natgillin/translations-raw huggingface dataset:
The mechanism of action of belimumab could increase the risk for the development of infections in adults and children with lupus, including opportunistic infections, and younger children may be at increased risk. 
Zaradi svojega mehanizma delovanja lahko belimumab poveča tveganje za razvoj okužb pri odraslih in otrocih z lupusom, vključno z oportunističnimi okužbami, pri čemer so mlajši otroci lahko izpostavljeni večjemu tveganju.
• wheezing, difficulty in breathing or shortness of breath 
• piskajoče dihanje, težave z dihanjem ali kratka sapa,
The effects of body weight and BMI on belimumab exposure after subcutaneous administration were not considered clinically meaningful. 
Vpliv telesne mase in ITM na izpostavljenost belimumabu po subkutani uporabi ni bil klinično pomemben.
The study will evaluate over a minimum of 1 year the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus. 
Študija bo ocenjevala v obdobju najmanj 1 leta incidenco smrtnosti zaradi vseh vzrokov in izbrane neželene učinke pri bolnikih s sistemskim eritematoznim lupusom.
The data presented in the table below reflect exposure to Benlysta administered (10 mg/kg intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days for up to 52 weeks) in 674 patients with SLE, including 472 exposed for at least 52 weeks, and 556 patients exposed to 200 mg Benlysta subcutaneously once weekly for up to 52 weeks. 
Podatki, prikazani v spodnji preglednici, odražajo izpostavljenost zdravilu Benlysta, uporabljenemu intravensko (10 mg/kg v obdobju 1 ure na 0., 14. in 28. dan ter nato vsakih 28 dni do 52 tednov), pri 674 bolnikih z SLE, od katerih je bilo 472 bolnikov izpostavljenih vsaj 52 tednov, ter 556 bolniki, izpostavljenimi 200 mg zdravila Benlysta subkutano enkrat na teden do 52 tednov.
• Keep in the carton in order to protect from light. 
• Shranjujte v škatli za zagotovitev zaščite pred svetlobo.
(Figure 6a) 
(Slika 6a)
The study was conducted in the US, South America, Europe, and Asia. 
Študija je bila izvedena v ZDA, Južni Ameriki, Evropi in Aziji.
It is not known if belimumab could be an indirect modulator of such cytokines. 
Ni znano, ali bi bil belimumab lahko citokinski modulator.
Once removed from the refrigerator, the syringe must be used within 12 hours or discarded. 
Ko ga vzamete iz hladilnika, morate peresnik uporabiti v 12 urah ali pa ga zavreči.
The European Medicines Agency has deferred the obligation to submit the results of studies with Benlysta subcutaneous administration in one or more subsets of the paediatric population in SLE (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila (EMA) je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Benlysta za subkutano uporabo za vse skupine pediatrične populacije za SLE (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
A clear to opalescent, colourless to pale yellow solution, with a pH of 6. 
Bistra do opalescentna, brezbarvna do bledo rumena raztopina s pH 6.
• Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. 
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
Univariate and multivariate analysis of the primary endpoint in pre-specified subgroups demonstrated that the greatest benefit was observed in patients with higher disease activity including patients with SELENA SLEDAI scores ≥ 10, or patients requiring steroids to control their disease, or patients with low complement levels. 
Univariatna in multivariatna analiza primarnega opazovanega dogodka v vnaprej opredeljenih podskupinah je pokazala največjo opaženo korist pri bolnikih z večjo aktivnostjo bolezni, vključno z bolniki, ki so imeli rezultat SELENA SLEDAI ≥ 10, ali bolnikih, ki so za obvladovanje bolezni potrebovali steroide, ali bolnikih z nizko koncentracijo komplementa.
• Do not remove the needle cap during this step. 
• Ne odstranite pokrovčka igle med tem korakom.
For intravenous infusion after reconstitution and dilution. 
Za intravensko infundiranje po rekonstituciji in redčenju.
Patients who develop an infection while undergoing treatment with Benlysta should be monitored closely and careful consideration given to interrupting immunosuppressant therapy including belimumab until the infection is resolved. 
Bolnike, ki se jim med zdravljenjem z zdravilom Benlysta pojavi okužba, je treba natančno nadzirati in temeljito je treba razmisliti o prekinitvi imunosupresivnega zdravljenja, tudi zdravljenja z belimumabom, dokler okužba ne mine.
SLE Responder Index (%) 
Indeks odziva SLE (%)
EU/1/11/700/001 1 vial - 120 mg EU/1/11/700/002 1 vial - 400 mg 
EU/1/11/700/001 1 viala - 120 mg EU/1/11/700/002 1 viala - 400 mg
Increased exposure for obese subjects receiving 10 mg/kg belimumab did not lead to an overall increase in AE rates or serious AEs compared to obese subjects receiving placebo. 
Večja izpostavljenost debelih oseb, ki so prejemale 10 mg/kg belimumaba, ni povzročila celotnega povečanja deležev neželenih učinkov ali resnih neželenih učinkov v primerjavi z debelimi osebami, ki so prejemale placebo.
SLE patients transitioning from 10 mg/kg intravenously every 4 weeks to 200 mg subcutaneously weekly using a 1 to 4 week switching interval had pre-dose belimumab serum concentrations at their first subcutaneous dose close to their eventual subcutaneous steady-state trough concentration (see section 4.2). 
Bolniki s SLE, ki so prešli z 10 mg/kg intravensko vsake 4 tedne na 200 mg subkutano vsak teden z 1do 4-tedenskim intervalom za prehod, so imeli koncentracijo belimumaba v serumu pred prvim subkutanim odmerkom blizu svoje navsezadnje dosežene koncentracije v stanju dinamičnega ravnovesja med subkutano uporabo (glejte poglavje 4.2).
After about 7 years, a 28% median reduction in IgG levels was observed, with 1.6% of subjects experiencing a decrease in IgG levels to below 400 mg/dl. Over the course of the study, the reported incidence of AEs generally remained stable or declined. 
Po približno sedmih letih so opazili 28% mediano znižanje koncentracije IgG; 1,6 % osebam se je koncentracija IgG znižala pod 400 mg/dl. Tekom študije je incidenca poročanih neželenih učinkov ostala enaka ali se je zmanjšala.
For anti-cardiolipin IgA antibody a 37% reduction at Week 52 was seen (p=0.0003), for anti-cardiolipin IgG antibody a 26% reduction at Week 52 was seen (p=0.0324) and for anti-cardiolipin IgM a 25% reduction was seen (p=NS, 
Pri antikardiolipinskih protitelesih IgA so po 52 tednih ugotovili 37 % zmanjšanje (p = 0,0003), za antikardiolipinska protitelesa IgG so po 52 tednih ugotovili 26 % zmanjšanje (p = 0,0324) in za antikardiolipinska protitelesa IgM so ugotovili 25 % zmanjšanje (p = neznačilno, 0,46).
The true occurrence of neutralising antibodies and non-specific anti-drug antibody in the study population is therefore not known. 
Dejansko pojavljanje nevtralizacijskih protiteles in nespecifičnih protiteles proti zdravilu v raziskovani populaciji zato ni znano.
• high temperature or fever 
• visoka telesna temperatura,
In the 5- to 11-year-old-group (n=13) the SELENA-SLEDAI score ranged from 4 to 13, and in 12- to 17-year-old-group (n=79) the SELENA-SLEDAI score ranged from 4 to 20. 
V skupini bolnikov, starih od 5 do 11 let (n=13), je bil rezultat SELENA-SLEDAI v razponu od 4 do 13, v skupini bolnikov, starih od 12 do 17 let (n=79) pa je bil rezultat SLENA-SLEDAI v razponu od 4 do 20.
Caution is however recommended in patients with severe renal impairment due to the lack of data (see section 5.2). 
Vendar pa je pri bolnikih s hudo okvaro ledvic priporočljiva previdnost, ker zanje ni podatkov (glejte poglavje 5.2).
The frequency given is the highest seen with either formulation. 
Navedena pogostnost je največja pogostnost, zabeležena z eno ali drugo farmacevtsko obliko.
The reconstituted solution, if not used immediately, should be protected from direct sunlight and stored refrigerated at 2°C to 8°C. 
Če pripravljena raztopina ni uporabljena takoj, jo je treba zaščititi pred neposredno sončno svetlobo in shraniti v hladilniku pri temperaturi od 2 °C do 8 °C.
Benlysta has not been studied in the following patient groups and is not recommended in: 
Zdravilo Benlysta ni raziskano v naslednjih skupinah bolnikov, zato ga ni priporočljivo uporabljati pri bolnikih s:
The safety and efficacy of Benlysta in children aged below 5 years has not been established. 
Varnost in učinkovitost zdravila Benlysta pri otrocih, mlajših od 5 let, nista ugotovljeni.
Patients treated with Benlysta should be made aware of the potential risk of severe or life-threatening hypersensitivity and the potential for delayed onset or recurrence of symptoms. 
Bolnike, zdravljene z zdravilom Benlysta, je treba seznaniti z možnim tveganjem hude ali smrtno nevarne preobčutljivosti in možnosti za njen zapoznel pojav ali ponovitev simptomov.
You may also wish to make a note of this information in case you are asked for it in the future. 
Priporočljivo je, da si to informacijo zapišete tudi vi, v primeru, da vas bodo kdaj povprašali po njih.
Paediatric population: No pharmacokinetic data are available for subcutaneous administration of Benlysta in paediatric patients. 
Pediatrična populacija: Farmakokinetičnih podatkov za sukbutano uporabo zdravila Benlysta pri pediatričnih bolnikih ni.
* Among patients with baseline prednisone dose >7.5 mg/day 
* Med bolniki z izhodiščnim odmerkom prednizona > 7,5 mg/dan
Tell your doctor if any of these may apply to you. 
→ Zdravniku morate povedati, če bi kaj od tega lahko veljalo za vas.
Anti-dsDNA positive AND low complement Placebo 
Pozitiven anti-dvDNK IN nizek komplement Placebo
Benlysta should not be infused concomitantly in the same intravenous line with other agents. 
Zdravila Benlysta se ne sme infundirati sočasno v isti intravenski liniji z drugimi zdravili.
Belimumab does not bind B cells directly, but by binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. 
Belimumab prepreči vezavo topnega BLyS, ki je dejavnik preživetja celic B, na njegove receptorje na celicah B. Belimumab se na celice B ne veže neposredno, toda z vezavo na BLyS zavre preživetje celic B, vključno z avtoreaktivnimi celicami B, in zmanjša diferenciacijo celic B v plazmatke, ki izdelujejo imunoglobuline.
They can occasionally be severe (uncommon, affecting up to 1 in 100 people), and could be life-threatening. 
Občasno so lahko hudi (občasni neželeni učinki, pojavijo se lahko pri največ 1 od 100 bolnikov ) ter so lahko smrtno nevarni.
Patients with hepatic impairment are unlikely to require dose adjustment (see section 5.2). 
Ni verjetno, da bi bolniki z okvaro jeter potrebovali prilagoditev odmerka (glejte poglavje 5.2).
Special Patient Populations 
Posebne skupine bolnikov
• Push the plunger all the way down until all of the solution is injected. 
• Potisnite bat do konca navzdol, dokler ni injicirana vsa raztopina.
If a mechanical reconstitution device is used to reconstitute Benlysta it should not exceed 500 rpm and the vial should be swirled for no longer than 30 minutes. 
Če za pripravo zdravila Benlysta uporabljate mehanično napravo za pripravo, njena hitrost ne sme preseči 500 obratov na minuto, viale pa se ne sme vrteti več kot 30 minut.
In the event of a severe reaction, Benlysta administration must be interrupted and appropriate medical therapy administered (see section 4.2). 
V primeru hude reakcije je treba dajanje zdravila Benlysta prekiniti in uporabiti ustrezna zdravila (glejte poglavje 4.2).
The safety of belimumab in patients with SLE has been evaluated in 3 pre-registration, placebo-controlled intravenous studies, 1 placebo-controlled subcutaneous study, and one post-marketing, placebo-controlled intravenous study. 
Varnost belimumaba pri bolnikih s SLE so ocenili v 3 s placebom kontroliranih študijah intravenske uporabe pred pridobitvijo dovoljenja za promet, 1 s placebom kontrolirani študiji subkutane uporabe in 1 s placebom kontrolirani študiji intravenske uporabe v obdobju trženja.
• Firmly press the pen all the way down onto the injection site and hold in place. 
• Trdno pritisnite injekcijski peresnik navzdol na mesto injiciranja in ga tam držite.
In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. 
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
The risk of hypersensitivity reactions is greatest with the first two doses; however the risk should be considered for every administration. 
Tveganje za preobčutljivostne reakcije je največje ob prvih dveh odmerkih, vendar pa je to tveganje treba upoštevati pri vsaki uporabi.
After use - needle is covered by needle guard 
Po uporabi -ščitnik obdaja iglo
• Use your free hand to gently pinch the skin around the injection site. 
• S prosto roko rahlo stisnite kožo okrog mesta injiciranja.
Elderly: Benlysta has been studied in a limited number of elderly patients. 
Starejši: Zdravilo Benlysta so raziskali pri majhnem številu starejših bolnikov.
No incompatibilities between Benlysta and polyvinylchloride or polyolefin bags have been observed. 
Ugotovljenih ni nobenih inkompatibilnosti med zdravilom Benlysta in polivinilkloridom ali poliolefinom.
Odds ratio (95% CI) vs Placebo *The five PRINTO/ACR components were percent change at Week 52 in: Parent's Global Assessment (Parent GA), PGA, SELENA SLEDAI score, 24-hour proteinuria, and, Paediatric Quality of Life Inventory - Generic Core Scale (PedsQL GC) physical functioning domain score. 
*Pet komponent PRINTO/ACR so bile odstotne spremembe naslednjih vrednosti po 52 tednih: starševska celotna ocena (Parent's Global Assessment), PGA, SELENA SLEDAI rezultat, 24-urna proteinurija ter ocena domene telesnega delovanja vprašalnika PedsQL GC (Paediatric Quality of Life Inventory - Generic Core Scale).
Flares in SLE were defined by the modified SELENA SLEDAI SLE Flare Index. 
Poslabšanja SLE so bila opredeljena z modificiranim indeksom poslabšanja SLE SELENA SLEDAI.
Table 1: Response rate at week 52 
Preglednica 1: Delež odziva po 52 tednih
Classical biotransformation studies have not been conducted. 
Klasičnih študij presnove niso izvedli.
Solution for injection in pre-filled pen (injection) Solution for injection in pre-filled syringe (injection) 
Raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija) Raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija)
The overall incidence of serious suicidal ideation or behaviour or self-injury without suicidal intent was 0.7% (15/2002) in patients receiving Benlysta and 0.2% (5/2001) in the placebo group. 
Skupna incidenca resnih samomorilnih misli ali vedenja ali samopoškodovanja brez samomorilnega namena je bila 0,7 % (15/2002) pri bolnikih, ki so prejemali zdravilo Benlysta in 0,2 % (5/2001) v skupini, ki je prejemala placebo.
The adverse reaction profile in paediatric patients is based on 52-week safety data from a placebo-controlled study in which 53 patients (6 to 17 years of age) with SLE received Benlysta (10 mg/kg intravenously on Days 0, 14, 28, and then every 28 days, on a background of concomitant treatments). 
Pediatrična populacija Profil neželenih učinkov pri pediatričnih bolnikih temelji na podatkih o varnosti iz 52-tedenske, s placebom kontrolirane študije, v kateri je 53 bolnikov (starih od 6 do 17 let) s SLE ob sočasnem zdravljenju prejemalo zdravilo Benlysta (10 mg/kg intravensko na dan 0, 14, 28, potem pa vsakih 28
What you need to know before you are given Benlysta Do not receive Benlysta: 
Kaj morate vedeti, preden boste dobili zdravilo Benlysta Zdravila Benlysta ne smete dobiti:
However, given the small number of subjects ≥65 years, an effect of age cannot be ruled out conclusively. 
Toda glede na majhno število preiskovancev, starih ≥ 65 let, vpliva starosti ni mogoče dokončno izključiti.
• burning sensation while passing urine. 
• pekoč občutek pri uriniranju.
Clean the injection site by wiping it with an alcohol swab (Figure 5). 
Očistite mesto injiciranja tako, da ga obrišete z alkoholnim lističem (Slika 5).
• alcohol swab (not included in the pack) 
• alkoholni listič (ni priložen v pakiranju)
• Position the pen straight over the injection site (at a 90o angle). 
• Postavite injekcijski peresnik naravnost nad mesto injiciranja (pod kotom 90 o).
Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology. 
Belimumab je humano monoklonsko protitelo IgG1λ, pridobljeno v celični liniji sesalcev (NS0) s tehnologijo rekombinantne DNK.
Women of childbearing potential/Contraception in males and females Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo med zdravljenjem z zdravilom Benlysta in vsaj še 4 mesece po koncu zdravljenja uporabljati učinkovito kontracepcijsko zaščito.
Benlysta should be infused over a 1-hour period. 
Zdravilo Benlysta je treba infundirati v obdobju 1 ure.
• Remove the ring cap by pulling or twisting it off. 
• Odstranite okrogli pokrovček tako, da ga potegnete ali zasučete.
The risk of hypersensitivity reactions is greatest with the first two infusions; however the risk should be considered for every infusion administered. 
Tveganje za preobčutljivostne reakcije je največje ob prvih dveh infundiranjih, vendar pa je to tveganje treba upoštevati pri vsakem infundiranju.
Table 3 - Paediatric response rate at Week 52 Response 
Preglednica 3 - Delež odziva pri pediatričnih bolnikih po 52 tednih
What Benlysta is and what it is used for What you need to know before you are given Benlysta How Benlysta is used 
Kaj je zdravilo Benlysta in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Benlysta Kako uporabljati zdravilo Benlysta
Using the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) Juvenile SLE Response Evaluation Criteria, a higher proportion of paediatric patients receiving Benlysta demonstrated improvement compared with placebo (Table 4). 
Upoštevaje merila za ovrednotenje odziva juvenilnega SLE po PRINTO/ACR (Paediatric Rheumatology International Trials Organisation/American College of Rheumatology) je bil delež doseženega izboljšanja pri pediatričnih bolnikih, ki so prejemali zdravilo Benlysta, večji kot s placebom
• Do not warm the syringe in any other way. 
• Ne segrevajte injekcijske brizge na noben drug način.
Gather and check supplies Gather supplies 
Zberite in preverite ves pribor Zberite pribor
It is recommended that the first subcutaneous injection of Benlysta should be under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary. 
Prvo subkutano injiciranje zdravila Benlysta je priporočljivo opraviti pod nadzorom zdravnika in v okolju, ki je ustrezno opremljeno za obvladovanje preobčutljivostnih reakcij, če bi se pojavile.
You may hear a second “click" a few seconds before the purple indicator stops moving. 
Nekaj sekund prej, preden se vijoličasti kazalnik neha premikati, lahko zaslišite drugi "klik".
Benlysta has not been studied in combination with other B cell targeted therapy or intravenous cyclophosphamide. 
Zdravilo Benlysta ni raziskano v kombinaciji z drugimi zdravili, usmerjenimi na celice B, ali z intravenskim ciklofosfamidom.
• Insert the entire needle into the pinched area of the skin at a slight angle (45°), using a dart-like motion. 
• Celotno iglo z rahlim sunkom zabodite v stisnjeno kožo pod srednjim naklonom (kot 45°).
Infections leading to discontinuation of treatment occurred in 0.7% of patients receiving Benlysta and 1.5% of patients receiving placebo. 
Okužbe, ki so povzročile prekinitev zdravljenja, so se pojavile pri 0,7 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 1,5 % bolnikov, ki so prejemali placebo.
Thereafter, patients can resume dosing on their usual day of administration, or start a new weekly schedule from the day that the missed dose was administered. 
Potem lahko bolnik nadaljuje uporabo na svoj običajni dan dajanja zdravila, ali začne nov tedenski urnik od dne, ko je injiciral pozabljeni odmerek.
The recommended dose is 200 mg (complete contents of one syringe) once a week, injected under your skin on the same day each week. 
Priporočeni odmerek je 200 mg (celotna vsebina ene injekcijske brizge) enkrat na teden, injiciran pod kožo vsak teden na isti dan.
However, consistent with results from other studies, in black patients with high disease activity (low complement and positive anti-dsDNA at baseline, n=141) the SRI-S2K response was 45.1% for Benlysta 10 mg/kg compared with 24.0% for placebo (odds ratio 3.00; 95% CI: 1.35, 6.68). 
A skladno z rezultati drugih študij je bil pri bolnikih črncih, ki so imeli zelo aktivno bolezen (izhodiščno nizek komplement in pozitivna anti-dsDNA, n = 141), odziv SRI-S2K za zdravilo Benlysta v odmerku 10 mg/kg 45,1 % in za placebo 24,0 % (razmerje obetov 3,00, 95 % iZ: 1,35, 6,68).
The safety and efficacy of Benlysta subcutaneous administration in children and adolescents (< 18 years of age) has not been established. 
Varnost in učinkovitost subkutane uporabe zdravila Benlysta pri otrocih in mladostnikih (mlajših od 18 let) nista ugotovljeni.
No treatment-related changes were noted in the male and female reproductive organs of sexually mature animals. 
Na reproduktivnih organih spolno zrelih samcev in samic niso ugotovili z zdravljenjem povezanih sprememb.
Benlysta is administered by intravenous infusion. 
Zdravilo Benlysta se uporablja v intravenski infuziji.
• Do not remove the ring cap during this step. 
• Ne odstranite okroglega pokrovčka med tem korakom.
WARNING: The 5 ml and 20 ml vials are reconstituted with different volumes of diluent, see below: 120 mg vial 
OPOZORILO: 5-ml in 20-ml viale je treba pripraviti z različnimi količinami vehikla, glejte spodaj:
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Benlysta. 
O sekundarnem prenosu okužb z oseb, ki so dobile živa cepiva, na bolnike, ki so prejemali zdravilo Benlysta, ni podatkov.
Other medicines and Benlysta 
Druga zdravila in zdravilo Benlysta
The safety and efficacy of Benlysta was evaluated in a randomised, double-blind, placebo-controlled, 52-week study (PLUTO) in 93 paediatric patients with a clinical diagnosis of SLE according to the ACR classification criteria. 
Varnost in učinkovitost zdravila Benlysta so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani, 52-tedenski študiji (PLUTO) pri 93 pediatričnih bolnikih s klinično diagnozo SLE po klasifikacijskih merilih ACR.
Caution should be exercised when considering Benlysta therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy. 
Previdnost je potrebna pri odločanju za zdravljenje z zdravilom Benlysta pri bolnikih z anamnezo malignoma in pri odločanju o nadaljnjem zdravljenju bolnikov, ki se jim pojavi malignom.
Dosing is not based on weight (see section 5.2). 
Odmerjanje ne temelji na telesni masi (glejte poglavje 5.2).
Benlysta demonstrated improvement in fatigue compared with placebo measured by the FACIT-Fatigue Scale. 
Z zdravilom Benlysta je bilo v primerjavi s placebom ugotovljeno izboljšanje utrujenosti, merjene z lestvico FACIT-Fatigue.
• Do not inject within 5 cm (2 inches) of the navel (belly button). 
• Ne injicirajte v predelu 5 cm okrog popka.
Protect the reconstituted solution from sunlight. 
Pripravljeno raztopino zaščitite pred sončno svetlobo.
Patients who had severe active lupus nephritis and patients who had severe active central nervous system (CNS) lupus were excluded. 
Bolniki s hudim aktivnim lupusnim nefritisom in bolniki s hudim aktivnim lupusom osrednjega živčevja so bili izključeni.