natgillin/translations-raw huggingface dataset:
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. 
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.
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, 
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.
Your doctor will decide if you need to stop using Benlysta. 
Zdravnik bo presodil, ali morate nehati dobivati zdravilo Benlysta.
• The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), sucrose and polysorbate 80. 
Druge sestavine zdravila so monohidrat citronske kisline (E330), natrijev citrat (E331), saharoza in polisorbat 80.
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). 
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).
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. 
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.
No in vivo interaction studies have been performed. 
Študij in vivo medsebojnega delovanja niso izvedli.
• Do not let the needle touch any surface. 
• Pazite, da se z iglo ničesar ne dotaknete.
Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of Benlysta. 
Pred infundiranjem zdravila Benlysta se lahko uporabi premedikacijo, vključno z antihistaminikom, z antipiretikom ali brez njega.
Delayed-type, non-acute hypersensitivity reactions 
občasni anafilaktična reakcija redki reakcije pozne, neakutne preobčutljivosti
Dispose and inspect Dispose of the used syringe 
Zavrzite in preglejte Uporabljeno injekcijsko brizgo zavrzite
The package leaflet should be provided to the patient each time Benlysta is administered (see section 4.2). 
Vsakemu bolniku je treba vsakokrat, ko prejme zdravilo Benlysta, dati navodilo za uporabo tega zdravila (glejte poglavje 4.2).
Citric acid monohydrate (E330), sodium citrate (E331), sucrose, polysorbate 80 
Citronska kislina monohidrat (E330), natrijev citrat (E331), saharoza, polisorbat 80.
• no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores, and 
• 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)
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. 
Če se pojavijo takšni simptomi ali znaki, je treba bolnika napotiti k nevrologu in opraviti ustrezne ukrepe za diagnosticiranje PML.
There is an association between plasma BLyS levels and SLE disease activity. 
BLyS v plazmi in aktivnost SLE sta povezani.
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 
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
Adverse reactions were reported in 87% of Benlysta-treated patients and 90% of placebo-treated patients. 
Neželeni učinki so bili opisani pri 87 % bolnikov, zdravljenih z zdravilom Benlysta, in 90 % bolnikov, ki so prejemali placebo.
Benlysta 200 mg weekly (n=554) 
Benlysta 200 mg/ teden (n = 554)
This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially sodium-free. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
Reproductive studies have been performed in pregnant cynomolgus monkeys receiving belimumab 150 mg/kg by intravenous infusion (approximately 9 times the anticipated maximum human clinical exposure) every 2 weeks for up to 21 weeks, and belimumab treatment was not associated with direct or indirect harmful effects with respect to maternal toxicity, developmental toxicity, or teratogenicity. 
Študije vpliva na sposobnost razmnoževanja so izvedli pri nosečih opicah cynomolgus, ki so prejemale belimumab v odmerku 150 mg/kg v intravenski infuziji (približno 9-kratnik predvidene največje klinične izpostavljenosti pri človeku) na 2 tedna do 21 tednov.
Benlysta is supplied as a white to off-white powder for solution for infusion, in a glass vial with a siliconised rubber stopper and a flip-off aluminium seal. 
Zdravilo Benlysta je na voljo kot bel do skoraj bel prašek za raztopino za infundiranje v stekleni viali s silikoniziranim gumijastim zamaškom in aluminijasto snemno zaporko.
Each 5 ml vial contains 120 mg belimumab. 
Ena 5-ml viala vsebuje 120 mg belimumaba.
• Check the expiry date on the pre-filled syringe. 
• Preverite rok uporabnosti na napolnjeni injekcijski brizgi.
Serious depression was reported in 0.3% (7/2002) of patients receiving Benlysta and <0.1% (1/2001) of patients receiving placebo. 
Pri 0,3 % (7/2002) bolnikov, ki so prejemali zdravilo Benlysta in pri < 0,1 % (1/2001) bolnikov, ki so prejemali placebo, so poročali o hudi depresiji.
Available in packs of 1 or 4 pre-filled syringes in each pack. 
Zdravilo je na voljo v pakiranjih z 1 ali 4 napolnjenimi injekcijskimi brizgami.
Gold needle guard Expiry date 
Zlati ščitnik igle Rok uporabnosti
In intravenous clinical studies, serious infusion and hypersensitivity reactions included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea. 
V kliničnih študijah intravenske uporabe so bile med resnimi infuzijskimi in preobčutljivostnimi reakcijami anafilaktična reakcija, bradikardija, hipotenzija, angioedem in dispneja.
On initiation or discontinuation of belimumab, therapeutic monitoring should be considered for patients being treated with CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin). 
Zato je treba pri bolnikih, ki prejemajo zdravila substrate CYP z ozkim terapevtskim indeksom, kjer je odmerek individualno prilagojen (npr. za varfarin), po uvedbi ali prenehanju zdravljenja z belimumabom izvajati terapevtski nadzor.
The median time to the first flare among patients having a flare was delayed in patients receiving Benlysta compared with placebo (190 days vs. 141 days). 
Mediani čas do prvega poslabšanja med bolniki, ki se jim je pojavilo poslabšanje, je bil med prejemniki zdravila Benlysta daljši (190 dni) kot med prejemniki placeba (141 dni).
Your doctor will decide if you can be given Benlysta. 
Zdravnik bo presodil, ali lahko dobite zdravilo Benlysta.
Some vaccines should not be given just before or during treatment with Benlysta 
Tik pred zdravljenjem z zdravilom Benlysta ali med zdravljenjem z njim se ne sme uporabljati določenih cepiv.
Benlysta can cause a reaction to the injection, or an allergic (hypersensitivity) reaction. 
Alergijske reakcije - Nemudoma poiščite zdravniško pomoč Zdravilo Benlysta lahko povzroči reakcijo na injiciranje ali alergijsko (preobčutljivostno) reakcijo.
• feeling sick, diarrhoea. 
• občutek slabosti (siljenje na bruhanje), driska.
Observed treatment difference vs. placebo (median difference) 
Opažena terapevtska razlika v primerjavi s placebom (povprečna razlika)
Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile Parma 
Provinciale Asolana No. 90 43056 San Polo di Torrile Parma
Background medicinal products included corticosteroids (96%; >7.5 mg/day 69%), immunosuppressives (42%), and anti-malarials 
Med osnovnimi zdravili so bili kortikosteroidi (96 %, > 7,5 mg/dan 69 %), imunosupresivi (42 %) in antimalariki (67
1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen. 
1 ml raztopine v brizgi iz stekla tipa 1 s fiksno iglo (iz nerjavečega jekla) v napolnjenem injekcijskem peresniku.
There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Benlysta. 
Med zdravljenjem z zdravilom Benlysta so poročali o depresiji, samomorilnih mislih in poskusih samomora.
In patients with anti-dsDNA antibodies at baseline, median anti-dsDNA antibodies levels at Week 52 were reduced by 56% in patients receiving Benlysta compared with 41% in patients receiving placebo. 
Med bolniki, ki so izhodiščno imeli protitelesa anti-dvDNK, se je mediana raven teh protiteles po 52 tednih zmanjšala za 56 % pri bolnikih, zdravljenih z zdravilom Benlysta, in za 41 % pri bolnikih, ki so prejemali placebo.
No specific studies with Benlysta have been conducted in patients with hepatic impairment. 
Pri bolnikih z okvaro jeter niso izvedli specifičnih študij z zdravilom Benlysta.
Severe flares were observed in 15.6% of the Benlysta group compared to 23.7% of the placebo group over the 52 weeks of observation (observed treatment difference =8.1%; hazard ratio=0.64, p=0.0011). 
Huda poslabšanja so med 52 tedni opazovanja ugotovili pri 15,6 % skupine, ki je prejemala zdravilo Benlysta, in pri 23,7 % skupine, ki je prejemala placebo (opažena terapevtska razlika = -8,1 %, razmerje tveganj = 0,64, p = 0,0011).
Patients were excluded from the study if they had severe active central nervous system lupus or severe active lupus nephritis. 
aktiven lupus osrednjega živčevja ali hud, aktiven lupusni nefritis.
• Do not share your Benlysta pre-filled syringe with another person. 
• Ne delite napolnjene injekcijske brizge zdravila Benlysta z nikomer drugim.
There were too few patients ≥65 years of age or black patients enrolled in the controlled clinical trials with subcutaneous Benlysta to draw meaningful conclusions about the effects of age or race on clinical outcomes. 
V kontrolirana klinična preskušanja s subkutano uporabo zdravila Benlysta je bilo vključenih premalo bolnikov, starih 65 let ali več, in premalo bolnikov črncev, da bi bilo mogoče smiselno sklepati o vplivu starosti in rase na klinične izide.
(Figure 7) 
(Slika 7)
Medicines that weaken your immune system, such as Benlysta, may put you at higher risk of getting a rare but serious and life-threatening brain infection called progressive multifocal leukoencephalopathy (PML). 
Zdravila, kot je zdravilo Benlysta, ki vam oslabijo imunski sistem, lahko povečajo tveganje, da zbolite za redko, toda smrtno nevarno okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija (PML).
The risk of first flare was reduced by 22% during the 52 weeks of observation in the group receiving Benlysta compared with the group receiving placebo (hazard ratio=0.78; p=0.0061). 
Tveganje za prvo poslabšanje se je v 52 tednih opazovanja v skupini, ki je prejemala zdravilo Benlysta, zmanjšalo za 22 % v primerjavi s skupino, ki je prejemala placebo (razmerje ogroženosti = 0,78, p =
After reconstitution, the solution contains 80 mg belimumab per ml. 
Po rekonstituciji vsebuje raztopina 80 mg belimumaba na mililiter.
Do not touch this area again before giving the injection. 
Tega mesta se pred injiciranjem ne smete več dotakniti.
‘Infusion or injection-related systemic reactions' covers a group of terms and can manifest as a range of symptoms including bradycardia, myalgia, headache, rash, urticaria, pyrexia, hypotension, hypertension, dizziness, and arthralgia. 
"Z infundiranjem ali injiciranjem povezane sistemske reakcije" zajemajo skupino izrazov; takšne reakcije se lahko kažejo s celo vrsto simptomov, med drugim z bradikardijo, mialgijo, glavobolom, izpuščajem, urtikarijo, pireksijo, hipotenzijo, hipertenzijo, omotico in artralgijo.
• Do not use if the solution looks cloudy, discoloured or has particles. 
• Ne uporabite, če je raztopina motna, spremenjene barve ali so v njej delci.
(Figure 6) 
(Slika 6)
• container with a tight-fitting lid for syringe disposal (not included in the pack). 
• vsebnik z dobro prilegajočim se pokrovom, kamor boste zavrgli brizgo (ni priložen v pakiranju)
Administration of subcutaneous or intravenous Benlysta may result in hypersensitivity reactions which can be severe, and fatal. 
Subkutana ali intravenska uporaba zdravila Benlysta lahko povzroči preobčutljivostne reakcije, ki so lahko hude in s smrtnim izidom.
Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA26 
Oznaka ATC: L04AA26
info.produkt@gsk.com 
medical.x.si@gsk.com
• Peel back the film of the tray and remove the pre-filled syringe by grasping the middle of the body. 
• Odlepite folijo z embalaže in vzemite ven napolnjeno injekcijsko brizgo tako, da jo primete na sredini.
(Figure 9) 
(Slika 9)
Adverse reactions are listed below by MedDRA system organ class and by frequency. 
Seznam neželenih učinkov Neželeni učinki so navedeni spodaj po organskih sistemih MedDRA in pogostnosti.
*‘Hypersensitivity reactions' covers a group of terms, including anaphylaxis, and can manifest as a range of symptoms including hypotension, angioedema, urticaria or other rash, pruritus, and dyspnoea. 
*"Preobčutljivostne reakcije" zajemajo skupino izrazov, vključno z anafilaksijo; takšne reakcije se lahko kažejo s celo vrsto simptomov, med drugim s hipotenzijo, angioedemom, urtikarijo ali drugimi oblikami izpuščaja, srbenjem in dispnejo.
Available in packs of 1 or 4 pre-filled pens and multipack containing 12 single-dose pre-filled pens (3 packs of 4 pre-filled pens). 
Zdravilo je na voljo v pakiranjih z 1 ali 4 napolnjenimi injekcijskimi peresniki in v skupnem pakiranju, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov z enkratnim odmerkom.
Components of SLE responder index 
Elementi indeksa odziva SLE
Background medicinal products included corticosteroids (76%; >7.5 mg/day 46%), immunosuppressives (56%), and anti-malarials (63%). 
Med osnovnimi zdravili so bili kortikosteroidi (76 %, > 7,5 mg/dan 46 %), imunosupresivi (56 %) in antimalariki (63
• container with a tight-fitting lid for pen disposal (not included in the pack). 
• vsebnik z dobro prilegajočim se pokrovom, kamor boste zavrgli peresnik (ni priložen v pakiranju)
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti bolečina v okončini
During clinical development Benlysta was studied in patients with SLE and renal impairment (261 subjects with moderate renal impairment, creatinine clearance ≥30 and <60 ml/min; 14 subjects with severe renal impairment, creatinine clearance ≥15 and <30 ml/min). 
(261 preiskovancev z zmerno okvaro ledvic, očistek kreatinina ≥ 30 in < 60 ml/min, 14 preiskovancev s hudo okvaro ledvic, očistek kreatinina ≥ 15 in < 30 ml/min).
Amount of Benlysta Vial size 
Velikost viale
1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) and needle cap. 
1 ml raztopine v brizgi iz stekla tipa 1 s fiksno iglo (iz nerjavečega jekla) in pokrovčkom igle.
No detrimental effects on such activities are predicted from the pharmacology of belimumab. 
Glede na farmakologijo belimumaba ni pričakovati škodljivih učinkov na takšne dejavnosti.
At baseline 62.2% of patients had high disease activity (SELENA SLEDAI score ≥10), 88% of patients had mucocutaneous, 78% had musculoskeletal, 8% had haematological, 12% had renal, and 8% had vascular organ involvement. 
bolnikov je imelo prizadetost mukokutanega, 78 % kostnomišičnega, 8 % hematološkega, 12 % ledvičnega in 8 % žilnega organskega področja.
The efficacy of Benlysta administered intravenously was evaluated in 2 randomized, double-blind, placebo-controlled studies in 1,684 patients with a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria. 
Intravenska infuzija pri odraslih Učinkovitost zdravila Benlysta intravenske uporabe so ocenili v 2 randomiziranih, dvojno slepih, s placebom kontroliranih študijah pri 1.684 bolnikih s klinično diagnozo SLE po klasifikacijskih merilih
In patients with low complement levels, normalization of C3 and C4 was observed by Week 52 in 42% and 53% of patients receiving Benlysta and in 21% and 20% of patients receiving placebo, respectively. 
Pri bolnikih z nizko koncentracijo komplementa so do 52. tedna ugotovili normalizacijo C3 oz. C4 pri 42 % oz. 52 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 21 % oz. 20 % tistih, ki so prejemali placebo.
• Dispose of the used syringe and needle cap in a container with a tight-fitting lid. 
• Uporabljeno injekcijsko brizgo in pokrovček igle zavrzite v vsebnik z dobro prilegajočim se pokrovom.
You inject Benlysta under your skin in your stomach area (abdomen) or upper leg (thigh). 
Zdravilo Benlysta si injicirajte pod kožo v predelu trebuha ali stegna.
Hypersensitivity reactions* 
Bolezni imunskega sistema pogosti preobčutljivostne reakcije*
Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. 
Tveganje je lahko večje pri bolnikih z anamnezo alergij na več zdravil ali izrazite preobčutljivosti.
Severe infections, including fatal cases, have been reported in SLE patients receiving immunosuppressant therapy, including belimumab (see section 4.8). 
Pri bolnikih z SLE, ki so prejemali imunosupresivna zdravila (vključno z belimumabom), so bile opisane hude okužbe, tudi s smrtnim izidom (glejte poglavje 4.8).
Administration of Benlysta may result in hypersensitivity reactions and infusion reactions which can be severe, and fatal. 
Infuzijske reakcije in preobčutljivost Uporaba zdravila Benlysta lahko povzroči preobčutljivostne in infuzijske reakcije, ki so lahko hude in s smrtnim izidom.
(Figure 3) 
(Slika 3)
Benlysta has not been studied in the following adult and paediatric patient groups, and is not recommended in: 
Zdravilo Benlysta ni raziskano v naslednjih skupinah odraslih in pediatričnih bolnikov, zato ga ni priporočljivo uporabljati pri bolnikih s: • hudim aktivnim lupusom osrednjega živčevja,
• Remove one sealed tray containing a pre-filled syringe from the refrigerator. 
• Iz hladilnika vzemite eno zaprto embalažo, v katerem je napolnjena injekcijska brizga.
Odds ratio (95% CI) vs placebo 
Razmerje obetov (95 % IZ) v primerjavi s placebom
Changes in B cells (including naïve, memory and activated B cells, and plasma cells) and IgG levels occurring in patients during ongoing treatment with intravenous belimumab were followed in a long-term uncontrolled extension study. 
V dolgoročni nekontrolirani podaljšani študiji so med potekajočim zdravljenjem z belimumabom intravensko spremljali spremembe števila celic B (vključno z naivnimi, spominskimi in aktiviranimi celicami B ter plazemskimi celicami) in koncentracij IgG.
At baseline 52% of patients had high disease activity (SELENA SLEDAI score ≥10), 59% of patients had mucocutaneous, 60% had musculoskeletal, 16% had haematological, 11% had renal and 9% had vascular organ domain involvement (BILAG A or B at baseline). 
bolnikov je imelo prizadetost mukokutanega, 60 % kostnomišičnega, 16 % hematološkega, 11 % ledvičnega in 9 % žilnega organskega področja (izhodiščno BILAG A ali B).
• The pre-filled pen should be used only once and then discarded. 
• Napolnjeni injekcijski peresnik uporabite le enkrat in ga nato zavrzite.
Benlysta can make you more likely to get infections, including infection of the urinary tract and airways. 
Zdravilo Benlysta vam lahko poveča verjetnost, da zbolite za okužbami, vključno z okužbami sečil in dihal.
The subcutaneous pharmacokinetic parameters below are based on population parameter estimates from 661 subjects, comprised of 554 SLE patients and 107 healthy subjects, who received Benlysta subcutaneously. 
661 preiskovancih (554 bolnikih s SLE in 107 zdravih preiskovancih), ki so zdravilo Benlysta prejemali subkutano.
Benlysta is supplied as a 1 ml colourless to slightly yellow solution in a single use pre-filled syringe with a needle cap. 
Zdravilo Benlysta je na voljo kot 1 ml brezbarvna do rahlo rumenkasta raztopina v napolnjeni injekcijski brizgi za enkratno uporabo s pokrovčkom igle.
They include symptoms such as rash, feeling sick, tiredness, muscle aches, headache, or facial swelling. 
Med takšnimi so izpuščaj, občutek slabosti, utrujenost, bolečine v mišicah, glavobol ali oteklost obraza.
Finger grips 
Držalo za prste
Tell your doctor or nurse immediately, or go to the Emergency department of your nearest hospital, if you get any of the following symptoms of an allergic or infusion reaction: 
Če se vam pojavi kateri koli od naslednjih simptomov alergijske ali z injiciranjem povezane reakcije, nemudoma obvestite zdravnika ali medicinsko sestro, ali pojdite v ambulanto za nujno pomoč najbližje bolnišnice:
Solution for injection in pre-filled syringe. 
Raztopina za injiciranje v napolnjeni injekcijski brizgi.
Suicidal behaviour, suicidal ideation 
Psihiatrične motnje pogosti depresija občasni samomorilno vedenje, samomorilne misli
Severe flares over 52 weeks: 
Huda poslabšanja v 52 tednih: Bolniki, ki se jim je pojavilo hudo poslabšanje
4 pre-filled syringes. 
4 napolnjeni injekcijski peresniki.
SRI response rate at week-76 (%) Observed treatment difference vs placebo (%) 
Delež odziva po SRI po 76 tednih ( %) Opažena terapevtska razlika v prim.
Alcohol swab 
Alkoholni listič
Check the expiry date 
Preverite rok uporabnosti
Benlysta reported higher rates of nausea, vomiting and diarrhoea relative to placebo, and compared with normal-weight patients (BMI ≥18.5 to ≤30 kg/m2). 
Bolezni prebavil: Debeli bolniki [indeks telesne mase (ITM) > 30 kg/m2], zdravljeni z zdravilom Benlysta intravenske uporabe, so navajali večje deleže navzee, bruhanja in driske glede na placebo in v primerjavi z bolniki z normalno telesno maso (ITM ≥ 18,5 do ≤ 30 kg/m2).
Warnings 
Opozorila
• itchy raised bumps or hives. 
• srbeče, dvignjene bulice ali koprivnica.
• Do not touch this area again before giving the injection. 
• Tega mesta se pred injiciranjem ne smete več dotakniti.
Belimumab was distributed to tissues with steady-state volume (Vss) of distribution of approximately 5 litres. 
Belimumab se je porazdelil v tkiva z volumnom porazdelitve v stanju dinamičnega ravnovesja (Vss)
EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes 
EU/1/11/700/006 1 napolnjena injekcijska brizga EU/1/11/700/007 4 napolnjene injekcijske brizge
• diarrhoea, vomiting 
• driska, bruhanje,
Administration of Benlysta may result in severe or life-threatening hypersensitivity reactions and infusion reactions. 
Dajanje zdravila Benlysta lahko povzroči hude ali smrtno nevarne preobčutljivostne in infuzijske reakcije.
Preparation of 120 mg solution for infusion 
Priprava 120 mg raztopine za infundiranje Rekonstitucija
Changes in biomarkers were seen in clinical trials with Benlysta administered intravenously. 
V kliničnih preskušanjih z zdravilom Benlysta intravenske uporabe so ugotovili spremembe bioloških označevalcev.
Malignancies and lymphoproliferative disorders 
Malignomi in limfoproliferativne motnje
Talk to your doctor before you use Benlysta: 
Preden dobite zdravilo Benlysta, se posvetujte z zdravnikom:
• Leave the syringe at room temperature for 30 minutes. 
• Injekcijsko brizgo za 30 minut pustite na sobni temperaturi (Slika 2).