natgillin/translations-raw huggingface dataset:
The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil doseţen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala adalimumab v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
If your child stops using Kromeya
Če je vaš otrok prenehal uporabljati zdravilo Kromeya
• Merkel cell carcinoma (a type of skin cancer);
• karcinom Merklovih celic (tip koţnega raka);
The recommended dose of Kromeya for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Kromeya pri bolnikih z ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS in pri bolnikih s psoriatičnim artritisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
The inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Vnetje povzroči poslabšanje vida in/ali prisotnost delcev v očesu (črnih pik ali koprenastih črt, ki se premikajo po vidnem polju).
Keep this patient reminder card with you during your treatment and for 4 months after your (or your child's) last injection of Kromeya.
To opozorilno kartico za bolnika imejte pri sebi med zdravljenjem in 4 mesece po vaši (ali otrokovi) zadnji injekciji zdravila Kromeya.
Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Z indukcijskima shemama 160/80 mg in 80/40 mg so do 8. tedna ugotovili podobne deleţe remisij; neţeleni učinki so bili pogostejši v skupini s shemo 160/80 mg.
- if your child has a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
• če ima vaš otrok hudo okuţbo, vključno s tuberkulozo, sepso (zastrupitev krvi) ali drugo oportunistično okuţbo (ponavadi okuţba povezana z oslabljenim imunskim sistemom).
Kromeya can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Zdravilo Kromeya lahko upočasni napredovanje prizadetosti sklepnih hrustancev in kosti, ki jo povzroči bolezen, in izboljša telesno delovanje.
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;
• razširitev v steni večje arterije, vnetje in krvni strdek v veni, zamašitev ţile;
If active tuberculosis is diagnosed, Kromeya therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Kromeya ne sme začeti (glejte poglavje
• fatty liver (build-up of fat in liver cells);
• zamaščenost jeter (kopičenje maščob v jetrnih celicah);
673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
673 bolnikov z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [BASDAI] je bila 7,0), ki so nezadostno reagirali na vsaj dve zdravili NSAID ali niso prenašali NSAID ali s kontraindikacijo za NSAID, je bilo vključenih v odprto fazo študije nr-axSpA II, v kateri so prejemali adalimumab 40 mg vsak drugi teden 28 tednov.
Adalimumab has not been studied in patients with hepatic or renal impairment.
Adalimumab niso proučili pri bolnikih z okvaro jeter ali ledvic.
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Kromeya treatment.
Ţenske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Kromeya.
If your doctor decides that methotrexate is inappropriate, Kromeya can be given alone.
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Kromeya dobivate samo.
A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in Psoriasis study I, and continued adalimumab in the open-label extension trial.
Skupno je 233 bolnikov, ki so imeli 16. in 33. teden odziv PASI 75, v študiji psoriaze I prejemalo stalno zdravljenje z adalimumabom 52 tednov ter so zdravljenje z adalimumabom nadaljevali v odprtem podaljšanem preskušanju.
• intestinal infections (including gastroenteritis);
• črevesne okuţbe (vključno z gastroenteritisom);
Each pack contains 1 vial (0.8 mL sterile solution), 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
Eno pakiranje vsebuje 1 vialo (0,8 ml sterilne raztopine), 1 sterilno injekcijsko brizgo, 1 sterilno iglo, 1 adapter za vialo in 2 alkoholna zloţenca.
Patients may first be given other disease-modifying medicines, such as methotrexate.
Morda bodo bolniki najprej dobili druga imunomodulirajoča zdravila, npr. metotreksat.
In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
V preskušanju faze 3 z adalimumabom pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrţevalnih reţimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 x ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising,
• znaki in simptomi, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura,
• symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
• znaki problemov z ţivčevjem kot je mravljinčenje; omrtvelost; dvojni vid ali šibkost rok ali nog;
Adalimumab/MTX n=268 (95% confidence interval)
Adalimumab /MTX n = 268 (95 % interval zaupanja)
The combination of Kromeya and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Kombinacija zdravila Kromeya in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDs ali antagonistov TNF”).
On rare occasions, a specific and severe type of lymphoma, has been observed in patients taking adalimumab.
V redkih primerih so pri bolnikih, ki dobivajo adalimumab, opazili specifično in resno obliko limfoma.
Efficacy outcomes
Rezultati učinkovitosti
After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Po zdravljenju z adalimumabom so pri bolnikih z revmatoidnim artritisom opaţali hitro zniţanje reaktantov akutne faze vnetja (C-reaktivnega proteina (CRP) in hitrosti sedimentacije eritrocitov (SR)) in serumskih citokinov (IL-6) v primerjavi z izhodiščem.
1.7 Leave the syringe at room temperature for 30 minutes to allow the medicine to warm up.
1.7 Injekcijsko brizgo pustite na sobni temperaturi 30 minut, da se zdravilo ogreje.
7.3 When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.
7.3 Ko bo zbiralnik za ostre predmete skoraj poln, ga morate izprazniti v skladu z lokalnimi predpisi o odstranjevanju vsebnikov za ostre predmete.
Low dose
Majhni odmerek
Table 26 Response, remission and mucosal healing in study UC-II (percent of patients)
Preglednica 26 Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient years.
Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene odprte nadaljevalne študije z medianim trajanjem pribliţno 3,3 leta s 6427 bolniki in prek 26439 bolnikov-let zdravljenja, je ugotovljeni deleţ malignomov (razen limfoma in nemelanomskih koţnih rakov) pribliţno 8,5 na 1000 bolnikov-let.
Keep this patient reminder card with you or your child during treatment and for 4 months after your (or your child's) last injection of Kromeya.
To opozorilno kartico za bolnika imejte pri sebi (ali jo naj ima pri sebi vaš otrok), med zdravljenjem in 4 mesece po vaši (ali otrokovi) zadnji injekciji zdravila Kromeya.
If your child takes Kromeya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če vaš otrok uporablja zdravilo Kromeya, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
Step 5 Prepare Injection
5. korak Pripravite injekcijo
Kromeya is intended for the treatment of the following inflammatory diseases:
Zdravilo Kromeya je namenjeno za zdravljenje naslednjih vnetnih bolezni, opisanih spodaj:
The decision to stop using Kromeya should be discussed with your child's doctor.
O odločitvi, da bi prenehali uporabljati zdravilo Kromeya, se morate posvetovati z otrokovim zdravnikom.
Injury, poisoning and procedural complications
Poškodbe, zastrupitve in zapleti pri posegih pogosti slabše celjenje
Physicians should exercise caution when considering the use of Kromeya in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri odločanju za uporabo zdravila Kromeya je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okuţbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okuţbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
Tell your doctor if you are taking azathioprine or mercaptopurine with Kromeya.
Povejte zdravniku, če jemljete azatioprin ali merkaptopurin sočasno z zdravilom Kromeya.
Psoriasis study III (REACH) compared the efficacy and safety of adalimumab versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Študija pri psoriazi III (REACH) je primerjala učinkovitost in varnost adalimumaba v primerjavi s placebom pri 72 bolnikih z zmerno do hudo kronično psoriazo v plakih in psoriazo na dlaneh in/ali stopalih.
Placebo/MTXAdalimumab/MTX (95% confidence interval b)
Adalimumab placebo/MTXAdalimumab/MTX (95 % interval zaupanja b)
Psoriasis study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Študija pri psoriazi IV je primerjala učinkovitost in varnost adalimumaba v primerjavi s placebom pri 217 odraslih bolnikih z zmerno do hudo psoriazo nohtov.
4.2 Insert the syringe tip into the yellow syringe connector and screw to connect.
4.2 Konico injekcijske brizge vstavite v rumen konektor in jo privijte.
Week 12
12. teden
Week 26
26. teden
For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5±5.6 µg/mL for the Standard Dose group and 3.5±2.2 µg/mL for the Low Dose group.
Pri bolnikih, ki so ostali na njihovi randomizirani terapiji, so bile povprečne najmanjše koncentracije adalimumaba v 52. tednu 9,5 ± 5,6 μg/ml v skupini s standardnim odmerkom in 3,5 ± 2,2 μg/ml v skupini z majhnim odmerkom.
Kromeya works by reducing this inflammation.
Zdravilo Kromeya deluje tako, da zmanjša tako vnetje.
Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week.
Po koncu obeh študij so 383 bolnikov vključili v odprto nadaljevalno študijo, med katero so bolniki dobivali 40 mg adalimumaba vsak drugi teden.
Kromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Zdravilo Kromeya je indicirano za zdravljenje odraslih s hudim aksialnim spondiloartritisom brez radiografskega dokaza za AS, toda z objektivnimi znaki vnetja s povišanimi CRP in/ali MRI, ki so nezadostno reagirali na ali ne prenašajo nesteroidnih protivnetnih zdravil.
Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Kromeya therapy and regularly during treatment to assess for preexisting or developing central demyelinating disorders.
Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom Kromeya in redno med zdravljenjem opravljati nevrološko oceno, da se oceni ţe obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega ţivčevja.
Upon completion of the first 52 weeks, 457 patients enrolled in an open- label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.
Po zaključenih prvih 52 tednih so 457 bolnikov vključili v odprto nadaljevalno fazo, med katero so dobivali 40 mg adalimumaba/MTX vsak drugi teden v obdobju do 10 let.
• The name on the syringe is not Kromeya.
• na injekcijski brizgi ni imena Kromeya.
In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
V kontroliranih delih kliničnih preizkušanj z antagonisti TNF je bilo opaţenih več primerov malignomov, vključno z limfomi, tako pri bolnikih, ki so prejemali antagonist TNF, kot pri kontrolnih bolnikih.
Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients) PsA study I
Preglednica 16: Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom (odstotek bolnikov) Študija pri psoriatičnem
This study evaluated the efficacy of adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Ta študija je ocenila učinkovitost treh shem (kombinirana terapija z adalimumabom 40 mg vsak drugi teden/metotreksatom, monoterapija z adalimumabom 40 mg vsak drugi teden in monoterapija z metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov.
• gallbladder inflammation, gallbladder stones;
• vnetje ţolčnika, ţolčni kamni;
Table 6 Undesirable effects
Preglednica 6 Neţeleni učinki
• inflammation of the pancreas which causes severe pain in the abdomen and back;
• vnetje trebušne slinavke, ki povzroča teţjo bolečino v trebuhu in hrbtu;
The results for the 40 mg every other week dose are summarised in Table 9.
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v preglednici 9.
Patients treated with adalimumab usually experienced improvement in haematological signs of chronic inflammation.
Z adalimumabom zdravljenim bolnikom so se ponavadi izboljšali hematološki znaki kroničnega vnetja.
Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Adalimumab so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so adalimumab jemali kot monoterapijo, kot pri tistih, ki so ga jemali hkrati z metotreksatom.
• Lower stomach area (inject at least 5 centimeters away from the belly button).
• spodnjem delu trebuha (zdravilo injicirajte vsaj 5 centimetrov stran od popka).
Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
V kliničnih študijah s sočasno uporabo anakinre in etanercepta, drugega antagonista TNF, so opazili hude okuţbe brez dodatnih kliničnih prednosti v primerjavi z etanerceptom samim.
Week 52 open-label
52. teden Odprta
Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumab treated patients.
Endoskopske študije črevesne sluznice so pokazale znake celjenja sluznice pri bolnikih, zdravljenih z adalimumabom.
Total sharp score c
Celotna Sharpova ocena c
The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost adalimumaba so ocenili pri več kot 1500 bolnikih z zmerno do zelo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
If you use less Kromeya than you should
Če ste uporabili manjši odmerek zdravila Kromeya, kot bi morali
SPARCC MRI spine d,j a Assessment of Spondyloarthritis International Society b
ASAS = ocena v spondiloartritičnem mednarodnem zdruţenju (Assessments in Spondyloarthritis International Society b
MRI sacroiliac joints d,i
MRI sakroiliakalnih sklepov d,i
Excipients with known effects
Pomoţne snovi z znanim delovanjem
In study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
V študiji I so v primerjavi s placebom ugotovili tudi značilno izboljšanje telesne in duševne komponente ocene SF-36.
• symptoms of nerve root compression (including low back pain and leg pain);
• znaki stisnjenja ţivčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah);
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Pri okuţbah je šlo predvsem za nazofaringitis, okuţbo zgornjih dihal in sinusitis.
TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Antagonisti TNF, z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega ţivčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barré- jevim sindromom.
Patients who maintained ≥PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Bolnike, ki so imeli 33. teden ohranjen odziv PASI ≥ 75 in so bili v obdobju A randomizirani na aktivno terapijo, so med obdobjem C ponovno randomizirali tako, da so dodatnih 19 tednov dobivali 40 mg adalimumaba vsak drugi teden ali placebo.
Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double−blind, placebo−controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Adalimumab 40 mg so vsak drugi teden ocenili v dveh randomiziranih 24-tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa - Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
• okuţbe dihalnega trakta (vključno s prehladom, izcedkom iz nosu, okuţbo sinusov, pljučnico);
Tell your doctor if your child is taking azathioprine or mercaptopurine with Kromeya.
Povejte zdravniku, če vaš otrok prejema azatioprin ali merkaptopurin sočasno z zdravilom Kromeya.
Week 26 placebo-controlled
teden Kontrolirana s placebom
Usually, Kromeya is used with methotrexate.
Zdravilo Kromeya ponavadi uporabljamo z metotreksatom.
• The liquid is clear, colorless, and free of particles (Figure H).
• je tekočina bistra, brezbarvna in brez delcev (Slika H).
If you have rheumatoid arthritis and you do not receive methotrexate with your Kromeya therapy, your doctor may decide to give Kromeya 40 mg every week or 80 mg every other week.
Če imate revmatoidni artritis in hkrati z zdravilom Kromeya ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg adalimumaba vsak teden ali 80 mg vsak drugi teden.
General disorders and administration site conditions*
Splošne teţave in spremembe na mestu aplikacije*
• If you are about to have surgery or dental procedures tell your doctor that you are taking Kromeya.
• Če boste imeli kirurški poseg ali poseg na zobeh, povejte svojemu zdravniku, da jemljete zdravilo Kromeya.
At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Po 52. tednih je klinično remisijo (DAS28 (CRP) < 2,6) doseglo 42,9 % bolnikov, ki so dobivali kombinirano terapijo z adalimumabom/metotreksatom, 20,6 % bolnikov, ki so dobivali metotreksat v monoterapiji, in 23,4 % bolnikov, ki so dobivali adalimumab v monoterapiji.
• The name on the vial is not Kromeya.
• Na nalepki ni imena Kromeya.
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Kromeya.
Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo zdravila Kromeya pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
Warning: Do not throw the vial away.
Opozorilo: Viale ne zavrzite.
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
• imunske bolezni, ki lahko prizadenejo pljuča, koţo in limfne vozle (najpogosteje takšno stanje imenujemo sarkoidoze);
Week 16 placebo-controlled
16. teden Kontrolirana s placebom26.
The results for the 40 mg every other week dose are summarised in Table 7.
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v preglednici 7.