FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic impairment: No formal study of the effect of hepatic impairment on the pharmacokinetics of tocilizumab has been conducted.
Slovenian: Okvara jeter: formalnih študij o vplivu okvare jeter na farmakokinetiko tocilizumaba niso izvedli.
English: Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton (EXP).
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki napolnjenega injekcijskega peresnika in na škatli poleg oznak EXP in Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: In patients with elevated ALT or AST above 5x ULN treatment is not recommended.
Slovenian: Zdravljenje s tocilizumabom se ne priporoča pri bolnikih z zvišano vrednostjo ALT ali AST nad 5-kratno ZMN.
English: It is recommended that all patients particularly paediatric or elderly 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, zlasti otroci ali starejši, cepijo v skladu z veljavnimi smernicami za cepljenje pred začetkom zdravljenja z zdravilom RoActemra.
English: Haematological abnormalities
Slovenian: Hematološke nepravilnosti
English: (See Fig. E).
Slovenian: (glejte sliko A).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 200 mg tocilizumab.
Slovenian: 1 viala vsebuje 200 mg tocilizumaba.
English: *τ = 2 week or 3 week for the two SC regimens
Slovenian: *τ = 2 tedna ali 3 tedne za dva subkutana režima
English: Events of cholesterol increased were less frequently reported in the pJIA population than in the adult RA population.
Slovenian: Neželeni učinek, o katerem pa so pri populaciji s pJIA poročali redkeje kot pri odrasli populaciji z revmatoidnim artritisom, je bil zvišan holesterol.
English: Investigations
Slovenian: del raziskave)
English: Talk to your doctor, pharmacist or nurse before using RoActemra.
Slovenian: Pred začetkom uporabe zdravila RoActemra se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: RoActemra is supplied in a single use pre-filled pen.
Slovenian: Zdravilo RoActemra je na voljo v napolnjenem injekcijskem peresniku za enkratno uporabo.
English: weeks (patients weighing ≥30 kg), 12 mg/kg IV every 2 weeks (patients weighing below 30 kg), 162 mg SC every week (patients weighing ≥30 kg), 162 mg SC every 10 days or every 2 weeks (patients weighing below 30 kg).
Slovenian: 140 bolnikov s sJIA, ki so dobivali tocilizumab v odmerkih 8 mg/kg intravensko vsaka 2 tedna (bolniki s telesno maso ≥ 30 kg), 12 mg/kg intravensko vsaka 2 tedna (bolniki s telesno maso < 30 kg), 162 mg subkutano vsak teden (bolniki s telesno maso ≥ 30 kg) in 162 mg subkutano vsakih 10 dni ali vsaka 2 tedna (bolniki s telesno maso < 30 kg).
English: Diverticulitis
Slovenian: Trombociti
English: The recommended injection sites (abdomen, thigh and upper arm) should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
Slovenian: Zdravila se ne sme injicirati v znamenja, brazgotine ali predele, kjer je koža občutljiva, podpluta, pordela, trda ali poškodovana.
English: During the 6-month controlled trials transient elevations in ALT/AST > 3 x ULN were observed in 2.1% of patients on RoActemra 8 mg/kg compared to 4.9% of patients on MTX and in 6.5% of patients who received 8 mg/kg RoActemra plus DMARDs compared to 1.5% of patients on placebo plus DMARDs.
Slovenian: ZMN zabeležili pri 2,1 % bolnikov, ki so dobivali 8 mg/kg zdravila RoActemra, pri 4,9 % bolnikov, ki so dobivali metotreksat, pri 6,5 % bolnikov, ki so dobivali 8 mg/kg zdravila RoActemra v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, ter pri 1,5 % tistih, ki so dobivali placebo v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
English: If you miss your once every other weekly dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time.
Slovenian: Če prejemate zdravilo RoActemra enkrat na dva tedna in je od izpuščenega odmerka minilo manj kot 7 dni, si injicirajte odmerek takoj, ko se spomnite, in naslednji odmerek vzemite po načrtu.
English: After IV dosing, approximately 90% of the steady-state was reached by week 12 for the 10 mg/kg (BW < 30 kg), and by week 16 for the 8 mg/kg (BW ≥ 30 kg) dose.
Slovenian: 12. tedna za odmerek 10 mg/kg (telesna masa < 30 kg) in do 16. tedna za odmerek 8 mg/kg (telesna masa ≥ 30 kg).
English: In a pooled analysis of studies II, III and IV, the proportion of patients achieving an ACR 20, 50 and 70 response was significantly higher (59% vs. 50%, 37% vs. 27%, 18% vs. 11%, respectively) in the RoActemra 8 mg/kg plus DMARD vs. the RoActemra 4 mg/kg plus DMARD group (p< 0.03).
Slovenian: V kumulativni analizi študij II, III in IV je bil delež bolnikov, ki so dosegli odziv ACR 20, 50 in 70, značilno večji med prejemniki 8 mg/kg zdravila RoActemra skupaj z imunomodulirajočimi antirevmatičnimi zdravili kot med prejemniki 4 mg/kg zdravila RoActemra skupaj z imunomodulirajočimi antirevmatičnimi zdravili (ACR 20: 59 % v prim.
English: Doses of 4 or 8 mg/kg of tocilizumab or placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Slovenian: Odmerke 4 ali 8 mg/kg tocilizumaba ali placebo so dobivali 52 tednov na štiri tedne kot terapijo z dvojno slepo kontrolo, v kombinaciji s stabilnim odmerkom metotreksata (od 10 do 25 mg na teden).
English: • Infusion rate
Slovenian: • hitrost infuzije,
English: Frequency category with preferred term
Slovenian: Prednostni izraz za neželeni učinek
English: These ISRs occurred in a 44% of patients ≥30 kg compared to 14.8% of patients below 30 kg.
Slovenian: Te reakcije na mestu injiciranja so se pojavile pri 44 % bolnikov s telesno maso ≥ 30 kg, v primerjavi s 14,8 % bolnikov, lažjih od 30 kg. Najpogostejše reakcije na mestu injiciranja so bile eritem na mestu injiciranja, oteklina, hematom, bolečina in srbenje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (WITHOUT BLUE BOX) - Multipack
Slovenian: ŠKATLA NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ PODATKOV MODREGA OKENCA) - skupno pakiranje
English: Drug-induced liver injury, Hepatitis, Jaundice,
Slovenian: • bolečina v telesu, zvišana telesna temperatura, mrzlica,
English: Cytokine Release Syndrome (CRS) (adults and paediatrics) The recommended posology for treatment of CRS given as a 60-minute intravenous infusion is 8 mg/kg in patients weighing greater than or equal to 30 kg or 12 mg/kg in patients weighing less than 30 kg. RoActemra can be given alone or in combination with corticosteroids.
Slovenian: Priporočeno odmerjanje za zdravljenje CRS je pri bolnikih, ki tehtajo 30 kg ali več, 8 mg/kg, pri bolnikih, ki tehtajo manj kot 30 kg, pa 12 mg/kg v obliki 60-minutne intravenske infuzije.
English: • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Slovenian: • Ne injicirajte v znamenja, brazgotine, podpludbe ali mesta, kjer je koža občutljiva, pordela,
English: As there are many co-morbid conditions that may effect laboratory values in pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Slovenian: Pri bolnikih s pJIA lahko veliko sočasnih bolezni vpliva na laboratorijske vrednosti, zato moramo pri vsakem bolniku posebej presoditi, ali je zdravljenje s tocilizumabom treba prekiniti.
English: Infusion reactions
Slovenian: Reakcije, povezane z infundiranjem
English: • Physician Information Pack
Slovenian: • izobraževalno gradivo za zdravnike,
English: The pharmacokinetics of RoActemra in pJIA patients was characterized by a population pharmacokinetic analysis which included 237 patients who were treated with 8 mg/kg IV every 4 weeks (patients weighing ≥ 30 kg), 10 mg/kg IV every 4 weeks (patients weighing below 30 kg), 162
Slovenian: Farmakokinetiko zdravila RoActemra pri bolnikih s pJIA so ovrednotili s populacijsko farmakokinetično analizo, ki je vključevala 237 bolnikov; bolnike so zdravili z odmerkom 8 mg/kg intravensko vsake 4 tedne (bolniki s telesno maso ≥ 30 kg), odmerkom 10 mg/kg intravensko vsake 4 tedne (bolniki s telesno maso pod 30 kg), odmerkom 162 mg subkutano na 2 tedna (bolniki s telesno maso ≥ 30 kg) ali 162 mg subkutano vsake 3 tedne (bolniki s telesno maso pod 30 kg).
English: Duration (days) Mean (SD)
Slovenian: Trajanje (dnevi)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA NAPOLNJEGA INJEKCIJSKEGA PERESNIKA
English: The recommended posology in patients above 2 years of age is 8 mg/kg once every 2 weeks in patients weighing greater than or equal to 30 kg or 12 mg/kg once every 2 weeks in patients weighing less than 30 kg.
Slovenian: Priporočeno odmerjanje za bolnike, starejše od 2 let, je 8 mg/kg telesne mase enkrat na 2 tedna pri bolnikih, ki tehtajo 30 kg ali več in 12 mg/kg enkrat na 2 tedna pri bolnikih, ki tehtajo manj kot 30 kg. Odmerek je treba izračunati glede na bolnikovo telesno maso pred vsakim dajanjem.
English: Evaluable patients had been treated with tocilizumab 8 mg/kg (12 mg/kg for patients < 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CRS; only the first episode of CRS was included in the analysis.
Slovenian: Ocenljive bolnike so zaradi hudega ali življenje ogrožajočega CRS zdravili s tocilizumabom v odmerku 8 mg/kg (bolnike s telesno maso < 30 kg z 12 mg/kg) z dodatkom velikih odmerkov kortikosteroidov ali brez njih.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of decreases in neutrophil counts remained consistent with what was seen in the 6-month controlled clinical trials.
Slovenian: V obdobju dvojno slepe kontrole ter pri dolgoročni izpostavljenosti sta vzorec in incidenca zmanjšanja števila nevtrofilcev ostala skladna s tem, kar so opazili v šestmesečnih kontroliranih kliničnih preskušanjih.
English: In the 6-month controlled trials decreases in platelet counts below 100 x 103/ μL occurred in 1.7% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 1% on placebo plus DMARDs.
Slovenian: V šestmesečnih kontroliranih kliničnih preskušanjih se je število trombocitov zmanjšalo pod 100 x 103/µl pri 1,7 % bolnikov, ki so dobivali 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, in pri < 1 % tistih, ki so dobivali placebo v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
English: In RA, pJIA and sJIA patients, 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 revmatoidnim artritisom, pJIA in sJIA je treba vrednosti ALT in AST prvih 6 mesecev zdravljenja kontrolirati na 4 do 8 tednov, pozneje pa na 12 tednov.
English: Hepatic impairment: No formal study of the effect of hepatic impairment on the pharmacokinetics of RoActemra has been conducted.
Slovenian: Okvara jeter: formalnih študij o vplivu okvare jeter na farmakokinetiko zdravila RoActemra niso izvedli.
English: • If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled syringe) once every week
Slovenian: • Če bolnik tehta 30 kg ali več: odmerek je 162 mg (vsebina ene napolnjene injekcijske brizge) enkrat na teden.
English: • Continue to keep the needle-shield pushed in.
Slovenian: • zmanjšano delovanje žleze ščitnice.
English: Study II LITHE
Slovenian: Študija II
English: Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Slovenian: Tel: +353 (0) 1 469 0700
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 5.7 mL/h in paediatric patients with systemic juvenile idiopathic arthritis.
Slovenian: Linearni očistek so ocenili kot parameter v analizi populacijske farmakokinetike in je pri pediatričnih bolnikih s sJIA znašal 5,7 ml/h.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevation in ALT/AST remained consistent with what was seen in the 6-month controlled clinical trials.
Slovenian: V obdobju dvojno slepe kontrole ter pri dolgoročni izpostavljenosti sta vzorec in incidenca zvišanja ALT/AST ostala skladna s tem, kar so opazili v šestmesečnih kontroliranih kliničnih preskušanjih.
English: • Pre-filled Syringe
Slovenian: • napolnjena injekcijska brizga
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 80 mg tocilizumab.
Slovenian: 1 viala vsebuje 80 mg tocilizumaba.
English: Predicted mean ± SD PK parameters at steady-state after subcutaneous dosing in GCA
Slovenian: Predvideno povprečje ± std. odklon farmakokinetičnih (FK) parametrov v stanju dinamičnega ravnovesja po subkutani uporabi pri bolnikih z GCA
English: For subcutaneous administration, the effective t1/2 is up to 13 days for 162 mg every week and 5 days for 162 mg every other week in patients with RA at steady-state.
Slovenian: Izločanje Za subkutano dajanje je pri bolnikih z revmatoidnim artritisom v stanju dinamičnega ravnovesja efektivni t1/2 do 13 dni za 162 mg vsak teden in 5 dni za 162 mg vsak drugi teden.
English: Doses of 8 mg/kg of tocilizumab were given every four weeks as monotherapy.
Slovenian: bolnikov pa 8 mg/kg tocilizumaba v monoterapiji.
English: • Hold the needle-shield of the syringe firmly with one hand and pull off the needle-cap with the other hand.
Slovenian: • Z eno roko trdno primite varovalo injekcijske igle, z drugo povlecite pokrovček injekcijske igle (glejte sliko D).
English: Statistically significant improvements in haemoglobin levels were observed with RoActemra compared with DMARDs (p< 0.0001) at week 24.
Slovenian: Po 24 tednih so pri zdravilu RoActemra v primerjavi z imunomodulirajočimi antirevmatičnimi zdravili ugotovili statistično značilno izboljšanje koncentracije hemoglobina (p < 0,0001).
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, elevation in
Slovenian: Med rednim laboratorijskim spremljanjem v 12-mesečnem kontroliranem kliničnem preskušanju zdravila RoActemra se je pri 34 % bolnikov pojavilo trajno zvišanje celokupnega holesterola na
English: Pharmacodynamic effects
Slovenian: Farmakokinetični parametri zdravila
English: In general, the ADRs in sJIA patients were similar in type to those seen in RA patients, see section 4.8.
Slovenian: V splošnem so neželeni učinki pri bolnikih s sJIA podobnega tipa kot tisti, opaženi pri bolnikih z revmatoidnim artritisom (glejte poglavje 4.8).
English: Pre-filled Syringe parts
Slovenian: Deli napolnjene injekcijske brizge
English: Doses of 4 or 8 mg/kg of RoActemraor placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Slovenian: Odmerke 4 ali 8 mg/kg zdravila RoActemra ali placebo so dobivali 52 tednov na štiri tedne kot terapijo z dvojno slepo kontrolo, v kombinaciji s stabilnim odmerkom metotreksata (od 10 do 25 mg na teden).
English: The decision to discontinue RoActemra in sJIA or pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.
Slovenian: O ukinitvi zdravila RoActemra zaradi nenormalnih laboratorijskih vrednosti je treba pri sJIA ali pJIA presojati za vsakega bolnika posebej.
English: These may affect 1 in 10 patients or more
Slovenian: Ti se lahko pojavijo pri več kot 1 od 10 bolnikov.
English: Figure H).
Slovenian: 6R).
English: RA, sJIA, pJIA and CRS Patients ≥ 30 kg
Slovenian: Bolniki s sJIA, pJIA in CRS ≥ 30 kg
English: Each pack contains 4 pre-filled syringes with multipacks containing 12 (3 packs of 4) pre-filled syringes.
Slovenian: Eno pakiranje vsebuje štiri napolnjene injekcijske brizge, skupno pakiranje vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
English: In the double-blind controlled studies 774 patients received RoActemra 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX/other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Slovenian: 4 mg/kg tocilizumaba v kombinaciji z metotreksatom, 1.870 bolnikov 8 mg/kg tocilizumaba v kombinaciji z metotreksatom oz. drugimi imunomodulirajočimi antirevmatičnimi zdravili, 288
English: In the 6-month controlled trials decreases in neutrophil counts below 1 x 109/ L occurred in 3.4% of patients on RoActemra 8 mg/kg plus DMARDs compared to < 0.1% of patients on placebo plus DMARDs.
Slovenian: V šestmesečnih kontroliranih kliničnih preskušanjih se je število nevtrofilcev zmanjšalo pod 1 x 109/l pri 3,4 % bolnikov, ki so dobivali 8 mg/kg zdravila RoActemra v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, in pri < 0,1 % bolnikov, ki so dobivali placebo v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
English: If the expiration date has passed, safely dispose of the pre-filled pen in a sharps container and get a new one.
Slovenian: Napolnjeni injekcijski peresnik, ki mu je potekel rok uporabnosti, varno odstranite v zabojnik za ostre predmete in si priskrbite novega.
English: RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Slovenian: Zdravilo RoActemra je indicirano za zdravljenje hudega ali življenje ogrožajočega sindroma sproščanja citokinov, ki ga sprožijo T-celice s himernim antigenskim receptorjem (Chimeric Antigen
English: • If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe), once every 3 weeks
Slovenian: • Če bolnik tehta manj kot 30 kg: odmerek je 162 mg (vsebina ene napolnjene injekcijske brizge) enkrat na 3 tedne.
English: The assessment of the time to first GCA flare showed a significantly lower risk of flare for the RoActemra subcutaneous weekly group compared to placebo plus 26 weeks prednisone and placebo plus 52 weeks prednisone taper groups and for the RoActemra subcutaneous every other weekly group compared to placebo plus 26 weeks prednisone (when compared at a 0.01 significance level).
Slovenian: tedenskim zmanjševanjem prednizona, ter v skupini, ki je prejemala zdravilo RoActemra subkutano vsak drugi teden, kot v skupini s placebom in 26-tedenskim zmanjševanjem prednizona (ob primerjavi na ravni značilnosti 0,01).
English: In the 6-month controlled trials decreases in neutrophil counts below 1 x 109/ l occurred in 3.4% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 0.1% of patients on placebo plus DMARDs.
Slovenian: V šestmesečnih kontroliranih kliničnih preskušanjih se je število nevtrofilcev zmanjšalo pod 1 x 109/l pri 3,4 % bolnikov, ki so dobivali 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, in pri < 0,1 % bolnikov, ki so dobivali placebo v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Revmatoidni artritis in gigantocelični arteriitis
English: Doses of 4 or 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).
Slovenian: Odmerke 4 ali 8 mg/kg tocilizumaba ali placebo so dobivali na štiri tedne v kombinaciji s stabilnim odmerkom metotreksata (od 10 do 25 mg na teden).
English: Infusion related reactions pJIA1, sJIA2
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije, povezane z infundiranjem pJIA 1, sJIA
English: In the double-blind controlled studies, 774 patients received tocilizumab 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Slovenian: V dvojno slepih, kontroliranih študijah je 774 bolnikov prejemalo 4 mg/kg tocilizumaba v kombinaciji z metotreksatom, 1870
English: The key secondary efficacy endpoint also based on the proportion of patients achieving sustained remission at week 52, comparing tocilizumab plus 26 weeks prednisone taper with placebo plus 52 weeks prednisone taper, was also met (Table 4).
Slovenian: Primerjali so tocilizumab skupaj s 26-tedenskim zmanjševanjem prednizona ter placebo skupaj z 52-tedenskim zmanjševanjem prednizona (preglednica 4).
English: NAME OF THE MEDICINAL PRODUCT RoActemra 162 mg solution for injection in pre-filled syringe Tocilizumab
Slovenian: Navodilo za uporabo RoActemra 162 mg raztopina za injiciranje v napolnjeni injekcijski brizgi tocilizumab
English: ALT ≥3 x ULN occurred in 3% of patients in the RoActemra subcutaneous weekly group compared to 2% in the placebo plus 52 week prednisone taper group and none in the placebo plus 26 week prednisone taper group.
Slovenian: Zvišanje jetrnih transaminaz Med rednim laboratorijskim spremljanjem v 12-mesečnem kontroliranem kliničnem preskušanju se je zvišanje ALT na ≥ 3-kratno ZMN pojavilo pri 3 % bolnikov, ki so prejemali zdravilo RoActemra subkutano vsak teden, pri 2 % bolnikov, ki so prejemali placebo in prednizon z 52-tedenskim zmanjševanjem odmerka, ter pri nobenem od bolnikov, ki so prejemali placebo in prednizon s 26-tedenskim zmanjševanjem odmerka.
English: How to store RoActemra
Slovenian: Shranjevanje zdravila RoActemra
English: Events of cholesterol increased were less frequently reported in the sJIA population than in the adult RA population.
Slovenian: Neželeni učinek, o katerem pa so pri populaciji s sJIA poročali redkeje kot pri odrasli populaciji z revmatoidnim artritisom, je bil zvišan holesterol.
English: Very rare reports of pancytopenia have occurred in the post marketing setting.
Slovenian: V obdobju po prihodu zdravila na trg so poročali o zelo redkih primerih pancitopenije.
English: • If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled syringe), once every 2 weeks.
Slovenian: • Če bolnik tehta 30 kg ali več: odmerek je 162 mg (vsebina ene napolnjene injekcijske brizge) enkrat na 2 tedna.
English: JIA ACR response rates at week 12 (% patients)
Slovenian: Odziv JIA ACR po 12 tednih (% bolnikov) Odziv tocilizumab n = 75
English: Slovenija
Slovenian: Slovenská republika
English: If the pre-filled syringe is not used within 5 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.
Slovenian: Če napolnjene injekcijske brizge ne uporabite v 5 minutah po odstranitvi pokrovčka, jo je treba zavreči v zabojnik za ostre predmete, odporen proti vbodom, in uporabiti novo.
English: In the 52-week open-label SC Study (WA28118), 23.4% and 35.4% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥130 mg/dL and total cholesterol value to ≥200
Slovenian: V 52-tedenski odprti študiji s subkutano obliko (WA28118) je imelo v katerem koli času med študijskim zdravljenjem (ne v izhodišču) 23,4 % bolnikov zvišano vrednost holesterola LDL na
English: Mean (SD) * p<0.0001 ** p<0.005 (threshold for significance for primary and key secondary tests of superiority) ***Descriptive p value <0.005 ****Flare: recurrence of GCA signs or symptoms and/or ESR ≥30 mm/h - Increase in the prednisone dose required Remission: absence of flare and normalization of the CRP Sustained remission: remission from week 12 to week 52 -Patients must adhere to the protocol-defined prednisone taper ¹ analysis of the time (in days) between clinical remission and first disease flare 2 p-values are determined using a Van Elteren analysis for non-parametric data § statistical analyses has not been performed
Slovenian: ***p ≤ 0,0001; **p < 0,001; *p < 0,05; ‡ p-vrednost < 0,05 v primerjavi s placebom + MTX, a cilj je bil eksplorativen (ni bil vključen v hierarhijo statističnega testiranja, zato ga niso kontrolirali glede številčnosti)
English: Predicted mean ± SD PK parameters at steady-state after IV dosing in pJIA RoActemra PK Parameter
Slovenian: Predvideno povprečje ± std. odklon farmakokinetičnih parametrov v stanju dinamičnega ravnovesja po intravenskem odmerjanju pri bolnikih s pJIA