natgillin/translations-raw huggingface dataset:
The pharmacokinetics of rituximab were assessed following two intravenous doses of 500 mg and 1,000 mg on days 1 and 15 in four studies.
Farmakokinetika rituksimaba ispitana je nakon dvije intravenske (i.v.) doze od 500 mg i 1000 mg,
Secondary efficacy Overall survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Sekundarna djelotvornost Ukupno preživljenje (medijan) log-rang p-vrijednost omjer hazarda (95 % CI) smanjenje rizika
Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen.
Opažena je stabilizacija ili poboljšanje ishoda nakon ponovne uspostave funkcije imunološkog sustava u imunokompromitiranih bolesnika s PML-om.
In a prospective, open label, international, multi-centre, phase III trial 1,193 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.
U prospektivnom, otvorenom, međunarodnom, multicentričnom ispitivanju faze III 1193 bolesnika s prethodno neliječenim uznapredovalim folikularnim limfomom primalo je početnu terapiju R-CHOP
Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 μg/mL for 2 x 500 mg dose and ranged from 298 to 341 μg/mL for 2 x 1,000 mg dose.
Prosječni Cmax rituksimaba u serumu nakon prve infuzije kretao se između 157 i 171 µg/ml pri dozi od 2 x 500 mg, odnosno između 298 i 341 µg/ml pri dozi od 2 x 1000 mg.
Placebo+MTX Rituximab+MTX 2 x 1,000 mg
Rituksimab + metotreksat 2 x 1000 mg
• A complex of symptoms occurring within a few weeks of an infusion of rituximab including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): • skup simptoma koji se pojavljuju u roku od nekoliko tjedana od primitka infuzije rituksimaba, a obuhvaćaju reakcije nalik alergijskima kao što su osip, svrbež, bol u zglobovima, otečeni limfni čvorovi i vrućica.
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.
primilo je barem jedan ciklus terapije rituksimab + metotreksat do kraja jedne godine ispitivanja * p < 0,05;
Your doctor may decide to treat you longer with Rixathon (up to 5 years), depending on how you respond to the medicine.
Ovisno o tome kako reagirate na lijek, liječnik će Vam možda produljiti liječenje lijekom Rixathon (do 5 godina).
This medicinal product contains 11.5 mmol (263.2 mg) sodium per 50 mL vial.
Ovaj lijek sadrži 11,5 mmol (263,2 mg) natrija po bočici od 50 ml.
Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Bolesnici s reumatoidnim artritisom koji prethodno nisu liječeni metotreksatom Primjena rituksimaba ne preporučuje se u bolesnika koji prethodno nisu bili liječeni metotreksatom jer nije utvrđen povoljan omjer koristi i rizika.
Clinical experience in Non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Klinička iskustva u liječenju ne-Hodgkinova limfoma i kronične limfocitne leukemije
• blocked or runny nose
• začepljen nos ili curenje iz nosa
Rixathon 100 mg sterile concentrate rituximab
Rixathon 100 mg sterilni koncentrat Rituximabum (rituksimab)
• IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
• reakcije povezane s infuzijom (uključujući sindrom otpuštanja citokina i sindrom lize tumora),
Very rare side effects (may affect up to 1 in 10,000 people):
• oticanje trbuha Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba):
• 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.
- gubitak snage ili slabost na jednoj strani tijela - zamagljen vid ili gubitak vida
Very rare cases of fatal PML have been reported following use of rituximab.
Nakon primjene rituksimaba prijavljeni su vrlo rijetki slučajevi PML-a sa smrtnim ishodom.
Severe vision loss5
konjunktivitis težak gubitak vida5
The HCP Alert card addressing the correct use of Rixathon contains the following key elements: - The advice that Rixathon is for intravenous use only and recommendations how to ensure this route of administration
HCP kartica s upozorenjima, koja sadrži informacije o pravilnoj upotrebi lijeka Rixathon, sadrži sljedeće ključne elemente:
At week 48 seropositive patients were 2-3 times more likely to achieve ACR responses compared to seronegative patients.
ACR odgovora u 48. tjednu nego seronegativni bolesnici.
Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
6.1 Popis pomoćnih tvari natrijev citrat polisorbat 80 natrijev klorid natrijev hidroksid kloridna kiselina voda za injekcije
Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Na koži ili sluznicama, primjerice u ustima, na genitalijama ili kapcima može se pojaviti crvenilo, često praćeno mjehurićima, a moguća je i vrućica.
† Outcome at 24 weeks Significant difference from placebo + MTX at the primary timepoint: ***p ≤ 0.0001
Značajna razlika u odnosu na placebo u primarnoj vremenskoj točki: *p < 0,05, **p < 0,001, ***p ≤ 0,0001
The recommended dose of Rixathon monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
• Relapsirajući/refraktorni folikularni limfom Preporučena doza lijeka Rixathon u monoterapiji kod početnog liječenja odraslih bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije iznosi 375 mg/m2 površine tijela, a primjenjuje se u obliku intravenske infuzije jedanput tjedno tijekom četiri tjedna.
Abdominal enlargement
povećana razina
Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome.
urtikariju/osip, umor, glavobolju, iritaciju grla, rinitis, svrbež, bol, tahikardiju, hipertenziju, hipotenziju, dispneju, dispepsiju, asteniju te obilježja sindroma lize tumora.
This medicinal product contains 2.3 mmol (52.6 mg) sodium per 10 mL vial.
Ovaj lijek sadrži 2,3 mmol (52,6 mg) natrija po bočici od 10 ml.
Depression, nervousness
Psihijatrijs ki poremećaji depresija, nervoza
Granulomatosis with polyangiitis and microscopic polyangiitis
Granulomatoza s poliangitisom i mikroskopski poliangitis
Some vaccines should not be given at the same time as Rixathon or in the months after you receive Rixathon.
Rixathon ili nekoliko mjeseci nakon liječenja lijekom Rixathon.
Vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation
proljev, bol u abdomenu, disfagija, stomatitis, konstipacija, dispepsija, anoreksija, iritacija grla povećanje abdomena gastrointestinal na perforacija7
Rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris
Reumatoidni artritis, granulomatoza s poliangitisom, mikroskopski poliangitis i obični pemfigus
Follicular non-Hodgkin's lymphoma
Folikularni ne-Hodgkinov limfom
The recommended dose of Rixathon used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
• Relapsirajući/refraktorni folikularni limfom Preporučena doza lijeka Rixathon u terapiji održavanja u bolesnika s relapsirajućim/refraktornim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi 375 mg/m2 površine tijela jedanput svaka 3 mjeseca (počevši 3 mjeseca nakon zadnje doze uvodne terapije) do progresije bolesti ili najdulje dvije godine (ukupno 8 infuzija).
NA NA NA
KLL-om.
Urticaria, sweating, night sweats, +skin disorder
znojenje, noćno znojenje,
Infusion-related reactions in the pemphigus vulgaris clinical study were common (58%).
Reakcije povezane s infuzijom bile su česte (58 %) u kliničkim ispitivanjima običnog pemfigusa.
Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p < 0.0001 log-rank test).The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Terapija održavanja rituksimabom dovela je do klinički relevantnih i statistički značajnih poboljšanja u primarnoj mjeri ishoda, što je bio PFS (vrijeme od randomizacije na terapiju održavanja do relapsa, progresije bolesti ili smrti), u usporedbi s opservacijskom skupinom (p < 0,0001, log-rang test).
Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time
Pregled rezultata djelotvornosti za rituksimab + FC u odnosu na samo FC (medijan vremena promatranja je 48,1 mjesec)
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Rixathon.
Prije svake primjene lijeka Rixathon uvijek treba primijeniti premedikaciju koja obuhvaća antipiretik i antihistaminik, npr. paracetamol i difenhidramin.
Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Bolesnici su mogli primiti dozu od 1000 mg i.v. u trenutku relapsa
IgG levels
snižene razine IgG
Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris
Kontraindikacije za primjenu kod reumatoidnog artritisa, granulomatoze s poliangitisom, mikroskopskog poliangitisa i običnog pemfigusa
granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
granulomatozu s poliangitisom, mikroskopski poliangitis ili obični pemfigus.
Serious viral infection2
ozbiljne virusne infekcije2, Pneumocysti s jirovecii
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Neurološki događaji Prijavljeni su slučajevi sindroma reverzibilne posteriorne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) odnosno sindroma reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS).
Anaphylaxis Tumour lysis syndrome, cytokine release syndrome4, serum sickness
Poremećaji imunološk og sustava reakcije povezane s infuzijom, angioedem preosjetljivost anafilaksija sindrom lize tumora, sindrom otpuštanja citokina4, serumska bolest akutna reverzibilna trombocitopeni ja povezana s infuzijom4
Arthralgia / musculoskeletal pain, osteoarthritis, bursitis
osteoartritis, burzitis
• bald spots on the scalp, chills, headache
• mjesta na vlasištu bez kose, zimica, glavobolja
Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough,
Poremećaji dišnog sustava, prsišta i sredoprsja bronhospazam4, bolest dišnog sustava, bol u prsima, dispneja,
In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
23 % bolesnika u skupini liječenoj ciklofosfamidom razvila se neutropenija 3. ili višeg stupnja prema
• pain in the muscles
• glavobolja • bol u trbuhu
Severe cardiac disorders 4 and
Poremećaji bubrega i mokraćnog sustava zatajenje bubrega4
At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of
Kasnija analiza trajanja ukupnog preživljenja, provedena nakon medijana praćenja od 60 mjeseci, potvrdila je prednost liječenja R-CHOP-om u odnosu na liječenje CHOP-om (p = 0,0071), što predstavlja smanjenje rizika za 32 %.
Severe bullous skin reactions, StevensJohnson Syndrome toxic epidermal necrolysis (Lyell's Syndrome)
Prijavljene su teške kožne reakcije poput toksične epidermalne nekrolize (Lyellov sindrom) i Stevens
Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
bolesnika u skupini liječenoj rituksimabom imalo štetne događaje koji su doveli do prekida liječenja.
+pancytopenia, +granulocytopenia disorders, aplastic anaemia, haemolytic anaemia, lymphadeno pathy increase in serum IgM levels3
hemolitička anemija, limfadentopatija prolazno povećanje serumske razine IgM-a3
This is because some people have a fall in their blood pressure while they are being given Rixathon.
12 sati prije primjene lijeka Rixathon zato što nekim bolesnicima može pasti krvni tlak tijekom primjene lijeka Rixathon.
Rixathon 100 mg concentrate for solution for infusion rituximab
Rixathon 100 mg koncentrat za otopinu za infuziju Rituximabum (rituksimab)
Primary efficacy Progression-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Primarna djelotvornost Preživljenje bez progresije bolesti (medijan) log-rang p-vrijednost omjer hazarda (95 % CI) smanjenje rizika
• flushing or redness of the skin
• crvenilo praćeno osjećajem vrućine ili crvenilo kože
The Patient Alert Card for Rixathon contains the following key elements: - The need to carry the card at all times and to show the card to all treating health care professionals - Warning on the risk of infections and PML, including the symptoms - The need for patients to contact their health care professional if symptoms occur
Kartica s upozorenjima za bolesnika za lijek Rixathon sadrži sljedeće ključne elemente: - Karticu uvijek treba nositi sa sobom i pokazati je svim zdravstvenim radnicima koji bolesnika liječe
Symptoms of infusion-related reactions were similar in type and severity to those seen in RA and GPA/MPA patients.
Vrsta i težina simptoma reakcija povezanih s infuzijom bile su slične kao i kod bolesnika s reumatoidnim artritisom i
The recommended dose of Rixathon in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Preporučena doza lijeka Rixathon u kombinaciji s kemoterapijom za uvodno liječenje bolesnika s prethodno neliječenim ili relapsirajućim/refraktornim folikularnim limfomom iznosi 375 mg/m2
In Trial 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, receiving rituximab in combination with methotrexate demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
U Ispitivanju 1, provedenom u bolesnika koji nisu zadovoljavajuće odgovorili na jednu ili više terapija TNF-inhibitorima ili ih nisu dobro podnosili, bolest je, sudeći prema radiološkim znakovima, nakon
Rixathon 500 mg concentrate for solution for infusion rituximab
Rixathon 500 mg koncentrat za otopinu za infuziju Rituximabum (rituksimab)
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.
100 bolesnik-godina (95 % CI 149-470) u trenutku primarne mjere ishoda nakon 6 mjeseci.
Infusionrelated reactions3 (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
hipotenzija, rinitis, tresavica, tahikardija, umor, bol u ustima i ždrijelu, periferni edem, eritem)
Following two intravenous infusions of rituximab at a dose of 1,000 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).
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
TNLT (median) log-rank p value hazard ratio (95% CI) risk reduction
TNLT (medijan) log-rang p-vrijednost omjer hazarda (95 % CI) smanjenje rizika
Long-term efficacy with multiple course therapy
Višestruki ciklusi liječenja
Dizziness may occur following administration of rituximab (see section 4.8).
Nakon primjene rituksimaba može se pojaviti omaglica (vidjeti dio 4.8).
Rixathon is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Rixathon je u kombinaciji s kemoterapijom indiciran u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji prethodno nisu liječeni.
The cumulative incidence rate curves showed that time to first major relapse was longer in patients with rituximab starting from month 2 and was maintained up to month 28 (Figure 3).
Krivulje kumulativne stope incidencije pokazuju dulje vrijeme do prvog teškog relapsa u bolesnika liječenih rituksimabom.
• hearing loss, loss of other senses b) If you are being treated for rheumatoid arthritis
• gubitak sluha, gubitak drugih osjeta b) Bolesnici koji se liječe od reumatoidnog artritisa Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
collapse
Nuspojava
• Skin reactions including hives, itching and rash
• kožne reakcije kao što su koprivnjača, svrbež i osip
The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p < 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
R-CVP-om (80,9 %) nego u skupini liječenoj CVP-om (57,2 %).
The projected median time to progression (TTP) for responding patients was 13.0 months.
TTP) iznosio je 13,0 mjeseci.
Initial treatment, bulky disease, weekly for 4 doses In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Početno liječenje, jedanput tjedno tijekom 4 tjedna U pivotalnom je ispitivanju 166 bolesnika s relapsirajućim ili kemorezistentnim, nisko malignim ili folikularnim B-staničnim ne-Hodgkinovim limfomom primilo rituksimab u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
• producing more tears, tear duct problems, inflamed eye (conjunctivitis)
• osjećaj omaglice ili tjeskobe • pojačano suzenje, tegobe sa suznim kanalima, upala oka (konjunktivitis)
Herpes zoster Nasopharyngitis
Infekcije i infestacije infekcije mokraćnih puteva bronhitis herpes zoster nazofaringitis
IgM levels4
Razine IgG-a
In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to
U bolesnika s granulomatozom s poliangitisom i mikroskopskim poliangitisom broj perifernih B stanica smanjio se na < 10 stanica/µl nakon dvije tjedne infuzije rituksimaba u dozi od
Paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety
Poremećaji živčanog sustava parestezija, hipoestezija, agitacija, nesanica, vazodilatacija, omaglica, anksioznost disgeuzija periferna neuropatija, paraliza facijalnog živca5
TNCT (median) log-rank p value hazard ratio (95% CI) risk reduction
TNCT (medijan) log-rang p-vrijednost omjer hazarda (95 % CI) smanjenje rizika
Three patients (8%) in the rituximab group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Pneumocystis jirovecii, infektivna tromboza, infekcija intervertebralnog diska, plućna infekcija, stafilokokna sepsa), dok je u skupini liječenoj standardnom dozom prednizona ozbiljnu infekciju
Hypercholestero lemia
Folikularni limfom Monoterapija
Patients randomised to the rituximab group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Bolesnici randomizirani u skupinu liječenu rituksimabom primili su početnu dozu od 1000 mg i.v. na
How Rixathon is given How it is given
Kako se primjenjuje lijek Rixathon Kako se Rixathon primjenjuje
Infusion related reactions4, angioedema
Poremećaji imunološkog sustava reakcije povezane s infuzijom3 (hipertenzija,
• infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Česte nuspojave (mogu se javiti u do 1 na 10 osoba): • infekcije krvi (sepsa), upala pluća, herpes zoster, prehlada, infekcije bronha, gljivične infekcije,
Duration of response * Disease free survival (DFS)** Time to new CLL treatment
TTF - vrijeme do prestanka učinka liječenja (engl.
Non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Ne-Hodgkinov limfom i kronična limfocitna leukemija
The most frequent adverse reactions considered due to receipt of rituximab IRRs.
Najčešće nuspojave koje se smatraju posljedicom primjene rituksimaba bile su reakcije povezane s infuzijom.
The frequencies of ADRs reported with rituximab alone or in combination with chemotherapy are summarised in Table 1.
Tablični prikaz nuspojava Učestalost nuspojava prijavljenih pri primjeni rituksimaba u monoterapiji ili u kombinaciji s kemoterapijom sažeta je u Tablici
vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
2 mg prvog dana liječenja te prednizolon 40 mg/m2/dan od prvog do petog dana liječenja) svaka 3 tjedna u osam ciklusa liječenja, ili rituksimab u dozi od 375 mg/m2 u kombinaciji s CHOP
Coagulation
omaglica
• Pain without injuring yourself
• gubitak tjelesne težine • bol koja nije posljedica ozljede
Blood and Neutropenia Anaemia,
aplastična anemija,
The estimated median terminal elimination half-life of rituximab was 22 days (range, 6.1 to 52 days).
Procijenjeni medijan terminalnog poluvremena eliminacije rituksimaba iznosi 22 dana
Laboratory evaluations
FARMACEUTSKI PODACI
In a multi-centre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
B-staničnim ne-Hodgkinovim folikularnim limfomom ili limfomom niskog stupnja malignosti, u kojih je postignut očekivan klinički odgovor na prethodno liječenje rituksimabom, ponovno liječeno rituksimabom u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
Asthma, bronchiolitis obliterans, lung disorder,
obliterirajući bronhiolitis,
Hypogammaglobulinaemia (IgA, IgG or IgM below the lower limit of normal) has been observed in granulomatosis with polyangiitis and microscopic polyangiitis patients treated with rituximab.
U bolesnika s granulomatozom s poliangitisom i mikroskopskim poliangitisom liječenih rituksimabom opažena je hipogamaglobulinemija (IgA, IgG ili IgM ispod donje granice normalnih vrijednosti).