natgillin/translations-raw huggingface dataset:
LIFMIOR can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo LIFMIOR je mogoče uporabiti kot monoterapijo, kadar bolnik ne prenese metotreksata ali kadar trajno zdravljenje z metotreksatom ni primerno.
If the child has any of the above symptoms he/she may be having an allergic reaction to LIFMIOR, so you should seek immediate medical attention.
Če ima otrok kateregakoli od zgoraj navedenih simptomov, ima mogoče alergijsko reakcijo na zdravilo LIFMIOR, zato morate nemudoma poiskati zdravniško pomoč.
However, it cannot be excluded that the combination of LIFMIOR with methotrexate could be associated with an increase in the rate of infections.
Vendar pa ni mogoče izključiti možnosti, da se lahko stopnja pogostnosti okužb pri zdravljenju s kombinacijo zdravila LIFMIOR in metotreksata poveča.
TNF-antagonists, such as LIFMIOR, affect the immune system and their use may affect the body's defenses against infection and cancer.
Antagonisti TNF, kot je zdravilo LIFMIOR, vplivajo na imunski sistem in lahko zmanjšajo sposobnost organizma za obrambo pred okužbami in rakom.
In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy).
V drugi opazovalni registrski študiji, ki so jo izvajali v več državah in v kateri so primerjali tveganje za neželene izide nosečnosti pri ženskah, izpostavljenih etanerceptu v prvih 90 dneh nosečnosti (n = 425), in pri ženskah, ki so bile izpostavljene nebiološkim zdravilom (n = 3.497), niso opazili povečanega tveganja za resne prirojene napake (grobo razmerje obetov [OR - Odds Ratio] = 1,22, 95 % IZ: 0,79-1,90; prilagojeno OR = 0,96, 95 % IZ: 0,58-1,60 po prilagoditvi glede na državo, materino bolezen, pariteto, starost matere in kajenje v zgodnji nosečnosti).
The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma.
Invazivne glivične okužbe, o katerih so najpogosteje poročali, so vključevale okužbe z vrstami Candida, Pneumocystis, Aspergillus in Histoplasma.
The safety and efficacy of LIFMIOR in patients with chronic infections have not been evaluated.
Varnost in učinkovitost zdravila LIFMIOR pri bolnikih s kroničnimi okužbami nista bili ovrednoteni.
In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with LIFMIOR or placebo for moderate to severe alcoholic hepatitis, LIFMIOR was not efficacious, and the mortality rate in patients treated with LIFMIOR was significantly higher after 6 months.
faze, v kateri so proučevali 48 hospitaliziranih bolnikov, zdravljenih z zdravilom LIFMIOR ali placebom zaradi zmernega do hudega alkoholnega hepatitisa, zdravilo LIFMIOR ni bilo učinkovito in stopnja smrtnosti bolnikov, zdravljenih z zdravilom LIFMIOR, je bila po 6 mesecih pomembno večja.
There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
O bolnikih, vključno z bolniki s pozitivnim revmatoidnim faktorjem, ki so razvili druga avtoprotitelesa v povezavi z lupusu podobnim sindromom ali izpuščaji, ki bi po klinični sliki in bioptičnem izvidu lahko pomenili subakutni kožni lupus ali diskoidni lupus, so poročali redko.
In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which LIFMIOR was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with LIFMIOR or sulfasalazine alone.
V klinični študiji odraslih bolnikov, ki so prejemali ustaljene odmerke sulfasalazina, ki mu je bilo dodano zdravilo LIFMIOR, se je pri bolnikih v skupini s kombinacijo obeh zdravil statistično pomembno zmanjšala povprečna koncentracija belih krvničk v primerjavi s skupinama, zdravljenima samo z zdravilom LIFMIOR ali samo s sulfasalazinom.
Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis.
Tumorje nekrotizirajoči faktor (TNF) je dominantni citokin v vnetnem procesu pri revmatoidnem artritisu.
Clearance is approximately 0.066 l/hr in patients with rheumatoid arthritis, somewhat lower than the value of 0.11 l/hr observed in healthy volunteers.
Očistek pri bolnikih z revmatoidnim artritisom je približno 0,066 l/h, nekoliko nižji kot pri zdravih prostovoljcih, pri katerih znaša 0,11 l/h.
If you stop using LIFMIOR
Če ste prenehali uporabljati zdravilo LIFMIOR
The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Vrste okužb, ki so jih opazili v kliničnih preskušanjih pri bolnikih z juvenilnim idiopatskim artritisom, starih od 2 do 18 let, so bile na splošno blage do zmerne in skladne s tistimi, ki jih pogosto vidimo pri skupinah ambulantnih pediatričnih bolnikov.
The safety and efficacy of LIFMIOR in patients with immunosuppression have not been evaluated.
Varnost in učinkovitost zdravila LIFMIOR pri bolnikih z imunosupresijo nista bili ovrednoteni.
Allergic reactions have included angioedema and urticaria; serious reactions have occurred.
Alergijske reakcije so vključevale angioedem in urtikarijo, opisani pa so bili tudi primeri resnih reakcij.
Name and address of the manufacturers of the biological active substance Boehringer Ingelheim Pharma KG
Ime in naslov izdelovalcev biološke učinkovine Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65
The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Največje od teh preskušanj (n = 277) je vključevalo bolnike med 18. in 70. letom starosti z aktivnim ankilozirajočim spondilitisom, definiranim po vizualni analogni lestvici (VAS) z vrednostjo ≥ 30 za povprečno trajanje in intenzivnost jutranje okorelosti ter VAS vrednost ≥ 30 za vsaj 2 od 3 sledečih parametrov: bolnikova splošna ocena; povprečna VAS vrednost bolečine v hrbtenici ponoči in celokupne bolečine v hrbtenici; povprečje 10 vprašanj v Bath Ankylosing Spondylitis Functional Index (BASFI).
This will help to reduce foaming (lots of bubbles) (see Diagram 8).
Tako boste zmanjšali penjenje raztopine (nastajanje mehurčkov) (glejte sliko 8).
After 12 weeks of treatment,
Zdravljenje je trajalo 12 tednov.
• if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of LIFMIOR (listed in section 6).
če ste vi ali otrok, za katerega skrbite, alergični na etanercept ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Month 12
12. mesec
• Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).
Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): karcinom Merklovih celic (vrsta kožnega raka); čezmerna aktivacija belih krvničk, povezanih z vnetjem (sindrom aktivacije makrofagov); ponovitev hepatitisa B (vnetje jeter); poslabšanje stanja, imenovanega dermatomiozitis (vnetje mišic in mišična oslabelost, ki ju spremlja kožni izpuščaj).
Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with LIFMIOR due to the development of neutralising antibodies in rodents.
Študij kancerogenosti in standardnih raziskav plodnosti in postnatalne toksičnosti zaradi tvorbe nevtralizirajočih protiteles pri glodalcih niso opravili.
If you notice a spot of blood at the injection site, you should press the cotton ball or gauze over the injection site for 10 seconds.
Če na mestu injiciranja opazite kapljo krvi, na mesto injiciranja za 10 sekund pritisnite vato ali gazo.
Compared to placebo, patients with rheumatic diseases treated with LIFMIOR had a significantly higher incidence of injection site reactions (36% vs. 9%).
V primerjavi s placebom je bila pri bolnikih z revmatskimi obolenji, zdravljenih z zdravilom LIFMIOR, pojavnost reakcij na mestu injiciranja pomembno večja (36 % proti 9 %).
*see Description of selected adverse reactions, below.
*glejte Opis izbranih neželenih učinkov v nadaljevanju
LIFMIOR showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Pokazali so, da je zdravilo LIFMIOR od izhodišča do 12 tednov statistično pomembno izboljšalo večino ocen z zdravjem povezane kakovosti življenja in telesne funkcije, vključno z BASFI (BASFIBath Ankylosing Spondylitis Functional Index; indeks Bath za ocenjevanje aktivnosti ankilizirajočega spondilitisa), rezultatom splošnega zdravstvenega stanja EuroQol 5D in rezultatom telesne komponente SF-36, v primerjavi s placebom.
Step 2: Choosing an injection site (see Diagram 2)
Korak 2: Izbira mesta injiciranja (glejte sliko 2)
As you lift the pen, the purple needle safety shield will automatically extend to cover the needle.
Ko peresnik umaknete, se bo vijolični varnostni ščit igle avtomatično podaljšal in pokril iglo.
Please tell your doctor if the child in your care has a history of alcohol abuse.
Povejte zdravniku, če ima otrok, za katerega skrbite, zgodovino zlorabe alkohola.
The use of LIFMIOR is not expected to affect the ability to drive or use machines.
Ni pričakovati, da bi zdravilo LIFMIOR vplivalo na sposobnost upravljanja vozil in strojev.
At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy.
Po 104 tednih je 8 preskušancev napredovalo do stopnje 2 obojestransko, merjene z rentgenskim slikanjem hrbtenice, kar po spremenjenih newyorških merilih za radiološko oceno kaže na aksialno spondilartropatijo.
Needle safety shield disappears inside the pen
varnostni ščit igle izgine v peresnik
The safety and efficacy of LIFMIOR were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Varnost in učinkovitost zdravila LIFMIOR je bila ugotovljena v dvodelni študiji pri 69 otrocih s poliartikularnim potekom juvenilnega idiopatskega artritisa z različnimi tipi nastopa bolezni (poliartritis, oligoartritis, sistemski nastop).
Malignancies and lymphoproliferative disorders
Maligne in limfoproliferativne bolezni
After cleaning, do not touch the stopper with your hands or allow it to touch any surface.
Po čiščenju se ga ne smete več dotikati z rokami; pazite tudi, da se z njim ne dotaknete drugih površin.
Each new injection should be given at least 3 cm from an old site.
Vsako naslednjo injekcijo morate dati vsaj 3 cm od mesta prejšnje injekcije.
Evidence of efficacy for the once weekly dosing regimen in this patient population has been based on data from the study in patients with ankylosing spondylitis.
Pri tej skupini bolnikov dokaz učinkovitosti režima odmerjanja enkrat na teden temelji na podatkih iz študije pri bolnikih z ankilozirajočim spondilitisom.
Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, LIFMIOR should be discontinued.
Take bolnike je treba nemudoma pregledati, vključno s pregledom celotne krvne slike, in v primeru krvne diskrazije prekiniti zdravljenje s tem zdravilom.
LIFMIOR N = 138
Zdravilo LIFMIOR N = 138
• if the child you are caring for is allergic to etanercept or any of the other ingredients of LIFMIOR (listed in section 6).
če je otrok, za katerega skrbite, alergičen na etanercept ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Avoid areas with scars or stretch marks.
Izogibajte se območij z brazgotinami ali strijami.
In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 4.8% of subjects with juvenile idiopathic arthritis.
Pri bolnikih, ki so jih v kliničnih preskušanjih zdravili z etanerceptom v odobrenih odmerkih do 12 mesecev, je bila kumulativna pogostnost protiteles proti etanerceptu približno 6 % pri bolnikih z revmatoidnim artritisom, 7,5 % pri bolnikih s psoriatičnim artritisom, 2 % pri bolnikih z ankilozirajočim spondilitisom, 7 % pri bolnikih s psoriazo, 9,7 % pri bolnikih z otroško psoriazo in 4,8 % pri bolnikih z juvenilnim idiopatskim artritisom.
Your doctor will decide how long you should take LIFMIOR and whether retreatment is needed based on your response.
Zdravnik bo na podlagi vašega odziva na zdravilo določil, koliko časa morate uporabljati zdravilo LIFMIOR in ali je potrebno ponovno zdravljenje.
Tell the doctor if the child develops any abdominal cramps and pain, diarrhoea, weight loss or blood in the stool.
Povejte zdravniku, če se pri otroku pojavijo krči v trebuhu in bolečine, driska, hujšanje ali kri v blatu.
Fold the paper cover back over the tray and place the carton containing any remaining pre-filled syringes back into the refrigerator.
Papirnato plast pretisnega omota prepognite nazaj in odložite škatlo s preostalimi napolnjenimi injekcijskimi brizgami nazaj v hladilnik.
You or the child should not use LIFMIOR with medicines that contain the active substance anakinra or abatacept.
Zdravila LIFMIOR vi ali otrok ne smete jemati skupaj z zdravili, ki vsebujejo učinkovino anakinro ali abatacept.
Long-term safety of LIFMIOR monotherapy (n=103), LIFMIOR plus methotrexate (n=294), or methotrexate monotherapy (n=197) were assessed for up to 3 years in a registry of 594 children aged 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Dolgoročno varnost zdravljenja z zdravilom LIFMIOR v monoterapiji (n = 103), zdravljenja z zdravilom LIFMIOR v kombinaciji z metotreksatom (n = 294) ali zdravljenja z metotreksatom v monoterapiji (n = 197) so ovrednotili za obdobje do 3 let na osnovi registra 594 otrok, starih od 2 do 18 let, z juvenilnim idiopatskim artritisom.
There is no apparent pharmacokinetic difference between males and females.
Med farmakokinetiko zdravila pri moških in ženskah ni bistvenih razlik.
• Holding the glass barrel of the syringe (not the white collar) in one hand, and the vial adaptor (not the vial) in the other, connect the syringe to the vial adaptor by inserting the tip into the opening and turn clockwise until completely secured (see Diagram 7).
Z držanjem steklenega dela brizge (ne belega omota) v eni roki in adapterja viale (ne same viale) v drugi brizgo spojite z adapterjem tako, da vstavite njeno konico v odprtino na adapterju in jo zavrtite v smeri urnega kazalca, dokler se ne ustavi (glejte sliko 7).
One rheumatoid arthritis patient mistakenly self-administered 62 mg LIFMIOR subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
En bolnik z revmatoidnim artritisom si je pomotoma subkutano injiciral 62 mg zdravila LIFMIOR 2-krat tedensko 3 tedne, pri tem pa ni prišlo do pojava kakršnegakoli neželenega učinka.
Autoantibody formation Treatment with LIFMIOR may result in the formation of autoimmune antibodies (see section 4.8).
Zdravljenje z zdravilom LIFMIOR lahko sproži nastajanje avtoimunskih protiteles (glejte poglavje 4.8).
• Hold the vial firmly on the flat surface with one hand.
Na ravni površini z eno roko čvrsto primite vialo.
These include rare reports of pancytopenia and very rare reports of aplastic anaemia.
Ta vključujejo tudi redke primere pancitopenije in zelo redke primere aplastične anemije.
Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of LIFMIOR compared to the 349 adult rheumatoid arthritis patients.
Nekateri neželeni učinki so bili pogosteje opaženi pri 69 bolnikih z juvenilnim idiopatskim artritisom, ki so zdravilo LIFMIOR prejemali 3 mesece, kot pri 349 odraslih bolnikih z revmatoidnim artritisom.
Physicians should use caution when using LIFMIOR in patients who also have moderate to severe alcoholic hepatitis.
Zdravniki naj bodo pazljivi, kadar uporabljajo zdravilo LIFMIOR pri bolnikih, ki imajo tudi zmeren do hud alkoholni hepatitis.
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Mnogo sprememb sklepov pri revmatoidnem artritisu in ankilozirajočem spondilitisu ter sprememb na koži pri psoriazi v plakih posredujejo vnetne molekule, povezane v mrežo, ki jo nadzira TNF.
• Wegener's granulomatosis: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Wegenerjeva granulomatoza: Zdravilo LIFMIOR ni priporočljivo za zdravljenje redke vnetne bolezni Wegenerjeve granulomatoze.
LIFMIOR in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Zdravilo LIFMIOR je v kombinaciji z metotreksatom indicirano za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih, kadar odziv na zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili, vključno z metotreksatom (če ta ni kontraindiciran), ni zadosten.
LIFMIOR powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Pred uporabo je treba LIFMIOR prašek za raztopino za injiciranje rekonstituirati v 1 ml vehikla (glejte poglavje 6.6).
The primary measure of efficacy (ASAS 20) was a ≥20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Primarno merilo učinkovitosti (ASAS 20) je bilo  20 % izboljšanje pri vsaj 3 od 4 domen lestvice Ocenjevanje pri ankilozirajočem spondilitisu (ASAS - Assessment in Ankylosing Spondylitis) (bolnikova splošna ocena, bolečina v hrbtenici, BASFI in vnetje) ter odsotnost poslabšanja pri četrti domeni.
The differences in TSS and JSN were not statistically significant between methotrexate and LIFMIOR 25 mg.
Razlike v ocenah TSS in JSN med metotreksatom in 25 mg zdravila LIFMIOR niso bile statistično pomembne.
In adults (aged 18 and over), LIFMIOR can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Pri odraslih (starih 18 let in več) se zdravilo LIFMIOR lahko uporablja pri zdravljenju zmernega ali hudega revmatoidnega artritisa, psoriatičnega artritisa, hudega aksialnega spondilartritisa, vključno z ankilozirajočim spondilitisom, in zmerne ali hude luskavice - v vseh primerih običajno šele po neuspešnem zdravljenju z drugimi običajnimi oblikami zdravljenja, ali če te oblike zdravljenja za vas niso primerne.
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Zdravljenje poliartritisa (pozitivnega ali negativnega za revmatoidni faktor) in razširjenega oligoartritisa pri otrocih in mladostnikih, starih 2 leti ali več, ki so se nezadostno odzvali na zdravljenje z metotreksatom ali ga niso prenašali.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Primarni opazovani dogodek učinkovitosti v vseh štirih študijah je bil tisti delež bolnikov v vsaki zdravljeni skupini, ki je po 12 tednih dosegel PASI 75 (tj. vsaj 75 % izboljšanje indeksa PASI - Psoriasis Area and Severity Index; indeks površine in izrazitosti psoriaze - v primerjavi z izhodiščem).
Withdrawing the LIFMIOR solution from the vial f.
Jemanje raztopine zdravila LIFMIOR iz viale f.
Clean the injection site with the alcohol swab using a circular motion, and allow it to dry.
Mesto injiciranja s krožnim gibom obrišite z alkoholno blazinico in pustite, da se posuši.
4 vials of powder
4 viale s praškom
Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept.
Študije toksičnosti za razvoj, ki so jih opravili na podganah in kuncih, niso pokazale nobenih znakov škodljivih učinkov etanercepta na zarodke ali novorojene podgane.
If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with LIFMIOR.
Če imate kakršnakoli vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, ki dobro poznajo zdravilo LIFMIOR.
†Please see sub-section ‘Undesirable effects in paediatric patients with juvenile idiopathic arthritis' above.
*glejte Opis izbranih neželenih učinkov v nadaljevanju prosimo, glejte podpoglavje ''Neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom'' zgoraj
The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Učinkovitost zdravila LIFMIOR je bila ocenjena v randomizirani, dvojno slepi in s placebom nadzorovani študiji pri 205 bolnikih s psoriatičnim artritisom.
Patients with a significant exposure to varicella virus should temporarily discontinue LIFMIOR therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Bolniki, ki so zelo izpostavljeni virusu noric, naj začasno prekinejo zdravljenje z zdravilom LIFMIOR, v poštev pa pridejo tudi za profilaktično zdravljenje z imunoglobulinom proti virusu varicella-zoster.
Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving LIFMIOR compared with control patients, particularly in patients with psoriasis.
Pri združevanju rezultatov nadzorovanih kliničnih preskušanj so opazili več primerov NMSC pri bolnikih, ki so prejemali zdravilo LIFMIOR, kot pri kontrolnih bolnikih, še zlasti pri bolnikih s psoriazo.
4 years.
4 leta
Adjusted mean change from baseline was 3.8 for LIFMIOR treated (n=95) versus 0.8 for placebo treated (n=105) patients (p<0.001).
Prilagojena povprečna sprememba od izhodišča je bila 3,8 pri bolnikih, zdravljenih z zdravilom LIFMIOR (n = 95), in 0,8 pri bolnikih, ki so prejemali placebo (n = 105) (p < 0,001).