FrancophonIA/ELRC3.0 huggingface dataset:
English: Cycle 5 (pre-dose Cycle 6) were higher among the MabThera subcutaneous group than the MabThera intravenous group; 97.5 µg/mL (42.6) versus 61.5 µg/mL (63.9) respectively with a resulting adjusted geometric mean ratio [90% CI] of 1.53 [1.27-1.85].
Slovenian: Geometrične sredine Ctrough (KV %) v 5. ciklu (pred odmerkom 6. cikla) so bile višje v skupini, ki je zdravilo MabThera prejemala podkožno (97,5 µg/ml (42,6)), kot v skupini, ki je zdravilo MabThera prejemala intravensko (61,5 µg/ml (63,9)); prilagojeno razmerje geometričnih sredin [90-% IZ] je bilo
English: ORRa
Slovenian: ORRa ocena
English: Patients treated with MabThera may receive non-live vaccinations.
Slovenian: Bolniki, ki se zdravijo z zdravilom MabThera, lahko prejmejo mrtva cepiva, vendar je lahko odgovor nanje zmanjšan.
English: Local cutaneous reactions of any grade in the MabThera subcutaneous arm were most common during the first subcutaneous cycle (Cycle 2), followed by the second, and the incidence decreased with subsequent injections.
Slovenian: Lokalne kožne reakcije katere koli stopnje so bile v skupini bolnikov, ki so prejemali podkožno obliko zdravila MabThera, najpogostejše med prvim ciklom zdravljenja s podkožno obliko (2. cikel).
English: The geometric mean tmax in the MabThera subcutaneous group was approximately 3 days as compared to the tmax occuring at or close to the end of the infusion for the MabThera intravenous group.
Slovenian: Geometrična sredina časa do največje koncentracije (tmax) je bila v skupini s podkožno obliko zdravila približno 3 dni; pri intravenski obliki zdravila MabThera je bil tmax dosežen na koncu ali blizu konca infuzije.
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocyt openia anaemia, +pancytopenia, +granulocytopeni a coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija, levkopenija, +febrilna nevtropenija, +trombocito penija anemija, +pancitopenija, +granulocitopeni ja motnje koagulacije,
English: • multiple-organ failure.
Slovenian: · odpoved več organov
English: During the treatment course in studies with MabThera 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.
Slovenian: Med zdravljenjem v študijah zdravila MabThera v kombinaciji s kemoterapijo sta bili 3. ali 4. stopnja levkopenije (R-CHOP 88 % v primerjavi s CHOP 79 %, R-FC 23 % v primerjavi s FC 12 %), nevtropenije (R-CVP 24 % v primerjavi s CVP 14 %, R-CHOP 97 % v primerjavi s CHOP 88 %, R-FC: 30 % v primerjavi s FC 19 % pri predhodno nezdravljeni KLL), pancitopenije (R-FC: 3 % v primerjavi s FC 1 % pri predhodno nezdravljeni KLL) po navadi pogostejši kot s kemoterapijo samo.
English: • low number of white blood cells, with or without fever or blood cells called “platelets”
Slovenian: · bakterijske ali virusne okužbe, bronhitis · majhno število belih krvnih celic (z zvišano telesno temperaturo ali brez nje) ali krvnih celic, ki jih imenujemo trombociti (krvne ploščice)
English: Exploratory analyses showed response rates among BSA, chemotherapy and gender subgroups were not notably different from the ITT population.
Slovenian: a na koncu indukcije b v času končne analize (mediana spremljanja 58 mesecev) Eksplorativne analize so pokazale, da v podskupinah, ločenih glede na telesno površino, kemoterapijo in spol, deleži odgovorov niso bili pomembno drugačni od populacije, ki so jo nameravali zdraviti.
English: b) If you are being treated for chronic lymphocytic leukaemia When you are treated with MabThera in combination with chemotherapy, you will receive MabThera infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Slovenian: Ko se boste zdravili z zdravilom MabThera v kombinaciji s kemoterapijo, boste dobili infuzijo zdravila MabThera 0. dan 1. cikla in nato 1. dan vsakega naslednjega cikla, skupaj 6 ciklov.
English: 10.49 years log-rank p value hazard ratio (95% CI) risk reduction Secondary efficacy Overall survival (median)
Slovenian: 10,49 let vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
English: MabThera 100 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Slovenian: MabThera 100 mg koncentrat za raztopino za infundiranje Prozorne viale iz stekla tipa I z gumijastim zamaškom, ki vsebujejo 100 mg rituksimaba v 10 ml.
English: You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.
Slovenian: Na začetku zdravljenja boste zdravilo MabThera vedno dobili v intravenski infuziji.
English: • MabThera subcutaneous formulation (n= 205): first cycle MabThera intravenous formulation plus 7 cycles of MabThera subcutaneous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks.
Slovenian: · Podkožna oblika zdravila MabThera (n = 205): prvi cikel z intravensko obliko zdravila MabThera in nato 7 ciklov podkožne oblike zdravila MabThera v kombinaciji z do 8 cikli kemoterapije CHOP ali CVP, uporabljene enkrat na 3 tedne.
English: The majority of patients had received MabThera in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Slovenian: Večina bolnikov je prejemala zdravilo MabThera v kombinaciji s kemoterapijo ali v okviru presaditve krvotvornih matičnih celic.
English: The most common infections in the MabThera arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Slovenian: MabThera so bile okužbe zgornjih dihal, gastroenteritis, okužbe sečil in herpes zoster.
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 MabThera 375 mg/m2 in combination with CVP (R-CVP).
Slovenian: V odprtem randomiziranem preskušanju so skupaj 332 predhodno še nezdravljenih bolnikov s folikularnimi limfomi randomizirali na prejemanje kemoterapije CVP (750 mg/m2 ciklofosfamida, 1,4 mg/m2 vinkristina do največ 2 mg 1. dan in 40 mg/m2/dan prednizolona od 1. do 5. dneva) na 3 tedne 8 ciklov, ali na 375 mg/m2 zdravila MabThera v kombinaciji s CVP (R-CVP).
English: In a non-randomized study, patients with relapsed low-grade NHL who received the MabThera intravenous formulation as monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 69% when assessed for >2-fold increase in antibody titer).
Slovenian: V nerandomizirani študiji so bolniki, ki so prejeli samostojno zdravljenje z zdravilom MabThera ob ponovitvi nizkomalignega NHL, v primerjavi z zdravimi kontrolnimi osebami, ki niso prejele zdravila, v manjšem deležu odgovorili na cepljenje s cepivom proti tetanusu (recall antigen) (16 % v primerjavi z 81 %) in neoantigenom KLH (Keyhole Limpet Haemocyanin) (4 % v primerjavi s 69 % ob določanju > 2-kratnega povečanja titra protiteles).
English: A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
Slovenian: Vzdrževalno zdravljenje Vzdrževalno infuzijo 500 mg intravensko je treba uporabiti v 12. in 18. mesecu in nato vsakih
English: B-cell levels in human neonates following maternal exposure to MabThera have not been studied in clinical trials.
Slovenian: V kliničnih preskušanjih niso proučevali števila celic B pri novorojenčkih mater, zdravljenih z zdravilom MabThera.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev izsledkov študij z rituksimabom za vse podskupine pediatrične populacije s kronično limfocitno levkemijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Clinical experience of MabThera concentrate for solution for infusion in Non-Hodgkin's lymphoma
Slovenian: Klinične izkušnje s koncentratom za raztopino za infundiranje zdravila MabThera pri ne-Hodgkinovem limfomu Folikularni limfom
English: It sticks to the surface of a type of white blood cell called “B-Lymphocyte”.
Slovenian: Veže se na površino vrste belih krvnih celic, ki jih imenujemo limfociti B. Ko se rituksimab veže na njihovo površino, odmrejo.
English: 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 MabThera plus CHOP (R-CHOP, n=234).
Slovenian: pri katerih so se folikularni limfomi ponovili ali se niso odzvali na zdravljenje, randomiziranih v prvi del indukcijskega zdravljenja s CHOP (ciklofosfamid, doksorubicin, vinkristin, prednizolon, n = 231) ali zdravljenje z zdravilom MabThera in CHOP (R-CHOP, n = 234).
English: For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+"
Slovenian: Pri vsakem izrazu so pri določitvi pogostnosti upoštevali neželene učinke vseh stopenj (od blage do hude), razen za izraze, označene s "+", kjer so pri določitvi pogostnosti upoštevali le hude neželene učinke (≥ 3. stopnja po lestvici skupnih meril toksičnosti Nacionalnega inštituta za raka
English: The recommended dose of MabThera 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).
Slovenian: Priporočeni odmerek zdravila MabThera za vzdrževalno zdravljenje bolnikov s predhodno nezdravljenimi folikularnimi limfomi, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m2 telesne površine enkrat na 2 meseca (z začetkom 2 meseca po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 12 infuzij).
English: Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with MabThera.
Slovenian: Pri bolnikih, zdravljenih z zdravilom MabThera, so se pojavili angina pektoris, srčne aritmije, kot sta atrijska undulacija in fibrilacija, srčno popuščanje in/ali miokardni infarkt.
English: Most common local cutaneous reactions were injection site erythema (26%), injection site pain (16%), and injection site swelling (5%).Two patients in SAWYER trial who experienced Grade 3 local cutaneous reactions (injection site erythema, injection site pain and injection site swelling).
Slovenian: Najpogostejše lokalne kožne reakcije so bile eritem na mestu injiciranja (26 %), bolečina na mestu injiciranja (16 %) in otekanje na mestu injiciranja (5 %).
English: MabThera was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Slovenian: Zdravilo MabThera so bolnikom s KLL dajali v obliki intravenske infuzije v odmerku 375 mg/m2 telesne površine v prvem ciklu zdravljenja, odmerek pa se je v naslednjih 5 ciklih zdravljenja povečal na 500 mg/m2 telesne površine (v kombinaciji s fludarabinom in ciklofosfamidom).
English: 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 Progression-free survival (PFS)
Slovenian: Razmerja ogroženosti za preživetje brez napredovanja bolezni glede na stopnjo po Binetu (ITT) - mediana opazovanja 48,1 meseca Preživetje brez napredovanja bolezni (PFS)
English: • A complex of symptoms occurring within a few weeks of an infusion of MabThera including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov): · skupek simptomov, ki se pojavi v nekaj tednih po prejemu infuzije zdravila MabThera, in vključuje alergijske reakcije, kot so kožni izpuščaji, srbenje, bolečine v sklepih, otekle bezgavke in zvišano telesno temperaturo,
English: • bald spots on the scalp, chills, headache
Slovenian: · plešasti predeli na lasišču, mrzlica, glavobol
English: Very rare side effects (may affect up to 1 in 10, 000 people):
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov):
English: Co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Slovenian: Sočasna uporaba zdravila MabThera ni vplivala na farmakokinetiko fludarabina ali ciklofosfamida.
English: The most frequent ADRs following receipt of MabThera in clinical studies were IRRs (refer to Table 2).
Slovenian: Najpogostejši neželeni učinki po prejemu zdravila MabThera v kliničnih preskušanjih so bile reakcije,
English: Local cutaneous reactions were very common in patients receiving MabThera subcutaneous in clinical trials.
Slovenian: Lokalne kožne reakcije so bile v kliničnih preskušanjih pri prejemnikih podkožne oblike zdravila MabThera pogoste.
English: In trial SparkThera, no severe administration-related reactions were reported.
Slovenian: V preskušanju SparkThera niso zabeležili hudih reakcij, povezanih z dajanjem zdravila.
English: No difference between the R-CHOP and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure, myocardial disease and manifestations of coronary artery disease.
Slovenian: Incidenca preostalih srčnih dogodkov 3. in 4. stopnje (vključno s srčnim popuščanjem, miokardno boleznijo in manifestacijami koronarne bolezni)
English: Mean change DAS28-ESR -1.97**
Slovenian: Povprečna sprememba v DAS28-ESR
English: • being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion
Slovenian: · bruhanje, driska, bolečine v trebuhu, draženje ali razjede v žrelu in ustih, težave s požiranjem,
English: This medicinal product contains less than 1mmol sodium per dose, i.e. essentially sodium free.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija na odmerek, kar pomeni, da je praktično brez natrija.
English: MabThera has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Slovenian: Zdravilo MabThera v kombinaciji z metotreksatom zmanjša hitrost napredovanja okvar sklepov, ki jih spremljamo z rentgenskim slikanjem, in izboljša funkcijsko zmogljivost.
English: The recommended dose of MabThera 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.
Slovenian: Priporočeni odmerek zdravila MabThera v kombinaciji s kemoterapijo za indukcijsko zdravljenje bolnikov s folikularnimi limfomi, ki se predhodno še niso zdravili ali se na prejšnje zdravljenje niso odzvali ali se jim je bolezen ponovila, je: 375 mg/m2 telesne površine na cikel do 8 ciklov.
English: 3Infusion related reactions (generalized oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalized pruritus, anaphylaxis, anaphylactoid reaction)
Slovenian: 3reakcije, povezane z infuzijo (generalizirani edem, bronhospazem, piskanje, edem grla,
English: In CLL patients, co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Slovenian: Pri bolnikih s KLL sočasna uporaba zdravila MabThera ni vplivala na farmakokinetiko fludarabina ali ciklofosfamida.
English: The reactions occurring within 24 hours of the subcutaneous injection consisted primarily of erythema pruritus, rash and injections site reactions such as pain, swelling and redness and were generally of mild or moderate (grade 1 or 2) and transient nature (see section 4.8).
Slovenian: Te reakcije so se pojavile v 24 urah po podkožnem injiciranju in so obsegale predvsem eritem, srbenje, izpuščaj in reakcije na mestu injiciranja, npr. bolečine, oteklost in pordelost.
English: Musculo skeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v sklepu/mišično-skeletna bolečina, osteoartroza,
English: See the MabThera package leaflet for more information.
Slovenian: Za več informacij preberite navodilo za uporabo zdravila MabThera.
English: In the induction of remission clinical trial, 24% of patients in the MabThera group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Slovenian: V kliničnem preskušanju indukcije remisije se je nevtropenija, ki je bila 3. stopnje ali več po CTC, pojavila pri 24 % prejemnikov zdravila MabThera (en cikel) in pri 23 % prejemnikov ciklofosfamida.
English: Bronchitis
Slovenian: burzitis
English: The estimated median terminal elimination half-life of MabThera was 22 days (range, 6.1 to 52 days).
Slovenian: Ocenjena mediana končnega razpolovnega časa izločanja podkožne oblike zdravila MabThera je bila 29,7 dneva (razpon: od 9,9 do 91,2 dneva).
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP R-CHOP p-value Risk Reduction1)
Slovenian: Indukcijsko zdravljenje: pregled rezultatov učinkovitosti CHOP v primerjavi z R-CHOP (mediana časa opazovanja 31 mesecev)
English: A two-stage phase III, international, multi-centre, randomised, controlled, open-label trial was conducted in patients with previously untreated follicular lymphoma, to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of MabThera subcutaneous formulation in combination with CHOP or CVP versus MabThera intravenous formulation in combination with CHOP or CVP.
Slovenian: Namenjeno je bilo proučitvi neinferiornosti farmakokinetičnega profila ter učinkovitosti in varnosti podkožne oblike zdravila MabThera v kombinaciji s CHOP ali CVP v primerjavi z intravensko obliko zdravila MabThera v kombinaciji s CHOP ali CVP.
English: Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Slovenian: O kardiovaskularnih neželenih učinkih so med kliničnimi preskušanji zdravila MabThera kot samostojnega zdravila poročali pri 18,8 % bolnikov.
English: In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
Slovenian: Če zdravilo MabThera 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.
English: The recommended dosage of MabThera in combination with chemotherapy for previously untreated and relapsed/refractory patients is: MabThera intravenous formulation 375 mg/m2 body surface area administered on day 0 of the first cycle of treatment followed by MabThera subcutaneous formulation injected at a fixed dose of 1600 mg per cycle, on day 1 of each subsequent cycle (in total: 6 cycles).
Slovenian: Priporočeni odmerek zdravila MabThera v kombinaciji s kemoterapijo pri bolnikih, ki predhodno še niso bili zdravljeni oziroma se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila, je intravenska oblika zdravila MabThera v odmerku 375 mg/m2 telesne površine, ki ga damo na dan 0 prvega cikla zdravljenja, v naslednjih ciklih zdravljenja pa podkožna oblika zdravila MabThera, ki jo v enotnem odmerku 1600 mg injiciramo 1. dan vsakega nadaljnjega cikla (skupaj 6 ciklov).
English: • severe skin problems causing blisters that can be life-threatening
Slovenian: · hude težave s kožo, ki povzročijo mehurje in so lahko smrtno nevarne
English: MabThera 500 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Slovenian: MabThera 500 mg koncentrat za raztopino za infundiranje En ml vsebuje 10 mg rituksimaba.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Slovenian: Na voljo je v obliki koncentrata za raztopino za infundiranje.
English: You might get infections more easily during your treatment with MabThera.
Slovenian: Med zdravljenjem z zdravilom MabThera ste lahko bolj nagnjeni k okužbam.
English: Patients treated with MabThera in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Slovenian: zmanjšanje aktivnosti bolezni (DAS28, Disease Activity Score) pomembno večje kot pri bolnikih, ki so se zdravili samo z metotreksatom (preglednica 12).
English: Since hypotension may occur during MabThera infusion, consideration should be given to withholding anti-hypertensive medications 12 hours prior to the MabThera infusion.
Slovenian: Ker se med infuzijo zdravila MabThera lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred infuzijo zdravila MabThera bolnik prenehal jemati zdravila proti visokemu krvnemu tlaku.
English: The study showed statistically significant results of MabThera and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
Slovenian: Rezultati Študija je pri doseganju CRoff ³ 2 meseca po 24 mesecih pri bolnikih z navadnim pemfigusom pokazala statistično značilno razliko med shemo zdravila MabThera in majhnega odmerka prednizona ter shemo s standardnim odmerkom prednizona (glejte preglednico 18).
English: 4 see also section infusion-related reactions below.
Slovenian: Glejte tudi spodnji odstavek o reakcijah, povezanih z infuzijo.
English: In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of MabThera as an intravenous infusion once weekly for four weeks.
Slovenian: V ključnem preskušanju je 166 bolnikov, pri katerih se je nizko maligni ne-Hodgkinov limfom ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, 4 tedne prejemalo po 375 mg/m2 zdravila MabThera v obliki intravenske infuzije enkrat na teden.
English: FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Slovenian: 810 bolnikov (403 R-FC, 407 FC) iz študije pri bolnikih v prvi liniji zdravljenja (preglednici 10a ter 10b) ter 552 bolnikov (276 R-FC, 276 FC) iz študije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (preglednica 11).
English: Skin and subcutaneous tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, Stevens-Johns on syndrome toxic epidermal necrolysis (Lyell's syndrome) 7
Slovenian: znojenje, nočno znojenje, +bolezen kože hude bulozne kožne reakcije, StevensJohnsonov sindrom,
English: The geometric mean Ctrough (CV%) values at
Slovenian: Geometrična sredina Ctrough (na 2 meseca) µg/ml