FrancophonIA/ELRC3.0 huggingface dataset:
English: It is a type of protein - called a “monoclonal antibody”.
Slovenian: Ta učinkovina je posebna vrsta beljakovine; takšne beljakovine imenujemo "monoklonska protitelesa".
English: 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.
Slovenian: 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.
English: • Check that the liquid is clear and colourless to pale yellow.
Slovenian: • Preverite, da je tekočina bistra in brezbarvna do bledorumena.
English: What you need to know before you use Kevzara Do not use Kevzara:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Kevzara Ne uporabljajte zdravila Kevzara
English: This is to check for low blood cell count, liver problems, or changes in your cholesterol levels.
Slovenian: Tako bo zdravnik preveril morebitno zmanjšanje števila krvnih celic, težave z jetri ali spremembe koncentracije holesterola.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Vpliv zdravljenja z zdravilom Kevzara na nastanek malignih bolezni ni znan, toda v kliničnih študijah so bile opisane maligne bolezni (glejte poglavje 4.8).
English: If anaphylaxis or other hypersensitivity reaction occurs, administration of Kevzara should be stopped immediately.
Slovenian: Če se pojavi anafilaksija ali druga preobčutljivostna reakcija, je treba dajanje zdravila Kevzara nemudoma končati.
English: Among opportunistic infections, tuberculosis, candidiasis, and pneumocystis were reported with Kevzara.
Slovenian: Med oportunističnimi okužbami so med uporabo zdravila Kevzara poročali o tuberkulozi, kandidozi in pnevmocistozi.
English: 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.
Slovenian: 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).
English: Viral reactivation has been reported with immunosuppressive biologic therapies.
Slovenian: Med uporabo imunosupresivnih bioloških zdravil so poročali o reaktivaciji virusov.
English: Week 24
Slovenian: Povprečna sprememba 24. teden
English: Traceability of Kevzara
Slovenian: Sledljivost zdravila Kevzara
English: 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.
Slovenian: 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.
English: Do not use the syringe if it has been out of the refrigerator for more than 14 days.
Slovenian: Ne uporabite brizge, ki je bila zunaj hladilnika več kot 14 dni.
English: What Kevzara looks like and contents of the pack
Slovenian: Izgled zdravila Kevzara in vsebina pakiranja
English: Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme elevations (see sections 4.4 and 4.8):
Slovenian: Priporočene prilagoditve odmerka v primeru nevtropenije, trombocitopenije ali zvišanja jetrnih encimov (glejte poglavji 4.4 in 4.8):
English: The most common serious adverse reactions were infections (see section 4.4).
Slovenian: Najpogostejši resen neželen učinek so bile okužbe (glejte poglavje 4.4).
English: The percentages of Kevzara + DMARDs-treated patients achieving ACR20, ACR50, and ACR70 responses in MOBILITY and TARGET are shown Table 3.
Slovenian: 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.
English: No correlation was observed between ADA development and either loss of efficacy or adverse events.
Slovenian: Med pojavom protiteles proti zdravilu in izgubo učinkovitosti ali neželenimi učinki niso ugotovili korelacije.
English: 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.
Slovenian: Četrti teden se je povprečni LDL zvišal za 14 mg/dl, povprečni trigliceridi za 23 mg/dl in povprečni HDL za 3 mg/dl.
English: Press down and hold the pen firmly against your skin.
Slovenian: Peresnik pritisnite dol in ga trdno držite ob kožo.
English: After use, place the pre-filled syringe/ pre-filled pen into a puncture-resistant container and discard as required by local regulations.
Slovenian: Po uporabi dajte napolnjeno injekcijsko brizgo/napolnjen injekcijski peresnik v vsebnik, odporen proti prebadanju, in zavrzite v skladu z lokalnimi predpisi.
English: • Using the syringe at room temperature may make the injection more comfortable.
Slovenian: • Če je brizga ogreta na sobno temperaturo, je lahko injiciranje manj neprijetno.
English: Physical function response
Slovenian: Odziv telesnega delovanja
English: These elevations were transient and did not result in any clinically evident hepatic injury in clinical studies (see section 4.8).
Slovenian: Ta zvišanja so bila v kliničnih študijah prehodna in niso povzročila klinično opazne prizadetosti jeter (glejte poglavje 4.8).
English: How to store Kevzara 6.
Slovenian: Shranjevanje zdravila Kevzara 6.
English: The most frequently observed serious infections with Kevzara included pneumonia and cellulitis (see section 4.8).
Slovenian: Med najpogosteje zabeleženimi resnimi okužbami med uporabo zdravila Kevzara sta bili pljučnica in celulitis (glejte poglavje 4.8).
English: 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.
Slovenian: Primarna opazovana dogodka sta bila delež bolnikov, ki so dosegli odziv ACR20 24. teden in spremembe ocene HAQ-DI od izhodišča 12. teden.
English: • Keep your hand away from the plunger.
Slovenian: • Roke ne približujte batu.
English: Do not use the pen if the date has passed.
Slovenian: Ne uporabite peresnika, če je ta datum že mimo.
English: Distribution In patients with RA, the apparent volume of distribution at steady state was 8.3 L.
Slovenian: Pri bolnikih z RA je bil navidezni volumen porazdelitve v stanju dinamičnega ravnovesja 8,3 l. Biotransformacija
English: Kevzara is given as an injection under the skin (called “subcutaneous” injection).
Slovenian: Zdravilo Kevzara se daje v injekcijah pod kožo (subkutanih injekcijah).
English: • Use your thumb and first (index) finger to pinch a fold of skin at the injection site.
Slovenian: • S palcem in kazalcem stisnite, da boste na mestu injiciranja naredili kožno gubo.
English: In the placebo-controlled population, the proportion of patients who discontinued treatment due to hypersensitivity reactions was higher among those treated with Kevzara (0.9% in 200 mg group, 0.5% in 150 mg group) than placebo (0.2%).
Slovenian: V populaciji, kontrolirani s placebom, je bil delež bolnikov, ki so zdravljenje prenehali zaradi preobčutljivostnih reakcij, med prejemniki zdravila Kevzara večji (0,9 % v skupini z 200 mg, 0,5 % v skupini s 150 mg) kot med prejemniki placeba (0,2 %).
English: Anti Drug Antibody (ADA) formation may affect pharmacokinetics of Kevzara.
Slovenian: Nastajanje protiteles proti zdravilu lahko vpliva na farmakokinetiko zdravila Kevzara.
English: The metabolic pathway of sarilumab has not been characterised.
Slovenian: Presnovna pot sarilumaba ni ugotovljena.
English: A more than dose-proportional increase in pharmacokinetic exposure was observed in patients with RA.
Slovenian: Pri bolnikih z RA so opažali več kot odmerku sorazmerno povečanje farmakokinetične izpostavljenosti.
English: Following single-dose sarilumab administration, in patients with RA, ANC decreased to the nadir between 3 to 4 days and thereafter recovered towards baseline (see section 4.4).
Slovenian: Po enkratnem odmerku sarilumaba je AŠN pri bolnikih z RA doseglo najnižjo točko od 3. do 4. dne, potem pa se je vrnilo proti izhodiščnemu (glejte poglavje 4.4).
English: Keep the remaining syringe in the carton in the refrigerator.
Slovenian: Preostalo brizgo pustite v škatli v hladilniku.
English: Treatment with Kevzara was associated with a higher incidence of transaminase elevations.
Slovenian: Zdravljenje z zdravilom Kevzara je bilo povezano z večjo pojavnostjo zvišanja transaminaz.
English: • you have any infection or you get a lot of infections.
Slovenian: • imate kakšno okužbo, ali če imate pogosto okužbe.
English: In patients who develop elevated ALT greater than 5 x ULN, treatment with Kevzara should be discontinued (see section 4.2).
Slovenian: Bolnikom, ki se jim ALT zviša na več kot 5-kratno ZNM, je treba zdravljenje z zdravilom Kevzara prenehati (glejte poglavje 4.2).
English: • Pull the needle out at the same angle it was injected.
Slovenian: • Izvlecite iglo pod istim kotom, kot ste jo zabodli.
English: Do not inject into skin that is tender, damaged or has bruises or scars.
Slovenian: Ne injicirajte v kožo, ki je občutljiva, poškodovana, imate podplutbe ali brazgotine.
English: No long-term animal studies have been performed to establish the carcinogenicity potential of sarilumab.
Slovenian: Dolgoročnih študij na živalih za ugotavljanje kancerogenosti sarilumaba niso izvedli.
English: Consider the risks and benefits of treatment prior to initiating Kevzara in patients who have:
Slovenian: Pred uvedbo zdravila Kevzara je treba pretehtati tveganja in koristi zdravljenja pri bolnikih, ki imajo:
English: • you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go away.
Slovenian: • ste imeli divertikulitis (to je bolezen spodnjega dela črevesa) ali razjede na želodcu ali v črevesju, ali če se vam pojavijo simptomi, kot so zvišana telesna temperatura ali bolečine v trebuhu, ki ne minejo.
English: Patients had at least 8 tender and 6 swollen joints at baseline.
Slovenian: Bolniki so imeli na začetku študije vsaj 8 občutljivih sklepov in 6 oteklih sklepov.
English: • Take one syringe out of the packaging by holding the middle of the syringe body.
Slovenian: • Vzemite brizgo iz pakiranja tako, da jo primete na sredi telesa brizge.
English: Animal studies showed no impairment of male or female fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale okvare plodnosti samcev ali samic (glejte poglavje 5.3).
English: Proper training should be provided to patients and/or caregivers on the preparation and administration of Kevzara prior to use.
Slovenian: Bolnikom in/ali negovalcem je treba pred takšno uporabo zagotoviti ustrezno usposabljanje o pripravi in dajanju zdravila.
English: Kevzara has not been studied in patients with severe renal impairment (see section 5.2).
Slovenian: Zdravilo Kevzara ni raziskano pri bolnikih s hudo okvaro ledvic (glejte poglavje 5.2).
English: If the window does not turn fully yellow, do not give yourself a second dose without speaking to your healthcare provider.
Slovenian: Če okence ne postane povsem rumeno, si ne dajte še enega odmerka, ne da bi se posvetovali z zdravnikom, farmacevtom ali medicinsko sestro.
English: Following single-dose subcutaneous (SC) administration of sarilumab 200 mg and 150 mg in patients with RA rapid reduction of CRP levels was observed.
Slovenian: Po enkratni subkutani (s.c.) uporabi 200 mg in 150 mg sarilumaba so pri bolnikih z RA opažali hitro znižanje koncentracije CRP.
English: For recommended dose modifications based on transaminase elevations see section 4.2.
Slovenian: Za priporočila o prilagoditvi odmerka glede na zvišanje transaminaz glejte poglavje 4.2.
English: • Take one pen out of the packaging by holding the middle of the pen body.
Slovenian: • Vzemite peresnik iz pakiranja tako, da ga primete na sredi telesa peresnika.
English: In patients with higher body weight (>100 Kg) both 150 mg and 200 mg doses demonstrated efficacy; however, patients weighing >100 Kg had greater therapeutic benefit with the 200 mg dose.
Slovenian: sta bila oba odmerka - 150 mg in 200 mg - učinkovita, toda bolnikom z maso > 100 kg je terapevtsko bolj koristil odmerek 200 mg.
English: Store pre-filled syringe/pre-filled pen in the original carton in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo/napolnjeni injekcijski peresnik shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: Patients should be closely monitored for the development of signs and symptoms of infection during treatment with Kevzara (see sections 4.2 and 4.8).
Slovenian: Bolnike je treba med zdravljenjem z zdravilom Kevzara skrbno nadzorovati glede pojava znakov ali simptomov okužbe (glejte poglavji 4.2 in 4.8).
English: ALT > 3 to 5 x ULN Treatment with Kevzara should be withheld until < 3 x ULN.
Slovenian: ALT > 3- do 5-kratna ZNM Zdravljenje z zdravilom Kevzara je treba prekiniti, dokler ni vrednost < 3-kratna ZNM.
English: Avoid concurrent use of live vaccines as well as live attenuated vaccines during treatment with Kevzara as clinical safety has not been established.
Slovenian: Med zdravljenjem z zdravilom Kevzara se izogibajte sočasni uporabi živih cepiv in živih oslabljenih cepiv, ker klinična varnost ni ugotovljena.
English: Table 4: Mean reductions from baseline to Week 24 in components of ACR score
Slovenian: Preglednica 4: Povprečna znižanja komponent ocene ACR od izhodišča do 24. tedna
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom.
English: Body weight influenced the pharmacokinetics of sarilumab.
Slovenian: Telesna masa je vplivala na farmakokinetiko sarilumaba.
English: Solution for injection (injection) Clear, colourless to pale yellow sterile solution of approximately pH 6.0.
Slovenian: raztopina za injiciranje (injekcija) Bistra, brezbarvna do bledorumena sterilna raztopina, ki ima pH približno 6,0.
English: No formal study of the effect of hepatic impairment on the pharmacokinetics of sarilumab was conducted (see section 4.2).
Slovenian: Okvara jeter Formalnih študij vpliva okvare jeter na farmakokinetiko sarilumaba niso izvedli (glejte poglavje 4.2).
English: The recommended dose of Kevzara is 200 mg once every 2 weeks administered as a subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Kevzara je 200 mg enkrat na 2 tedna v subkutani injekciji.
English: In patients experiencing liver enzyme elevation, modification of treatment regimen, such as interruption of Kevzara or reduction in dose, resulted in decrease or normalization of liver enzymes (see section 4.2).
Slovenian: Pri bolnikih, ki so se jim zvišale vrednosti jetrnih encimov, je prilagoditev sheme zdravljenja (npr. prekinitev uporabe zdravila Kevzara ali zmanjšanje odmerka) prinesla znižanje ali normalizacijo jetrnih encimov (glejte poglavje 4.2).
English: * q2w=every two weeks † p-value <0.001 ††p-value <0.0001 ‡ Primary end point
Slovenian: * na 2t = na 2 tedna † Vrednost p < 0,001 ††Vrednost p < 0,0001 ‡ Primarni opazovani dogodek
English: A patient may self-inject Kevzara or the patient's caregiver may administer Kevzara if their healthcare professional determines that it is appropriate.
Slovenian: Bolniki si lahko zdravilo Kevzara injicira sam ali mu zdravilo injicira njegov negovalec, če zdravnik presodi, da je to primerno.
English: • IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints,
Slovenian: • IL-6 igra pomembno vlogo pri simptomih revmatoidnega artritisa, npr. pri bolečinah, oteklosti sklepov, jutranji okorelosti in utrujenosti.
English: For the 150 mg every two weeks dose regimen, the estimated mean (± standard deviation, SD) steadystate area under curve (AUC), Cmin, and Cmax of sarilumab were 210 ± 115 mg.day/L, 6.95 ± 7.60 mg/L, and 20.4 ± 8.27 mg/L, respectively.
Slovenian: Z odmerno shemo 150 mg na 2 tedna so bila za sarilumab v stanju dinamičnega ravnovesja ocenjena povprečja (± standardni odklon): površina pod krivuljo (AUC) 210 ± 115 mg.dan/l, Cmin 6,95 ± 7,60 mg/l in Cmax 20,4 ± 8,27 mg/l.
English: In patients who develop an ANC less than 0.5 x 109/L, treatment with Kevzara should be discontinued.
Slovenian: Pri bolnikih, ki se jim AŠN zmanjša na manj kot 0,5 x 109/l, je treba zdravljenje z zdravilom Kevzara prenehati.
English: No formal study of the effect of renal impairment on the pharmacokinetics of sarilumab was conducted.
Slovenian: Formalnih študij vpliva okvare ledvic na farmakokinetiko sarilumaba niso izvedli.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Kevzara.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se pred začetkom uporabe zdravila Kevzara posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Table 1: ADRs in controlled clinical studies
Slovenian: Preglednica 1: Neželeni učinki zdravila v kontroliranih kliničnih študijah
English: In both studies, patients treated with either 200 mg or 150 mg of Kevzara + DMARDs every two weeks had higher ACR20, ACR50, and ACR70 response rates versus placebo-treated patients at Week 24.
Slovenian: V obeh študijah so imeli bolniki, zdravljeni z 200 mg ali 150 mg zdravila Kevzara v kombinaciji z DMARD na dva tedna, 24. teden višje deleže odzivov ACR20, ACR50 in ACR70 kot bolniki, ki so prejemali placebo.
English: Keep the remaining pen in the carton in the refrigerator.
Slovenian: Preostali peresnik pustite v škatli v hladilniku.
English: • infections in your sinuses or throat, blocked or runny nose and sore throat (upper respiratory tract infection)
Slovenian: • okužba v obnosnih votlinah (sinusih) ali žrelu, zamašen nos ali izcedek iz nosu in vneto žrelo (okužba zgornjih dihal)
English: If you are unsure when to inject your next dose: ask your doctor, pharmacist or nurse for instructions.
Slovenian: Če ste negotovi glede tega, kdaj injicirati naslednji odmerek, za nasvet prosite zdravnika, farmacevta ali medicinsko sestro.
English: In patients experiencing a decrease in absolute neutrophil count (ANC), modification of treatment regimen such as interruption of Kevzara or reduction in dose resulted in an increase or normalization of ANC (see section 4.2).
Slovenian: Pri bolnikih, ki se jim je zmanjšalo absolutno število nevtrofilcev (AŠN), je prilagoditev sheme zdravljenja (npr. prekinitev uporabe zdravila Kevzara ali zmanjšanje odmerka) prinesla povečanje ali normalizacijo AŠN (glejte poglavje 4.2).
English: Kevzara should not be administered to patients with known hypersensitivity to sarilumab (see section 4.3).
Slovenian: Zdravila Kevzara ne smejo dobiti bolniki z znano preobčutljivostjo za sarilumab (glejte poglavje 4.3).
English: Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating treatment with Kevzara.
Slovenian: Bolnike je treba pred uvedbo zdravila Kevzara oceniti glede dejavnikov tveganja za tuberkulozo in jih testirati za latentno okužbo.
English: It contains 150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Slovenian: Vsebuje 150 mg zdravila Kevzara za podkožno injiciranje (subkutano injiciranje) enkrat na dva tedna.
English: Initiating treatment with Kevzara is not recommended in patients with elevated transaminases, ALT or AST greater than 1.5 x ULN.
Slovenian: Uvedba zdravljenja z zdravilom Kevzara ni priporočljiva pri bolnikih z zvišanimi transaminazami, ALT ali AST na 1,5-kratno ZNM.
English: • Change injection site each time you inject.
Slovenian: • Vsakič, ko zdravilo injicirate, uporabite drugo injekcijsko mesto.
English: Events of gastrointestinal perforation have been reported in clinical studies, primarily as complications of diverticulitis.
Slovenian: V kliničnih študijah so bili opisani primeri perforacije prebavil, predvsem kot zaplet divertikulitisa.
English: • If you see any blood, press a cotton ball or gauze on the site.
Slovenian: • Če opazite kri, na mesto injiciranja pritisnite s kosmom vate ali zložencem iz gaze.
English: Following these instructions, Kevzara can be self-injected or administered by a care-giver.
Slovenian: Ob upoštevanju teh navodil, si lahko zdravilo Kevzara injicirate sami ali vam ga injicira oseba, ki skrbi za vas.
English: Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
Slovenian: Neuporabljene peresnike shranjujte v originalni škatli in v hladilniku na temperaturi od 2 do 8°C.
English: Kevzara has not been investigated in combination with Janus kinase (JAK) inhibitors or biological DMARDs such as Tumor Necrosis Factor (TNF) antagonists.
Slovenian: Zdravilo Kevzara ni raziskano v kombinaciji z zaviralci Janus-kinaze (JAK) ali z biološkimi DMARD,
English: Serious side effect
Slovenian: Resen neželen učinek
English: Non-clinical data reveal no special hazard for humans based on repeated-dose toxicity studies, carcinogenic risk assessment and reproductive and developmental toxicity studies.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih odmerkih, kancerogenega potenciala ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Kevzara Monotherapy Any Dose N = 467
Slovenian: Monoterapija z zdravilom Kevzara, kateri koli odmerek N = 467
English: Do not expose the syringe to direct sunlight.
Slovenian: Ne izpostavljajte peresnika neposredni sončni svetlobi.
English: Table 5: Mean Radiographic Change from Baseline at Week 24 and Week 52 in MOBILITY
Slovenian: Preglednica 5: Povprečna rentgenografska sprememba po 24 tednih in 52 tednih v primerjavi z izhodiščem v študiji MOBILITY
English: How to use Kevzara
Slovenian: Kako uporabljati zdravilo Kevzara
English: If confirmed by repeat testing, treatment with Kevzara should be discontinued.
Slovenian: Če je potrjeno s ponovnim testiranjem, je treba zdravljenje z zdravilom
English: Pull off the needle cap.
Slovenian: Snemite pokrovček igle.
English: The solution should not be used if it is cloudy, discoloured, or contains particles, or if any part of the device appears to be damaged.
Slovenian: Raztopine se ne sme uporabiti, če je motna, spremenjene barve ali vsebuje delce, ali če je kateri koli del pripomočka videti poškodovan.
English: The overall rates of infections and serious infections in the Kevzara monotherapy population were consistent with rates in the Kevzara + DMARDs population.
Slovenian: Celotni deleži okužb in resnih okužb so se v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, skladali z deleži v populaciji, ki je prejemala kombinacije zdravila Kevzara + DMARD.