natgillin/translations-raw huggingface dataset:
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
1 uključuje reaktivaciju i primarne infekcije; učestalost se temelji na R-FC režimu u relapsirajućem/refraktornom KLL-u
In clinical trials fewer than 1% (17/3,189) of patients experienced a serious IRR.
Manje od 1 % (17/3189) bolesnika u kliničkim ispitivanjima imalo je ozbiljnu reakciju povezanu s infuzijom.
• Infections, see section 4.4.
vidjeti dio 4.4 • infekcije, vidjeti dio 4.4
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.
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
• memory loss, trouble thinking, difficulty walking or sight loss -these may be due to a very rare,
• 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).
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.
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
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.
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.
The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Sigurnosni profil rituksimaba u bolesnika s PV-om podudarao se s profilom opaženim u bolesnika s reumatoidnim artritisom i GPA-om/MPA-om.
Fever , chills, asthenia, headache
mučnina, osip, vrućica,
• severe skin problems causing blisters that can be life-threatening.
• teški problemi s kožom uz stvaranje mjehurića na koži koji mogu biti opasni po život.
Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24
Tablica 5 Nuspojave zabilježene u bolesnika s običnim pemfigusom liječenih rituksimabom u kliničkom ispitivanju do 24. mjeseca
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.
Modified Total Sharp Score, mTSS) i njegovim sastavnicama, stupnju erozije i stupnju suženja zglobnog prostora.
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
*: 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
Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Rixathon je indiciran za liječenje bolesnika s umjerenim do teškim oblikom običnog pemfigusa (PV).
Lung infiltration
infiltracija pluća
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%).
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
albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95
ekstranodalna sijela, zahvaćenost koštane srži) omjer hazarda za preživljenje bez događaja (R-CHOP u odnosu na CHOP) bio je manji od 0,83, a za ukupno preživljenje manji od 0,95.
Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with Rixathon.
Sve bolesnike mora se prije početka liječenja lijekom Rixathon testirati na virus hepatitisa B (HBV).
The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
iznosio je 408 µg/ml (raspon 97-764 µg/ml), dok je prosječan terminalni poluvijek bio 32 dana (raspon
In case of such an event, with a suspected relationship to rituximab, treatment should be permanently discontinued.
uz sumnju na povezanost s rituksimabom, liječenje se mora trajno prekinuti.
Adverse drug reaction rituximab + low-dose prednisone (n = 38)
Rituksimab + niska doza prednizona (n = 38)
• multiple-organ failure.
• zatajenje više organa
Keep this medicine out of the sight and reach of children.
Kako čuvati lijek Rixathon Lijek čuvajte izvan pogleda i dohvata djece.
Rixathon 100 mg concentrate for solution for infusion Rixathon 500 mg concentrate for solution for infusion
Rixathon 100 mg koncentrat za otopinu za infuziju Rixathon 500 mg koncentrat za otopinu za infuziju
Patients randomised to the rituximab group received an initial intravenous infusion of 1000 mg rituximab on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Bolesnici randomizirani u skupinu liječenu rituksimabom primili su početnu intravensku infuziju rituksimaba u dozi od 1000 mg na 1. dan ispitivanja te su primali prednizon u peroralnoj dozi od 0,5 mg/kg na dan, koja se postupno smanjivala tijekom 3 mjeseca ako su imali umjerenu bolest, odnosno u peroralnoj dozi od 1 mg/kg na dan, koja se postupno smanjivala tijekom 6 mjeseci ako su imali tešku bolest.
The recommended dosage of Rixathon in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Preporučena doza lijeka Rixathon u kombinaciji s kemoterapijom za prethodno neliječene bolesnike i bolesnike koji nisu odgovorili na liječenje ili su u relapsu iznosi 375 mg/m2 tjelesne površine primijenjeno nultog dana prvog ciklusa liječenja, nakon čega slijedi 500 mg/m2 tjelesne površine primijenjeno prvog dana svakog sljedećeg ciklusa, tijekom ukupno 6 ciklusa.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
24 sata na temperaturi od 2 °C do 8 °C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
CLL affects a particular lymphocyte, the B cell, which originates from the bone marrow and develops in the lymph nodes.
Kronična limfocitna leukemija zahvaća određene limfocite, B-stanice, koje nastaju u koštanoj srži, a razvijaju se u limfnim čvorovima.
If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Imate li reumatoidni artritis, granulomatozu s poliangitisom, mikroskopski poliangitis ili obični pemfigus, obavijestite svog liječnika
Cardiac Disorders
Kardiovaskularne nuspojave
A total of 19/34 (56%) patients with PV, who were treated with rituximab, tested positive for ADA antibodies by 18 months.
Post-hoc retrospektivna laboratorijska ocjena Ukupno 19/34 (56 %) bolesnika s PV-om liječenih rituksimabom bilo je pozitivno na antitijela na lijek u 18. mjesecu.
Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 x 1,000 mg dose group.
Srednje terminalno poluvrijeme eliminacije iznosilo je od 15 do 16 dana u skupini koja je primala dozu od 2 x 500 mg te 17 do 21 dan u skupini koja je primala dozu od 2 x 1000 mg.
A total of 392/3,095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
U kliničkim ispitivanjima je nakon terapije rituksimabom ukupno 392/3095 (12,7 %) oboljelih od reumatoidnog artritisa bilo pozitivno na antitijela na lijek.
Infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections, herpes zoster and urinary tract infections.
Infekcije su pretežno bile blage do umjerene i uglavnom su obuhvaćale infekcije gornjih dišnih putova, herpes zoster i infekcije mokraćnih putova.
There was no apparent negative impact of the presence of ADA on safety or efficacy in the induction of remission trial.
Prisutnost antitijela na lijek nije imala primjetnog negativnog utjecaja na sigurnost ni djelotvornost u ispitivanju primjene lijeka za poticanje remisije.
Chemical and physical stability of Rixathon diluted in 5% glucose solution has been demonstrated for 24 hours at 2°C - 8°C and subsequently 12 hours at room temperature (≤25°C).
• Nakon aseptičkog razrjeđivanja u otopini glukoze: Dokazana je kemijska i fizička stabilnost lijeka Rixathon razrijeđenog u 5 %-tnoj otopini glukoze tijekom 24 sata na temperaturi od 2 °C do 8 °C te potom 12 sati na sobnoj temperaturi (≤ 25°C).
Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 x 500 mg dose and ranged from 355 to 404 μg/mL for the 2 x 1,000 mg dose.
Nakon druge se infuzije prosječni Cmax kretao između 183 i 198 µg/ml pri dozi od 2 x 500 mg, odnosno između 355 i 404 µg/ml pri dozi od 2 x 1000 mg.
Ninety-nine patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
U kliničkom je ispitivanju 99 bolesnika liječeno rituksimabom (375 mg/m2, jedanput tjedno tijekom 4 tjedna) i glukokortikoidima za poticanje remisije GPA i MPA (vidjeti dio 5.1).
What you need to know before you are given Rixathon Do not take Rixathon if
• što morate znati prije nego primite lijek Rixathon
% SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID † Outcome at 24 weeks Significant difference from placebo at the primary time point: * p < 0.05, ** p < 0.001, *** p ≤ 0.0001 MCID HAQ-DI ≥ 0.22, MCID SF-36 PHS > 5.42, MCID SF-36 MHS > 6.33
% bolesnika sa SF-36 PHS MCID Srednja vrijednost promjene SF-36 MHS % bolesnika sa SF-36 MHS MCID † Ishod nakon 24 tjedna
The study showed statistically significant results of rituximab and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
Rezultati U 24. mjesecu ispitivanja kombinacija rituksimaba i niske doze prednizona ostvarila je statistički značajne rezultate u odnosu na standardnu dozu prednizona s obzirom na postizanje potpune remisije bez primjene kortikosteroida tijekom ≥ 2 mjeseca u bolesnika s PV-om (vidjeti Tablicu 18).
< 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
375 mg/m2 i održao na toj razini u većine bolesnika do trenutka mjere ishoda nakon 6 mjeseci.
In a long-term observational safety study, 97 GPA/MPA patients received treatment with rituximab (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
U dugoročnom opservacijskom ispitivanju sigurnosti 97 bolesnika s GPA-om/MPA-om primalo je rituksimab (srednja vrijednost broja infuzija: 8 [raspon: 1 - 28]) tijekom razdoblja do 4 godine,
Median FU, months
Medijan TTF/PFS/EFS, mjeseci stope OS,
All IRR symptoms were mild or moderate and most of them were reported from the SOCs Respiratory, Thoracic and Mediastinal Disorders and Skin and Subcutaneous Tissue disorders.
Svi simptomi reakcija povezanih s infuzijom bili su blage ili umjerene težine i većinom se radilo o poremećajima dišnog sustava, prsišta i sredoprsja te poremećajima kože i potkožnog tkiva.
Toxic Epidermal Necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Poremećaji kože i potkožnog tkiva alopecija toksična epidermalna nekroliza (Lyellov sindrom), StevensJohnsonov sindrom5
All patients treated with Rixathon for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Svim bolesnicima s reumatoidnim artritisom, granulomatozom s poliangitisom, mikroskopskim poliangitisom ili običnim pemfigusom koji se liječe lijekom Rixathon potrebno je uz svaku infuziju dati karticu s upozorenjima za bolesnika.
In most cases, the infusion can be resumed at a 50% reduction in rate (e.g. from 100 mg/h to 50 mg/h) when symptoms have completely resolved.
100 mg/sat na 50 mg/sat) kada se simptomi u potpunosti povuku.
Decreased IgG levels4
Pretrage snižene razine IgM-a4
Rixathon 100 mg concentrate for solution for infusion Each 10 mL vial contains 100 mg of rituximab.
Rixathon 100 mg koncentrat za otopinu za infuziju Jedna bočica od 10 ml sadrži 100 mg rituksimaba (rituximabum).
When you are treated with Rixathon in combination with chemotherapy, you will receive Rixathon infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
b) Bolesnici koji se liječe od kronične limfocitne leukemije Kada se liječite lijekom Rixathon u kombinaciji s kemoterapijom, primit ćete infuziju lijeka Rixathon nultog dana prvog ciklusa, a zatim prvog dana svakog sljedećeg ciklusa tijekom ukupno 6 ciklusa.
Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) scores were observed in patients treated with rituximab compared to patients treated with methotrexate alone.
Functional Assessment of Chronic Illness Therapy - Fatigue, FACIT-Fatigue) u odnosu na bolesnike liječene samo metotreksatom.
The recommended dose of Rixathon used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
Preporučena doza lijeka Rixathon u terapiji održavanja u bolesnika s prethodno neliječenim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi 375 mg/m2 površine tijela jedanput svaka 2 mjeseca (počevši 2 mjeseca nakon zadnje doze uvodne terapije) do progresije bolesti ili najdulje dvije godine (ukupno 12 infuzija).
In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
U ispitivanju u prvoj liniji liječenja, nakon medijana promatranja od 48,1 mjeseca, medijan preživljenja bez progresije bolesti (PFS) iznosio je 55 mjeseci u R-FC skupini i 33 mjeseca u FC
Bronchitis, sinusitis, gastroenteritis, tinea pedis
Infekcije i infestacije infekcija gornjih dišnih putova, infekcije mokraćnih putova bronhitis, sinusitis, gastroenteritis, tinea pedis
Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Tablica 4 Nuspojave koje su nastupile u ≥ 5% bolesnika koji su primali rituksimab za terapiju održavanja GPA i MPA i koje su se pojavile s većom učestalošću nego u usporednoj skupini Organski sustav
Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
Klinička iskustva u liječenju granulomatoze s poliangitisom (Wegenerova granulomatoza) i mikroskopskog poliangitisa
In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or rituximab in combination with FC (R-FC).
552 bolesnika s relapsirajućim/refraktornim KLL-om randomizirano da primaju FC kemoterapiju (fludarabin 25 mg/m2, ciklofosfamid 250 mg/m2, prva tri dana) svaka 4 tjedna kroz 6 ciklusa, ili rituksimab u kombinaciji s FC kemoterapijom (R-FC).
• severe blistering skin conditions that can be life-threatening.
• stvaranje teških plikova po koži koji mogu ugroziti život.
Rixathon 500 mg concentrate for solution for infusion Each 50 mL vial contains 500 mg of rituximab.
Rixathon 500 mg koncentrat za otopinu za infuziju Jedna bočica od 50 ml sadrži 500 mg rituksimaba (rituximabum).
• being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion
• povraćanje, proljev, bol u trbuhu, nadraženost ili pojava vrijedova u grlu i ustima, otežano gutanje, zatvor, probavne tegobe
Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT)48.1 months median observation time
Omjeri hazarda za preživljenje bez progresije bolesti prema Binetovom stadiju (ITT populacija) - medijan vremena promatranja je 48,1 mjesec
• tightening of the muscles in the airways which causes wheezing (bronchospasm), inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose
• stezanje mišića u dišnim putovima koje uzrokuje piskanje pri disanju (bronhospazam), upala,
Rixathon is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Rixathon je u kombinaciji s CHOP kemoterapijom (ciklofosfamid, doksorubicin, vinkristin, prednizolon) indiciran u liječenju bolesnika s CD20 pozitivnim difuznim ne-Hodgkinovim limfomom velikih B-stanica.
This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of Rixathon treatment.
Nakon toga, treba tijekom i nakon 4tjednog uvodnog liječenja lijekom Rixathon peroralno davati prednizon u dozi od 1 mg/kg na dan (ne više od 80 mg na dan i što brže postupno smanjivati dozu, ovisno o kliničkoj potrebi).
• pain in the muscles or in the hands or feet
• napeti ili bolni mišići • bol u mišićima ili u šakama ili stopalima
No patients in the rituximab arm had fatal adverse events.
Ni u jednog bolesnika u skupini koja je primala rituksimab nije zabilježen štetni događaj sa smrtnim ishodom.
Sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
gljivična infekcija, infekcije nepoznate etiologije, +akutni bronhitis, +sinusitis, hepatitis B1
• severe vision loss
• zatajenje bubrega • težak gubitak vida
Median PFS: 28.8 Not reached p < 0.0001
Medijan PFS: Nije dostignuto p < 0,0001
Rheumatoid arthritis only
Samo reumatoidni artritis
Nervous System Disorders
Poremećaji živčanog sustava omaglica tremor
Hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Poremećaji metaboliz ma i prehrane hiperglikemija, smanjenje težine, periferni edem, edem lica,
d) Granulomatosis with polyangiitis or microscopic polyangiitis
d) granulomatoze s poliangitisom ili mikroskopskog poliangitisa
In a prospective, open label, international, multi-centre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
U prospektivnom, otvorenom, međunarodnom, multicentričnom kliničkom ispitivanju faze III, 465 bolesnika s relapsirajućim/refraktornim folikularnim limfomom randomizirano je u prvom koraku u skupinu koja je primala početno liječenje CHOP-om (ciklofosfamid, doksorubicin, vinkristin,
The percentage of patients reporting ADRs upon re-treatment with further courses of rituximab was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Postotak bolesnika koji su prijavili nuspojave nakon ponovnog liječenja dodatnim ciklusima rituksimaba bio je sličan postotku bolesnika koji su prijavili nuspojave nakon početnog liječenja
The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001) Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Skraćenice: ND: nije dostupno, ORR: stopa ukupnog odgovora na liječenje, CR: potpun odgovor, PR: djelomičan odgovor
Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 x 500 mg dose and 317 to 370 μg/mL for 2 x 1,000 mg dose.
Prosječni Cmax rituksimaba u serumu nakon prve infuzije bio je 170 do 175 µg/ml pri dozi od 2 x 500 mg, odnosno 317 do 370 µg/ml pri dozi od 2 x 1000 mg.
Table 17 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Tablica 17 Potpuna remisija nakon 6 mjeseci prema statusu bolesti Rituksimab
For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; CR 10%, PR 28%) with a projected median TTP for responding patients of 17.8 months (range 5.4-26.6).
26 % - 51 %; CR 10 %, PR 28 %), a procijenjeni medijan TTP-a u bolesnika koji su odgovorili na liječenje 17,8 mjeseci (raspon 5,4 - 26,6 mjeseci).
This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial.
Ovaj lijek sadrži 2,3 mmol (ili 52,6 mg) natrija po bočici od 10 ml.
In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or rituximab 375 mg/m2 plus CHOP (R-CHOP).
U randomiziranom otvorenom ispitivanju ukupno je 399 prethodno neliječenih starijih bolesnika (u dobi od 60 do 80 godina) s difuznim limfomom velikih B-stanica primalo standardnu CHOP kemoterapiju (ciklofosfamid 750 mg/m2, doksorubicin 50 mg/m2, vinkristin 1,4 mg/m2 do najviše
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva akne
The recommended dosage of Rixathon for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Preporučena doza lijeka Rixathon za liječenje običnog pemfigusa iznosi 1000 mg primijenjeno intravenskom infuzijom, a potom se nakon dva tjedna primjenjuje druga doza od 1000 mg intravenskom infuzijom u kombinaciji s glukokortikoidima, čija se doza postupno smanjuje.
Cmax following second infusion, was 207 μg/mL for the 2 x 500 mg dose and ranged from 377 to 386 μg/mL for the 2 x 1,000 mg dose.
Nakon druge infuzije vrijednost Cmax iznosila je 207 µg/ml pri dozi od 2 x 500 mg te 377 do 386 µg/ml pri dozi od 2 × 1000 mg.
• feeling restless, problems falling asleep
• nemir, teškoće s usnivanjem
Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
Svi bolesnici u kojih je broj CD4+ T-limfocita bio manji od 250/mm3 morali su primati profilaksu za pneumoniju koju uzrokuje