FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during post-marketing surveillance occurring in patients with rheumatoid arthritis receiving rituximab
Slovenian: Povzetek neželenih učinkov, o katerih so poročali med kliničnimi študijami ali po prihodu zdravila na trg pri bolnikih z revmatoidnim artritisom, ki so prejemali zdravilo rituksimab.
English: This medicinal product contains 52.6 mg sodium per 10 mL vial, equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Slovenian: To zdravilo vsebuje 52,6 mg natrija na 10 mL viale, kar je enako 2,6% največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: Mean change DAS28-ESR ‐1.97** Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Slovenian: Ravni signifikantnosti so bile opredeljene kot *p < 0,05; **p < 0,001; ***p < 0,0001.
English: In a prospective, open label, international, multicentre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
Slovenian: V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju III. faze je 1193 bolnikov s predhodno nezdravljenimi folikularnimi limfomi prejelo indukcijsko zdravljenje z R-CHOP (n=881), RCVP (n=268) ali R-FCM (n=44) po presoji raziskovalca.
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab 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. 76% when assessed for >2-fold increase in antibody titer).
Slovenian: V nerandomizirani študiji so imeli bolniki, ki so prejeli samostojno zdravljenje z rituksimabom ob ponovitvi nizkomalignega NHL, v primerjavi z zdravimi kontrolnimi osebami, ki niso prejele zdravila, v manjšem deležu dogovorili 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 s 76%, ko so določevali > 2-kratno povečanje v titru protiteles).
English: • The active ingredient in Ritemvia is called rituximab.
Slovenian: • Zdravilna učinkovina zdravila Ritemvia je rituksimab.
English: The two treatment groups were well balanced with regards to baseline characteristics and disease status.
Slovenian: Terapevtski skupini sta bili ob začetku zdravljenja dobro uravnoteženi glede na osnovne lastnosti in stanje bolezni.
English: Skin and subcutaneous tissue disorders alopecia toxic epidermal necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Slovenian: Bolezni kože in podkožja alopecija toksična epidermalna nekroliza (Lyellov sindrom), StevensJohnsonov sindrom5
English: Patients randomised to the standard-dose prednisone group received an initial 1 mg/kg/day oral prednisone tapered off over 12 months if they had moderate disease or 1.5 mg/kg/day oral prednisone tapered off over 18 months if they had severe disease.
Slovenian: Bolniki, randomizirani v skupino s standardnim odmerkom prednizona, so uvodoma prejeli 1 mg/kg/dan peroralnega prednizona z zmanjševanjem odmerka v obdobju 12 mesecev, če so imeli zmerno bolezen, ali 1,5 mg/kg/dan peroralnega prednizona z zmanjševanjem odmerka v obdobju 18 mesecev, če so imeli hudo bolezen.
English: 3 patients (8%) in the rituximab group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Slovenian: V skupini z zdravilom rituksimab se je pri 3 bolnikih (8%) pojavilo 5 resnih okužb (pljučnica zaradi Pneumocystis jirovecii, infekcijska tromboza, intervertebralni disciitis, okužba pljuč, stafilokokna sepsa); v skupini s standardnim odmerkom prednizona se je resna okužba (pljučnica zaradi Pneumocystis jirovecii) pojavila pri 1 bolniku (3%).
English: serum sickness-like reaction
Slovenian: reakcija, podobna serumski bolezni
English: The safety profile of rituximab in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the rituximab group.
Slovenian: Varnostne značilnosti zdravila rituksimab v kombinaciji s kratkotrajno uporabo majhnih odmerkov glukokortikoida za zdravljenje bolnikov z navadnim pemfigusom so raziskali v randomizirani, kontrolirani, multicentrični odprti študiji faze III, v kateri so 38 bolnikov randomizirali v skupino, ki je prejemala rituksimab.
English: Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial.
Slovenian: Pomožnesnovi: To zdravilo vsebuje 2,3 mmol (ali 52,6 mg) natrija na 10-ml vialo.
English: Multiple courses of treatment are associated with a similar ADR profile to that observed following first exposure.
Slovenian: Pri večkratnem zdravljenju je profil neželenih učinkov podoben tistemu, ki so ga opazili ob prvem zdravljenju.
English: decreased IgG
Slovenian: Koncentracija IgG
English: In addition to adverse reactions seen in RA clinical trials for rituximab, 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 rituksimaba 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: 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 rituximab and patients closely monitored during administration.
Slovenian: Pred zdravljenjem z zdravilom rituksimab 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: In the relapsed/refractory CLL study grade 3/4 thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in the FC group.
Slovenian: V študiji pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, so o trombocitopeniji stopnje 3 ali 4 poročali pri 11% bolnikov v skupini R-FC v primerjavi z 9% v skupini FC.
English: Signs and symptoms included visual disturbance, headache, seizures and altered mental status, with or without associated hypertension.
Slovenian: Znaki in simptomi so vključuvali motnje vida, glavobol, konvulzije in motnje zavesti, s pridruženo hipertenzijo ali brez nje.
English: Alopecia Pruritus
Slovenian: +alopecija urtikarija,
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2 mg/kg/day) for 3-6 months or rituximab (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 rituksimabom (375 mg/m2) enkrat na teden 4 tedne.
English: This medicine contains 263.2 mg sodium (main component of cooking/table salt) in each 50 mL vial.
Slovenian: To zdravilo vsebuje 263,2 mg natrija (glavne sestavine kuhinjske soli) na 50 mL viale.
English: If you get any of these, tell a doctor or nurse straight away.
Slovenian: Če se pri vas pojavi kateri koli od teh znakov ali simptomov, nemudoma obvestite zdravnika ali medicinsko sestro.
English: These can be complemented with other appropriate markers as per local guidelines.
Slovenian: To vključuje najmanj določanje statusa HBsAg in HBcAb, ki ju lahko dopolnimo z ostalimi primernimi označevalci v skladu z lokalnimi smernicami.
English: In these patients the rate of clinically relevant infection while on rituximab was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Slovenian: 100 bolnik-let, ko so se zdravili z rituksimabom, v primerjavi s 4,97 na 100 bolnik-let po tem, ko so prejeli nadaljnje zdravljenje z biološkim DMARD.
English: The most commonly reported events considered as ADRs were infusion-related reactions and infections.
Slovenian: Najpogosteje zabeleženi dogodki, ocenjeni kot neželeni učinki zdravila, so bile z infundiranjem povezane reakcije in okužbe.
English: The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Slovenian: Farmakokinetiko rituksimaba so ocenili po dveh 500 mg in 1.000 mg intravenskih odmerkih ob dnevih 1 in 15 v štirih preskušanjih.
English: The frequencies of ADRs reported with rituximab alone or in combination with chemotherapy are summarised in Table 1.
Slovenian: Pogostnosti neželenih učinkov, zabeleženih med samostojnim zdravljenjem z rituksimabom ali v kombinaciji s kemoterapijo, so povzete v preglednici 1.
English: Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61% with rituximab 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 rituksimabom v primerjavi z opazovano skupino (Coxova regresijska analiza, 95-% interval zaupanja: 45-72 %).
English: CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro-B cells, normal plasma cells or other normal tissue.
Slovenian: pro-B-celicah, normalnih plazmatkah ali drugem normalnem tkivu.
English: Diffuse large B cell non-Hodgkin's lymphoma
Slovenian: Difuzni velikocelični B ne-Hodgkinov limfom
English: The reactions reported were usually reversible with a reduction in rate, or interruption, of rituximab infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Slovenian: Reakcije, o katerih so poročali, so bile običajno reverzibilne z zmanjšanjem hitrosti ali prekinitvijo infuzije rituksimaba in dajanjem antipiretika, antihistaminika in občasno kisika, fiziološke raztopine intravensko ali bronhodilatatorja, in glukokortikoidov, če je bilo to potrebno.
English: In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Slovenian: Pri bolnikih s KLL sočasna uporaba rituksimaba ni vplivala na farmakokinetiko fludarabina ali ciklofosfamida.
English: • short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Slovenian: kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobulini - IgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih celic, okvara živcev v rokah in nogah, paraliza obraza,
English: 14 patients (37%) in the rituximab group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Slovenian: Z zdravljenjem povezane okužbe so se pojavile pri 14 bolnikih (37%) v skupini z zdravilom rituksimab in pri 15 bolnikih (42%) v skupini s standardnim odmerkom prednizona.
English: Cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
Slovenian: Pri bolnikih, ki so prejemali rituksimab, so poročali o reaktivaciji virusa hepatitisa B, vključno s fulminantnim hepatitisom s smrtnim izidom.
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: Patients with non-Hodgkin's lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest X-ray.
Slovenian: Pri bolnikih z ne-Hodgkinovim limfomom v takem primeru preverimo - vključno z laboratorijskimi testi - možnost pojava sindroma razpada tumorja in pljučno infiltracijo z rentgenskim pregledom prsnega koša.
English: The Physician information about Ritemvia should contain the following key elements:
Slovenian: Gradivo za zdravnika o zdravilu Ritemvia mora vsebovati naslednje ključne vsebine:
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, limfocitov B. Ko se veže na površino teh celic,
English: Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma
Slovenian: Koliko zdravila boste dobili in kako pogosto a) Če se zdravite zaradi ne-Hodgkinovega limfoma
English: The most frequent adverse reactions considered due to receipt of rituximab were IRRs.
Slovenian: Najpogostejši neželeni učinki, za katere so menili, da so nastali zaradi prejetja rituksimaba, so bile reakcije, povezane z infuzijo.
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab-arms compared to control arms.
Slovenian: V kliničnih preskušanjih so o okužbah spodnjih dihal (vključno s pljučnico) v skupini z rituksimabom poročali s podobno incidenco kot v kontrolnih skupinah.
English: If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis.
Slovenian: Če ponovno pride do enakih neželenih reakcij, razmislimo o ukinitvi zdravljenja.
English: Maintenance and relapse infusions were administered no sooner than 16 weeks following the previous infusion.
Slovenian: Vzdrževalne infuzije in infuzije zaradi recidiva so bile uporabljene nič prej kot 16 tednov po prejšnji infuziji.
English: Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: natrijev klorid, trinatrijev citrat dihidrat, polisorbat 80, voda za injekcije.
English: Patients randomised to the rituximab group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Slovenian: Ti bolniki so prejeli začetni odmerek 1.000 mg intravensko 1. dan študije in drugi odmerek 1.000 mg intravensko 15. dan študije.
English: FU: follow-up; NR: not reached at time of clinical cut off, TNCT: time to next chemotherapy treatment; TNLT: time to next anti lymphoma treatment.
Slovenian: NR: ni doseženo ob času kliničnega zaključka zbiranja podatkov (not reached), TNCT: čas do naslednje kemoterapije; TNLT: čas do naslednjega zdravljenja limfoma; CR: popolni odgovor; CRu: nepotrjeni popolni odgovor.
English: Rituximab binding to CD20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Slovenian: Vezava rituksimaba na antigen CD20 na limfocitih B povzroči celično smrt v procesu apoptoze.
English: Overall survival (median)
Slovenian: Celokupno preživetje (OS)
English: What Ritemvia is used for
Slovenian: Za kaj uporabljamo zdravilo Ritemvia
English: R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test).
Slovenian: Skupina R-CVP je imela glede primarnega opazovanega dogodka (časa do neuspeha zdravljenja) značilno prednost pred skupino CVP (27 mesecev v primerjavi s 6,6 meseca, p < 0,0001, log-rang test).
English: • severe blistering skin conditions that can be life-threatening.
Slovenian: huda stanja z mehurji na koži, ki so lahko življenjsko ogrožujoča.
English: Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome.
Slovenian: Med drugimi simptomi so bili pordevanje, angioedem, bronhospazem, bruhanje, navzea, urtikarija/izpuščaj, utrujenost, glavobol, draženje žrela, rinitis, srbenje, bolečina, tahikardija, hipertenzija, hipotenzija, dispneja, dispepsija, astenija in značilnosti sindroma razpada tumorja.
English: This medicine contains 52.6 mg sodium (main component of cooking/table salt) in each 10 mL vial.
Slovenian: To zdravilo vsebuje 52,6 mg natrija (glavne sestavine kuhinjske soli) na 10 mL viale.
English: Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Slovenian: Rdečina, pogosto povezana z mehurji, se lahko pojavi na koži ali na sluznici, kot je notranjost ustne votline, področje genitalij ali vek, prisotna je lahko tudi zvišana telesna temperatura,
English: Infections and infestations upper respiratory tract infection, urinary tract infections bronchitis, sinusitis, gastroenteritis, tinea pedis
Slovenian: Infekcijske in parazitske bolezni okužba zgornjih dihal, okužbe sečil bronhitis, sinuzitis, gastroenteritis, tinea pedis
English: • fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell
Slovenian: • zvišana telesna temperatura, kašelj, vneto grlo, pekoča bolečina pri uriniranju, občutek šibkosti ali splošno slabo počutje;
English: fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Slovenian: okužbe neznanega vzroka, vnetje obnosnih votlin, hepatitis B,
English: Limited experience with doses higher than the approved dose of intravenous rituximab formulation is available from clinical trials in humans.
Slovenian: Iz kliničnih preskušanj pri človeku je le malo izkušenj z odmerki, večjimi od odobrenega odmerka intravenske oblike rituksimaba.
English: Median TTF: years Not reached p < 0.001
Slovenian: mediana TTF: 2,6 leta ni doseženo p < 0,001
English: Patients randomised to the rituximab group received an initial intravenous infusion of 1000 mg rituximab on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Slovenian: Bolniki, randomizirani v skupino z zdravilom rituksimab, so prejeli uvodno intravensko infuzijo 1.000 mg zdravila rituksimab 1. dan študije v kombinaciji z 0,5 mg/kg/dan peroralnega prednizona (z zmanjševanjem odmerka v obdobju 3 mesecev), če so imeli zmerno bolezen , ali v kombinaciji z 1 mg/kg/dan peroralnega prednizona (z zmanjševanjem odmerka v obdobju 6 mesecev), če so imeli hudo bolezen, ter drugo intravensko infuzijo 1.000 mg 15. dan študije.
English: Immune system disorders infusion related reactions4, angioedema hypersensitivit y anaphylaxi s tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytope nia4
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: cell return, with counts > 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Slovenian: Pri večini bolnikov (81 %) se je število celic B ponovno povečalo na > 10 celic/µl do 12. meseca, do 18. meseca pa še pri večjem, 87-% deležu bolnikov.
English: There were no differences reported for the incidence of anaemia.
Slovenian: Incidenca anemije se ni razlikovala.
English: Experience from rheumatoid arthritis
Slovenian: Izkušnje pri revmatoidnem artritisu
English: Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection, e.g. hypogammaglobulinaemia (see section 4.8).
Slovenian: Pri odločanju za uporabo zdravila rituksimab 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, npr. s hipogamaglobulinemijo (glejte poglavje 4.8).
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; N/A: not applicable *: only applicable to patients achieving a CR, nPR, PR; **: only applicable to patients achieving a CR;
Slovenian: NR: nedoseženo; n.a. neaplikabilno *: aplikabilno samo za bolnike, ki so dosegli CR, nPR (nodularni delni odgovor), PR; **: aplikabilno samo za bolnike, ki so dosegli CR
English: Very rare cases of fatal PML have been reported following the use of rituximab.
Slovenian: Pri uporabi rituksimaba so poročali o zelo redkih smrtnih primerih PML.
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: 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.
Slovenian: Ko se simptomi popolnoma izboljšajo, lahko pri večini primerov infuzijo nadaljujemo s polovično hitrostjo infundiranja (npr. s 100 mg/h na 50 mg/h).
English: The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Slovenian: Najpogostejše okužbe v skupini z zdravilom rituksimab so bile okužbe z virusoma herpes simpleks in herpes zoster, bronhitis, okužbe sečil, glivične okužbe in konjunktivitis.
English: The recommended dosage of Ritemvia for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Slovenian: Priporočeno odmerjanje zdravila Ritemvia za indukcijo remisije pri zdravljenju granulomatoze s poliangiitisom in mikroskopskega poliangiitisa je 375 mg/m2 telesne površine v intravenski infuziji 1-krat na teden 4 tedne (skupaj štiri infuzije).
English: Biotec Services International Ltd. Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK And
Slovenian: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, Velika Britanija in
English: Elderly No dose adjustment is required in elderly patients (aged >65 years).
Slovenian: Starejši Starejšim bolnikom (> 65 let) odmerka ni treba prilagoditi.
English: Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Slovenian: Zelo redko sta bila opisana toksična epidermalna nekroliza (Lyellov sindrom) ali Stevens-Johnsonov sindrom, v nekaterih primerih s smrtnim izidom.
English: Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.
Slovenian: Navadni pemfigus je avtoimunska bolezen, ki povzroča boleče mehurje na koži ter sluznici ust, nosu, žrela in spolovil.
English: Also do not breast-feed for 12 months after your last treatment with Ritemvia.
Slovenian: Prav tako ne smete dojiti še 12 mesecev po zadnjem odmerku zdravila Ritemvia.
English:  Infections, see section 4.4.
Slovenian: • okužbe, glejte poglavje 4.4;