natgillin/translations-raw huggingface dataset:
Therefore patients with a history of cardiac disease and/ or cardiotoxic chemotherapy should be monitored closely.
6 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.
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.
Čeprav zdravilo MabThera pri samostojnem zdravljenju ne deluje mielosupresivno, je potrebna previdnost pri bolnikih, pri katerih je število nevtrofilcev < l, 5 x 109/ l in/ ali trombocitov < 75 x 109/ l, ker so klinični podatki pri njih omejeni.
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.
Zdravilo MabThera so uporabili pri 21 bolnikih z avtologno transplantacijo kostnega mozga in pri drugih rizičnih skupinah, pri katerih se predvideva zmanjšano delovanje kostnega mozga, ne da bi se sprožila mielotoksičnost.
6 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.
When MabThera is given in combination with CHOP or CVP (cyclophosphamide, vincristine, and prednisone) chemotherapy, regular full blood counts should be performed according to usual medical practice.
Kadar dajemo zdravilo MabThera v kombinaciji s kemoterapevtiki CHOP ali CVP (ciklofosfamid, vinkristin in prednizon), moramo redno spremljati celotno krvno sliko v skladu z običajno klinično prakso.
Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Med zdravljenjem z zdravilom MabThera se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4. 8).
MabThera should not be administered to patients with an active and/ or severe infection (e. g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Zdravila MabThera se ne sme dajati bolnikom z aktivno in/ ali hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4. 3).
Physicians should exercise caution when considering the use of MabThera in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Pri odločanju za uporabo zdravila MabThera morajo biti zdravniki previdni pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb ali s sočasnimi boleznimi, zaradi katerih so lahko bolniki dodatno nagnjeni k pojavu resnih okužb (glejte poglavje 4. 8).
Very rare cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
Zelo redko so pri bolnikih, ki so prejemali rituksimab, poročali o reaktivaciji virusa hepatitisa B, vključno s fulminantnim hepatitisom s smrtnim izidom.
The reports are confounded by both the underlying disease state and the cytotoxic chemotherapy.
Poleg citotoksične kemoterapije je k nastanku teh poročil pripomoglo tudi stanje že obstoječe bolezni.
Patients with a history of hepatitis B infection should be carefully monitored for signs of active hepatitis B infection when rituximab is used in association with cytotoxic chemotherapy.
Bolnike z anamnezo okužbe s hepatitisom B je treba skrbno spremljati za znake aktivne okužbe hepatitisa B, kadar hkrati z rituksimabom prejemajo tudi citotoksično kemoterapijo.
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).
Med uporabo zdravila MabThera pri bolnikih z ne- Hodgkinovim limfomom in KLL so po prihodu zdravila na trg zelo redko poročali o primerih progresivne multifokalne levkoencefalopatije (PML) (glejte poglavje 4. 8).
The safety of immunization with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom MabThera pri bolnikih z ne - Hodgkinovim limfomom in kronično limfocitno levkemijo niso proučevali, cepljenje z živimi virusnimi cepivi ni priporočljivo.
Patients treated with MabThera may receive non-live vaccinations.
Bolniki, ki se zdravijo z zdravilom MabThera lahko prejmejo mrtva cepiva, vendar je lahko odgovor nanje zmanjšan.
69% when assessed for > 2-fold increase in antibody titer).
V nerandomizirani študiji so imeli bolniki, ki so prejeli samostojno zdravljenje z zdravilom MabThera ob ponovitvi nizkomalignega ne- Hodgkinovega limfoma v primerjavi s kontrolo (zdrave osebe, ki niso prejele zdravila), nižji delež odgovora na cepljenje s cepivom proti tetanusu (recall antigen) (16% v primerjavi z 81%) in neoantigenom KLH (Keyhole Limpet Haemocyanin) (4% v primerjavi z 69%, ko so določevali > 2- kratno povečanje v titru protiteles).
Mean pre-therapeutic antibody titers against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Srednji pred- terapevtski titri protiteles proti naboru antigenov (Streptococcus pneumoniae, influenca A, mumps, rdečke, norice) so bili ohranjeni najmanj 6 mesecev po zdravljenju z zdravilom MabThera.
Infusion reactions MabThera is associated with infusion reactions, which may be related to release of cytokines and/ or other chemical mediators.
Reakcije, povezane z infuzijo Zdravilo MabThera lahko povzroči reakcije, povezane z infuzijo, ki nastanejo zaradi sprostitve citokinov in/ ali drugih kemičnih mediatorjev.
Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of these events (see section 4.8).
Premedikacija z intravenskimi glukokortikoidi pomembno zmanjša incidenco in resnost teh dogodkov (glejte poglavje 4. 8).
Most infusion events reported were mild to moderate in severity.
Večina dogodkov, povezanih z infuzijo, je bila blaga do zmerna.
The proportion of affected patients decreases with subsequent infusions.
Delež prizadetih bolnikov se z nadaljnjimi infuzijami zmanjšuje.
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.
7 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.
In most cases, the infusion can be resumed at a 50% reduction in rate (e. g. from 100 mg/ h to 50 mg/ h) when symptoms have completely resolved.
Ko se simptomi popolnoma izboljšajo, lahko pri večini primerov infuzijo nadaljujemo s polovično hitrostjo infundiranja (npr. s 100 mg/ h na 50 mg/ h).
Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins, including MabThera, to patients.
Pri intravenskem dajanju beljakovin, vključno z zdravilom MabThera, so poročali o anafilaktičnih in drugih reakcijah preobčutljivosti.
Medicinal products for the treatment of hypersensitivity reactions, e. g., epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
Zdravila za zdravljenje reakcij preobčutljivosti, npr. adrenalin, antihistaminiki in glukokortikoidi, morajo biti na voljo za takojšnjo uporabo, če bi se med dajanjem zdravila MabThera pojavile alergijske reakcije.
The presence of HACA may be associated with worsening infusion or allergic reactions after the second infusion of subsequent courses (see section 5.1).
Po drugi infuziji nadaljnjih ciklov so lahko HACA povezana z intenzivnejšimi z infuzijo povezanimi ali alergijskimi reakcijami (glejte poglavje 5. 1).
7 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).
Therefore, in patients with a known cardiac history, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Pred zdravljenjem z zdravilom MabThera moramo pri bolnikih z znanimi boleznimi srca razmisliti o možnih kardiovaskularnih zapletih, ki lahko nastanejo kot posledica reakcij, povezanih z infuzijo, bolnike pa med dajanjem zdravila skrbno nadzorovati.
Infections Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Okužbe Med zdravljenjem z zdravilom MabThera se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4. 8).
MabThera should not be administered to patients with an active and/ or severe infection (e. g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e. g. in hypogammaglobulinemia or where levels of CD4 or CD8 are very low).
Zdravila MabThera se ne sme dajati bolnikom z aktivno in/ ali hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4. 3) ali hudo imunokompromitiranim bolnikom (npr. s hipogamaglobulinemijo ali pri zelo nizkih vrednostih CD4 ali CD8).
Physicians should exercise caution when considering the use of MabThera in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Pri odločanju za uporabo zdravila MabThera je potrebna previdnost pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb ali s sočasnimi boleznimi, zaradi katerih so lahko bolniki dodatno nagnjeni k pojavu resnih okužb (glejte poglavje 4. 8).
Very rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported following use of MabThera for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and Vasculitis.
Pri uporabi zdravila MabThera za zdravljenje revmatoidnega artritisa in avtoimunskih bolezni, ki vključujejo sistemski eritematozni lupus (SLE) in vaskulitis, so poročali o zelo redkih primerih progresivne multifokalne levkoencefalopatije (PML).
These cases involved patients with multiple risk factors for PML, including the underlying disease and long-term immunosuppressive therapy or chemotherapy.
V teh primerih so imeli bolniki več dejavnikov tveganja za PML, vključno z obstoječo boleznijo in dolgotrajnim imunosupresivnim zdravljenjem ali kemoterapijo.
In patients with non-Hodgkin’ s lymphoma receiving rituximab in combination with cytotoxic chemotherapy, very rare cases of hepatitis B reactivation have been reported (see non-Hodgkin’ s lymphoma).
Pri bolnikih z ne- Hodgkinovim limfomom, ki so prejemali rituksimab v kombinaciji s citotoksično kemoterapijo, so zelo redko poročali o reaktivaciji virusa hepatitisa B (glejte ne- Hodgkinov limfom).
Immunization Physicians should review the patient’ s vaccination status and follow current immunization guidelines prior to MabThera therapy.
Cepljenje Zdravniki morajo pred zdravljenjem z zdravilom MabThera pregledati status cepljenja bolnikov in upoštevati veljavne smernice za cepljenje.
Vaccination should be completed at least 4 weeks prior to first administration of MabThera.
Cepljenje naj bo zaključeno najmanj štiri tedne pred prvo aplikacijo zdravila MabThera.
The safety of immunization with live viral vaccines following MabThera therapy has not been studied.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom MabThera niso proučevali.
However, response rates to non- live vaccines may be reduced.
Bolniki, ki se zdravijo z zdravilom MabThera lahko prejmejo mrtva cepiva, vendar je lahko odgovor nanje zmanjšan.
42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs.
V randomizirani študiji so imeli bolniki z revmatoidnim artritisom, ki so se zdravili z zdravilom MabThera in metotreksatom v primerjavi z bolniki, ki so dobivali samo metotreksat, podoben delež odgovorov na cepivo proti tetanusu (recall antigen) (39% v primerjavi z 42%), nižji delež odgovorov na polisaharidno cepivo proti pnevmokoku (43% v primerjavi z 82% na vsaj 2
82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs.
8 serotipa) in neoantigen KLH (47% v primerjavi s 93%).
93%), when given 6 months after MabThera/ Rituxan as compared to patients only receiving methotrexate.
Bolniki so dobili cepivo 6 mesecev po zdravilu MabThera.
Should non-live vaccinations be required whilst receiving MabThera therapy, these should be completed at least 4 weeks prior to commencing the next course of MabThera
Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z zdravilom MabThera, mora biti zaključeno najmanj 4 tedne pred začetkom naslednjega cikla zdravila MabThera.
In the overall experience of MabThera repeat treatment over one year, the proportions of patients with positive antibody titers against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Pri ponovnem enoletnem zdravljenju z zdravilom MabThera so bili deleži bolnikov s pozitivnim titrom protiteles proti S. pneumoniae, influenci, mumpsu, rdečkah, noricah in tetanusnem toksoidu na splošno podobni kot izhodiščni.
8 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.
There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Iz kliničnih preskušanj ni zadostnih podatkov za popolno oceno varnosti uporabe drugih DMARD (vključno z zaviralci TNF in drugimi biološkimi zdravili), ki sledijo zdravljenju z zdravilom MabThera (glejte poglavje 4. 5).
The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with MabThera, however patients should be closely observed for signs of infection if biologic agents and/ or DMARDs are used following MabThera therapy.
Podatki, ki so na voljo, nakazujejo, da je pojavnost klinično pomembnih okužb nespremenjena, ko ta zdravila uporabimo pri bolnikih, ki so jih prej zdravili z zdravilom MabThera, vendar jih moramo skrbno opazovati glede znakov okužbe, če po zdravljenju z zdravilom MabThera prejmejo biološka zdravila in/ ali DMARD.
Malignancy Immunomodulatory drugs may increase the risk of malignancy.
Maligne bolezni Imunomodulirajoča zdravila lahko povečajo tveganje za razvoj malignih bolezni.
On the basis of limited experience with MabThera in rheumatoid arthritis patients (see section 4.8) a possible risk for the development of solid tumours cannot be excluded at this time, although present data do not seem to suggest any increased risk.
Na osnovi omejenih izkušenj z zdravilom MabThera pri zdravljenju revmatoidnega artritisa (glejte poglavje 4. 8) možnega tveganja za razvoj solidnih tumorjev trenutno ni mogoče izključiti, čeprav sedanji podatki ne kažejo kakršnegakoli povečanega tveganja.
4.5 Interaction with other medicinal products and other forms of interaction
9 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Currently, there are limited data on possible drug interactions with MabThera.
Trenutno so na voljo omejeni podatki o mogočih medsebojnih učinkih pri uporabi zdravila MabThera.
Co-administration with methotrexate had no effect on the pharmacokinetics of MabThera in rheumatoid arthritis patients.
Sočasno dajanje metotreksata ni imelo vpliva na farmakokinetiko zdravila MabThera pri bolnikih z revmatoidnim artritisom.
Patients with human anti-mouse antibody or human anti-chimeric antibody (HAMA/ HACA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Bolniki s titri humanih protimišjih protiteles ali humanih protihimernih protiteles (HAMA/ HACA) imajo lahko alergijske reakcije ali reakcije preobčutljivosti, če jih zdravimo z drugimi diagnostničnimi ali terapevtskimi monoklonskimi protitelesi.
In a small cohort of patients with rheumatoid arthritis, 280 patients received subsequent therapy with other DMARDs of whom 185 received a biologic DMARD following MabThera.
V majhni kohorti bolnikov z revmatodnim artritisom jih je 280 prejelo nadaljnje zdravljenje z drugimi DMARD, od katerih jih je po zdravljenju z zdravilom MabThera 185 prejelo biološke DMARD.
In these patients the rate of clinically relevant infection while on MabThera only was 6.99 per 100 patient years compared to 5.49 per 100 patients years following treatment with the biologic DMARD.
Delež klinično pomembnih okužb pri teh bolnikih, ko so se zdravili z zdravilom MabThera je bil 6, 99 na 100 bolnik- let v primerjavi s 5, 49 na 100 bolnik- let po tem, ko so prejeli nadaljnje zdravljenje z biološkim DMARD.
Pregnancy IgG immunoglobulins are known to cross the placental barrier.
Imunoglobulini IgG lahko prehajajo preko posteljice.
B cell levels in human neonates following maternal exposure to MabThera have not been studied in clinical trials.
Števila celic B pri novorojenčkih mater, zdravljenih z zdravilom MabThera, v kliničnih preskušanjih niso proučevali.
There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
Pri nekaterih novorojenčki, ki so se rodili materam, ki so se med nosečnostjo zdravile z rituksimabom, pa so poročali o prehodnem zmanjšanju števila celic B in limfocitopeniji.
For these reasons MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Zato nosečnice ne smejo prejemati zdravila MabThera, razen če pričakovana korist prevlada nad možnim tveganjem.
Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during treatment and for 12 months following MabThera therapy.
Ker se rituksimab v telesu bolnikov z zmanjšanim številom celic B zadržuje dolgo, morajo ženske v rodnem obdobju med zdravljenjem z zdravilom MabThera in še 12 mesecev po njem uporabljati učinkovita kontracepcijska sredstva.
Developmental toxicity studies performed in cynomolgus monkeys revealed no evidence of embryotoxicity in utero.
Študije razvojne toksičnosti, ki so jih izvedli na opicah Cynomologus, niso pokazale embriotoksičnosti in utero.
New born offspring of maternal animals exposed to MabThera were noted to have depleted B cell populations during the post natal phase.
Med novorojenimi mladiči, katerih matere so bile izpostavljene zdravilu MabThera, so bile skupine z upadom celic B v postnatalnem obdobju.
However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with MabThera and for 12 months following MabThera treatment.
Ni znano, ali se rituksimab izloča v materino mleko, vendar zaradi dejstva, da se materin IgG izloča v materino mleko, in da so rituksimab določili v mleku doječih opic, ženske med zdravljenjem z zdravilom MabThera in 12 mesecev po njem ne smejo dojiti.
No studies on the effects of MabThera on the ability to drive and use machines have been performed, although the pharmacological activity and adverse events reported to date do not indicate that such an effect is likely.
Študij o vplivu zdravila MabThera na sposobnost vožnje in upravljanja s stroji niso izvedli, čeprav farmakološko delovanje in neželeni dogodki, o katerih so poročali, ne kažejo na to, da bi lahko prišlo do takih učinkov.
Experience from non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia.
Izkušnje pri ne- Hodgkinovem limfomu in kronični limfocitni levkemiji
The overall safety profile of MabThera in non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia is based on data from patients from clinical trials and from post-marketing surveillance.
Celokupni varnostni profil zdravila MabThera pri ne- Hodgkinovem limfomu in kronični limfocitni levkemiji temelji na podatkih bolnikov iz kliničnih preskušanj in iz nadzora v obdobju trženja.
The most frequently observed adverse drug reactions (ADRs) in patients receiving MabThera were infusion-related reactions which occurred in the majority of patients during the first infusion.
Pri večini bolnikov so se pojavile med prvo infuzijo.
The incidence of infusion-related symptoms decreases substantially with subsequent infusions and is less than 1% after eight doses of MabThera.
Incidenca simptomov, povezanih z infuzijo, se z nadaljnjimi infuzijami bistveno zmanjšuje in je po osmih odmerkih zdravila MabThera manjša kot 1%.
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.
The most frequent reported or observed serious adverse drug reactions were: • Infusion-related reactions (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4. • Infections, see section 4.4. • Cardiovascular events, see section 4.4.
Resni neželeni učinki, o katerih so poročali oz. jih opazili najpogosteje, so bili: • reakcije, povezane z infuzijo (vključno s sindromom sproščanja citokinov in sindromom razpada tumorja) (glejte poglavje 4. 4), • okužbe (glejte poglavje 4. 4), • kardiovaskularni dogodki (glejte poglavje 4. 4).
Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Med resnimi neželenimi učinki so poročali tudi o reaktivaciji virusa hepatitisa B in PML (glejte poglavje 4. 4).
The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in the tables below.
Pogostnosti neželenih učinkov, o katerih so poročali pri samostojnem zdravljenju z zdravilom MabThera ali v kombinaciji s kemoterapijo, so povzete v spodnji preglednici.
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100) and rare (≥ 1/ 10,000 to < 1/ 1000).
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti kot zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100) in redki (≥ 1/ 10. 000 do < 1/ 1. 000).
The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “ unknown”.
Neželeni učinki, ki so jih opazili samo med nadzorom v obdobju trženja in tisti, za katere pogostnosti niso mogli oceniti, so navedeni pod "neznano".