natgillin/translations-raw huggingface dataset:
Two subcutaneous doses of RoActemra (162 mg every week and 162 mg every other week) were compared to two different placebo control groups randomised 2:1:1:1.
Dva subkutana odmerka zdravila RoActemra (162 mg vsak teden in 162 mg vsak drugi teden) so primerjali z dvema različnima kontrolnima skupinama s placebom; bolniki so bili randomizirani v razmerju 2:1:1:1.
Tell your doctor if you are taking any other medicines (or your child is, if they are the patient), or have recently taken any.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo (ali vaš otrok, če je on bolnik).
• If you have cancer, tell your doctor.
• Če imate raka, morate to povedati svojemu zdravniku.
Patients randomized to tocilizumab had fewer ACR30 flares and higher overall ACR responses than patients receiving placebo regardless of a history of prior biologic use.
Pri bolnikih, randomiziranih v skupino s tocilizumabom, je bilo manj poslabšanj ACR 30, celokupni odzivi ACR pa so bili višji kot pri bolnikih, ki so prejemali placebo, ne glede na predhodno uporabo bioloških zdravil.
• Prevention of medical errors and injection/infusion reactions
• preprečevanje napak pri uporabi zdravila in reakcij, povezanih z injiciranjem/infundiranjem,
Seventeen (24%) tocilizumab treated patients versus 1 (3%) placebo patient were able to reduce their dose of corticosteroid by at least 20% without experiencing a subsequent JIA ACR30 flare or occurrence of systemic symptoms to week 12 (p=0.028).
Sedemnajstim (24 %) bolnikom, ki so se zdravili s tocilizumabom, v primerjavi z 1 (3 %) bolnikom, ki je prejemal placebo, so lahko zmanjšali odmerek kortikosteroida za najmanj 20 % brez posledičnega poslabšanja merila JIA ACR 30 ali pojava sistemskih simptomov do 12. tedna (p = 0,028).
• Monitoring of the patient for injection/infusion reactions
• spremljanje bolnika zaradi reakcij, povezanih z injiciranjem/infundiranjem,
• The active substance is tocilizumab.
• Učinkovina je tocilizumab.
If the pre-filled pen does not reach room temperature, this could cause your injection to feel uncomfortable and it could take longer to inject.
Če napolnjeni injekcijski peresnik ne doseže sobne temperature, lahko to povzroči, da injiciranje občutite kot neprijetno in le-to morda traja dlje.
A change in dose should only be based on a consistent change in the patient's body weight over time.
Sprememba odmerka mora temeljiti na spremembi bolnikove telesne mase v določenem obdobju.
However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.
Vendar je mogoče zdravilo RoActemra uporabljati tudi samostojno, če vaš zdravnik presodi, da metotreksat za vas ni primeren.
• Clean the chosen injection site area using the alcohol pad (See Fig. C), to reduce the risk of infection.
• Izbrano mesto injiciranja očistite z alkoholnim zložencem (glejte sliko C), da zmanjšate tveganje za okužbe.
Yes (N = 27)
da (n = 27)
Table 7: Efficacy Results for Study VI (WA19924) ADA + Placebo (IV) N = 162
Rezultati učinkovitosti za študijo VI (WA19924) ADA + placebo
The needle shield will then move out and lock into place covering the needle (See Figure L).
Zaščita za iglo se bo nato pomaknila in zaprla iglo (glejte sliko L).
Patients (which includes younger children with sJIA or pJIA who may be less able to communicate their symptoms) and parents/guardians of sJIA or pJIA patients, should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Bolnikom (tudi mlajšim otrokom s sJIA ali pJIA, ki še ne znajo dobro sporočati svojih simptomov) in staršem/skrbnikom bolnikov s sJIA ali pJIA morate naročiti, naj se nemudoma posvetujejo z zdravnikom, če se pojavi kakršen koli simptom okužbe, da bodo deležni hitre ocene stanja in ustreznega zdravljenja.
• Take the box containing the syringe out of the refrigerator and open the box.
• Vzemite škatlo z napolnjeno injekcijsko brizgo iz hladilnika in jo odprite.
Forty eight percent (48.1%, 39/81) of the patients treated with placebo flared compared with 25.6% (21/82) of tocilizumab treated patients.
48,1 % (39/81) bolnikih, ki so se zdravili s placebom, v primerjavi s 25,6 % (21/82) bolnikov, ki so se zdravili s tocilizumabom.
If you have any questions or concerns about your RoACTEMRA pre-filled pen, talk to your healthcare provider familiar with RoACTEMRA.
Če imate kakršna koli vprašanja ali pomisleke glede napolnjenega injekcijskega peresnika z zdravilom RoACTEMRA, se obrnite na zdravstvenega delavca, ki pozna zdravilo RoACTEMRA.
For storage conditions of the diluted medicinal product see section 6.3.
Za pogoje shranjevanja razredčenega zdravila glejte poglavje 6.3.
Other medicines and RoActemra
Druga zdravila in zdravilo RoActemra
• Dose calculation (RA, sJIA and pJIA patients), preparation of infusion and infusion rate
• izračun odmerka (bolniki z revmatoidnim artritisom, sJIA in pJIA), priprava infuzije in hitrost infundiranja,
For SF-36, the mean change from baseline at week 24 in the mental component score was 6.22 for the subcutaneous arm and 6.54 for the intravenous arm, and for the physical component score was also similar with 9.49 for the subcutaneous arm and 9.65 for the intravenous arm.
Po SF-36 je bila povprečna sprememba od izhodiščne vrednosti v 24. tednu za mentalno komponento ocene 6,22 v subkutani skupini in 6,54 v intravenski skupini, podobna je bila tudi za fizično komponento ocene: 9,49 v subkutani skupini in 9,65 v intravenski skupini.
Such reactions may be more severe, and potentially fatal in patients who have experienced hypersensitivity reactions during previous infusions even if they have received premedication with steroids and antihistamines.
Tovrstne reakcije so lahko hujše in morebiti tudi smrtne pri bolnikih, pri katerih so se preobčutljivostne reakcije pojavile med predhodnimi infundiranji, tudi če so le-ti prejeli premedikacijo s steroidi in antihistaminiki.
• Remove the syringe from the box and visually examine the syringe, as well as the medicine in the syringe.
• Napolnjeno injekcijsko brizgo vzemite iz škatle in jo vizualno preglejte, preglejte tudi zdravilo skozi okence.
DAS28 ≤ 3.2, n (%) ACR20 response, n (%) ACR50 response, n (%) ACR70 response, n (%)
DAS28 ≤ 3,2, n (%) odziv ACR20, n (%) odziv ACR50, n (%) odziv ACR70, n (%)
The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber with a fluororesin coating).
Injekcijska brizga je zaprta s trdnim varovalom za injekcijsko iglo (tesnilo iz elastomerja s polipropilenskim ovojem) in zamaškom bata (butilna guma, prevlečena s fluorirano smolo).
In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19 and CYP3A4 enzyme expression.
Študije in vitro na kulturah človeških jetrnih celic so pokazale, da IL-6 zmanjša ekspresijo encimov CYP1A2, CYP2C9, CYP2C19 in CYP3A4.
Since RoActemra is given by a doctor or nurse, it is unlikely that you will miss a dose.
Ker vam bo zdravilo RoActemra dal zdravnik ali medicinska sestra, ni verjetno, da bi izpustili odmerek.
All patients received background glucocorticoid (prednisone) therapy.
Vsi bolniki so prejemali osnovno zdravljenje z glukokortikoidom (prednizon).
OTHER SPECIAL WARNING(S), IF NECESSARY Allow the syringe to sit at room temperature outside the box for 25 to 30 minutes before use
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vzemite brizgo iz škatle in jo pustite na sobni temperaturi 25 do 30 minut pred uporabo
The bioavailability for the SC formulation was 0.8.
Biološka uporabnost subkutane oblike je bila 0,8.
The rate of infections in the tocilizumab all exposure population was 163.7 per 100 patient years.
Delež okužb v vsej populaciji, ki je prejemala tocilizumab, je bil 163,7 na 100 bolnik-let.
The safety of RoActemra has been studied in 5 Phase III, double-blind controlled trials and their extension periods.
Varnost zdravila RoActemra so preučevali v petih dvojno slepih kontroliranih preskušanjih faze III ter v njihovih podaljšanih fazah.
Macrophage activation syndrome (MAS) is a serious life-threatening disorder that may develop in sJIA patients.
Sindrom aktivacije makrofagov je resna, življenje ogrožajoča bolezen, ki se lahko razvije pri bolnikih s sJIA.
It is important to choose the correct angle to ensure the medication is delivered under the skin (into fatty tissue), otherwise the injection could be painful and the medication may not work.
Pomembno je, da izberete pravilen kot, saj lahko le tako zagotovite prehod zdravila pod kožo (v maščobno tkivo), sicer je injekcija lahko boleča in morda zdravilo ne bi delovalo.
• It is important to use the correct angle to make sure the medicine is delivered under the skin (into fatty tissue), or the injection could be painful and the medicine may not work.
• Pomembno je, da uporabite pravilen kot, da zagotovite injiciranje zdravila pod kožo (v maščobno tkivo), sicer je injiciranje lahko boleče in zdravilo morda ne bo delovalo.
• abdominal pain/tenderness and/or change in bowel function
• bolečina v trebuhu/občutljivost in/ali spremembe v delovanju prebavil.
Study II, a two year study with planned analyses at week 24, week 52 and week 104, evaluated 1196 patients who had an inadequate clinical response to MTX.
Študija II je bila dveletna študija z načrtovano analizo v 24., 52. ter 104. tednu, ocenila je 1196 bolnikov z nezadostnim kliničnim odzivom na metotreksat.
• simvastatin or atorvastatin, used to reduce cholesterol levels
• simvastatin ali atorvastatin, ki se uporabljata za zniževanje koncentracije holesterola,
The safety profile comes from 4158 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in RA studies (n=4009), while the remaining experience comes from GCA (n=149) studies.
Podatki o varnostnih značilnosti izvirajo od 4158 bolnikov, izpostavljenih zdravilu RoActemra v kliničnih preskušanjih; večina teh bolnikov je sodelovala v študijah pri revmatoidnem artritisu (n = 4009), preostale izkušnje pa izvirajo iz študij pri GCA (n = 149).
• Do not leave the pre-filled pen to warm up in direct sunlight.
• Napolnjenega injekcijskega peresnika med ogrevanjem ne izpostavljajte neposredni sončni svetlobi.
Health related and quality of life outcomes
Izidi, povezani s splošnim zdravstvenim stanjem in kakovostjo življenja
These injection site reactions (including erythema, pruritus, pain and haematoma) were mild to moderate in severity.
Reakcije na mestu injiciranja (vključno z eritemom, pruritusom, bolečino in hematomom) so bile blage do zmerne.
If an adult with RA or GCA or a child or adolescent with sJIA misses or forgets a dose
Če odrasel z revmatoidnim artritisom ali GCA oziroma otrok ali mladostnik s sJIA izpusti ali pozabi odmerek
The majority was resolved without any treatment and none necessitated drug discontinuation.
Večina je izzvenela brez zdravljenja in nobena ni zahtevala ukinitve zdravljenja.
Tocilizumab administered to cynomolgus monkeys during early gestation, was observed to have no direct or indirect harmful effect on pregnancy or embryonal-foetal development.
Uporaba tocilizumaba pri opicah cynomolgus med zgodnjo gestacijo ni niti neposredno niti posredno škodljivo vplivala na nosečnost ali embrio-fetalni razvoj.
Prepare the Injection Site
Pripravite mesto injiciranja
The efficacy of RoActemra for the treatment of CRS was assessed in a retrospective analysis of data from clinical trials of CAR T-cell therapies (tisagenlecleucel and axicabtagene ciloleucel) for hematological malignancies.
Učinkovitost zdravila RoActemra pri zdravljenju CRS so ocenili v retrospektivni analizi podatkov iz kliničnih preskušanj zdravljenj s T-celicami s himernim antigenskim receptorjem (tisagenlecleucel in aksicabtagen ciloleucel) pri hematoloških malignostih.
• Place the pre-filled pen on a clean, flat surface and let the pre-filled pen warm up for 45 minutes to allow it to reach room temperature.
• Napolnjeni injekcijski peresnik postavite na čisto, ravno površino in ga pustite 45 minut, da se ogreje na sobno temperaturo.
A higher frequency of injection site reactions was observed in the subcutaneous arms compared with placebo subcutaneous injections in the intravenous arms.
Večjo pogostnost reakcij na mestu injiciranja so opazili v skupinah s subkutanim dajanjem v primerjavi s subkutanimi injekcijami placeba v skupinah z intravenskim dajanjem.
• abnormal liver function tests (increased transaminases)
• nenormalni testi jetrnega delovanja (zvišanje transaminaz),
In this case you will get training on how to inject RoActemra yourself.
V tem primeru vas bodo poučili, kako si lahko injicirate zdravilo RoActemra sami.
The study consisted of a 52-week blinded period (Part 1), followed by a 104-week open-label extension (Part 2).
Študija je obsegala 52-tedensko slepo obdobje (1. del), ki mu je sledilo 104-tedensko podaljšanje z odprtim načrtom zdravljenja (2. del).
The comparator group was weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an eight week period).
Primerjalna skupina so bili bolniki, ki so tedensko dobivali metotreksat (odmerek so jim prilagajali od 7,5 mg do največ 20 mg na teden v obdobju osmih tednov).
The t1/2 of tocilizumab was concentration-dependent.
Razpolovni čas (t1/2) tocilizumaba je odvisen od koncentracije.
No (N = 58)
ne (n = 58)
If the plunger is not fully depressed the needle shield will not extend to cover the needle when it is removed.
Če bat ni popolnoma potisnjen, se varovalo injekcijske igle ne bo podaljšalo, da bo iglo prekrilo, ko jo boste odstranili.
• Do not warm up the syringe in any other way.
• Napolnjene injekcijske brizge ne segrevajte kakor koli drugače.
• RoActemra is used to treat adults and children aged 2 years and over with severe or lifethreatening cytokine release syndrome (CRS), a side-effect in patients treated with chimeric antigen receptor (CAR) T-cell therapies used to treat certain types of cancer.
• Zdravilo RoActemra se uporablja za zdravljenje odraslih in otrok, starih 2 leti in več, s hudim ali življenje ogrožajočim sindromom sproščanja citokinov, neželenim učinkom pri bolnikih, zdravljenih s T-celicami s himernim antigenskim receptorjem (Chimeric Antigen Receptor, CAR) - terapije, ki se uporablja za zdravljenje določenih vrst raka.
No serious adverse reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg, although dose limiting neutropenia was observed.
Pri zdravih prostovoljcih, ki so dobili posamične odmerke do 28 mg/kg, ni bilo resnih neželenih učinkov, opazili pa so nevtropenijo, ki je omejila odmerek.
The usual dose of RoActemra is 8 mg for every kg of body weight if you weigh 30 kg or more.
Običajni odmerek zdravila RoActemra je 8 mg na kg telesne mase, če tehtate 30 kg ali več.
The safety profile comes from 4510 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in adult RA studies (n=4009), while the remaining experience comes from GCA (n=149), pJIA (n=240) and sJIA (n=112) studies.
Povzetek varnostnih značilnosti Podatki o varnostnih značilnosti izvirajo od 4510 bolnikov, izpostavljenih zdravilu RoActemra v kliničnih preskušanjih; večina teh bolnikov je sodelovala v študijah pri revmatoidnem artritisu pri odraslih (n = 4009), preostale izkušnje pa izvirajo iz študij pri GCA (n = 149), pJIA (n = 240) in sJIA (n = 112).
Mild renal impairment (estimated creatinine clearance based on Cockcroft-Gault formula) did not impact the pharmacokinetics of RoActemra.
Blaga okvara ledvic (ocenjeni očistek kreatinina po Cockcroft-Gaultovi formuli) ni vplivala na farmakokinetiko zdravila RoActemra.
Patients who completed Part I of the study and achieved at least a JIA ACR30 response at week 16 compared to baseline were eligible to enter the blinded withdrawal period (Part II) of the study.
Bolniki, ki so zaključili I. del študije in so po 16. tednih dosegli najmanj odziv JIA ACR 30 glede na izhodiščno vrednost, so se lahko vključili v slepo fazo odtegnitve (II.
• warfarin or phenprocoumon, used as a blood thinning agents
• varfarin ali fenprokumon, ki se uporabljata za redčenje krvi,
The most commonly reported ADRs (occurring in ≥ 5% of patients treated with tocilizumab monotherapy or in combination with DMARDs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Najpogosteje opisani neželeni učinki (ki so se pojavili pri ≥ 5 % bolnikov, zdravljenih s tocilizumabom v monoterapiji ali v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili) so bili okužbe zgornjih dihal, nazofaringitis, glavobol, hipertenzija in zvišanje ALT.
RoActemra must not be given to children weighing less than 10 kg.
Zdravila RoActemra ne smete dajati otrokom, ki tehtajo manj kot 10 kg.
• Recommendations for dose interruptions in sJIA and pJIA patients
• priporočila za prekinitev odmerjanja pri bolnikih s sJIA in pJIA.
The adjusted mean change in the pain VAS after 12 weeks of tocilizumab treatment was a reduction of 41 points on a scale of 0 - 100 compared to a reduction of 1 for placebo patients (p<0.0001).
Prilagojena povprečna sprememba v bolečini VAS po 12 tednih zdravljenja s tocilizumabom je bila zmanjšanje za 41 točk na skali 0-100 v primerjavi z zmanjšanjem za 1 za bolnike, ki so prejemali placebo (p < 0,0001).
• theophylline, used to treat asthma
• teofilin, ki se uporablja za zdravljenje astme,
2 See section 4.4
2 Glejte poglavje 4.4.
Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.
Če ste noseči, če bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
They are usually effective, but can have side effects if used at high doses for a long time.
Običajno so ta zdravila učinkovita, vendar pa lahko dolgotrajna uporaba velikih odmerkov vodi do pojava neželenih učinkov.
Do not attempt to use the upper arm area by yourself (See Figure D).
Območja nadlahti ne uporabljajte, če si zdravilo dajete sami (glejte sliko D).
Week 24 ACR20, n (%) ACR50, n (%) 165 (56.9)** 139 (47.6) ACR70, n (%) 112 (38.6)** Week 52 ACR20, n (%) ACR50, n (%) 162 (55.9)** 144 (49.3) ACR70, n (%) 125 (43.1)** 105 (36.0) HAQ-DI (adjusted mean change from baseline) Week 52
ACR, n (%) 142 (49,0)*** 115 (39,4) 24. teden ACR20, n (%) ACR50, n (%) 165 (56,9)** 139 (47,6) ACR70, n (%) 112 (38,6)** 88 (30,1) 52. teden ACR20, n (%) ACR50, n (%) 162 (55,9)** 144 (49,3) ACR70, n (%) 125 (43,1)** 105 (36,0)
Patients with latent TB should be treated with standard anti-mycobacterial therapy before initiating RoActemra.
Bolniki z latentno tuberkulozo morajo pred uvedbo zdravila RoActemra dobiti standardno protimikrobno terapijo.
• Patient alert card - to address the risk of getting infections which can become serious if not treated.
- da opozori na tveganje za okužbe, ki lahko postanejo resne, če niso zdravljene.
Exploratory Endpoints Week 24: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%) Week 52: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%)
24. teden: ACR/EULAR remisija (Boolean), n (%) ACR/EULAR remisija (Index), n (%) 52. teden: ACR/EULAR remisija (Boolean), n (%) ACR/EULAR remisija (Index), n (%) mTSS - ocena po prirejeni Sharpovi lestvici (mTSS, modified Total Sharp Score)
> 3 x ULN to 5x ULN
> 3- do 5-kratna ZMN
Such reactions may be more severe, and potentially fatal in patients who have experienced hypersensitivity reactions during previous treatment with RoActemra even if they have received premedication with steroids and antihistamines.
Tovrstne reakcije so lahko hujše in morebiti tudi smrtne pri bolnikih, pri katerih so se preobčutljivostne reakcije pojavile med predhodnim zdravljenjem z zdravilom RoActemra, tudi če so le-ti prejeli premedikacijo s steroidi in antihistaminiki.
• After you remove the green cap, the pre-filled pen is ready for use.
• Ko odstranite zelen pokrovček, je napolnjeni injekcijski peresnik pripravljen za uporabo.
• Do not remove the needle-cap on your syringe until Step 5.
• Ne odstranjujte pokrovčka za injekcijsko iglo na napolnjeni injekcijski brizgi do koraka 5.
• Continue to pinch the skin while you keep the pre-filled pen in place.
• Še naprej držite kožno gubo, medtem ko držite napolnjeni injekcijski peresnik na mestu.
Hepatic transaminases increased, Weight increased, Total bilirubin increased*
Preiskave zvišanje jetrnih transaminaz, zvečanje telesne mase, zvišanje celotnega bilirubina*
RoActemra is usually given in combination with another medicine for RA called methotrexate.
Zdravilo RoActemra se po navadi uporablja v kombinaciji z drugim zdravilom za zdravljenje revmatoidnega artritisa, imenovanim metotreksat.
The primary endpoint was the proportion of patients achieving DAS28 remission (DAS28 < 2.6) at week 24.
Primarni cilj je bil delež bolnikov, ki so dosegli remisijo glede na DAS28 (DAS28 < 2,6) v 24. tednu.
RoActemra subcutaneous formulation is not intended for intravenous administration.
Subkutana oblika zdravila RoActemra ni namenjena intravenski aplikaciji.
Patients should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Bolnikom morate naročiti, naj se nemudoma posvetujejo z zdravnikom, če se pojavi kakršen koli simptom okužbe, da bodo deležni hitre ocene stanja in ustreznega zdravljenja.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
čas običajno ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če je bilo razredčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
The efficacy of tocilizumab was assessed in a three-part study WA19977 including an open-label extension in children with active pJIA.
Učinkovitost tocilizumaba pri otrocih z aktivnim pJIA so ocenili v študiji WA19977, sestavljeni iz treh delov, vključno z odprtim, podaljšanim spremljanjem.
Do not use it if the expiration date has passed because it may not be safe to use.
Če je rok uporabnosti potekel, ga ne uporabljajte, ker morda ni varen za uporabo.
• Do not inject into areas that could be bothered by a belt or waistband.
• Ne injicirajte v mesta, kjer bi lahko prišlo do draženja s pasom.
The most common events occurring during infusion were headache, nausea and hypotension and within 24 hours of infusion were dizziness and hypotension.
Najbolj pogosti neželeni učinki med infundiranjem so bili glavobol, navzea in hipotenzija, v 24 urah po infundiranju pa omotica in hipotenzija.
Most of the patients in the population pharmacokinetic analysis had normal renal function or mild renal impairment.
Večina bolnikov v analizi populacijske farmakokinetike je imela normalno delovanje ledvic ali blago okvaro ledvic.
• Do not remove the pre-filled pen cap until you are ready to inject RoACTEMRA.
• Ne odstranjujte pokrovčka napolnjenega injekcijskega peresnika, dokler niste pripravljeni na injiciranje zdravila RoACTEMRA.
In the 12 week double-blind, controlled phase, 75 patients received treatment with tocilizumab (8 mg/kg or 12 mg/kg based upon body weight).
V 12-tedenski, dvojno slepi, kontrolirani fazi je 75 bolnikov prejelo zdravljenje s tocilizumabom (8 mg/kg ali 12 mg/kg telesne mase).
• Do not use the syringe if it appears to be damaged
• Ne uporabljajte napolnjene injekcijske brizge, če se vam zdi poškodovana.
For persistent increases in this range, reduce RoActemra dose frequency to every other week injection or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised.
V primeru dolgotrajnih zvišanj v tem razponu zmanjšajte pogostnost odmerjanja injekcij zdravila RoActemra na enkrat na dva tedna ali prekinite njegovo uporabo, dokler se alanin-aminotransferaza (ALT) ali aspartat-aminotransferaza (AST) ne normalizira.