natgillin/translations-raw huggingface dataset:
The total patient years duration in the RoActemra all exposure population was 138.5 patient years during the 12 month double blind, placebo controlled phase of the study.
Med 12-mesečno dvojno slepo, s placebom kontrolirano fazo študije je celotna izpostavljenost zdravilu RoActemra v vsej izpostavljeni populaciji trajala 138,5 bolnik-let.
For the 162 mg every week dosing regimen, the steady-state Cavg was 51% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg. For the 162 mg every other week regimen, the steady-state Cavg was 129% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg.
Pri odmernem režimu 162 mg enkrat na dva tedna je bila pri bolnikih s telesno maso, manjšo od 60 kg, Csrednja v stanju dinamičnega ravnovesja 129 % večja kot pri bolnikih s telesno maso od 60 do 100 kg.
The following parameters (predicted mean ± SD) were estimated for a dose of 8 mg/kg tocilizumab given every 4 weeks: steady-state area under curve (AUC) = 38000 ± 13000 h µg/mL, trough concentration (Cmin) = 15.9 ± 13.1 µg/mL and maximum concentration (Cmax) = 182 ± 50.4 µg/mL, and the accumulation ratios for AUC and Cmax were small, 1.32 and 1.09, respectively.
Za zdravilo RoActemra, uporabljenov odmerku 8 mg/kg vsake 4 tedne, so bili ocenjeni naslednji parametri (napovedano povprečje ± standardni odklon): površina pod krivuljo (AUC) v stanju dinamičnega ravnovesja = 38.000 ± 13.000 h•µg/ml, najmanjša koncentracija (Cmin) = 15,9 ± 13,1 µg/ml in največja koncentracija (Cmax) = 182 ± 50,4 µg/ml; deleža kopičenja sta bila majhna (1,32 za AUC in 1,09 za Cmax).
Rash, Pruritus, Urticaria
• izpuščaj in srbenje, koprivnica,
The radiographic response of subcutaneous administered RoActemra was assessed in a double-blind, controlled, multicenter study in patients with active RA (SC-II).
V dvojno slepi, kontrolirani, multicentrični študiji pri bolnikih z aktivnim revmatoidnim artritisom (SC-II) so radiološko ocenjevali subkutano dano zdravilo RoActemra.
Maintain dose
Priporočeni odmerek
Figure I
PRILOGA I
Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA or GCA.
Zdravila RoActemra zaradi nezadostnih kliničnih izkušenj ni priporočljivo uporabljati z drugimi biološkimi zdravili za zdravljenje revmatoidnega artritisa ali gigantoceličnega arteriitisa.
During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, a decrease in neutrophil count below 1 × 109/L occurred in 2.9% of patients on the subcutaneous weekly dose.
V okviru rutinskega laboratorijskega spremljanja v šestmesečnem kontroliranem kliničnem preskušanju SC-I z zdravilom RoActemra se je število nevtrofilcev zmanjšalo pod 1 x 109/l pri 2,9 %
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 4 pre-filled syringes.
raztopina za injiciranje v napolnjenem injekcijskem peresniku 4 napolnjeni injekcijski peresniki.
The recommended dose The dose for RA and GCA adults is 162 mg (the content of 1 pre-filled syringe) given once a week.
Priporočeni odmerek Za odrasle z revmatoidnim artritisom in gigantoceličnim arteriitisom je odmerek 162 mg (vsebina 1
RoActemra PK Parameter
Farmakokinetični parameter zdravila RoActemra
• If you miss your dose by more than 7 days, or you are not sure when to inject RoActemra, call your doctor or pharmacist.
• Če je od izpuščenega odmerka minilo 7 dni ali več ali niste gotovi, kdaj si morate spet injicirati zdravilo RoActemra, se posvetujte z zdravnikom ali farmacevtom.
In SC-I, a total of 625 patients treated with RoActemra 162mg weekly were tested for anti-RoActemra antibodies in the 6 month controlled period.
V šestmesečnem kontroliranem obdobju študije SC-I so pri skupno 625 bolnikih, zdravljenih s 162 mg zdravila RoActemra na teden, preverili prisotnost protiteles proti zdravilu RoActemra.
and total cholesterol value to ≥ 200 mg/dL at any time during study treatment, respectively.
bolnikov zvišano vrednost celokupnega holesterola na ≥ 200 mg/dl.
During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with tocilizumab therapy.
Perforacija v prebavilih Med šestmesečnimi kontroliranimi kliničnimi preskušanji je bil celokupni delež perforacij v prebavilih med uporabo tocilizumaba 0,26 na 100 bolnik-let.
This data does not suggest a relevant risk for cancer initiation and progression under RoActemra treatment.
RoActemra obstajalo pomembno tveganje za nastanek in napredovanje raka.
Patients demonstrate a comparable (to healthy subjects) decrease of absolute neutrophil counts following RoActemra administration (see section 4.8).
Pri bolnikih se je po prejemu zdravila RoActemra absolutno število nevtrofilcev zmanjšalo primerljivo z zdravimi prostovoljci (glejte poglavje 4.8).
In GCA patients, at steady state, the effective t ½ of RoActemra varied between 18.3 and 18.9 days for 162 mg weekly regimen, and between 4.2 and 7.9 days for 162 mg every other weekly regimen.
do 18,9 dneva s shemo 162 mg vsak teden in od 4,2 do 7,9 dneva s shemo 162 mg vsak drugi teden.
PBO
NP
At Week 52, the mean change in HAQ-DI was -0.58 in the tocilizumab 8 mg/kg plus MTX group compared with -0.39 in the placebo + MTX group.
- 0,58 v skupini s tocilizumabom 8 mg/kg in metotreksatom v primerjavi z - 0,39 v skupini s placebom in metotreksatom.
During routine laboratory monitoring in the tocilizumab all exposure population, elevation in ALT or AST ≥ 3xULN occurred in 3.7% and <1% of patients, respectively.
Med rutinskim laboratorijskim spremljanjem se je dvig ALT na ≥ 3-kratno ZMN pojavil pri 3,7 % bolnikov v celotni populaciji, ki je prejemala tocilizumab, dvig AST na ≥ 3-kratno ZMN pa pri < 1 % bolnikov v celotni populaciji, ki je prejemala tocilizumab.
Platelets During routine laboratory monitoring in the 12 week controlled phase, 3% of patients in the placebo group and 1% in the tocilizumab group had a decrease in platelet count to ≤ 100 x 103/µl.
Trombociti Med rutinskim laboratorijskim spremljanjem v 12-tedenski kontrolirani fazi se je število trombocitov zmanjšalo na ≤ 100 x 103/µl pri 3 % bolnikov v skupini, ki je prejemala placebo in pri 1 % v skupini, ki je prejemala tocilizumab.
Following subcutaneous administration, the effective t1/2 of RoActemra in sJIA patients is up to 14 days for both the 162 mg QW and Q2W regimens during a dosing interval at steady state.
Po subkutanem dajanju je efektivni t1/2 zdravila RoActemra pri bolnikih s sJIA med odmernim intervalom v stanju dinamičnega ravnovesja do 14 dni za oba 162-mg režima, vsak teden in vsaka 2 tedna.
Accumulation Cmax Accumulation Cmin Accumulation Cmean or AUCτ *
Akumulacija: Cmax Akumulacija: Cmin Akumulacija: Csrednja ali AUCτ*
Each 10 mL vial contains 200 mg tocilizumab (20 mg/mL).
Ena 10-ml viala vsebuje 200 mg tocilizumaba (20 mg/ml).
In study SC-II, inhibition of structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde modified mean total Sharp score (mTSS).
Okvaro so izrazili kot spremembo od izhodišča po van der Heijdovi modifikaciji povprečne celotne ocene po Sharpu (mTSS,
With routine laboratory monitoring it was seen that approximately 24% of patients receiving RoActemra in clinical trials experienced sustained elevations in total cholesterol ≥ 6.2 mmol/ l, with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/ l. Elevations in lipid parameters responded to treatment with lipid-lowering agents.
Rutinsko laboratorijsko spremljanje je pokazalo, da se je pri približno 24 % bolnikov, ki so v kliničnih preskušanjih dobivali zdravilo RoActemra, pojavilo dolgotrajno zvišanje celotnega holesterola na ≥ 6,2 mmol/l, pri 15 % pa dolgotrajno zvišanje LDL na ≥ 4,1 mmol/l.
Do not touch the injection site again before giving the injection.
Pred injiciranjem se mesta injiciranja ne dotikajte.
The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.7 mL/h in GCA patients,
Linearni očistek so ocenili kot parameter v analizi populacijske farmakokinetike in je bil pri bolnikih z GCA 6,7 ml/h.
Decreases below 0.5 x 109/ L were reported in 0.3% patients receiving RoActemra 8 mg/kg plus DMARDs.
O zmanjšanju pod 0,5 x 109/l so poročali pri 0,3 % bolnikov, ki so dobivali 8 mg/kg zdravila RoActemra v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
After subcutaneous administration, the effective t1/2 of RoActemra in pJIA patients is up to 10 days for patients < 30 kg (162 mg SC Q3W) and up to 7 days for patients >= 30 kg (162 mg SC Q2W) during a dosing interval at steady state.
Po subkutanem dajanju je efektivni t1/2 zdravila RoActemra pri bolnikih s pJIA med odmernim intervalom v stanju dinamičnega ravnovesja do 10 dni za bolnike s telesno maso < 30 kg (162 mg vsak tretji teden) in do 7 dni za bolnike s telesno maso ≥ 30 kg (162 mg vsak drugi teden).
Keep the vial in the outer carton in order to protect from light.
Viale shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
RoActemra, in combination with methotrexate (MTX), is indicated for:
4.1 Terapevtske indikacije Zdravilo RoActemra je v kombinaciji z metotreksatom indicirano za zdravljenje:
As recommended for other biological treatments, all patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Tuberkuloza Kot velja za druga biološka zdravila, je treba vse bolnike pred začetkom zdravljenja z zdravilom
These may affect up to 1 in 10 patients
Ti se lahko pojavijo pri največ 1 od 10 bolnikov.
• diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
• divertikulitis (zvišana telesna temperatura, slabost s siljenjem na bruhanje, driska, zaprtje,
At body weight ≥ 100 kg, the predicted mean (± SD) steadystate AUC, Cmin and Cmax of RoActemra were 50000 ± 16800 μg•h/mL, 24.4 ± 17.5 μg/mL, and 226 ± 50.3 μg/mL, respectively, which are higher than mean exposure values for the patient population
Pri telesni masi ≥ 100 kg je napovedano povprečje (± standardni odklon) ocenjenih parametrov znašalo: AUC v stanju dinamičnega ravnovesja 50.000 ± 16.800 h•μg/ml, najmanjša koncentracija (Cmin) 24,4 ± 17,5 µg/ml in največja koncentracija (Cmax) 226 ± 50,3 μg/ml.
Safely dispose of the pre-filled pen in a sharps container and get a new one.
V tem primeru napolnjeni injekcijski peresnik varno odstranite v zabojnik za ostre predmete in si vzemite novega.
In patients treated with RoActemra 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.
V vseh študijah so med zdravljenjem z 8 mg/kg zdravila RoActemra 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.
Four (2.5%) patients in the RoActemra arm and two (1.2%) patients in the adalimumab arm experienced CTC grade 3 or 4 neutrophil count decreases.
(2,5 %) iz skupine, ki je prejemala zdravilo RoActemra in dveh bolnikih (1,2 %) iz skupine, ki je prejemala adalimumab, se je pojavilo zmanjšanje števila nevtrofilcev stopnje 3 ali 4 po CTC.
Decreases in neutrophil and platelet counts have occurred following treatment with tocilizumab 8 mg/kg in combination with MTX (see section 4.8).
Po zdravljenju z 8 mg/kg tocilizumaba v kombinaciji z metotreksatom se je zmanjšalo število nevtrofilcev in trombocitov (glejte poglavje 4.8).
NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/mL concentrate for solution for infusion Tocilizumab
Navodilo za uporabo RoActemra 20 mg/ml koncentrat za raztopino za infundiranje tocilizumab
Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
This medicinal product contains 1.17 mmol (or 26.55 mg) sodium per maximum dose of 1200 mg. To be taken into consideration by patients on a controlled sodium diet. Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium free'.
Odmerki tega zdravila, manjši od 1.025 mg, vsebujejo manj kot 1 mmol natrija (23 mg), kar v bistvu pomeni "brez natrija".
• Do not take the next dose until you have informed your doctor AND your doctor has told you to take the next dose if you have experienced any allergic reaction symptoms after RoActemra administration.
ne uporabite naslednjega odmerka, dokler niste o tem obvestili svojega zdravnika IN vam je ta svetoval, da si lahko daste naslednji odmerek zdravila.
RoActemra can be used alone following discontinuation of glucocorticoids.
Po ukinitvi glukokortikoida se zdravilo RoActemra lahko uporablja samostojno.
In RA and GCA patients, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Pri bolnikih z revmatoidnim artritisom in GCA je treba vrednosti ALT in AST prvih 6 mesecev zdravljenja kontrolirati na 4 do 8 tednov, pozneje pa na 12 tednov.
Study VI (WA19924), a 24 week double-blinded study that compared tocilizumab monotherapy with adalimumab monotherapy, evaluated 326 patients with RA who were intolerant of MTX or where continued treatment with MTX was considered inappropriate (including MTX inadequate responders).
V 24-tedenski dvojno slepi študiji VI (WA19924) so pri 326 bolnikih z revmatoidnim artritisom, ki niso prenašali metotreksata ali za katere so smatrali, da nadaljevanje zdravljenja z metotreksatom ni primerno (vključno s tistimi, ki se niso zadostno odzvali na zdravljenje z metotreksatom) primerjali zdravljenje s tocilizumabom v monoterapiji z zdravljenjem z adalimumabom v monoterapiji.
RoActemra is supplied as a 0.9 mL pre-filled syringe containing 162 mg tocilizumab solution for injection.
Zdravilo RoActemra je na voljo v napolnjeni injekcijski brizgi, ki vsebuje 162 mg tocilizumaba v 0,9 ml raztopine za injiciranje.
Unadjusted difference in proportions (99.5% CI)
(99,5-% IZ)
Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi saharoza polisorbat 80 natrijev hidrogenfosfat dodekahidrat natrijev dihidrogenfosfat dihidrat voda za injekcije
In patients not previously treated with RoActemra, initiation is not recommended in patients with an absolute neutrophil count (ANC) below 2 x 109/l.
Pri bolnikih, ki predhodno niso bili zdravljeni z zdravilom RoActemra, zdravljenja ni priporočljivo uvesti pri bolnikih z absolutnim številom nevtrofilcev (ANC), ki je nižje od 2 x 109/l.
Study I evaluated 673 patients who had not been treated with MTX within six months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response.
Študija I je ocenila 673 bolnikov, ki 6 mesecev pred randomizacijo niso dobivali metotreksata,
The pharmacokinetic parameters of RoActemra do not change with time.
Farmakokinetični parametri zdravila RoActemra se s časom ne spreminjajo.
Decreases in neutrophil and platelet counts have occurred following treatment with RoActemra 8 mg/kg in combination with MTX (see section 4.8).
Po zdravljenju z 8 mg/kg zdravila RoActemra v kombinaciji z metotreksatom se je zmanjšalo število nevtrofilcev in trombocitov (glejte poglavje 4.8).
In general, side effects in pJIA patients were of a similar type to those in adults with RA.
V splošnem so neželeni učinki, opaženi pri bolnikih s pJIA, podobni tistim pri bolnikih z revmatoidnim artritisom.
If following insertion of the needle you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.
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.
RA and CRS Patients (≥ 30 kg)
Bolniki z revmatoidnim artritisom in CRS (≥ 30 kg)
The safety observed in the tocilizumab arm was consistent with the known safety profile of tocilizumab and no new or unexpected adverse drug reactions were observed (see Table 1).
Varnost, ki so jo opazili v skupini s tocilizumabom, je bila v skladu z znanim varnostnim profilom tocilizumaba, novih ali nepričakovanih neželenih učinkov niso opazili
It is recommended that all patients particularly 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 starejši, cepijo v skladu z veljavnimi smernicami za cepljenje pred začetkom zdravljenja z zdravilom RoActemra.
Each vial contains 80 mg of tocilizumab* in 4 mL (20 mg/mL).
Ena viala vsebuje 80 mg tocilizumaba* v 4 ml (20 mg/ml).
sJIA,pJIA and CRS Patients < 30 kg
Bolniki s sJIA, pJIA in CRS < 30 kg
162 mg Q2W below 30 kg
162 mg vsaka 2 tedna pod 30 kg
Keep the vial in the outer carton in order to protect from light
Viale shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
Chugai Pharma France Tél: +33 (0) 1 56 37 05 20
Tél: +33 (0) 1 56 37 05 20
Doses of 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable DMARDs.
Odmerke 8 mg/kg tocilizumaba ali placebo so dobivali na štiri tedne v kombinaciji s stabilnimi odmerki imunomodulirajočih antirevmatičnih zdravil.
In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19, and CYP3A4 enzyme expression.
CYP1A2, CYP2C9, CYP2C19 in CYP3A4.
In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the RoActemra 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 zdravilo RoActemra, 3,6 na 100 bolnik-let izpostavljenosti, v skupini, ki je dobivala metotreksat, pa 1,5 na 100 bolnik-let izpostavljenosti.
As there are many co-morbid conditions that may effect laboratory values in sJIA or pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Pri bolnikih s sJIA ali pJIA lahko veliko sočasnih bolezni vpliva na laboratorijske vrednosti, zato moramo pri vsakem bolniku posebej presoditi, ali je zdravljenje s tocilizumabom treba prekiniti.
The pharmacokinetic parameters of RoActemra did not change with time.
Farmakokinetični parametri zdravila RoActemra se s časom niso spreminjali.
In general, the ADRs in pJIA and sJIA patients were similar in type to those seen in RA patients, see section 4.8.
V splošnem so neželeni učinki pri bolnikih s pJIA in sJIA podobnega tipa kot tisti, ki so jih opazili pri bolnikih z revmatoidnim artritisom (glejte poglavje 4.8).
The effects of RoActemra on C-reactive protein (CRP), neutrophils and signs and symptoms of infection should be considered when evaluating a patient for a potential infection.
Pri ocenjevanju možne okužbe pri bolniku je treba upoštevati učinke zdravila RoActemra na C-reaktivni protein (CRP), nevtrofilce ter znake in simptome okužbe.
RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.
Zdravilo RoActemra v kombinaciji z metotreksatom zmanjša hitrost napredovanja okvar sklepov, ki jih spremljamo z rentgenskim slikanjem, in izboljša funkcijsko zmogljivost.
DAS28 Remission
Podobno je dosegel remisijo glede na DAS28
The recommended posology in patients above 2 years of age is subcutaneous 162 mg once every 2 weeks in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 3 weeks in patients weighing less than 30 kg.
Bolniki s pJIA Priporočeno odmerjanje za bolnike, starejše od 2 let, je 162 mg subkutano enkrat na 2 tedna pri bolnikih, ki tehtajo 30 kg ali več, in 162 mg subkutano enkrat na 3 tedne pri bolnikih, ki tehtajo manj kot 30 kg.
4 vials of 4 mL
4 viale s 4 ml
Patients < 30 kg were randomized 1:1 to receive either tocilizumab 8 mg/kg or 10 mg/kg IV every 4 weeks for 4 doses.
Bolnike s telesno maso < 30 kg so randomizirali v razmerju 1:1, dobili so 4 odmerke tocilizumaba po 8 mg/kg ali
• Throw away the needle-cap in the puncture resistant container or sharps container.
• Odvrzite pokrovček injekcijske igle v zabojnik za ostre predmete, odporen proti vbodom.
*τ = 1 week or 2 weeks for the two SC regimens
*τ = 1 teden ali 2 tedna za dva subkutana režima
No dose adjustment is required in patients with mild renal impairment.
Bolnikom z blago okvaro ledvic odmerka ni treba prilagoditi.
N/A= Not applicable HR = Hazard Ratio CI = Confidence Interval
IZ = interval zaupanja
The safety and efficacy of RoActemra subcutaneous formulation in children with conditions other than sJIA or pJIA have not been established.
Varnost in učinkovitost zdravila RoActemra v subkutani obliki pri otrocih sta bili dokazani le za sJIA
Each vial contains 200 mg of tocilizumab* in 10 mL (20 mg/mL).
Ena viala vsebuje 200 mg tocilizumaba* v 10 ml (20 mg/ml).
Each 4 mL vial contains 80 mg tocilizumab (20 mg/mL).
Ena 4-ml viala vsebuje 80 mg tocilizumaba (20 mg/ml).
Statistically significant improvements in haemoglobin levels were observed with tocilizumab compared with DMARDs (p< 0.0001) at week 24.
Po 24 tednih so pri tocilizumabu v primerjavi z imunomodulirajočimi antirevmatičnimi zdravili ugotovili statistično značilno izboljšanje koncentracije hemoglobina (p < 0,0001).
The primary endpoint was the proportion of patients with at least 30% improvement in the JIA ACR core set (JIA ACR30 response) at week 12 and absence of fever (no temperature recording ≥ 37.5°C in the preceding 7 days).
Primarni cilj je bil delež bolnikov z najmanj 30-% izboljšanjem v osnovnem naboru JIA ACR (odziv
For the 162 every other week dose, the predicted mean (±SD) steady-state AUC2week, Cmin, and Cmax of RoActemra were 3430 ± 2660 µg•h/mL, 5.7 ± 6.8 µg/mL, and 13.2 ± 8.8 µg/mL, respectively.
Za odmerek 162 mg vsak drugi teden je bila pričakovana povprečna (± SD) površina pod krivuljo 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.
Abdominal pain, Mouth ulceration, Gastritis
razjeda v ustih, gastritis vnetje ustne sluznice,
Patients were required to be >18 years of age with active RA diagnosed according to ACR criteria who had at least 8 tender and 6 swollen joints at baseline.
Bolniki so morali biti starejši od 18 let in imeti aktiven revmatoidni artritis, diagnosticiran po merilih ACR, izhodiščno so imeli vsaj osem bolečih in šest oteklih sklepov.
ANC 0.5 to 1 Interrupt RoActemra dosing When ANC increases > 1 x 109/ l resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
Ko se absolutno število nevtrofilcev poveča > 1 x 109/l, znova uvedite zdravilo RoActemra v odmerku 4 mg/kg in povečajte na 8 mg/kg, kot je klinično ustrezno.
Platelets During routine laboratory monitoring in the RoActemra 6 month clinical trial SC-I, none of the patients on the SC weekly dose had a decrease in platelet count to ≤50 × 103 / μL.
V okviru rutinskega laboratorijskega spremljanja v šestmesečnem kliničnem preskušanju SC-I z zdravilom RoActemra se ni število trombocitov zmanjšalo ≤ 50 x 103/µl pri nobenem od bolnikov, ki so prejemali subkutani tedenski odmerek.
RoActemra is supplied as a 0.9 mL pre-filled pen containing 162 mg tocilizumab solution for injection.
Zdravilo RoActemra je na voljo v napolnjenem injekcijskem peresniku, ki vsebuje 162 mg tocilizumaba v 0,9 ml raztopine za injiciranje.