natgillin/translations-raw huggingface dataset:
A good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients compared to patients treated with methotrexate alone (Table 9).
Dober do zmeren odziv po klasifikaciji Evropske lige za boj proti revmatizmu (EULAR, European League Against Rheumatism) je bil dosežen pri pomembno več bolnikih, ki so se zdravili z rituksimabom, kakor pri bolnikih, ki so se zdravili samo z metotreksatom (preglednica 9).
Radiographic response In Study 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score and its components, the erosion score and joint space narrowing score.
Izrazili so jih s spremembo skupne ocene okvar sklepov (po prirejeni Sharpovi lestvici) in njenih komponent: ocene erozij in ocene zožitve sklepne špranje.
Patients originally receiving rituximab/ MTX demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
Pri bolnikih, ki so prvotno prejemali rituksimab in metotreksat, je bilo po 56 tednih na posnetkih značilno manj znakov napredovanja kot pri tistih, ki so prvotno dobivali samo metotreksat.
A higher proportion of patients receiving the original rituximab/ MTX treatment also had no erosive progression over 56 weeks (Table 8).
Prav tako pri večjem deležu bolnikov, ki so prvotno prejemali rituksimab in metotreksat, ni prišlo do napredovanja erozij v 56 tednih (preglednica 8).
Radiographic mean changes over
Povprečne radiološke spremembe v 56 tednih v študiji 1.
56 weeks in Study 1
placebo + rituximab + metotreksat metotreksat 2×1g
Placebo+MTX
študija 1
p=0.0046 Erosion Score
skupna ocena okvar sklepov (po
p=0.0114 Joint Space narrowing score
Sharpovi lestvici) ocena erozij
0.99
p = p =
0.41
0, 99
p=0.0006 Proportion of patients with no erosive
delež bolnikov brez napredovanja
progression over 56 weeks
erozij v 56 tednih
p=0.0494
p = 0, 0494
Quality of life outcomes
Vpliv na kakovost življenja
1.3, respectively, Study 1).
Pri bolnikih, zdravljenih z rituksimabom, so opazili značilna znižanja v indeksu nezmožnosti (HAQ - DI), utrujenosti (FACIT- F) (preglednica 9) in izboljšanje v fizični in mentalni domeni zdravja SF- 36, v primerjavi z bolniki, ki so se zdravili le z metotreksatom (SF- 36 fizični 5, 8 v primerjavi z 0, 9, SF- 36 mentalni 4, 7 v primerjavi z 1, 3; študija 1).
Disease Activity and Quality of Life Outcomes at Week 24 in Study 1
kakovost življenja po 24. tednih v študiji 1.
Week 24 response:
Odziv v 24. tednu:
Change from baseline
placebo + rituksimab +
Placebo+MTX1 N= 201 mean (SD)
metotreksat n = 201
Rituximab+MTX1 N= 298 mean (SD) switch
metotreksat n = 298
p-value
povprečje (SD)
EULAR Good/ moderate
EULAR dober/ zmeren 1
-0.1 (0.5)
HAQ FACIT- F2 1
-0.5 (9.8) 3
- 0, 4 (0, 6) - 9, 1 (11, 3)
MTX Health assessment questionnaire (HAQ), Functional assessment of chronic illness therapy (FACIT-F)
Vprašalnik za oceno zdravstvenega stanja (HAQ, Health assessment questionnaire), 2 funkcijska ocena zdravljena kronične bolezni (FACIT- F, Functional assessment of chronic illness therapy).
At week 24, in all three studies, the proportion of rituximab treated patients showing a clinically relevant improvement in HAQ-DI (defined as an individual total score decrease of > 0.25) was higher than among patients receiving methotrexate alone.
Delež bolnikov s klinično pomembnim izboljšanjem indeksa nezmožnosti HAQ- DI (definirano kot individualno zmanjšanje rezultata > 0, 25) je bil pri bolnikih zdravljenih z rituksimabom v vseh treh študijah po 24. tednu večji kot pri bolnikih, ki so prejemali le metotreksat.
Laboratory evaluations A total of 96/ 1039 (9.2%) patients with rheumatoid arthritis tested positive for HACA in clinical studies following therapy with MabThera.
26 Laboratorijske vrednosti Skupno je bilo 96 od 1039 (9, 2%) bolnikov z revmatoidnim artritisom v kliničnih študijah zdravljenja z zdravilom MabThera pozitivnih na HACA.
24 The presence of HACA may be associated with worsening of infusion or allergic reactions after the second infusion of subsequent courses.
Po drugi infuziji nadaljnjih ciklov so lahko HACA povezana z intenzivnejšimi z infuzijo povezanimi ali alergijskimi reakcijami.
Furthermore, in one case with HACA, failure to deplete B cells after receipt of further treatment courses has been observed.
Pri enem primeru pojava HACA so po prejetju nadaljnjih ciklov zdravljenja opazili nezmožnost zmanjšanja števila celic B.
In 675 patients in clinical studies, the following shifts in anti-nuclear antibody (ANA) status were observed before and after rituximab:
V kliničnih preskušanjih so pri 675 bolnikih opazili spremembo pri protijedrnih protitelesih (ANA, anti- nuclear antibody) pred dajanjem rituksimaba in po njem:
26% ANA negative to positive and 32% ANA positive to negative.
26% ANA negativnih je postalo ANA pozitivnih in 32% ANA pozitivnih je postalo ANA negativnih.
There was no evidence of new onset autoimmune disease.
Znakov o novem nastopu avtoimune bolezni ni bilo.
In rheumatoid factor (RF) positive patients, marked decreases were observed in rheumatoid factor concentrations following treatment with rituximab in all three studies (range 45-64%).
Pri bolnikih s pozitivnim revmatoidnim faktorjem (RF) so opazili izrazito zmanjšanje koncentracije revmatoidnega faktorja po zdravljenju z rituksimabom v vseh treh študijah (razpon 45– 64%).
Hyperuricemia (grade 3/ 4) occurred in 143/ 950 (15%) patients, with the majority post-infusion on days 1 and/ or 15.
Hiperurikemija (stopnje 3/ 4) se je pojavila pri 143 od 950 (15%) bolnikov, večinoma prvi in/ ali petnajsti dan po infuziji.
It was not associated with any clinical symptoms, and none of these patients developed evidence of renal disease.
Povezave s kliničnimi simptomi ni bilo in pri nobenem od bolnikov ni bilo znakov ledvične bolezni.
Plasma total immunoglobulin concentrations, total lymphocytes counts, and white cells generally remained within normal limits following MabThera treatment, with the exception of a transient drop in white cells counts over the first four weeks following therapy.
Celokupna koncentracija imunoglobulinov v plazmi, celokupno število limfocitov in belih krvnih celic je po zdravljenju z zdravilom MabThera večinoma ostajalo v okviru normalne ravni z izjemo prehodnega upada števila celic B v prvih štirih tednih po zdravljenju.
Titers of Ig G antigen specific antibody to mumps, rubella, varicella, tetanus toxoid, influenza and streptococcus pneumococci remained stable over 24 weeks following exposure to MabThera in rheumatoid arthritis patients.
Pri bolnikih z revmatoidnim artritisom so titri specifičnih IgG protiteles za antigene mumpsa, rdečk, noric, toksoida tetanusa, gripo in Streptococcus pneumococci ostali stabilni prek 24 tednov po zdravljenju z zdravilom MabThera.
Multiple course therapy Following completion of the 24-week double blind comparative study period, patients were permitted to enroll into an open-label long term follow up study.
Večkratno zdravljenje Po zaključitvi 24- tedenskega obdobja dvojno slepe primerjalne študije so bolnikom dovolili, da se vključijo v odprto dolgotrajno študijo spremljanja.
Patients received subsequent courses of MabThera as needed according to the treating clinician’ s assessment of disease activity and irrespective of the peripheral B lymphocyte count.
Bolniki so dobivali nadaljnje cikle zdravila MabThera v skladu z zdravnikovo oceno aktivnosti bolezni in ne glede na število perifernih limfocitov B.
The time interval between courses was variable, with the majority of patients receiving further therapy 6-12 months after the previous course.
Časovni interval med cikli je bil spremenljiv, večina bolnikov je prejela nadaljnje zdravljenje 6 do 12 mesecev po prejšnjem ciklu.
Some patients required even less frequent retreatment.
Nekateri bolniki so potrebovali še manj pogosto ponovno zdravljenje.
The response to further therapy was at least the same magnitude as that following the initial treatment course, as evidenced by the change from baseline DAS28.
Odziv na nadaljnje zdravljenje je bil najmanj enakovreden odzivu po začetnem ciklu zdravljenja, kar je bilo vidno iz spremembe od izhodiščne vrednosti DAS28.
Mean change in DAS28 from original baseline: first course -2.18, second course -2.75.
Povprečna sprememba v DAS28 od začetne izhodiščne vrednosti: prvi cikel - 2, 18, drugi cikel - 2, 75.
non-Hodgkin’ s lymphoma
Ne- Hodgkinov limfom
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 tumor burden, and central compartment volume of distribution (V1) were 0.14 L/ day, 0.59 L/ day, and 2.7 L, respectively.
2, 7 l.
The estimated median terminal elimination half-life of rituximab was 22 days (range, 6.1 to 52 days).
Ocenjena mediana končne razpolovne dobe izločanja rituksimaba je bila 22 dni (od 6, 1 do 52 dni).
Baseline CD19-positive cell counts and size of measurable tumor lesions contributed to some of the variability in CL2 of rituximab in data from 161 patients given 375 mg/ m2 as an intravenous infusion for 4 weekly doses.
K variabilnosti Cl2 rituksimaba pri 161 bolnikih, ki so v štirih tednih enkrat na teden dobili 375 mg/ m2 rituksimaba z intravensko infuzijo, je prispevalo začetno število CD19 pozitivnih celic in velikost izmerljivih tumorskih lezij.
However, a large component of inter-individual variability remained for CL2 after correction for CD19-positive cell counts and tumor lesion size.
Bolniki z večjim številom CD19 pozitivnih celic ali večjimi tumorskimi lezijami so imeli večji Cl2, vseeno pa je precejšnja variabilnost Cl2 med posamezniki ostala tudi po prilagoditvi števila CD19 pozitivnih celic in velikosti tumorskih lezij.
This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small.
Razlike v V1 glede na telesno površino (1, 53 do 2, 32 m2) so bile 27, 1%, glede na zdravljenje s CHOP pa 19, 0%, kar je relativno malo.
Rituximab, administered as an intravenous infusion at a dose of 375 mg/ m2 at weekly intervals for 4 doses to 203 patients with NHL naive to rituximab, yielded a mean Cmax following the fourth infusion of 486 µg/ mL (range, 77.5 to 996.6 µg/ mL).
27 Povprečna Cmax po četrti infuziji pri 203 bolnikih z ne- Hodgkinovim limfomom, ki se z rituksimabom prej še niso zdravili in so prejeli po 375 mg/ m2 rituksimaba z intravensko infuzijo v štirih odmerkih enkrat na teden, je bila 486 µg/ ml (od 77, 5 do 996, 6 µg/ ml).
25 Upon administration of rituximab at a dose of 375 mg/ m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/ mL (range, 16 – 582 µg/ mL) after the first infusion to 550 µg/ mL (range, 171 – 1177 µg/ mL) after the eighth infusion.
Pri 37 bolnikih z ne- Hodgkinovim limfomom, ki so prejeli 375 mg/ m2 rituksimaba z intravensko infuzijo v osmih odmerkih enkrat na teden, se je povprečna Cmax povečala z vsako naslednjo infuzijo, tako da se je iz povprečne vrednosti 243 µg/ ml (od 16 do 582 µg/ ml) po prvi infuziji povečala na 550 µg/ ml (171 do 1177 µg/ ml) po osmi infuziji.
The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/ m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Farmakokinetični profil rituksimaba, dajanega v 6 infuzijah po 375 mg/ m2 v kombinaciji s šestimi cikli kemoterapije CHOP, je bil podoben kot pri dajanju samega rituksimaba.
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).
Po dveh intravenskih infuzijah rituksimaba v odmerku 1000 mg v razmiku dveh tednov je bil povprečni končni razpolovni čas 20, 8 dni (razpon 8, 58 do 35, 9 dni), povprečni sistemski očistek je bil 0, 23 l/ dan (razpon 0, 091 do 0, 67 l/ dan), povprečen volumen distribucije v stanju dinamičnega ravnovesja pa 4, 6 l (razpon 1, 7 do 7, 51 l).
Population pharmacokinetic analysis of the same data gave similar mean values for systemic clearance and half-life, 0.26 L/ day and 20.4 days, respectively.
Populacijska farmakokinetična analiza istih podatkov je dala podobne povprečne vrednosti za sistemski očistek in razpolovni čas, 0, 26 l/ dan in 20, 4 dni.
Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
Populacijska farmakokinetična analiza je pokazala, da sta bila telesna površina in spol najbolj pomembni so- spremenljivki za razlago variabilnosti v farmakokinetičnih parametrih med posamezniki.
Following the intravenous administration of 500 and 1000 mg doses of rituximab on two occasions, two weeks apart, mean Cmax values were 183 μ g/ mL (range, 81.8 to 279 μ g/ mL) and 370 μ g/ mL (212 to 637 μ g/ mL), and mean half-lives were 17.9 days (range, 12.3 to 31.3 days) and 19.7 days (range, 12.3 to 34.6 days), respectively.
Po intravenskem dajanju 500 in 1000 mg odmerkov rituksimaba dvakrat, v razmiku dveh tednov, so bile povprečne vrednosti Cmax 183 µg/ ml (razpon 81, 8 do 279 µg/ ml) in povprečni razpolovni čas 17, 9 dni (razpon 12, 3 do 31, 3 dneva), po enakem dajanju 1000 mg pa so bile povprečne vrednosti Cmax 370 µg/ ml (212 do 637 µg/ ml), povprečni razpolovni čas 19, 7 dneva (razpon 12, 3 do 34, 6 dneva).
No pharmacokinetic data are available for patients receiving multiple courses of therapy.
Pri bolnikih, ki so prejeli več ciklov zdravljenja, farmakokinetičnih podatkov ni na voljo.
The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 x 1000 mg, iv, 2 weeks apart), were similar with a mean maximum serum concentration of 369 μ g/ mL and a mean terminal half-life of 19.2 days.
Farmakokinetični parametri pri bolnikih, ki niso zadovoljivo odgovorili na zdravljenje z zaviralci TNF, po enakem odmerjanju (2 x 1000 mg, intravensko, v razmiku 2 tednov) so bili podobni s povprečno maksimalno koncentracijo v serumu 369 µg/ ml in povprečnim končnim razpolovnim časom 19, 2 dneva.
Rituximab has shown to be highly specific to the CD20 antigen on B cells.
Rituksimab se je izkazal kot visokospecifičen za antigen CD20 na celicah B.
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.
Študije toksičnosti pri opicah Cynomologus niso pokazale drugih učinkov od pričakovanega farmakološkega upada števila celic B v periferni krvi in limfnem tkivu.
Developmental toxicity studies have been performed in cynomolgus monkeys at dosages up to 100 mg/ kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
Študije razvojne toksičnosti so izvajali na opicah Cynomologus z odmerki do 100 mg/ kg (zdravljenje od 20. do 50. gestacijskega dne) in niso pokazale znakov toksičnosti za zarodek zaradi rituksimaba.
However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted post natally and was accompanied by a decrease in IgG level in the newborn animals affected.
Opazili pa so od odmerka odvisen farmakološki upad števila celic B v limfoidnih organih zarodka, ki je trajal tudi postnatalno, spremljalo ga je tudi znižanje IgG pri mladičih, ki so bili temu podvrženi.
No long-term animal studies have been performed to establish the carcinogenic potential of rituximab, or to determine its effects on fertility in males or females.
Za ugotovitve kancerogenega potenciala rituksimaba ali za določitev vpliva na sposobnost za razmnoževanje pri moških ali ženskah dolgoročnih študij na živalih ni.
However, due to its character it is unlikely that rituximab has any mutagenic potential.
Vendar pa zaradi lastnosti rituksimaba ni verjetno, da bi imel kakršen koli mutageni potencial.
26 6.2 Incompatibilities
6. 2 Inkompatibilnosti
The prepared infusion solution of MabThera is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature.
Pripravljena infuzijska raztopina MabThere je fizikalno in kemijsko stabilna 24 ur pri temperaturi 2 do 8 °C in nato še 12 ur pri sobni temperaturi.
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.
Zdravilo ni namenjeno shranjevanju po raztopitvi in razredčenju, daljšemu od 24 ur pri temperaturi med 2 °C in 8 °C, razen če je to potekalo v nadzorovanih in validiranih aseptičnih pogojih.
Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 ml.
Prozorne viale iz stekla tipa I z gumijastim zamaškom, ki vsebujejo 100 mg rituksimaba v 10 ml.
Packs of 2 vials.
V ovojnini sta 2 viali.
Aseptically withdraw the necessary amount of MabThera, and dilute to a calculated concentration of 1 to 4 mg/ ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ ml (0.9%) solution for injection or 5% D-Glucose in water.
Aseptično odvzamemo potrebno količino zdravila MabThera in jo razredčimo, da dobimo izračunano koncentracijo od 1 do 4 mg/ ml rituksimaba v infuzijski vrečki, ki vsebuje sterilno apirogeno 0, 9 -% raztopino natrijevega klorida za injiciranje (9 mg/ ml) ali 5 -% raztopino D- glukoze v vodi.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Parenteralna zdravila je treba pred dajanjem vizualno podrobno preveriti glede prisotnosti delcev in razbarvanja.
2 June 1998 Date of last renewal:
2. junij 1998 Datum zadnje obnove:
20 MAY 2008
20. maj 2008
MabThera 500 mg (10 mg/ ml) concentrate for solution for infusion
MabThera 500 mg (10 mg/ ml) koncentrat za raztopino za infundiranje
Each single-use vial containing 500 mg of Rituximab.
Vsaka viala za enkratno uporabo vsebuje 500 mg rituksimaba.
Rheumatoid arthritis
31 Revmatoidni artritis
29 modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Zdravilo MabThera je v kombinaciji z metotreksatom indicirano za zdravljenje odraslih bolnikov z zelo aktivnim revmatoidnim artritisom, ki niso zadostno odgovorili na druga imunomodulirajoča zdravila (DMARD, disease- modifying anti- rheumatic drugs), vključno z enim ali več zaviralci tumorje nekrotizirajočega faktorja (TNF), ali jih niso prenašali.
Chronic lymphocytic leukaemia
32 Kronična limfocitna levkemija
30 The recommended dosage of MabThera in combination with chemotherapy is 375 mg/ m2 body surface area administered on day 1 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.
Priporočeni odmerek zdravila MabThera v kombinaciji s kemoterapijo je 375 mg/ m2 telesne površine, ki ga damo 1. dan prvega cikla zdravljenja, v naslednjih ciklih zdravljenja pa dajemo 1. dan 500 mg/ m2 telesne površine, skupaj 6 ciklov.
Special populations Paediatric use MabThera is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Uporaba pri otrocih Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila MabThera pri otrocih in mladostnikih ni priporočljiva.
Method of Administration
33 Način uporabe
Premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy for treatment of non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia.
Če zdravila MabThera za zdravljenje ne- Hodgkinovega limfoma in kronične limfocitne levkemije ne dajemo v kombinaciji s kemoterapijo, ki vsebuje glukokortikoide, velja razmisliti o premedikaciji z glukokortikoidi.
31 Subsequent infusions Subsequent doses of MabThera can be infused at an initial rate of 100 mg/ hr, and increased by 100 mg/ hr increments at 30 minutes intervals, to a maximum of 400 mg/ hr.
Nadaljnje infuzije Nadaljnje odmerke zdravila MabThera lahko dajemo z začetno hitrostjo 100 mg/ h, ki jo lahko vsakih 30 minut povečujemo po 100 mg/ h, dokler ne dosežemo največje hitrosti infundiranja 400 mg/ h.
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
34 kažejo na nevrološko disfunkcijo, in če je tako, ali so lahko povezani s PML.
32 Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen.
Po ponovni vzpostavitvi imunskega sistema pri imunsko oslabljenih bolnikih s PML so opazili stabilizacijo ali izboljšanje izida.
Therefore patients with a history of cardiac disease and/ or cardiotoxic chemotherapy should be monitored closely.
35 Pri bolnikih, zdravljenih z zdravilom MabThera, so se pojavili angina pektoris ali srčne aritmije, kot sta atrijska undulacija in fibrilacija, srčno popuščanje ali miokardni infarkt, zato je treba bolnike z anamnezo bolezni srca in/ ali kardiotoksično kemoterapijo natančno opazovati.
33 Consideration should be given to the need for regular full blood counts, including platelet counts, during monotherapy with MabThera.
Pri samostojnem zdravljenju z zdravilom MabThera je treba premisliti o nujnosti rednega določanja števila celic celotne krvne slike, vključno s trombociti.
The reactions reported were usually reversible with a reduction in rate, or interruption, of MabThera infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
36 zmanjšanjem hitrosti ali prekinitvijo infuzije zdravila MabThera in dajanjem antipiretika, antihistaminika in občasno kisika, fiziološke raztopine intravensko ali bronhodilatatorja, in glukokortikoidov, če je bilo to potrebno.
34 In clinical studies 10/ 990 (1%) patients with rheumatoid arthritis who received a first infusion of MabThera at any dose experienced a serious reaction during the infusion (see section 4.8).
V kliničnih študijah je 10 od 990 (1%) bolnikov z revmatoidnim artritisom imelo resno reakcijo med prvo infuzijo zdravila MabThera ne glede na odmerek (glejte poglavje 4. 8).
82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs.
37 serotipa) in neoantigen KLH (47% v primerjavi s 93%).
35 Concomitant/ Sequential use of other DMARDs The concomitant use of MabThera and antirheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Sočasna/ zaporedna uporaba drugih DMARD Sočasna uporaba zdravila MabThera in zdravil za zdravljenje revmatičnih bolezni, razen omenjenih v indikaciji in odmerjanju za revmatoidni artritis, ni priporočljiva.
4.5 Interaction with other medicinal products and other forms of interaction
38 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
IgG immunoglobulins are known to cross the placental barrier.
Imunoglobulini IgG lahko prehajajo preko posteljice.
36 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trial in patients with CLL.
Okužbe (predvsem bakterijske in virusne) so v kliničnih preskušanjih opazili pri 30– 55% bolnikov z ne- Hodgkinovim limfomom in pri 30– 50% bolnikov s KLL.