FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation of treatment with Benlysta should be considered if there is no improvement in disease control after 6 months of treatment.
Slovenian: Če se urejenost bolezni po 6 mesecih zdravljenja ne izboljša, je treba razmisliti o prenehanju zdravljenja z zdravilom Benlysta.
English: These are common side effects (may affect up to 1 in 10 people).
Slovenian: To so pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov).
English: EU/1/11/700/003 1 pre-filled pen EU/1/11/700/004 4 pre-filled pens EU/1/11/700/005 12 (3x4) pre-filled pens (multipack) EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes
Slovenian: EU/1/11/700/003 1 napolnjen injekcijski peresnik EU/1/11/700/004 4 napolnjeni injekcijski peresniki EU/1/11/700/005 12 (3x4) napolnjenih injekcijskih peresnikov (skupno pakiranje) EU/1/11/700/006 1 napolnjena injekcijska brizga EU/1/11/700/007 4 napolnjene injekcijske brizge
English: The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation.
Slovenian: Zvišana raven citokinov med kroničnim vnetjem zavre nastajanje nekaterih encimov CYP450.
English: Benlysta was administered intravenously to black patients in a randomised (2:1), double-blind, placebo-controlled, 52-week Phase III/IV study (EMBRACE).
Slovenian: Črnci Zdravilo Benlysta so dajali intravensko bolnikom črncem v randomizirani (2:1), dvojno slepi, s placebom kontrolirani 52-tedenski študiji III./IV.
English: The median time to the first flare was delayed in the pooled group receiving Benlysta compared to the group receiving placebo (110 vs 84 days, hazard ratio=0.84, p=0.012).
Slovenian: Mediani čas do prvega poslabšanja je bil v kumulativni skupini prejemnikov zdravila Benlysta daljši kot med prejemniki placeba (110 dni v primerjavi s 84 dnevi, razmerje tveganj = 0,84, p = 0,012).
English: • Ask your doctor or pharmacist for instructions on how to properly dispose of a used pen or container of used pens.
Slovenian: • Zdravnika ali farmacevta vprašajte, kako pravilno zavreči uporabljeno injekcijsko brizgo ali vsebnik z uporabljenimi brizgami.
English: Intravenous use.
Slovenian: Po intravenski uporabi 10
English: Purple indicator
Slovenian: Vijoličasti kazalnik
English: Patients were on a stable SLE treatment regimen consisting of (alone or in combination): corticosteroids, anti-malarials, NSAIDs or other immunosuppressives.
Slovenian: Bolniki so prejemali stabilno shemo zdravljenja SLE s (samimi ali v kombinaciji): kortikosteroidi, antimalariki, nesteroidnimi protivnetnimi zdravili ali drugimi imunosupresivi.
English: Contents of the pack and other information Step-by-step instructions for using the pre-filled syringe
Slovenian: Vsebina pakiranja in dodatne informacije Navodila korak za korakom za uporabo napolnjene injekcijske brizge
English: Multipack:12 pre-filled pens (3 cartons of 4 pre-filled pens).
Slovenian: Skupno pakiranje: 12 napolnjenih injekcijskih peresnikov (3 škatle po 4 napolnjene injekcijske peresnike).
English: Progressive multifocal leukoencephalopathy (PML) has been reported with Benlysta treatment for SLE.
Slovenian: Med zdravljenjem SLE z zdravilom Benlysta so poročali o progresivni multifokalni levkoencefalopatiji (PML).
English: benlysta syringe
Slovenian: benlysta brizga
English: There was a higher proportion of paediatric patients achieving an SRI response in patients receiving Benlysta compared with placebo.
Slovenian: Delež pediatričnih bolnikov, ki so dosegli odziv SRI, je bil večji pri bolnikih, ki so prejemali zdravilo Benlysta, kot med tistimi, ki so prejemali placebo.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema pogosti levkopenija
English: • bacterial infections (see ‘Infections' above)
Slovenian: Ti se lahko pojavijo pri več kot 1 od 10 bolnikov:  bakterijske okužbe (glejte poglavje »Infekcije« zgoraj),
English: Each 20 ml vial contains 400 mg belimumab.
Slovenian: Ena 20-ml viala vsebuje 400 mg belimumaba.
English: In the two Phase III studies in adults, 4 of the 563 (0.7%) patients in the 10 mg/kg group and 27 out of 559 (4.8%) patients in the 1 mg/kg group tested positive for persistent presence of anti-belimumab antibodies.
Slovenian: V dveh študijah III. faze pri odraslih so imeli pozitiven izvid stalne prisotnosti protiteles proti belimumabu 4 od 563 (0,7 %) bolnikov v skupini, ki je prejemala 10 mg/kg, in 27 od 559 (4,8 %) bolnikov v skupini, ki je prejemala 1 mg/kg.
English: Very common Diarrhoea, nausea
Slovenian: Bolezni prebavil zelo pogosti driska, navzea
English: (Figure 1)
Slovenian: (Slika 1)
English: Benlysta can make you more likely to get infections, including infection of the urinary tract and airways, younger children may be at increased risk.
Slovenian: Zdravilo Benlysta vam lahko poveča verjetnost, da zbolite za okužbami, vključno z okužbami sečil in dihal, mlajši otroci so lahko izpostavljeni večjemu tveganju.
English: Severe flares were observed in 22.6% of the Benlysta group compared to 42.5% of the placebo group over the 52 weeks of observation (observed treatment difference = 19.9%; hazard ratio= 0.38, 95% CI: 0.18, 0.82).
Slovenian: Huda poslabšanja so opazili pri 22,6 % bolnikov v skupini, ki je prejemala zdravilo Benlysta v primerjavi z 42,5 % bolnikov v skupini, ki je prejemala placebo, tekom 52 tednov opazovanja (opažena razlika med zdravljenjema = 19,9 %; razmerje ogroženosti = 0,38, 95 % IZ: 0,18; 0,82).
English: The infusion must be discontinued immediately if the patient experiences a potentially life-threatening adverse reaction (see sections 4.4 and 4.8).
Slovenian: Če se bolniku pojavi potencialno življensko nevaren neželeni učinek, je treba infundiranje nemudoma prekiniti (glejte poglavji 4.4 in 4.8).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: SLE responder index
Slovenian: Indeks odziva SLE
English: The active ingredient is belimumab.
Slovenian: Učinkovina je belimumab.
English: 400 mg vial
Slovenian: 400-mg viala
English: • any medicine that affects your B cells (to treat cancer or inflammatory diseases).
Slovenian:  ciklofosfamid (zdravilo za zdravljenje nekaterih vrst raka in avtoimunskih bolezni)  katero koli zdravilo, ki vpliva na celice B (za zdravljenje raka ali vnetnih bolezni)
English: Contact your doctor or go to a hospital straight away.
Slovenian: Posvetujte se z zdravnikom ali poiščite pomoč v najbližji bolnišnici.
English: Failure to follow these instructions may affect proper function of the pre-filled syringe.
Slovenian: Če teh navodil ne upoštevate, se lahko zgodi, da napolnjeni injekcijski peresnik ne bo deloval pravilno.
English: • Do not shake.
Slovenian: • Ne pretresajte.
English: Steady-state geometric mean Cmax, Cmin, and AUC values were 305 µg/mL, 42 µg/mL, and 2569 day•µg/mL in the 5- to 11-year-old-group, and 317 µg/mL, 52 µg/mL, and 3126 day•µg/mL in the 12- to 17-year-old-group (n=43).
Slovenian: 2569 dan•µg/ml ter v starostni skupini od 12 do 17 let 317 µg/ml, 52 µg/ml in 3126 dan•µg/ml.
English: Following subcutaneous administration, belimumab had a terminal half-life of 18.3 days.
Slovenian: Izločanje Terminalni razpolovni čas belimumaba po subkutani uporabi je bil 18,3 dneva.
English: Serious infections occurred in 5% of patients in both groups receiving Benlysta or placebo; serious opportunistic infections accounted for 0.4% and 0% of these, respectively.
Slovenian: Resne okužbe so se pojavile pri 5 % tako med bolniki, ki so prejemali zdravilo Benlysta kot med bolniki, ki so prejemali placebo; resnih oportunističnih okužb je bilo med prvimi 0,4 % in med drugimi 0 %.
English: Rarely, less severe delayed reactions to Benlysta can also occur, usually 5 to 10 days after an infusion.
Slovenian: Redkeje se lahko pojavijo tudi manj hude, zapoznele reakcije na zdravilo Benlysta, po navadi od 5 do
English: The median time to the first severe flare among patients having a severe flare was delayed in patients receiving Benlysta compared with placebo (171 days vs. 118 days).
Slovenian: Mediani čas do prvega hudega poslabšanja med bolniki, ki se jim je pojavilo hudo poslabšanje, je bil med prejemniki zdravila Benlysta daljši (171 dni) kot med prejemniki placeba (118 dni).
English: Assay sensitivity for neutralising antibodies and non-specific anti-drug antibody (ADA) is limited by the presence of active drug in the collected samples.
Slovenian: anti-drug antibody) je omejena s prisotnostjo aktivnega zdravila v zbranih vzorcih.
English: Anti-dsDNA positive AND low complement
Slovenian: Pozitiven anti-dvDNK IN nizek komplement
English: The mean change of score at Week 52 from baseline is significantly greater with Benlysta compared to placebo (4.70 vs 2.46, p=0.0006).
Slovenian: Povprečna sprememba rezultata od izhodišča do 52. tedna je bila z zdravilom Benlysta značilno večja kot s placebom (4,70 v primerjavi z 2,46, p = 0,0006).
English: Benlysta in pre-filled pen or pre-filled syringe is administered by subcutaneous injection.
Slovenian: Zdravilo Benlysta v napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi se uporablja za subkutano injiciranje.
English: • gauze pad or cotton wool ball (not included in the pack)
Slovenian: • zloženec gaze ali kosem vate (ni priložen v pakiranju)
English: • if you have had an organ transplant or a bone marrow or stem cell transplant
Slovenian: • Če imate presajen organ ali ste imeli presaditev kostnega mozga ali matičnih celic.
English: • injection site reactions, for example: rash, redness, itching or swelling of the skin where you have injected Benlysta.
Slovenian: • reakcije na mestu injiciranja, na primer izpuščaj, pordelost, srbenje ali oteklost kože na mestu,
English: • If needed, press a cotton ball or gauze pad on the injection site.
Slovenian: • Če je treba, na mesto injiciranja pritisnite s kosmom vate ali zložencem gaze.
English: Needle guard activated
Slovenian: Aktiviran ščitnik igle
English: The proportion of patients who discontinued treatment due to adverse reactions was 7% for Benlysta-treated patients and 8% for placebo-treated patients.
Slovenian: Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje, je bil med prejemniki zdravila Benlysta 7 % in med prejemniki placeba 8 %.
English: Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).
Slovenian: Zdravilo Benlysta je indicirano kot dodatno zdravilo pri odraslih bolnikih z aktivnim, na avtoprotitelesa pozitivnim sistemskim eritematoznim lupusom (SLE - systemic lupus erythematosus), ki imajo kljub standardnemu zdravljenju visoko stopnjo bolezenske aktivnosti (npr. pozitivno anti-dvDNK in nizek komplement) (glejte poglavje 5.1).
English: Do not use if the expiry date has passed
Slovenian: Ne uporabite zdravila, če je rok uporabnosti že potekel.
English: • The pre-filled syringe should be used only once and then discarded.
Slovenian: • Napolnjeno injekcijsko brizgo uporabite le enkrat in jo nato zavrzite.
English: • Do not inject in areas where the skin is tender, bruised, red or hard.
Slovenian: • Ne injicirajte v občutljivo, podpluto, pordelo ali zatrdelo kožo.
English: Step-by-step instructions for using the pre-filled syringe
Slovenian: Navodila korak za korakom za uporabo napolnjene injekcijske brizge
English: Stopping treatment with Benlysta
Slovenian: Zaključek zdravljenja z zdravilom Benlysta
English: Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).
Slovenian: Zdravilo Benlysta je indicirano kot dodatno zdravilo pri bolnikih, starih 5 let in več, z aktivnim, na avtoprotitelesa pozitivnim sistemskim eritematoznim lupusom (SLE - systemic lupus erythematosus), ki imajo kljub standardnemu zdravljenju visoko stopnjo bolezenske aktivnosti (npr. pozitivno anti-dvDNK in nizek komplement) (glejte poglavje 5.1).
English: Psychiatric disorders: In the pre-registration intravenous clinical studies, serious psychiatric events were reported in 1.2% (8/674) of patients receiving Benlysta 10 mg/kg and 0.4% (3/675) of patients receiving placebo.
Slovenian: Psihiatrične motnje: V študijah intravenske uporabe pred pridobitvijo dovoljenja za promet z zdravilom so o resnih psihiatričnih dogodkih poročali pri 1,2 % (8/674) bolnikov, ki so prejemali 10 mg/kg zdravila Benlysta in pri 0,4 % (3/675) bolnikov, ki so prejemali placebo.
English: • severe active central nervous system lupus
Slovenian: • hudim aktivnim lupusom osrednjega živčevja,
English: FACIT-fatigue score improvement from baseline at week-52 (mean):
Slovenian: Izboljšanje rezultata FACIT-fatigue od izhodišča do 52. tedna (povprečje):
English: An additional, previously identified serologically active group, those patients with low complement and positive anti-dsDNA at baseline, also demonstrated a greater relative response, see Table 2 for results of this example of a higher disease activity group.
Slovenian: Poleg tega so večji relativni odziv ugotovili tudi v predhodno identificirani serološko aktivni skupini bolnikov z izhodiščno nizkim komplementom in pozitivnim anti-dvDNK; glejte preglednico 2 za rezultate tega primera skupine z večjo bolezensko aktivnostjo.
English: In adult patients with hypergammaglobulinemia, normalization of IgG levels was observed by Week 52 in 49% and 20% of patients receiving Benlysta and placebo, respectively.
Slovenian: Pri odraslih bolnikih s hipergamaglobulinemijo so normalizacijo koncentracije IgG do 52. tedna ugotovili pri 49 % prejemnikov zdravila Benlysta in pri 20 % prejemnikov placeba.
English: It reduces the number of B cells in your blood by blocking the action of BLyS, a protein that helps B cells to live longer and is found in high levels in people with lupus.
Slovenian: BLyS je beljakovina, ki pomaga celicam B živeti dlje in je v veliki koncentraciji prisotna pri osebah z lupusom.
English: • Do not recycle or throw the used syringe, or container of used syringes in household waste.
Slovenian: • Uporabljene injekcijske brizge ali vsebnika z uporabljenimi brizgami ne smete reciklirati ali odvreči med gospodinjske odpadke.
English: The incidence of infusion reactions and hypersensitivity reactions after intravenous administration occurring within 3 days of an infusion was 12% in the group receiving Benlysta and 10% in the group receiving placebo, with 1.2% and 0.3%, respectively, requiring permanent treatment discontinuation.
Slovenian: Pojavnost infuzijskih in preobčutljivostnih reakcij po intravenski uporabi, ki so se pojavile v okviru 3 dni po infundiranju, je bila 12 % v skupini, ki je prejemala zdravilo Benlysta, in 10 % v skupini, ki je prejemala placebo; v prvi skupini je bilo treba zdravljenje za stalno prenehati pri 1,2 % in v drugi pri 0,3 % bolnikov.
English: (Figure 10)
Slovenian: (Slika 10)
English: Benlysta 120 mg powder for concentrate for solution for infusion Type 1 glass vials (5 ml), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminum seal containing 120 mg of powder.
Slovenian: Benlysta 120 mg prašek za koncentrat za raztopino za infundiranje Steklena viala iz stekla tipa I (5 ml), zaprta z zamaškom iz silikonizirane klorobutilne gume in aluminijsko snemno zaporo, ki vsebuje 120 mg praška.
English: Benlysta 120 mg powder for concentrate for solution for infusion Benlysta 400 mg powder for concentrate for solution for infusion belimumab This medicine is subject to additional monitoring.
Slovenian: Benlysta 120 mg prašek za koncentrat za raztopino za infundiranje Benlysta 400 mg prašek za koncentrat za raztopino za infundiranje belimumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Body weight/Body Mass Index (BMI)
Slovenian: Telesna masa/Indeks telesne mase (ITM)
English: Median IgG levels at Week 52 were reduced by 11% in patients receiving Benlysta compared with an increase of 0.7% in patients receiving placebo.
Slovenian: Do 52. tedna se je mediana koncentracija IgG pri bolnikih, ki so prejemali zdravilo Benlysta zmanjšala za 11 %, pri bolnikih, ki so prejemali placebo pa se je povečala za 0,7 %.
English: Therefore, no dose adjustment is recommended for patients with renal impairment.
Slovenian: Zato bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
English: Proportion of patients with at least 50% improvement in any 2 of 5 components* and no more than one of the remaining worsening by more than 30%
Slovenian: Preglednica 4 - Delež odziva po PRINTO/ACR po 52 tednih Delež bolnikov z vsaj 50-% izboljšanjem katerih koli 2 od 5 komponent* in s poslabšanjem ne več kot ene od preostalih za več kot 30 %
English: Background medicinal products included corticosteroids (86%; >7.5 mg/day prednisone equivalent 60%), immunosuppressives (46%), and antimalarials (69%).
Slovenian: Med osnovnimi zdravili so bili kortikosteroidi (86 %, > 7,5 mg/dan ekvivalenta prednizona 60 %), imunosupresivi (46 %) in antimalariki (69 %).
English: Hepatic impairment: No specific studies have been conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab.
Slovenian: Okvara jeter: Specifičnih študij za ugotavljanje vplivov okvare jeter na farmakokinetiko belimumaba niso izvedli.
English: A single Benlysta pre-filled syringe or pre-filled pen can be stored at temperatures up to a maximum of 25°C for a period of up to 12 hours.
Slovenian: Posamezna napolnjena injekcijska brizga ali napolnjen injekcijski peresnik zdravila Benlysta se lahko shranjuje pri temperaturi do 25 °C za obdobje do 12 ur.
English: Available in packs of 1 or 4 pre-filled pens in each pack and multipacks comprising 12 pre-filled pens (3 packs of 4 pre-filled pens).
Slovenian: Zdravilo je na voljo v pakiranjih z 1 ali 4 napolnjenimi injekcijskimi peresniki v vsakem pakiranju in v skupnem pakiranju, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov.
English: There have been reports of depression, suicidal thoughts, and suicide attempts including suicide during treatment with Benlysta.
Slovenian: Med zdravljenjem z zdravilom Benlysta so poročali o depresiji, samomorilnih mislih in poskusih samomora vključno s samomorom.
English: Severe flares were observed in 10.6% of patients in the group receiving Benlysta compared with 18.2% of patients in the group receiving placebo over the 52 weeks of observation (observed treatment difference = -7.6%).
Slovenian: Huda poslabšanja so med 52 tedni opazovanja ugotovili pri 10,6 % bolnikov v skupini, ki je prejemala zdravilo Benlysta, in pri 18,2 % bolnikov v skupini, ki je prejemala placebo (opažena razlika med zdravljenjem = -7,6 %).
English: In patients with low complement levels, normalization of C3 and C4 was observed by Week 52 in 38% and 44% of patients receiving Benlysta and in 17% and 18% of patients receiving placebo, respectively.
Slovenian: Pri bolnikih z nizko koncentracijo komplementa so do 52. tedna ugotovili normalizacijo C3 oz. C4 pri 38 % oz. 44 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 17 % oz. 18 % tistih, ki so prejemali placebo.
English: The most frequently reported adverse reactions (≥5% of patients with SLE treated with Benlysta plus standard of care and at a rate ≥1% greater than placebo) were viral upper respiratory tract infections,
Slovenian: Najpogosteje zabeleženi neželeni učinki (≥ 5 % bolnikov s SLE, ki so prejemali zdravilo Benlysta in standardno oskrbo, in z deležem, ≥ 1 % večjim kot med prejemniki placeba) so bili virusna okužba zgornjih dihal, bronhitis in driska.
English: Your doctor will decide if you need to stop using Benlysta.
Slovenian: Zdravnik bo presodil, ali morate nehati dobivati zdravilo Benlysta.
English: • The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), sucrose and polysorbate 80.
Slovenian: Druge sestavine zdravila so monohidrat citronske kisline (E330), natrijev citrat (E331), saharoza in polisorbat 80.
English: The adjusted mean change of score at Week 52 from baseline is significantly greater with Benlysta compared to placebo (4.4 vs. 2.7, p=0.0130).
Slovenian: Prilagojena povprečna sprememba rezultata od izhodišča do 52. tedna je bila z zdravilom Benlysta značilno večja kot s placebom (4,4 v primerjavi z 2,7, p = 0,0130).
English: Benlysta 400 mg powder for concentrate for solution for infusion Type 1 glass vials (20 ml), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminum seal containing 400 mg of powder.
Slovenian: Benlysta 400 mg prašek za koncentrat za raztopino za infundiranje Steklena viala iz stekla tipa I (20 ml), zaprta z zamaškom iz silikonizirane klorobutilne gume in aluminijsko snemno zaporo, ki vsebuje 400 mg praška.
English: No in vivo interaction studies have been performed.
Slovenian: Študij in vivo medsebojnega delovanja niso izvedli.
English: • Do not let the needle touch any surface.
Slovenian: • Pazite, da se z iglo ničesar ne dotaknete.
English: Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of Benlysta.
Slovenian: Pred infundiranjem zdravila Benlysta se lahko uporabi premedikacijo, vključno z antihistaminikom, z antipiretikom ali brez njega.
English: Delayed-type, non-acute hypersensitivity reactions
Slovenian: občasni anafilaktična reakcija redki reakcije pozne, neakutne preobčutljivosti
English: Dispose and inspect Dispose of the used syringe
Slovenian: Zavrzite in preglejte Uporabljeno injekcijsko brizgo zavrzite
English: The package leaflet should be provided to the patient each time Benlysta is administered (see section 4.2).
Slovenian: Vsakemu bolniku je treba vsakokrat, ko prejme zdravilo Benlysta, dati navodilo za uporabo tega zdravila (glejte poglavje 4.2).
English: Citric acid monohydrate (E330), sodium citrate (E331), sucrose, polysorbate 80
Slovenian: Citronska kislina monohidrat (E330), natrijev citrat (E331), saharoza, polisorbat 80.
English: • no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores, and
Slovenian: • zmanjšanje rezultata SELENA-SLEDAI za ≥ 4 točke in • brez novih točk organskega področja BILAG (British Isles Lupus Assessment Group) A ali 2 novi točki organskega področja BILAG B ter • brez poslabšanja (povečanja za < 0,30 točke) rezultata PGA (Physician's Global Assessment)
English: Patients should be monitored for any of these new or worsening symptoms or signs, and if such symptoms/signs occur, referral to a neurologist and appropriate diagnostic measures for PML should be considered.
Slovenian: Če se pojavijo takšni simptomi ali znaki, je treba bolnika napotiti k nevrologu in opraviti ustrezne ukrepe za diagnosticiranje PML.
English: There is an association between plasma BLyS levels and SLE disease activity.
Slovenian: BLyS v plazmi in aktivnost SLE sta povezani.
English: The percentage of patients receiving greater than 7.5 mg/day prednisone (or equivalent) at baseline whose average corticosteroid dose was reduced by at least 25% from baseline to a dose equivalent to prednisone
Slovenian: Odstotek bolnikov, ki so izhodiščno prejemali več kot 7,5 mg/dan prednizona (ali ekvivalenta) in se jim je povprečni odmerek kortikosteroida v obdobju od 40. do 52. tedna zmanjšal za vsaj 25 % v primerjavi z izhodiščem na odmerek, enakovreden ≤ 7,5 mg/dan prednizona, je bil med prejemniki zdravila
English: Adverse reactions were reported in 87% of Benlysta-treated patients and 90% of placebo-treated patients.
Slovenian: Neželeni učinki so bili opisani pri 87 % bolnikov, zdravljenih z zdravilom Benlysta, in 90 % bolnikov, ki so prejemali placebo.
English: Benlysta 200 mg weekly (n=554)
Slovenian: Benlysta 200 mg/ teden (n = 554)
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially sodium-free.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.