natgillin/translations-raw huggingface dataset:
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).
• 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).
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and toxicity to reproduction.
Predklinični podatki na osnovi študije toksičnosti ponavljajočih se odmerkov in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Very common Bacterial infections, e.g. bronchitis, urinary tract infection
Infekcijske in parazitske bolezni zelo pogosti bakterijske okužbe, npr. bronhitis,
The intravenous studies did not exclude patients with a history of psychiatric disorders.
Bolniki z anamnezo psihiatričnih motenj v študijah intravenske uporabe niso bili izključeni.
Benlysta is supplied as a 1 ml colourless to slightly yellow solution in a single use pre-filled pen.
Zdravilo Benlysta je na voljo kot 1 ml brezbarvna do rahlo rumenkasta raztopina v napolnjenem injekcijskem peresniku za enkratno uporabo.
The recommended injection sites are the abdomen or thigh.
Priporočeni mesti injiciranja sta trebuh ali stegno.
Gauze pad or cotton wool ball
Zloženec gaze ali kosem vate
Percent of patients with no worsening by BILAG index (%) Odds ratio (95% CI) vs placebo
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 (%)
• Dispose of the used pen and ring cap in a container with a tight-fitting lid.
• Uporabljen injekcijski peresnik in okrogel pokrovček zavrzite v vsebnik z dobro prilegajočim se pokrovom.
Inject Benlysta Insert the needle
Injicirajte zdravilo Benlysta Zabodite iglo
Benlysta 200 mg solution for injection in pre-filled syringe belimumab This medicine is subject to additional monitoring.
Benlysta 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku belimumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
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.
Pediatrična populacija Priporočena shema odmerjanja za otroke, stare 5 let in več, je 10 mg/kg zdravila Benlysta na dan 0, 14
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.
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.
FACIT-fatigue score improvement from baseline at week-52 (mean)
Izboljšanje rezultata FACIT-fatigue od izhodišča do 52. tedna (povprečje)
Benlysta significantly reduced circulating overall, transitional, naïve, and SLE B cells, as well as plasma cells at Week 52.
Zdravilo Benlysta je po 52 tednih značilno zmanjšalo število vseh, tranzicijskih, naivnih in SLE celic B
BLyS levels are elevated in patients with SLE and other autoimmune diseases.
Bolniki s SLE in drugimi avtoimunskimi boleznimi imajo večjo koncentracijo BLyS.
Delayed-type, non-acute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial oedema.
Opazili so tudi reakcije pozne, neakutne preobčutljivosti, ki vključujejo simptome, kot so kožni izpuščaj, navzea, utrujenost, bolečine v mišicah, glavobol in edem obraza.
Benlysta 400 mg powder for concentrate for solution for infusion belimumab
Benlysta 400 mg prašek za koncentrat za raztopino za infundiranje belimumab
In patients with anti-dsDNA antibodies at baseline, by Week 52, 18% of patients treated with Benlysta had converted to anti-dsDNA negative compared with 15% of the patients receiving placebo.
Med bolniki, ki so izhodiščno imeli protitelesa anti-dvDNK, je do 52. tedna postalo negativnih 18 % bolnikov zdravljenih z zdravilom Benlysta in 15 % bolnikov, ki so prejemali placebo.
Solutions diluted in sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection may be stored at 2°C to 8°C or room temperature (15°C to 25°C).
(0,45 %) raztopino natrijevega klorida ali raztopino Ringerjevega laktata za injiciranje, je lahko shranjena pri temperaturi od 2 °C do 8 °C ali pri sobni temperaturi (15 do 25 °C).
The reduction in systemic clearance estimated by population PK modelling for patients at the midpoints of the renal impairment categories relative to patients with median creatinine clearance in the PK population (79.9 ml/min) were 1.4% for mild (75 ml/min), 11.7% for moderate (45 ml/min) and 24.0% for severe (22.5 ml/min) renal impairment.
Zmanjšanje sistemskega očistka, ocenjeno s populacijskim farmakokinetičnim modeliranjem za bolnike na srednji točki kategorije okvare ledvic glede na bolnike z medianim očistkom kreatinina v farmakokinetični populaciji (79,9 ml/min), je bilo
Leucopenia: The incidence of leucopenia reported as an adverse event was 3% in the group receiving Benlysta and 2% in the group receiving placebo.
Benlysta, 3 % in v skupini, ki je prejemala placebo, 2 %.
• Do not remove the needle cap until just before the injection.
• Pokrovček igle odstranite šele tik pred injiciranjem.
The intravenous pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients who received Benlysta 10 mg/kg in the two Phase III studies.
563 bolnikih, ki so prejemali 10 mg/kg zdravila Benlysta v dveh študijah III. faze.
Benlysta 120 mg powder for concentrate for solution for infusion belimumab
Benlysta 120 mg prašek za koncentrat za raztopino za infundiranje belimumab
SRI response rate at week 52 (%) Observed treatment difference vs placebo (%)
Delež odziva po SRI po 52 tednih (%) Opažena terapevtska razlika v prim.
Injecting Benlysta
Injiciranje zdravila Benlysta
Preparation of 400 mg solution for infusion
Priprava 400 mg raztopine za infundiranje Rekonstitucija
≤7.5 mg/day during Weeks 40 through 52, was 18.2% in the group receiving Benlysta and 11.9% in the group receiving placebo (p=0.0732).
Benlysta 18,2 % in med prejemniki placeba 11,9 % (p = 0,0732).
• Do not remove the ring cap until just before the injection.
• Okrogli pokrovček odstranite šele tik pred injiciranjem.
After reconstitution, a volume of 5 ml (corresponding to 400 mg belimumab) can be withdrawn from each 20 ml vial.
Po rekonstituciji je mogoče iz ene 20-ml viale potegniti volumen 5 ml (to ustreza 400 mg belimumaba).
The reconstituted medicinal product is diluted to 250 ml with sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection.
Pripravljeno zdravilo je treba razredčiti do 250 ml z 0,9 % (9 mg/ml) raztopino natrijevega klorida,
• Check the expiry date on the pre-filled pen.
• Preverite rok uporabnosti na napolnjenem injekcijskem peresniku.
A single Benlysta pre-filled pen can be stored at room temperature (up to 25°C) for a maximum of 12 hours - as long as it is protected from light.
25 °C) do največ 12 ur - dokler je zaščiten pred svetlobo.
After reconstitution, a volume of 1.5 ml (corresponding to 120 mg belimumab) can be withdrawn from each 5 ml vial.
Po rekonstituciji je mogoče iz ene 5-ml viale potegniti volumen 1,5 ml (to ustreza 120 mg belimumaba).
The clinical status of the subject and the adverse reaction profile of Benlysta should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Pri ocenjevanju bolnikove zmožnosti za izvajanje opravil, ki zahtevajo presojo in motorične ali kognitivne sposobnosti, je treba upoštevati njegovo klinično stanje in profil neželenih učinkov zdravila Benlysta.
Injection site reactions: In the subcutaneous trial, the frequency of injection site reactions was 6.1% (34/556) and 2.5% (7/280) for patients receiving Benlysta and placebo, respectively.
Reakcije na mestu injiciranja: V preskušanju s subkutano uporabo je bila pogostnost reakcij na mestu injiciranja v skupini bolnikov, ki je prejemala zdravilo Benlysta, 6,1 % (34/556) in v skupini bolnikov,
In a pooled analysis of the two studies, the percentage of patients receiving >7.5 mg/day prednisone (or equivalent) at baseline, whose average corticosteroid dose was reduced by at least 25% to a dose equivalent to prednisone ≤7.5 mg/day during Weeks 40 through 52, was 17.9% in the group receiving Benlysta and 12.3% in the group receiving placebo (p=0.0451).
tedna zmanjšal za vsaj 25 % na odmerek, enakovreden ≤7,5 mg/dan prednizona, 17,9 % med prejemniki zdravila Benlysta in 12,3 % med prejemniki placeba (p = 0,0451).
After reconstitution, a volume of 5 ml (corresponding to 400 mg belimumab) can be withdrawn from each vial.
Po rekonstituciji je mogoče iz ene viale potegniti volumen 5 ml (to ustreza 400 mg belimumaba).
The majority of patients were also receiving one or more of the following concomitant treatments for SLE: corticosteroids, immunomodulatory medicinal products, anti-malarials, non-steroidal anti-inflammatory medicinal products.
Večina bolnikov je za SLE sočasno dobivala tudi eno ali več naslednjih zdravil: kortikosteroide,
After reconstitution, a volume of 1.5 ml (corresponding to 120 mg belimumab) can be withdrawn from each vial.
Po rekonstituciji je mogoče iz ene viale potegniti volumen 1,5 ml (to ustreza 120 mg belimumaba).
Inspect the Benlysta solution
Preglejte raztopino zdravila Benlysta
Follow these instructions on how to use the pre-filled syringe correctly.
Za pravilno uporabo napolnjenega injekcijskega peresnika upoštevajte ta navodila.