natgillin/translations-raw huggingface dataset:
The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Varnostne značilnosti rituksimaba pri bolnikih z navadnim pemfigusom so se skladale z varnostnimi značilnostmi, opaženimi pri bolnikih z revmatoidnim artritisom in GPA/MPA.
Progression of Kaposi's sarcoma has been observed in rituximab-exposed patients with pre-existing Kaposi's sarcoma.
Pri bolnikih s Kaposijevim sarkomom, ki so se zdravili z rituksimabom, so opazili napredovanje Kaposijevega sarkoma.
This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.
Ne-Hodgkinov limfom je bolezen limfatičnega tkiva (ta je del imunskega sistema), ki prizadene vrsto belih krvnih celic, limfocite B. Zdravilo Rixathon lahko uporabljamo samostojno ali skupaj z drugimi zdravili, ki jih imenujemo kemoterapija.
Patients with human anti-mouse antibody (HAMA) or anti-drug antibody (ADA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
imajo lahko alergijske ali preobčutljivostne reakcije, če jih zdravimo z drugimi diagnostičnimi ali terapevtskimi monoklonskimi protitelesi.
Toxic Epidermal Necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Bolezni kože in podkožja alopecija toksična epidermalna nekroliza (Lyellov sindrom), StevensJohnsonov sindrom5
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).
V randomiziranem, odprtem preskušanju je 399 predhodno nezdravljenih starejših (starih od 60 do 80 let) bolnikov z difuznim velikoceličnim B limfomom prejelo osem ciklov standardne kemoterapije CHOP (750 mg/m2 ciklofosfamida, 50 mg/m2 doksorubicina, 1,4 mg/m2 do največ 2 mg/m2 vinkristina na prvi dan ter 40 mg/m2 prednizolona na 1. do 5. dan) vsake 3 tedne 8 ciklov ali pa 375 mg/m2
A Patient Alert Card will be included in the carton.
- izobraževalni letak za zdravstvenega delavca - izobraževalni letak za bolnika Opozorilna kartica za bolnika bo priložena v škatli.
The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with autoimmune arthritis.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z rituksimabom za vse podskupine pediatrične populacije z avtoimunskim artritisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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.
Povprečni končni razpolovni čas izločanja je bil 15 do 16 dni za 2 x 500 mg odmerek ter 17 do 21 dni za 2 x 1.000 mg odmerek.
All patients received concomitant 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion.
Vsi bolniki so sočasno peroralno prejemali 60 mg prednizona od 2. do 7. dne in 30 mg od
In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximabtreated patients vs 5% for azathioprine treated patients.
V kliničnem preskušanju vzdrževalnega zdravljenja je bila pojavnost nevtropenije vseh stopenj v skupini z rituksimabom 0 % in v skupini z azatioprinom 5 %.
The chemotherapy should be given after the Rixathon infusion.
Kemoterapijo boste dobili po infuziji zdravila Rixathon.
Rixathon is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
d) granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa Zdravilo Rixathon se uporablja za zdravljenje granulomatoze s poliangiitisom (prej imenovane Wegenerjeva granulomatoza) ali mikroskopskega poliangiitisa; daje se v kombinaciji s kortikosteroidi.
B lymphocytes are involved in the cause of these conditions.
V nastanek teh bolezni so vpleteni limfociti B.
Rituximab was administered as two intravenous infusions separated by an interval of 15 days.
Rituksimab so bolniki prejeli v dveh intravenskih infuzijah v razmiku 15 dni.
Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Izkušnje pri granulomatozi s poliangiitisom in mikroskopskem poliangiitisu
Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal products 12 hours prior to the Rixathon infusion.
Ker se med infuzijo rituksimaba lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred infuzijo zdravila Rixathon bolnik prenehal jemati zdravila proti visokemu krvnemu tlaku.
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.
V kliničnem preskušanju indukcije remisije, v katerega so vključili 99 bolnikov, zdravljenih z rituksimabom, je bil celotni delež okužb na primarni končni točki po 6 mesecih približno 237 na
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
Razmerja ogroženosti za preživetje brez napredovanja bolezni glede na stopnjo po Binetu (ITT) - mediana opazovanja 48,1 meseca
• Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue,
• kožne reakcije, kot so koprivnica, srbenje in izpuščaji, • alergijske reakcije, vključno s piskanjem ali kratko sapo, otekanjem obraza in jezika ter kolapsom.
Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with rituximab compared to < 1% on observation.
O resnih neželenih dogodkih, povezanih s srcem (vključno z atrijsko fibrilacijo, miokardnim infarktom, popuščanjem levega prekata, ishemijo miokarda), so poročali pri 3 % bolnikov, ki so prejemali rituksimab in pri manj kot 1 % bolnikov v opazovani skupini.
A total of 19/34 (56%) patients with PV, who were treated with rituximab, tested positive for ADA antibodies by 18 months.
Po 18 mesecih je imelo skupno 19 od 34 (56 %) bolnikov z navadnim pemfigusom, zdravljenih z rituksimabom, pozitiven izvid za ADA.
• Inflammation, irritation and / or tightness of the lungs, and throat, coughing
• vnetje, draženje in/ali stiskanje v pljučih ter v žrelu, kašljanje,
Table 18 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Odstotek bolnikov z navadnim pemfigusom, ki so po 24 mesecih dosegli popolno remisijo brez kortikosteroidnega zdravljenja v obdobju dveh mesecev ali več (populacija z-namenom-zdravljenja - navadni pemfigus) rituksimab + prednizon n = 38
IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with to those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
V kliničnih preskušanjih so bile z infuzijo povezane reakcije pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom in navadnim pemfigusom podobne tistim pri bolnikih z revmatoidnim artritisom (glejte poglavje 4.8).
Concentrate for solution for infusion.
Na voljo je v obliki koncentrata za raztopino za infundiranje.
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.
150 bolnikov, ki so v preskušanju 1 sprva prejemali placebo + metotreksat, je do enega leta prejelo vsaj en cikel rituksimaba + metotreksata
PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rixathon Alert Card for patients with non-oncology diseases
Opozorilna kartica za bolnike, ki prejemajo zdravilo Rixathon za neonkološke bolezni
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.
Po drugi infuziji je bila povprečna Cmax 183 do 198 μg/ml za 2 x 500 mg odmerek ter 355 do 404 μg/ml za 2 x 1.000 mg odmerek.
This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
hiperurikemijo, hiperkaliemijo, hipokalciemijo, hiperfosfatemijo, akutno ledvično odpoved, zvišano laktat-dehidrogenazo (LDH), ter ga lahko spremlja akutna odpoved dihal in smrt.
Headache Dizziness
srčno popuščanje
Dyspepsia, diarrhoea, gastrooesophageal reflux, mouth ulceration, upper abdominal pain
Bolezni prebavil dispepsija, diareja, gastroezofagealni refluks, razjede v ustih, bolečina v zgornjem delu trebuha
• infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
• okužba krvi (sepsa), pljučnica, pasovec, prehlad, okužbe sapnic (bronhov), glivične okužbe,
Rixathon 100 mg concentrate for solution for infusion Each 10 mL vial contains 100 mg of rituximab.
Rixathon 100 mg koncentrat za raztopino za infundiranje Ena 10 ml viala vsebuje 100 mg rituksimaba (rituximabum).
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.
Vsem bolnikom, ki se z zdravilom Rixathon zdravijo zaradi revmatoidnega artritisa, granulomatoze s poliangiitisom, mikroskopskega poliangiitisa ali navadnega pemfigusa, je treba ob vsaki infuziji dati opozorilno kartico (glejte Dodatek IIIA - Označevanje).
Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following Rixathon treatment, as appropriate according to local clinical practice guidelines.
Pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom ali navadnim pemfigusom je med zdravljenjem z zdravilom Rixathon in po njem priporočljiva profilaksa proti pljučnici, ki jo povzroča Pneumocystis jirovecii, kot je ustrezno glede na lokalne smernice klinične prakse.
Rixathon 500 mg concentrate for solution for infusion Each 50 mL vial contains 500 mg of rituximab.
Rixathon 500 mg koncentrat za raztopino za infundiranje Ena 50 ml viala vsebuje 500 mg rituksimaba (rituximabum).
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.
Po drugi infuziji je bila Cmax 207 μg/ml za 2 x 500 mg odmerek ter 377 do 386 μg/ml za 2 x 1.000 mg odmerek.
Also do not breast-feed for 12 months after your last treatment with Rixathon.
Prav tako ne smete dojiti še 12 mesecev po zadnjem odmerku zdravila Rixathon.
In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy).
Pri bolnikih, ki so se zdravili zaradi hematoloških malignih bolezni, so se celice B začele obnavljati v 6 mesecih zdravljenja, njihovo število pa se je v splošnem vrnilo v normalno stanje v
Hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Presnovne in prehranske motnje hiperglikemij a, zmanjšanje telesne mase, periferni edem, edem obraza, zvišanje LDH, hipokalciemij a
Rixathon 100 mg concentrate for solution for infusion Rixathon 500 mg concentrate for solution for infusion
Rixathon 100 mg koncentrat za raztopino za infundiranje Rixathon 500 mg koncentrat za raztopino za infundiranje
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).
Priporočeni odmerek zdravila Rixathon za vzdrževalno zdravljenje bolnikov s ponovitvijo folikularnih limfomov ali neodzivno boleznijo, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m2 telesne površine enkrat na 3 mesece (z začetkom 3 mesece po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 8 infuzij).
ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
The reactions reported were usually reversible with a reduction in rate, or interruption, of rituximab infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Reakcije, o katerih so poročali, so bile običajno reverzibilne z zmanjšanjem hitrosti ali prekinitvijo infuzije rituksimaba in dajanjem antipiretika, antihistaminika in občasno kisika,
The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Najpogostejše okužbe v skupini z rituksimabom so bile okužbe z virusoma herpes simpleks in herpes zoster, bronhitis, okužbe sečil,
Duration of response* Disease free survival (DFS)** Time to new treatment
trajanje odgovora* preživetje brez bolezni**
Patient subpopulations - rituximab monotherapy
Podskupine bolnikov - samostojno zdravljenje z rituksimabom
collapse
Dihala
This is a type of protein called a “monoclonal antibody”.
Zdravilo Rixathon vsebuje učinkovino rituksimab, ki je vrsta beljakovine, imenovana monoklonsko protitelo.
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.
Neželeni učinki, navedeni v preglednici 3, so se v skupini, ki je prejemala rituksimab, pojavili z incidenco ≥ 5 % in pogosteje kot v primerjalni skupini.
Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Iz populacijske farmakokinetične analize pri 298 bolnikih z ne-Hodgkinovim limfomom, ki so prejeli enkratno ali večkratno infuzijo rituksimaba (odmerki od 100 do 500 mg/m2) samostojno ali v kombinaciji s CHOP, lahko ocenimo nespecifični očistek tipične populacije bolnikov (Cl1): 0,14 l/dan,
Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Rituksimab se veže specifično na transmembranski antigen, CD20, neglikoziliran fosfoprotein, ki se nahaja na limfocitih pre-B in dozorelih limfocitih B. Antigen je izražen pri > 95 % vseh B-celičnih ne-Hodgkinovih limfomov.
In patients with non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, premedication with glucocorticoids should be considered if Rixathon is not given in combination with glucocorticoid-containing chemotherapy.
Če zdravilo Rixathon za zdravljenje ne-Hodgkinovega limfoma in kronične limfocitne levkemije ni uporabljeno v kombinaciji s kemoterapijo, ki vključuje glukokortikoid, je treba razmisliti o premedikaciji z glukokortikoidi.
In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction.
V kliničnem preskušanju vzdrževalnega zdravljenja se je vsaj ena z infuzijo povezana reakcija pojavila pri 7 od 57 (12 %) bolnikov v skupini z rituksimabom.
• unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch
• neobičajni občutki na koži - na primer omrtvičenost, mravljinčenje, zbadanje, pekoč občutek,
• 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
• skrčenje mišic v dihalih, ki povzroči piskajoče dihanje (bronhospazem), vnetje, draženje pljuč,
Sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
glivične okužbe, okužbe neznane etiologije, +akutni bronhitis, +sinuzitis, hepatitis B1
A total of 1,078 patients responded to induction therapy, of which 1,018 were randomised to rituximab maintenance therapy (n=505) or observation (n=513).
Na indukcijsko zdravljenje se je odzvalo 1.078 bolnikov, od teh jih je bilo 1.018 randomiziranih v vzdrževalno zdravljenje z rituksimabom
The HCP educational leaflet about Rixathon for non-oncology indications contains the following key elements: - The need for close supervision during administration in an environment where full resuscitation facilities are immediately available - The need to check, prior to Rixathon treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system, and recent history of, or planned, vaccination, and a history of infusion-related reaction - The need to monitor patients for infections, especially PML, during and after Rixathon treatment - Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML - The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
- informacije o nujnosti skrbnega nadzora med aplikacijo v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo, - informacije o nujnosti, da pred dajanjem zdravila Rixathon preverijo, ali je bolnik morda okužen, imunsko oslabljen, ali jemlje zdravila, ki vplivajo na imunski sistem, ali jih je jemal v preteklosti, ali se je nedavno cepili oziroma to namerava, in anamnezo reakcij, povezanih z infuzijo
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
Okrajšave: NA: ni na voljo; ORR: celokupni odgovor (overall response rate); CR: popolni odgovor
Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to rituximab.
Na odgovor na rituksimab naslednji dejavniki niso imeli statistično značilnega vpliva (Fisherjev natančni test): starost, spol, gradus limfoma, začetna diagnoza, prisotnost ali odsotnost obsežne bolezni, normalna ali visoka koncentracija LDH ali ekstranodalna bolezen.
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.
Zdravilo Rixathon je indicirano za samostojno zdravljenje bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila.
Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the Rixathon infusion.
Ker se med aplikacijo rituksimaba lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred infuzijo zdravila Rixathon bolnik prenehal jemati zdravila proti visokemu krvnemu tlaku.
Toxic Epidermal Necrolysis (Lyell syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Zelo redko sta bila opisana toksična epidermalna nekroliza (Lyellov sindrom) ali Stevens-Johnsonov sindrom, v nekaterih primerih s smrtnim izidom.
• becoming very red in the face and other areas of the skin as a consequence of dilation of the blood vessels
• močna zardelost obraza in drugih predelov kože zaradi razširjenja žil,
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.
Začetno zdravljenje, obsežna bolezen, 4 odmerki, enkrat na teden Združeni podatki treh preskušanj navajajo, da je 39 bolnikov, pri katerih se je nizko maligni ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo in so imeli obsežno bolezen (ena lezija ≥ 10 cm v premeru), prejelo 4 odmerke po 375 mg/m2
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 rezultatov o učinkovitosti za rituksimab v kombinaciji s kemoterapijo FC v primerjavi s samo kemoterapijo FC - mediana opazovanja 48,1 meseca
• Rixathon will be given to you on the same day as your chemotherapy.
ga boste dobili isti dan kot kemoterapijo.
Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of rituximab for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Pri uporabi rituksimaba za zdravljenje avtoimunskih bolezni so poročali o smrtnih primerih progresivne multifokalne levkoencefalopatije, in sicer pri revmatoidnem artritisu in avtoimunskih boleznih, za katere zdravilo ni odobreno, sistemskem eritematoznem lupusu (SLE) in vaskulitisu.
This is because Rixathon can affect the way some other medicines work.
Zdravilo Rixathon namreč lahko vpliva na delovanje nekaterih drugih zdravil in obratno - tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Rixathon.
• you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis,
• imate hudo srčno popuščanje ali hudo, neurejeno srčno bolezen in imate tudi revmatoidni artritis, granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadni pemfigus.
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 Vključuje reaktivacijo in primarne okužbe; pogostnost temelji na režimu R-FC pri bolnikih s KLL, pri katerih se je bolezen ponovila, ali pri neodzivnih bolnikih.
Serum ickness-like reaction
reakcija, podobna serumski bolezni
The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
in očiščeno z afinitetno kromatografijo ter ionsko izmenjavo, vključno s specifičnimi postopki inaktivacije in odstranjevanja virusov.
Lung infiltration
infiltracija pljuč
Infusion-related reactions in the pemphigus vulgaris clinical study were common (58%).
V klinični študiji pri navadnem pemfigusu so bile z infundiranjem povezane reakcije pogoste (58 %).
What Rixathon is and what it is used for What Rixathon is
Kaj je zdravilo Rixathon in za kaj ga uporabljamo
Overall survival
Celokupno preživetje (OS)