natgillin/translations-raw huggingface dataset:
Treatment with Kevzara was associated with increases in lipid parameters such as LDL cholesterol, HDL cholesterol, and/or triglycerides (see section 4.8).
Zdravljenje z zdravilom Kevzara je bilo povezano z zvišanjem vrednosti lipidov, na primer holesterola LDL, holesterola HDL in/ali trigliceridov (glejte poglavje 4.8).
• You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button (navel).
• Injicirate lahko v stegno ali v trebuh; razen v predel 5 cm okrog popka.
Transaminases increased
Zvišanje vrednosti transaminaz
In 17 patients with RA, one week following a single 200-mg subcutaneous administration of sarilumab, exposure of simvastatin and simvastatin acid decreased by 45% and 36%, respectively (see section 4.5).
Pri 17 bolnikih z RA se je en teden po enkratnem 200-mg subkutanem odmerku sarilumaba izpostavljenost simvastatinu zmanjšala za 45 % in izpostavljenost simvastatinski kislini za 36 % (glejte poglavje 4.5).
Low Platelet Count Lab Value (cells x 103/µL)
Majhno število trombocitov Laboratorijska vrednost (celice x 103/µl)
• Low white blood cell counts shown by blood tests
• majhno število belih krvnih celic (pokaže se na preiskavi krvi)
Figure 2: Percent of ACR20 Response by Visit for TARGET
Slika 2: Odstotek odziva ACR20 po obisku v študiji TARGET
DAS28-ESR remission (< 2.6), n (%)
DAS28-SR remisija (< 2,6), n (%)
DAS28-ESR (primary endpoint)
DAS28-SR (primarni opazovani dogodek)
The excretion of sarilumab in milk has not been studied in animals (see section 5.3).
Izločanja sarilumaba v mleko pri živalih niso raziskali (glejte poglavje 5.3).
Results at 52 weeks in MOBILITY were similar to the results at 24 weeks for TARGET.
Rezultati študije MOBILITY so bili po 52 tednih podobni rezultatom študije TARGET po 24 tednih.
All presentations contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel staked needle and an elastomer plunger stopper.
Vse oblike vsebujejo 1,14 ml raztopine v brizgi (steklo tipa 1), opremljeni z nameščeno iglo iz nerjavnega jekla in elastomernim čepom bata.
Kevzara has no or negligible influence on the ability to drive or operate machinery.
Zdravilo Kevzara nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Kevzara 200 mg was superior to adalimumab 40 mg in reducing disease activity and improving physical function, with more patients achieving clinical remission over 24 weeks (see Table 6).
200 mg zdravila Kevzara je bilo superiorno 40 mg adalimumaba pri zmanjšanju aktivnosti bolezni in izboljšanju telesnega delovanja in po 24 tednih je z njim doseglo klinično remisijo več bolnikov (glejte preglednico 6).
• You and your doctor should decide if you should use Kevzara if you are breast-feeding.
• Skupaj z zdravnikom se morate odločiti, ali naj uporabljate zdravilo Kevzara, ko dojite.
Sarilumab is a human monoclonal antibody selective for the interleukin-6 (IL-6) receptor, produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Sarilumab je človeško monoklonsko protitelo, selektivno za receptor interlevkina-6 (IL-6), pridobljeno v celicah jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
Table 2: Incidence of liver enzyme abnormalities in controlled clinical studies
Preglednica 2: Pojavnost nenormalnih vrednosti jetrnih encimov v kontroliranih kliničnih študijah
The median tmax after a single subcutaneous dose was observed in 2 to 4 days.
Mediani tmax po enkratnem subkutanem odmerku je bil dosežen v 2
The pre-filled syringe/pre-filled pen should be inspected before use.
Napolnjeno injekcijsko brizgo/napolnjeni injekcijski peresnik je treba pred uporabo pregledati.
Push the plunger down.
Potisnite bat dol.
• abnormal liver function tests
• nenormalni testi delovanja jeter
s*
RD*
Caution should be exercised in patients who start Kevzara treatment while on therapy with CYP3A4 substrates (e.g., oral contraceptives or statins), as Kevzara may reverse the inhibitory effect of IL-6 and restore CYP3A4 activity, leading to decreased exposure and activity of CYP3A4 substrate.
Previdnost je potrebna pri bolnikih, ki začnejo zdravljenje z zdravilom Kevzara med zdravljenjem s substrati CYP3A4 (npr. peroralnimi kontraceptivi ali statini), ker lahko zdravilo Kevzara preobrne zaviralni učinek IL-6 in obnovi aktivnost CYP3A4 ter tako zmanjša izpostavljenost substratu CYP3A4 in njegovo aktivnost (glejte poglavje 5.2).
• injection-site reactions (including redness and itching).
• reakcije na mestu injiciranja (vključno s pordelostjo in srbenjem).
• Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action.
• Zdravilo Kevzara se veže na drugo beljakovino, imenovano interlevkin-6 (IL-6), in prepreči njeno delovanje.
Other medicines and Kevzara
Druga zdravila in zdravilo Kevzara
• you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild fever), or have been in close contact with someone with TB.
• imate tuberkulozo (TB), simptome TB (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišano telesno temperaturo) ali če ste bili v tesnem stiku s kom, ki ima TB.
If you stop using Kevzara
Če ste prenehali uporabljati zdravilo Kevzara
These elevations were not associated with clinically relevant increases in direct bilirubin, nor were they associated with clinical evidence of hepatitis or hepatic insufficiency (see section 4.4).
Ta zvišanja niso bila povezana s klinično pomembnim zvišanjem vrednosti direktnega bilirubina; prav tako niso bila povezana s kliničnimi manifestacijami hepatitisa ali insuficience jeter (glejte poglavje
There is no specific treatment for Kevzara overdose.
Specifičnega zdravljenja za preveliko odmerjanje zdravila Kevzara ni.
Patients presenting with new onset abdominal symptoms such as persistent pain with fever should be evaluated promptly (see section 4.8).
Bolnike z novonastalimi trebušnimi simptomi, na primer z dolgotrajnimi bolečinami in zvišano telesno temperaturo, je treba nemudoma oceniti (glejte poglavje 4.8).
Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25 ºC.
Ko je zdravilo Kevzara vzeto iz hladilnika, ga je treba uporabiti v 14 dneh in ga je treba shranjevati na temperaturi do 25 °C.
• Do not take Kevzara if you are pregnant unless your doctor specifically recommends it.
• Če ste noseči, ne jemljite zdravila Kevzara, razen če vam to izrecno svetuje zdravnik.
Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs).
Zdravilo Kevzara je v kombinaciji z metotreksatom (MTX) indicirano za zdravljenje zmerno do zelo aktivnega revmatoidnega artritisa (RA) pri odraslih bolnikih, ki so se neustrezno odzvali ne eno ali več imunomodulirajočih antirevmatičnih zdravil (DMARD - disease modifying antirheumatic drugs) ali takšnih zdravil ne prenesejo.
Reduction in platelets was not associated with bleeding events (see section 4.8).
Zmanjšanje števila trombocitov ni bilo povezano s krvavitvami (glejte poglavje 4.8).
Keep the carton in an insulated bag with an ice pack when travelling.
Ko potujete, imejte škatlo shranjeno v izolirani vrečki z ledenim vložkom.
Ask your doctor, pharmacist or nurse how to throw away the container.
Zdravnika, farmacevta ali medicinsko sestro vprašajte, kako zavreči vsebnik.
Clinically appropriate dose modification of concomitant DMARDs should be considered.
Razmisliti je treba o klinično ustrezni prilagoditvi sočasno uporabljanih
No data are available on the effect of sarilumab on human fertility.
Podatkov o vplivu sarilumaba na plodnost pri človeku ni.
Kevzara is used to treat adults with moderately to severely active rheumatoid arthritis if previous therapy did not work well enough or was not tolerated.
Zdravilo Kevzara uporabljamo za zdravljenje odraslih z zmerno do zelo aktivnim revmatoidnim artritisom, če pred tem uporabljena zdravila niso dovolj dobro delovala ali jih niso prenesli.
In isolated cases, disseminated rather than localised infections were observed in patients often taking concomitant immunosuppressants such as MTX or corticosteroids, which in addition to RA may predispose them to infections.
posameznih primerih so opažali diseminirane (ne lokalizirane) okužbe pri bolnikih, ki so pogosto sočasno uporabljali imunosupresive, npr. metotreksat ali kortikosteroide, ki lahko poleg RA povečujejo nagnjenost k okužbam.
p-value versus adalimumab *Includes patients who increased the frequency of dosing of adalimumab 40 mg to every week because of an inadequate response
*Vključuje bolnike, ki so zaradi neustreznega odziva pogostnost uporabe 40 mg adalimumaba povečali na vsak teden.
Kevzara can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate.
Zdravilo Kevzara je mogoče znova začeti uporabljati v odmerku 150 mg na 2 tedna in odmerek povečati na 200 mg na 2 tedna, kot je klinično primerno.
At steady state, exposure over the dosing interval measured by AUC increased approximately 2fold with a 1.33-fold increase in dose from 150 to 200 mg every two weeks.
V stanju dinamičnega ravnovesja se je izpostavljenost v odmernem intervalu, merjena z AUC, povečala približno 2-krat ob 1,33-kratnem povečanju odmerka s 150 mg na 200 mg na 2
Radiographs of hands and feet were obtained at baseline, 24 weeks, and 52 weeks and scored independently by at least two well-trained readers who were blinded to treatment group and visit number.
Rentgenske posnetke dlani in stopal so naredili na začetku študije, 24. teden in 52. teden; posnetke sta neodvisno ocenila vsaj dva dobro usposobljena pregledovalca, ki nista bila seznanjena s terapevtsko skupino in številom obiskov.
Kevzara should not be administered in patients with an active infection, including localised infections.
Zdravila Kevzara se ne sme dajati bolnikom, ki imajo aktivno okužbo; to velja tudi za lokalizirane okužbe.
Before you use Kevzara, your doctor will do a blood test to check your liver function.
Preden boste uporabili zdravilo Kevzara, bo zdravnik opravil preiskave krvi, da bo preveril delovanje jeter.
• The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.
• Druge sestavine so arginin, histidin, polisorbat 20, saharoza in voda za injekcije.
In a usability study sarilumab exposure after 200 mg Q2W was slightly higher (Cmax + 24-34%, AUC(0-2w) +7-21%) after use of a pre-filled pen compared to the pre-filled syringe.
V študiji uporabnosti je bila izpostavljenost sarilumabu po 200 mg na 2 tedna nekoliko večja (Cmax + 24-34 %, AUC(0-2t) +7-21 %) z uporabo napolnjenega injekcijskega peresnika kot z uporabo napolnjene injekcijske brizge.
The absolute bioavailability for sarilumab after SC injection was estimated to be 80% by population PK analysis.
Na podlagi populacijske farmakokinetične analize je ocenjena absolutna biološka uporabnost sarilumaba po s.c. injiciranju 80 %.
Reports of gastrointestinal perforation were primarily reported as complications of diverticulitis including lower GI perforation and abscess.
O perforacijah prebavil so poročali predvsem kot o zapletu divertikulitisa, vključno s perforacijo v spodnjih prebavilih in z abscesi.
Before you are given Kevzara, your doctor will check you for TB.
Preden boste dobili zdravilo Kevzara, vas bo zdravnik testiral glede TB.
• Contact details of the prescriber for Kevzara.
• Kontaktne podatke zdravnika, ki je predpisal zdravilo Kevzara.
Patients treated with Kevzara should be given the patient alert card.
Bolniki, zdravljeni z zdravilom Kevzara, morajo dobiti opozorilno kartico bolnika.
MTX exposure is not expected to be changed by sarilumab coadministration; however, no clinical data was collected.
Ni pričakovati, da bi sočasna uporaba sarilumaba spremenila izpostavljenost metotreksatu, vendar pa o tem ni nobenih kliničnih podatkov.
• underlying conditions that may predispose them to infection;
• neko osnovno bolezen, ki lahko poveča nagnjenost k okužbam,
Keep holding the pen firmly against your skin.
Peresnik še naprej držite trdno ob kožo.
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections.
Pomožne snovi: histidin, arginin, polisorbat 20, saharoza, voda za injekcije.
Treatment with Kevzara + MTX was associated with significantly less radiographic progression of structural damage as compared with placebo.
Zdravljenje z zdravilom Kevzara + metotreksatom je bilo povezano z značilno manjšim rentgenografskim napredovanjem strukturne okvare kot uporaba placeba.
The weight of evidence for IL-6Rα inhibition mainly indicates anti-tumour effects mediated by multiple mechanisms predominantly involving STAT-3 inhibition.
Zbrani dokazi o zavrtju IL-6Rα kažejo predvsem protitumorske učinke, ki jih posreduje več mehanizmov, predvsem preko zavrtja STAT-3.
• Use the pre-filled syringe exactly as described in the “Instructions for Use”.
• Napolnjen injekcijski peresnik uporabite natančno tako, kot je opisano v "Navodilih za uporabo".
Kevzara should not be injected into skin that is tender, damaged, or has bruises or scars.
Zdravila Kevzara se ne sme injicirati v kožo, ki je občutljiva, poškodovana, ima podplutbe ali brazgotine.
The safety and efficacy of Kevzara in children up to 18 years of age have not been established.
Pediatrična populacija: Varnost in učinkovitost zdravila Kevzara nista ugotovljeni pri otrocih do 18. leta starosti.
The pharmacokinetics of sarilumab were characterised in 2186 patients with RA treated with sarilumab which included 751 patients treated with 150 mg and 891 patients treated with 200 mg subcutaneous doses every two weeks for up to 52 weeks.
Farmakokinetiko sarilumaba so raziskali pri 2186 bolnikih z RA, zdravljenih do 52 tednov s sarilumabom subkutano na 2 tedna, med njimi je bilo 751 bolnikov zdravljenih s 150 mg in 891 bolnikov zdravljenih z 200 mg.
Results at 24 weeks in TARGET were similar to the results at 52 weeks in MOBILITY (see Table 3).
Rezultati študije TARGET so bili po 24 tednih podobni rezultatom študije MOBILITY po 52 tednih (glejte preglednico 3).
• The active substance is sarilumab.
• Zdravilna učinkovina je sarilumab.
Liver enzyme abnormalities are summarised in Table 2.
Nenormalne vrednosti jetrnih encimov so povzete v preglednici 2.
Insert the needle into the fold of skin at roughly a 45º angle.
Zabodite iglo v to kožno gubo pod kotom približno 45 stopinj.
Mild to moderate renal impairment did not affect the pharmacokinetics of sarilumab.
Blaga do zmerna okvara ledvic ni vplivala na farmakokinetiko sarilumaba.
In vitro and in vivo studies with sarilumab using human tumour cell lines showed inhibition of STAT-3 activation and inhibition of tumour growth in human tumour xenograft animal models.
Študije sarilumaba na celičnih linijah človeških tumorskih celic in vitro in in vivo so pokazale zavrtje aktivacije STAT-3 in zavrtje tumorske rasti v živalskih ksenotransplantacijskih modelih človeških tumorjev.
If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.
Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, ali pokličite telefonsko številko družbe sanofi-aventis d.o.o., ki je navedena na navodilu za uporabo.
The activity of sarilumab in reducing inflammation is associated with laboratory changes such as decrease in ANC and elevation in lipids (see section 4.4).
Vpliv sarilumaba na zmanjšanje vnetja je povezan z laboratorijskimi spremembami, npr. z znižanjem AŠN in zvišanjem lipidov (glejte poglavje 4.4).
Elevated levels of interleukin-6 (IL-6) may down-regulate CYP activity such as in patients with RA and hence increase drug levels compared to subjects without RA.
Zvišana raven interlevkina-6 (IL-6) lahko zmanjša aktivnost CYP kot npr. pri bolnikih z RA in tako lahko zviša koncentracijo zdravil v primerjavi z osebami brez RA.
Treatment with Kevzara should be discontinued.
Zdravljenje z zdravilom Kevzara je treba prenehati.
If a dose of Kevzara is missed and it has been 3 days or less since the missed dose, the next dose should be administered as soon as possible.
Če je bolnik pozabil uporabiti zdravilo Kevzara in so od izpuščenega odmerka minili 3 dnevi ali manj, je treba odmerek uporabiti čim prej.
Do not recycle your used puncture-resistant container.
Ne reciklirajte uporabljenega vsebnika za ostre odpadke.
This is because Kevzara can affect the way some other medicines work.
Zdravilo Kevzara namreč lahko vpliva na delovanje nekaterih drugih zdravil.
Treatment with Kevzara should be withheld until >1 x 109/L.
Zdravljenje z zdravilom Kevzara je treba prekiniti, dokler ni dosežena vrednost > 1 x 109/l.
>3 x ULN5 x ULN >5 x ULN
> 3 x ZNM5-kratna ZNM > 5 x ZNM
What Kevzara is and what it is used for What Kevzara is
Kaj je zdravilo Kevzara in za kaj ga uporabljamo Kaj je zdravilo Kevzara
Do not touch the injection site again before the injection.
Ne dotikajte se več mesta injiciranja, preden injicirate zdravilo.
Lipid parameters should be assessed approximately 4 to 8 weeks following initiation of treatment with Kevzara, then at approximately 6 month intervals.
Vrednosti lipidov je treba oceniti približno 4 do 8 tednov po uvedbi zdravljenja z zdravilom Kevzara in nato v 6-mesečnih presledkih.
Treatment with Kevzara should be withheld until >100 x 103/µL.
Zdravljenje z zdravilom Kevzara je treba prekiniti, dokler ni dosežena vrednost > 100 x 103/µl.
It is a type of protein - called a “monoclonal antibody”.
Ta učinkovina je posebna vrsta beljakovine; takšne beljakovine imenujemo "monoklonska protitelesa".
Patients should be closely monitored for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Bolnike je treba skrbno nadzirati glede pojava znakov ali simptomov tuberkuloze; to velja tudi za bolnike, ki so imeli pred uvedbo zdravljenja negativen izvid testiranja za latentno tuberkulozo.
• Check that the liquid is clear and colourless to pale yellow.
• Preverite, da je tekočina bistra in brezbarvna do bledorumena.
What you need to know before you use Kevzara Do not use Kevzara:
Kaj morate vedeti, preden boste uporabili zdravilo Kevzara Ne uporabljajte zdravila Kevzara
This is to check for low blood cell count, liver problems, or changes in your cholesterol levels.
Tako bo zdravnik preveril morebitno zmanjšanje števila krvnih celic, težave z jetri ali spremembe koncentracije holesterola.
To allow for a direct comparison of frequency of laboratory abnormalities between placebo and active treatment, data from weeks 0-12 were used as this was prior to patients being permitted to switch from placebo to Kevzara.
Podatki od tedna od 0 do 12 so bili uporabljeni za neposredno primerjavo pogostnosti laboratorijskih nepravilnosti med zdravljenjem s placebom in zdravilom; v tem obdobju je bilo bolnikom dovoljeno preiti s placeba na zdravilo Kevzara.
The impact of treatment with Kevzara on the development of malignancies is not known but malignancies were reported in clinical studies (see section 4.8).
Vpliv zdravljenja z zdravilom Kevzara na nastanek malignih bolezni ni znan, toda v kliničnih študijah so bile opisane maligne bolezni (glejte poglavje 4.8).
If anaphylaxis or other hypersensitivity reaction occurs, administration of Kevzara should be stopped immediately.
Če se pojavi anafilaksija ali druga preobčutljivostna reakcija, je treba dajanje zdravila Kevzara nemudoma končati.
Among opportunistic infections, tuberculosis, candidiasis, and pneumocystis were reported with Kevzara.
Med oportunističnimi okužbami so med uporabo zdravila Kevzara poročali o tuberkulozi, kandidozi in pnevmocistozi.
MONARCH was a 24 -week randomised double-blind, double-dummy study that compared Kevzara 200 mg monotherapy with adalimumab 40 mg monotherapy administered subcutaneously every two weeks in 369 patients with moderately to severely active RA who were inappropriate for treatment with MTX including those who were intolerant of or inadequate responders to MTX.
Študija MONARCH je bila 24-tedenska, randomizirana, dvojno slepa študija z vzporednim placebom, ki je primerjala monoterapijo z 200 mg zdravila Kevzara in monoterapijo s 40 mg adalimumaba, uporabljanima subkutano na dva tedna pri 369 bolnikih z zmerno do zelo aktivnim RA, ki niso bili primerni za zdravljenje z metotreksatom (vključno z bolniki, ki metotreksata niso prenesli ali se nanj niso ustrezno odzvali).
Viral reactivation has been reported with immunosuppressive biologic therapies.
Med uporabo imunosupresivnih bioloških zdravil so poročali o reaktivaciji virusov.
Week 24
Povprečna sprememba 24. teden
Traceability of Kevzara
Sledljivost zdravila Kevzara
In MOBILITY, structural joint damage was assessed radiographically and expressed as change in van der Heijde-modified Total Sharp Score (mTSS) and its components, the erosion score, and joint space narrowing score at Week 52.
V študiji MOBILITY so strukturno prizadetost sklepov ocenjevali rentgenografsko; izrazili so jo s spremembo van der Heijdejeve modificirane celotne Sharpove ocene (mTSS) in njenih komponent, oceno erozij in oceno zožitve sklepne špranje po 52 tednih.
Do not use the syringe if it has been out of the refrigerator for more than 14 days.
Ne uporabite brizge, ki je bila zunaj hladilnika več kot 14 dni.
What Kevzara looks like and contents of the pack
Izgled zdravila Kevzara in vsebina pakiranja
Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme elevations (see sections 4.4 and 4.8):
Priporočene prilagoditve odmerka v primeru nevtropenije, trombocitopenije ali zvišanja jetrnih encimov (glejte poglavji 4.4 in 4.8):
The most common serious adverse reactions were infections (see section 4.4).
Najpogostejši resen neželen učinek so bile okužbe (glejte poglavje 4.4).
The percentages of Kevzara + DMARDs-treated patients achieving ACR20, ACR50, and ACR70 responses in MOBILITY and TARGET are shown Table 3.
Odstotki bolnikov, ki so prejemali kombinacijo zdravila Kevzara in DMARD ter so v študijah MOBILITY in TARGET dosegli odzive ACR20, ACR50 in ACR70, so prikazani v preglednici 3.
No correlation was observed between ADA development and either loss of efficacy or adverse events.
Med pojavom protiteles proti zdravilu in izgubo učinkovitosti ali neželenimi učinki niso ugotovili korelacije.
At Week 4 the mean LDL increased by 14 mg/dL; mean triglycerides increased by 23 mg/dL; and mean HDL increased by 3 mg/dL. After Week 4 no additional increases were observed.
Četrti teden se je povprečni LDL zvišal za 14 mg/dl, povprečni trigliceridi za 23 mg/dl in povprečni HDL za 3 mg/dl.
Press down and hold the pen firmly against your skin.
Peresnik pritisnite dol in ga trdno držite ob kožo.
After use, place the pre-filled syringe/ pre-filled pen into a puncture-resistant container and discard as required by local regulations.
Po uporabi dajte napolnjeno injekcijsko brizgo/napolnjen injekcijski peresnik v vsebnik, odporen proti prebadanju, in zavrzite v skladu z lokalnimi predpisi.
• Using the syringe at room temperature may make the injection more comfortable.
• Če je brizga ogreta na sobno temperaturo, je lahko injiciranje manj neprijetno.
Physical function response
Odziv telesnega delovanja
These elevations were transient and did not result in any clinically evident hepatic injury in clinical studies (see section 4.8).
Ta zvišanja so bila v kliničnih študijah prehodna in niso povzročila klinično opazne prizadetosti jeter (glejte poglavje 4.8).
How to store Kevzara 6.
Shranjevanje zdravila Kevzara 6.
The most frequently observed serious infections with Kevzara included pneumonia and cellulitis (see section 4.8).
Med najpogosteje zabeleženimi resnimi okužbami med uporabo zdravila Kevzara sta bili pljučnica in celulitis (glejte poglavje 4.8).
The primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24 and the changes from baseline HAQ-DI score at Week 12.
Primarna opazovana dogodka sta bila delež bolnikov, ki so dosegli odziv ACR20 24. teden in spremembe ocene HAQ-DI od izhodišča 12. teden.
• Keep your hand away from the plunger.
• Roke ne približujte batu.