FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Each 5 ml vial contains 120 mg belimumab.
Slovenian: Ena 5-ml viala vsebuje 120 mg belimumaba.
English: • Check the expiry date on the pre-filled syringe.
Slovenian: • Preverite rok uporabnosti na napolnjeni injekcijski brizgi.
English: Serious depression was reported in 0.3% (7/2002) of patients receiving Benlysta and <0.1% (1/2001) of patients receiving placebo.
Slovenian: 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.
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma Italy
Slovenian: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma Italija
English: Available in packs of 1 or 4 pre-filled syringes in each pack.
Slovenian: Zdravilo je na voljo v pakiranjih z 1 ali 4 napolnjenimi injekcijskimi brizgami.
English: Gold needle guard Expiry date
Slovenian: Zlati ščitnik igle Rok uporabnosti
English: In intravenous clinical studies, serious infusion and hypersensitivity reactions included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
Slovenian: V kliničnih študijah intravenske uporabe so bile med resnimi infuzijskimi in preobčutljivostnimi reakcijami anafilaktična reakcija, bradikardija, hipotenzija, angioedem in dispneja.
English: 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).
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Your doctor will decide if you can be given Benlysta.
Slovenian: Zdravnik bo presodil, ali lahko dobite zdravilo Benlysta.
English: Some vaccines should not be given just before or during treatment with Benlysta
Slovenian: Tik pred zdravljenjem z zdravilom Benlysta ali med zdravljenjem z njim se ne sme uporabljati določenih cepiv.
English: Benlysta can cause a reaction to the injection, or an allergic (hypersensitivity) reaction.
Slovenian: Alergijske reakcije - Nemudoma poiščite zdravniško pomoč Zdravilo Benlysta lahko povzroči reakcijo na injiciranje ali alergijsko (preobčutljivostno) reakcijo.
English: • feeling sick, diarrhoea.
Slovenian: • občutek slabosti (siljenje na bruhanje), driska.
English: Observed treatment difference vs. placebo (median difference)
Slovenian: Opažena terapevtska razlika v primerjavi s placebom (povprečna razlika)
English: Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile Parma
Slovenian: Provinciale Asolana No. 90 43056 San Polo di Torrile Parma
English: Background medicinal products included corticosteroids (96%; >7.5 mg/day 69%), immunosuppressives (42%), and anti-malarials
Slovenian: Med osnovnimi zdravili so bili kortikosteroidi (96 %, > 7,5 mg/dan 69 %), imunosupresivi (42 %) in antimalariki (67
English: 1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Slovenian: 1 ml raztopine v brizgi iz stekla tipa 1 s fiksno iglo (iz nerjavečega jekla) v napolnjenem injekcijskem peresniku.
English: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Benlysta.
Slovenian: Med zdravljenjem z zdravilom Benlysta so poročali o depresiji, samomorilnih mislih in poskusih samomora.
English: 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.
Slovenian: 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.
English: No specific studies with Benlysta have been conducted in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter niso izvedli specifičnih študij z zdravilom Benlysta.
English: 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).
Slovenian: 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).
English: Patients were excluded from the study if they had severe active central nervous system lupus or severe active lupus nephritis.
Slovenian: aktiven lupus osrednjega živčevja ali hud, aktiven lupusni nefritis.
English: • Do not share your Benlysta pre-filled syringe with another person.
Slovenian: • Ne delite napolnjene injekcijske brizge zdravila Benlysta z nikomer drugim.
English: 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.
Slovenian: 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.
English: (Figure 7)
Slovenian: (Slika 7)
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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 =
English: After reconstitution, the solution contains 80 mg belimumab per ml.
Slovenian: Po rekonstituciji vsebuje raztopina 80 mg belimumaba na mililiter.
English: Do not touch this area again before giving the injection.
Slovenian: Tega mesta se pred injiciranjem ne smete več dotakniti.
English: ‘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.
Slovenian: "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.
English: • Do not use if the solution looks cloudy, discoloured or has particles.
Slovenian: • Ne uporabite, če je raztopina motna, spremenjene barve ali so v njej delci.
English: (Figure 6)
Slovenian: (Slika 6)
English: Needle cap
Slovenian: Barnard Castle
English: • container with a tight-fitting lid for syringe disposal (not included in the pack).
Slovenian: • vsebnik z dobro prilegajočim se pokrovom, kamor boste zavrgli brizgo (ni priložen v pakiranju)
English: Administration of subcutaneous or intravenous Benlysta may result in hypersensitivity reactions which can be severe, and fatal.
Slovenian: Subkutana ali intravenska uporaba zdravila Benlysta lahko povzroči preobčutljivostne reakcije, ki so lahko hude in s smrtnim izidom.
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA26
Slovenian: Oznaka ATC: L04AA26
English: info.produkt@gsk.com
Slovenian: medical.x.si@gsk.com
English: • Peel back the film of the tray and remove the pre-filled syringe by grasping the middle of the body.
Slovenian: • Odlepite folijo z embalaže in vzemite ven napolnjeno injekcijsko brizgo tako, da jo primete na sredini.
English: (Figure 9)
Slovenian: (Slika 9)
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Slovenian: Seznam neželenih učinkov Neželeni učinki so navedeni spodaj po organskih sistemih MedDRA in pogostnosti.
English: *‘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.
Slovenian: *"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.
English: 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).
Slovenian: 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.
English: Components of SLE responder index
Slovenian: Elementi indeksa odziva SLE
English: Background medicinal products included corticosteroids (76%; >7.5 mg/day 46%), immunosuppressives (56%), and anti-malarials (63%).
Slovenian: Med osnovnimi zdravili so bili kortikosteroidi (76 %, > 7,5 mg/dan 46 %), imunosupresivi (56 %) in antimalariki (63
English: • container with a tight-fitting lid for pen disposal (not included in the pack).
Slovenian: • vsebnik z dobro prilegajočim se pokrovom, kamor boste zavrgli peresnik (ni priložen v pakiranju)
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti bolečina v okončini
English: 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).
Slovenian: (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).
English: Amount of Benlysta Vial size
Slovenian: Velikost viale
English: 1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) and needle cap.
Slovenian: 1 ml raztopine v brizgi iz stekla tipa 1 s fiksno iglo (iz nerjavečega jekla) in pokrovčkom igle.
English: No detrimental effects on such activities are predicted from the pharmacology of belimumab.
Slovenian: Glede na farmakologijo belimumaba ni pričakovati škodljivih učinkov na takšne dejavnosti.
English: 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.
Slovenian: bolnikov je imelo prizadetost mukokutanega, 78 % kostnomišičnega, 8 % hematološkega, 12 % ledvičnega in 8 % žilnega organskega področja.
English: 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.
Slovenian: 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
English: 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.
Slovenian: 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.
English: • Dispose of the used syringe and needle cap in a container with a tight-fitting lid.
Slovenian: • Uporabljeno injekcijsko brizgo in pokrovček igle zavrzite v vsebnik z dobro prilegajočim se pokrovom.
English: You inject Benlysta under your skin in your stomach area (abdomen) or upper leg (thigh).
Slovenian: Zdravilo Benlysta si injicirajte pod kožo v predelu trebuha ali stegna.
English: Hypersensitivity reactions*
Slovenian: Bolezni imunskega sistema pogosti preobčutljivostne reakcije*
English: Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.
Slovenian: Tveganje je lahko večje pri bolnikih z anamnezo alergij na več zdravil ali izrazite preobčutljivosti.
English: Severe infections, including fatal cases, have been reported in SLE patients receiving immunosuppressant therapy, including belimumab (see section 4.8).
Slovenian: 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).
English: Administration of Benlysta may result in hypersensitivity reactions and infusion reactions which can be severe, and fatal.
Slovenian: Infuzijske reakcije in preobčutljivost Uporaba zdravila Benlysta lahko povzroči preobčutljivostne in infuzijske reakcije, ki so lahko hude in s smrtnim izidom.
English: (Figure 3)
Slovenian: (Slika 3)
English: Benlysta has not been studied in the following adult and paediatric patient groups, and is not recommended in:
Slovenian: Zdravilo Benlysta ni raziskano v naslednjih skupinah odraslih in pediatričnih bolnikov, zato ga ni priporočljivo uporabljati pri bolnikih s: • hudim aktivnim lupusom osrednjega živčevja,
English: • Remove one sealed tray containing a pre-filled syringe from the refrigerator.
Slovenian: • Iz hladilnika vzemite eno zaprto embalažo, v katerem je napolnjena injekcijska brizga.
English: Odds ratio (95% CI) vs placebo
Slovenian: Razmerje obetov (95 % IZ) v primerjavi s placebom
English: 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.
Slovenian: 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.
English: 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).
Slovenian: bolnikov je imelo prizadetost mukokutanega, 60 % kostnomišičnega, 16 % hematološkega, 11 % ledvičnega in 9 % žilnega organskega področja (izhodiščno BILAG A ali B).
English: • The pre-filled pen should be used only once and then discarded.
Slovenian: • Napolnjeni injekcijski peresnik uporabite le enkrat in ga nato zavrzite.
English: Benlysta can make you more likely to get infections, including infection of the urinary tract and airways.
Slovenian: Zdravilo Benlysta vam lahko poveča verjetnost, da zbolite za okužbami, vključno z okužbami sečil in dihal.
English: 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.
Slovenian: 661 preiskovancih (554 bolnikih s SLE in 107 zdravih preiskovancih), ki so zdravilo Benlysta prejemali subkutano.
English: Benlysta is supplied as a 1 ml colourless to slightly yellow solution in a single use pre-filled syringe with a needle cap.
Slovenian: Zdravilo Benlysta je na voljo kot 1 ml brezbarvna do rahlo rumenkasta raztopina v napolnjeni injekcijski brizgi za enkratno uporabo s pokrovčkom igle.
English: They include symptoms such as rash, feeling sick, tiredness, muscle aches, headache, or facial swelling.
Slovenian: Med takšnimi so izpuščaj, občutek slabosti, utrujenost, bolečine v mišicah, glavobol ali oteklost obraza.
English: Finger grips
Slovenian: Držalo za prste
English: 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:
Slovenian: 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:
English: Solution for injection in pre-filled syringe.
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Suicidal behaviour, suicidal ideation
Slovenian: Psihiatrične motnje pogosti depresija občasni samomorilno vedenje, samomorilne misli
English: Severe flares over 52 weeks:
Slovenian: Huda poslabšanja v 52 tednih: Bolniki, ki se jim je pojavilo hudo poslabšanje
English: 4 pre-filled syringes.
Slovenian: 4 napolnjeni injekcijski peresniki.
English: SRI response rate at week-76 (%) Observed treatment difference vs placebo (%)
Slovenian: Delež odziva po SRI po 76 tednih ( %) Opažena terapevtska razlika v prim.
English: Alcohol swab
Slovenian: Alkoholni listič
English: Check the expiry date
Slovenian: Preverite rok uporabnosti
English: 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).
Slovenian: 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).
English: Warnings
Slovenian: Opozorila
English: • itchy raised bumps or hives.
Slovenian: • srbeče, dvignjene bulice ali koprivnica.
English: • Do not touch this area again before giving the injection.
Slovenian: • Tega mesta se pred injiciranjem ne smete več dotakniti.
English: Belimumab was distributed to tissues with steady-state volume (Vss) of distribution of approximately 5 litres.
Slovenian: Belimumab se je porazdelil v tkiva z volumnom porazdelitve v stanju dinamičnega ravnovesja (Vss)
English: EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes
Slovenian: EU/1/11/700/006 1 napolnjena injekcijska brizga EU/1/11/700/007 4 napolnjene injekcijske brizge
English: • diarrhoea, vomiting
Slovenian: • driska, bruhanje,
English: Administration of Benlysta may result in severe or life-threatening hypersensitivity reactions and infusion reactions.
Slovenian: Dajanje zdravila Benlysta lahko povzroči hude ali smrtno nevarne preobčutljivostne in infuzijske reakcije.
English: Preparation of 120 mg solution for infusion
Slovenian: Priprava 120 mg raztopine za infundiranje Rekonstitucija
English: Changes in biomarkers were seen in clinical trials with Benlysta administered intravenously.
Slovenian: V kliničnih preskušanjih z zdravilom Benlysta intravenske uporabe so ugotovili spremembe bioloških označevalcev.
English: Malignancies and lymphoproliferative disorders
Slovenian: Malignomi in limfoproliferativne motnje
English: Talk to your doctor before you use Benlysta:
Slovenian: Preden dobite zdravilo Benlysta, se posvetujte z zdravnikom:
English: • Leave the syringe at room temperature for 30 minutes.
Slovenian: • Injekcijsko brizgo za 30 minut pustite na sobni temperaturi (Slika 2).
English: Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi študije toksičnosti ponavljajočih se odmerkov in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Very common Bacterial infections, e.g. bronchitis, urinary tract infection
Slovenian: Infekcijske in parazitske bolezni zelo pogosti bakterijske okužbe, npr. bronhitis,
English: The intravenous studies did not exclude patients with a history of psychiatric disorders.
Slovenian: Bolniki z anamnezo psihiatričnih motenj v študijah intravenske uporabe niso bili izključeni.
English: Benlysta is supplied as a 1 ml colourless to slightly yellow solution in a single use pre-filled pen.
Slovenian: Zdravilo Benlysta je na voljo kot 1 ml brezbarvna do rahlo rumenkasta raztopina v napolnjenem injekcijskem peresniku za enkratno uporabo.
English: The recommended injection sites are the abdomen or thigh.
Slovenian: Priporočeni mesti injiciranja sta trebuh ali stegno.
English: Gauze pad or cotton wool ball
Slovenian: Zloženec gaze ali kosem vate
English: Percent of patients with no worsening by BILAG index (%) Odds ratio (95% CI) vs placebo
Slovenian: Odstotek bolnikov z zmanjšanjem SELENA-SLEDAI ≥ 4 (%) Razmerje obetov (95 % IZ) v primerjavi s placebom Odstotek bolnikov brez poslabšanja indeksa BILAG (%) Razmerje obetov (95 % IZ) v primerjavi s placebom Odstotek bolnikov brez poslabšanja po PGA (%)
English: • Dispose of the used pen and ring cap in a container with a tight-fitting lid.
Slovenian: • Uporabljen injekcijski peresnik in okrogel pokrovček zavrzite v vsebnik z dobro prilegajočim se pokrovom.
English: Inject Benlysta Insert the needle
Slovenian: Injicirajte zdravilo Benlysta Zabodite iglo
English: Benlysta 200 mg solution for injection in pre-filled syringe belimumab This medicine is subject to additional monitoring.
Slovenian: Benlysta 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku belimumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: The recommended dose regimen for children aged 5 years and older is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Slovenian: Pediatrična populacija Priporočena shema odmerjanja za otroke, stare 5 let in več, je 10 mg/kg zdravila Benlysta na dan 0, 14
English: In patients with anti-dsDNA antibodies, 16% of patients treated with Benlysta converted to anti-dsDNA negative compared with 7% of the patients receiving placebo by Week 52.
Slovenian: Med bolniki s protitelesi anti-dvDNK je do 52. tedna postalo negativnih 16 % bolnikov, zdravljenih z zdravilom Benlysta, in 7 % tistih, ki so prejemali placebo.
English: FACIT-fatigue score improvement from baseline at week-52 (mean)
Slovenian: Izboljšanje rezultata FACIT-fatigue od izhodišča do 52. tedna (povprečje)