natgillin/translations-raw huggingface dataset:
During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, one patient (1%, 1/100) in the RoActemra subcutaneous weekly group had a single transient occurence of decrease in platelet count to <100 × 103 / μL without associated bleeding events.
Trombociti Med rednim laboratorijskim spremljanjem v 12-mesečnem kontroliranem kliničnem preskušanju zdravila RoActemra se je pri enem bolniku (1 %, 1/100), ki je prejemal zdravilo RoActemra subkutano vsak teden, pojavilo prehodno zmanjšanje števila trombocitov na < 100 × 103/µl brez spremljajočih krvavitev.
A 52-week, open-label, multi-centre, PK/PD and safety study (WA28118) was conducted in paediatric patients with sJIA, aged 1 to 17 years, to determine the appropriate SC dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Pri pediatričnih bolnikih s sJIA, starih od 1 do 17 let, so izvedli 52-tedensko, odprto, multicentrično študijo farmakokinetike/farmakodinamike in varnosti (WA28118) za določitev ustreznega subkutanega odmerka zdravila RoActemra, ki bi imel primerljiv farmakokinetični/farmakodinamični in varnostni profil v primerjavi z intravenskim režimom.
Hepatic transaminases increased pJIA
Preiskave zvišanje jetrnih transaminaz pJIA
The efficacy of tocilizumab in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Učinkovitost tocilizumaba za ublažitev znakov in simptomov revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih multicentričnih študijah.
Placebo + MTX N=287
MTX n = 287
The total clearance of RoActemra was concentration-dependent and is the sum of the linear and non-linear clearance.
Celotni očistek zdravila RoActemra je odvisen od koncentracije in je vsota linearnega in nelinearnega očistka.
In the open label extension phase, elevation in ALT or AST ≥ 3 x ULN occurred in 12% and 4% of patients, respectively, in the tocilizumab group.
V odprti, podaljšani fazi se je dvig ALT na ≥ 3-kratno ZMN pojavil pri 12 % bolnikov, dvig AST na ≥ 3-kratno ZMN pa pri 4 % bolnikov v skupini, ki je prejemala tocilizumab.
The total clearance of tocilizumab was concentrationdependent and is the sum of the linear and non-linear clearance.
Celotni očistek tocilizumaba je odvisen od koncentracije in je vsota linearnega in nelinearnega očistka.
During routine laboratory monitoring in the 12 week controlled phase, a decrease in neutrophil counts below 1 x 109/l occurred in 7% of patients in the tocilizumab group, and no decreases in the placebo group.
Med rutinskim laboratorijskim spremljanjem v 12-tedenski, kontrolirani fazi se je zmanjšanje števila nevtrofilcev pod 1 x 109/l pojavilo pri 7 % bolnikov v skupini, ki je prejemala tocilizumab, v skupini, ki je prejemala placebo, pa ni bilo zmanjšanja.
Fatal anaphylaxis has been reported after marketing authorisation during treatment with intravenous RoActemra (see section 4.4).
V obdobju po prihodu zdravila na trg so poročali o primeru smrtne anafilaksije med zdravljenjem z intravensko obliko zdravila RoActemra (glejte poglavje 4.4).
The median doses for escape patients in the RoActemra weekly and every other weekly groups were 3129.75 mg and 3847 mg, respectively.
RoActemra vsak teden 3129,75 mg in v skupini z zdravilom RoActemra vsak drugi teden 3847 mg.
Systemic Effects In the tocilizumab treated patients, 85% who had fever due to sJIA at baseline were free of fever (no temperature recording ≥ 37.5°C in the preceding 14 days) at week 12 versus 21% of placebo patients
Od bolnikov, ki so imeli pred začetkom zdravljenja povišano telesno temperaturo zaradi sJIA, jih 85 % v skupini, ki je prejemala tocilizumab, po 12 tednih ni imelo povišane telesne temperature (brez povišane telesne temperature ≥ 37,5 °C v preteklih 14 dneh), v primerjavi z 21 % bolnikov, ki so prejemali placebo (p < 0,0001).
• high blood fat (cholesterol) levels
• zvišana raven maščob v krvi (holesterola),
Side effects could occur at least up to 3 months after your last dose of RoActemra.
Neželeni učinki se lahko pojavijo vsaj še 3 mesece po zadnjem odmerku zdravila
In study I, superiority of tocilizumab 8 mg/kg was demonstrated against the active comparator MTX.
študiji I so dokazali superiornost 8 mg/kg tocilizumaba nad primerjalno učinkovino metotreksatom.
No dose adjustment is required in patients with mild or moderate renal impairment.
Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi.
RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Zdravilo RoActemra je indicirano za zdravljenje aktivnega sistemskega juvenilnega idiopatskega artritisa (sJIA) pri bolnikih, starih 2 leti ali več, ki se niso zadostno odzvali na predhodno zdravljenje z nesteroidnimi protivnetnimi zdravili ali sistemskimi kortikosteroidi.
Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted.
Razredčiti smete le raztopine, ki so bistre do opalescentne, brezbarvne do bledorumene in ne vsebujejo vidnih delcev.
Restart with weekly or every other week injection, as clinically appropriate.
Ponovno začnite z dajanjem injekcij zdravila RoActemra enkrat na teden ali enkrat na dva tedna, kot je klinično ustrezno.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
In the SC Study (WA28118), a total of 41.2% (21/51) sJIA patients experienced ISRs to RoActemra SC.
V študiji s subkutano obliko (WA28118) je imelo reakcije na mestu injiciranja pri subkutanem injiciranju zdravila RoActemra skupno 41,2 % (21/51) bolnikov s sJIA.
The most commonly reported Adverse Drug Reactions (ADRs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Najpogosteje opisani neželeni učinki so bili okužbe zgornjih dihal, nazofaringitis, glavobol, hipertenzija in zvišanje ALT.
During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg RoActemra + DMARD.
V obdobju dvojno slepe kontrole je incidenca zvišanja indirektnega bilirubina (parameter rutinskih laboratorijskih preiskav) nad ZMN pri bolnikih, zdravljenih z 8 mg/kg zdravila RoActemra in DMARD, znašala 6,2 %.
An elevation in ALT or AST ≥3 x ULN occurred in 9.6% and 3.8% patients treated with RoActemra SC,
Zvišanje vrednosti ALT ≥ 3 x ZMN se je pojavilo pri 9,6 % in zvišanje vrednosti AST ≥ 3 x ZMN pri 3,8 % bolnikov, zdravljenih s subkutano obliko zdravila RoActemra.
Other Secondary Endpoints Time to first GCA flare¹ (Tocilizumab groups vs Placebo+26)
Drugi sekundarni opazovani dogodki Čas do prvega poslabšanja GCA¹ (skupini s tocilizumabom v primerjavi s placebom + 26)
All patients received background non-biologic DMARD(s).
Vsi bolniki so prejeli osnovno zdravljenje z nebiološkimi imunomodulirajočimi antirevmatičnimi zdravili.
0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle.
0,9 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) z vstavljeno iglo.
If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid any injury with the needle.
Če igla ni pokrita, napolnjeni injekcijski peresnik previdno odložite v zabojnik za ostre predmete, da se izognete morebitni poškodbi z iglo.
The Marketing Authorisation Holder (MAH) shall provide an educational pack covering the therapeutic indications RA, sJIA, pJIA and GCA, targeting all physicians who are expected to prescribe/use RoActemra containing the following:
Imetnik dovoljenja za promet mora zagotoviti, da bo vsem zdravnikom, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo RoActemra, razdelil izobraževalno gradivo za indikacije revmatoidni artritis, sJIA, pJIA in GCA, ki vključuje:
• In RA, GCA, pJIA and sJIA, 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 RA, GCA, pJIA in sJIA je treba vrednosti ALT in AST prvih 6 mesecev zdravljenja spremljati na 4 do 8 tednov, pozneje pa na 12 tednov.
In Studies II, III and V, RoActemra was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
V študijah II, III in V so zdravilo RoActemra dajali intravensko na štiri tedne v kombinaciji z metotreksatom; primerjava je bila kombinacija placeba in metotreksata.
• If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
• Če je od vašega izpuščenega tedenskega odmerka minilo manj kot 7 dni, ga vzemite na dan naslednjega načrtovanega odmerka.
RoActemra versus adalimumab in monotherapy
Zdravilo RoActemra v primerjavi z adalimumabom v monoterapiji
• If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor.
• Če ste se pred kratkim cepili ali se nameravate cepiti, morate to povedati zdravniku.
Protect the syringe from freezing and from light.
Napolnjeno injekcijsko brizgo zaščitite pred svetlobo in zmrzovanjem.
During the 6-month controlled trials, increases of lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol have been reported commonly.
celotnega holesterola, trigliceridov, holesterola LDL in/ali holesterola HDL.
Modify the dose of the concomitant MTX if appropriate For persistent increases in this range, reduce RoActemra dose to 4 mg/kg or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised
RoActemra na 4 mg/kg ali prekinite njegovo uporabo, dokler se alaninaminotransferaza (ALT) ali aspartat-aminotransferaza (AST) ne normalizira.
• adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate.
• odraslih bolnikov s hudim, aktivnim in napredujočim revmatoidnim artritisom, ki predhodno še niso bili zdravljeni z metotreksatom.
If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
Če je od vašega izpuščenega tedenskega odmerka minilo manj kot 7 dni, ga vzemite na dan naslednjega načrtovanega odmerka.
Interstitial Lung Disease
Intersticijska bolezen pljuč
Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Tocilizumab se specifično veže na topne in membransko vezane receptorje za IL-6 (sIL-6R in mIL
10 mg/kg Q4W below 30 kg
10 mg/kg na 4 tedne pod 30 kg
Steady-state was reached following the first administration for Cmax and after 8 and 20 weeks for AUC and Cmin, respectively.
Stanje dinamičnega ravnovesja je bilo za Cmax doseženo po prvi uporabi, za AUC po 8 tednih in za Cmin po 20 tednih.
The mean change in Patient's global VAS from baseline at week 52 was lower (showing greater improvement) in the RoActemra weekly and every other weekly dose groups [-19.0, -25.3, respectively] than in both placebo groups [placebo plus 26 weeks -3.4, placebo plus 52 weeks -7.2], although only the RoActemra every other weekly plus 26 weeks prednisone taper group showed a statistically significant difference compared to placebo [placebo plus 26 weeks taper p=0.0059, and placebo plus 52 weeks taper p=0.0081].
Povprečna sprememba bolnikove celotne ocene po VAS od izhodišča do 52. tedna je bila manjša (tj. kaže večje izboljšanje) v skupinah z zdravilom RoActemra vsak teden in vsak drugi teden [-19,0 v prvi, -25,3 v drugi] kot v skupinah s placebom [placebo + 26 tednov -3,4, placebo + 52 tednov -7,2], vendar je bila statistično značilna le razlika med skupino z zdravilom RoActemra vsak teden v kombinaciji s 26-tedenskim zmanjševanjem prednizona in skupinama s placebom [placebo + 26-tedensko zmanjševanje p = 0,0059 in placebo + 52-tedensko zmanjševanje p = 0,0081].
In the open label extension phase, decreases in neutrophil counts below 1 x 109/l, occurred in 15% of the tocilizumab group.
V odprti, podaljšani fazi se je zmanjšanje števila nevtrofilcev pod 1 x 109/l pojavilo pri 15 % v skupini, ki je prejemala tocilizumab.
• If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
• Če se vam med infundiranjem ali po njem pojavi alergijska reakcija, npr. tiščanje v prsih, piskajoče dihanje, huda omotica ali vrtoglavost, otekanje ustnic ali izpuščaj na koži, morate to nemudoma povedati zdravniku.
• adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
• odraslih bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom (avtoimunsko boleznijo), če predhodno zdravljenje ni bilo dovolj učinkovito.
It is not known whether RoActemra is passed into breast milk.
Ni znano, ali se zdravilo RoActemra izloča v materino mleko.
Read and follow the Instructions for Use that come with your RoACTEMRA pre-filled pen before you start using it and each time you get a prescription refill.
Preden začnete uporabljati zdravilo RoACTEMRA v napolnjenem injekcijskem peresniku in vsakič, ko zanj dobite nov recept, preberite in upoštevajte Navodila za uporabo, ki so priložena napolnjenemu injekcijskemu peresniku.
The efficacy of RoActemra in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Učinkovitost zdravila RoActemra za ublažitev znakov in simptomov revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih multicentričnih študijah.
DMARD - Disease modifying anti-rheumatic drug - p< 0.01, TCZ vs. PBO + MTX/DMARD - p< 0.0001, TCZ vs. PBO + MTX/DMARD
DMARD - imunomodulirajoče antirevmatično zdravilo (Disease modifying anti-rheumatic drug) - p < 0,01, tocilizumab v primerjavi s placebom + metotreksatom/imunomodulirajočim antirevmatičnim zdravilom - p < 0,0001, tocilizumab v primerjavi s placebom + metotreksatom/imunomodulirajočim antirevmatičnim zdravilom
RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Zdravilo RoActemra se lahko daje v monoterapiji, če bolniki metotreksata ne prenašajo ali zanje nadaljnje zdravljenje z metotreksatom ni primerno.
It is unknown whether RoActemra is excreted in human breast milk.
Ni znano, ali se zdravilo RoActemra pri človeku izloča v materino mleko.
Patients must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously.
Bolniki morajo ob prejemu subkutane oblike zdravila RoActemra tehtati najmanj 10 kg.
In clinical trials, tocilizumab has not been studied in patients during an episode of active MAS.
V kliničnih študijah tocilizumaba pri bolnikih med epizodo aktivnega sindroma aktivacije makrofagov niso proučevali.
In all patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Pri vseh bolnikih je treba meritev lipidov opraviti od 4 do 8 tednov po uvedbi zdravljenja z zdravilom
RoActemra helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks.
Zdravilo RoActemra pomaga olajšati simptome, npr. bolečine in oteklost sklepov, in lahko tudi izboljša vašo sposobnost za vsakodnevna opravila.
The incidence of infections leading to dose interruptions was also numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (21.4%)
Incidenca okužb, ki so vodile v prekinitev odmerjanja, je bila prav tako številčno višja pri bolnikih s telesno maso < 30 kg, ki so se zdravili z 10 mg/kg tocilizumaba (21,4 %) v primerjavi z bolniki s telesno maso ≥ 30 kg, ki so se zdravili z 8 mg/kg tocilizumaba (7,6 %).
ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients) Study I AMBITION
Odzivi ACR v študijah, kontroliranih splacebom/metotreksatom/imunomodulirajočimi antirevmatičnimi zdravili (% bolnikov)
In the 52-week open-label SC Study (WA28118), neutrophil count decrease to below 1 × 109/L occurred in 23.5% of patients treated with RoActemra SC. Decreases in platelet counts to below 100 ×
V 52-tedenski odprti študiji s subkutano obliko (WA28118) se je pri 23,5 % bolnikov, zdravljenih s subkutano obliko zdravila RoActemra, pojavilo zmanjšanje števila nevtrofilcev pod 1 × 109/l.
Hepatic transaminase elevations
Zvišanje jetrnih transaminaz
Subcutaneous use
Subkutana uporaba
Subcutaneous Use
subkutana uporaba
Very rare side effects:
Zelo redki neželeni učinki:
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za redčenje pred uporabo
However, if you are worried, talk to your doctor, pharmacist or nurse.
A če vas skrbi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
When platelet count > 100 x 103/ μL resume RoActemra dosing every other week and increase to every week injection as clinically appropriate.
Ko je število trombocitov > 100 x 103/μl, znova uvedite zdravilo RoActemra z odmerjanjem enkrat na dva tedna in povečajte pogostnost odmerjanja na enkrat na teden, kot je klinično ustrezno.
At steady-state, predicted AUC and Cmin were 3.2 and 30 fold higher at 8 mg/kg as compared to 4 mg/kg, respectively.
V stanju dinamičnega ravnovesja je bila AUC po odmerku 8 mg/kg 3,2-krat večja, Cmin pa 30-krat večja kot po odmerku 4 mg/kg.
‡p-value < 0.05 vs.
***Opisna vrednost p < 0,005
During routine laboratory monitoring in the RoActemra all exposure population, a decrease in neutrophil count below 1 × 109/L occurred in 15.4% of patients treated with SC RoActemra.
Med rednim laboratorijskim spremljanjem v celotni populaciji, izpostavljeni zdravilu RoActemra, se je število nevtrofilcev zmanjšalo pod 1 × 109/l pri 15,4 % bolnikov, zdravljenih s subkutano obliko zdravila RoActemra.
In GCA patients, the central volume of distribution was 4.09 L, the peripheral volume of distribution was 3.37 L, resulting in a volume of distribution at steady state of 7.46 L.
Pri bolnikih z GCA je bil centralni volumen porazdelitve 4,09 l in periferni volumen porazdelitve 3,37 l, tako da je volumen porazdelitve v stanju dinamičnega ravnovesja 7,46 l.
Keep the RoActemra syringe and all medicines out of the sight and reach of children.
Napolnjeno injekcijsko brizgo RoActemra in vsa zdravila shranjujte nedosegljivo otrokom.
Reduction of tocilizumab dosing frequency due to laboratory abnormalities has not been studied in sJIA or pJIA patients.
Zmanjšanja pogostnosti odmerjanja tocilizumaba zaradi nenormalnih laboratorijskih vrednosti pri bolnikih s sJIA ali pJIA niso proučevali.
ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients)
Odzivi ACR v študijah, kontroliranih s placebom/metotreksatom/imunomodulirajočimi antirevmatičnimi zdravili (% bolnikov).
If following pressing the activation button the purple indicator does not move, you must dispose of the pre-filled pen in a puncture resistant container.
Če se po pritisku gumba za aktivacijo vijolični indikator ne premakne, je treba napolnjeni injekcijski peresnik zavreči v zabojnik za ostre predmete, odporen proti vbodom.
RoActemra is used for children aged 2 years and over who have active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Zdravilo RoActemra se uporablja za zdravljenje otrok, starih 2 leti in več, ki imajo aktivni sistemski juvenilni idiopatski artritis (sJIA), vnetno bolezen, ki povzroči bolečino in otekanje enega ali več sklepov, kot tudi povišano telesno temperaturo in izpuščaj.
The mean change in HAQ-DI was maintained at Week 104 in the tocilizumab 8 mg/kg plus MTX group (-0.61).
Povprečna sprememba po HAQ-DI je bila po 104. tednu v skupini s tocilizumabom 8 mg/kg in metotreksatom ohranjena (- 0,61).
• If you have liver disease, tell your doctor.
• Če imate katero koli jetrno bolezen, morate to povedati zdravniku.
The bioavailability for the subcutaneous formulation was 79%.
biološka uporabnost za subkutano obliko pri bolnikih s pJIA je bila 96 %.
respectively.
Malignomi
In the long-term exposure population the overall rate of gastrointestinal perforation was 0.28 events per 100 patient years.
V dolgoročno izpostavljeni populaciji je bil celokupni delež perforacij v prebavilih med uporabo tocilizumaba 0,28 na 100 bolnik-let.
Adults will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Odrasli boste prejeli zdravilo RoActemra enkrat na 4 tedne v intravenski infuziji (kapalni infuziji v veno), ki bo trajala eno uro.
These are common: they may affect up to 1 in every 10 users
Ti so pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov.
The recommended dose The dose for all adults is 162 mg (the content of 1 pre-filled pen) given once a week.
Za vse odrasle je odmerek 162 mg (vsebina 1 napolnjenega injekcijskega peresnika), dan enkrat na teden.
Do not touch the trigger fingers on the syringe as this may damage the syringe.
Ne prijemajte sprostitvenih sponk na injekcijski brizgi, ker jo lahko poškodujete.
Keep the RoACTEMRA pre-filled pen and disposal container out of the reach of children.
Napolnjeni injekcijski peresnik z zdravilom RoACTEMRA in zabojnik za odstranjevanje shranjujte nedosegljivo otrokom.
The data available so far does not suggest any effect on fertility from this treatment.
Razpoložljivi podatki ne kažejo, da bi to zdravljenje vplivalo na plodnost.
The PCS mean change from baseline to week 52 was higher (showing more improvement) in the RoActemra weekly and every other weekly dose groups [4.10, 2.76, respectively] than in the two placebo groups [placebo plus 26 weeks; -0.28, placebo plus 52 weeks; -1.49], although only the comparison between RoActemra weekly plus 26 weeks prednisone taper group and placebo plus 52 weeks prednisone taper group (5.59, 99% CI: 8.6, 10.32) showed a statistically significant difference (p=0.0024).
Povprečna sprememba PCS od izhodišča do 52. tedna je bila večja (tj. kaže večje izboljšanje) v skupinah z zdravilom RoActemra vsak teden in vsak drugi teden [4,10 v prvi, 2,76 v drugi] kot v skupinah s placebom [placebo + 26 tednov -0,28, placebo + 52 tednov -1,49], vendar je bila statistično značilna le razlika med skupino z zdravilom RoActemra vsak teden v kombinaciji s 26-tedenskim zmanjševanjem prednizona in skupino s placebom v kombinaciji z 52tedenskim zmanjševanjem prednizona (5,59; 99-% IZ: 8,6, 10,32; p = 0,0024).
The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 1 year have not been established.
Pediatrična populacija Varnost in učinkovitost zdravila RoActemra v subkutani obliki pri otrocih od rojstva do 1. leta nista dokazani.
Cellulitis, Pneumonia, Oral herpes simplex, Herpes zoster
oralni herpes simpleks, herpes zoster divertikulitis
If the needle is not covered proceed carefully, and place the syringe into the puncture resistant container to avoid injury with the needle.
Če se injekcijska igla ne prekrije, pazljivo nadaljujte in napolnjeno injekcijsko brizgo odvrzite v zabojnik za ostre predmete, da se izognete poškodbi z injekcijsko iglo.
RoActemra should be diluted to a final volume of 50 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.
Zdravilo RoActemra je treba razredčiti na končni volumen 50 ml s sterilno, apirogeno 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje upoštevaje aseptičen postopek.
RoActemra should be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.
Zdravilo RoActemra je treba razredčiti na končni volumen 100 ml s sterilno, apirogeno 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje upoštevaje aseptičen postopek.
Inject RoACTEMRA
Injicirajte zdravilo RoACTEMRA