natgillin/translations-raw huggingface dataset:
Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1.
Etanercept je dimer himerne beljakovine, ustvarjen z genskim inženirstvom s spajanjem zunajcelične vezalne domene receptorja-2 za humani tumorje nekrotizirajoči faktor (TNFR2/p75) in domene Fc humanega imunoglobulina IgG1.
With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 3).
S hitrim in kratkim gibom potisnite iglo do konca v kožo pod kotom 45 do 90 stopinj (glejte sliko 3).
The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
Upočasnitev slabšanja okvar perifernih sklepov so ugotovili pri bolnikih s poliartikularno simetrično prizadetostjo sklepov.
If re-treatment with LIFMIOR is indicated, the above guidance on treatment duration should be followed.
Če je indicirano ponovno zdravljenje z zdravilom LIFMIOR, se ravnamo po zgornjih smernicah glede trajanja zdravljenja.
Elevated liver enzymes
Zvečane vrednosti jetrnih encimov
• Remove the protective cover from the syringe tip by breaking the white cap along the perforation.
S konice injekcijske brizge odstranite zaščitni pokrovček, tako da prelomite belo kapico na perforiranem delu.
Take the LIFMIOR carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface.
Škatlo z napolnjenimi injekcijskimi brizgami zdravila LIFMIOR vzemite iz hladilnika in jo odložite na ravno delovno površino.
LIFMIOR is administered by an injection under the skin (by subcutaneous injection).
Zdravilo LIFMIOR se injicira pod kožo (subkutano injiciranje).
Instead, the safety and efficacy of LIFMIOR were assessed in four randomised, double-blind, placebo-controlled studies.
Namesto tega so varnost in učinkovitost zdravila LIFMIOR ocenili v štirih randomiziranih, dvojno slepih, s placebom nadzorovanih študijah.
Remove only the portion of liquid as directed by your child's doctor.
Izvlecite le toliko tekočine, kot vam je to naročil otrokov zdravnik.
There appears to be no correlation between antibody development and clinical response or adverse events.
Zdi se, da med nastajanjem protiteles na eni strani in kliničnim odzivom ali neželenimi učinki na drugi ni povezave.
The double-blind period was followed by an open-label period during which all patients receive LIFMIOR 50 mg weekly for up to an additional 92 weeks.
Dvojno slepemu obdobju je sledilo odprto obdobje, med katerim so vsi bolniki prejemali zdravilo LIFMIOR v odmerku 50 mg na teden, kar je trajajo do 92 dodatnih tednov.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Študija 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot študija 1, le da so imeli bolniki ob presejanju še vrednost indeksa PASI vsaj 10.
TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
TNF in limfotoksin sta provnetna citokina, ki se vežeta na dva različna tipa receptorjev na površini celice: 55-kilodaltonske (p55) in 75-kilodaltonske (p75) receptorje TNF.
• With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level.
• Ko je brizga še vedno pritrjena na vialo in adapter, primite vialo obrnjeno na glavo, približno v višini oči.
Disposing of supplies
Odstranjevanje odpadkov
In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with LIFMIOR (see sections 4.4 and 4.8).
Poleg tega so v dvojno slepem, s placebom nadzorovanem preskušanju pri odraslih bolnikih, ki so prejemali tudi metotreksat, opazili, da so imeli bolniki, zdravljeni z zdravilom LIFMIOR in anakinro, večjo stopnjo resnih okužb (7 %) in nevtropenije kot bolniki, zdravljeni z zdravilom LIFMIOR (glejte poglavji 4.4 in 4.8).
Remove one pre-filled syringe and one alcohol swab and place them on the work surface.
Iz škatle vzemite eno napolnjeno injekcijsko brizgo in eno alkoholno blazinico ter ju položite na delovno površino.
Adult patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either LIFMIOR or anakinra alone (historical data).
Pri odraslih bolnikih, zdravljenih z zdravilom LIFMIOR in anakinro, so opazili večjo stopnjo resnih okužb kot pri bolnikih, zdravljenih samo z zdravilom LIFMIOR ali samo z anakinro (retrospektivni podatki).
Administration of LIFMIOR should be discontinued if a patient develops a serious infection.
Zdravljenje z zdravilom LIFMIOR je treba prekiniti, če pride do resne okužbe.
Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products as well as the parent compound.
Koncentracije etanercepta v serumu so bile določene z metodo encimskega imunskega testa (ELISA), ki zazna tako ELISA reaktivne razgradne produkte kot tudi izhodno snov.
Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥1:40) was higher in patients treated with LIFMIOR (11%) than in placebo-treated patients (5%).
Pri bolnikih z revmatoidnim artritisom, ki so jih testirali na antinuklearna protitelesa (ANA), je bil odstotek tistih, ki so razvili nova pozitivna ANA ( 1:40), večji pri bolnikih, ki so prejemali zdravilo LIFMIOR (11 %), kot pri tistih, ki so prejemali placebo (5 %).
Whether used alone or in combination with methotrexate, LIFMIOR can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Zdravilo LIFMIOR samo ali v kombinaciji z metotreksatom lahko upočasni razvoj poškodb v sklepih zaradi revmatoidnega artritisa in izboljša sposobnost opravljanja vsakodnevnih opravil.
Posology and administration are the same as for adults 18-64 years of age.
Prilagajanje odmerka ni potrebno; odmerjanje in način uporabe sta enaka kot pri odraslih, starih od 18 do 64 let.
LIFMIOR, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Dokazali so, da zdravilo LIFMIOR samo ali v kombinaciji z metotreksatom upočasni hitrost napredovanja poškodb sklepov, merjenih z rentgenskim slikanjem, in izboljša telesno funkcijo.
• The risk of Congestive Heart Failure (CHF).
• tveganje za kongestivno srčno popuščanje
Week 12 results are shown in the table below.
Rezultati po 12 tednih so prikazani v spodnji preglednici.
Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or the powder for solution for injection presentations (see below for dosing for specific indications).
Bolnikom, ki tehtajo manj kot 62,5 kg, je treba odmerek natančno izračunati na podlagi mg/kg in uporabiti zdravilo LIFMIOR v obliki praška in vehikla za raztopino za injiciranje ali praška za raztopino za injiciranje (za odmerjanje pri specifičnih indikacijah glejte nadaljevanje).
All subdomains of the HAQ were improved in patients treated with LIFMIOR compared to controls at 3 and 6 months.
Po vseh kriterijih vprašalnika HAQ je bilo vidno izboljšanje pri bolnikih na zdravilu LIFMIOR v 3. in 6. mesecu zdravljenja v primerjavi s kontrolno skupino.
Instructions for use and handling
OZNAČEVANJE IN NAVODILO ZA UPORABO
Significant advantages for LIFMIOR in combination with methotrexate compared with LIFMIOR monotherapy and methotrexate monotherapy were also observed after 24 months.
Pomembne prednosti zdravila LIFMIOR v kombinaciji z metotreksatom pred monoterapijo z zdravilom LIFMIOR ali monoterapijo z metotreksatom so ugotovili tudi po 24 mesecih.
One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with LIFMIOR for up to approximately 6 years, including 231 patients treated with LIFMIOR in combination with methotrexate in the 2-year active-controlled study.
Sto devetindvajset (129) novih malignih obolenj različnih tipov so ugotovili pri 4.114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih preskušanjih z zdravilom LIFMIOR do približno 6 let, vključno z 231 bolniki, ki so bili zdravljeni s kombinacijo zdravila LIFMIOR in metotreksata v dvoletni študiji, nadzorovani z učinkovino.
The dosage of LIFMIOR is based on body weight for paediatric patients.
Odmerjanje zdravila LIFMIOR za pediatrične bolnike temelji na njihovi telesni masi.
The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by a sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Učinkovitost zdravila LIFMIOR so ugotavljali v randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 211 pediatričnih bolnikih, starih 4 do 17 let, z zmerno do hudo psoriazo v plakih (definirano z oceno sPGA ≥ 3, ki zajema ≥ 10 % telesne površine (BSA - Body Surface Area), in PASI ≥ 12).
ACR 70 Month 3
ACR 70 3. mesec 6. mesec
There have been rare reports of CNS demyelinating disorders in patients treated with LIFMIOR (see section 4.8).
Poročali so o redkih primerih demielinizirajočih obolenj centralnega živčnega sistema (CŽS) pri bolnikih, zdravljenih s tem zdravilom (glejte poglavje 4.8).
When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Ko se očiščeni predel kože posuši, ga z eno roko nežno stisnite in trdno primite.
If these signs occur, tell your doctor immediately, or take the child to the casualty department at your nearest hospital.
Če se ti znaki pojavijo, se nemudoma posvetujte z zdravnikom ali pa otroka odpeljite v ambulanto za nujno pomoč najbližje bolnišnice.
This is done by holding the collar of the white cap while grasping the end of the white cap with the other hand and bending it down and then up until it is broken (see Diagram 6).
To naredite tako, da držite omot in z drugo roko sukate belo kapico gor in dol, dokler se ne prelomi (glejte sliko 6).
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
Revmatoidni artritis, psoriatični artritis in aksialni spondilartritis, vključno z ankilozirajočim spondilitisom
Results are summarised in the table below.
Izsledki so povzeti v spodnji preglednici.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including LIFMIOR, in the postmarketing setting.
Pri otrocih, mladostnikih in mladih odraslih (do 22. leta starosti), ki so se zdravili z antagonisti TNF (začetek zdravljenja ≤ 18 let), vključno z zdravilom LIFMIOR, so v obdobju trženja poročali o malignostih, med katerimi so bile tudi smrtne.
LIFMIOR treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of juvenile idiopathic arthritis or paediatric plaque psoriasis.
Zdravljenje z zdravilom LIFMIOR lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem juvenilnega idiopatskega artritisa ali otroške psoriaze v plakih.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).
O različnih malignih obolenjih (vključno z rakom dojke in pljuč ter limfomi) so poročali tudi v obdobju trženja zdravila (glejte poglavje 4.4).
Soluble TNFRs are thought to regulate TNF biological activity.
Topni receptorji verjetno uravnavajo biološko aktivnost TNF.
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the LIFMIOR group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
V analizi, v kateri je veljalo, da je pri vseh bolnikih, ki so iz kateregakoli razloga izpadli iz študije, bolezen napredovala, je bil odstotni delež bolnikov brez napredovanja bolezni (sprememba TSS ≤ 0,5) po 12 mesecih večji v skupini z zdravilom LIFMIOR kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of LIFMIOR (n=57) or placebo (n=55) twice a week for 24 weeks.
Randomizirali so sto dvanajst (112) bolnikov, ki so 24 tednov dvakrat na teden dobivali 25 mg odmerek zdravila LIFMIOR (n = 57) ali placebo (n = 55).
Malignant melanoma (see section 4.4), lymphoma, leukaemia
nemelanomski kožni rak* (glejte poglavje maligni melanom (glejte poglavje 4.4), limfom, levkemija karcinom Merklovih celic (glejte poglavje
In the 2-year active-controlled study where patients were treated with either LIFMIOR alone, methotrexate alone or LIFMIOR in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni študiji, nadzorovani z učinkovino, v kateri so bili bolniki zdravljeni z zdravilom LIFMIOR, metotreksatom ali kombinacijo zdravila LIFMIOR in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
V nadzorovanih delih kliničnih preskušanj z antagonisti TNF so pri bolnikih, ki so prejemali antagonist TNF, opazili več primerov limfomov kot pri kontrolni skupini bolnikov.
The side effects and their frequencies seen in children and adolescents are similar to those described above.
Neželeni učinki pri otrocih in mladostnikih so bili po vrsti in pogostnosti podobni neželenim učinkom, opisanim zgoraj.
Step 2: Choosing an injection site
Korak 2: Izbira mesta injiciranja
Do not use the pen if it is dropped with the needle cap off.
Peresnika ne uporabljajte, če vam pade na tla, ko pokrovček igle ni nameščen.
LIFMIOR was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Zdravilo LIFMIOR se ni izkazalo za genotoksičnega v vrsti študij in vivo in in vitro.
A single 50 mg/ml injection of LIFMIOR was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Enkratna injekcija zdravila LIFMIOR v odmerku 50 mg/ml je bioekvivalentna dvema sočasnima injekcijama po 25 mg/ml.
Eligible patients had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy.
Bolniki, primerni za vključitev v študijo, so imeli v anamnezi fototerapijo ali sistemsko terapijo ali pa z lokalno terapijo njihove bolezni ni bilo mogoče zadostno obvladati.
However, the solution may be used for up to 6 hours when stored at a temperature up to 25°C.
Raztopina je uporabna največ 6 ur, če jo hranite pri temperaturi do 25 °C.
In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received LIFMIOR were observed compared with younger patients.
V študijah 3. faze pri revmatoidnem artritisu, psoriatičnem artritisu in ankilozirajočem spondilitisu pri bolnikih, starih 65 let ali več, ki so prejeli zdravilo LIFMIOR, na splošno niso opazili nobenih razlik glede neželenih učinkov, resnih neželenih učinkov in resnih okužb v primerjavi z mlajšimi bolniki.
Both TNFRs exist naturally in membrane-bound and soluble forms.
Oboji receptorji v naravi obstajajo v dveh oblikah, tj. vezani na membrano in v topni obliki.
Dimeric soluble receptors such as etanercept possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.
Topni dimerni receptorji, kot je etanercept, imajo večjo afiniteto za TNF kot monomerni receptorji in so veliko bolj učinkoviti kompetitivni antagonisti vezave TNF na celične receptorje.
The proportion of patients treated with LIFMIOR who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Delež bolnikov, ki so razvili protitelesa proti kardiolipinu, je bil podobno povečan pri zdravilu LIFMIOR v primerjavi s placebom.
All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, paleness) whilst on LIFMIOR, they should seek immediate medical advice.
Vse bolnike in starše/skrbnike je treba opozoriti, da morajo pri bolniku v primeru pojava znakov ali simptomov, ki kažejo na krvno diskrazijo ali okužbo (npr. trdovratna zvišana telesna temperatura, vnetje žrela, podplutbe, krvavitve, bledica), med zdravljenjem s tem zdravilom takoj poiskati zdravniško pomoč.
LIFMIOR treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Zdravljenje z zdravilom LIFMIOR lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa, juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, radiografsko nezaznavnega aksialnega spondilartritisa, psoriaze v plakih ali otroške psoriaze v plakih.
Patients in the LIFMIOR in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Pri bolnikih, ki so prejemali zdravilo LIFMIOR v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS - Disease Activity Score) in HAQ tako po 24 kot po 52 tednih statistično pomembno večji kot pri bolnikih, ki so jih zdravili z enim samim zdravilom (izsledki so povzeti v spodnji preglednici).
• Latex: The needle cap of the MYCLIC pen is made from latex (dry natural rubber).
Lateks: Pokrovček igle peresnika MYCLIC je izdelan iz lateksa (suhega naravnega kavčuka).
In the double-blind period, patients received LIFMIOR 50 mg weekly or placebo for 12 weeks.
V dvojno slepem obdobju so bolniki prejemali zdravilo LIFMIOR v odmerku 50 mg na teden ali placebo 12 tednov.
The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex).
Pokrovček igle napolnjenega injekcijskega peresnika vsebuje posušen naravni kavčuk (derivat lateksa).
Clear glass vial (4 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Viala iz prozornega stekla (4 ml, steklo tipa I) z gumijastim zamaškom, aluminijastim obročkom in plastično zaporko (tipa "flip-off").
ACR 20 Month 3
ACR 20 3. mesec 6. mesec
In the postmarketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists.
V obdobju trženja so pri bolnikih, zdravljenih z antagonisti TNF, poročali o primerih levkemije.
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue
• znaki lupusa ali lupusu podobnega sindroma, kot so spremembe telesne mase, trdovraten kožni izpuščaj, vročina, bolečina v sklepih ali mišicah ali utrujenost;
• With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 18).
S hitrim in kratkim gibom potisnite iglo do konca v kožo pod kotom 45 do 90 stopinj (glejte sliko 18).
Disease flare was defined as a ≥ 30% worsening in three of six JRA core set criteria and ≥ 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Ponoven izbruh bolezni je bil definiran kot  30 % poslabšanje treh od šestih osnovnih kazalcev JRA in  30 % izboljšanje največ enega od šestih glavnih kazalcev JRA ter najmanj dva aktivno prizadeta sklepa.
If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Če ste na predvideni odmerek zdravila LIFMIOR pozabili, ga morate injicirati takoj, ko se spomnite, razen če je naslednji odmerek predviden za naslednji dan.
Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
tuberkuloza, oportunistična okužba (vključno z invazivnimi glivičnimi, protozojskimi, bakterijskimi, atipičnimi mikobakterijskimi, virusnimi okužbami in okužbami z bakterijo Legionella)*
• Vaccinations: If possible, children should be up to date with all vaccinations before using LIFMIOR.
• Cepljenja: Najbolje je, da otrok pred začetkom zdravljenja z zdravilom LIFMIOR opravi vsa predvidena cepljenja.
With the other hand, push STRAIGHT DOWN FIRMLY on the adaptor package until you feel the adaptor spike penetrate the vial stopper and FEEL AND HEAR THE ADAPTOR RIM LOCK INTO PLACE (see Diagram 3).
Z drugo roko MOČNO pritisnite embalažo z adapterjem NARAVNOST NAVZDOL, dokler ne začutite, da je konica adapterja predrla gumijasti zamašek viale in OBČUTITE TER SLIŠITE, da je ADAPTER NAMEŠČEN (glejte sliko 3).
ACR 20 and 50 responses were higher in patients treated with LIFMIOR at 3 and 6 months than in patients treated with placebo (ACR 20: LIFMIOR 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: LIFMIOR 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 LIFMIOR vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Odstotek bolnikov, ki so po 3 oziroma 6 mesecih dosegli odziv ACR 20 ali ACR 50, je bil v skupini bolnikov, ki so bili zdravljeni z zdravilom LIFMIOR, večji kot pri bolnikih, ki so prejemali placebo (ACR 20 po 3 oz. 6 mesecih: zdravilo LIFMIOR 62 % oz. 59 %, placebo 23 % oz. 11 %; ACR 50 po 3 oz. 6 mesecih: zdravilo LIFMIOR 41 % oz. 40 %, placebo 8 % oz. 5 %; p < 0,01 za zdravilo LIFMIOR proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
Undesirable effects in paediatric patients with juvenile idiopathic arthritis In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients (see below, Undesirable effects in adults).
Neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom Na splošno so bili neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom po vrsti in pogostnosti podobni tistim pri odraslih (glejte spodaj, Neželeni učinki pri odraslih).
8 vials of powder
8 vial s praškom
However, due to their transient nature, the incidence of antibodies detected at each assessment point was typically less than 7% in rheumatoid arthritis subjects and psoriasis subjects.
Vendar je bila pojavnost protiteles, odkritih ob vsakem periodičnem določanju, zaradi njihove začasne narave pri bolnikih z revmatoidnim artritisom in bolnikih s psoriazo manjša od 7 %.
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with LIFMIOR compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with LIFMIOR compared to none of placebo-treated patients).
Tudi odstotek bolnikov, ki so razvili nova pozitivna avtoprotitelesa proti dvojno vijačni DNK, je bil večji, merjeno z radioimunskimi testi (15 % pri zdravilu LIFMIOR in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri zdravilu LIFMIOR in 0 % pri placebu).