natgillin/translations-raw huggingface dataset:
However, your doctor may decide that you may inject RoActemra yourself.
Vaš zdravnik se lahko nato odloči, da si boste zdravilo RoActemra injicirali sami.
After removing the pre-filled pen from the refrigerator the pre-filled pen should be allowed to reach room temperature (18°C to 28°C) by waiting for 45 minutes, before injecting RoActemra.
Po tem, ko vzamemo napolnjeni injekcijski peresnik iz hladilnika, ga pustimo 45 minut, da doseže sobno temperaturo (18 °C do 28 °C), preden zdravilo RoActemra injiciramo.
Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice.
študiji kroničnih toksičnih učinkov pri opicah cynomolgus niso opazili učinkov na endokrino aktivnih in reproduktivnih organih in reproduktivna sposobnost miši s pomanjkanjem IL-6 ni bila prizadeta.
This was not observed in either of the placebo plus prednisone taper groups.
Tega niso opažali v nobeni od skupin, ki sta prejemali placebo in prednizon v zmanjšujočem se odmerku.
• If you have had tuberculosis, tell your doctor.
• Če ste kdaj imeli tuberkulozo, morate to povedati zdravniku.
One of these events, urticaria, was considered serious.
Enega izmed teh neželenih učinkov, urtikarijo,so šteli za resnega.
If you miss a dose of RoActemra
Če ste izpustili odmerek zdravila RoActemra
RoActemra AUC, Cmin and Cmax increased with increase of body weight.
AUC, Cmin in Cmax zdravila RoActemra so se zvečale s povečanjem telesne mase.
Approximately 90% of the steady-state (AUCτ) was reached by week 14 in the every other weekly and week 17 in the weekly dose groups.
Približno 90-% stanje dinamičnega ravnovesja (AUCτ) je bilo pri uporabi vsak drugi teden doseženo do 14. tedna in pri uporabi vsak teden do
RoActemra monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established.
Za zdravljenje akutnih relapsov se zdravila RoActemra v monoterapiji ne sme uporabljati, saj učinkovitost za zdravljenje le-teh ni bila dokazana.
After week 52, all patients could receive open-label treatment with tocilizumab 8 mg/kg.
Po 52. tednu so imeli vsi bolniki možnost prejemati odprto zdravljenje s tocilizumabom v odmerku 8 mg/kg.
Patients with sJIA must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously (see section 4.2).
Bolniki s sJIA morajo ob prejemu subkutane oblike zdravila RoActemra tehtati najmanj 10 kg (glejte poglavje 4.2).
Choose and prepare an injection site
Izberite in pripravite mesto vboda
The long-term exposure population includes all patients who received at least one dose of tocilizumab either in the double-blind control period or open label extension phase in the studies.
Dolgoročno izpostavljena populacija vključuje vse bolnike, ki so dobili vsaj en odmerek tocilizumaba v obdobju dvojno slepe kontrole ali pa v odprti, podaljšani fazi študij.
What you need to know before you are given RoActemra
Kaj morate vedeti, preden boste prejeli zdravilo RoActemra
RoActemra is for single-use only.
Zdravilo RoActemra je namenjeno samo za enkratno uporabo.
Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo + 52) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo + 52) HR (99% CI)
Čas do prvega poslabšanja GCA¹ (bolniki z novonastalo boleznijo; skupini s tocilizumabom v primerjavi s placebom + 26) RO (99-% IZ) Čas do prvega poslabšanja GCA¹ (bolniki z novonastalo boleznijo; skupini s tocilizumabom v primerjavi s placebom + 52) RO (99-% IZ)
No impact on RoActemra exposure was noted in these patients.
Pri teh bolnikih niso ugotovili vpliva na izpostavljenost zdravilu RoActemra.
The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids.
Priporočeno odmerjanje je 162 mg subkutano enkrat na teden skupaj z glukokortikoidom, katerega odmerek postopoma zmanjšujemo.
At the start, your doctor or nurse may inject RoActemra.
Na začetku zdravljenja vam bo zdravnik ali medicinska sestra injicirala zdravilo RoActemra.
Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
V primeru pojava simptomov resne alergijske reakcije morajo bolniki nemudoma poiskati zdravniško pomoč (glejte poglavje 4.4).
For ALT or AST elevations > 3-5 x ULN, RoActemra treatment should be interrupted.
V primeru zvišanja ALT ali AST na > 3- do 5-kratno ZMN je treba zdravljenje z zdravilom RoActemra prekiniti.
• cold sores (oral herpes simplex), blisters
• pasovec (herpes zoster), • herpes (oralni herpes simpleks), mehurji,
The primary endpoint at week 24 was the proportion of patients who achieved an ACR 20 response.
Primarni cilj v 24. tednu je bil delež bolnikov, ki so dosegli odziv ACR 20.
Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Bolnike s simptomi, ki lahko nakazujejo zaplete divertikulitisa (npr. z bolečinami v trebuhu, krvavitvijo in/ali nepojasnjeno spremembo v razporedu iztrebljanja in zvišano telesno temperaturo), je treba takoj pregledati, da bi zgodaj odkrili divertikulitis, ki ga lahko spremlja perforacija v prebavilih.
RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidaemia) managed as part of usual standard of care.
Bolniki z revmatoidnim artritisom imajo večje tveganje za srčno-žilne bolezni, zato mora njihova običajna standardna obravnava vključevati obvladanje dejavnikov tveganja (npr. hipertenzije,
If you stop using RoActemra You should not stop using RoActemra without discussing with your doctor first.
Če ste prenehali uporabljati zdravilo RoActemra Zdravila RoActemra ne smete nehati uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
Patients included in the trial had a total disease duration of at least 6 months and active disease but were not experiencing an acute flare requiring corticosteroid doses of more than 0.5 mg/kg prednisone equivalent.
Pri bolnikih, vključenih v študijo, je bolezen trajala vsaj 6 mesecev, bila je aktivna, vendar ob vključitvi bolniki niso doživljali nenadnega poslabšanja bolezni, za katerega bi potrebovali odmerke kortikosteroida,
A statistically significant superior treatment effect was seen in favour of tocilizumab 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 5).
Učinek zdravljenja s tocilizumabom je bil statistično značilno boljši kot z adalimumabom v kontroli aktivnosti bolezni od začetka zdravljenja do 24. tedna za primarni cilj študije, spremembo DAS28, in za vse sekundarne cilje (preglednica 5).
After the Injection
Po injiciranju
What do I need to know to use my RoActemra pre-filled syringe safely?
Kaj morate vedeti za varno uporabo vaše napolnjene injekcijske brizge RoActemra
• Once the needle is removed completely from the skin, you can release the plunger, allowing the needle-shield to protect the needle.
• Ko injekcijsko iglo popolnoma odstranite iz kože, lahko izpustite bat, kar omogoči, da varovalo igle zaščiti iglo (glejte sliko H).
Concomitant administration of a single dose of 10 mg/kg RoActemra with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Sočasna uporaba posamičnega odmerka 10 mg/kg zdravila RoActemra in 10 do 25 mg metotreksata enkrat na teden ni klinično pomembno vplivala na izpostavljenost metotreksatu.
RA The recommended posology is subcutaneous 162 mg once every week.
Priporočeno odmerjanje je 162 mg subkutano enkrat na teden.
Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Tocilizumab je rekombinantno humanizirano antihumano monoklonsko protitelo podskupine imunoglobulinov G1 (IgG1) proti topnim in membranskim receptorjem za interlevkin-6.
The safety profile of intravenous RoActemra in sJIA has been studied in 112 patients from 2 to 17 years of age.
Varnostni profil intravenske oblike zdravila RoActemra pri bolnikih s sJIA so preučevali pri 112 bolnikih, starih od 2 do 17 let.
For recommended modifications, including RoActemra discontinuation, based on transaminases levels see section 4.2.
Za priporočene prilagoditve odmerjanja, vključno z ukinitvijo zdravila RoActemra, na podlagi vrednosti transaminaz glejte poglavje 4.2.
What RoActemra is and what it is used for What you need to know before you use RoActemra How to use RoActemra
Kaj je zdravilo RoActemra in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo RoActemra Kako boste prejeli zdravilo RoActemra
• RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
• Zdravilo RoActemra se uporablja za zdravljenje odraslih bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom (avtoimunsko boleznijo), če predhodna zdravljenja niso učinkovala dovolj dobro.
RoActemra is used to improve the symptoms of sJIA and can be given in combination with methotrexate or alone.
Zdravilo RoActemra se uporablja za izboljšanje simptomov sJIA in se lahko daje v kombinaciji z metotreksatom ali samostojno.
If the needle cap is removed for more than 5 minutes, it may be more difficult to perform an injection as the medicine can dry out and block the needle.
Če bi napolnjeno injekcijsko brizgo brez pokrovčka pustili več kot 5 minut, bi lahko bilo injiciranje težje, saj se lahko zdravilo izsuši in zamaši injekcijsko iglo.
The proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was also comparable on the subcutaneous (65.2%) versus intravenous (67.4%) arms, with a weighted difference in proportions of - 2.3% (95% CI - 8.1, 3.4).
Prav tako je bil primerljiv delež bolnikov, ki so v 24. tednu dosegli klinično pomembno izboljšanje po HAQ-DI (sprememba od izhodišča ≥ 0,3 enote) v subkutani (65,2 %) v primerjavi z intravensko skupino (67,4 %) z uravnoteženo razliko v deležih -2,3 % (95-% interval zaupanja, -8,1; 3,4).
Each of the RoActemra-treated groups and one of the placebo-treated groups followed a pre-specified prednisone-taper regimen over 26 weeks, while the second placebo-treated group followed a pre-specified prednisone-taper regimen over 52 weeks, designed to be more in keeping with standard practice.
V obeh skupinah z zdravilom RoActemra in v eni skupini s placebom je bila uporabljena vnaprej določena shema 26-tedenskega zmanjševanja prednizona, druga skupina s placebom pa je prejemala vnaprej določeno shemo 52-tedenskega zmanjševanja prednizona, ki predstavlja boljši približek standardni praksi.
The safety profile of tocilizumab has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Varnostni profil tocilizumaba so preučevali v štirih s placebom kontroliranih študijah (študije II, III, IV in V), eni z metotreksatom kontrolirani študiji (študija I) ter v njihovih odprtih, podaljšanih fazah
• mouth or skin blisters
• mehurji na ustih ali koži,
How to use RoActemra
Kako uporabljati zdravilo RoActemra
Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as RoActemra, is introduced.
Zato se lahko ekspresija CYP450 po uvedbi močnih zaviralcev citokinov, kakršno je zdravilo RoActemra,
RA and CRS adult patients (≥ 30 kg)
Odrasli bolniki z RA in CRS (≥ 30 kg)
Concentrate for solution for infusion 200 mg/10 mL
Koncentrat za raztopino za infundiranje 200 mg/10 ml
Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Ne injicirajte v bradavice, brazgotine, modrice ali področja, kjer je koža občutljiva, rdeča, trda ali poškodovana.
Although IL-6 does not seem to be a critical cytokine for foetal growth or the immunological control of the maternal/foetal interface, a relation of this finding to RoActemra cannot be excluded.
Čeprav ne kaže, da bi bil citokin IL-6 ključen za rast ploda ali imunološki nadzor stika mati-plod, povezanosti tega izsledka z zdravilom RoActemra ni mogoče izključiti.
Radiographic mean changes over 52 weeks in Study II PBO + MTX (+ TCZ from week 24) N = 393
Povprečne radiološke spremembe v 52 tednih študije II Placebo + MTX (+ TCZ od 24. tedna)
The concentrationdependent non-linear clearance plays a major role at low tocilizumab concentrations.
Od koncentracije odvisni nelinearni očistek igra pomembno vlogo pri nizkih koncentracijah tocilizumaba.
After proper training in injection technique, patients may self-inject with RoActemra if their physician determines that it is appropriate.
Po primernem usposabljanju o tehniki injiciranja si lahko bolniki sami injicirajo zdravilo RoActemra,
Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Ena 200-mg viala vsebuje 0,20 mmol (4,43 mg) natrija.
It is unknown whether tocilizumab is excreted in human breast milk.
Ni znano, ali se tocilizumab pri človeku izloča v materino mleko.
ADRs from clinical trials and/or post marketing experience with RoActemra based on spontaneous case reports, literature cases and cases from non-interventional study programs are listed in Table 1 and are presented by MedDRA system organ class.
Neželeni učinki iz kliničnih preskušanj in/ali obdobja po prihodu zdravila RoActemra na trg, v katerem so vir spontana poročila, literaturni podatki in podatki iz neintervencijskih študijskih programov, so navedeni v preglednici 1 po organskih sistemih MedDRA. Za posamezen neželeni učinek je ustrezna skupina pogostnosti določena glede na naslednji dogovor: zelo pogosti (≥ 1/10),
• high blood fat (cholesterol) levels.
• zvišana raven maščob v krvi (holesterola).
Primary Endpoint - Mean Change from baseline at Week 24 DAS28 (adjusted mean) Difference in adjusted mean (95% CI) Secondary Endpoints - Percentage of Responders at Week 24
Primarni cilj - povprečna sprememba od začetka zdravljenja do 24. tedna DAS28 (prilagojena povprečna vrednost) Razlika v prilagojeni povprečni vrednosti (95-% interval zaupanja) Sekundarni cilji - delež odzivnih bolnikov v 24. tednu
• Liver enzyme abnormalities Laboratory Value
• Nenormalne vrednosti jetrnih encimov Laboratorijska vrednost
Cases of liver failure resulting in liver transplantation have been reported.
Poročali so o primerih odpovedi in posledične presaditve jeter.
* Includes elevations collected as part of routine laboratory monitoring (see text below) 1 See section 4.3
* Vključuje povišanja, ki so jih opazili v okviru rutinskih laboratorijskih preiskav (glejte spodnje besedilo).
If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time while not at the clinic during or following an RoACTEMRA injection you should seek emergency care immediately.
Če se pri vas pojavijo simptomi (ki pa niso vsi mogoči), kot so kožni izpuščaj, srbež, mrzlica, otekanje obraza, ustnic, jezika ali vratu, bolečina v prsnem košu, sopenje, težko dihanje ali požiranje, občutek omotičnosti ali omedlevanja kadar koli po dani injekciji zdravila RoActemra (ko niste v bolnišnici), takoj poiščite zdravniško pomoč.
Approximately half of the patients who developed an ANC < 1 x 109/ L did so within 8 weeks after starting therapy.
Med bolniki, ki se jim je absolutno število nevtrofilcev zmanjšalo na < 1 x 109/l, se je to pri približno polovici zgodilo v 8 tednih po začetku zdravljenja.
Concomitant administration of a single dose of 10 mg/kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Sočasna uporaba posamičnega odmerka 10 mg/kg tocilizumaba in 10 do 25 mg metotreksata enkrat na teden ni klinično pomembno vplivala na izpostavljenost metotreksatu.
The ACR response rates were numerically lower for patients with prior biologic treatment as shown in Table 9 below.
Odzivi ACR so bili številčno nižji pri bolnikih, ki so se predhodno že zdravili z biološkimi zdravili,
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali medicinsko sestro.
Children with sJIA (aged 2 and over)
Otroci s sJIA (stari 2 leti ali več)
Fifty out of seventy five (67%) tocilizumab treated patients had a haemoglobin < LLN at baseline.
Petdeset od petinsedemdeset (67 %) bolnikov, ki so se zdravili s tocilizumabom, je imelo hemoglobin pred začetkom zdravljenja pod spodnjo mejo normale.
Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Polisorbat 80, saharoza, natrijev hidrogenfosfat dodekahidrat, natrijev dihidrogenfosfat dihidrat in voda za injekcije.
Viral reactivation (e.g. hepatitis B virus) has been reported with biologic therapies for RA.
V zvezi z biološkim zdravljenjem revmatoidnega artritisa so poročali o reaktivaciji virusov (npr. virusa hepatitisa B).
When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. .
Bolnike, zdravljene z individualno prilagojenimi zdravili, ki se presnavljajo s CYP450 3A4, 1A2 ali
However, if you are worried, talk to your doctor.
za katerega skrbite, se pogovorite s svojim zdravnikom.
Forty (80%) of these patients had an increase in their haemoglobin to within the normal range at week 12, in comparison to 2 out of 29 (7%) of placebo treated patients with haemoglobin < LLN at baseline (p<0.0001).
Štiridesetim (80 %) od teh bolnikov se je hemoglobin na vrednost znotraj normale zvišal do 12. tedna v primerjavi z 2 od 29 (7 %) bolnikov, ki so prejemali placebo in ki so imeli pred začetkom zdravljenja hemoglobin pod spodnjo mejo normale
Proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was higher for RoActemra subcutaneous every other week (58%) versus placebo
Delež bolnikov, ki so dosegli klinično pomembno izboljšanje po HAQ-DI v 24. tednu (sprememba od izhodišča ≥ 0,3 enote), je bil večji pri subkutanem dajanju zdravila RoActemra vsak drugi teden (58 %) v primerjavi s placebom (46,8 %).
RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
Zdravilo RoActemra upočasni nastanek okvar hrustanca in kosti v sklepih, ki jih povzroča bolezen, ter izboljša vašo sposobnost za opravljanje običajnih dnevnih aktivnosti.
The recommended dose modifications, including tocilizumab discontinuation, based on transaminases levels, in line with SmPC section 4.2.
Priporočene prilagoditve odmerjanja, vključno z ukinitvijo zdravila RoActemra, na podlagi vrednosti transaminaz so opisane v SmPC, poglavje 4.2.
pJIA Patients < 30 kg
Bolniki s pJIA < 30 kg
Additionally, proliferative lesions were not observed in a 6-month chronic toxicity study in cynomolgus monkeys or in IL-6 deficient mice.
Poleg tega v 6-mesečni študiji kronične toksičnosti pri opicah cynomolgus in pri miših s pomanjkanjem IL-6 niso opazili proliferativnih lezij.
When platelet count > 100 x 103/ μ resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
Ko je število trombocitov > 100 x 103/μl, znova uvedite zdravilo RoActemra v odmerku 4 mg/kg in povečajte na 8 mg/kg, kot je klinično ustrezno.
The Nurse Information Pack should contain the following key elements:
Izobraževalno gradivo za medicinske sestre mora vključevati naslednje ključne elemente:
The clinical data are insufficient to assess the potential incidence of malignancy following exposure to RoActemra.
Kliničnih podatkov za oceno možne incidence malignomov po izpostavljenosti zdravilu RoActemra ni dovolj.
Frequency categories with preferred terms
Skupine pogostnosti s prednostnimi izrazi za neželene učinke Zelo pogosti
Number and Proportion of Patients with a JIA ACR30 Flare and Proportion of Patients with JIA ACR30/50/70/90 Responses at Week 40, by Previous Biologic Use (ITT Population - Study Part II)
Število bolnikov in njihov delež v odstotkih, ki zaradi nenadnega poslabšanja bolezni niso dosegli merila JIA ACR 30 in deleži bolnikov, ki so po predhodnem zdravljenju z biološkim zdravilom dosegli odzive JIA ACR30/50/70/90 po 40 tednih (populacija, ki so jo nameravali zdraviti, II.
Two patients developed positive anti-tocilizumab antibodies with one of these patients having a hypersensitivity reaction leading to withdrawal.
Pri dveh bolnikih so se pojavila protitelesa proti tocilizumabu, eden od njiju je imel preobčutljivostno reakcijo, ki je vodila v ukinitev zdravljenja.
Patients in studies I - V had a mean Disease Activity Score (DAS28) of 6.5-6.8 at baseline.
Bolniki v študijah I-V so imeli povprečno izhodiščno oceno aktivnosti bolezni DAS28 (Disease Activity Score) od 6,5 do 6,8.
The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving RoActemra (28-34%) compared to 1-12% of control patients at 24 weeks.
Delež bolnikov, ki so dosegli klinično remisijo glede na DAS28 (DAS28 < 2,6), je bil po 24 tednih značilno večji med bolniki, ki so dobivali zdravilo RoActemra (28-34 %), kot med kontrolnimi bolniki (1-12 %).
At the conclusion of Part I, JIA ACR 30/50/70/90 responses were 89.4%, 83.0%, 62.2%, and 26.1%, respectively.
Ob zaključku I. dela so bili odzivi JIA ACR 30 89,4 %, JIA ACR 50 83,0 %, JIA ACR 70 62,2 % in
• The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
• Druge sestavine zdravila so saharoza, polisorbat 80, natrijev hidrogenfosfat dodekahidrat, natrijev dihidrogenfosfat dihidrat in voda za injekcije.
Record your Injection
Zabeležite si injiciranje
The overall clinical adverse event profile was similar between tocilizumab and adalimumab.
Celokupni klinični profil neželenih učinkov je bil pri tocilizumabu in adalimumabu podoben.
Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Preden boste dobili zdravilo RoActemra, bo zdravnik opravil preiskave krvi, da bo ugotovil, ali imate majhno število belih krvnih celic, majhno število trombocitov ali zvišane jetrne encime.
The accumulation ratios for AUC, Cmin, and Cmax were 2.67, 6.02, and 2.12, respectively.
Deleži kopičenja so bili 2,67 za AUC, 6,02 za Cmin in 2,12 za Cmax.
• Hold your RoACTEMRA pre-filled pen with the green cap pointing down (See Figure C).
• Napolnjeni injekcijski peresnik z zdravilom RoACTEMRA držite tako, da je zelen pokrovček usmerjen navzdol (glejte sliko C).
RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
Zdravilo RoActemra se lahko daje v monoterapiji (če bolniki metotreksata ne prenašajo ali zdravljenje z njim ni primerno) ali v kombinaciji z metotreksatom.
Of these 52 patients, 37 (71%) were naive to RoActemra and 15 (29%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Od teh 52 bolnikov je 37 (71 %) zdravilo RoActemra prejelo prvič, 15 (29 %) pa je predhodno prejemalo intravensko obliko zdravila RoActemra in ob izhodišču prešlo na subkutano obliko zdravila RoActemra.
months).
tednih.