FrancophonIA/ELRC3.0 huggingface dataset:
English: It is unknown whether tocilizumab is excreted in human breast milk.
Slovenian: Ni znano, ali se tocilizumab pri človeku izloča v materino mleko.
English: ADRs from clinical trials and/or post marketing experience with RoActemra based on spontaneous case reports, literature cases and cases from non-interventional study programs are listed in Table 1 and are presented by MedDRA system organ class.
Slovenian: Neželeni učinki iz kliničnih preskušanj in/ali obdobja po prihodu zdravila RoActemra na trg, v katerem so vir spontana poročila, literaturni podatki in podatki iz neintervencijskih študijskih programov, so navedeni v preglednici 1 po organskih sistemih MedDRA. Za posamezen neželeni učinek je ustrezna skupina pogostnosti določena glede na naslednji dogovor: zelo pogosti (≥ 1/10),
English: • high blood fat (cholesterol) levels.
Slovenian: • zvišana raven maščob v krvi (holesterola).
English: Primary Endpoint - Mean Change from baseline at Week 24 DAS28 (adjusted mean) Difference in adjusted mean (95% CI) Secondary Endpoints - Percentage of Responders at Week 24
Slovenian: Primarni cilj - povprečna sprememba od začetka zdravljenja do 24. tedna DAS28 (prilagojena povprečna vrednost) Razlika v prilagojeni povprečni vrednosti (95-% interval zaupanja) Sekundarni cilji - delež odzivnih bolnikov v 24. tednu
English: • Liver enzyme abnormalities Laboratory Value
Slovenian: • Nenormalne vrednosti jetrnih encimov Laboratorijska vrednost
English: Cases of liver failure resulting in liver transplantation have been reported.
Slovenian: Poročali so o primerih odpovedi in posledične presaditve jeter.
English: * Includes elevations collected as part of routine laboratory monitoring (see text below) 1 See section 4.3
Slovenian: * Vključuje povišanja, ki so jih opazili v okviru rutinskih laboratorijskih preiskav (glejte spodnje besedilo).
English: If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time while not at the clinic during or following an RoACTEMRA injection you should seek emergency care immediately.
Slovenian: Če se pri vas pojavijo simptomi (ki pa niso vsi mogoči), kot so kožni izpuščaj, srbež, mrzlica, otekanje obraza, ustnic, jezika ali vratu, bolečina v prsnem košu, sopenje, težko dihanje ali požiranje, občutek omotičnosti ali omedlevanja kadar koli po dani injekciji zdravila RoActemra (ko niste v bolnišnici), takoj poiščite zdravniško pomoč.
English: Approximately half of the patients who developed an ANC < 1 x 109/ L did so within 8 weeks after starting therapy.
Slovenian: Med bolniki, ki se jim je absolutno število nevtrofilcev zmanjšalo na < 1 x 109/l, se je to pri približno polovici zgodilo v 8 tednih po začetku zdravljenja.
English: 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.
Slovenian: Sočasna uporaba posamičnega odmerka 10 mg/kg tocilizumaba in 10 do 25 mg metotreksata enkrat na teden ni klinično pomembno vplivala na izpostavljenost metotreksatu.
English: The ACR response rates were numerically lower for patients with prior biologic treatment as shown in Table 9 below.
Slovenian: Odzivi ACR so bili številčno nižji pri bolnikih, ki so se predhodno že zdravili z biološkimi zdravili,
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali medicinsko sestro.
English: Children with sJIA (aged 2 and over)
Slovenian: Otroci s sJIA (stari 2 leti ali več)
English: Fifty out of seventy five (67%) tocilizumab treated patients had a haemoglobin < LLN at baseline.
Slovenian: Petdeset od petinsedemdeset (67 %) bolnikov, ki so se zdravili s tocilizumabom, je imelo hemoglobin pred začetkom zdravljenja pod spodnjo mejo normale.
English: Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Slovenian: Polisorbat 80, saharoza, natrijev hidrogenfosfat dodekahidrat, natrijev dihidrogenfosfat dihidrat in voda za injekcije.
English: Viral reactivation (e.g. hepatitis B virus) has been reported with biologic therapies for RA.
Slovenian: V zvezi z biološkim zdravljenjem revmatoidnega artritisa so poročali o reaktivaciji virusov (npr. virusa hepatitisa B).
English: When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. .
Slovenian: Bolnike, zdravljene z individualno prilagojenimi zdravili, ki se presnavljajo s CYP450 3A4, 1A2 ali
English: However, if you are worried, talk to your doctor.
Slovenian: za katerega skrbite, se pogovorite s svojim zdravnikom.
English: Forty (80%) of these patients had an increase in their haemoglobin to within the normal range at week 12, in comparison to 2 out of 29 (7%) of placebo treated patients with haemoglobin < LLN at baseline (p<0.0001).
Slovenian: Štiridesetim (80 %) od teh bolnikov se je hemoglobin na vrednost znotraj normale zvišal do 12. tedna v primerjavi z 2 od 29 (7 %) bolnikov, ki so prejemali placebo in ki so imeli pred začetkom zdravljenja hemoglobin pod spodnjo mejo normale
English: Proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was higher for RoActemra subcutaneous every other week (58%) versus placebo
Slovenian: Delež bolnikov, ki so dosegli klinično pomembno izboljšanje po HAQ-DI v 24. tednu (sprememba od izhodišča ≥ 0,3 enote), je bil večji pri subkutanem dajanju zdravila RoActemra vsak drugi teden (58 %) v primerjavi s placebom (46,8 %).
English: RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
Slovenian: Zdravilo RoActemra upočasni nastanek okvar hrustanca in kosti v sklepih, ki jih povzroča bolezen, ter izboljša vašo sposobnost za opravljanje običajnih dnevnih aktivnosti.
English: The recommended dose modifications, including tocilizumab discontinuation, based on transaminases levels, in line with SmPC section 4.2.
Slovenian: Priporočene prilagoditve odmerjanja, vključno z ukinitvijo zdravila RoActemra, na podlagi vrednosti transaminaz so opisane v SmPC, poglavje 4.2.
English: pJIA Patients < 30 kg
Slovenian: Bolniki s pJIA < 30 kg
English: PBO + MTX
Slovenian: + MTX
English: Additionally, proliferative lesions were not observed in a 6-month chronic toxicity study in cynomolgus monkeys or in IL-6 deficient mice.
Slovenian: Poleg tega v 6-mesečni študiji kronične toksičnosti pri opicah cynomolgus in pri miših s pomanjkanjem IL-6 niso opazili proliferativnih lezij.
English: When platelet count > 100 x 103/ μ resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
Slovenian: 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.
English: The Nurse Information Pack should contain the following key elements:
Slovenian: Izobraževalno gradivo za medicinske sestre mora vključevati naslednje ključne elemente:
English: The clinical data are insufficient to assess the potential incidence of malignancy following exposure to RoActemra.
Slovenian: Kliničnih podatkov za oceno možne incidence malignomov po izpostavljenosti zdravilu RoActemra ni dovolj.
English: Frequency categories with preferred terms
Slovenian: Skupine pogostnosti s prednostnimi izrazi za neželene učinke Zelo pogosti
English: Number and Proportion of Patients with a JIA ACR30 Flare and Proportion of Patients with JIA ACR30/50/70/90 Responses at Week 40, by Previous Biologic Use (ITT Population - Study Part II)
Slovenian: Število bolnikov in njihov delež v odstotkih, ki zaradi nenadnega poslabšanja bolezni niso dosegli merila JIA ACR 30 in deleži bolnikov, ki so po predhodnem zdravljenju z biološkim zdravilom dosegli odzive JIA ACR30/50/70/90 po 40 tednih (populacija, ki so jo nameravali zdraviti, II.
English: Two patients developed positive anti-tocilizumab antibodies with one of these patients having a hypersensitivity reaction leading to withdrawal.
Slovenian: Pri dveh bolnikih so se pojavila protitelesa proti tocilizumabu, eden od njiju je imel preobčutljivostno reakcijo, ki je vodila v ukinitev zdravljenja.
English: Patients in studies I - V had a mean Disease Activity Score (DAS28) of 6.5-6.8 at baseline.
Slovenian: Bolniki v študijah I-V so imeli povprečno izhodiščno oceno aktivnosti bolezni DAS28 (Disease Activity Score) od 6,5 do 6,8.
English: The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving RoActemra (28-34%) compared to 1-12% of control patients at 24 weeks.
Slovenian: Delež bolnikov, ki so dosegli klinično remisijo glede na DAS28 (DAS28 < 2,6), je bil po 24 tednih značilno večji med bolniki, ki so dobivali zdravilo RoActemra (28-34 %), kot med kontrolnimi bolniki (1-12 %).
English: At the conclusion of Part I, JIA ACR 30/50/70/90 responses were 89.4%, 83.0%, 62.2%, and 26.1%, respectively.
Slovenian: Ob zaključku I. dela so bili odzivi JIA ACR 30 89,4 %, JIA ACR 50 83,0 %, JIA ACR 70 62,2 % in
English: • The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Slovenian: • Druge sestavine zdravila so saharoza, polisorbat 80, natrijev hidrogenfosfat dodekahidrat, natrijev dihidrogenfosfat dihidrat in voda za injekcije.
English: Record your Injection
Slovenian: Zabeležite si injiciranje
English: The overall clinical adverse event profile was similar between tocilizumab and adalimumab.
Slovenian: Celokupni klinični profil neželenih učinkov je bil pri tocilizumabu in adalimumabu podoben.
English: Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Slovenian: Preden boste dobili zdravilo RoActemra, bo zdravnik opravil preiskave krvi, da bo ugotovil, ali imate majhno število belih krvnih celic, majhno število trombocitov ali zvišane jetrne encime.
English: The accumulation ratios for AUC, Cmin, and Cmax were 2.67, 6.02, and 2.12, respectively.
Slovenian: Deleži kopičenja so bili 2,67 za AUC, 6,02 za Cmin in 2,12 za Cmax.
English: • Hold your RoACTEMRA pre-filled pen with the green cap pointing down (See Figure C).
Slovenian: • Napolnjeni injekcijski peresnik z zdravilom RoACTEMRA držite tako, da je zelen pokrovček usmerjen navzdol (glejte sliko C).
English: RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
Slovenian: Zdravilo RoActemra se lahko daje v monoterapiji (če bolniki metotreksata ne prenašajo ali zdravljenje z njim ni primerno) ali v kombinaciji z metotreksatom.
English: Of these 52 patients, 37 (71%) were naive to RoActemra and 15 (29%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Slovenian: Od teh 52 bolnikov je 37 (71 %) zdravilo RoActemra prejelo prvič, 15 (29 %) pa je predhodno prejemalo intravensko obliko zdravila RoActemra in ob izhodišču prešlo na subkutano obliko zdravila RoActemra.
English: ADA + Placebo (IV) N = 162
Slovenian: ADA + placebo (iv.)
English: months).
Slovenian: tednih.
English: Your doctor will perform blood tests before you are given RoActemra, and during your treatment, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Slovenian: Preden boste dobili zdravilo RoActemra in med zdravljenjem z njim, bo zdravnik opravil preiskave krvi, da bo ugotovil, ali imate majhno število belih krvnih celic, majhno število trombocitov ali zvišane jetrne encime.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7)
English: RoActemra is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Slovenian: Zdravilo RoActemra je rekombinantno humanizirano antihumano monoklonsko protitelo podskupine imunoglobulinov G1 (IgG1) proti topnim in membranskim receptorjem za interlevkin-6.
English: In general, the adverse drug reactions in patients with sJIA were similar in type to those seen in RA patients (see Undesirable Effects section above).
Slovenian: Na splošno so bili neželeni učinki pri bolnikih s sJIA podobnega tipa, kot so jih opazili pri bolnikih z revmatoidnim artritisom (glejte poglavje Neželeni učinki zgoraj).
English: The potential for central demyelination with RoActemra is currently unknown.
Slovenian: Trenutno ni znano, kolikšna je možnost centralne demielinizacije med uporabo zdravila RoActemra.
English: Table 2: List of ADRs occurring in clinical trial patients with sJIA or pJIA receiving tocilizumab as monotherapy or in combination with MTX.
Slovenian: Seznam neželenih učinkov iz kliničnega preskušanja pri bolnikih s sJIA ali pJIA, zdravljenih s tocilizumabom v monoterapiji ali v kombinaciji z metotreksatom
English: 162 mg every other weekly
Slovenian: 162 mg vsak drugi teden
English: If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance.
Slovenian: Če vas kar koli skrbi ali imate vprašanja o vaši napolnjeni injekcijski brizgi, se posvetujte s svojim zdravstvenim delavcem ali farmacevtom.
English: Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.
Slovenian: Med simptomi so lahko bolečine v trebuhu, nepojasnjene spremembe v razporedu iztrebljanja z zvišano telesno temperaturo.
English: The developed model had the same structure as the population PK model developed earlier based on data from RA patients (see Table 10).
Slovenian: Razviti model je imel enako zgradbo kot model populacijske farmakokinetike, oblikovan pred tem na podlagi podatkov bolnikov z revmatoidnim artritisom (glejte preglednico 9).
English: During the 6-month controlled period, in SC-I, the frequency of injection site reactions was 10.1% (64/631) and 2.4% (15/631) for the subcutaneous RoActemra and the subcutaneous placebo (intravenous group) weekly injections, respectively.
Slovenian: V 6-mesečnem kontroliranem obdobju je bila v SC-I pogostnost reakcij na mestu injiciranja 10,1 % (64/631) za subkutano obliko tocilizumaba in 2,4 % (15/631) za tedenske injekcije subkutanega placeba (intravenska skupina).
English: The rate of anaphylactic reactions (occurring in a total of 6/3778patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Slovenian: Delež anafilaktičnih reakcij (ki so se pojavile pri skupaj 6 od 3778 bolnikov, 0,2 %) je bil pri odmerku 4 mg/kg nekajkrat večji kot pri odmerku 8 mg/kg.
English: In a randomized open-label study, adult RA patients treated with RoActemra and MTX were able to mount an effective response to both the 23-valent pneumococcal polysaccharide and tetanus toxoid vaccines which was comparable to the response seen in patients on MTX only.
Slovenian: V randomizirani odprti študiji so odrasli bolniki z revmatoidnim artritisom, ki so jih zdravili z zdravilom RoActemra in metotreksatom, razvili učinkovit odziv na 23valentno pnevmokokno polisaharidno cepivo in cepivo s tetanusnim toksoidom.
English: Increases in haemoglobin levels were observed, through RoActemra decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Slovenian: Opažali so povečanje koncentracije hemoglobina, ker zdravilo RoActemra zmanjša učinke IL-6 na nastajanje hepcidina in tako poveča razpoložljivost železa.
English: Once the nonlinear clearance pathway is saturated, at higher tocilizumab concentrations, clearance is mainly determined by the linear clearance.
Slovenian: Ko je pot nelinearnega očistka nasičena, očistek pri višjih koncentracijah tocilizumaba določa predvsem linearni očistek.
English: Roche d.o.o.
Slovenian: Hrvatska Roche d.o.o.
English: In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of tocilizumab, to the level similar to, or slightly higher than, those observed in healthy subjects.
Slovenian: V študiji pri bolnikih z revmatoidnim artritisom so se koncentracije simvastatina (CYP3A4) en teden po enkratnem odmerku tocilizumaba znižale za 57 % in dosegle podobne ali malo višje koncentracije od teh, ki so jih izmerili pri zdravih ljudeh.
English: RoActemra binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Slovenian: Zdravilo RoActemra se specifično veže na topne in membransko vezane receptorje za IL-6 (sIL-6R in mIL-6R).
English: • If following insertion of the needle, you cannot press down the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe (starting again at Step 2).
Slovenian: • Če po tem, ko injekcijsko iglo vstavite, ne morete pritisniti bata, je treba napolnjeno injekcijsko iglo zavreči v zabojnik za ostre predmete, odporen proti vbodom, in uporabiti novo (začeti ponovno pri 2. koraku).
English: In the tocilizumab all exposure population, 11 patients (5.9%) experienced infusion reactions during the infusion and 38 patients (20.2%) experienced an event within 24 hours of an infusion.
Slovenian: V vsej populaciji, ki se je zdravila s tocilizumabom, je 11 bolnikov (5,9 %) imelo reakcijo, povezano z infundiranjem, med infundiranjem, 38 bolnikov
English: No patients treated with SC RoActemra experienced a decrease in platelet count to ≤50 × 103 / μL.
Slovenian: Pri nobenem bolniku, zdravljenem s subkutano obliko zdravila RoActemra, niso opazili zmanjšanja števila trombocitov na ≤ 50 × 103/μl.
English: • The RoACTEMRA pre-filled pen should not be reused.
Slovenian: • Istega napolnjenega injekcijskega peresnika z zdravilom RoACTEMRA ne smete uporabiti ponovno.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
Slovenian: Shranjujte v hladilniku Ne zamrzujte
English: • Do not reuse the same pre-filled pen.
Slovenian: • Ne poskušajte ponovno uporabiti iste napolnjene injekcijske brizge.
English: The mean [SD] change scores were as follows: RoActemra weekly plus 26 weeks 5.61 [10.115], RoActemra every other weekly plus 26 weeks 1.81 [8.836], placebo plus 26 weeks 0.26 [10.702], and placebo plus 52 weeks -1.63 [6.753].
Slovenian: Povprečne ocene [std. odklon] so bile: RoActemra vsak teden + 26-tedensko 5,61 [10,115], RoActemra vsak drugi teden + 26-tedensko 1,81 [8,836], placebo + 26-tedensko 0,26 [10,702] in placebo + 52-tedensko -1,63 [6,753].
English: Certain types of vaccines should not be used while receiving RoActemra.
Slovenian: Med zdravljenjem z zdravilom RoActemra se ne smejo uporabljati nekatere vrste cepiv.
English: The concentration-dependent non-linear clearance plays a major role at low RoActemra concentrations.
Slovenian: Od koncentracije odvisni nelinearni očistek igra pomembno vlogo pri nizkih koncentracijah zdravila RoActemra.
English: Limited information is available regarding switching patients from RoActemra intravenous formulation to RoActemra subcutaneous fixed dose formulation.
Slovenian: Podatkov o prehajanju bolnikov z intravenske oblike zdravila RoActemra na subkutano obliko s fiksnim odmerkom je malo.
English: Ask your healthcare provider any questions you may have.
Slovenian: Nanj se obrnite, če imate kakršna koli vprašanja.
English: The safety of subcutaneous RoActemra in RA includes a double-blind, controlled, multicenter study, SC-I. SC-I was a non-inferiority study that compared the efficacy and safety of RoActemra 162 mg administered every week versus 8 mg/kg intravenous in 1262 patients with RA.
Slovenian: Varnost uporabe subkutane oblike zdravila RoActemra pri zdravljenju revmatoidnega artritisa vključuje dvojno slepo, kontrolirano, multicentrično študijo SC-I. SC-I je bila študija ne-inferiornosti, ki je pri 1262 bolnikih z revmatoidnim artritisom primerjala učinkovitost in varnost 162 mg zdravila
English: for patients weighing ≥ 30 kg respectively provide PK exposure and PD responses to support efficacy and safety outcomes similar to those achieved with the approved RoActemra IV regimens for pJIA.
Slovenian: manjšo od 30 kg, in 162 mg vsaka 2 tedna pri bolnikih s telesno maso ≥ 30 kg, zagotavljata farmakokinetično izpostavljenost in farmakodinamične odzive, ki podpirajo izide glede učinkovitosti in varnosti, podobne tistim, ki so bili doseženi z odobrenimi režimi intravenske oblike zdravila RoActemra za pJIA.
English: Infections and Infestations
Slovenian: Infekcijske in parazitske bolezni
English: The rate of anaphylactic reactions (occurring in a total of 8/4,009 patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Slovenian: Delež anafilaktičnih reakcij (ki so se pojavile pri skupaj 8 od 4009 bolnikov, 0,2 %) je bil pri odmerku 4 mg/kg nekajkrat večji kot pri odmerku 8 mg/kg.
English: If a patient misses a subcutaneous injection of RoActemra by more than 7 days of the scheduled dose or is unsure when to inject RoActemra, call the doctor or pharmacist.
Slovenian: Če bolnik prejema zdravilo RoActemra s subkutano injekcijo in je od izpuščenega odmerka minilo več kot 7 dni ali bolnik ni prepričan, kdaj si mora spet injicirati zdravilo RoActemra, naj se posvetujte z zdravnikom ali farmacevtom.
English: Concentrate for solution for infusion 80 mg/4 mL
Slovenian: Koncentrat za raztopino za infundiranje 80 mg/4 ml
English: The most common events observed were nasopharyngitis and upper respiratory tract infections.
Slovenian: Najbolj pogosti neželeni učinki so bili nazofaringitis in okužbe zgornjih dihal.
English: Of these 51 patients, 26 (51%) were naive to RoActemra and 25 (49%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Slovenian: Od teh 51 bolnikov je 26 (51 %) zdravilo RoActemra prejelo prvič, 25 (49 %) pa jih je predhodno prejemalo intravensko obliko zdravila RoActemra in ob izhodišču prešlo na subkutano obliko zdravila RoActemra.
English: What you need to know to use your RoActemra pre-filled pen (ACTPen) safely.
Slovenian: Kaj morate vedeti za varno uporabo napolnjenega injekcijskega peresnika (ACTPen) z zdravilom RoACTEMRA
English: Each mL concentrate contains 20 mg tocilizumab*.
Slovenian: En ml koncentrata vsebuje 20 mg tocilizumaba*.
English: After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature (18°C to 28°C) by waiting for 25 to 30 minutes, before injecting RoActemra .
Slovenian: Po tem, ko vzamemo napolnjeno injekcijsko brizgo iz hladilnika, jo pustimo 25 do 30 minut, da doseže sobno temperaturo (18 °C do 28 °C), preden zdravilo RoActemra injiciramo.
English: The rate of serious infections was numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (12.2 per 100 patient years) compared to patients weighing ≥30 kg, treated with 8 mg/kg tocilizumab (4.0 per 100 patient years).
Slovenian: Delež resnih okužb je bil številčno večji pri bolnikih s telesno maso < 30 kg, ki so se zdravili z 10 mg/kg tocilizumaba (12,2 na 100 bolnik-let) v primerjavi z bolniki s telesno maso ≥ 30 kg, ki so se zdravili z 8 mg/kg tocilizumaba