FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common local cutaneous reactions in the MabThera subcutaneous arm were injection site erythema (13%), injection site pain (7%), and injection site oedema (4%).
Slovenian: Najpogostejše lokalne kožne reakcije v skupini bolnikov, ki so prejemali podkožno obliko zdravila MabThera, so bile eritem na mestu injiciranja (13 %), bolečina na mestu injiciranja (7 %) in edem na mestu injiciranja (4 %).
English: Following two intravenous infusions of MabThera 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).
Slovenian: Revmatoidni artritis Po dveh intravenskih infuzijah zdravila MabThera 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).
English: The Patient information about MabThera should contain the following key elements:
Slovenian: Izobraževalno gradivo za bolnika o zdravilu MabThera mora vsebovati naslednje ključne vsebine:
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: pogosti (³ 1/100 do < 1/10), občasni (³ 1/1000 do < 1/100), redki (³ 1/10.000 do < 1/1000), zelo redki
English: • low mood and loss of interest or enjoyment in doing things, feeling nervous
Slovenian: · slabo razpoloženje in izguba zanimanja ali veselja za početje stvari, živčnost · motnje okušanja - na primer spremenjen okus stvari
English: • Feeling generally unwell or listless.
Slovenian: · splošno slabo počutje ali brezvoljnost.
English: In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
Slovenian: V študiji pri bolnikih v prvi liniji zdravljenja po mediani opazovanja 48,1 meseca je bila mediana preživetja brez napredovanja bolezni 55 mesecev v skupini R-FC in 33 mesecev v skupini FC (p < 0,0001, test log-rang).
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 MabThera.
Slovenian: Povprečni predterapevtski titri protiteles proti naboru antigenov (Streptococcus pneumoniae, influenca A, mumps, rdečke, norice) so se ohranili najmanj 6 mesecev po zdravljenju z zdravilom
English: • Pain in the tummy, back, muscles and/or joints
Slovenian: · bolečina v trebuhu, hrbtu, mišicah in/ali sklepih.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or MabThera (375 mg/m2) once weekly for 4 weeks.
Slovenian: Bolnike so v razmerju 1:1 randomizirali na zdravljenje s peroralnim ciklofosfamidom (2 mg/kg/dan) vsak dan od 3 do 6 mesecev ali z zdravilom MabThera (375 mg/m2) enkrat na teden 4 tedne.
English: Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50 % of patients in clinical trials involving MabThera intravenous formulation, and were predominantly seen during the first infusion, usually in the first one to two hours.
Slovenian: O znakih in simptomih, ki bi lahko nakazovali reakcije, povezane z infuzijo, so poročali pri več kot 50 % bolnikov v kliničnih preskušanjih, v katerih so uporabljali intravensko obliko zdravila MabThera; večinoma so jih opazili med prvo infuzijo, po navadi v prvih dveh urah.
English: The use of MabThera subcutaneous formulation as monotherapy in patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy cannot be recommended as the safety of the once weekly subcutaneous administration has not been established.
Slovenian: Uporabe podkožne oblike zdravila MabThera v monoterapiji pri bolnikih s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se jim je bolezen po kemoterapiji drugič ali že večkrat ponovila, ni mogoče priporočiti, ker varnosti podkožnega dajanja enkrat na teden niso ugotavljali.
English: These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.
Slovenian: Med njimi so bolečina, oteklost, podplutba, krvavitev, pordelost kože, srbenje in izpuščaj.
English: Store in a refrigerator (2 °C to 8 °C).
Slovenian: Shranjujte v hladilniku (2 do 8 °C).
English: The safety of immunisation with live viral vaccines following MabThera therapy has not been studied.
Slovenian: Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom MabThera niso proučevali.
English: The 1400 mg strength is intended for subcutaneous use in non Hodgkin lymphoma (NHL) only.
Slovenian: Jakost zdravila 1400 mg je namenjena podkožni uporabi le za zdravljenje ne-Hodgkinovega limfoma (NHL).
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group.
Slovenian: Razlika med terapevtskima skupinama glede celokupnega preživetja je pokazala značilno klinično razliko (p = 0,029, log-rang test s stratifikacijo po centru): po 53 mesecih je bil delež preživetja v skupini z R-CVP 80,9 % in v skupini s CVP 71,1 %.
English: For subjects weighing 60-90 kg and < 60 kg, average Ctrough values following intravenous dosing were approximately 16% and 34% lower compared to the subcutaneous regimen, respectively.
Slovenian: Pri bolnikih s telesno maso 60-90 kg in < 60 kg so bile povprečne Ctrough po intravenskem odmerjanju v primerjavi s podkožnim manjše: približno 16 % manjše v skupini s telesno maso 60-90 kg in približno 34 % manjše v skupini s telesno maso < 60 kg.
English: What MabThera is and what it is used for What you need to know before you are given MabThera How MabThera is given
Slovenian: Kaj je zdravilo MabThera in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo MabThera Kako se daje zdravilo MabThera
English: • inflammation of blood vessels including those leading to skin symptoms
Slovenian: · srčno popuščanje · simptomi vnetja žil, vključno s tistimi, ki vodijo v kožo
English: Although MabThera is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Slovenian: Čeprav zdravilo MabThera pri samostojnem zdravljenju ne deluje mielosupresivno, je potrebna previdnost pri bolnikih, ki imajo število nevtrofilcev < 1,5 x 109/l in/ali trombocitov < 75 x 109/l.
English: An analysis of overall survival confirmed the significant benefit of MabThera maintenance over observation (p=0.0039 log-rank test).
Slovenian: Analiza celokupnega preživetja je potrdila pomembno korist vzdrževalnega zdravljenja z zdravilom MabThera v primerjavi z opazovano skupino (p = 0,0039, test log-rang).
English: In the NHL phase 3 trial SABRINA (BO22334), local cutaneous reactions were reported in up to 20% of patients receiving subcutaneous MabThera.
Slovenian: V kliničnem preskušanju faze III SABRINA (BO22334) je do 20 % bolnikov, ki so prejemali podkožno obliko zdravila MabThera, navedlo lokalne kožne reakcije.
English: asthma, too little oxygen reaching the body organs
Slovenian: astma, telesne organe doseže premalo kisika, · oteklost trebuha.
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first infusion for both doses.
Slovenian: večja po drugi infuziji v primerjavi s prvo infuzijo pri obeh odmerkih.
English: The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Slovenian: so bili prisotni znani dejavniki tveganja za PRES/RPLS, vključno z bolnikovo osnovno boleznijo, hipertenzijo, imunosupresivnim zdravljenjem in/ali kemoterapijo.
English: The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1400 mg irrespective of the patient's body surface area.
Slovenian: Priporočeni odmerek podkožne oblike zdravila MabThera za odrasle bolnike je podkožna injekcija fiksnega odmerka 1400 mg ne glede na bolnikovo telesno površino.
English: The safety profile of MabThera in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Slovenian: Varnostni profil zdravila MabThera pri bolnikih z zelo aktivnim revmatoidnim artritisom je povzet v spodnjem besedilu.
English: The overall safety profile of MabThera in non-Hodgkin's lymphoma and CLL is based on data from patients from clinical trials and from post-marketing surveillance.
Slovenian: Celotni varnostni profil zdravila MabThera pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji (KLL) temelji na podatkih bolnikov iz kliničnih preskušanj in iz nadzora med obdobjem trženja.
English: ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Slovenian: Celokupen odgovor je znašal 57 % (95-% interval zaupanja 41 %-73 %; popoln odgovor 14 %, delni odgovor 43 %), mediana časa do napredovanja bolezni je bila pri odzivnih bolnikih 19,4 meseca (razpon 5,3 do 38,9 meseca).
English: MabThera has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Slovenian: Zdravilo MabThera so uporabili pri 21 bolnikih po avtologni transplantaciji kostnega mozga in pri drugih rizičnih skupinah, pri katerih je pričakovano zmanjšano delovanje kostnega mozga, ne da bi se pojavila mielotoksičnost.
English: MabThera intravenous formulation was used at the standard dose of 375 mg/m2
Slovenian: Intravenska oblika zdravila MabThera je bila uporabljena v standardnem odmerku 375 mg/m2
English: Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Slovenian: Pomožne snovi: To zdravilo vsebuje 2,3 mmol (ali 52,6 mg) natrija na 10-ml vialo in 11,5 mmol (ali 263,2 mg) natrija na 50-ml vialo.
English: • high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “LDH” in the blood, low calcium levels in the blood
Slovenian: · velika koncentracija krvnega sladkorja, hujšanje, oteklost obraza in telesa, visoka raven encima LDH v krvi, majhna koncentracija kalcija v krvi
English: c) If you are being treated for rheumatoid arthritis Each course of treatment is made up of two separate infusions which are given 2 weeks apart.
Slovenian: Če se zdravite zaradi navadnega pemfigusa Vsak cikel zdravljenja obsega dve ločeni infuziji, ki ju boste dobili v presledku 2 tednov.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
English: The Physician information about MabThera should contain the following key elements:
Slovenian: Izobraževalno gradivo za zdravnika o zdravilu MabThera mora vsebovati naslednje ključne vsebine:
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with MabThera and observation.
Slovenian: Med vzdrževalnim zdravljenjem je bila incidenca srčnih bolezni 3. ali 4. stopnje med bolniki, zdravljenimi z zdravilom MabThera, in opazovano skupino primerljiva.
English: MabThera subcutaneous formulation
Slovenian: MabThera podkožna oblika
English: − * Worst case imputation a Non-inferiority was demonstrated since the lower bound ( − 3.2%) was higher than the pre-determined non-inferiority margin ( − 20%).
Slovenian: * Imputacija za najslabši primer a Neinferiornost je bila dokazana, ker je bila spodnja meja (-3,2 %) višja od vnaprej opredeljene meje neinferiornosti b 95,1-% interval zaupanja vključuje dodatni 0,001 alfa na račun vmesne analize učinkovitosti.
English: Table 8: Distribution/Elimination - Pharmacokinetic parameters of MabThera subcutaneous compared to MabThera intravenous Trial BP22333 (SparkThera) Geometric mean Ctrough
Slovenian: Porazdelitev/izločanje - farmakokinetični parametri zdravila MabThera podkožno v primerjavi z zdravilom MabThera intravensko Preskušanje BP22333 (SparkThera)
English: • tightening of the muscles in the airways which causes wheezing (bronchospasm),
Slovenian: · skrčenje mišic v dihalih, ki povzroči piskajoče dihanje (bronhospazem), vnetje, draženje pljuč,
English: Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Slovenian: Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (posterior reversible encephalopathy syndrome - PRES) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (reversible posterior leukoencephalopathy syndrome - RPLS).
English: MabThera 1400 mg can be given alone or with other medicines called “chemotherapy”.
Slovenian: Zdravilo MabThera 1400 mg lahko uporabljamo samostojno ali skupaj z drugimi zdravili, ki jih imenujemo kemoterapija.
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the MabThera arms compared to control arms.
Slovenian: V kliničnih preskušanjih so o okužbah spodnjih dihal (vključno s pljučnico) v skupini z zdravilom MabThera poročali s podobno incidenco kot v kontrolnih skupinah.
English: • Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heart beat, and tiredness
Slovenian: · spremembe krvnega tlaka, slabost, kožni izpuščaji, zvišana telesna temperatura, srbenje, smrkav ali zamašen nos ter kihanje, drgetanje, hitro bitje srca in utrujenost, · glavobol,
English: Table 3 Summary of key results from four phase III randomized trials evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Slovenian: Povzetek ključnih rezultatov štirih randomiziranih preskušanj III. faze, ki so ocenjevala korist zdravila MabThera v kombinaciji z različnimi shemami kemoterapije pri folikularnih limfomih
English: The final analysis confirmed that R-CHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Slovenian: Končna analiza je potrdila, da je bilo zdravljenje z R-CHOP povezano s klinično pomembnim in statistično značilnim podaljšanjem trajanja preživetja brez dogodkov (primarni parameter učinkovitosti; dogodki so bili smrt, ponovitev bolezni ali napredovanje limfoma ali uvedba novega protilimfomskega zdravljenja) (p = 0,0001).
English: MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk.
Slovenian: Zdravilo MabThera je za uporabo pripravljena, bistra do opalescenčna, brezbarvna do rumenkasta tekočina, ki je na voljo kot raztopina za podkožno injiciranje v brezbarvni stekleni viali z zamaškom iz butilne gume, z aluminijsko prekrivno zaporo in plastično modro snemno ploščico.
English: Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61 % with MabThera maintenance treatment when compared to observation (95 % CI; 45 %-72 %).
Slovenian: Tveganje za napredovanje bolezni ali smrt je bilo zmanjšano za 61 % z vzdrževalnim zdravljenjem z zdravilom MabThera v primerjavi z opazovano skupino (Coxova regresijska analiza, 95-% interval zaupanja: 45-72 %).
English: • The active ingredient is rituximab.
Slovenian: · Zdravilna učinkovina je rituksimab.
English: In addition to adverse reactions seen in RA clinical trials for MabThera, progressive multifocal leukoencephalopathy (PML) (see section 4.4) and serum sickness-like reaction have been reported during post marketing experience.
Slovenian: Poleg neželenih učinkov, o katerih so poročali v kliničnih preskušanjih uporabe zdravila MabThera pri revmatoidnem artritisu, so po prihodu zdravila na trg poročali tudi o progresivni multifokalni levkoencefalopatiji (PML) (glejte poglavje 4.4) ter reakciji, podobni serumski bolezni.
English: The MabThera intravenous formulation has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Slovenian: Intravensko obliko zdravila MabThera so uporabili pri 21 bolnikih po avtologni transplantaciji kostnega mozga in pri drugih rizičnih skupinah, pri katerih je pričakovano zmanjšano delovanje kostnega mozga, ne da bi se pojavila mielotoksičnost.
English: The objective of the first stage was to establish the rituximab subcutaneous dose that resulted in comparable MabThera subcutaneous formulation serum Ctrough levels compared with MabThera intravenous formulation, when given as part of induction treatment every 3 weeks (see section 5.2).
Slovenian: Cilj prve stopnje je bil določiti podkožni odmerek rituksimaba, ki med uporabo podkožne oblike zdravila MabThera v serumu doseže podobno najmanjšo koncentracijo pred naslednjim odmerkom (Ctrough), kot je dosežena z intravensko obliko zdravila MabThera, če je zdravilo uporabljeno v okviru indukcijskega zdravljenja enkrat na 3 tedne (glejte poglavje 5.2).
English: • This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.
Slovenian: · Ne-Hodgkinov limfom je bolezen limfnega sistema (ta je del imunskega sistema) in prizadene vrsto belih krvnih celic, limfocite B.
English: decreased IgG levels4
Slovenian: zmanjšane koncentracije IgG4
English: In SAWYER trial (BO25341) the incidence of treatment-induced/enhanced anti-rituximab antibodies was similar in the two treatment arms; 15% intravenous vs. 12% subcutaneous.
Slovenian: V preskušanju SAWYER (BO25341) je bila incidenca z zdravljenjem povzročenega/okrepljenega nastajanja protiteles proti rituksimabu v obeh terapevtskih skupinah podobna: 15 % v skupini z intravensko obliko v primerjavi z 12 % v skupini s podkožno obliko.
English: 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.
Slovenian: 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-%
English: Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Slovenian: Pred zdravljenjem z zdravilom MabThera moramo pri bolnikih, z znanimi boleznimi srca in tistih, pri katerih so v preteklosti opazili kardio-pulmonalne neželene učinke, razmisliti o možnih kardiovaskularnih zapletih, ki lahko nastanejo kot posledica reakcij, povezanih z infuzijo, bolnike pa med dajanjem zdravila skrbno nadzorovati.
English: Geometric mean Ctrough and geometric mean AUCτ from the BP22333 and BO22334 trials are summarized in Table 8.
Slovenian: BP22333 in BO22334 sta povzeti v preglednici 8.
English: The most frequent adverse reactions considered due to receipt of MabThera were IRRs.
Slovenian: Najpogostejši neželeni učinki, za katere so menili, da so nastali zaradi prejetja zdravila MabThera, so bile reakcije, povezane z infuzijo.
English: Repeated treatment courses with MabThera are possible.
Slovenian: Zdravljenje z zdravilom MabThera se lahko ponovi.
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 10a).
Slovenian: Analiza celokupnega preživetja je pokazala signifikantno korist zdravljenja R-FC glede na samo kemoterapijo FC (p = 0,0319, test log-rang) (preglednica 10a).
English: Very rare cases of fatal PML have been reported following use of MabThera.
Slovenian: Pri uporabi zdravila MabThera so poročali o zelo redkih smrtnih primerih PML.
English: Hypersensitivity to the active substance or to murine proteins, hyaluronidase or to any of the other excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilno učinkovino ali mišje beljakovine, hialuronidazo ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: MabThera 1400 mg
Slovenian: MabThera 1400 mg rituksimab
English: For information related to the autoimmune indications, please refer to the SmPC of MabThera intravenous formulation.
Slovenian: Za informacije v zvezi z avtoimunskimi indikacijami glejte SmPC intravenske oblike zdravila MabThera.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,400 mg/11.7 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1400 mg/11,7 ml
English: Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium.
Slovenian: Ena 10-ml viala vsebuje 2,3 mmol (52,6 mg) natrija.
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%).
Slovenian: Delež bolnikov z odgovorom na zdravljenje (CR, CRu - nepotrjeni popolni odgovor (complete response/uncomfirmed), PR) je bil značilno večji (p < 0,0001, test hi-kvadrat) v skupini RCVP (80,9 %) kot v skupini CVP (57,2 %).
English: • Pain without injuring yourself
Slovenian: · izguba telesne mase, · bolečina, ne da bi se poškodovali,
English: Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of MabThera in NHL and CLL (see section 4.8).
Slovenian: V obdobju trženja so bili med uporabo zdravila MabThera pri zdravljenju NHL in KLL opisani zelo redki primeri progresivne multifokalne levkoencefalopatije (PML) (glejte poglavje 4.8).
English: Subcutaneous formulation:
Slovenian: Podkožna oblika
English: Immune system disorders infusionrelated reactions4, angioedema hypersensitivity anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytopenia
Slovenian: Bolezni imunskega sistema z infuzijo povezane reakcije4, angioedem preobčutljivost anafilaksija sindrom lize tumorja, sindrom sproščanja citokinov4, serumska bolezen z infuzijo povezana akutna reverzibilna trombocitopenija4
English: • unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch
Slovenian: · neobičajni občutki na koži - na primer omrtvičenost, mravljinčenje, zbadanje, pekoč občutek, občutek gomazenja na koži, slabše zaznavanje dotika
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to MabThera therapy.
Slovenian: Zdravniki morajo pred zdravljenjem z zdravilom MabThera pregledati status cepljenja bolnikov in upoštevati veljavne smernice za cepljenje.