natgillin/translations-raw huggingface dataset:
In the 6-month controlled studies the rate of all infections reported with tocilizumab 8 mg/kg plus DMARD treatment was 127 events per 100 patient years compared to 112 events per 100 patient years in the placebo plus DMARD group.
V šestmesečnih kontroliranih študijah je bil delež vseh okužb med uporabo 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 127 na 100 bolnik-let, med uporabo placeba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili pa 112 na 100 bolnik-let.
• Place the needle-shield of the pre-filled pen against your pinched skin at a 90° angle (See
• Zaščito za iglo napolnjenega injekcijskega peresnika nastavite proti kožni gubi pod kotom 90 °
• Do not leave the pre-filled pen unattended.
• Napolnjenega injekcijskega peresnika ne puščajte brez nadzora.
• the medicine is cloudy
• je zdravilo motno,
ACR 30 ACR 50 ACR 70
JIA ACR 30 JIA ACR 50 JIA ACR 70
GCA (SC)
Povprečje (SD)
In clinical studies with RoActemra, patients who screened positive for hepatitis were excluded.
Bolniki, ki so bili na presejalnem testu za hepatitis pozitivni, niso bili vključeni v klinična preskušanja z zdravilom RoActemra.
A statistically significant superior treatment effect was seen in favour of RoActemra over adalimumab in control of disease activity from baseline to week 24 for the primary endpoint of change in DAS28 and for all secondary endpoints (Table 7).
Učinek zdravljenja z zdravilom RoActemra je bil statistično značilno boljši kot z adalimumabom v kontroli aktivnosti bolezni od začetka zdravljenja do 24. tedna za primarni cilj študije, spremembo
Each 20 mL vial contains 400 mg tocilizumab (20 mg/mL).
Ena 20-ml viala vsebuje 400 mg tocilizumaba (20 mg/ml).
In the 6-month controlled studies the rate of all infections reported with RoActemra 8 mg/kg plus DMARD treatment was 127 events per 100 patient years compared to 112 events per 100 patient years in the placebo plus DMARD group.
V šestmesečnih kontroliranih študijah je bil delež vseh okužb med uporabo 8 mg/kg zdravila RoActemra v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 127 na 100 bolnik-let, med uporabo placeba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili pa 112 na 100 bolnik-let.
Store vials in a refrigerator (2°C-8°C).
Viale shranjujte v hladilniku (2 °C - 8 °C).
In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the tocilizumab group and 1.5 events per 100 patient years of exposure in the MTX group.
V študiji monoterapije je bil delež resnih okužb v skupini, ki je dobivala tocilizumab, 3,6 na 100 bolnik-let izpostavljenosti, v skupini, ki je dobivala metotreksat, pa 1,5 na 100 bolnik-let izpostavljenosti.
Accumulation Cmax Accumulation Ctrough Accumulation Cmean or AUCτ *
Akumulacija: Cmax Akumulacija: Ctrough Akumulacija: Csrednja ali AUCτ*
162 mg Q3W below 30 kg
162 mg vsake 3 tedne pod 30 kg
TCZ IV 8 mg/kg + DMARD
8 mg/kg DMARD
Cmax of RoActemra were 3430 ± 2660 µg•h/mL, 5.7 ± 6.8 µg/mL, and 13.2 ± 8.8 µg/mL,
AUC2 tedna v stanju dinamičnega ravnovesja = 3430 ± 2660 µg•h/ml, najmanjša koncentracija (Cmin) = 5,7 ± 6,8 µg/ml in največja koncentracija (Cmax) = 13,2 ± 8,8 µg/ml.
In the long-term exposure population, the overall rate of infections with RoActemra was 108 events per 100 patient years exposure.
V dolgoročno izpostavljeni populaciji je bil celokupni delež okužb med uporabo zdravila RoActemra
Do not use this medicine after the expiry date which is stated on the pre-filled syringe label and carton (EXP).
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki napolnjene injekcijske brizge in na škatli poleg oznak EXP in Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
For recommended dose modifications based on ANC and platelet counts, see section 4.2.
Za priporočene prilagoditve odmerka na podlagi absolutnega števila nevtrofilcev in števila trombocitov glejte poglavje 4.2.
The primary efficacy endpoint assessed by the proportion of patients achieving steroid free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper, was met (Table 4).
52 tednih dosegli trajno remisijo brez steroidov z uporabo zdravila RoActemra in 26-tedenskega zmanjševanja prednizona, v primerjavi z bolniki, ki so prejemali placebo in 26-tedensko zmanjševanje prednizona (preglednica 4).
The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving tocilizumab (28-34%) compared to 1-12% of control patients at 24 weeks.
24 tednih značilno večji med bolniki, ki so dobivali tocilizumab (28-34 %), kot med kontrolnimi bolniki (1-12 %).
The types of ADRs in pJIA patients were similar to those seen in RA and sJIA patients, see section 4.8.
so bili podobnega tipa kot tisti, ki so jih opazili pri bolnikih z revmatoidnim artritisom in sJIA (glejte poglavje 4.8).
HR (99% CI) Time to first GCA flare¹ (Tocilizumab groups vs Placebo+52)
Čas do prvega poslabšanja GCA¹ (skupini s tocilizumabom v primerjavi s placebom + 52)
RoActemra should be used with caution in patients with previous history of intestinal ulceration or diverticulitis.
Zato morate pri bolnikih z anamnezo razjede v prebavilih ali divertikulitisa zdravilo RoActemra uporabljati previdno.
Tocilizumab-treated patients reported an improvement in all patient-reported outcomes (Health Assessment Questionnaire Disability Index - HAQ-DI), Short Form-36 and Functional Assessment of Chronic Illness Therapy questionnaires.
vprašalniki HAQ-DI (Health Assessment Questionaire-Disability Index), SF-36 (Short Form-36) in
When compared to the adult RA population, events of nasopharyngitis, headache, nausea, and decreased neutrophil count were more frequently reported in the pJIA population.
V primerjavi z odraslo populacijo z revmatoidnim artritisom so o naslednjih neželenih učinkih poročali pogosteje pri populaciji s pJIA: nazofaringitisu, glavobolu, navzei in zmanjšanem številu nevtrofilcev.
In patients treated with tocilizumab 8 mg/kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Neprekinjene trajne odzive prek 3 let so opazili v odprtih, podaljšanih fazah študij I - V. V vseh študijah so med zdravljenjem z 8 mg/kg tocilizumaba v primerjavi z uporabo placeba v kombinaciji z metotreksatom ali drugimi imunomodulirajočimi antirevmatičnimi zdravili zabeležili značilno izboljšanje vseh posameznih elementov odziva ACR, vključno s številom bolečih in oteklih sklepov, bolnikovo in zdravnikovo oceno bolezni, kazalci preostalih sposobnosti, oceno bolečine in CRP.
The half life of tocilizumab in pJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 10 mg/kg for body weight < 30 kg) during a dosing interval at steady state.
Razpolovni čas tocilizumaba pri bolnikih s pJIA je do 16 dni za obe skupini, ločeni glede na telesno maso (8 mg/kg tocilizumaba za bolnike s telesno maso ≥ 30 kg ali 10 mg/kg za bolnike s telesno maso
The corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000
Neželeni učinki pri bolnikih s pJIA in sJIA, zdravljenih s tocilizumabom, so navedeni v preglednici 2 po organskih sistemih MedDRA. Za posamezen neželeni učinek je ustrezna skupina pogostnosti določena glede na naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) ali občasni (≥ 1/1000 do < 1/100).
The decision to discontinue RoActemra in pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.
O ukinitvi zdravila RoActemra zaradi nenormalnih laboratorijskih vrednosti je treba pri pJIA presojati za vsakega bolnika posebej.
Discontinue RoActemra.
Ukinite zdravilo RoActemra.
Hypercholesterolae mia*
Presnovne in prehranske motnje hiperholesterole mija*
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 400 mg tocilizumab.
1 viala vsebuje 400 mg tocilizumaba.
• Place the syringe on a clean flat surface and allow the syringe to come to room temperature (18°C - 28°C) for about 25-30 minutes to warm up.
minut, da se ogreje na sobno temperaturo (18 °C - 28 °C).
Renal impairment: No formal study of the effect of renal impairment on the pharmacokinetics of tocilizumab has been conducted.
Okvara ledvic: formalnih študij o vplivu okvare ledvic na farmakokinetiko tocilizumaba niso izvedli.
• Liver enzyme abnormalities
• Nenormalne vrednosti jetrnih encimov
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 162 mg of RoActemra (tocilizumab) in 0.9 mL.
En napolnjeni injekcijski peresnik vsebuje 162 mg zdravila RoActemra (tocilizumab) v 0,9 ml.
Tocilizumab PK Parameter
Farmakokinetični parameter tocilizumaba
Tocilizumab N=82
MTX n = 288
Injection site reaction
Reakcije na mestu injiciranja
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA and/or GCA.
4.2 Odmerjanje in način uporabe Zdravljenje mora vpeljati zdravnik, ki ima izkušnje s prepoznavanjem in zdravljenjem revmatoidnega artritisa in/ali GCA.
After IV dosing, approximately 90% of the steady-state was reached by week 8 for both the 12 mg/kg (BW < 30 kg) and 8 mg/kg Q2W (BW ≥ 30 kg) regimens.
8. tedna za oba odmerna režima vsaka 2 tedna: 12 mg/kg (telesna masa < 30 kg) in 8 mg/kg (telesna masa ≥ 30 kg).
In RA patients the central volume of distribution was 3.72 L, the peripheral volume of distribution was 3.35 L resulting in a volume of distribution at steady state of 7.07 L.
Pri bolnikih z revmatoidnim artritisom je bil centralni volumen porazdelitve 3,72 l in periferni volumen porazdelitve 3,35 l, tako da je volumen porazdelitve v stanju dinamičnega ravnovesja 7,07 l.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Imetnik dovoljenja za promet z zdravilom
• If it is not used within 5 minutes of cap removal, the syringe must be disposed of in the puncture resistant container or sharps container and a new syringe must be used.
• 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.
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 tocilizumab 8 mg/kg plus DMARD vs. the tocilizumab 4 mg/kg plus DMARD group (p< 0.03).
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 tocilizumaba skupaj z imunomodulirajočimi antirevmatičnimi zdravili kot med prejemniki 4 mg/kg tocilizumaba skupaj z imunomodulirajočimi antirevmatičnimi zdravili (ACR 20: 59 % v prim.
In Study II, in patients with an inadequate response to MTX, inhibition of structural joint damage was assessed radiographically and expressed as change in modified Sharp score and its components, the erosion score and joint space narrowing score.
V študiji II so pri bolnikih z nezadostnim odzivom na metotreksat radiološko ocenjevali zavrtje strukturne okvare sklepov.
In patients who develop an ANC < 0.5 x 109/ L or a platelet count < 50 x 103/μL, continued treatment is not recommended.
Nadaljnje zdravljenje ni priporočljivo pri bolnikih, pri katerih ANC pade pod 0,5 x 109/l ali pa število trombocitov pod 50 x 103/µl.
In Studies II, III and V, tocilizumab was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
V študijah II, III in V so tocilizumab dajali intravensko na štiri tedne v kombinaciji z metotreksatom;
Doses of 8 mg/kg RoActemra or placebo were given every four weeks in combination with stable DMARDs.
Odmerke 8 mg/kg zdravila RoActemra ali placebo so dobivali na štiri tedne v kombinaciji s stabilnimi odmerki imunomodulirajočih antirevmatičnih zdravil.
Each vial contains 400 mg of tocilizumab* in 20 mL (20 mg/mL).
Ena viala vsebuje 400 mg tocilizumaba* v 20 ml (20 mg/ml).
Patients (treated with or without MTX) were randomised (tocilizumab:placebo = 2:1) to one of two treatment groups, 75 patients received tocilizumab infusions every two weeks, either 8 mg/kg for patients ≥ 30 kg or 12 mg/kg for patients < 30 kg and 37 patients were assigned to receiving placebo infusions every two weeks.
Infuzije tocilizumaba v odmerku 8 mg/kg za bolnike z ≥ 30 kg ali 12 mg/kg za bolnike z < 30 kg je vsake dva tedna prejemalo 75 bolnikov, infuzije placeba vsake dva tedna pa 37 bolnikov.
x ULN occurred in 9.8% and 4.0% patients treated with RoActemra SC, respectively.
Zvišanje vrednosti ALT na ≥ 3 x ZMN se je pojavilo pri 9,8 % in zvišanje vrednosti AST ≥ 3 x ZMN pri 4,0 % bolnikov, zdravljenih s subkutano obliko zdravila RoActemra.
If a patient misses a subcutaneous once every 2 week injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose immediately and the next dose on the next scheduled day.
Če bolnik prejema zdravilo RoActemra s subkutano injekcijo enkrat na dva tedna in je od izpuščenega odmerka minilo manj kot 7 dni, mu je treba naročiti, da izpuščeni odmerek vzame nemudoma, naslednji odmerek pa po običajnem razporedu.
• injection site reactions
• reakcije na mestu injiciranja,
Radiographic Endpoints (mean change from baseline)
HAQ-DI (prilagojena povprečna sprememba od izhodišča)
In 6-month controlled clinical studies, the rate of serious infections with tocilizumab 8 mg/kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group.
V šestmesečnih kontroliranih kliničnih študijah je bil delež resnih okužb med uporabo 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 5,3 na 100 bolnik-let izpostavljenosti, med uporabo placeba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili pa 3,9 na 100 bolnik-let izpostavljenosti.
The safety of tocilizumab in CRS has been evaluated in a retrospective analysis of data from clinical trials, where 51 patients were treated with intravenous tocilizumab 8 mg/kg (12 mg/kg for patients less than 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CAR Tcell-induced CRS.
Bolniki s sindromom sproščanja citokinov (CRS) Varnost tocilizumaba pri CRS so ocenili v retrospektivni analizi podatkov iz kliničnih preskušanj, kjer so 51 bolnikov zdravili zaradi hudega ali življenje ogrožajočega CRS, povzročenega s T-celicami s himernim antigenskim receptorjem.
In 6-month controlled clinical studies, the rate of serious infections with RoActemra 8 mg/kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group.
V šestmesečnih kontroliranih kliničnih študijah je bil delež resnih okužb med uporabo 8 mg/kg zdravila RoActemra v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili 5,3 na 100 bolnik-let izpostavljenosti, med uporabo placeba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili pa 3,9 na 100 bolnik-let izpostavljenosti.
Children with sJIA
Bolniki s sJIA
• Nurse Information Pack
• izobraževalno gradivo za medicinske sestre,
Missed dose
Izpuščeni odmerek
Patients in the adalimumab arm received an adalimumab SC injection (40 mg) q2w plus an IV placebo infusion q4w.
Bolniki v skupini z adalimumabom so prejeli subkutano injekcijo adalimumaba (40 mg) vsaka 2 tedna in intravensko infuzijo placeba vsake 4 tedne.
Renal impairment: No formal study of the effect of renal impairment on the pharmacokinetics of RoActemra has been conducted.
Okvara ledvic: formalnih študij o vplivu okvare ledvic na farmakokinetiko zdravila RoActemra niso izvedli.
Leukopenia, Neutropenia, Hypofibrinogenaem ia
Bolezni krvi in limfatičnega sistema levkopenija, nevtropenija, hipofibrinogenemija
Mild renal impairment (creatinine clearance based on Cockcroft-Gault < 80 mL/min and ≥ 50 mL/min) did not impact the pharmacokinetics of tocilizumab.
Blaga okvara ledvic (očistek kreatinina po Cockcroft-Gaultovi formuli < 80 ml/min in
Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in RoActemra-treated patients compared to control patients (1.3-2.1).
Pri bolnikih, zdravljenih z zdravilom RoActemra, so ugotovili značilno znižanje (povprečno izboljšanje) DAS28 za 3,1 do 3,4 od izhodišča v primerjavi s kontrolnimi bolniki (1,3 do 2,1).
In Study I, tocilizumab was administered intravenously every four weeks as monotherapy.
V študiji I so tocilizumab uporabljali kot monoterapijo in ga dajali intravensko na štiri tedne.
The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 140 sJIA patients treated with 8 mg/kg IV every 2 weeks (patients with a body weight ≥ 30 kg ) 12 mg/kg IV every 2 weeks (patients with a body weight < 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).
Farmakokinetiko zdravila RoActemra pri bolnikih s sJIA so ovrednotili s populacijsko farmakokinetično analizo, ki je vključevala 140 bolnikov; bolnike so zdravili z odmerkom 8 mg/kg intravensko vsaka 2 tedna (bolniki s telesno maso ≥ 30 kg), odmerkom 12 mg/kg intravensko vsaka 2 tedna (bolniki s telesno maso pod 30 kg), odmerkom 162 mg subkutano vsak teden (bolniki s telesno maso ≥ 30 kg) ali 162 mg subkutano vsakih 10 dni ali vsaka 2 tedna (bolniki s telesno maso pod 30 kg).
During routine laboratory monitoring in the tocilizumab all exposure population, a decrease in neutrophil count below 1 × 109/L occurred in 3.7% of patients.
Med rutinskim laboratorijskim spremljanjem se je zmanjšanje števila nevtrofilcev pod 1 x 109/l pojavilo pri 3,7 % bolnikov v celotni populaciji, ki je prejemala tocilizumab.
For subcutaneous administration, the concentration-dependent apparent t 1/2 is up to 12 days for 162 mg every week and 5 days for 162 mg every other week in patients with RA at steady-state.
Izločanje Za subkutano dajanje je pri bolnikih z revmatoidnim artritisom v stanju dinamičnega ravnovesja od koncentracije odvisni navidezni t1/2 do 12 dni za 162 mg vsak teden in 5 dni za 162 mg vsak drugi teden.
In Study IV, tocilizumab was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
V študiji IV so tocilizumab dajali intravensko na 4 tedne v kombinaciji z drugimi imunomodulirajočimi antirevmatičnimi zdravili; primerjava je bila kombinacija placeba in imunomodulirajočih antirevmatičnih zdravil.
1 vial of 4 mL
1 viala s 4 ml
A statistically significant superior treatment effect was seen in favour of RoActemra over placebo in achieving steroid-free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper and with placebo plus 52 weeks prednisone taper.
Terapevtski učinek zdravila RoActemra je bil statistično značilno superioren placebu, kar zadeva doseganje trajne remisije brez steroidov po 52 tednih uporabe zdravila RoActemra skupaj s 26
The dose is 12 mg for every kg of body weight if you weigh less than 30 kg. RoActemra can be given alone or in combination with corticosteroids.
Odmerek je 12 mg na kg telesne mase, če tehtate manj kot 30 kg.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® Multipack: 12 (3 packs of 4) pre-filled pens.
raztopina za injiciranje v napolnjenem injekcijskem peresniku, ACTPen® skupno pakiranje: 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov 162 mg/0,9 ml
During the 6-month controlled trials transient elevations in ALT/AST > 3 x ULN were observed in 2.1% of patients on tocilizumab 8 mg/kg compared to 4.9% of patients on MTX and in 6.5% of patients who received 8 mg/kg tocilizumab plus DMARDs compared to 1.5% of patients on placebo plus DMARDs.
ZMN zabeležili pri 2,1 % bolnikov, ki so dobivali 8 mg/kg tocilizumaba, pri 4,9 % bolnikov, ki so dobivali metotreksat, pri 6,5 % bolnikov, ki so dobivali 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, ter pri 1,5 % tistih, ki so dobivali placebo v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
• Take the box containing the pre-filled pen out of the refrigerator.
• Iz hladilnika vzemite škatlo z napolnjenim injekcijskim peresnikom.
*τ = 2 week or 1 week for the two SC regimens
*τ = 2 tedna ali 1 teden za dva subkutana režima
• If you weigh 30 kg or more: the dose is 8 mg for every kilogram of body weight The dose is calculated based on your body weight at each administration.
• Če tehtate 30 kg ali več: odmerek je 8 mg na kg telesne mase.
RoActemra 162 mg solution for injection in pre-filled syringe Tocilizumab
RoActemra 162 mg injekcija tocilizumab sc
Hepatic transaminase elevations During routine laboratory monitoring in the RoActemra 6-month controlled clinical trial SC-I,
Zvišanje jetrnih transaminaz V okviru rutinskega laboratorijskega spremljanja v šestmesečnem kontroliranem kliničnem preskušanju SC-I z zdravilom RoActemra se je zvišanje ALT ≥ 3 x ZMN pojavilo pri 6,5 % bolnikov,
kg (n=25) dosed with 162 mg of RoActemra every 10 days (Q10D; n=8) or every 2 weeks (Q2W; n=17) for 52 weeks.
bolniki s telesno maso ≥ 30 kg (n = 26) so prejemali odmerek 162 mg zdravila RoActemra vsak teden, bolniki s telesno maso manj kot 30 kg (n = 25) pa so prejemali 162 mg zdravila RoActemra vsakih 10 dni (n = 8) ali vsaka 2 tedna (n = 17) 52 tednov.
In clinical studies with tocilizumab, patients who screened positive for hepatitis were excluded.
Bolniki, ki so bili na presejalnem testu za hepatitis pozitivni, niso bili vključeni v klinična preskušanja s tocilizumabom.
During routine laboratory monitoring in the 12 week controlled phase, elevation in ALT or AST ≥ 3 x
V šestmesečnih kontroliranih kliničnih preskušanjih so prehodno zvišanje ALT/AST na > 3-kratno
Hepatic impairment: No formal study of the effect of hepatic impairment on the pharmacokinetics of tocilizumab has been conducted.
Okvara jeter: formalnih študij o vplivu okvare jeter na farmakokinetiko tocilizumaba niso izvedli.
Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton (EXP).
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.
In patients with elevated ALT or AST above 5x ULN treatment is not recommended.
Zdravljenje s tocilizumabom se ne priporoča pri bolnikih z zvišano vrednostjo ALT ali AST nad 5-kratno ZMN.
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.
Priporočljivo je, da se vsi bolniki, zlasti otroci ali starejši, cepijo v skladu z veljavnimi smernicami za cepljenje pred začetkom zdravljenja z zdravilom RoActemra.
Haematological abnormalities
Hematološke nepravilnosti
(See Fig. E).
(glejte sliko A).
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 200 mg tocilizumab.
1 viala vsebuje 200 mg tocilizumaba.
*τ = 2 week or 3 week for the two SC regimens
*τ = 2 tedna ali 3 tedne za dva subkutana režima
Events of cholesterol increased were less frequently reported in the pJIA population than in the adult RA population.
Neželeni učinek, o katerem pa so pri populaciji s pJIA poročali redkeje kot pri odrasli populaciji z revmatoidnim artritisom, je bil zvišan holesterol.
Investigations
del raziskave)
Talk to your doctor, pharmacist or nurse before using RoActemra.
Pred začetkom uporabe zdravila RoActemra se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
RoActemra is supplied in a single use pre-filled pen.
Zdravilo RoActemra je na voljo v napolnjenem injekcijskem peresniku za enkratno uporabo.