natgillin/translations-raw huggingface dataset:
Fatal anaphylaxis has been reported after marketing authorisation during treatment with tocilizumab (see section 4.4).
V obdobju po prihodu zdravila na trg so poročali o primeru smrtne anafilaksije med zdravljenjem s tocilizumabom (glejte poglavje 4.4).
No patient developed positive antitocilizumab antibodies post baseline.
Pri nobenem bolniku se niso pojavila pozitivna protitelesa proti tocilizumabu po izhodišču.
During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with RoActemra therapy.
Med šestmesečnimi kontroliranimi kliničnimi preskušanji je bil celokupni delež perforacij v prebavilih med uporabo zdravila RoActemra 0,26 na 100 bolnik-let.
Available data with the IV formulation suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Razpoložljivi podatki z intravensko obliko kažejo, da je klinično izboljšanje opazno v 12 tednih od začetka zdravljenja z zdravilom RoActemra.
to <1/100).
(1,3 do 2,1).
The mean change in HAQ-DI was maintained at Week 104 in the RoActemra 8 mg/kg plus MTX group (-0.61).
Povprečna sprememba po HAQ-DI je bila po 104. tednu v skupini z zdravilom RoActemra 8 mg/kg in metotreksatom ohranjena (- 0,61).
In study SC-I, the mean decrease in HAQ-DI from baseline to week 24 was 0.6 on both the subcutaneous and intravenous arms.
Izidi, povezani s splošnim zdravstvenim stanjem in kakovostjo življenja V študiji SC-I je bilo povprečno zmanjšanje po HAQ-DI od izhodišča do 24. tedna 0,6 v subkutani in intravenski skupini.
(See Fig. H)
(glejte sliko H).
Vigilance for the timely detection of serious infection is recommended for patients receiving biological treatments for moderate to severe RA, sJIA or pJIA 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, sJIA ali pJIA 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.
Leave a gap of at least 3 months after your last treatment before you start breast-feeding.
Preden ponovno začnete dojiti, morajo od vašega zadnjega zdravljenja miniti vsaj 3 meseci.
Placebo + 26 weeks prednisone taper N=50
Placebo + 26 tednov zmanjševanja prednizona n = 50
In the tocilizumab group, the events included, but were not limited to rash, urticaria, diarrhea, epigastric discomfort, arthralgia and headache.
V skupini, ki je prejemala tocilizumab, so neželeni učinki med drugimi vključevali izpuščaj, urtikarijo, diarejo, nelagodje v epigastriju, artralgijo in glavobol.
Serious hypersensitivity reactions have been reported in association with infusion of RoActemra (see section 4.8).
Opisane so bile hude preobčutljivostne reakcije, povezane z infundiranjem zdravila RoActemra (glejte poglavje 4.8).
Change in EQ5D scores from baseline to week 52 were RoActemra weekly plus 26 weeks 0.10 [0.198], RoActemra every other weekly plus 26 weeks 0.05 [0.215], placebo plus 26 weeks 0.07 [0.293], and placebo plus 52 weeks -0.02 [0.159].
Spremembe ocene EQ5D od izhodišča do 52. tedna so bile z zdravilom RoActemra + 26-tedensko 0,10 [0,198], RoActemra vsak drugi teden + 26-tedensko 0,05 [0,215], placebo + 26-tedensko 0,07
The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA or GCA.
Zdravljenje s tem zdravilom vam bo predpisal in začel zdravstveni delavec z izkušnjami pri odkrivanju in zdravljenju revmatoidnega artritisa ali gigantoceličnega arteriitisa.
It is recommended that all patients, particularly sJIA and pJIA patients, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating RoActemra therapy.
Priporočljivo je, da se vsi bolniki, še posebno bolniki s sJIA in pJIA, cepijo v skladu z veljavnimi smernicami za cepljenje pred začetkom zdravljenja z zdravilom RoActemra.
Reports of gastrointestinal perforation on RoActemra were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Poročila o perforaciji v prebavilih med zdravljenjem z zdravilom RoActemra so se v glavnem nanašala na zaplete divertikulitisa, vključno z generaliziranim gnojnim peritonitisom, perforacijo v spodnjem delu prebavil, fistulo in abscesom.
The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag.
Potrebno količino koncentrata zdravila RoActemra (0,4 ml/kg) morate izvleči iz viale in dati v 100-ml vrečko za infundiranje.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih se odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Patients had mean DAS28 at baseline of 6.7 on subcutaneous and 6.6 on placebo arms.
Bolniki so imeli povprečno izhodiščno oceno DAS28 v subkutani skupini 6,7, v intravenski pa 6,6.
Eleven (6.8%) patients in the tocilizumab arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Pri enajstih bolnikih (6,8 %) iz skupine, ki je prejemala tocilizumab in petih bolnikih (3,1 %) iz skupine, ki je prejemala adalimumab, se je pojavilo zvišanje ALT stopnje 2 ali več po CTC.
Haematological abnormalities:
Hematološke nepravilnosti:
Serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, have been observed with RoActemra (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo RoActemra, so opazili primere z zdravili povzročene resne okvare jeter, vključno z akutno odpovedjo jeter, hepatitisom in zlatenico (glejte poglavje 4.8).
• Do not hold the syringe by the plunger while removing the needle-cap.
• Ne držite injekcijske brizge za bat, ko odstranjujete pokrovček injekcijske igle.
162 mg weekly
162 mg vsak teden
RoActemra 20 mg/mL concentrate for solution for infusion Tocilizumab
RoActemra 20 mg/ml koncentrat za raztopino za infundiranje tocilizumab
• inflammation of the liver (hepatitis), jaundice
• smrtne alergijske reakcije (anafilaksija [smrtna]), • vnetje jeter (hepatitis), zlatenica.
The dose-response curve for tocilizumab flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in RoActemra concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with > 800 mg of RoActemra.
Krivulja odmerek-odziv za tocilizumab je pri večji izpostavljenosti bolj položna, kar pomeni manjše poraste učinkovitosti pri vsakem nadaljnjem povečanju koncentracije tocilizumaba; tako pri bolnikih, zdravljenih z več kot 800 mg tocilizumaba, niso dokazali klinično pomembnih porastov učikovitosti.
sJIA (SC)
sJIA (subkutana oblika)
Parts of your RoACTEMRA pre-filled pen (See Figure A).
Deli napolnjenega injekcijskega peresnika z zdravilom RoACTEMRA (glejte sliko A).
These may affect up to 1 in every 100 patients
Ti se lahko pojavijo pri največ 1 od 100 bolnikov.
In tocilizumab-treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
Pri bolnikih, ki so dobivali tocilizumab, so ugotovili zmanjšanje koncentracije CRP v normalno območje že 2. teden, ohranilo pa se je ves čas zdravljenja.
RoActemra has a minor influence on the ability to drive and use machines (see section 4.8, dizziness).
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo RoActemra ima blag vpliv na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8,
Excipients with known effects Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Ena 80-mg viala vsebuje 0,10 mmol (2,21 mg) natrija.
Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA or pJIA.
Zaradi nezadostnih kliničnih izkušenj zdravila RoActemra ni priporočljivo uporabljati z drugimi biološkimi zdravili za zdravljenje revmatoidnega artritisa, sJIA ali pJIA.
• Do not touch the syringe trigger fingers as this may damage the syringe
• Ne dotikajte se in ne premikajte sprostitvenih sponk, ker lahko poškodujete injekcijsko brizgo.
Available non-clinical data do not suggest an effect on fertility under RoActemra treatment.
Razpoložljivi neklinični podatki ne kažejo, da bi zdravljenje z zdravilom RoActemra vplivalo na plodnost.
Reported serious infections, some with fatal outcome, included active tuberculosis, which may present with intrapulmonary or extrapulmonary disease, invasive pulmonary infections, including candidiasis, aspergillosis, coccidioidomycosis and pneumocystis jirovecii, pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
Med opisanimi resnimi okužbami, od katerih so se nekatere končale tudi s smrtnim izidom, so bile aktivna tuberkuloza, ki se lahko pojavi v intrapulmonalni ali ekstrapulmonalni obliki, invazivne okužbe pljuč, kot so kandidoza, aspergiloza, kokcidioidomikoza in
Vigilance for the timely detection of serious infection is recommended for patients receiving immunosuppressive agents such as RoActemra as signs and symptoms of acute inflammation may be lessened, due to suppression of the acute phase reactants.
Med zdravljenjem z imunosupresivnimi zdravili, kot je zdravilo RoActemra, je treba nameniti pozornost pravočasnemu odkrivanju resnih okužb, kajti znaki in simptomi akutnega vnetja se zaradi zavrtja reaktantov akutne faze lahko zmanjšajo.
Each patient continued in Part II of the study until Week 40 or until the patient satisfied JIA ACR30 flare criteria (relative to Week 16) and qualified for escape to tocilizumab therapy (same dose received in Part I).
delu študije nadaljeval do 40. tedna ali dokler ni izpolnil merila JIA ACR 30 za nenadno poslabšanje bolezni (glede na 16. teden)
All patients should be up-to-date with all their vaccinations before they start treatment with RoActemra.
Vsi bolniki morajo pred začetkom zdravljenja z zdravilom RoActemra prejeti vsa cepiva.
Decrease in neutrophil count sJIA
zmanjšanje števila nevtrofilcev sJIA
Exploratory efficacy results showed that RoActemra SC improved median Juvenile Arthritis Disease Activity Score (JADAS)-71 for RoActemra naïve patients and maintained the median JADAS-71 for patients who switched from IV to SC RoActemra treatment over the entire course of the study for patients in both body weight groups (below 30 kg and ≥ 30 kg).
(Juvenile Arthritis Disease Activity Score, JADAS)-71 pri bolnikih, ki predhodno niso bili zdravljeni s tocilizumabom, in ohranilo vse eksploratorne parametre učinkovitosti pri bolnikih, ki so prešli z intravenskega na subkutano zdravljenje z zdravilom RoActemra (in ga prejemali v celotnem obdobju študije) pri bolnikih iz obeh skupin glede na telesno maso (pod 30 kg in ≥ 30 kg).
In clinical trials, RoActemra has not been studied in patients during an episode of active MAS.
V kliničnih študijah zdravila RoActemra pri bolnikih med epizodo aktivnega sindroma aktivacije makrofagov niso proučevali.
Rheumatoid arthritis patients demonstrated a similar pattern of absolute neutrophil counts following tocilizumab administration (see section 4.8).
Pri bolnikih z revmatoidnim artritisom se je po prejemu tocilizumaba absolutno število nevtrofilcev spreminjalo na podoben način (glejte poglavje 4.8).
When ANC increases > 1 x 109/ L resume RoActemra dosing every other week and increase to every week injection, as clinically appropriate.
Ko se absolutno število nevtrofilcev poveča > 1 x 109/l, znova uvedite zdravilo RoActemra z odmerjanjem enkrat na dva tedna in povečajte pogostnost odmerjanja na enkrat na teden, kot je klinično ustrezno.
In sJIA, pJIA and RA patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Pri bolnikih s sJIA, pJIA in revmatoidnim artritisom je treba meritev lipidov opraviti od 4 do 8 tednov po uvedbi zdravljenja z zdravilom RoActemra.
Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet.
Izčrpna navodila za aplikacijo zdravila RoActemra v napolnjeni injekcijski brizgi so v navodilu za uporabo.
elevation in ALT or AST ≥3 x ULN occurred in 6.5% and 1.4% of patients, respectively on the subcutaneous weekly dose.
ki so prejemali subkutani tedenski odmerek, zvišanje AST ≥ 3 x ZMN pa pri 1,4 % bolnikov, ki so prejemali subkutani tedenski odmerek.
The required amount of RoActemra concentrate (0.6 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag.
Potrebno količino koncentrata zdravila RoActemra (0,6 ml/kg) morate izvleči iz viale in dati v 50-ml vrečko za infundiranje.
Patients in the tocilizumab arm received an intravenous (IV) infusion of tocilizumab (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Bolniki v skupini s tocilizumabom so prejeli intravensko infuzijo tocilizumaba (8 mg/kg) vsake 4 tedne in subkutano injekcijo placeba vsaka 2 tedna.
Reports of gastrointestinal perforation on tocilizumab were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Poročila o perforaciji v prebavilih med zdravljenjem s tocilizumabom so se v glavnem nanašala na zaplete divertikulitisa, vključno z generaliziranim gnojnim peritonitisom, perforacijo v spodnjem delu prebavil, fistulo in abscesom.
• If any patient has recently been vaccinated (either adult or child), or is planning a vaccination, tell your doctor.
• Če ste se pred kratkim cepili ali se nameravate cepiti, morate to povedati zdravniku (odrasli in otroci).
Laboratory Abnormalities
Laboratorijske nepravilnosti
The efficacy of tocilizumab for the treatment of active sJIA was assessed in a 12 week randomised, double blind, placebo-controlled, parallel group, two arm study.
Učinkovitost tocilizumaba za zdravljenje aktivnega sJIA so ocenili v 12-tedenski, randomizirani,
Talk to your doctor if you have any questions about giving yourself or a child patient you look after an injection.
Če imate kakršna koli vprašanja o tem, kako si lahko sami daste injekcijo ali jo daste otroku (bolniku),
Eleven (6.8%) patients in the RoActemra arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Pri enajstih bolnikih (6,8 %) iz skupine, ki je prejemala zdravilo RoActemra in petih bolnikih (3,1 %) iz skupine, ki je prejemala adalimumab, se je pojavilo zvišanje ALT stopnje 2 ali več po CTC.
For study I (SC-I), patients were required to be >18 years of age with moderate to severe active RA diagnosed according to ACR criteria who had at least 4 tender and 4 swollen joints at baseline.
Študija I (SC-I) je zajela bolnike, starejše od 18 let, ki so imeli zmerno do hudo aktiven revmatoidni artritis, diagnosticiran po merilih ACR in so imeli izhodiščno vsaj štiri boleče in štiri otekle sklepe.
• the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
• hudega, aktivnega in napredujočega revmatoidnega artritisa (RA) pri odraslih, ki se predhodno niso zdravili z metotreksatom; • zmerno do hudo aktivnega revmatoidnega artritisa pri odraslih bolnikih, ki se niso zadostno odzvali na predhodno zdravljenje z enim ali več imunomodulirajočimi antirevmatičnimi zdravili ali zaviralci tumorje nekrotizirajočega faktorja (TNF) ali takšnega zdravljenja niso prenašali.
RoActemra is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion.
Zdravilo RoActemra je na voljo v vialah po 4, 10 ali 20 ml koncentrata za raztopino za infundiranje.
Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation, were reported in 1 out of 112 patients (< 1%) treated with tocilizumab during the controlled and up to and including the open label clinical trial.
Klinično pomembne preobčutljivostne reakcije, povezane s tocilizumabom, ki so povzročile ukinitev zdravljenja, so bile opisane pri 1 od 112 bolnikov (< 1 %), zdravljenih s tocilizumabom med kontroliranim in odprtim kliničnim preskušanjem.
The required amount of RoActemra concentrate (0.5 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag.
Potrebno količino koncentrata zdravila RoActemra (0,5 ml/kg) morate izvleči iz viale in dati v 50-ml vrečko za infundiranje.
The expression of hepatic CYP450 enzymes is suppressed by cytokines, such as IL-6, that stimulate chronic inflammation.
Citokini, kot je IL-6, ki stimulirajo kronično vnetje, zavirajo ekspresijo jetrnih encimov CYP450.
Primary Endpoint ****Sustained remission (Tocilizumab groups vs Placebo+26) Responders at Week 52, n (%)
Primarni opazovani dogodek ****Trajna remisija (skupini s tocilizumabom v primerjavi s placebom + 26)
Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with RoActemra during the controlled and open label clinical studies.
Klinično pomembne preobčutljivostne reakcije, ki so bile povezane z uporabo zdravila RoActemra in so zahtevale prekinitev zdravljenja, so zabeležili pri skupaj 56 od 4009 bolnikov (1,4 %), ki so v kontroliranih in odprtih kliničnih študijah dobivali zdravilo RoActemra.
During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, 34% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dL), with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L (160 mg/dL) in the RoActemra subcutaneous weekly group.
Med rednim laboratorijskim spremljanjem v 12-mesečnem kontroliranem kliničnem preskušanju zdravila RoActemra se je pri 34 % bolnikov pojavilo trajno zvišanje celokupnega holesterola na > 6,2 mmol/l (240 mg/dl); stalno zvišanje LDL na ≥ 4,1 mmol/l (160 mg/dl) se je pojavilo pri 15 % v skupini, ki je prejemala zdravilo RoActemra vsak teden.
In RA and GCA patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Pri bolnikih z revmatoidnim artritisom in GCA je treba meritev lipidov opraviti od 4 do 8 tednov po uvedbi zdravljenja z zdravilom RoActemra.
pJIA (SC)
pJIA (subkutana oblika)
A total of 2,876 patients have been tested for anti-tocilizumab antibodies in the 6-month controlled clinical trials.
Imunogenost V šestmesečnih kontroliranih kliničnih preskušanjih so protitelesa proti tocilizumabu preverili pri skupaj 2876 bolnikih.
• Slowly inject all of the medicine by gently pushing the plunger all the way down.
• Počasi injicirajte vso zdravilo z nežnim pritiskom na bat vse do konca (glejte sliko F).
***p≤0.0001; **p<0.001; *p<0.05;
Povprečje (Std. odklon) * p < 0,0001
The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 9.5 mL/h.
Linearni očistek so ocenili kot parameter v analizi populacijske farmakokinetike, znašal je 9,5 ml/h.
In Study I, RoActemra was administered intravenously every four weeks as monotherapy.
V študiji I so zdravilo RoActemra uporabljali kot monoterapijo in ga dajali intravensko na štiri tedne.
Studies I-V enrolled patients ≥ 18 years of age with active RA diagnosed according to the American College of Rheumatology (ACR) criteria and who had at least eight tender and six swollen joints at baseline.
stare ≥ 18 let, ki so imeli aktiven revmatoidni artritis, diagnosticiran po merilih Ameriškega revmatološkega združenja ACR (American College of Rheumatology) in so imeli izhodiščno vsaj osem bolečih in šest oteklih sklepov.
During routine laboratory monitoring in the Roactemra 12 month controlled clinical trial, a decrease in neutrophil count below 1 × 109/L occurred in 4% of patients in the RoActemra subcutaneous weekly group.
Med rednim laboratorijskim spremljanjem v 12-mesečnem kontroliranem kliničnem preskušanju zdravila RoActemra se je število nevtrofilcev zmanjšalo pod 1 × 109/l pri 4 % bolnikov v skupini, ki je prejemala zdravilo RoActemra subkutano vsak teden.
Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in pJIA patients.
Zmanjšanja odmerka tocilizumaba zaradi nenormalnih laboratorijskih vrednosti pri bolnikih s pJIA niso proučevali.
• Once the plunger is pushed all the way down, keep pressing down on the plunger to be sure all of the medicine is injected before taking the needle out of the skin.
• Ko je bat popolnoma potisnjen navzdol, ga potiskajte toliko časa, da se zdravilo injicira v celoti,
Children with pJIA will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Otroci s pJIA bodo zdravilo RoActemra prejeli enkrat na 4 tedne v intravenski infuziji (kapalni infuziji v veno), ki bo trajala eno uro.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous infusion after dilution The diluted product should be used immediately Read the package leaflet before use
Razredčeno zdravilo je treba uporabiti takoj Pred uporabo preberite priloženo navodilo
Children with sJIA will be given RoActemra once every 2 weeks through a drip in the vein (intravenous infusion) over one hour.
Otroci s sJIA bodo zdravilo RoActemra prejeli enkrat na 2 tedna v intravenski infuziji (kapalni infuziji v veno), ki bo trajala eno uro.
The pharmacokinetics of RoActemra were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with 162 mg subcutaneous every week, 162 mg subcutaneous every other week, and or 4 or 8 mg/kg intravenous every 4 weeks for 24 weeks.
Farmakokinetiko zdravila RoActemra so proučili s populacijsko farmakokinetično analizo podatkov 3552 bolnikov z revmatoidnim artritisom, ki so se zdravili s 162 mg subkutano vsak teden, 162 mg subkutano vsak drugi teden in 4 ali 8 mg/kg intravensko vsake 4 tedne 24 tednov.
Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with tocilizumab during the controlled and open label clinical studies.
Klinično pomembne preobčutljivostne reakcije, ki so bile povezane z uporabo tocilizumaba in so zahtevale prekinitev zdravljenja, so zabeležili pri skupaj 56 od 4009 bolnikov (1,4 %), ki so v kontroliranih in odprtih kliničnih študijah dobivali tocilizumab.
• Puncture-resistant container or sharps container for safe disposal of needle-cap and used syringe
• zabojnik za ostre predmete, odporen proti vbodom, za varno odstranjevanje zamaška napolnjenega injekcijskega peresnika in uporabljenega napolnjenega injekcijskega peresnika
In RoActemra -treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
Pri bolnikih, ki so dobivali zdravilo RoActemra, so ugotovili zmanjšanje koncentracije CRP v normalno območje že 2. teden, ohranilo pa se je ves čas zdravljenja.
RoActemra has been shown to inhibit sIL-6R and mIL-6R-mediated signalling.
Ugotovljeno je, da zdravilo RoActemra zavira signaliziranje prek sIL-6R in mIL-6R.
Do not remove the green cap while allowing your RoACTEMRA pre-filled pen to reach room temperature.
Dokler napolnjeni injekcijski peresnik z zdravilom RoACTEMRA ne doseže sobne temperature, ne odstranjujte zelenega pokrovčka.
Patients in the RoActemra arm received an intravenous (IV) infusion of RoActemra (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Bolniki v skupini z zdravilom RoActemra so prejeli intravensko infuzijo zdravila RoActemra (8 mg/kg) vsake 4 tedne in subkutano injekcijo placeba vsaka 2 tedna.