natgillin/translations-raw huggingface dataset:
Your doctor will perform blood tests before you are given RoActemra, and during your treatment, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Preden boste dobili zdravilo RoActemra in med zdravljenjem z njim, bo zdravnik opravil preiskave krvi, da bo ugotovil, ali imate majhno število belih krvnih celic, majhno število trombocitov ali zvišane jetrne encime.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7)
RoActemra is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Zdravilo RoActemra je rekombinantno humanizirano antihumano monoklonsko protitelo podskupine imunoglobulinov G1 (IgG1) proti topnim in membranskim receptorjem za interlevkin-6.
In general, the adverse drug reactions in patients with sJIA were similar in type to those seen in RA patients (see Undesirable Effects section above).
Na splošno so bili neželeni učinki pri bolnikih s sJIA podobnega tipa, kot so jih opazili pri bolnikih z revmatoidnim artritisom (glejte poglavje Neželeni učinki zgoraj).
The potential for central demyelination with RoActemra is currently unknown.
Trenutno ni znano, kolikšna je možnost centralne demielinizacije med uporabo zdravila RoActemra.
Table 2: List of ADRs occurring in clinical trial patients with sJIA or pJIA receiving tocilizumab as monotherapy or in combination with MTX.
Seznam neželenih učinkov iz kliničnega preskušanja pri bolnikih s sJIA ali pJIA, zdravljenih s tocilizumabom v monoterapiji ali v kombinaciji z metotreksatom
162 mg every other weekly
162 mg vsak drugi teden
If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance.
Če vas kar koli skrbi ali imate vprašanja o vaši napolnjeni injekcijski brizgi, se posvetujte s svojim zdravstvenim delavcem ali farmacevtom.
Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.
Med simptomi so lahko bolečine v trebuhu, nepojasnjene spremembe v razporedu iztrebljanja z zvišano telesno temperaturo.
The developed model had the same structure as the population PK model developed earlier based on data from RA patients (see Table 10).
Razviti model je imel enako zgradbo kot model populacijske farmakokinetike, oblikovan pred tem na podlagi podatkov bolnikov z revmatoidnim artritisom (glejte preglednico 9).
During the 6-month controlled period, in SC-I, the frequency of injection site reactions was 10.1% (64/631) and 2.4% (15/631) for the subcutaneous RoActemra and the subcutaneous placebo (intravenous group) weekly injections, respectively.
V 6-mesečnem kontroliranem obdobju je bila v SC-I pogostnost reakcij na mestu injiciranja 10,1 % (64/631) za subkutano obliko tocilizumaba in 2,4 % (15/631) za tedenske injekcije subkutanega placeba (intravenska skupina).
The rate of anaphylactic reactions (occurring in a total of 6/3778patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Delež anafilaktičnih reakcij (ki so se pojavile pri skupaj 6 od 3778 bolnikov, 0,2 %) je bil pri odmerku 4 mg/kg nekajkrat večji kot pri odmerku 8 mg/kg.
In a randomized open-label study, adult RA patients treated with RoActemra and MTX were able to mount an effective response to both the 23-valent pneumococcal polysaccharide and tetanus toxoid vaccines which was comparable to the response seen in patients on MTX only.
V randomizirani odprti študiji so odrasli bolniki z revmatoidnim artritisom, ki so jih zdravili z zdravilom RoActemra in metotreksatom, razvili učinkovit odziv na 23valentno pnevmokokno polisaharidno cepivo in cepivo s tetanusnim toksoidom.
Increases in haemoglobin levels were observed, through RoActemra decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Opažali so povečanje koncentracije hemoglobina, ker zdravilo RoActemra zmanjša učinke IL-6 na nastajanje hepcidina in tako poveča razpoložljivost železa.
Once the nonlinear clearance pathway is saturated, at higher tocilizumab concentrations, clearance is mainly determined by the linear clearance.
Ko je pot nelinearnega očistka nasičena, očistek pri višjih koncentracijah tocilizumaba določa predvsem linearni očistek.
In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of tocilizumab, to the level similar to, or slightly higher than, those observed in healthy subjects.
V študiji pri bolnikih z revmatoidnim artritisom so se koncentracije simvastatina (CYP3A4) en teden po enkratnem odmerku tocilizumaba znižale za 57 % in dosegle podobne ali malo višje koncentracije od teh, ki so jih izmerili pri zdravih ljudeh.
RoActemra binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Zdravilo RoActemra se specifično veže na topne in membransko vezane receptorje za IL-6 (sIL-6R in mIL-6R).
• If following insertion of the needle, you cannot press down the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe (starting again at Step 2).
• 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 (začeti ponovno pri 2. koraku).
In the tocilizumab all exposure population, 11 patients (5.9%) experienced infusion reactions during the infusion and 38 patients (20.2%) experienced an event within 24 hours of an infusion.
V vsej populaciji, ki se je zdravila s tocilizumabom, je 11 bolnikov (5,9 %) imelo reakcijo, povezano z infundiranjem, med infundiranjem, 38 bolnikov
No patients treated with SC RoActemra experienced a decrease in platelet count to ≤50 × 103 / μL.
Pri nobenem bolniku, zdravljenem s subkutano obliko zdravila RoActemra, niso opazili zmanjšanja števila trombocitov na ≤ 50 × 103/μl.
• The RoACTEMRA pre-filled pen should not be reused.
• Istega napolnjenega injekcijskega peresnika z zdravilom RoACTEMRA ne smete uporabiti ponovno.
SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
Shranjujte v hladilniku Ne zamrzujte
• Do not reuse the same pre-filled pen.
• Ne poskušajte ponovno uporabiti iste napolnjene injekcijske brizge.
The mean [SD] change scores were as follows: RoActemra weekly plus 26 weeks 5.61 [10.115], RoActemra every other weekly plus 26 weeks 1.81 [8.836], placebo plus 26 weeks 0.26 [10.702], and placebo plus 52 weeks -1.63 [6.753].
Povprečne ocene [std. odklon] so bile: RoActemra vsak teden + 26-tedensko 5,61 [10,115], RoActemra vsak drugi teden + 26-tedensko 1,81 [8,836], placebo + 26-tedensko 0,26 [10,702] in placebo + 52-tedensko -1,63 [6,753].
Certain types of vaccines should not be used while receiving RoActemra.
Med zdravljenjem z zdravilom RoActemra se ne smejo uporabljati nekatere vrste cepiv.
The concentration-dependent non-linear clearance plays a major role at low RoActemra concentrations.
Od koncentracije odvisni nelinearni očistek igra pomembno vlogo pri nizkih koncentracijah zdravila RoActemra.
Limited information is available regarding switching patients from RoActemra intravenous formulation to RoActemra subcutaneous fixed dose formulation.
Podatkov o prehajanju bolnikov z intravenske oblike zdravila RoActemra na subkutano obliko s fiksnim odmerkom je malo.
Ask your healthcare provider any questions you may have.
Nanj se obrnite, če imate kakršna koli vprašanja.
The safety of subcutaneous RoActemra in RA includes a double-blind, controlled, multicenter study, SC-I. SC-I was a non-inferiority study that compared the efficacy and safety of RoActemra 162 mg administered every week versus 8 mg/kg intravenous in 1262 patients with RA.
Varnost uporabe subkutane oblike zdravila RoActemra pri zdravljenju revmatoidnega artritisa vključuje dvojno slepo, kontrolirano, multicentrično študijo SC-I. SC-I je bila študija ne-inferiornosti, ki je pri 1262 bolnikih z revmatoidnim artritisom primerjala učinkovitost in varnost 162 mg zdravila
for patients weighing ≥ 30 kg respectively provide PK exposure and PD responses to support efficacy and safety outcomes similar to those achieved with the approved RoActemra IV regimens for pJIA.
manjšo od 30 kg, in 162 mg vsaka 2 tedna pri bolnikih s telesno maso ≥ 30 kg, zagotavljata farmakokinetično izpostavljenost in farmakodinamične odzive, ki podpirajo izide glede učinkovitosti in varnosti, podobne tistim, ki so bili doseženi z odobrenimi režimi intravenske oblike zdravila RoActemra za pJIA.
Infections and Infestations
Infekcijske in parazitske bolezni
The rate of anaphylactic reactions (occurring in a total of 8/4,009 patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Delež anafilaktičnih reakcij (ki so se pojavile pri skupaj 8 od 4009 bolnikov, 0,2 %) je bil pri odmerku 4 mg/kg nekajkrat večji kot pri odmerku 8 mg/kg.
If a patient misses a subcutaneous injection of RoActemra by more than 7 days of the scheduled dose or is unsure when to inject RoActemra, call the doctor or pharmacist.
Če bolnik prejema zdravilo RoActemra s subkutano injekcijo in je od izpuščenega odmerka minilo več kot 7 dni ali bolnik ni prepričan, kdaj si mora spet injicirati zdravilo RoActemra, naj se posvetujte z zdravnikom ali farmacevtom.
Concentrate for solution for infusion 80 mg/4 mL
Koncentrat za raztopino za infundiranje 80 mg/4 ml
The most common events observed were nasopharyngitis and upper respiratory tract infections.
Najbolj pogosti neželeni učinki so bili nazofaringitis in okužbe zgornjih dihal.
Of these 51 patients, 26 (51%) were naive to RoActemra and 25 (49%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Od teh 51 bolnikov je 26 (51 %) zdravilo RoActemra prejelo prvič, 25 (49 %) pa jih je predhodno prejemalo intravensko obliko zdravila RoActemra in ob izhodišču prešlo na subkutano obliko zdravila RoActemra.
What you need to know to use your RoActemra pre-filled pen (ACTPen) safely.
Kaj morate vedeti za varno uporabo napolnjenega injekcijskega peresnika (ACTPen) z zdravilom RoACTEMRA
Each mL concentrate contains 20 mg tocilizumab*.
En ml koncentrata vsebuje 20 mg tocilizumaba*.
After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature (18°C to 28°C) by waiting for 25 to 30 minutes, before injecting RoActemra .
Po tem, ko vzamemo napolnjeno injekcijsko brizgo iz hladilnika, jo pustimo 25 do 30 minut, da doseže sobno temperaturo (18 °C do 28 °C), preden zdravilo RoActemra injiciramo.
The rate of serious infections was numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (12.2 per 100 patient years) compared to patients weighing ≥30 kg, treated with 8 mg/kg tocilizumab (4.0 per 100 patient years).
Delež resnih okužb je bil številčno večji pri bolnikih s telesno maso < 30 kg, ki so se zdravili z 10 mg/kg tocilizumaba (12,2 na 100 bolnik-let) v primerjavi z bolniki s telesno maso ≥ 30 kg, ki so se zdravili z 8 mg/kg tocilizumaba
Treatment with RoActemra, particularly when administered concomitantly with MTX, may be associated with elevations in hepatic transaminases, therefore, caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment (see sections 4.2 and 4.8).
Zdravljenje z zdravilom RoActemra lahko spremlja zvišanje jetrnih transaminaz, zlasti če se uporablja z metotreksatom, zato morate biti pri odločanju za uporabo zdravila RoActemra pri bolnikih z aktivno boleznijo jeter ali okvaro jeter previdni (glejte poglavji 4.2 ter 4.8).
Signs and symptoms of liver toxicity These may affect up to 1 in every 1000 users
Znaki jetrne toksičnosti: Ti se lahko pojavijo pri največ 1 od 1000 bolnikov.
Nervous system disorders Headache pJIA
Bolezni živčevja glavobol pJIA
The pre-filled syringe should not be shaken.
Napolnjene injekcijske brizge se ne sme stresati.
A patient or parent/guardian can self-inject RoActemra only if the physician determines that it is appropriate and the patient or parent/guardian agrees to medical follow-up as necessary and has been trained in proper injection technique.
Po ustreznem usposabljanju o primerni tehniki injiciranja si lahko bolnik (ali njegovi starši/skrbniki) zdravilo RoActemra aplicira sam, če zdravnik potrdi, da je to primerno in se bolnik (ali njegovi starši/skrbniki) strinja z zdravniškim spremljanjem po potrebi.
The overall safety profile observed in the RoActemra treatment groups was consistent with the known safety profile of RoActemra (see Table 1).
celoti so se varnostne značilnosti, opažene v terapevtskih skupinah z zdravilom RoActemra, ujemale z znanimi varnostnimi značilnostmi zdravila RoActemra (glejte preglednico 1).
If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of RoActemra should be stopped immediately, appropriate therapy initiated and tocilizumab should be permanently discontinued.
Če pride do anafilaktične ali druge hude preobčutljivostne reakcije, je treba dajanje zdravila RoActemra nemudoma prekiniti, pričeti s primernim zdravljenjem in uporabo tocilizumaba trajno ukiniti.
Subcutaneous
Subkutano
Once the non-linear clearance pathway is saturated, at higher RoActemra concentrations, clearance is mainly determined by the linear clearance.
Ko je pot nelinearnega očistka nasičena, očistek pri višjih koncentracijah zdravila RoActemra določa predvsem linearni očistek.
Active hepatic disease and hepatic impairment
Aktivna bolezen jeter in okvara jeter
In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of RoActemra, to the level similar to, or slightly higher than, those observed in healthy subjects.
V študiji pri bolnikih z revmatoidnim artritisom so se koncentracije simvastatina (CYP3A4) en teden po enkratnem odmerku zdravila RoActemra znižale za 57 % in dosegle podobne ali malo višje koncentracije od teh, ki so jih izmerili pri zdravih ljudeh.
Administration of RoActemra should be interrupted if a patient develops a serious infection until the infection is controlled (see section 4.8).
Če se pojavi resna okužba, je treba uporabo zdravila RoActemra prekiniti, dokler okužba ni obvladana (glejte poglavje 4.8).
There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA patients.
Ni izkušenj z uporabo zdravila RoActemra z zaviralci TNF ali drugimi biološkimi zdravili za revmatoidni artritis.
Study SC-II evaluated patients with moderate to severe active RA who had an inadequate clinical response to their existing rheumatologic therapy, including one or more DMARD(s) where approximately 20% had a history of inadequate response to at least one TNF inhibitor.
V študiji SC-II so ocenjevali bolnike z zmernim do hudo aktivnim revmatoidnim artritisom, ki se niso zadostno klinično odzvali na svoje obstoječe revmatološko zdravljenje, vključno z enim ali več imunomodulirajočimi antirevmatičnimi zdravili, pri čemer jih približno 20 % v preteklosti ni imelo zadostnega odziva na najmanj enega zaviralca TNF.
Elderly No dose adjustment is required in elderly patients >65 years of age.
Starejši Starejšim bolnikom (> 65 let) odmerka ni treba prilagoditi.
The rate of infection/serious infection events was balanced between the RoActemra weekly group (200.2/9.7 events per 100 patient years) vs. placebo plus 26 weeks prednisone taper (156.0/4.2 events per 100 patient years) and placebo plus 52 weeks taper (210.2/12.5 events per 100 patient years) groups.
RoActemra (200,2/9,7 dogodkov na 100 bolnik-let), s placebom in 26-tedenskim zmanjševanjem prednizona (156,0/4,2 dogodkov na 100 bolnik-let) in s placebom in 52-tedenskim zmanjševanjem (210,2/12,5 dogodkov na 100 bolnik-let).
The frequency of ADRs in pJIA patients can be found in Table 2.
Pogostnost neželenih učinkov pri bolnikih s pJIA je navedena v preglednici 2.
Check the liquid in the RoACTEMRA pre-filled pen (See Figure C).
Preverite raztopino v napolnjenem injekcijskem peresniku zdravila RoACTEMRA (glejte sliko C).
• Do not throw away (dispose of) the pre-filled pen and the green cap in your household trash and do not recycle them.
• Napolnjenega injekcijskega peresnika in zelenega pokrovčka ne smete odvreči (odložiti) med gospodinjske odpadke; prav tako ju ni mogoče reciklirati.
Available data suggest that clinical improvement is observed within 6 weeks of initiation of treatment with RoActemra.
Razpoložljivi podatki kažejo, da je klinično izboljšanje opaženo v 6 tednih po začetku zdravljenja z zdravilom RoActemra.
• Insert the needle all the way into the pinched skin at an angle between 45° to 90° with a quick,
• Injekcijsko iglo popolnoma vstavite v kožno gubo pod kotom 45° do 90° hitro in odločno (glejte sliko E).
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. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Bolnike, zdravljene z individualno prilagojenimi zdravili, ki se presnavljajo s CYP450 3A4, 1A2 ali 2C9 (npr. metilprednizolon, deksametazon (z možnim odtegnitvenim sindromom peroralnih glukokortikoidov), atorvastatin, zaviralci kalcijevih kanalčkov, teofilin, varfarin, fenprokumon,
Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including RoActemra (see section 4.8, Undesirable effects).
Pri bolnikih, ki so prejemali imunosupresivna zdravila, vključno z zdravilom RoActemra, so poročali o resnih in včasih smrtnih okužbah (glejte poglavje 4.8, Neželeni učinki).
The purpose of Part 2 was to describe the long-term safety and maintenance of efficacy after 52 weeks of RoActemra therapy, to explore the rate of relapse and the requirement for RoActemra therapy beyond 52 weeks, and to gain insight into the potential long-term steroid-sparing effect of RoActemra.
deleža ponovitev in potrebe po več kakor 52-tedenskem zdravljenju z zdravilom RoActemra ter pridobitev vpogleda v možen dolgoročni učinek zdravila RoActemra na varčevanje z glukokortikoidi.
In general, the safety profile observed in patients with pJIA was consistent with the known safety profile of RoActemra with the exception of ISRs (see Table 1).
Na splošno se je varnostni profil, opažen pri bolnikih s pJIA, skladal z znanim varnostnim profilom zdravila RoActemra, z izjemo reakcij na mestu injiciranja (glejte preglednico 1).
Therefore, RoActemra doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Odmerki zdravila RoActemra, večji od 800 mg na infuzijo, torej niso priporočljivi (glejte poglavje 4.2).
The long-term exposure population includes all patients who received at least one dose of RoActemra 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 zdravila RoActemra v obdobju dvojno slepe kontrole ali pa v odprti, podaljšani fazi študije.
The dose-response curve for RoActemra flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in RoActemra concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with > 800 mg of RoActemra.
Krivulja odmerek-odziv za zdravilo RoActemra je pri večji izpostavljenosti bolj položna, kar pomeni manjše poraste učinkovitosti pri vsakem nadaljnjem povečanju koncentracije zdravila RoActemra; tako pri bolnikih, zdravljenih z več kot 800 mg zdravila RoActemra, niso dokazali klinično pomembnih porastov učikovitosti.
In the open-label extension of Study II the inhibition of progression of structural joint damage in tocilizumab plus MTX-treated patients was maintained in the second year of treatment.
V odprti, podaljšani fazi študije II se je zaviranje strukturne okvare sklepov pri bolnikih, ki so prejemali tocilizumab in metotreksat, ohranilo v drugem letu zdravljenja.
The accumulation ratios for AUC, Cmin, and Cmax were 6.32, 6.30, and 5.27, respectively.
Deleži kopičenja so bili 6,32 za AUC, 6,30 za Cmin in 5,27 za Cmax.
1p<0.0001, tocilizumab vs. placebo
1p < 0,0001, tocilizumab v primerjavi s placebom
If you stop being given RoActemra
Če so vam prenehali dajati zdravilo RoActemra
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.
Če se simptomi tuberkuloze (vztrajen kašelj, izguba telesne mase, ravnodušnost, blago zvišana telesna temperatura) ali katere koli druge okužbe pojavijo med zdravljenjem ali po njem, to nemudoma povejte svojemu zdravniku.
The majority of ISRs reported were Grade 1 events and all ISRs reported were non-serious and none required patient withdrawal from treatment or dose interruption.
Večina reakcij na mestu injiciranja, o katerih so poročali, je bila 1. stopnje, vse so bile neresne in nobena od njih ni zahtevala prenehanja zdravljenja ali prekinitve odmerjanja.
Patients who transition from tocilizumab IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified health care professional.
Bolniki, ki prehajajo z zdravljenja z intravenskim tocilizumabom na subkutano dajanje, si morajo v času naslednjega načrtovanega intravenskega odmerka prvi subkutani odmerek aplicirati pod nadzorom usposobljenega zdravstvenega delavca.
The adjusted mean change in the pain VAS after 40 weeks of tocilizumab treatment was 32.4 mm on a 0-100 mm scale compared to a reduction of 22.3 mm for placebo patients (highly statistically significant; p=0.0076).
32,4 mm na lestvici 0-100 mm v primerjavi z zmanjšanjem za 22,3 mm za bolnike na placebu (zelo statistično signifikantno; p = 0,0076).
One patient in the 10 mg/kg < 30kg group developed positive anti-tocilizumab antibodies without developing a hypersensitivity reaction and subsequently withdrew from the study.
Pri enem bolniku, ki se je zdravil z 10 mg/kg v skupini s telesno maso < 30 kg, so se pojavila protitelesa proti tocilizumabu brez preobčutljivostne reakcije.
The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the RoActemra arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Povprečno povišanje LDL od pričetka zdravljenja je bilo 0,64 mmol/l (25 mg/dl) pri bolnikih v skupini z zdravilom RoActemra in 0,19 mmol/l (7 mg/dl) pri bolnikih v skupini z adalimumabom.
There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist.
Bolniki, ki so že bili zdravljeni z antagonistom TNF, imajo lahko večje tveganje za nevtropenijo.
When platelet count is > 100 x 103/µl resume RoActemra
Ko je število trombocitov > 100 x 103/μl, znova uvedite zdravilo RoActemra.
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and / or GCA.
Zdravljenje mora vpeljati zdravnik, ki ima izkušnje s prepoznavanjem in zdravljenjem revmatoidnega artritisa, sJIA, pJIA in/ali GCA.
• RoActemra can also be used to treat adults who have not had previous methotrexate treatment if they have severe, active and progressive rheumatoid arthritis.
• Zdravilo RoActemra se lahko uporablja tudi za zdravljenje odraslih bolnikov s hudim, aktivnim in napredujočim revmatoidnim artritisom brez predhodnega zdravljenja z metotreksatom.
All TCZ
teden TCZ