji su odgovorili na CHOP tako i onima koji su odgovorili na R-CHOP.
English: In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if Blitzima is not given in combination with glucocorticoid-containing chemotherapy.
Croatian: U bolesnika s ne-Hodgkinovim limfomom i KLL-om potrebno je razmotriti premedikaciju glukokortikoidima ako se Blitzima ne primjenjuje u kombinaciji s kemoterapijom koja sadrži glukokortikoide.
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Croatian: Na temelju populacijske farmakokinetičke analize podataka za 97 bolesnika s s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom koji su primali rituksimab u dozi od 375 mg/m jedanput tjedno tijekom četiri tjedna, procijenjen medijan terminalnog poluvremena eliminacije bio je 23 dana (raspon od 9 do 49 dana).
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (antiCCP) who were treated with rituximab in combination with methotrexate showed an enhanced response compared to patients negative to both.
Croatian: Djelotvornost u bolesnika seropozitivnih na autoantitijela (RF i/ili anti-CCP) Bolesnici seropozitivni na reumatoidni faktor (RF) i/ili antitijela na cikličke citrulinirane peptide (antiCCP) koji su liječeni rituksimabom i metotreksatom na liječenje su odgovorili bolje nego bolesnici koji su bili negativni na oba antitijela.
English: 150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p <0.05, ** p < 0.001.
Croatian: 150 bolesnika prvotno nasumično raspodijeljenih u skupinu koja je primala placebo + metotreksat u Ispitivanju 1 primilo je barem jedan ciklus terapije rituksimab + metotreksat do kraja jedne godine ispitivanja * p < 0,05; ** p < 0,001.
English: Patients treated with Blitzima must be given the patient alert card with each infusion.
Croatian: Bolesnici koji se liječe lijekom Blitzima moraju kod svake infuzije dobiti karticu s upozorenjima za bolesnika.
English: Subsequent doses of Blitzima can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Croatian: Sljedeće doze lijeka Blitzima mogu se dati početnom brzinom infuzije od 100 mg/sat, a brzina se može povećavati za 100 mg/sat u razmacima od 30 minuta, do najviše 400 mg/sat.
English: Following induction of remission with other standard of care immunosuppressants, Blitzima maintenance treatment should be initiated during the 4 week period that follows disease remission.
Croatian: Nakon poticanja remisije primjenom drugih imunosupresiva koji se koriste u standardnom liječenju, terapiju održavanja lijekom Blitzima treba započeti tijekom 4-tjednog razdoblja nakon nastupa remisije bolesti.
English: Blitzima contains sodium
Croatian: Blitzima sadrži natrij
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group．
Croatian: S obzirom na ukupno preživljenje, razlika između liječenih skupina bila je klinički značajna (p = 0,029, log-rang test stratificiran prema centru): stope preživljenja nakon 53 mjeseca bile su 80,9 % za bolesnike u R-CVP skupini, u usporedbi sa 71,1 % za bolesnike u CVP skupini.
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Croatian: Farmakokinetički profil rituksimaba kada se primjenjuje u 6 infuzija u dozi od 375 mg/m u kombinaciji sa 6 ciklusa CHOP kemoterapije sličan je profilu rituksimaba kada se primjenjuje samostalno.
English: Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%.
Croatian: Prema Kaplan-Meierovoj procjeni, medijan preživljenja bez događaja iznosio je 35 mjeseci za R-CHOP skupinu, odnosno 13 mjeseci za CHOP skupinu, što predstavlja smanjenje rizika za 41 %.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Croatian: Ukupna stopa odgovora nakon osmog ciklusa iznosila je 76,2 % u skupini liječenoj R-CHOPom, a 62,4 % u skupini liječenoj CHOP-om (p = 0,0028).
English: Treatment difference (Rituximabcyclophosphamide)
Croatian: Razlika između terapija (rituksimabciklofosfamid)
English: Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Croatian: Terapija održavanja lijekom Blitzima indicirana je u liječenju bolesnika oboljelih od folikularnog limfoma koji su odgovorili na uvodnu terapiju.
English: The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients.
Croatian: Ukupna stopa infekcija iznosila je približno 94 na 100 bolesnik-godina u bolesnika koji su primali rituksimab.
English: Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still >25 x 109/L.
Croatian: U tih bolesnika treba razmotriti smanjenje brzine infuzije pri primjeni prve doze ili raspodjelu doziranja u dva dana tijekom prvog ciklusa, ali i bilo kojeg sljedećeg ciklusa ako je broj limfocita i dalje > 25 x 10
English: The prepared Blitzima solution should be administered as an intravenous infusion through a dedicated line.
Croatian: Pripremljenu otopinu lijeka Blitzima treba primijeniti intravenskom infuzijom kroz posebnu infuzijsku liniju.
English: Before you are given Blitzima, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Croatian: Lijekovi koji se daju prije svake primjene lijeka Blitzima Prije nego primite lijek Blitzima, primit ćete druge lijekove (premedikaciju) koji sprječavaju ili ublažavaju moguće nuspojave.
English: Some vaccines should not be given at the same time as Blitzima or in the months after you receive Blitzima.
Croatian: Neka se cjepiva ne smiju davati istodobno s lijekom Blitzima ili nekoliko mjeseci nakon liječenja lijekom Blitzima.
English: What Blitzima is used for
Croatian: Za što se Blitzima koristi
English: Blitzima should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Croatian: Blitzima se treba primijeniti u obliku dvije i.v. infuzije od 500 mg u razmaku od dva tjedna, nakon čega se primjenjuje doza od 500 mg i.v. infuzijom svakih 6 mjeseci.
English: In a prospective, open label, international, multicentre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
Croatian: U prospektivnom, otvorenom, međunarodnom, multicentričnom ispitivanju faze III 1193 bolesnika s prethodno neliječenim uznapredovalim folikularnim limfomom primalo je početnu terapiju R-CHOPom (n = 881), R-CVP-om (n = 268) ili R-FCM-om (n = 44) prema odabiru ispitivača.
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 × 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 μg/mL and a mean terminal half-life of 19.2 days.
Croatian: Farmakokinetički parametri u populaciji koja nije zadovoljavajuće odgovorila na liječenje TNFinhibitorom su uz isti režim doziranja (2 x 1000 mg, intravenski, u razmaku od dva tjedna) bili slični, uz prosječnu najvišu koncentraciju u serumu od 369 µg/ml i srednji terminalni poluvijek od 19,2 dana.
English: You will always be given Blitzima as a drip (intravenous infusion).
Croatian: Lijek Blitzima ćete uvijek primiti ukapavanjem u venu (intravenskom infuzijom).
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult
Croatian: To odgovara 2,6% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Following two intravenous infusions of rituximab at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 L (range, 1.7 to 7.51 L).
Croatian: Nakon dvije intravenske infuzije rituksimaba u dozi od 1000 mg u razmaku od dva tjedna prosječan terminalni poluvijek bio je 20,8 dana (raspon 8,58 do 35,9 dana), prosječan sistemski klirens 0,23 l/dan (raspon 0,091 do 0,67 l/dan), a prosječan volumen raspodjele u stanju dinamičke ravnoteže 4,6 l (raspon od 1,7 do 7,51 l).
English: In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Croatian: Sveukupno iskustvo s ponavljanim ciklusima rituksimaba tijekom godine dana u liječenju reumatoidnog artritisa pokazalo je da su udjeli bolesnika s pozitivnim titrom antitijela protiv S. pneumoniae, influence, zaušnjaka, rubele, varičele i toksoida tetanusa općenito bili slični udjelima na početku liječenja.
English: Eye disorders lacrimation disorder, conjunctivitis severe vision loss5
Croatian: Poremećaji oka poremećaj u izlučivanju suza, konjunktivitis težak gubitak vida5
English: The safety profile of rituximab in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Croatian: Sigurnosni profil rituksimaba u bolesnika sa srednje teškim ili teškim reumatoidnim artritisom (RA) sažeto je prikazan u nastavku.
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Croatian: Na temelju populacijske farmakokinetičke analize u 298 bolesnika s NHL-om koji su primili jednu ili više infuzija rituksimaba, samog ili u kombinaciji s CHOP terapijom (primijenjene doze rituksimaba bile su u rasponu od 100 do 500 mg/m2), procjene za tipičnu populaciju bolesnika bile su: za nespecifični klirens (CL1) 0,14 l/dan, specifični klirens (CL2) kojemu su vjerojatno pridonijele B-stanice ili zahvaćenost tumorom 0,59 l/dan, a za volumen distribucije u središnjem odjeljku (V1) 2,7 l.
English: Table 16 Percentage of patients who achieved complete remission at 6 months (Intent-to-treat population*)
Croatian: Tablica 16 Postotak bolesnika koji su postigli potpunu remisiju nakon 6 mjeseci (populacija s namjerom liječenja*) Rituksimab (n = 99)
English: Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
Croatian: Mogući mehanizmi stanične lize posredovane efektorom uključuju citotoksičnost ovisnu o komplementu, nastalu kao rezultat vezanja C1q, i staničnu citotoksičnost ovisnu o antitijelima, posredovanu jednim ili više Fcγ receptora na površini granulocita, makrofaga i NKstanica.
English: Blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
Croatian: Kronična limfocitna leukemija (KLL) Blitzima je u kombinaciji s kemoterapijom indicirana za liječenje bolesnika s prethodno neliječenim i relapsirajućim/refraktornim KLL-om.
English: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Croatian: Staklene bočice (bezbojno staklo tipa I) s butil gumenim čepom koje sadrže 100 mg rituksimaba u 10 ml.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Croatian: Pneumocystic jirovecii tijekom i nakon liječenja lijekom Blitzima, prema potrebi i u skladu s lokalnim smjernicama za kliničku praksu.
English: Mundipharma CVA Tél/Tel: + 32 15 45 1180
Croatian: Luxembourg/Luxemburg Mundipharma CVA Tél/Tel: + 32 15 45 1180
English: Safety and efficacy of Blitzima have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Croatian: Sigurnost i djelotvornost lijeka Blitzima u kombinaciji s drugim kemoterapijskim protokolima u liječenju difuznog ne-Hodgkinovog limfoma velikih B-stanica nisu ustanovljene.
English: Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) kožni papilom
English: Treatment difference (Rituximab --cyclophosphamide)
Croatian: Razlika između terapija (rituksimab- ciklofosfamid)
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomisation, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progressionfree survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Croatian: Unaprijed utvrđena primarna analiza provedena je nakon medijana promatranja od 25 mjeseci od randomizacije terapija održavanja rituksimabom u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj. preživljenju bez progresije bolesti (PFS) prema procjeni ispitivača, u usporedbi s opservacijskom skupinom (Tablica 7).
English: Infusion related reactions2 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Croatian: Događaji su se smatrali nuspojavama lijeka tek nakon što je provedena temeljita ocjena i utvrđena barem razumna mogućnost uzročne povezanosti između lijeka i štetnog događaja.
English: The Patient information about Blitzima should contain the following key elements:
Croatian: Informacije za bolesnike o lijeku Blitzima moraju sadržavati sljedeće ključne elemente:
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Croatian: U kliničkom ispitivanju primjene lijeka za poticanje remisije srčani događaji prijavljeni su po stopi od 273 na 100 bolesnik-godina (95 % CI 149-470) u trenutku primarne mjere ishoda nakon 6 mjeseci.
English: Cardiac disorders angina pectoris, atrial fibrillation, heart failure, myocardial infarction atrial flutter
Croatian: Srčani poremećaji angina pektoris, fibrilacija atrija, zatajenje srca, infarkt undulacija atrija
English: Consultation with a neurologist should be considered as clinically indicated.
Croatian: Ako je klinički indicirano, valja razmotriti konzultaciju s neurologom.