natgillin/translations-raw huggingface dataset:
Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.
Zdravilo Kevzara je bistra, brezbarvna do bledo rumena raztopina za injiciranje v napolnjeni injekcijski brizgi.
200 mg solution for injection
200 mg raztopina za injiciranje
ACR70 response, n (%)
Odziv ACR70, n (%)
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.
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
• Always keep the container out of the sight and reach of children.
• Vsebnik vedno shranjujte nedosegljiv otrokom!
Week 52
Povprečna sprememba 52. teden
Pinch the skin.
Potegnite peresnik od kože.
Adalimumab 40 mg q2w* (N=185)
Adalimumab 40 mg na 2t* (N = 185)
In the Kevzara + DMARDs long-term safety population, the rate of GI perforations was 0.14 events per 100 patient-years.
DMARD je bil delež perforacij prebavil 0,14 dogodka na 100 bolnik-let.
• Neutrophil count should be monitored 4 to 8 weeks after start of therapy and according to clinical judgment thereafter.
• Število nevtrofilcev je treba kontrolirati od 4 do 8 tednov po začetku zdravljenja, pozneje pa v skladu s klinično presojo.
It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled pens (3 packs of 2).
Na voljo je v pakiranjih z 1 ali 2 napolnjenima injekcijskima peresnikoma ali skupnih pakiranjih s 6 napolnjenimi injekcijskimi peresniki (3 pakiranja po 2).
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.
V funkcionalnih preizkusih na podlagi človeških celic je sarilumab blokiral signalizacijsko pot IL-6,
TARGET TNF Inhibitor Inadequate Responders
TARGET Bolniki, ki se niso ustrezno odzvali na zaviralec TNF
• a group of medicines called “Janus kinase (JAK) inhibitors” (used for disease like rheumatoid arthritis and cancer)
• kakšno zdravilo iz skupine zdravil, ki jih imenujemo "zaviralci Janus-kinaze (JAK)"
The contribution of these concomitant medications relative to Kevzara in the development of gastrointestinal perforations is not known (see section 4.4).
Koliko so k nastanku perforacij prebavil v primerjavi z zdravilom Kevzara pripomogla ta sočasna zdravila, ni znano (glejte poglavje 4.4).
For recommended dose modifications based on ANC results see section 4.2.
Za priporočila o prilagoditvi odmerka glede na AŠN glejte poglavje 4.2.
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.
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
Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.
Zdravilo Kevzara je bistra, brezbarvna do bledo rumena raztopina za injiciranje v napolnjenem injekcijskem peresniku.
• Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., ANC less than 2 x 109/L.
• Uvedba zdravljenja z zdravilom Kevzara ni priporočljiva pri bolnikih z majhnim številom nevtrofilcev, tj. AŠN manj kot 2 x 109/l.
Each pre-filled syringe contains 1.14 ml of solution delivering one single dose.
Ena napolnjena injekcijska brizga vsebuje 1,14 ml raztopine, kar ustreza enkratnemu odmerku.
Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant conventional DMARDs (cDMARDs).
zdravilo Kevzara 150 mg ali placebo na 2 tedna sočasno s konvencionalnimi DMARD (kDMARD).
Cases of herpes zoster were observed in clinical studies with Kevzara.
V kliničnih študijah zdravila Kevzara so poročali o primerih herpesa zostra.
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.
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.
Platelet count Treatment with Kevzara was associated with a reduction in platelet counts in clinical studies.
Zdravljenje z zdravilom Kevzara je bilo v kliničnih študijah povezano z zmanjšanjem števila trombocitov.
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.
zvišanje ALT, eritem na mestu injiciranja, okužbe zgornjih dihal in okužbe sečil.
150 mg solution for injection
150 mg raztopina za injiciranje
Injection site erythema Injection site pruritus
Eritem na mestu injiciranja Srbenje na mestu injiciranja
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).
ki imajo pozitiven serološki izvid za virus hepatitisa B (HBV) ali virus hepatitisa C (HCV) (glejte poglavje 4.4).
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.
starejših od 65 let) so pokazale, da starost, spol in rasa ne vplivajo pomembno na farmakokinetiko sarilumaba.
There were no meaningful differences between doses.
Po 4. tednu niso opažali dodatnih zvišanj.Med odmerki ni bilo pomembnih razlik.
Store in a refrigerator (2ºC - 8ºC).
Shranjujte v hladilniku (2-8 °C).
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
Primarni opazovani dogodki so bili delež bolnikov, ki so dosegli odziv ACR20 24. teden, spremembe ocene po vprašalniku HAQ-DI (Health Assessment Questionnaire
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).
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).
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.
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.
Treatment with Kevzara should be withheld in patients who develop a serious infection until the infection is controlled.
Pri bolnikih, ki se jim pojavi resna okužba, je treba zdravljenje prekiniti do tedaj, ko je okužba obvladana.
Read all of the instructions carefully before using a pen.
Pred uporabo brizge natančno in v celoti preberite navodila za uporabo.
Lipid abnormalities
Okvara ledvic
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.
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.
• low platelet counts shown by blood tests
• majhno število trombocitov (pokaže se na preiskavi krvi)
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.
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.
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.
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.
DAS28-CRP remission (< 2.6)
52. teden Remisija DAS28CRP (< 2,6)
Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant MTX.
Bolniki so prejemali zdravilo Kevzara 200 mg, zdravilo Kevzara 150 mg ali placebo na 2 tedna sočasno z metotreksatom.
kevzara 150 mg syringe
kevzara 150 mg brizga
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.
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.
The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and light-orange cap.
Sestavni deli brizge so predsestavljeni v napolnjen injekcijski peresnik za enkratno uporabo z rumenim pokrovčkom igle in svetlooranžnim pokrovčkom.
• Write down the date of removal from the refrigerator in the space provided on the outer carton.
• V predvideni prostor na zunanji škatli vpišite datum, ko ste zdravilo vzeli iz hladilnika.
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).
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).
Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at least 30 minutes.
Položite brizgo na ravno površino in pustite, da se segreje na sobno temperaturo (< 25°C); pustite jo vsaj 30 minut.
There are limited data available on overdose with Kevzara.
Podatkov o prevelikem odmerjanju zdravila Kevzara je malo.
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
Modificirana celotna Sharpova ocena (mTSS) ‡ Ocena erozij (0-280) Ocena zožitve sklepne špranje
Once removed from the refrigerator, do not store the syringe above 25ºC.
Ko brizgo vzamete iz hladilnika, jo shranjujte na temperaturi do 25°C.
Ask your healthcare professional to show you the right way to use the syringe before your first injection.
Preden si prvič injicirate zdravilo, zdravnika prosite, naj vam pokaže, kako pravilno uporabljati brizgo.
• Keep the syringe in the original carton in order to protect it from light.
• Brizgo shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 60 minutes.
Položite peresnik na ravno površino in pustite, da se segreje na sobno temperaturo (< 25 °C); pustite ga vsaj 60 minut.
Pre-filled syringe 150 mg:
Napolnjen injekcijski peresnik 150 mg:
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.
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.
Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors, ATC code: L04AC14
Oznaka ATC: L04AC14
Name and address of the manufacturer of the biological active substance Regeneron Pharmaceuticals Inc.
Ime in naslov izdelovalca biološke učinkovine
solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes.
raztopina za injiciranje Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
• Platelet count should be monitored 4 to 8 weeks after start of therapy and according to clinical judgment thereafter.
• Število trombocitov je treba kontrolirati od 4 do 8 tednov po začetku zdravljenja, pozneje pa v skladu s klinično presojo.
Liver enzymes
Jetrni encimi
Do not try to put the cap back on the syringe.
Ne poskušajte pokrovčka nameščati nazaj na brizgo.
For single use only Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo!
Do not use this medicine if the solution in the pen is cloudy, discoloured or contains particles, or if any part of the pre-filled pen looks damaged.
Ne uporabite tega zdravila, če je raztopina v peresniku motna, spremenjene barve ali vsebuje delce, ali če je kateri koli del napolnjenega injekcijskega peresnika videti poškodovan.
Method of Administration Subcutaneous use.
Način uporabe subkutana uporaba
Ask your healthcare professional to show you the right way to use the pen before your first injection.
Preden si prvič injicirate zdravilo, zdravnika prosite, naj vam pokaže, kako pravilno uporabljati peresnik.
Let the syringe warm up to room temperature for at least 30 minutes before using.
Brizgo pred uporabo vsaj 30 minut pustite, da se ogreje na sobno temperaturo.
In the Kevzara monotherapy population, observations were consistent with the Kevzara + DMARDs population.
Opažanja v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, so se skladala s tistimi v populaciji, ki je prejemala zdravilo Kevzara + DMARD.
Sucrose
Okence
The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a dark-orange polypropylene finger flange.
Napolnjena injekcijska brizga 200 mg: Napolnjena injekcijska brizga za enkratno uporabo ima pokrovček igle iz stiren-butadienskega elastomera in je opremljena z belim polistirenskim čepom bata ter temnooranžno polipropilensko polipropilenskim držalom za prste.
kevzara 200 mg syringe
kevzara 200 mg brizga
Decreases in neutrophil counts below 0.5 x 109/L occurred in 0.8% and 0.6% of patients in the 200 mg and 150 mg Kevzara+ DMARDs groups, respectively.
Zmanjšanje števila nevtrofilcev pod 0,5 x 109/l se je pojavilo pri 0,8 % prejemnikov 200 mg zdravila Kevzara + DMARD in pri 0,6 % prejemnikov 150 mg zdravila Kevzara + DMARD.
What Kevzara is used for
Za kaj uporabljamo zdravilo Kevzara
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people):
Resen neželen učinek Zdravnika takoj obvestite, če menite, da imate okužbo (pojavi se lahko pri največ 1 od 10 oseb).
Treatment with Kevzara 200 mg and 150 mg + MTX inhibited the progression of structural damage by 91% and 68%, respectively, compared to placebo + MTX at Week 52.
Po 52 tednih je zdravljenje z 200 mg oz. 150 mg zdravila Kevzara skupaj z metotreksatom je v primerjavi s placebom skupaj z metotreksatom zavrlo napredovanje strukturne okvare za 91 % (200 mg) oz. 68 % (150 mg).
Patients treated with Kevzara + MTX (47.6% in the 200 mg treatment group and 47.0% in the 150 mg treatment group) achieved a clinically relevant improvement in HAQ-DI (change from baseline of
Prejemniki zdravila Kevzara + metotreksata (47,6 % v skupini z 200 mg in 47,0 % v skupini s
Active Comparator-controlled Study
Študija, kontrolirana z zdravilno učinkovino
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on neutrophil counts were consistent with those seen in the placebo-controlled population (see section 4.4).
Kevzara + DMARD in v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, skladala s tistimi v populaciji, kontrolirani s placebom (glejte poglavje 4.4).
Do not freeze or heat the syringe.
Brizge ne zamrzujte in ne segrevajte.
Positive responses in the neutralizing antibody (NAb) assay were detected in 1.0%, 1.6%, and 0.2% of patients on Kevzara 200 mg, Kevzara 150 mg, and placebo respectively.
Izvid preskusa za nevtralizacijska protitelesa (NAb) je bil pozitiven pri 1,0 % prejemnikov 200 mg zdravila Kevzara, 1,6 % prejemnikov 150 mg zdravila Kevzara in 0,2 % prejemnikov placeba.
Upper respiratory tract infection Urinary tract infection Nasopharyngitis Oral herpes
Nazofaringitis Oralni herpes
Week 12
Teden študije
In MOBILITY and TARGET, patients receiving Kevzara 200 mg + DMARDs every two weeks or Kevzara 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs in physical component summary (PCS) and no worsening on the mental component summary (MCS) at Week 24.
Kevzara + DMARD na dva tedna po 24 tednih v primerjavi z izhodiščem izboljšal bolj kot prejemnikom placeba + DMARD, povzetek mentalne komponente (MCS - mental component summary) pa se ni poslabšal.
Do not re-use the syringe.
Peresnika nikoli ne uporabite ponovno.
Prior to initiating Kevzara, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Podatkov o sekundarnem prenosu okužbe z oseb, ki so prejele živa cepiva, na bolnike, zdravljene z zdravilom Kevzara, ni. Priporočljivo je, da pred zdravljenjem z zdravilom Kevzara vsi bolniki opravijo vsa cepljenja v skladu s trenutnimi smernicami za cepljenja.
KEVZARA 150 mg injection sarilumab
KEVZARA 150 mg injekcija sarilumab s.c.
KEVZARA 200 mg q2w* + cDMARDs (N = 184)
KEVZARA 200 mg na 2t* + kDMARD (N = 184)
The rates of serious infections were 4.3, 3.0, and 3.1 events per 100 patient-years, in the 200 mg, 150 mg Kevzara + DMARDs, and placebo + DMARDs groups, respectively.
Deleži resnih okužb na 100 bolnik-let so bili 4,3 z 200 mg zdravila Kevzara + DMARD, 3,0 s 150 mg zdravila Kevzara + DMARD in 3,1 s placebom + DMARD.
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the rates of malignancies were consistent with the rate observed in the placebo-controlled population (see section 4.4).
Deleži malignih bolezni 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 (glejte poglavje 4.4).
Sarilumab had no effect on maintenance of pregnancy or on the neonates evaluated up to 1 month after birth in body weight measurements, in parameters of functional or morphological development including skeletal evaluations, in immunophenotyping of peripheral blood lymphocytes, and in microscopic evaluations.
vključno z ocenami okostja, imunofenotipizacijo limfocitov v periferni krvi in z mikroskopskimi ocenami.
KEVZARA 150 mg q2w* + cDMARDs (N = 181)
KEVZARA 150 mg na 2t* + kDMARD (N = 181)
How Kevzara works
Kako deluje zdravilo Kevzara
There were no reports of gastrointestinal perforation in the Kevzara monotherapy population.
V populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, niso poročali o perforacijah prebavil.
Do not put the cap back on. Do not throw the used pens in household waste.
Ne zavrzite uporabljenih peresnikov med gospodinjske odpadke.
• Once taken out the refrigerator, do not store Kevzara above 25 ºC.
• Ko zdravilo Kevzara vzamete iz hladilnika, ga shranjujte na temperaturi do 25°C.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with the Blue Box - MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED SYRINGES
ZUNANJA ŠKATLA s podatki za modro okence - SKUPNO PAKIRANJE S 6 (3 PAKIRANJA PO 2) NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI
Kevzara 200 mg q2w (N=184)
Kevzara 200 mg na 2t (N = 184)
The parts of the Kevzara pre-filled syringe are shown in this picture.
Ta slika prikazuje dele napolnjene injekcijske brizge zdravila Kevzara.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Injection sites (abdomen, thigh and upper arm) should be rotated with each injection.
Mesto injiciranja je treba pri vsakem injiciranju krožno menjati (trebuh,
solution for injection 1 pre-filled syringe
raztopina za injiciranje 1 napolnjena injekcijska brizga
• Do not freeze or heat the syringe.
• Brizge ne zamrzujte in ne segrevajte.
Learning how to use the pre-filled pen
Učenje uporabe napolnjenega injekcijskega peresnika
• Initiating treatment with Kevzara is not recommended in patients with a platelet count below 150 x103/µL.
• Uvedba zdravljenja z zdravilom Kevzara ni priporočljiva pri bolnikih z majhnim številom trombocitov, tj. številom trombocitov pod 150 x 103/µl.
Let the pen warm up to room temperature for at least 60 minutes before using.
Peresnik pred uporabo vsaj 60 minut pustite, da se ogreje na sobno temperaturo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 1 PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - PAKIRANJE Z 1 NAPOLNJENO INJEKCIJSKO BRIZGO
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON without Blue Box - 2 PRE-FILLED SYRINGES (MULTIPACK PRESENTATION)
NOTRANJA ŠKATLA brez podatkov za modro okence - 2 NAPOLNJENA INJEKCIJSKA PERESNIKA (SKUPNO PAKIRANJE)
Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1).
Zdravilo Kevzara je mogoče uporabljati kot samostojno zdravljenje (v monoterapiji), če bolnik ne prenaša metotreksata ali zdravljenje z metotreksatom zanj ni primerno
≥0.3 units) at Week 52 compared to 26.1% in the placebo + MTX treatment group.
150 mg) so po 52 tednih dosegli klinično pomembno izboljšanje HAQ-DI (spremembo ≥ 0,3 enote v primerjavi z izhodiščem); v skupini s placebom + metotreksatom je bil ta delež 26,1 %.
Decreases in neutrophil counts below 1 x 109/L occurred in 6.4% and 3.6% of patients in the 200 mg and 150 mg Kevzara + DMARDs group, respectively, compared to no patients in the placebo + DMARDs group.
Število nevtrofilcev se je zmanjšalo pod 1 x 109/l pri 6,4 % prejemnikov 200 mg zdravila Kevzara + DMARD, pri 3,6 % prejemnikov 150 mg zdravila Kevzara + DMARD in pri nobenem prejemniku placeba + DMARD.
Always keep the container out of the sight and reach of children.
Vsebnik vedno shranjujte nedosegljiv otrokom!
KEVZARA 200 mg injection sarilumab
KEVZARA 200 mg injekcija sarilumab subkutana uporaba
Put your used syringe and the cap into a puncture-resistant container right away after use.
Uporabljeno brizgo in pokrovček takoj po uporabi odvrzite v vsebnik za ostre odpadke.
• slowing down damage to joints
• upočasni okvaro sklepov,
Decreases in platelet counts below 100 x 103/µL occurred in 1.2% and 0.6% of patients on 200 mg and 150 mg Kevzara + DMARDs, respectively, compared to no patients on placebo + DMARDs.
Število trombocitov se je zmanjšalo pod 100 x 103/µl pri 1,2 % prejemnikov 200 mg zdravila Kevzara + DMARD, pri 0,6 % prejemnikov 150 mg zdravila Kevzara + DMARD in pri nobenem prejemniku placeba + DMARD.
Kevzara is available as 150 mg or 200 mg pre-filled syringes.
Zdravilo Kevzara je na voljo v napolnjenih injekcijskih brizgah s 150 mg ali 200 mg.
• Multipack containing 6 (3 packs of 2) pre-filled pens
• Skupno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi peresniki