natgillin/translations-raw huggingface dataset:
repeat testing, see For persistent increases > 3 x ULN, discontinue RoActemra section 4.4).
V primeru dolgotrajnih zvišanj > 3- kratno ZMN ukinite zdravilo RoActemra.
> 5 x ULN
> 5- kratna ZMN
• Low absolute neutrophil count (ANC)
• Nizko absolutno število nevtrofilcev (ANC, absolute neutrophil count)
Laboratory Value (cells x 109/ l)
Laboratorijska vrednost (celic x 109/ l)
ANC > 1
> 1
ANC 0.5 to 1
ANC 0, 5 do 1
When ANC increases > 1 x 109/ l resume RoActemra at 4 mg/ kg and increase to 8 mg/ kg as clinically appropriate
Ko se absolutno število nevtrofilcev poveča > 1 x 109/ l, znova uvedite zdravilo RoActemra v odmerku 4 mg/ kg in povečajte na 8 mg/ kg, kot je klinično ustrezno.
• Low platelet count
• Nizko število trombocitov
Laboratory Value (cells x 103/ μ l)
Laboratorijska vrednost (celic x 103/ μl)
When platelet count > 100 x 103/ μ l resume RoActemra at 4 mg/ kg and increase to 8 mg/ kg as clinically appropriate
Ko je število trombocitov > 100 x 103/ μl, znova uvedite zdravilo RoActemra v odmerku 4 mg/ kg in povečajte na 8 mg/ kg, kot je klinično ustrezno.
< 50 Discontinue RoActemra
< 50 Ukinite zdravilo RoActemra.
RoActemra is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.
Posebne populacije Pediatrični bolniki: zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila RoActemra ni priporočljiva pri otrocih do 18. leta starosti.
No dose adjustment is required in patients aged 65 years and older.
3 Starejši bolniki: bolnikom, starim 65 let ali več, odmerka ni treba prilagoditi.
No dose adjustment is required in patients with mild renal impairment.
Okvara ledvic: bolnikom z blago okvaro ledvic odmerka ni treba prilagoditi.
Renal
Uporaba zdravila RoActemra ni raziskana pri bolnikih z zmerno do hudo okvaro ledvic (glejte poglavje 5. 2).
3 function should be monitored closely in these patients.
Delovanje ledvic je treba pri teh bolnikih skrbno nadzorovati.
Therefore, no dose recommendations can be made.
Okvara jeter: uporaba zdravila RoActemra pri bolnikih z okvaro jeter ni raziskana, zato ni mogoče dati priporočil za odmerjanje.
Method of administration After dilution, RoActemra should be administered as an intravenous infusion over 1 hour.
Način uporabe Po razredčenju je treba zdravilo RoActemra dati v 1- urni intravenski infuziji.
RoActemra should be diluted to a final volume of 100 ml with sterile, non-pyrogenic sodium chloride 9 mg/ ml (0.9%) solution for injection using aseptic technique.
Zdravilo RoActemra je treba razredčiti na končni volumen 100 ml s sterilno, apirogeno 0, 9 -% (9 mg/ ml) raztopino natrijevega klorida za injiciranje upoštevaje aseptičen postopek.
For further information on dilution prior to administration, see section 6.6.
Za nadaljnje informacije o razredčenju pred uporabo glejte poglavje 6. 6.
Infections RoActemra treatment should not be initiated in patients with active infections (see section 4.3).
Okužbe Zdravljenja z zdravilom RoActemra ne smete uvesti pri bolnikih z aktivnimi okužbami (glejte poglavje 4. 3).
Administration of RoActemra should be interrupted if a patient develops a serious infection until the infection is controlled (see section 4.8).
Če se pojavi resna okužba, je treba uporabo zdravila RoActemra prekiniti, dokler okužba ni obvladana (glejte poglavje 4. 8).
Healthcare professionals should exercise caution when considering the use of RoActemra in patients with a history of recurring or chronic infections or with underlying conditions (e. g. diverticulitis, diabetes) which may predispose patients to infections.
Zdravniki morajo biti previdni pri odločanju za uporabo zdravila RoActemra pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb ali z drugimi boleznimi (npr. divertikulitisom, sladkorno boleznijo), ki lahko povečajo nagnjenost k okužbam.
Vigilance for the timely detection of serious infection is recommended for patients receiving biological treatments for moderate to severe RA as signs and symptoms of acute inflammation may be lessened, associated with suppression of the acute phase reaction.
Med zdravljenjem zmernega do hudega revmatoidnega artritisa z biološkimi zdravili je treba nameniti pozornost pravočasnemu odkrivanju resnih okužb, kajti znaki in simptomi akutnega vnetja se zaradi zavrte reakcije akutne faze lahko zmanjšajo.
The effects of tocilizumab on C-reactive protein (CRP), neutrophils and signs and symptoms of infection should be considered when evaluating a patient for a potential infection.
Pri ocenjevanju možne okužbe pri bolniku je treba upoštevati učinke tocilizumaba na C- reaktivni protein (CRP), nevtrofilce ter znake in simptome okužbe.
Tuberculosis As recommended for other biological treatments in RA, patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Tuberkuloza Kot velja za druga biološka zdravila pri revmatoidnem artritisu, je treba bolnike pred začetkom zdravljenja z zdravilom RoActemra presejalno pregledati glede latentne tuberkuloze.
Complications of diverticulitis Events of diverticular perforations as complications of diverticulitis have been reported uncommonly with RoActemra (see section 4.8).
Zapleti divertikulitisa Občasno so pri zdravljenju z zdravilom RoActemra poročali o perforaciji divertiklov kot zapletu divertikulitisa (glejte poglavje 4. 8).
Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/ or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Bolnike s simptomi, ki lahko nakazujejo zaplete divertikulitisa (npr. z bolečinami v trebuhu, krvavitvijo in/ ali nepojasnjeno spremembo v razporedu iztrebljanja in zvišano telesno temperaturo), je treba takoj pregledati, da bi zgodaj odkrili divertikulitis, ki ga lahko spremlja perforacija v prebavilih.
Hypersensitivity reactions Serious hypersensitivity reactions have been reported in association with infusion of RoActemra in approximately 0.3% of patients (see section 4.8).
4 Preobčutljivostne reakcije Pri približno 0, 3% bolnikov so bile opisane resne preobčutljivostne reakcije, povezane z infuzijo zdravila RoActemra (glejte poglavje 4. 8).
Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during administration of RoActemra.
Med dajanjem zdravila RoActemra mora biti na voljo ustrezno zdravljenje za takojšnjo uporabo v primeru anafilaktične reakcije.
4 Active hepatic disease and hepatic impairment Treatment with RoActemra, particularly when administered concomitantly with MTX, may be associated with elevations in hepatic transaminases (see section 4.8).
Aktivna bolezen jeter in okvara jeter Zdravljenje z zdravilom RoActemra lahko spremlja zvišanje jetrnih transaminaz, zlasti če se uporablja z metotreksatom (glejte poglavje 4. 8).
Therefore, caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment, as the safety of RoActemra in these patients has not been adequately studied (see section 4.2).
Pri odločanju za uporabo zdravila RoActemra pri bolnikih z aktivno boleznijo jeter ali okvaro jeter, morate biti zato previdni, kajti varnost zdravila RoActemra pri teh bolnikih ni dovolj raziskana (glejte poglavje 4. 2).
Hepatic transaminase elevations In clinical trials, transient or intermittent mild and moderate elevations of hepatic transaminases have been reported commonly with RoActemra treatment, without progression to hepatic injury (see section 4.8).
Zvišanje jetrnih transaminaz V kliničnih preskušanjih so med zdravljenjem z zdravilom RoActemra pogosto poročali o prehodnem ali intermitentnem blagem do zmernem zvišanju jetrnih transaminaz, brez napredovanja v poškodbo jeter (glejte poglavje 4. 8).
MTX) were used in combination with RoActemra.
Zvišanje je bilo pogostejše med kombinirano uporabo zdravila RoActemra s potencialno hepatotoksičnimi zdravili (npr. z metotreksatom).
Caution should be exercised when considering initiation of RoActemra treatment in patients with elevated ALT or AST > 1.5 x ULN.
Previdnost je potrebna, če razmišljate o uvedbi zdravila RoActemra pri bolnikih, ki imajo ALT ali AST zvišano na > 1, 5- kratno ZMN.
In patients with baseline ALT or AST > 5 x ULN, treatment is not recommended.
Zdravljenje ni priporočljivo pri bolnikih, pri katerih sta ALT ali AST izhodiščno > 5- krat nad ZMN.
ALT and AST levels should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Vrednosti ALT in AST je treba prvih 6 mesecev zdravljenja kontrolirati na 4 do 8 tednov, pozneje pa na 12 tednov.
For recommended modifications based on transaminases see section 4.2.
Za priporočene prilagoditve odmerjanja na podlagi transaminaz glejte poglavje 4. 2.
For ALT or AST elevations > 3– 5 x ULN, confirmed by repeat testing, RoActemra treatment should be interrupted.
V primeru zvišanja ALT ali AST na > 3 - do 5- kratno ZMN, ki je potrjeno s ponovnim testiranjem, je treba zdravljenje z zdravilom RoActemra prekiniti.
Once the patient ’ s hepatic transaminases are below 3 x ULN, treatment with RoActemra may recommence at 4 or 8 mg/ kg.
Ko se jetrne transaminaze bolniku znižajo pod 3 - kratno ZMN, lahko zdravljenje z zdravilom RoActemra znova začnete z odmerkom 4 ali 8 mg/ kg.
Haematological abnormalities Decreases in neutrophil and platelet counts have occurred following treatment with tocilizumab 8 mg/ kg in combination with MTX (see section 4.8).
Hematološke nepravilnosti Po zdravljenju z 8 mg/ kg tocilizumaba v kombinaciji z metotreksatom se je zmanjšalo število nevtrofilcev in trombocitov (glejte poglavje 4. 8).
Caution should be exercised when considering initiation of RoActemra treatment in patients with a low neutrophil or platelet count (i. e.
Previdnost je potrebna, če razmišljate o uvedbi zdravila RoActemra pri bolnikih z nizkim številom nevtrofilcev ali trombocitov (tj.
ANC < 2 x 109/ l or platelet count below 100 x 103/ μ l).
ANC < 2 x 109/ l ali številom trombocitov pod 100 x 103/ µl).
In patients with an ANC < 0.5 x 109/ l or a platelet count < 50 x 103/ μ l treatment is not recommended.
Zdravljenje ni priporočljivo pri bolnikih z ANC < 0, 5 x 109/ l ali številom trombocitov pod < 50 x 103/ µl.
Neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice.
Nevtrofilce in trombocite morate kontrolirati od 4 do 8 tednov po začetku zdravljenja, pozneje pa v skladu s standardno klinično prakso.
For recommended dose modifications based on ANC and platelet counts, see section 4.2.
Za priporočene prilagoditve odmerka na podlagi absolutnega števila nevtrofilcev in števila trombocitov glejte poglavje 4. 2.
Lipid parameters Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with tocilizumab (see section 4.8).
Vrednosti lipidov Pri bolnikih, ki so dobivali tocilizumab so opazili zvišanje vrednosti lipidov, vključno z zvišanjem celotnega holesterola, lipoproteina majhne gostote (LDL), lipoproteina velike gostote (HDL) in trigliceridov (glejte poglavje 4. 8).
Assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Meritev lipidov je treba opraviti od 4 do 8 tednov po uvedbi zdravljenja z zdravilom RoActemra.
Neurological disorders Physicians should be vigilant for symptoms potentially indicative of new-onset central demyelinating disorders.
Nevrološke motnje Zdravniki morajo biti pozorni na simptome, ki bi lahko pomenili novonastalo centralno demielinizacijsko motnjo.
Malignancy The risk of malignancy is increased in patients with RA.
5 Malignomi Bolniki z revmatoidnim artritisom imajo večje tveganje za malignome.
Vaccinations Live and live attenuated vaccines should not be given concurrently with RoActemra as clinical safety has not been established.
Cepljenja Med zdravljenjem z zdravilom RoActemra ne smete uporabljati živih in živih oslabljenih cepiv, ker klinična varnost ni ugotovljena.
5 Cardiovascular risk RA patients have an increased risk for cardiovascular disorders and should have risk factors (e. g. hypertension, hyperlipidaemia) managed as part of usual standard of care.
Srčno- žilno tveganje Bolniki z revmatoidnim artritisom imajo večje tveganje za srčno- žilne bolezni, zato mora njihova običajna standardna obravnava vključevati obvladanje dejavnikov tveganja (npr. hipertenzije, hiperlipidemije).
Combination with TNF antagonists There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA.
Kombinacija z zaviralci TNF Ni izkušenj z uporabo zdravila RoActemra z zaviralci TNF ali drugimi biološkimi zdravili za revmatoidni artritis.
Sodium This medicinal product contains 1.17 mmol (or 26.55 mg) sodium per maximum dose of 1200 mg.
Natrij To zdravilo vsebuje 1, 17 mmol (ali 26, 55 mg) natrija na največji odmerek 1200 mg.
Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i. e. essentially ‘ sodium free’.
Odmerki tega zdravila, manjši od 1025 mg, vsebujejo manj kot 1 mmol natrija (23 mg), kar v bistvu pomeni "brez natrija".
Concomitant administration of a single dose of 10 mg/ kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Sočasna uporaba posamičnega odmerka 10 mg/ kg tocilizumaba in 10 do 25 mg metotreksata enkrat na teden ni klinično pomembno vplivala na izpostavljenost metotreksatu.
The expression of hepatic CYP450 enzymes is suppressed by the cytokines, such as IL-6, that stimulate chronic inflammation.
Citokini, kot je IL- 6, ki stimulirajo kronično vnetje, zavirajo ekspresijo jetrnih encimov CYP450.
In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19, and CYP3A4 enzyme expression.
Študije in vitro na kulturah človeških jetrnih celic so pokazale, da IL- 6 zmanjša ekspresijo encimov CYP1A2, CYP2C9, CYP2C19 in CYP3A4.
When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2, 2C9 or 2C19 (e. g. atorvastatin, calcium channel blockers, theophylline, warfarin, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Bolnike, zdravljene z individualno prilagojenimi zdravili, ki se presnavljajo s CYP450 3A4, 1A2, 2C9 ali 2C19 (npr. atorvastatin, zaviralci kalcijevih kanalčkov, teofilin, varfarin, fenitoin, ciklosporin ali benzodiazepini), morate po uvedbi ali prenehanju dajanja tocilizumaba nadzorovati, ker utegnejo za ohranitev terapevtskega učinka potrebovati večje odmerke.
Given its long elimination half-life (t1/ 2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Glede na dolg eliminacijski razpolovni čas (t1/ 2) tocilizumaba lahko njegov učinek na aktivnost encima CYP450 traja še več tednov po koncu zdravljenja.
Pregnancy There are no adequate data from the use of tocilizumab in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi tocilizumaba pri nosečnicah.
A study in animals has shown an increased risk of spontaneous abortion/ embryo-foetal death at a high dose (see section 5.3).
Študije na živalih so pokazale, da pri večjih odmerkih obstaja večje tveganje spontanega splava ali embrio- fetalne smrti (glejte poglavje 5. 3).
Women of childbearing potential must use effective contraception during and up to 6 months after treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 6 mesecev po njem.
Lactation It is unknown whether tocilizumab is excreted in human breast milk.
Dojenje Ni znano, ali se tocilizumab pri človeku izloča v materino mleko.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with RoActemra should be made taking into account the benefit of breast-feeding to the child and the benefit of RoActemra therapy to the woman.
Pri odločitvi za nadaljevanje ali prekinitev dojenja oz. za nadaljevanje ali prekinitev zdravljenja z zdravilom RoActemra je treba upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom RoActemra za žensko.
However, given that dizziness has been commonly reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has resolved.
Glede na to, da so o omotici pogosto poročali, je treba bolnikom, pri katerih se pojavi ta neželeni učinek, svetovati, naj ne vozijo ali upravljajo s stroji, dokler vrtoglavica ne izzveni.
A total of 3,778 patients received at least one dose of RoActremra 4 mg/ kg or 8 mg/ kg.
Vsaj en odmerek 4 mg/ kg ali 8 mg/ kg zdravila RoActemra je dobilo skupaj 3778 bolnikov.
The adverse drug reactions (ADRs) presented in Table 1 are based on the safety of tocilizumab studied in 4 placebo-controlled studies (studies II, III, IV and V) and 1 MTX-controlled study (study I) (see section 5.1).
Neželeni učinki v preglednici 1 temeljijo na podatkih o varnosti tocilizumaba, pridobljenih iz štirih s placebom kontroliranih študijah (študije II, III, IV in V) in ene z metotreksatom kontrolirane študije (študija I) (glejte poglavje 5. 1).
In these studies, 774 patients received tocilizumab 4 mg/ kg in combination with MTX, 1,582 patients received tocilizumab 8 mg/ kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/ kg monotherapy.
V teh študijah je 774 bolnikov dobivalo 4 mg/ kg tocilizumaba v kombinaciji z metotreksatom, 1582 bolnikov 8 mg/ kg tocilizumaba v kombinaciji z metotreksatom oz. drugimi imunomodulirajočimi antirevmatičnimi zdravili, 288 bolnikov pa 8 mg/ kg tocilizumaba v monoterapiji.
The long-term open label extension studies included 2,562 patients who received tocilizumab 8 mg/ kg with or without DMARDs.
Dolgoročne odprte podaljšane študije so vključile 2562 bolnikov, ki so dobivali 8 mg/ kg tocilizumaba, z imunomodulirajočimi antirevmatičnimi zdravili ali brez njih.
The total exposure in the long-term safety analysis was 3,685 patient years.
Celotna izpostavljenost v dolgoročni analizi varnosti je bila 3685 bolnik- let.
The most commonly reported ADRs (occurring in ≥ 5% of patients treated with tocilizumab monotherapy or in combination with DMARDs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Najpogosteje opisani neželeni učinki (ki so se pojavili pri ≥ 5% bolnikov, zdravljenih s tocilizumabom v monoterapiji ali v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili) so bili okužbe zgornjih dihal, nazofaringitis, glavobol, hipertenzija in zvišanje ALT.
The ADRs listed in Table 1 are presented by system organ class and frequency categories, defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10) or uncommon (≥ 1/ 1,000 to < 1/ 100).
Neželeni učinki v preglednici 1 so navedeni po organskih sistemih in skupinah pogostnosti upoštevaje naslednjo razvrstitev: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10) ali občasni (≥ 1/ 1000 do < 1/ 100).
Summary of ADRs occurring in patients with RA receiving tocilizumab as monotherapy or in combination with MTX or other DMARDs
Povzetek neželenih učinkov pri bolnikih z revmatoidnim artritisom, zdravljenih s tocilizumabom v monoterapiji ali v kombinaciji z metotreksatom ali drugimi imunomodulirajočimi antirevmatičnimi zdravili.
Upper respiratory tract infections
okužbe zgornjih dihal
Mouth ulceration, Gastritis
Bolezni prebavil Bolezni kože in podkožja
Skin and subcutaneous tissue disorders
razjeda v ustih, gastritis izpuščaj, srbenje
Nervous system disorders
vnetje ustne sluznice urtikarija
Headache, Dizziness
Bolezni živčevja
Investigations
glavobol, omotica
Hepatic transaminases increased
Preiskave Žilne bolezni Bolezni krvi in limfatičnega sistema
Blood and lymphatic system disorders
zvišanje jetrnih transaminaz hipertenzija levkopenija, nevtropenija
Leukopenia, Neutropenia
zvišanje celotnega bilirubina
7 Infections In the controlled studies the rate of all infections reported with tocilizumab 8 mg/ kg plus DMARD treatment was 127 events per 100 patient years compared to 112 events per 100 patient years in the placebo plus DMARD group.
7 Okužbe V kontroliranih študijah je bil delež vseh okužb med uporabo 8 mg/ kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 127 na 100 bolnik- let, med uporabo placeba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili pa 112 na 100 bolnik- let.
In the long-term open label extension studies, the rate of infections with RoActemra plus DMARDs was 116 events per 100 patient years exposure.
V dolgoročnih odprtih podaljšanih študijah je bil delež okužb med uporabo zdravila RoActemra v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 116 na 100 bolnik- let izpostavljenosti.
In controlled clinical studies, the rate of serious infections with tocilizumab 8 mg/ kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group.
V kontroliranih kliničnih študijah je bil delež resnih okužb med uporabo 8 mg/ kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 5, 3 na 100 bolnik- let izpostavljenosti, med uporabo placeba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili pa 3, 9 na 100 bolnik- let izpostavljenosti.
In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the tocilizumab group and 1.5 events per 100 patient years of exposure in the MTX group.
V študiji monoterapije je bil delež resnih okužb v skupini, ki je dobivala tocilizumab, 3, 6 na 100 bolnik- let izpostavljenosti, v skupini, ki je dobivala metotreksat, pa 1, 5 na 100 bolnik- let izpostavljenosti.
In the long-term safety population (core and extension studies), the rate of serious infections observed with tocilizumab plus DMARD treatment was 3.9 events per 100 patient years exposure.
V dolgoročnih (osnovnih in podaljšanih) populacijskih študijah varnosti je bil delež resnih okužb med uporabo tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 3, 9 na 100 bolnik- let izpostavljenosti.
Reported serious infections included pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
Med opisanimi resnimi okužbami so bile pljučnica, flegmona, herpes zoster, gastroenteritis, divertikulitis, sepsa in bakterijski artritis.
Serious infections were rarely fatal.
Resne okužbe so bile redko usodne.
Complications of diverticulitis During the six month controlled trials, complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess have been reported uncommonly with tocilizumab therapy.
Zapleti divertikulitisa Med šestmesečnimi kontroliranimi preskušanji so bili med zdravljenjem s tocilizumabom občasno opisani zapleti divertikulitisa, med njimi generaliziran gnojni peritonitis, perforacija v spodnjem delu prebavil, fistule in absces.
Infusion reactions Adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the tocilizumab 8 mg/ kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
Reakcije, povezane z infuzijo Neželene učinke, povezane z infuzijo (izbrane učinke, ki so se pojavili med infuzijo ali v 24 urah po njej), je navedlo 6, 9% bolnikov v skupini, ki je dobivala 8 mg/ kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, in 5, 1% bolnikov v skupini, ki je dobivala placebo in imunomodulirajoča antirevmatična zdravila.