FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor before using Kevzara if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite zdravilo Kevzara.
English: * q2w = every 2 weeks ‡ Visual analogue scale †p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo
Slovenian: * na 2t = na 2 tedna ‡ Vizualna analogna skala †Vrednost p < 0,01 za razliko od placeba.
English: Kevzara 150 mg + cDMARD
Slovenian: Kevzara 150 mg + kDMARD
English: After the last steady state dose of 150 mg and 200 mg sarilumab, the median times to non-detectable concentration are 30 and 49 days, respectively.
Slovenian: Po zadnjem odmerku sarilumaba v stanju dinamičnega ravnovesja je mediani čas do nezaznavne koncentracija po 150 mg 30 dni in po 200 mg 49 dni.
English: Kevzara 200 mg + cDMARD
Slovenian: Kevzara 200 mg + kDMARD
English: Do not
Slovenian: Česa ne smete
English: In MOBILITY and TARGET, patients receiving sarilumab 200 mg + DMARDs every two weeks or sarilumab 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs.
Slovenian: V študijah MOBILITY in TARGET so prejemniki 200 mg sarilumaba + DMARD na 2 tedna ali 150 mg sarilumaba + DMARD na 2 tedna dosegli v primerjavi z izhodiščem večje izboljšanje kot prejemniki placeba + DMARD.
English: For the 200 mg every two weeks dose regimen, the estimated mean (± SD) steady-state AUC, Cmin and Cmax of sarilumab were 396 ± 194 mg.day/L, 16.7 ± 13.5 mg/L, and 35.4 ± 13.9 mg/L, respectively.
Slovenian: Z odmerno shemo 200 mg na 2 tedna so bila za sarilumab v stanju dinamičnega ravnovesja ocenjena povprečja (± standardni odklon): AUC 396 ± 194 mg.dan/l, Cmin 16,7 ± 13,5 mg/l in Cmax 35,4 ± 13,9
English: Comprehensive instructions for the administration of Kevzara in a pre-filled syringe/pre-filled pen are given in the package leaflet.
Slovenian: Natančna navodila za dajanje zdravila Kevzara v napolnjeni injekcijski brizgi/napolnjenem injekcijskem peresniku so navedena v navodilu za uporabo.
English: Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3).
Slovenian: Sarilumab zavira z IL-6 posredovano signalizacijo, ki vključuje splošni prenašalec signalov glikoprotein 130 (gp 130) in STAT-3 (Signal Transducer and
English: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a light-orange polypropylene finger flange.
Slovenian: Napolnjena injekcijska brizga za enkratno uporabo ima pokrovček igle iz stiren-butadienskega elastomera in je opremljena z belim polistirenskim batnim zamaškom ter svetlooranžnim polipropilenskim držalom za prste.
English: In the placebo-controlled population, malignancies occurred at the same rate in patients receiving either Kevzara + DMARDs or placebo + DMARDs (1.0 events per 100 patient-years).
Slovenian: V populaciji, kontrolirani s placebom, so se maligne bolezni pri prejemnikih zdravila Kevzara + DMARD pojavile v enakem deležu kot pri prejemnikih placeba + DMARD (1,0 dogodek na 100 bolnik-let).
English: This device is a single-dose pre-filled pen (called “pen” in these instructions).
Slovenian: Ta pripomoček je napolnjeni injekcijski peresnik z enim odmerkom (v teh navodilih jo imenujemo preprosto "peresnik").
English: The efficacy and safety of Kevzara were assessed in three randomised, double-blind, controlled multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was an active comparator-controlled study) in patients older than 18 years with moderately to severely active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Slovenian: Učinkovitost in varnost zdravila Kevzara so raziskali v treh randomiziranih, dvojno slepih, kontroliranih multicentričnih študijah (študiji MOBILITY in TARGET sta bili kontrolirani s placebom, študija MONARCH pa je bila kontrolirana z zdravilno učinkovino).
English: No dose adjustment is required in patients with mild to moderate renal impairment.
Slovenian: Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: The modulation of IL-6 effect on CYP enzymes by sarilumab may be clinically relevant for CYP substrates with a narrow therapeutic index, where the dose is individually adjusted.
Slovenian: Modulacija učinka IL-6 na encime CYP s sarilumabom je lahko klinično pomembna za substrate CYP
English: Placebo cDMARDs (N = 181)
Slovenian: Placebo kDMARD (N = 181)
English: It contains 200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Slovenian: Vsebuje 200 mg zdravila Kevzara za podkožno injiciranje (subkutano injiciranje) enkrat na dva tedna.
English: This device is a single-dose pre-filled syringe (called “syringe” in these instructions).
Slovenian: Ta pripomoček je napolnjena injekcijska brizga z enim odmerkom (v teh navodilih jo imenujemo preprosto "brizga").
English: Liver Enzyme Abnormalities Lab Value
Slovenian: Nepravilnosti jetrnih encimov Laboratorijska vrednost Priporočilo
English: In patients who develop a platelet count less than 50 x 103/ µL, treatment with Kevzara should be discontinued.
Slovenian: Pri bolnikih, ki se jim število trombocitov zmanjša pod 50 x 10 3/µl, je treba zdravljenje z zdravilom Kevzara prenehati.
English: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including Kevzara for RA.
Slovenian: Pri bolnikih, ki so prejemali imunosupresivna zdravila, vključno z zdravilom Kevzara za RA, so poročali o resnih in včasih smrtnih okužbah z bakterijami, mikobakterijami, invazivnimi glivami, virusi ali drugimi oportunističnimi patogeni.
English: ACR50 response, n (%)
Slovenian: Odziv ACR50, n (%)
English: Hypersensitivity reactions have been reported in association with Kevzara (see section 4.8).
Slovenian: V povezavi z zdravilom Kevzara so bile opisane preobčutljivostne reakcije (glejte poglavje 4.8).
English: ACR20 response, n (%)
Slovenian: Odziv ACR20, n (%)
English: Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., absolute neutrophil count (ANC) less than 2 x 109/L.
Slovenian: Zdravila Kevzara ni priporočljivo uvesti bolnikom, ki imajo majhno število nevtrofilcev, tj. absolutno število nevtrofilcev (AŠN) manj kot 2 x 109/l.
English: Learning how to use the pre-filled syringe
Slovenian: Učenje uporabe napolnjene injekcijske brizge
English: ALT and AST levels should be monitored 4 to 8 weeks after start of therapy and every 3 months thereafter.
Slovenian: Raven ALT in AST je treba kontrolirati od 4 do 8 tednov po začetku zdravljenja, nato pa na 3 mesece.
English: sanofi-aventis groupe: 54, rue la Boétie 75008 Paris France
Slovenian: sanofi-aventis groupe: 54, rue la Boétie 75008 Paris Francija
English: Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
English: Do not inject if the liquid is cloudy, discoloured or contains particles.
Slovenian: Ne injicirajte zdravila, če je tekočina motna, spremenjene barve ali vsebuje delce.
English: Do not use the syringe if it has been damaged or the needle cap is missing or not attached.
Slovenian: Ne uporabite brizge, če je poškodovana, če pokrovček igle manjka ali če ni nameščen.
English: It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled syringes (3 packs of 2).
Slovenian: Na voljo je v pakiranjih z 1 ali 2 napolnjenima injekcijskima brizgama ali skupnih pakiranjih s 6 napolnjenimi injekcijskimi brizgami (3 pakiranja po 2).
English: In an enhanced pre-/postnatal developmental toxicity study, pregnant Cynomolgus monkeys were administered sarilumab once-weekly intravenously from early gestation to natural birth (approximately 21 weeks) Maternal exposure up to approximately 83 times the human exposure based on AUC after subcutaneous doses of 200 mg every 2 weeks, did not cause any maternal or embryofetal effects.
Slovenian: V stopnjevani pre-/postnatalni študiji razvojne toksičnosti so brejim opicam Cynomolgus enkrat na teden dajali sarilumab intravensko od zgodnje gestacije do naravnega poroda (približno 21 tednov).
English: Kevzara 150 mg solution for injection in pre-filled syringe Kevzara 150 mg solution for injection in pre-filled pen Kevzara 200 mg solution for injection in pre-filled syringe Kevzara 200 mg solution for injection in pre-filled pen
Slovenian: Kevzara 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Kevzara 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Kevzara 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Kevzara 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: DAS28-CRP remission (< 2.6) ACR20
Slovenian: 12. teden Remisija DAS28CRP (< 2,6) ACR20
English: Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.
Slovenian: Zdravilo Kevzara je bistra, brezbarvna do bledo rumena raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: 200 mg solution for injection
Slovenian: 200 mg raztopina za injiciranje
English: ACR70 response, n (%)
Slovenian: Odziv ACR70, n (%)
English: Patients receiving Kevzara 200 mg or 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline in physical function compared to placebo at Week 16 and Week 12 in MOBILITY and TARGET, respectively.
Slovenian: Bolniki, ki so prejemali 200 mg ali 150 mg Kevzara + DMARD na dva tedna, so v primerjavi s placebom dosegli večje izboljšanje telesnega delovanja v primerjavi z izhodiščem, in sicer po 16 tednih v študiji MOBILITY in po
English: • Always keep the container out of the sight and reach of children.
Slovenian: • Vsebnik vedno shranjujte nedosegljiv otrokom!
English: Week 52
Slovenian: Povprečna sprememba 52. teden
English: Pinch the skin.
Slovenian: Potegnite peresnik od kože.
English: Adalimumab 40 mg q2w* (N=185)
Slovenian: Adalimumab 40 mg na 2t* (N = 185)
English: In the Kevzara + DMARDs long-term safety population, the rate of GI perforations was 0.14 events per 100 patient-years.
Slovenian: DMARD je bil delež perforacij prebavil 0,14 dogodka na 100 bolnik-let.
English: • Neutrophil count should be monitored 4 to 8 weeks after start of therapy and according to clinical judgment thereafter.
Slovenian: • Število nevtrofilcev je treba kontrolirati od 4 do 8 tednov po začetku zdravljenja, pozneje pa v skladu s klinično presojo.
English: It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled pens (3 packs of 2).
Slovenian: Na voljo je v pakiranjih z 1 ali 2 napolnjenima injekcijskima peresnikoma ali skupnih pakiranjih s 6 napolnjenimi injekcijskimi peresniki (3 pakiranja po 2).
English: In functional human cell-based assays, sarilumab was able to block the IL-6 signalling pathway, measured as STAT-3 inhibition, only in the presence of IL-6.
Slovenian: V funkcionalnih preizkusih na podlagi človeških celic je sarilumab blokiral signalizacijsko pot IL-6,
English: TARGET TNF Inhibitor Inadequate Responders
Slovenian: TARGET Bolniki, ki se niso ustrezno odzvali na zaviralec TNF
English: • a group of medicines called “Janus kinase (JAK) inhibitors” (used for disease like rheumatoid arthritis and cancer)
Slovenian: • kakšno zdravilo iz skupine zdravil, ki jih imenujemo "zaviralci Janus-kinaze (JAK)"
English: The contribution of these concomitant medications relative to Kevzara in the development of gastrointestinal perforations is not known (see section 4.4).
Slovenian: Koliko so k nastanku perforacij prebavil v primerjavi z zdravilom Kevzara pripomogla ta sočasna zdravila, ni znano (glejte poglavje 4.4).
English: For recommended dose modifications based on ANC results see section 4.2.
Slovenian: Za priporočila o prilagoditvi odmerka glede na AŠN glejte poglavje 4.2.
English: IL-6 is a pleiotropic cytokine that stimulates diverse cellular responses such as proliferation, differentiation, survival, and apoptosis and can activate hepatocytes to release acute-phase proteins, including C-reactive protein (CRP) and serum amyloid A. Elevated levels of IL-6 are found in the synovial fluid of patients with rheumatoid arthritis and play an important role in both the pathologic inflammation and joint destruction which are hallmarks of RA.
Slovenian: IL-6 je pleiotropen citokin, ki stimulira različne celične odzive, npr. proliferacijo, diferenciacijo, preživetje in apoptozo ter lahko aktivira hepatocite, da sproščajo beljakovine akutne faze, vključno s
English: Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.
Slovenian: Zdravilo Kevzara je bistra, brezbarvna do bledo rumena raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: • Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., ANC less than 2 x 109/L.
Slovenian: • Uvedba zdravljenja z zdravilom Kevzara ni priporočljiva pri bolnikih z majhnim številom nevtrofilcev, tj. AŠN manj kot 2 x 109/l.
English: Each pre-filled syringe contains 1.14 ml of solution delivering one single dose.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 1,14 ml raztopine, kar ustreza enkratnemu odmerku.
English: Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant conventional DMARDs (cDMARDs).
Slovenian: zdravilo Kevzara 150 mg ali placebo na 2 tedna sočasno s konvencionalnimi DMARD (kDMARD).
English: Cases of herpes zoster were observed in clinical studies with Kevzara.
Slovenian: V kliničnih študijah zdravila Kevzara so poročali o primerih herpesa zostra.
English: The rates of discontinuations due to hypersensitivity in the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population were consistent with the placebo-controlled population.
Slovenian: Deleži prenehanj zaradi preobčutljivosti so se v dolgoročni varnostni populaciji z zdravilom Kevzara + DMARD in v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, skladali z deležem v populaciji, kontrolirani s placebom.
English: Platelet count Treatment with Kevzara was associated with a reduction in platelet counts in clinical studies.
Slovenian: Zdravljenje z zdravilom Kevzara je bilo v kliničnih študijah povezano z zmanjšanjem števila trombocitov.
English: The most frequent adverse reactions observed with Kevzara in clinical studies were neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.
Slovenian: zvišanje ALT, eritem na mestu injiciranja, okužbe zgornjih dihal in okužbe sečil.
English: 150 mg solution for injection
Slovenian: 150 mg raztopina za injiciranje
English: Injection site erythema Injection site pruritus
Slovenian: Eritem na mestu injiciranja Srbenje na mestu injiciranja
English: The safety and efficacy of Kevzara have not been studied in patients with hepatic impairment, including patients with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology (see section 4.4).
Slovenian: ki imajo pozitiven serološki izvid za virus hepatitisa B (HBV) ali virus hepatitisa C (HCV) (glejte poglavje 4.4).
English: Population pharmacokinetic analyses in adult patients with RA (ranging in age from18 to 88 years with 14% over 65 years) showed that age, gender and race did not meaningfully influence the pharmacokinetics of sarilumab.
Slovenian: starejših od 65 let) so pokazale, da starost, spol in rasa ne vplivajo pomembno na farmakokinetiko sarilumaba.
English: There were no meaningful differences between doses.
Slovenian: Po 4. tednu niso opažali dodatnih zvišanj.Med odmerki ni bilo pomembnih razlik.
English: Store in a refrigerator (2ºC - 8ºC).
Slovenian: Shranjujte v hladilniku (2-8 °C).
English: The primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24, changes from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 16, and change from baseline in van der Heijde-modified Total Sharp Score (mTSS) at Week
Slovenian: Primarni opazovani dogodki so bili delež bolnikov, ki so dosegli odziv ACR20 24. teden, spremembe ocene po vprašalniku HAQ-DI (Health Assessment Questionnaire
English: In MOBILITY, the improvement in physical functioning as measured by HAQ-DI was maintained up to Week 52 (-0.75, -0.71, and -0.46 for Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, and placebo + MTX treatment groups, respectively).
Slovenian: V študiji MOBILITY se je izboljšanje telesnega delovanja, merjeno s HAQ-DI, ohranilo do 52. tedna (-0,75 z 200 mg zdravila Kevzara + metotreksat, -0,71 s 150 mg zdravila Kevzara + metotreksat in0,46 s placebom + metotreksatom).
English: At Week 52, 55.6% of patients receiving Kevzara 200 mg and 47.8% of patients receiving Kevzara 150 mg had no progression of structural damage (as defined by a change in the TSS of zero or less) compared with 38.7% of patients receiving placebo.
Slovenian: Po 52 tednih strukturna okvara (opredeljena kot sprememba TSS 0 ali manj) ni napredovala pri 55,6 % prejemnikov 200 mg zdravila Kevzara, pri 47,8 % prejemnikov 150 mg zdravila Kevzara in pri 38,7 % prejemnikov placeba.
English: Treatment with Kevzara should be withheld in patients who develop a serious infection until the infection is controlled.
Slovenian: Pri bolnikih, ki se jim pojavi resna okužba, je treba zdravljenje prekiniti do tedaj, ko je okužba obvladana.
English: Read all of the instructions carefully before using a pen.
Slovenian: Pred uporabo brizge natančno in v celoti preberite navodila za uporabo.
English: Lipid abnormalities
Slovenian: Okvara ledvic
English: Do not use this medicine if the solution in the syringe is cloudy, discoloured or contains particles, or if any part of the pre-filled syringe looks damaged.
Slovenian: Ne uporabite tega zdravila, če je raztopina v brizgi motna, spremenjene barve ali vsebuje delce, ali če je kateri koli del napolnjene injekcijske brizge videti poškodovan.
English: • low platelet counts shown by blood tests
Slovenian: • majhno število trombocitov (pokaže se na preiskavi krvi)
English: In the placebo-controlled population, the rates of infections were 84.5, 81.0, and 75.1 events per 100 patient-years, in the 200 mg and 150 mg Kevzara + DMARDs and placebo + DMARDs groups respectively.
Slovenian: V populaciji, kontrolirani s placebom, so bili deleži okužb na 100 bolnik-let 84,5 z 200 mg zdravila Kevzara + DMARD, 81,0 s 150 mg zdravila Kevzara + DMARD in 75,1 s placebom + DMARD.
English: In the placebo-controlled population, injection site reactions were reported in 9.5%, 8%, and 1.4% of patients receiving Kevzara 200 mg, 150 mg, and placebo respectively.
Slovenian: V populaciji, kontrolirani s placebom, je reakcije na mestu injiciranja navedlo 9,5 % prejemnikov 200 mg zdravila Kevzara, 8 % prejemnikov 150 mg zdravila Kevzara in 1,4 % prejemnikov placeba.
English: DAS28-CRP remission (< 2.6)
Slovenian: 52. teden Remisija DAS28CRP (< 2,6)
English: Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant MTX.
Slovenian: Bolniki so prejemali zdravilo Kevzara 200 mg, zdravilo Kevzara 150 mg ali placebo na 2 tedna sočasno z metotreksatom.
English: kevzara 150 mg syringe
Slovenian: kevzara 150 mg brizga
English: Less progression of both erosion and joint space narrowing scores at 24 and 52 weeks was reported in the sarilumab treatment groups compared to the placebo group.
Slovenian: V terapevtskih skupinah s sarilumabom je bila ocena napredovanja erozij in zožitve sklepnih špranj po 24 in 52 tednih manjša kot v skupini s placebom.
English: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and light-orange cap.
Slovenian: Sestavni deli brizge so predsestavljeni v napolnjen injekcijski peresnik za enkratno uporabo z rumenim pokrovčkom igle in svetlooranžnim pokrovčkom.
English: • Write down the date of removal from the refrigerator in the space provided on the outer carton.
Slovenian: • V predvideni prostor na zunanji škatli vpišite datum, ko ste zdravilo vzeli iz hladilnika.
English: MOBILITY demonstrated significant improvement in physical function, as measured by the HAQ-DI at Week 16 compared to placebo (-0.58, -0.54, and -0.30 for Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, and placebo + MTX, every two weeks, respectively).
Slovenian: Študija MOBILITY je v primerjavi s placebom po 16 tednih pokazala značilno izboljšanje telesnega delovanja (merjenega s HAQ-DI) (-0,58 z 200 mg zdravila Kevzara + metotreksat, -0,54 s 150 mg zdravila Kevzara + metotreksat in -0,30 s placebom + metotreksatom, vse na 2 tedna).
English: Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at least 30 minutes.
Slovenian: Položite brizgo na ravno površino in pustite, da se segreje na sobno temperaturo (< 25°C); pustite jo vsaj 30 minut.
English: There are limited data available on overdose with Kevzara.
Slovenian: Podatkov o prevelikem odmerjanju zdravila Kevzara je malo.
English: Mean change at Week 24 Modified Total Sharp Score (mTSS) Erosion score (0-280) Joint space narrowing score Mean change at Week 52 Modified Total Sharp Score (mTSS) ‡ Erosion score (0-280) Joint space narrowing score
Slovenian: Modificirana celotna Sharpova ocena (mTSS) ‡ Ocena erozij (0-280) Ocena zožitve sklepne špranje
English: Once removed from the refrigerator, do not store the syringe above 25ºC.
Slovenian: Ko brizgo vzamete iz hladilnika, jo shranjujte na temperaturi do 25°C.
English: Ask your healthcare professional to show you the right way to use the syringe before your first injection.
Slovenian: Preden si prvič injicirate zdravilo, zdravnika prosite, naj vam pokaže, kako pravilno uporabljati brizgo.
English: • Keep the syringe in the original carton in order to protect it from light.
Slovenian: • Brizgo shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 60 minutes.
Slovenian: Položite peresnik na ravno površino in pustite, da se segreje na sobno temperaturo (< 25 °C); pustite ga vsaj 60 minut.
English: Pre-filled syringe 150 mg:
Slovenian: Napolnjen injekcijski peresnik 150 mg:
English: In MOBILITY, a greater proportion of patients treated with Kevzara 200 mg or 150 mg every two weeks plus MTX achieved remission, defined as Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) < 2.6 compared with placebo + MTX at Week 52.
Slovenian: 150 mg zdravila Kevzara na dva tedna v kombinaciji z metotreksatom, kot bolnikov, ki so prejemali placebo in metotreksat; remisija je bila opredeljena kot DAS28-CRP (Disease Activity Score 28-CReactive Protein) < 2,6.
English: Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors, ATC code: L04AC14
Slovenian: Oznaka ATC: L04AC14
English: Name and address of the manufacturer of the biological active substance Regeneron Pharmaceuticals Inc.
Slovenian: Ime in naslov izdelovalca biološke učinkovine
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes.
Slovenian: raztopina za injiciranje Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
English: • Platelet count should be monitored 4 to 8 weeks after start of therapy and according to clinical judgment thereafter.
Slovenian: • Število trombocitov je treba kontrolirati od 4 do 8 tednov po začetku zdravljenja, pozneje pa v skladu s klinično presojo.
English: Liver enzymes
Slovenian: Jetrni encimi