FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder (MAH) shall provide an educational pack covering the therapeutic indications RA, sJIA, pJIA and GCA, targeting all physicians who are expected to prescribe/use RoActemra containing the following:
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bo vsem zdravnikom, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo RoActemra, razdelil izobraževalno gradivo za indikacije revmatoidni artritis, sJIA, pJIA in GCA, ki vključuje:
English: • In RA, GCA, pJIA and sJIA, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Slovenian: • Pri bolnikih z RA, GCA, pJIA in sJIA je treba vrednosti ALT in AST prvih 6 mesecev zdravljenja spremljati na 4 do 8 tednov, pozneje pa na 12 tednov.
English: In Studies II, III and V, RoActemra was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
Slovenian: V študijah II, III in V so zdravilo RoActemra dajali intravensko na štiri tedne v kombinaciji z metotreksatom; primerjava je bila kombinacija placeba in metotreksata.
English: • If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
Slovenian: • Če je od vašega izpuščenega tedenskega odmerka minilo manj kot 7 dni, ga vzemite na dan naslednjega načrtovanega odmerka.
English: RoActemra versus adalimumab in monotherapy
Slovenian: Zdravilo RoActemra v primerjavi z adalimumabom v monoterapiji
English: • If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor.
Slovenian: • Če ste se pred kratkim cepili ali se nameravate cepiti, morate to povedati zdravniku.
English: Protect the syringe from freezing and from light.
Slovenian: Napolnjeno injekcijsko brizgo zaščitite pred svetlobo in zmrzovanjem.
English: Step 2.
Slovenian: Korak 2.
English: During the 6-month controlled trials, increases of lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol have been reported commonly.
Slovenian: celotnega holesterola, trigliceridov, holesterola LDL in/ali holesterola HDL.
English: Modify the dose of the concomitant MTX if appropriate For persistent increases in this range, reduce RoActemra dose to 4 mg/kg or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised
Slovenian: RoActemra na 4 mg/kg ali prekinite njegovo uporabo, dokler se alaninaminotransferaza (ALT) ali aspartat-aminotransferaza (AST) ne normalizira.
English: • adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate.
Slovenian: • odraslih bolnikov s hudim, aktivnim in napredujočim revmatoidnim artritisom, ki predhodno še niso bili zdravljeni z metotreksatom.
English: If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
Slovenian: Če je od vašega izpuščenega tedenskega odmerka minilo manj kot 7 dni, ga vzemite na dan naslednjega načrtovanega odmerka.
English: Interstitial Lung Disease
Slovenian: Intersticijska bolezen pljuč
English: Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Slovenian: Tocilizumab se specifično veže na topne in membransko vezane receptorje za IL-6 (sIL-6R in mIL
English: 10 mg/kg Q4W below 30 kg
Slovenian: 10 mg/kg na 4 tedne pod 30 kg
English: Steady-state was reached following the first administration for Cmax and after 8 and 20 weeks for AUC and Cmin, respectively.
Slovenian: Stanje dinamičnega ravnovesja je bilo za Cmax doseženo po prvi uporabi, za AUC po 8 tednih in za Cmin po 20 tednih.
English: The mean change in Patient's global VAS from baseline at week 52 was lower (showing greater improvement) in the RoActemra weekly and every other weekly dose groups [-19.0, -25.3, respectively] than in both placebo groups [placebo plus 26 weeks -3.4, placebo plus 52 weeks -7.2], although only the RoActemra every other weekly plus 26 weeks prednisone taper group showed a statistically significant difference compared to placebo [placebo plus 26 weeks taper p=0.0059, and placebo plus 52 weeks taper p=0.0081].
Slovenian: Povprečna sprememba bolnikove celotne ocene po VAS od izhodišča do 52. tedna je bila manjša (tj. kaže večje izboljšanje) v skupinah z zdravilom RoActemra vsak teden in vsak drugi teden [-19,0 v prvi, -25,3 v drugi] kot v skupinah s placebom [placebo + 26 tednov -3,4, placebo + 52 tednov -7,2], vendar je bila statistično značilna le razlika med skupino z zdravilom RoActemra vsak teden v kombinaciji s 26-tedenskim zmanjševanjem prednizona in skupinama s placebom [placebo + 26-tedensko zmanjševanje p = 0,0059 in placebo + 52-tedensko zmanjševanje p = 0,0081].
English: In the open label extension phase, decreases in neutrophil counts below 1 x 109/l, occurred in 15% of the tocilizumab group.
Slovenian: V odprti, podaljšani fazi se je zmanjšanje števila nevtrofilcev pod 1 x 109/l pojavilo pri 15 % v skupini, ki je prejemala tocilizumab.
English: • If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
Slovenian: • Če se vam med infundiranjem ali po njem pojavi alergijska reakcija, npr. tiščanje v prsih, piskajoče dihanje, huda omotica ali vrtoglavost, otekanje ustnic ali izpuščaj na koži, morate to nemudoma povedati zdravniku.
English: • adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Slovenian: • odraslih bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom (avtoimunsko boleznijo), če predhodno zdravljenje ni bilo dovolj učinkovito.
English: België/Belgique/Belgien N.V. Roche S.A.
Slovenian: België/Belgique/Belgien
English: It is not known whether RoActemra is passed into breast milk.
Slovenian: Ni znano, ali se zdravilo RoActemra izloča v materino mleko.
English: Figure L
Slovenian: Slika L
English: Step 7.
Slovenian: Korak 7.
English: Read and follow the Instructions for Use that come with your RoACTEMRA pre-filled pen before you start using it and each time you get a prescription refill.
Slovenian: Preden začnete uporabljati zdravilo RoACTEMRA v napolnjenem injekcijskem peresniku in vsakič, ko zanj dobite nov recept, preberite in upoštevajte Navodila za uporabo, ki so priložena napolnjenemu injekcijskemu peresniku.
English: The efficacy of RoActemra in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Slovenian: Učinkovitost zdravila RoActemra za ublažitev znakov in simptomov revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih multicentričnih študijah.
English: DMARD - Disease modifying anti-rheumatic drug - p< 0.01, TCZ vs. PBO + MTX/DMARD - p< 0.0001, TCZ vs. PBO + MTX/DMARD
Slovenian: DMARD - imunomodulirajoče antirevmatično zdravilo (Disease modifying anti-rheumatic drug) - p < 0,01, tocilizumab v primerjavi s placebom + metotreksatom/imunomodulirajočim antirevmatičnim zdravilom - p < 0,0001, tocilizumab v primerjavi s placebom + metotreksatom/imunomodulirajočim antirevmatičnim zdravilom
English: RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Slovenian: Zdravilo RoActemra se lahko daje v monoterapiji, če bolniki metotreksata ne prenašajo ali zanje nadaljnje zdravljenje z metotreksatom ni primerno.
English: It is unknown whether RoActemra is excreted in human breast milk.
Slovenian: Ni znano, ali se zdravilo RoActemra pri človeku izloča v materino mleko.
English: Patients must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously.
Slovenian: Bolniki morajo ob prejemu subkutane oblike zdravila RoActemra tehtati najmanj 10 kg.
English: In clinical trials, tocilizumab has not been studied in patients during an episode of active MAS.
Slovenian: V kliničnih študijah tocilizumaba pri bolnikih med epizodo aktivnega sindroma aktivacije makrofagov niso proučevali.
English: In all patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Slovenian: Pri vseh bolnikih je treba meritev lipidov opraviti od 4 do 8 tednov po uvedbi zdravljenja z zdravilom
English: RoActemra helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks.
Slovenian: Zdravilo RoActemra pomaga olajšati simptome, npr. bolečine in oteklost sklepov, in lahko tudi izboljša vašo sposobnost za vsakodnevna opravila.
English: The incidence of infections leading to dose interruptions was also numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (21.4%)
Slovenian: Incidenca okužb, ki so vodile v prekinitev odmerjanja, je bila prav tako številčno višja pri bolnikih s telesno maso < 30 kg, ki so se zdravili z 10 mg/kg tocilizumaba (21,4 %) v primerjavi z bolniki s telesno maso ≥ 30 kg, ki so se zdravili z 8 mg/kg tocilizumaba (7,6 %).
English: ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients) Study I AMBITION
Slovenian: Odzivi ACR v študijah, kontroliranih splacebom/metotreksatom/imunomodulirajočimi antirevmatičnimi zdravili (% bolnikov)
English: In the 52-week open-label SC Study (WA28118), neutrophil count decrease to below 1 × 109/L occurred in 23.5% of patients treated with RoActemra SC. Decreases in platelet counts to below 100 ×
Slovenian: V 52-tedenski odprti študiji s subkutano obliko (WA28118) se je pri 23,5 % bolnikov, zdravljenih s subkutano obliko zdravila RoActemra, pojavilo zmanjšanje števila nevtrofilcev pod 1 × 109/l.
English: Hepatic transaminase elevations
Slovenian: Zvišanje jetrnih transaminaz
English: Subcutaneous use
Slovenian: Subkutana uporaba
English: Subcutaneous Use
Slovenian: subkutana uporaba
English: Very rare side effects:
Slovenian: Zelo redki neželeni učinki:
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za redčenje pred uporabo
English: However, if you are worried, talk to your doctor, pharmacist or nurse.
Slovenian: A če vas skrbi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: When platelet count > 100 x 103/ μL resume RoActemra dosing every other week and increase to every week injection as clinically appropriate.
Slovenian: Ko je število trombocitov > 100 x 103/μl, znova uvedite zdravilo RoActemra z odmerjanjem enkrat na dva tedna in povečajte pogostnost odmerjanja na enkrat na teden, kot je klinično ustrezno.
English: At steady-state, predicted AUC and Cmin were 3.2 and 30 fold higher at 8 mg/kg as compared to 4 mg/kg, respectively.
Slovenian: V stanju dinamičnega ravnovesja je bila AUC po odmerku 8 mg/kg 3,2-krat večja, Cmin pa 30-krat večja kot po odmerku 4 mg/kg.
English: ‡p-value < 0.05 vs.
Slovenian: ***Opisna vrednost p < 0,005
English: During routine laboratory monitoring in the RoActemra all exposure population, a decrease in neutrophil count below 1 × 109/L occurred in 15.4% of patients treated with SC RoActemra.
Slovenian: Med rednim laboratorijskim spremljanjem v celotni populaciji, izpostavljeni zdravilu RoActemra, se je število nevtrofilcev zmanjšalo pod 1 × 109/l pri 15,4 % bolnikov, zdravljenih s subkutano obliko zdravila RoActemra.
English: In GCA patients, the central volume of distribution was 4.09 L, the peripheral volume of distribution was 3.37 L, resulting in a volume of distribution at steady state of 7.46 L.
Slovenian: Pri bolnikih z GCA je bil centralni volumen porazdelitve 4,09 l in periferni volumen porazdelitve 3,37 l, tako da je volumen porazdelitve v stanju dinamičnega ravnovesja 7,46 l.
English: Keep the RoActemra syringe and all medicines out of the sight and reach of children.
Slovenian: Napolnjeno injekcijsko brizgo RoActemra in vsa zdravila shranjujte nedosegljivo otrokom.
English: Reduction of tocilizumab dosing frequency due to laboratory abnormalities has not been studied in sJIA or pJIA patients.
Slovenian: Zmanjšanja pogostnosti odmerjanja tocilizumaba zaradi nenormalnih laboratorijskih vrednosti pri bolnikih s sJIA ali pJIA niso proučevali.
English: ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients)
Slovenian: Odzivi ACR v študijah, kontroliranih s placebom/metotreksatom/imunomodulirajočimi antirevmatičnimi zdravili (% bolnikov).
English: If following pressing the activation button the purple indicator does not move, you must dispose of the pre-filled pen in a puncture resistant container.
Slovenian: Če se po pritisku gumba za aktivacijo vijolični indikator ne premakne, je treba napolnjeni injekcijski peresnik zavreči v zabojnik za ostre predmete, odporen proti vbodom.
English: RoActemra is used for children aged 2 years and over who have active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Slovenian: Zdravilo RoActemra se uporablja za zdravljenje otrok, starih 2 leti in več, ki imajo aktivni sistemski juvenilni idiopatski artritis (sJIA), vnetno bolezen, ki povzroči bolečino in otekanje enega ali več sklepov, kot tudi povišano telesno temperaturo in izpuščaj.
English: The mean change in HAQ-DI was maintained at Week 104 in the tocilizumab 8 mg/kg plus MTX group (-0.61).
Slovenian: Povprečna sprememba po HAQ-DI je bila po 104. tednu v skupini s tocilizumabom 8 mg/kg in metotreksatom ohranjena (- 0,61).
English: • If you have liver disease, tell your doctor.
Slovenian: • Če imate katero koli jetrno bolezen, morate to povedati zdravniku.
English: The bioavailability for the subcutaneous formulation was 79%.
Slovenian: biološka uporabnost za subkutano obliko pri bolnikih s pJIA je bila 96 %.
English: respectively.
Slovenian: Malignomi
English: In the long-term exposure population the overall rate of gastrointestinal perforation was 0.28 events per 100 patient years.
Slovenian: V dolgoročno izpostavljeni populaciji je bil celokupni delež perforacij v prebavilih med uporabo tocilizumaba 0,28 na 100 bolnik-let.
English: Adults will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Slovenian: Odrasli boste prejeli zdravilo RoActemra enkrat na 4 tedne v intravenski infuziji (kapalni infuziji v veno), ki bo trajala eno uro.
English: These are common: they may affect up to 1 in every 10 users
Slovenian: Ti so pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov.
English: Tel: +385 1 47 22 333 Ireland
Slovenian: Tel: + 385 1 47 22 333
English: The recommended dose The dose for all adults is 162 mg (the content of 1 pre-filled pen) given once a week.
Slovenian: Za vse odrasle je odmerek 162 mg (vsebina 1 napolnjenega injekcijskega peresnika), dan enkrat na teden.
English: Do not touch the trigger fingers on the syringe as this may damage the syringe.
Slovenian: Ne prijemajte sprostitvenih sponk na injekcijski brizgi, ker jo lahko poškodujete.
English: Keep the RoACTEMRA pre-filled pen and disposal container out of the reach of children.
Slovenian: Napolnjeni injekcijski peresnik z zdravilom RoACTEMRA in zabojnik za odstranjevanje shranjujte nedosegljivo otrokom.
English: The data available so far does not suggest any effect on fertility from this treatment.
Slovenian: Razpoložljivi podatki ne kažejo, da bi to zdravljenje vplivalo na plodnost.
English: The PCS mean change from baseline to week 52 was higher (showing more improvement) in the RoActemra weekly and every other weekly dose groups [4.10, 2.76, respectively] than in the two placebo groups [placebo plus 26 weeks; -0.28, placebo plus 52 weeks; -1.49], although only the comparison between RoActemra weekly plus 26 weeks prednisone taper group and placebo plus 52 weeks prednisone taper group (5.59, 99% CI: 8.6, 10.32) showed a statistically significant difference (p=0.0024).
Slovenian: Povprečna sprememba PCS od izhodišča do 52. tedna je bila večja (tj. kaže večje izboljšanje) v skupinah z zdravilom RoActemra vsak teden in vsak drugi teden [4,10 v prvi, 2,76 v drugi] kot v skupinah s placebom [placebo + 26 tednov -0,28, placebo + 52 tednov -1,49], vendar je bila statistično značilna le razlika med skupino z zdravilom RoActemra vsak teden v kombinaciji s 26-tedenskim zmanjševanjem prednizona in skupino s placebom v kombinaciji z 52tedenskim zmanjševanjem prednizona (5,59; 99-% IZ: 8,6, 10,32; p = 0,0024).
English: The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 1 year have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila RoActemra v subkutani obliki pri otrocih od rojstva do 1. leta nista dokazani.
English: Cellulitis, Pneumonia, Oral herpes simplex, Herpes zoster
Slovenian: oralni herpes simpleks, herpes zoster divertikulitis
English: If the needle is not covered proceed carefully, and place the syringe into the puncture resistant container to avoid injury with the needle.
Slovenian: Če se injekcijska igla ne prekrije, pazljivo nadaljujte in napolnjeno injekcijsko brizgo odvrzite v zabojnik za ostre predmete, da se izognete poškodbi z injekcijsko iglo.
English: RoActemra should be diluted to a final volume of 50 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.
Slovenian: Zdravilo RoActemra je treba razredčiti na končni volumen 50 ml s sterilno, apirogeno 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje upoštevaje aseptičen postopek.
English: 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.
Slovenian: 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.
English: Inject RoACTEMRA
Slovenian: Injicirajte zdravilo RoACTEMRA
English: Fatal anaphylaxis has been reported after marketing authorisation during treatment with tocilizumab (see section 4.4).
Slovenian: V obdobju po prihodu zdravila na trg so poročali o primeru smrtne anafilaksije med zdravljenjem s tocilizumabom (glejte poglavje 4.4).
English: No patient developed positive antitocilizumab antibodies post baseline.
Slovenian: Pri nobenem bolniku se niso pojavila pozitivna protitelesa proti tocilizumabu po izhodišču.
English: During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with RoActemra therapy.
Slovenian: Med šestmesečnimi kontroliranimi kliničnimi preskušanji je bil celokupni delež perforacij v prebavilih med uporabo zdravila RoActemra 0,26 na 100 bolnik-let.
English: Available data with the IV formulation suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Slovenian: Razpoložljivi podatki z intravensko obliko kažejo, da je klinično izboljšanje opazno v 12 tednih od začetka zdravljenja z zdravilom RoActemra.
English: to <1/100).
Slovenian: (1,3 do 2,1).
English: The mean change in HAQ-DI was maintained at Week 104 in the RoActemra 8 mg/kg plus MTX group (-0.61).
Slovenian: Povprečna sprememba po HAQ-DI je bila po 104. tednu v skupini z zdravilom RoActemra 8 mg/kg in metotreksatom ohranjena (- 0,61).
English: 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.
Slovenian: 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.
English: (See Fig. H)
Slovenian: (glejte sliko H).
English: 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.
Slovenian: 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.
English: Leave a gap of at least 3 months after your last treatment before you start breast-feeding.
Slovenian: Preden ponovno začnete dojiti, morajo od vašega zadnjega zdravljenja miniti vsaj 3 meseci.
English: Placebo + 26 weeks prednisone taper N=50
Slovenian: Placebo + 26 tednov zmanjševanja prednizona n = 50
English: In the tocilizumab group, the events included, but were not limited to rash, urticaria, diarrhea, epigastric discomfort, arthralgia and headache.
Slovenian: V skupini, ki je prejemala tocilizumab, so neželeni učinki med drugimi vključevali izpuščaj, urtikarijo, diarejo, nelagodje v epigastriju, artralgijo in glavobol.
English: Serious hypersensitivity reactions have been reported in association with infusion of RoActemra (see section 4.8).
Slovenian: Opisane so bile hude preobčutljivostne reakcije, povezane z infundiranjem zdravila RoActemra (glejte poglavje 4.8).
English: 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].
Slovenian: 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
English: The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA or GCA.
Slovenian: Zdravljenje s tem zdravilom vam bo predpisal in začel zdravstveni delavec z izkušnjami pri odkrivanju in zdravljenju revmatoidnega artritisa ali gigantoceličnega arteriitisa.
English: 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.
Slovenian: 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.
English: Reports of gastrointestinal perforation on RoActemra were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Slovenian: 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.
English: The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag.
Slovenian: Potrebno količino koncentrata zdravila RoActemra (0,4 ml/kg) morate izvleči iz viale in dati v 100-ml vrečko za infundiranje.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih se odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Patients had mean DAS28 at baseline of 6.7 on subcutaneous and 6.6 on placebo arms.
Slovenian: Bolniki so imeli povprečno izhodiščno oceno DAS28 v subkutani skupini 6,7, v intravenski pa 6,6.
English: 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.
Slovenian: 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.
English: Haematological abnormalities:
Slovenian: Hematološke nepravilnosti: