FrancophonIA/ELRC3.0 huggingface dataset:
English: During the treatment course in studies with rituximab in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Slovak: %; R-CHOP 97 % vs. CHOP 88 %, R-FC 30 % vs. FC 19 % u dovtedy neliečenej CLL), pancytopénia (R-FC 3
English: 3infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
Slovak: 3reakcie súvisiace s podaním infúzie (hypertenzia nauzea, vyrážka, pyrexia, pruritus, urtikária, dráždenie v hrdle, návaly tepla, hypotenzia, rinitída, zimnica, tachykardia, únava, orofaryngálna bolesť,
English: The infusion rate may be increased upon improvement of symptoms.
Slovak: Po zlepšení príznakov je možné rýchlosť infúzie zvýšiť.
English: Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the post-marketing setting.
Slovak: Po uvedení lieku na trh boli u pacientov s reumatoidnou artritídou hlásené závažné IRR s fatálnymi následkami.
English: CR rates
Slovak: Miera CR
English: Subsequent doses of Ritemvia 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.
Slovak: Nasledujúce dávky Ritemvie sa môžu podať počiatočnou rýchlosťou infúzie 100 mg/hod.
English: 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 32%.
Slovak: Následná analýza doby celkového prežívania pri priemernej dobe sledovania 60 mesiacov potvrdila úžitok liečby R-CHOP v porovnaní s CHOP (p=0,0071), čo predstavuje zníženie rizika o 32%.
English: Hazard Ratio (95% CI)
Slovak: Štatistická miera rizika (Hazard Ratio) (95%
English: Progression‐free survival (PFS) Overall survival
Slovak: PFS - progression free survival, prežívanie bez progresie
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1×109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1×109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Slovak: 42 dňom po poslednej dávke ) alebo sa neutropénia vyskytla s oneskoreným nástupom (definované ako počet neutrofilov pod 1 x 109/l po 42 dni po poslednej dávke u pacientov, ktorí predtým nemali prolongovanú neutropéniu alebo u pacientov, u ktorých došlo k zotaveniu pred 42. dňom ) po liečbe rituximabom a FC.
English: Cardiovascular reactions during clinical trials with rituximab monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Slovak: % pacientov hlásené kardiovaskulárne reakcie, pri čom najčastejšie hlásenými príhodami boli hypotenzia a hypertenzia.
English: 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).
Slovak: V randomizovanom, otvorenom skúšaní dostávalo 399 predtým neliečených starších pacientov (vek 60 až 80 rokov) s difúznym lymfómom veľkých B-buniek štandardnú CHOP chemoterapiu (cyklofosfamid 750 mg/m2, doxorubicín 50 mg/m2, vinkristín 1,4 mg/m2 až do maxima 2 mg v 1. deň a prednizolón 40 mg/m2/deň počas 1.-5. dňa) každé 3 týždne počas 8 cyklov, alebo rituximab 375 mg/m2 a CHOP (R-CHOP).
English: Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
Slovak: Klinická skúsenosť s granulomatózou s polyangiitídou (Wegenerovou) a mikroskopickou polyangiitídou
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of rituximab.
Slovak: V prípade výskytu alergickej reakcie počas podávania rituximabu majú byť okamžite dostupné lieky na liečbu reakcií z precitlivenosti, napr. epinefrín (adrenalín), antihistaminiká a glukokortikoidy.
English: Gastrointesti nal disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Slovak: hnačka, bolesť brucha, dysfágia, stomatitída, zápcha, dyspepsia, anorexia, dráždenie v hrdle zväčšenie brucha gastrointestináln a perforácia7
English: Investigations decreased IgM levels4
Slovak: Laboratórne a funkčné vyšetrenia znížené hladiny IgM4
English: ORR, % CR,%
Slovak: % vs FC 1 %
English: Vascular disorders
Slovak: Dyspepsia Zápcha
English: b) Granulomatosis with polyangiitis or microscopic polyangiitis
Slovak: b) granulomatózy s polyangiitídou alebo mikroskopickej polyangiitídy
English: Muscle weakness Musculoskeletal pain Pain in extremities
Slovak: Bolesť svalov a kostí Bolesť v končatinách
English: b) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Slovak: Ak sa liečite na granulomatózu s polyangiitídou alebo mikroskopickú polyangiitídu
English: Severe IRRs with fatal outcome have been reported in the post-marketing setting.
Slovak: Po uvedení lieku na trh boli hlásené závažné IRR s fatálnymi následkami.
English: Nervous system disorders paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety dysgeusia peripheral neuropathy, facial nerve palsy5
Slovak: vazodilatácia, závrat, úzkosť dysgeúzia periférna neuropatia, ochrnutie tvárového nervu5
English: The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Slovak: 1%, stupeň 3/4) a neodlišovala sa medzi liečebnými ramenami.
English: Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins to patients.
Slovak: Po intravenóznom podaní bielkovín pacientom boli hlásené prípady anafylaktických reakcií a iných reakcií z precitlivenosti.
English: Study Treatment, N
Slovak: Štúdia Liečba,
English: In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Slovak: definovali ako akákoľvek nežiaduca udalosť vyskytujúca sa v priebehu 24 hodín od infúzie a považovaná skúšajúcimi za súvisiacu s infúziou u populácie hodnotenej z dôvodu bezpečnosti.
English: • long lasting depression
Slovak: Konsekvencie dlhodobej deplécie
English: Ritemvia, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Slovak: Granulomatóza s polyangiitídou a mikroskopická polyangiitída Ritemvia, v kombinácii s glukokortikoidmi, je indikovaná na liečbu dospelých pacientov so závažnou, aktívnou granulomatózou s polyangiitídou (Wegenerova)
English: Millmount Healthcare Ltd.
Slovak: Millmount Healthcare
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).
Slovak: Miera úplnej odpovede po 8 cykloch bola 76,2%
English: Experience from pemphigus vulgaris
Slovak: Skúsenosti pri pemphigus vulgaris
English: The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Slovak: v.) dávkach 500 mg a 1 000 mg v 1. a 15. deň v štyroch štúdiách.
English: adjusted)
Slovak: (konjunktivitída)
English: (10 mg/mL) 500 mg / 50 mL
Slovak: 500 mg / 50 ml
English: For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Slovak: opakovaných liečení bola ORR 38 % (IS95 % 26 % - 51 %; 10 % CR, 28 % PR).
English: In a multicentre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses.
Slovak: V multicentrickom skúšaní s jedným ramenom dostávalo 37 pacientov s relapsovaným alebo chemorezistentným nízko-stupňovým alebo folikulovým B-bunkovým NHL 375 mg/m2 rituximabu v intravenóznej infúzii raz týždenne, spolu osem dávok.
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Slovak: odporúčaného maximálneho denného príjmu sodíka v potrave pre dospelých.
English: Herpes virus infection Herpes zoster Oral herpes Conjunctivitis
Slovak: Infekcia herpetickým vírusom Pásový opar
English: Physician information
Slovak: PÍSOMNÁ INFORMÁCIA
English: Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with rituximab.
Slovak: U pacientov liečených rituximabom sa vyskytla angina pectoris, srdcové arytmie ako je atriálny flutter a fibrilácia, srdcové zlyhanie a/alebo infarkt myokardu.
English: levels4
Slovak: Č. šarže
English: Ritemvia 500 mg concentrate for solution for infusion
Slovak: Ritemvia 500 mg infúzny koncentrát
English: Table 6 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Slovak: hodnotiacich prínos rituximabu a rôznych chemoterapeutických režimov pri folikulovom lymfóme
English: • Feeling generally unwell or listless.
Slovak: Celkový pocit choroby alebo malátnosti.
English: Musculoskeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Slovak: Poruchy kostrovej a svalovej sústavy a spojivového tkaniva artralgia/muskuloskeletálna bolesť
English: Do not breast-feed while you are being treated with Ritemvia.
Slovak: Počas liečby Ritemviou nedojčite.
English: • Information that the product should be administered as IV only to avoid administration route errors.
Slovak: Ritemvia majú obsahovať nasledujúce kľúčové prvky: informácie, že tento liek sa má podávať výhradne intravenózne, aby sa zabránilo chybám cesty podania.
English: Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral blood and in lymphoid tissue.
Slovak: V toxikologických štúdiách na makakoch sa nedokázal žiadny iný účinok okrem predpokladanej, farmakologicky navodenej deplécie
English: R-FC (N=408)
Slovak: (N = 408)
English: Sodium chloride Tri-sodium citrate dihydrate Polysorbate 80
Slovak: Zoznam pomocných látok chlorid sodný dihydrát trinátriumcitrátu polysorbát 80 voda na injekciu
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 × 500 mg dose and 317 to 370 μg/mL for 2 × 1000 mg dose.
Slovak: Cmax sérového rituximabu po prvej infúzii bola 170 až 175 μg/ml pri dávke 2 x 500 mg a 317 až 370 μg/ml pri dávke 2 x 1 000 mg. Cmax po druhej infúzii bola 207 μg/ml pri dávke 2 x 500 mg a pohybovala sa od 377 do 386 μg/ml pri dávke 2 x 1 000 mg.
English: 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 respectively.
Slovak: Arbor, ECOG, β-2-mikroglobulín, LDH, albumín, B-symptómy, rozsiahle ochorenie, extranodálne miesta, účasť kostnej drene) miera rizika pre prežívanie bez udalostí a pre celkové prežívanie (R
English: Ritemvia 100 mg concentrate for solution for infusion
Slovak: Ritemvia 100 mg infúzny koncentrát
English: Granulomatosis with polyangiitis and microscopic polyangiitis
Slovak: Granulomatóza s polyangiitídou a mikroskopická polyangiitída
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Ritemvia (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card?
Slovak: Karta k Ritemvie (rituximab) pre pacientov s neonkologickými ochoreniami
English: serum sickness-like reaction
Slovak: reakcia podobná sérovej chorobe
English: This medicinal product contains 263.2 mg sodium per 50 mL vial, equivalent to 13.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Slovak: Tento liek obsahuje 263,2 mg sodíka na v 50 mL injekčnú liekovku, čo zodpovedá 13,2%
English: Gastrointestinal perforation in some cases leading to death has been observed in patients receiving rituximab for treatment of non-Hodgkin's lymphoma.
Slovak: U pacientov, ktorí dostávali rituximab na liečbu non-Hodgkinovho lymfómu, sa pozorovala gastrointestinálna perforácia, ktorá v niektorých prípadoch viedla k úmrtiu.
English: All patients received concomitant 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion.
Slovak: Všetci pacienti súbežne dostali perorálnu dávku 60 mg prednizónu na 2. −
English: Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well.
Slovak: Granulomatóza s polyangiitídou a mikroskopická polyangiitída sú dve formy zápalu krvných ciev,
English: 1) Estimates were calculated by hazard ratios
Slovak: Odhady sa vypočítali podľa pomerov šancí 2)
English: however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
Slovak: Nie sú k dispozícii dostatočné a dobre kontrolovateľné údaje zo štúdií u gravidných žien, avšak u niektorých dojčiat narodených matkám, ktorým sa podával rituximab počas gravidity, boli hlásené prechodná deplécia B-buniek a lymfocytopénia.
English: Persistent depressive disorder Major depression Irritability
Slovak: Pretrvávajúca depresívna porucha „Veľká depresia“ (t.
English: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK
Slovak: Bridgend, CF31 3RT, Spojené kráľovstvo
English: 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
Slovak: 5 % pacientov dostávajúcich rituximab pri udržiavacej liečbe GPA a MPA a s vyššou frekvenciou ako porovnávacia skupina po 6 mesiacoch
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, 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 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Slovak: V otvorenom randomizovanom skúšaní bol celkový počet 322 doteraz neliečených pacientov s folikulovým lymfómom, ktorí boli randomizovaní buď na prijímanie CVP chemoterapie (cyklofosfamid 750 mg/m2, vinkristín 1,4 mg/m2 až do maxima 2 mg v 1. deň, a prednizoló 40 mg/m2/deň od 1. - 5. dňa) každé 3 týždne počas 8 cyklov, alebo rituximabu 375 mg/m2 v kombinácii s CVP (R-CVP).
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.
Slovak: A, mumps, rubeola, varicella) ostali nezmenené prinajmenšom po dobu 6 mesiacov po liečbe rituximabom.
English: Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course.
Slovak: Závažné IRR boli menej časté (0,5
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.
Slovak: 2% absolútnym rozdielom v incidencii medzi skupinou liečenou rituximabom a skupinou liečenou štandardnou dávkou prednizónu až do 24. mesiaca.
English: 1 vial contains 500 mg of rituximab.
Slovak: 1 injekčná liekovka obsahuje 500 mg rituximabu.
English: Patient's
Slovak: Starší pacienti
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).
Slovak: Po podaní dvoch intravenóznych infúzií rituximabu v dávke 1000 mg s odstupom dvoch týždňov bol priemerný terminálny polčas 20,8 dní (rozsah, 8,58 až 35,9 dní), priemerný systémový klírens bol
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the rituximab group and at a higher frequency than the comparator group.
Slovak: 5 % v skupine s rituximabom a vo vyššej frekvencii ako v porovnávacej skupine.
English: Rituximab in combination with methotrexate significantly increased the proportion of patients achieving at least a 20% improvement in ACR score compared with patients treated with methotrexate alone (Table 12).
Slovak: 20% zlepšenie v ACR skóre v porovnaní s pacientami, ktorí sa liečili len metotrexátom (Tabuľka 12).
English: Observation (N = 167)
Slovak: Pozorovanie (N =
English: This medicinal product contains 52.6 mg sodium per 10 mL vial, equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Slovak: Tento liek obsahuje 52,6 mg sodíka na v 10 mL injekčnú liekovku, čo zodpovedá 2,6%
English: • pain in the tummy
Slovak: bolesť v mieste infúzie
English: The recommended dosage of Ritemvia 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.
Slovak: Odporúčané dávkovanie rituximabu na liečbu pemphigus vulgaris je 1 000 mg podaných i.v. infúziou,
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).
Slovak: ORR na liečbu bola 36% (IS95% 21% - 51%; CR 3%, PR
English: Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Slovak: Skúsenosti s granulomatózou s polyangiitídou a mikroskopickou polyangiitídou)
English: Respiratory, thoracic and mediastinal disorders bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Slovak: zväčšujúci sa kašeľ, rinitída astma, bronchiolitis obliterans, porucha pľúc, hypoxia intersticiáln a pľúcna choroba7
English: Infusion related reactions
Slovak: Reakcie súvisiace s podávaním infúzie
English: Localised candida infections as well as Herpes zoster were reported at a higher incidence in the rituximab-containing arm of randomised studies.
Slovak: V randomizovaných štúdiách v ramene s rituximabom boli lokalizované infekcie kandidami, ako aj herpes zoster, hlásené s vyšším výskytom.
English: For intravenous use after dilution
Slovak: Na vnútrožilové podanie po nariedení
English: • Fever or cough all the time
Slovak: Horúčka alebo pretrvávajúci kašeľ
English: Cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
Slovak: B vrátane fulminantnej hepatitídy končiacej úmrtím.
English: approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Slovak: 1 000 absolvovalo 5 alebo viac cyklov.
English: Ask your pharmacist how to throw away medicines that you no longer use.
Slovak: Nepoužitý liek vráťte do lekárne.
English: 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.
Slovak: Ďalšie symptómy zahŕňajú nával horúčavy, angioedém, bronchospazmus, vracanie, nauzeu, urtikáriu/vyrážku, únavu,
English: The most frequent reported or observed serious adverse drug reactions were:  IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Slovak: IRR (vrátane syndrómu uvoľnenia cytokínov, syndrómu rozpadu nádoru), pozri časť 4.4.
English: Body system
Slovak: Respiračný systém
English: p-value a
Slovak: p-hodnotaa
English: N/A N/A
Slovak: %) a
English: Each vial contains 500 mg of rituximab.
Slovak: Každá injekčná liekovka obsahuje 500 mg rituximabu.
English: Each vial contains 100 mg of rituximab.
Slovak: Každá injekčná liekovka obsahuje 100 mg rituximabu.
English: Non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Slovak: Non-Hodgkinov lymfóm a chronická lymfocytová leukémia Reakcie súvisiace s infúziou
English: • respiratory failure
Slovak: respiračné ochorenie,
English: The vial contains 500 mg of rituximab.
Slovak: Injekčná liekovka obsahuje 500 mg rituximabu.
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Slovak: Ďalšie hlásené závažné ADRs vrátane reaktivácie hepatitídy
English: Combination therapy
Slovak: Monoterapia
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 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.
Slovak: 10 buniek/μl po dvoch týždenných infúziách rituximabu 375 mg/m2 a u väčšiny pacientov ostal na takej úrovni do 6 mesiacov.
English: Severe infections were reported in about 4% of patients treated with rituximab monotherapy.
Slovak: Závažné infekcie boli hlásené u približne 4 % pacientov,
English: • blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
Slovak: • problémy so zrážaním krvi, znížená tvorba červených krviniek a zvýšený rozklad červených krviniek (aplastická hemolytická anémia), opuchnuté alebo zväčšené lymfatické uzliny pokles nálady a strata záujmu alebo radosti z obvyklých činností, nervozita problémy s chuťou - napríklad zmena vo vnímaní chutí problémy so srdcom - napríklad spomalenie srdcového tepu alebo bolesť na hrudi (angína)
English: 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%).
Slovak: 0,0001, test chí2) v skupine R-CVP (80,9
English: 1 vial contains 100 mg of rituximab.
Slovak: 1 injekčná liekovka obsahuje 100 mg rituximabu.
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
Slovak: (WHO) nemali žiadny vplyv na farmakokinetiku rituximabu.
English: Urinary tract infection Bronchitis
Slovak: Infekcia močových ciest