FrancophonIA/ELRC3.0 huggingface dataset:
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including progressive multifocal leukoencephalopathy (PML).
Croatian: vezane uz potencijalno povećani rizik od infekcija, uključujući progresivnu multifokalnu leukoencefalopatiju (PML).
English: • Pain in the tummy, back, muscles and/or joints
Croatian: • bol u trbuhu, leđima, mišićima i/ili zglobovima
English: Rituximab (n=57)
Croatian: Rituksimab (n = 57)
English: ▼This medicinal product is subject to additional monitoring.
Croatian: ▼Ovaj je lijek pod dodatnim praćenjem.
English: The recommended dosage of Rixathon for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Croatian: Preporučena doza lijeka Rixathon za poticanje remisije granulomatoze s poliangitisom i mikroskopskog poliangitisa iznosi 375 mg/m2 tjelesne površine primijenjeno intravenskom infuzijom jedanput tjedno tijekom 4 tjedna (ukupno četiri infuzije).
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: (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: A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
Croatian: U ukupno 6/34 (18 %) bolesnika liječenih rituksimabom u sklopu kliničkog ispitivanja terapije održavanja razvila su se antitijela na lijek.
English: Chronic lymphocytic leukaemia (CLL)
Croatian: Kronična limfocitna leukemija (KLL)
English: Significant benefit from maintenance treatment with rituximab was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
Croatian: U primarnoj analizi uočena je i značajna korist od terapije održavanja rituksimabom u pogledu sekundarnih mjera ishoda: preživljenja bez pojave događaja (EFS), vremena do sljedećeg liječenja limfoma (engl. time to next anti-lymphoma treatment, TNLT), vremena do sljedeće kemoterapije (engl. time to next chemotherapy, TNCT) te stope ukupnog odgovora (ORR) (Tablica 7).
English: • Inflammation, irritation and / or tightness of the lungs, and throat, coughing
Croatian: • upala, iritacija i/ili stezanje u plućima i grlu, kašalj
English: Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection, e.g. hypogammaglobulinaemia (see section 4.8).
Croatian: Liječnici trebaju biti oprezni ako razmatraju primjenu rituksimaba u bolesnika s anamnezom rekurentnih ili kroničnih infekcija ili postojećim bolestima koje ih mogu dodatno predisponirati za ozbiljne infekcije, primjerice hipogamaglobulinemijom (vidjeti dio 4.8).
English: • respiratory failure
Croatian: • zatajenje disanja
English: 1 vial of 50 mL 2 vials of 50 mL
Croatian: 1 bočica od 50 ml 2 bočice od 50 ml
English: The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
Croatian: Bočica od 50 ml sadrži 500 mg rituksimaba (10 mg/ml).
English: • swelling of the hands or ankles
Croatian: • oticanje šaka ili gležnjeva
English: Rixathon is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Croatian: Rixathon je dostupan u sterilnim, jednokratnim apirogenim bočicama, bez konzervansa.
English: In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
Croatian: U KLL-u je ukupna incidencija srčanih poremećaja stupnja 3 ili 4 bila niska i u ispitivanju prve linije liječenja (4 % R-FC, 3 % FC) i u ispitivanju relapsirajuće/refraktorne bolesti (4 % R-FC, 4 % FC).
English: • Feeling generally unwell or listless.
Croatian: • opće loše osjećanje ili bezvoljnost
English: • muscle problems - such as tight muscles, joint or muscle pain, back and neck pain
Croatian: • mišićne tegobe - kao što je napetost u mišićima, bol u zglobovima ili mišićima, bol u vratu i leđima
English: Rixathon is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Croatian: Rixathon se u kombinaciji s kortikosteroidima primjenjuje za liječenje granulomatoze s poliangitisom (ranije se zvala Wegenerova granulomatoza) i mikroskopskog poliangitisa.
English: Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171-1,177 µg/mL) after the eighth infusion.
Croatian: Nakon primjene rituksimaba u dozi od 375 mg/m2 u obliku intravenske infuzije, osam puta u u razmacima od tjedan dana u 37 bolesnika s NHL-om, srednja vrijednost Cmax povećavala se sa svakom sljedećom infuzijom, a vrijednosti su se kretale od prosječnih 243 µg/ml (raspon 16-582 µg/ml) nakon prve infuzije do 550 µg/ml (raspon 171-1177 µg/ml) nakon osme infuzije.
English: See section 5.1 for further information.
Croatian: (vidjeti dio 5.1).
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab arms compared to control arms.
Croatian: Tijekom kliničkih ispitivanja prijavljene su infekcije donjih dišnih puteva (uključujući upalu pluća), a incidencija im je bila slična u skupinama koje su primale rituksimab i u kontrolnim skupinama.
English: At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either rituximab (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for 18 months) or azathioprine (administered orally at a dose of 2 mg/kg/day for 12 months, then 1.5 mg/kg/day for 6 months, and finally 1 mg/kg/day for 4 months (treatment discontinuation after these 22 months)).
Croatian: Nakon postizanja remisije, a najviše mjesec dana od primjene posljednje pulsne doze ciklofosfamida, bolesnici su bili randomizirani za primanje rituksimaba (dvije i.v. infuzije od 500 mg u razmaku od dva tjedna [1. dana i 15. dana], a zatim 500 mg i.v. svakih 6 mjeseci tijekom 18 mjeseci) ili azatioprina (primijenjenog peroralno u dozi od 2 mg/kg na dan tijekom 12 mjeseci, zatim u dozi od 1,5 mg/kg na dan tijekom 6 mjeseci i na kraju u dozi od 1 mg/kg na dan tijekom 4 mjeseca [prekid liječenja nakon ta 22 mjeseca]).
English: • Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth
Croatian: • probavne smetnje, proljev, refluks kiseline, iritacija i/ili pojava vrijedova u grlu i ustima
English: 42-months p=0.029
Croatian: 42 mjeseca p = 0,029
English: A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Croatian: Ukupno je 23/99 (23 %) bolesnika liječenih rituksimabom u ispitivanju poticanja remisije do 18. mjeseca bilo pozitivno na antitijela na lijek.
English: Progression-free survival (PFS) Overall survival
Croatian: Progression Free Survival)
English: The efficacy and safety of rituximab in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study.
Croatian: Kliničko iskustvo u liječenju običnog pemfigusa Djelotvornost i sigurnost rituksimaba u kombinaciji s kratkoročnom terapijom niskom dozom glukokortikoida (prednizona) ocjenjivale su se u novodijagnosticiranih bolesnika s umjerenim do teškim pemfigusom (74 bolesnika s običnim pemfigusom [PV] i 16 bolesnika koji su imali pemphigus foliaceus [PF]) u randomiziranom, otvorenom, kontroliranom, multicentričnom ispitivanju.
English: In patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Rixathon infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Croatian: U bolesnika s reumatoidnim artritisom, granulomatozom s poliangitisom (Wegenerovom granulomatozom) ili mikroskopskim poliangitisom u remisiji ili s običnim pemfigusom treba primijeniti premedikaciju metilprednizolonom u dozi od 100 mg intravenski radi smanjenja incidencije i težine reakcija povezanih s infuzijom, a primjena mora završiti 30 minuta prije početka infuzije lijeka Rixathon.
English: Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose.
Croatian: Bolesnicima u skupini liječenoj rituksimabom koji su doživjeli relaps mogla se primijeniti dodatna infuzija rituksimaba u dozi od 1000 mg te ponovno uvesti prednizon ili povećati njegova doza.
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with Rixathon.
Croatian: Preporučuje se prije početka liječenja lijekom Rixathon odrediti razine imunoglobulina.
English: The 10 mL vial contains 100 mg of rituximab (10 mg/mL).
Croatian: Bočica od 10 ml sadrži 100 mg rituksimaba (10 mg/ml).
English: A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Croatian: Ukupno je 197 bolesnika u dobi od 15 ili više godina s teškom aktivnom granulomatozom s poliangitisom (75 %) i mikroskopskim poliangitisom (24 %) sudjelovalo i liječeno u randomiziranom,
English: • If you are having Rixathon alone
Croatian: • ako se liječite samo lijekom Rixathon
English: In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Croatian: U populaciji bolesnika s PV-om 5 (13 %) bolesnika liječenih rituksimabom i 3 (8 %) bolesnika liječena standardnom dozom prednizona imala su umjereni oblik bolesti, dok su 33 (87 %) bolesnika liječena rituksimabom i
English: 10 mL vial: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Croatian: Bočica od 10 ml: staklene bočice (bezbojno staklo tipa I) s butil gumenim čepom koje sadrže 100 mg rituksimaba u 10 ml.
English: Most adverse events in the rituximab arm were mild or moderate in intensity.
Croatian: Većina štetnih događaja u skupini bolesnika liječenih rituksimabom bila je blagog ili umjerenog intenziteta.
English: Rixathon monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Croatian: Monoterapija lijekom Rixathon indicirana je u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije.
English: The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Croatian: Većina je bolesnika primala rituksimab u kombinaciji s kemoterapijom ili u sklopu presađivanja hematopoetskih matičnih stanica.
English: The recommended dosage of Rixathon is 1,000 mg by intravenous infusion followed by a second 1,000 mg intravenous infusion two weeks later.
Croatian: Rixathon je 1000 mg primijenjeno intravenskom infuzijom, a potom drugih 1000 mg intravenskom infuzijom nakon dva tjedna.
English: Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the Rixathon infusion.
Croatian: S obzirom da tijekom primjene rituksimaba može doći do hipotenzije, potrebno je razmotriti mogućnost izostavljanja antihipertenzivnog lijeka 12 sati prije davanja infuzije lijeka Rixathon.
English: Packs of 1 or 2 vials.
Croatian: Pakiranje od 1 ili 2 bočice.
English: • Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica,
Croatian: • abnormalni osjeti na koži, kao što su utrnulost, trnci, bockanje ili žarenje, išijas, migrena,
English: Toxic Epidermal Necrolysis (Lyell syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Croatian: Vrlo su rijetko prijavljeni toksična epidermalna nekroliza (Lyellov sindrom) i Stevens-Johnsonov sindrom, ponekad sa smrtnim ishodom.
English: • Pain on passing water (urinary tract infection)
Croatian: • bol pri mokrenju (infekcija mokraćnih putova)
English: • A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems
Croatian: • osjećaj začepljenosti ili pulsirajuća bol iza nosa, obraza i očiju (sinusitis), bol u trbuhu,
English: Aseptic handling must be ensured when preparing the infusion.
Croatian: Kod pripreme infuzije mora se osigurati aseptičko rukovanje.
English: Initial treatment, weekly for 4 doses
Croatian: Početno liječenje, prošireni tumor, jedanput tjedno tijekom 4 tjedna
English: • long lasting depression
Croatian: • dugotrajna depresija
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rixathon Alert Card for patients with non-oncology diseases
Croatian: Rixathon kartica s upozorenjima za bolesnike s neonkološkim bolestima
English: - The need to provide patients with the Patient Alert Card with each infusion
Croatian: - Bolesnici moraju kod svake infuzije dobiti Karticu s upozorenjima za bolesnika.
English: • heart beating faster than normal
Croatian: • bol u mišićima • brže kucanje srca nego obično
English: Repeated courses of treatment with Rixathon are possible.
Croatian: Ciklusi liječenja lijekom Rixathon mogu se ponavljati.
English: The most common infections in the rituximab arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Croatian: Najčešće infekcije u skupini liječenoj rituksimabom uključivale su infekcije gornjih dišnih putova, gastroenteritis, infekcije mokraćnih putova i herpes zoster.
English: Median EFS: 36 Not reached p < 0.0001
Croatian: Medijan EFS: Nije dostignuto p < 0,0001
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane hiperkolesterolemija
English: In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
Croatian: ukupna stopa infekcija iznosila je približno 237 na 100 bolesnik-godina (95 % CI 197 - 285) u trenutku primarne mjere ishoda nakon 6 mjeseci.
English: Depression, anxiety
Croatian: Psihijatrijski poremećaji depresija, tjeskoba
English: The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Croatian: Najčešći simptomi bile su alergijske reakcije, kao što su glavobolja, svrbež, iritacija grla, crvenilo praćeno osjećajem vrućine, osip, urtikarija, hipertenzija i vrućica.
English: In case of such an event with a suspected relationship to Rixathon, treatment should be permanently discontinued.
Croatian: uz sumnju na povezanost s lijekom Rixathon, liječenje se mora trajno prekinuti.
English: Serum ickness-like reaction
Croatian: reakcija nalik serumskoj bolesti
English: Patient subpopulations - rituximab combination therapy
Croatian: Podskupine bolesnika - liječenje rituksimabom u kombinaciji
English: A course of Rixathon consists of two 1,000 mg intravenous infusions.
Croatian: Ciklus liječenja lijekom Rixathon čine dvije intravenske infuzije od 1000 mg.
English: 50 mL vial: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Croatian: Bočica od 50 ml: staklene bočice (bezbojno staklo tipa I) s butil gumenim čepom koje sadrže 500 mg rituksimaba u 50 ml.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Croatian: 1 Kategorija učestalosti dodijeljena na temelju laboratorijskih vrijednosti prikupljenih tijekom rutinskih laboratorijskihkontrola u kliničkim ispitivanjima 2 Kategorija učestalosti dodijeljena na temelju podataka nakon stavljanja lijeka u promet.
English: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with Rixathon.
Croatian: Kontracepcija u muškaraca i žena Zbog dugog vremena zadržavanja rituksimaba u bolesnika s deplecijom B-stanica, žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije tijekom i 12 mjeseci nakon terapije lijekom
English: The ORR was 36% (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Croatian: 21 % - 51 %; CR 3 %, PR 33 %), a medijan TTP-a u bolesnika koji su odgovorili na liječenje 9,6 mjeseci (raspon od 4,5 do 26,8 mjeseci).
English: • recurrence of a previous Hepatitis B infection d) If you are being treated for pemphigus vulgaris
Croatian: • povratak ranije hepatitis B infekcije d) Bolesnici koji se liječe od običnog pemfigusa
English: The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Croatian: Najčešće infekcije u skupini koja je primala rituksimab bile su herpes simplex i herpes zoster, bronhitis, infekcije mokraćnih putova, gljivične infekcije te konjunktivitis.
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2,
Croatian: U otvorenom randomiziranom ispitivanju ukupno su 322 prethodno neliječena bolesnika s folikularnim limfomom slučajnim odabirom određena za primanje CVP kemoterapije (ciklofosfamid
English: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
Croatian: Teško zatajenje srca (New York Heart Association stupanj IV) ili teška nekontrolirana srčana bolest
English: Hepatitis-B reactivation
Croatian: Reaktivacija hepatitisa B
English: Dyspepsia, diarrhoea, gastrooesophageal reflux, mouth ulceration, upper abdominal pain
Croatian: Poremećaji probavnog sustava dispepsija, proljev, gastroezofagealni refluks, vrijed usta, bol u gornjem abdomenu
English: Only the highest frequency observed in the trials is reported 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Croatian: 1 uključuje reaktivaciju i primarne infekcije; učestalost se temelji na R-FC režimu u relapsirajućem/refraktornom KLL-u
English: In clinical trials fewer than 1% (17/3,189) of patients experienced a serious IRR.
Croatian: Manje od 1 % (17/3189) bolesnika u kliničkim ispitivanjima imalo je ozbiljnu reakciju povezanu s infuzijom.
English: • Infections, see section 4.4.
Croatian: vidjeti dio 4.4 • infekcije, vidjeti dio 4.4
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 x 500 mg dose and ranged from 21 to 22 days for the 2 x 1,000 mg dose.
Croatian: Srednje terminalno poluvrijeme eliminacije nakon druge infuzije i drugog ciklusa iznosilo je 19 dana za dozu od 2 x 500 mg te od 21 do 22 dana za dozu od
English: • memory loss, trouble thinking, difficulty walking or sight loss -these may be due to a very rare,
Croatian: • gubitak pamćenja, smetnje pri razmišljanju, poteškoće pri hodu ili gubitak vida - ove nuspojave mogu biti posljedica vrlo rijetke i ozbiljne infekcije mozga koja može završiti smrću (progresivna multifokalna leukoencefalopatija ili PML).
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Croatian: Tablica 3 Nuspojave koje su u 6 mjeseci nastupile u ≥ 5 % bolesnika koji su primali rituksimab za poticanje remisije GPA i MPA i koje su se pojavile s većom učestalošću nego u usporednoj skupini
English: Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome.
Croatian: Za bolesnike s KLL-om preporučuje se profilaksa primjerenom hidracijom i primjenom lijekova koji inhibiraju stvaranje mokraćne kiseline 48 sati prije početka terapije kako bi se smanjio rizik od sindroma lize tumora.
English: The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Croatian: Sigurnosni profil rituksimaba u bolesnika s PV-om podudarao se s profilom opaženim u bolesnika s reumatoidnim artritisom i GPA-om/MPA-om.
English: Fever , chills, asthenia, headache
Croatian: mučnina, osip, vrućica,
English: • severe skin problems causing blisters that can be life-threatening.
Croatian: • teški problemi s kožom uz stvaranje mjehurića na koži koji mogu biti opasni po život.
English: Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24
Croatian: Tablica 5 Nuspojave zabilježene u bolesnika s običnim pemfigusom liječenih rituksimabom u kliničkom ispitivanju do 24. mjeseca
English: Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Croatian: Modified Total Sharp Score, mTSS) i njegovim sastavnicama, stupnju erozije i stupnju suženja zglobnog prostora.
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; n.a.: not applicable *: only applicable to patients achieving a CR, nPR, PR **: only applicable to patients achieving a CR
Croatian: *: primjenjivo samo za bolesnike koji su postigli CR, nPR ili PR; ND: nije dostignuto; n.p.: nije primjenjivo **: primjenjivo samo za bolesnike koji su postigli CR
English: Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Croatian: Rixathon je indiciran za liječenje bolesnika s umjerenim do teškim oblikom običnog pemfigusa (PV).
English: Lung infiltration
Croatian: infiltracija pluća