natgillin/translations-raw huggingface dataset:
For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
Pri bolnikih, ki so dobivali 50 mg enkrat na teden ves čas študije, so se odzivi glede učinkovitosti še naprej izboljševali, tako da je v 24. tednu PASI 75 doseglo 71 % bolnikov.
It is recommended that the conduct of these tests should be recorded in the patient's alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Zdravnike predpisovalce opominjamo na nevarnost lažno negativnih rezultatov tuberkulinskega kožnega testa, še zlasti pri bolnikih, ki so hudo bolni ali imunoinkompetentni.
There were no differences in rates of infection among patients treated with LIFMIOR and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
V stopnjah pogostnosti okužb med bolniki, zdravljenimi z zdravilom LIFMIOR, in tistimi, ki so prejemali placebo za zdravljenje psoriaze v plakih, v preskušanjih, nadzorovanih s placebom, ki so trajala do 24 tednov, ni bilo razlik.
Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
resne okužbe (vključno s pljučnico, celulitisom, bakterijskim artritisom, sepso in parazitsko okužbo)*
These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Te okužbe so povzročale bakterije, mikobakterije, glivice, virusi in paraziti (vključno s protozoji).
• Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision
• znaki avtoimunskih reakcij (reakcije, pri katerih se tvorijo protitelesa, ki lahko poškodujejo normalna telesna tkiva), kot so bolečina, srbenje, oslabelost, težave z dihanjem, motnje mišljenja, zaznavanja ali vida;
Please tell your doctor if you or the child in your care have a history of alcohol abuse.
Povejte zdravniku, če imate vi ali otrok, za katerega skrbite, zgodovino zlorabe alkohola.
In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with LIFMIOR developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
V nadzorovanih preskušanjih bolnikov s psoriazo v plakih so se reakcije na mestu injiciranja v prvih 12 tednih zdravljenja pojavile pri približno 13,6 % bolnikov, zdravljenih z zdravilom LIFMIOR, in pri 3,4 % bolnikov, ki so dobivali placebo.
Worsening of cardiac failure congestive (see section 4.4)
Srčne bolezni poslabšanje kongestivnega srčnega popuščanja (glejte poglavje 4.4)
Push the open end of the pen firmly against the skin, so that the needle safety shield is pushed completely inside of the pen.
Pritisnite odprti konec peresnika čvrsto navzdol proti koži, da varnostni ščit igle ne bo več viden.
From the start of part 2, the median time to flare was ≥ 116 days for patients who received LIFMIOR and 28 days for patients who received placebo.
Od začetka drugega dela študije je bil mediani čas do ponovnega izbruha bolezni  116 dni pri bolnikih na zdravilu LIFMIOR in 28 dni pri bolnikih na placebu.
This combination has not demonstrated increased clinical benefit; such use is not recommended (see section 4.4).
Ta kombinacija ni pokazala povečane klinične koristi, zato njena uporaba ni priporočljiva (glejte poglavje 4.4).
Patients were observed off treatment for the occurrence of rebound (PASI ≥150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Bolnike so brez zdravljenja spremljali glede preobratnih znakov (PASI  150 % izhodiščnega) in časa do recidiva (opredeljenega kot izginotje vsaj polovice izboljšanja, doseženega med izhodiščem in 24. tednom).
The long-term safety of LIFMIOR in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Varnost dolgotrajnega kombiniranega zdravljenja z zdravilom LIFMIOR in drugimi imunomodulirajočimi antirevmatičnimi zdravili (DMARD - Disease-Modifying AntiRheumatic Drugs) ni bila ugotovljena.
0.8†,φ a: Patients who did not complete 12 months in the study were considered to be non-responders.
HAQ v izhodišču po 52 tednih a: Bolniki, ki v študiji niso sodelovali 12 mesecev, so bili obravnavani kot neodzivni.
Undesirable effects in paediatric patients with plaque psoriasis In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Neželeni učinki pri pediatričnih bolnikih s psoriazo v plakih V 48-tedenski študiji pri 211 otrocih, starih 4 do 17 let, z otroško psoriazo v plakih so bili poročani neželeni učinki podobni tistim, ki so jih opažali v predhodnih študijah pri odraslih s psoriazo v plakih.
Ankylosing Spondylitis Response
Odziv ankilozirajočega spondilitisa
LIFMIOR should be discarded if not used within four weeks after removal from the refrigerator.
Zdravilo LIFMIOR zavrzite, če ga ne porabite v štirih tednih po odvzemu iz hladilnika.
After 12 weeks of treatment, patients in the placebo group began treatment with blinded LIFMIOR (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Po 12 tednih zdravljenja so bolniki v skupini s placebom začeli slepo zdravljenje z zdravilom LIFMIOR (25 mg dvakrat na teden), bolniki v skupinah z aktivnim zdravljenjem pa so do 24. tedna nadaljevali z odmerkom, na katerega so bili prvotno randomizirani.
Histiocytosis haematophagic (macrophage activation syndrome)*
hematofagna histiocitoza (sindrom aktivacije makrofagov)*
Be careful not to bend or twist the cover during removal to avoid damage to the needle.
Pazite, da med odstranjevanjem pokrovčka le-tega ne ukrivite ali zavihate, da ne poškodujete igle.
Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.
Radiografijo dlani in zapestja so opravili v izhodišču in v 6., 12. in 24. mesecu.
In a double blind, placebo controlled, randomised clinical study in adult patients with psoriatic arthritis 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
V dvojno slepi s placebom nadzorovani randomizirani klinični študiji pri odraslih bolnikih s psoriatičnim artritisom je 184 bolnikov v 4. tednu dobilo tudi multivalentno polisaharidno cepivo proti pnevmokokom.
TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
TNF in limfotoksin obstajata pretežno v obliki homotrimerov, njuna biološka aktivnost pa je odvisna od navzkrižne vezave na receptorje TNF na površini celice.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Pri bolnikih, ki so dobivali 25 mg dvakrat na teden ves čas študije, se je odziv PASI 75 med 12. in 36. tednom še naprej izboljševal.
These mean concentrations in patients with paediatric plaque psoriasis were similar to the concentrations observed in patients with juvenile idiopathic arthritis (treated with 0.4 mg/kg etanercept twice weekly, up to maximum dose of 50 mg per week).
Te povprečne koncentracije pri bolnikih s pediatrično psoriazo v plakih so bile podobne koncentracijam, ki so jih opazili pri bolnikih z juvenilnim idiopatskim artritisom (zdravljenih z 0,4 mg/kg etanercepta dvakrat na teden, do največjega odmerka 50 mg na teden).
• To break the seal, bend the larger end down and then up until broken (see Diagram 13).
Plombo prelomite tako, da upognete daljši del brizge navzdol in nato navzgor, dokler se ne prelomi (glejte sliko 13).
Do not use LIFMIOR
Ne uporabljajte zdravila LIFMIOR
Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
Bolnikom, ki tehtajo 62,5 kg ali več, lahko dajemo odmerke zdravila z napolnjeno injekcijsko brizgo ali napolnjenim injekcijskim peresnikom s stalnim odmerkom.
This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis.
V tem poglavju so prikazani podatki iz štirih randomiziranih nadzorovanih preskušanj pri odraslih z revmatoidnim artritisom, ene študije pri odraslih s psoriatičnim artritisom, ene študije pri odraslih z ankilozirajočim spondilitisom, ene študije pri odraslih z radiografsko nezaznavnim aksialnim spondilartritisom, štirih študij pri odraslih s psoriazo v plakih, treh študij pri bolnikih z juvenilnim idiopatskim artritisom in ene študije pri otrocih s psoriazo v plakih.
Pancytopenia and aplastic anaemia
Pancitopenija in aplastična anemija
Serious haematological, neurological and autoimmune reactions have also been reported.
Poročali so tudi o pojavu resnih hematoloških, nevroloških in avtoimunskih neželenih učinkov.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.
Zdravljenje aktivnega in progresivnega psoriatičnega artritisa pri odraslih, če je bil odziv na zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili nezadosten.
This section presents data from three studies in juvenile idiopathic arthritis, one study in paediatric patients with plaque psoriasis, four studies in adults with rheumatoid arthritis, and four studies in adults with plaque psoriasis.
V tem poglavju so prikazani podatki iz treh študij pri bolnikih z juvenilnim idiopatskim artritisom, ene študije pri otrocih s psoriazo v plakih, štirih študij pri odraslih z revmatoidnim artritisom in štirih študij pri odraslih s psoriazo v plakih.
In studies when adult patients received concurrent treatment with LIFMIOR plus anakinra, a higher rate of serious infections compared to LIFMIOR alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1000/mm3).
V študijah, v katerih so odrasli bolniki sočasno prejemali zdravilo LIFMIOR in anakinro, so opažali večjo stopnjo resnih okužb v primerjavi s samim zdravilom LIFMIOR in pri 2 % bolnikov (3/139) se je pojavila nevtropenija (absolutna koncentracija nevtrofilcev < 1.000/mm
Radiographs of hands/wrists and feet were read at baseline and 6, 12, and 24 months.
Radiografske slike dlani in zapestij ter stopal so ocenili v izhodišču in po 6, 12 in 24 mesecih.
How to use LIFMIOR
Kako uporabljati zdravilo LIFMIOR
This combination has not demonstrated increased clinical benefit; such use is not recommended (see section 4.5).
Ta kombinacija ni pokazala povečane klinične koristi, zato njena uporaba ni priporočljiva (glejte poglavje 4.5).
If any of the following happen to the child, do not give the child more LIFMIOR.
Če se pri otroku pojavi karkoli od naslednjega, mu zdravila LIFMIOR ne smete več dajati.
In part 2, 6 of 25 (24%) patients remaining on LIFMIOR experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
V drugem delu je 6 od 25 (24 %) bolnikov, ki so ostali na zdravilu LIFMIOR, doživelo ponoven izbruh bolezni, v primerjavi z 20 od 26 (77 %) bolnikov, ki so v drugem delu prejemali placebo (p = 0,007).
Serious allergic/anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis
resne alergijske/ anafilaktične reakcije (vključno z angioedemom in bronhospazmom), sarkoidoza poslabšanje simptomov dermatomiozitisa
In clinical studies, concurrent administration of abatacept and LIFMIOR resulted in increased incidences of serious adverse events.
V kliničnih študijah je sočasna uporaba abatacepta in zdravila LIFMIOR zvečala pojavnost resnih neželenih učinkov.
The highest dose level evaluated has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 administered twice weekly.
Največje ocenjeno odmerjanje je bilo: intravenski polnilni odmerek 32 mg/m2, nato pa 16 mg/m2 2-krat tedensko subkutano.
• A needle-free demonstration device
• peresnik brez igle za prikaz uporabe
You can help by reporting any side effects you may get.
Tudi sami lahko k temu prispevate tako, da poročate o kateremkoli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vas.
Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of LIFMIOR following its long-term use in patients with JIA.
Pri bolnikih z JIA prav tako niso izvedli študij za ovrednotenje učinka prekinitve zdravljenja ali zmanjšanja priporočenega odmerka zdravila LIFMIOR po njegovi dolgotrajni uporabi.
The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
V študiji so ocenili 215 odraslih bolnikov (spremenjena populacija, ki so jo nameravali zdraviti) z aktivnim nr-AxSpa (starih od 18 do 49 let), opredeljenih kot bolniki, ki izpolnjujejo merila ASAS za razvrstitev aksialnega spondilartritisa, ki pa niso ustrezali spremenjenim newyorškim merilom za AS. Bolniki so morali imeti tudi nezadostni odziv na vsaj dva NSAID ali intoleranco zanju.
Some have occurred within a few weeks after initiating treatment with LIFMIOR in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Nekatere okužbe so se pojavile nekaj tednov po začetku zdravljenja bolnikov, ki so imeli poleg revmatoidnega artritisa tudi druga obolenja (npr. sladkorno bolezen, kongestivno srčno popuščanje, aktivne ali kronične okužbe v anamnezi) (glejte poglavje 4.4).
L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Water for injections
L-argininijev klorid natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat voda za injekcije
Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy).
Poleg tega so redko poročali o perifernih demielinizirajočih polinevropatijah (vključno z Guillain-Barréjevim sindromom, kronično vnetno demielinizirajočo polinevropatijo, demielinizirajočo polinevropatijo in multifokalno motorično nevropatijo).
In the toxicological studies with LIFMIOR, no dose-limiting or target organ toxicity was evident.
V študijah toksičnosti zdravila LIFMIOR ni bilo opaziti toksičnosti, ki bi omejevala odmerjanje, niti toksičnosti za tarčne organe.
• While holding the vial in one hand, remove the plastic packaging from the vial adaptor (see Diagram 5).
Z eno roko še vedno držite vialo, z drugo pa odstranite plastično embalažo z adapterja (glejte sliko 5).
b. One cotton ball or gauze
b. Eno vato ali gazo.
LIFMIOR is supplied with pre-filled syringes containing water for injection.
Zdravilu LIFMIOR je priložena napolnjena injekcijska brizga, ki vsebuje vodo za injekcije.
However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
Vendar pa omejeni podatki o varnosti iz registra bolnikov nakazujejo, da je pri subkutani uporabi zdravila v odmerku 0,8 mg/kg enkrat na teden pri otrocih, starih od 2 do 3 let, varnostni profil podoben profilu pri odraslih in otrocih, starih 4 leta in več (glejte poglavje 5.1).
Do NOT remove the grey stopper or aluminium ring around the top of the vial.
Z vrha viale NE odstranjujte sivega gumijastega zamaška niti aluminijastega obročka.
Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
Starost bolnikov je bila od 18 do 70 let in vsi so imeli aktivni psoriatični artritis (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) v najmanj eni od naslednjih oblik: (1) distalna interfalangealna prizadetost (DIP); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali (5) spondilitisu podobna ankiloza.
• With the syringe still attached, gently move the vial in circles a few times, to dissolve the powder (see Diagram 9).
Medtem ko je brizga še vedno v viali, nekajkrat nežno krožno zavrtite vialo, da se prašek raztopi (glejte sliko 9).
Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
vaskulitis (vključno z vaskulitisom s pozitivnimi antinevtrofilnimi citoplazemskimi protitelesi)
Non-interactions
Medsebojno nedelovanje
If you forget to inject LIFMIOR
Če ste pozabili injicirati zdravilo LIFMIOR
In this study, 53 patients received placebo, 214 patients received 50 mg LIFMIOR once weekly and 153 patients received 25 mg LIFMIOR twice weekly.
V tej študiji je 53 bolnikov dobivalo placebo, 214 bolnikov 50 mg zdravila LIFMIOR enkrat na teden in 153 bolnikov 25 mg zdravila LIFMIOR dvakrat na teden.
There have been reports of hypoglycaemia following initiation of LIFMIOR in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
Hipoglikemija pri bolnikih, ki se zdravijo zaradi sladkorne bolezni Po uvedbi zdravila LIFMIOR so pri bolnikih, ki so prejemali zdravila za zdravljenje sladkorne bolezni, poročali o hipoglikemiji, zaradi katere je bilo treba pri nekaterih od teh bolnikov zmanjšati odmerek zdravila za zdravljenje sladkorne bolezni.
DSGA b, clear or almost clear *p ≤ 0.0001 compared with placebo a. No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving LIFMIOR 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
b, čisto ali skoraj čisto *p  0,0001 v primerjavi s placebom a. V študijah 2 in 4 po 24 tednih niso opravili statističnih primerjav s placebom, ker je skupina, ki je prvotno dobivala placebo, začela dobivati 25 mg zdravila LIFMIOR dvakrat na teden ali 50 mg enkrat na teden od 13. do 24. tedna.
Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Zvišano koncentracijo TNF najdemo tudi v sinovijski tekočini in psoriatičnem plaku bolnikov s psoriatičnim artritisom ter v serumu in sinovijski tekočini bolnikov z ankilozirajočim spondilitisom.
In a study of 49 adult patients with rheumatoid arthritis treated with LIFMIOR, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Študija pri 49 odraslih bolnikih z revmatoidnim artritisom ni pokazala, da bi zdravljenje z zdravilom LIFMIOR zmanjšalo zapoznelo preobčutljivostno reakcijo, zmanjšalo raven imunoglobulinov ali spremenilo število efektorskih celic.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their LIFMIOR dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
V šudiji 3 je večina bolnikov (77 %), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek zdravila LIFMIOR po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
Mannitol (E421) Sucrose
Prašek manitol (E421) saharoza trometamol
LIFMIOR 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Učinek 25 mg odmerka zdravila LIFMIOR je bil pomembno boljši kot pri metotreksatu glede ocene erozije sklepov, tako po 12 kot po 24 mesecih.
• Remove the plastic cap from the LIFMIOR vial (see Diagram 1).
Z viale zdravila LIFMIOR odstranite plastično zaporko (glejte sliko 1).
• Use a new alcohol swab to clean the grey stopper on the LIFMIOR vial.
Z novo alkoholno blazinico očistite sivi gumijasti zamašek na viali.
Approximately 15% of subjects who received LIFMIOR achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Približno 15 % bolnikov, zdravljenih z zdravilom LIFMIOR, je do 3. in 6. meseca doseglo odziv ACR 70, v primerjavi z manj kot 5 % tistih, ki so prejemali placebo.
Step 1: Preparing for an LIFMIOR injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of the used MYCLIC pen
Korak 1: Priprava na injiciranje zdravila LIFMIOR Korak 2: Izbira mesta injiciranja Korak 3: Injiciranje raztopine zdravila LIFMIOR Korak 4: Odstranjevanje uporabljenega peresnika MYCLIC
LIFMIOR has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Ugotovili so, da zdravilo LIFMIOR izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in upočasni hitrost napredovanja okvar perifernih sklepov, merjenih z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
Opportunistic infections have been reported in association with LIFMIOR, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
V povezavi z zdravilom LIFMIOR so poročali o oportunističnih okužbah, vključno z invazivnimi glivičnimi, parazitskimi (vključno s protozojskimi), virusnimi (vključno s herpesom zoster), bakterijskimi (vključno z bakterijama Listeria in Legionella) in atipičnimi mikobakterijskimi okužbami.
Based on pharmacokinetic data (see section 5.2), no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Iz farmakokinetičnih podatkov (glejte poglavje 5.2) izhaja, da pri bolnikih z ledvično ali jetrno okvaro prilagajanje odmerka ni potrebno.
The long-term safety and effectiveness of LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Dolgoročna varnost in učinkovitost zdravila LIFMIOR, v odmerkih 0,8 mg/kg (do 50 mg) enkrat na teden, je bila ovrednotena v odprti podaljšani študiji, v kateri je sodelovalo 181 otrok s psoriazo v plakih, ki so se zdravili do 2 leti po zaključku 48-tedenske študije, navedene zgoraj.
After the 12-week double-blind treatment period, all patients received LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
Po 12-tedenskem obdobju dvojno slepega zdravljenja so vsi bolniki prejemali zdravilo LIFMIOR v odmerku 0,8 mg/kg (do 50 mg) enkrat na teden še dodatnih 24 tednov.
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in LIFMIOR-treated patients.
V kliničnih študijah z zdravilom LIFMIOR, ki so trajale več kot 2 leti in so vključevale 351 bolnikov z ankilozirajočim spondilitisom, so poročali o 6 primerih malignega obolenja.