natgillin/translations-raw huggingface dataset:
Patients had active SLE disease, defined as a SELENA-SLEDAI score ≥6 and positive autoantibodies at screening as described in the adult trials.
Bolniki so imeli aktivno bolezen SLE, opredeljeno kot rezultat SELENASLEDAI ≥ 6 in pozitivna avtoprotitelesa ob presejanju, kot je opisano za preskušanja pri odraslih.
• Do not perform the injection if you do not have all the supplies listed.
• Ne injicirajte zdravila, če nimate vsega naštetega.
As belimumab is a monoclonal antibody no genotoxicity studies have been conducted.
Ker je belimumab monoklonsko protitelo, študij genotoksičnosti niso izvedli.
Patients who had severe active lupus nephritis, severe active CNS lupus, primary immunodeficiency, IgA deficiency or acute or chronic infections requiring management were excluded from the study.
Bolniki s hudim aktivnim lupusnim nefritisom, hudim aktivnim lupusom osrednjega živčevja (CŽS), primarno imunsko pomanjkljivostjo, pomanjkanjem IgA ali akutnimi ali kroničnimi okužbami, ki zahtevajo nadzor, so bili izključeni iz študije.
Other possible side effects: Very common side effects
Drugi možni neželeni učinki: Zelo pogosti neželeni učinki
These are very common and may affect more than 1 in 10 people.
Okužbe so zelo pogoste in se lahko pojavijo pri več kot 1 od 10 bolnikov.
• if your lupus affects your kidneys or nervous system
• Če vam lupus prizadene ledvice ali živčevje.
There are a limited amount of data from the use of Benlysta in pregnant women.
Podatkov o uporabi zdravila Benlysta pri nosečnicah je malo.
Maximum serum concentrations of belimumab were generally observed at, or shortly after, the end of the infusion.
Največjo koncentracijo belimumaba v serumu so praviloma ugotovili na koncu infundiranja ali kmalu po koncu infundiranja.
Infusion reactions occurred more frequently during the first two infusions and tended to decrease with subsequent infusions (see section 4.8).
Infuzijske reakcije so se pogosteje pojavile med prvima dvema infundiranjema; med nadaljnjimi infundiranji se je njihova pogostnost zmanjševala (glejte poglavje 4.8).
Patients were randomised in a 2:1 ratio to receive belimumab 200 mg or placebo subcutaneously once weekly for 52 weeks.
Bolniki so bili za 52 tednov v razmerju 2:1 randomizirani na prejemanje 200 mg belimumaba ali placeba subkutano enkrat na teden.
The safety and efficacy of Benlysta administered intravenously have been studied in black patients.
Varnost in učinkovitost zdravila Benlysta, uporabljenega intravensko, so preučevali pri bolnikih črncih.
This was consistent with the findings from the adult intravenous clinical trials.
To se sklada z izsledki kliničnih preskušanj intravenske uporabe pri odraslih.
The response for the individual components of the endpoint were consistent with that of the SRI (Table 3).
Odziv po posameznih elementih cilja študije se je skladal z odzivom po SRI (Preglednica 3).
SRI response rate (excluding complement and anti-dsDNA changes) at week 52 (%)
Delež odziva po SRI (izključujoč spremembe komplementa in anti-dvDNK) po 52 tednih
Infusion or injection-related systemic reactions and hypersensitivity: Infusion or injection-related systemic reactions and hypersensitivity were generally observed on the day of administration, but acute hypersensitivity reactions may also occur several days after dosing.
Z infundiranjem ali injiciranjem povezane sistemske reakcije in preobčutljivost: Z infundiranjem ali injiciranjem povezane sistemske reakcije in preobčutljivost so na splošno opažali na dan uporabe, toda akutne preobčutljivostne reakcije se lahko pojavijo tudi nekaj dni po uporabi.
Continue to hold the pen down until the purple indicator has stopped moving.
Še naprej držite injekcijski peresnik pritisnjen navzdol, dokler se vijoličasti kazalnik ne neha premikati.
The safety registry will evaluate the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus.
Register varnosti bo ocenil incidenco umrljivosti zaradi vseh vzrokov in neželenih učinkov posebnega interesa pri bolnikih s sistemskim eritematoznim lupusom.
This study was conducted in the US, South America, Europe and Asia.
Ta študija je bila izvedena v ZDA, Južni Ameriki, Evropi in Aziji.
If a dose is missed, it should be administered as soon as possible.
V primeru izpuščenega odmerka je treba zdravilo uporabiti čim prej.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po pripravi in redčenju zdravila glejte poglavje 6.3.
Then add the required volume of the reconstituted Benlysta solution into the infusion bag or bottle.
Potem dodajte potrebno količino pripravljene raztopine zdravila Benlysta v infuzijsko vrečko ali steklenico.
The total time from reconstitution of Benlysta to completion of infusion should not exceed 8 hours.
Celotni čas od rekonstitucije zdravila Benlysta do konca infundiranja ne sme preseči 8 ur.
In the subcutaneous study where serum samples from more than 550 patients with SLE were tested, no antibelimumab antibodies were detected during or after treatment with belimumab 200 mg subcutaneously.
V študiji subkutane uporabe, v kateri so testirali vzorce seruma več kot 550 bolnikov s SLE, niso odkrili protiteles proti belimumabu ne med zdravljenjem z 200 mg belimumaba subkutano ne po zdravljenju.
Depression and suicide
Depresija in samomorilnost
Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B).
Belimumab je človeško monoklonsko protitelo IgG1λ, specifično za topno humano B-limfocite stimulirajočo beljakovino (BLyS, ki jo označujejo tudi BAFF in TNFSF13B).
• Choose an injection site (abdomen or thigh) as seen in Figure 4.
• Izberite mesto injiciranja (trebuh ali stegno), kot prikazuje Slika 4.
Besides an expected pharmacological effect i.e. reduction of B cells, animal studies in monkeys do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section
Poleg pričakovanega farmakološkega učinka (tj. zmanjšanja števila celic B) študije na opicah ne kažejo neposrednih ali posrednih toksičnih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
Paediatric population: The pharmacokinetic parameters are based on individual parameter estimates from a population pharmacokinetic analysis of 53 patients from a study in paediatric patients.
Farmakokinetični parametri temeljijo na ocenah posameznih parametrov v populacijski farmakokinetični analizi 53 bolnikov iz študije pri pediatričnih bolnikih.
The maximum serum concentration (Cmax) of belimumab at steady state was 108 µg/ml.
Največja koncentracija belimumaba v serumu (Cmax) v stanju dinamičnega ravnovesja je bila 108 µg/ml.
It can affect almost any organ in the body, and is thought to involve a type of white blood cells called B cells.
Prizadene lahko skoraj vsak organ v telesu in domnevno je v njegov nastanek vpletena vrsta belih krvnih celic, ki jih imenujemo celice B. Zdravilo Benlysta vsebuje belimumab (monoklonsko protitelo).
However, belimumab was detected in the milk from female monkeys administered 150 mg/kg every 2 weeks.
Vendar pa so belimumab odkrili v mleku opičjih samic, ki so prejemale 150 mg/kg na 2 tedna.
Rarely, less severe delayed reactions to Benlysta can also occur, usually 5 to 10 days after an injection.
Redkeje se lahko pojavijo tudi manj hude, zapoznele reakcije na zdravilo Benlysta, po navadi od 5 do 10 dni po injiciranju.
Transition from intravenous to subcutaneous administration
Prehod z intravenske na subkutano uporabo
Based on simulations with population PK parameters the steady-state average belimumab concentrations for 200 mg subcutaneous every week were similar to 10 mg/kg intravenous every 4 weeks.
Na podlagi simulacij s populacijskimi FK parametri je bila povprečna koncentracija belimumaba v stanju dinamičnega ravnovesja med uporabo 200 mg subkutano vsak teden podobna kot med uporabo 10 mg/kg intravensko na 4 tedne.
Medicine given before an infusion
Zdravila, uporabljena pred infundiranjem
The mechanism of action of belimumab could increase the risk for the development of infections, including opportunistic infections.
Zaradi svojega mehanizma delovanja lahko belimumab poveča tveganje za razvoj okužb, vključno z oportunističnimi okužbami.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Benlysta with other agents.
Študij fizikalne ali biokemične kompatibilnosti za oceno soapliciranja zdravila Benlysta z drugimi zdravili niso izvedli.
The primary efficacy endpoint was the SLE Responder Index (SRI) at Week 52 as described in the adult intravenous trials.
Primarni cilj študije učinkovitosti je bil indeks odziva SLE (SRI-SLE Responder Index) po 52 tednih, kot je opisano za preskušanja intravenske uporabe pri odraslih.
After 7 and a half years of treatment (including the 72-week parent study), a substantial and sustained decrease in various B cell subsets was observed leading to 87% median reduction in naïve B cells, 67% in memory B cells, 99% in activated B cells, and 92% median reduction in plasma cells after more than 7 years of treatment.
Po sedmih letih in pol (vključno z 72 tedni v matični študiji) so opažali bistveno in dolgotrajno zmanjšanje števila različnih podskupin celic B, ki je povzročilo 87 %mediano zmanjšanje števila naivnih celic B, 67 % spominskih celic B, 99 % aktiviranih celic B in 92 % mediano zmanjšanje števila plazmatk po več kot 7 letih zdravljenja.
• If needed, firm the injection site by pulling or stretching the skin.
• Če je treba, utrdite mesto injiciranja tako, da kožo potegnete ali napnete.
There were no serious depression-related events or suicides reported in either group.
V nobeni skupini niso poročali o resnih dogodkih, povezanih z depresijo ali samomorih.
Patients with malignant neoplasm within the last 5 years have not been studied, with the exception of those with basal or squamous cell cancers of the skin, or cancer of the uterine cervix, that has been fully excised or adequately treated.
Bolniki, ki so imeli v zadnjih 5 letih maligno novotvorbo niso raziskani; izjema so bolniki z bazalnoceličnim ali ploščatoceličnim rakom kože ali rakom materničnega vratu, ki je bil v celoti izrezan ali ustrezno zdravljen.
Push the plunger all the way down
Potisnite bat čisto do konca navzdol
It is likely that Benlysta can pass into breast milk.
Zdravilo Benlysta verjetno lahko prehaja v materino mleko.
The proportion of black patients achieving an SRI-S2K response was higher in patients receiving Benlysta but the difference was not statistically significant compared with placebo.
Delež bolnikov črncev, ki so dosegli odziv SRI-S2K, je bil večji pri bolnikih, ki so prejemali zdravilo Benlysta, toda razlika v primerjavi s placebom ni bila statistično značilna.
Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE.
Zdravljenje z zdravilom Benlysta mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje pri diagnosticiranju in zdravljenju SLE.
Contents of the pack and other information What Benlysta contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Benlysta
• When the injection is complete, lift the pen from the injection site.
• Ko je injiciranje končano, dvignite injekcijski peresnik z mesta injiciranja.
BLISS-52 was conducted in South America, Eastern Europe, Asia, and Australia.
Študija BLISS-52 je bila izvedena v južni Ameriki, vzhodni Evropi, Aziji in Avstraliji.
If you feel depressed or have thoughts of harming yourself or committing suicide, you may find it helpful to tell a relative or close friend and ask them to read this leaflet.
Če ste depresivni ali razmišljate o samopoškodovanju ali samomoru, bi morda bilo koristno, da poveste sorodniku ali dobremu prijatelju in ga prosite, da prebere to navodilo za uporabo.
If a patient is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose (see section 5.2).
Če bolnik prehaja z intravenske na subkutano uporabo zdravila Benlysta, je treba prvo subkutano injekcijo dati od 1 do 4 tedne po zadnjem intravenskem odmerku (glejte poglavje 5.2).
• Look in the inspection window to check that the Benlysta solution is colourless to slightly yellow in colour.
• Poglejte skozi okence za ogled in preverite, da je raztopina zdravila Benlysta brezbarvna ali rahlo rumenkasta.
Of these patients, 64.5% had SELENA SLEDAI scores ≥ 10 at baseline.
64,5 % teh bolnikov je imelo izhodiščno rezultat SELENA SLEDAI ≥ 10.
Live vaccines should not be given for 30 days before, or concurrently with Benlysta, as clinical safety has not been established.
V 30 dneh pred uporabo zdravila Benlysta in sočasno z njegovo uporabo se ne sme uporabljati živih cepiv, ker klinična varnost ni ugotovljena.
You are usually given Benlysta on the first day of treatment then again 14 and 28 days later.
Zdravilo Benlysta se ponavadi uporablja tako, da ga dobite prvi dan zdravljenja ter nato čez 14 in čez 28
Your doctor will discuss with you whether you should stop treatment with Benlysta while you are breast-feeding, or if you should stop breast-feeding.
Zdravnik se bo z vami pogovoril o tem, ali naj med obdobjem dojenja prenehate zdravljenje z zdravilom Benlysta ali naj prenehate dojiti.
Patients should be instructed to seek immediate medical attention if they experience any of these symptoms.
Bolnikom je treba naročiti, naj v primeru, če se jim pojavi kateri od teh simptomov, nemudoma poiščejo zdravniško pomoč.
After reconstitution with water for injections, the reconstituted solution, if not used immediately, should be protected from direct sunlight, and stored refrigerated at 2°C to 8°C.
Po rekonstituciji z vodo za injekcije je treba pripravljeno raztopino - če ni uporabljena takoj - zaščititi pred neposredno sončno svetlobo in shraniti v hladilniku pri temperaturi od 2 do 8 °C.
• severe active lupus nephritis (see section 5.1)
• hudim aktivnim lupusnim nefritisom (glejte poglavje 5.1),
Data presented below are pooled from the intravenous clinical studies (10 mg/kg intravenous dose only) and the subcutaneous clinical study.
Spodaj predstavljeni podatki so kumulativni podatki kliničnih študij z intravensko uporabo (samo intravenski odmerek 10 mg/kg) in klinične študije s subkutano uporabo.
Two doses up to 20 mg/kg administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.
Dva odmerka do 20 mg/kg, uporabljena pri ljudeh v intravenski infuziji v presledku 21 dni, nista bila povezana z večjo incidenco neželenih učinkov kot odmerki 1, 4 ali 10 mg/kg.
B cell numbers recovered after the cessation of belimumab treatment by about 1 year post-partum in adult monkeys and by 3 months of life in infant monkeys; IgM levels in infants exposed to belimumab in utero recovered by 6 months of age.
Število celic B se je po prenehanju zdravljenja z belimumabom popravilo v obdobju do približno 1 leta postpartalno pri odraslih opicah in do 3 mesecev življenja pri opičjih mladičih; Koncentracija IgM pri dojenčkih, in utero izpostavljenih belimumabu, se je popravila do 6. meseca starosti.
The healthcare professional must provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4).
Zdravnik mora bolnika ustrezno usposobiti za podkožno injiciranje in ga seznaniti z znaki in simptomi preobčutljivostnih reakcij (glejte poglavje 4.4).
The mechanism of action of belimumab could increase the risk for the development of infections in adults and children with lupus, including opportunistic infections, and younger children may be at increased risk.
Zaradi svojega mehanizma delovanja lahko belimumab poveča tveganje za razvoj okužb pri odraslih in otrocih z lupusom, vključno z oportunističnimi okužbami, pri čemer so mlajši otroci lahko izpostavljeni večjemu tveganju.
• wheezing, difficulty in breathing or shortness of breath
• piskajoče dihanje, težave z dihanjem ali kratka sapa,
The effects of body weight and BMI on belimumab exposure after subcutaneous administration were not considered clinically meaningful.
Vpliv telesne mase in ITM na izpostavljenost belimumabu po subkutani uporabi ni bil klinično pomemben.
The study will evaluate over a minimum of 1 year the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus.
Študija bo ocenjevala v obdobju najmanj 1 leta incidenco smrtnosti zaradi vseh vzrokov in izbrane neželene učinke pri bolnikih s sistemskim eritematoznim lupusom.
The data presented in the table below reflect exposure to Benlysta administered (10 mg/kg intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days for up to 52 weeks) in 674 patients with SLE, including 472 exposed for at least 52 weeks, and 556 patients exposed to 200 mg Benlysta subcutaneously once weekly for up to 52 weeks.
Podatki, prikazani v spodnji preglednici, odražajo izpostavljenost zdravilu Benlysta, uporabljenemu intravensko (10 mg/kg v obdobju 1 ure na 0., 14. in 28. dan ter nato vsakih 28 dni do 52 tednov), pri 674 bolnikih z SLE, od katerih je bilo 472 bolnikov izpostavljenih vsaj 52 tednov, ter 556 bolniki, izpostavljenimi 200 mg zdravila Benlysta subkutano enkrat na teden do 52 tednov.
• Keep in the carton in order to protect from light.
• Shranjujte v škatli za zagotovitev zaščite pred svetlobo.
(Figure 6a)
(Slika 6a)
The study was conducted in the US, South America, Europe, and Asia.
Študija je bila izvedena v ZDA, Južni Ameriki, Evropi in Aziji.
It is not known if belimumab could be an indirect modulator of such cytokines.
Ni znano, ali bi bil belimumab lahko citokinski modulator.
Once removed from the refrigerator, the syringe must be used within 12 hours or discarded.
Ko ga vzamete iz hladilnika, morate peresnik uporabiti v 12 urah ali pa ga zavreči.
The European Medicines Agency has deferred the obligation to submit the results of studies with Benlysta subcutaneous administration in one or more subsets of the paediatric population in SLE (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila (EMA) je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Benlysta za subkutano uporabo za vse skupine pediatrične populacije za SLE (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
A clear to opalescent, colourless to pale yellow solution, with a pH of 6.
Bistra do opalescentna, brezbarvna do bledo rumena raztopina s pH 6.
• Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
Univariate and multivariate analysis of the primary endpoint in pre-specified subgroups demonstrated that the greatest benefit was observed in patients with higher disease activity including patients with SELENA SLEDAI scores ≥ 10, or patients requiring steroids to control their disease, or patients with low complement levels.
Univariatna in multivariatna analiza primarnega opazovanega dogodka v vnaprej opredeljenih podskupinah je pokazala največjo opaženo korist pri bolnikih z večjo aktivnostjo bolezni, vključno z bolniki, ki so imeli rezultat SELENA SLEDAI ≥ 10, ali bolnikih, ki so za obvladovanje bolezni potrebovali steroide, ali bolnikih z nizko koncentracijo komplementa.
• Do not remove the needle cap during this step.
• Ne odstranite pokrovčka igle med tem korakom.
For intravenous infusion after reconstitution and dilution.
Za intravensko infundiranje po rekonstituciji in redčenju.
Patients who develop an infection while undergoing treatment with Benlysta should be monitored closely and careful consideration given to interrupting immunosuppressant therapy including belimumab until the infection is resolved.
Bolnike, ki se jim med zdravljenjem z zdravilom Benlysta pojavi okužba, je treba natančno nadzirati in temeljito je treba razmisliti o prekinitvi imunosupresivnega zdravljenja, tudi zdravljenja z belimumabom, dokler okužba ne mine.
SLE Responder Index (%)
Indeks odziva SLE (%)
EU/1/11/700/001 1 vial - 120 mg EU/1/11/700/002 1 vial - 400 mg
EU/1/11/700/001 1 viala - 120 mg EU/1/11/700/002 1 viala - 400 mg
Increased exposure for obese subjects receiving 10 mg/kg belimumab did not lead to an overall increase in AE rates or serious AEs compared to obese subjects receiving placebo.
Večja izpostavljenost debelih oseb, ki so prejemale 10 mg/kg belimumaba, ni povzročila celotnega povečanja deležev neželenih učinkov ali resnih neželenih učinkov v primerjavi z debelimi osebami, ki so prejemale placebo.
SLE patients transitioning from 10 mg/kg intravenously every 4 weeks to 200 mg subcutaneously weekly using a 1 to 4 week switching interval had pre-dose belimumab serum concentrations at their first subcutaneous dose close to their eventual subcutaneous steady-state trough concentration (see section 4.2).
Bolniki s SLE, ki so prešli z 10 mg/kg intravensko vsake 4 tedne na 200 mg subkutano vsak teden z 1do 4-tedenskim intervalom za prehod, so imeli koncentracijo belimumaba v serumu pred prvim subkutanim odmerkom blizu svoje navsezadnje dosežene koncentracije v stanju dinamičnega ravnovesja med subkutano uporabo (glejte poglavje 4.2).
After about 7 years, a 28% median reduction in IgG levels was observed, with 1.6% of subjects experiencing a decrease in IgG levels to below 400 mg/dl. Over the course of the study, the reported incidence of AEs generally remained stable or declined.
Po približno sedmih letih so opazili 28% mediano znižanje koncentracije IgG; 1,6 % osebam se je koncentracija IgG znižala pod 400 mg/dl. Tekom študije je incidenca poročanih neželenih učinkov ostala enaka ali se je zmanjšala.
For anti-cardiolipin IgA antibody a 37% reduction at Week 52 was seen (p=0.0003), for anti-cardiolipin IgG antibody a 26% reduction at Week 52 was seen (p=0.0324) and for anti-cardiolipin IgM a 25% reduction was seen (p=NS,
Pri antikardiolipinskih protitelesih IgA so po 52 tednih ugotovili 37 % zmanjšanje (p = 0,0003), za antikardiolipinska protitelesa IgG so po 52 tednih ugotovili 26 % zmanjšanje (p = 0,0324) in za antikardiolipinska protitelesa IgM so ugotovili 25 % zmanjšanje (p = neznačilno, 0,46).
The true occurrence of neutralising antibodies and non-specific anti-drug antibody in the study population is therefore not known.
Dejansko pojavljanje nevtralizacijskih protiteles in nespecifičnih protiteles proti zdravilu v raziskovani populaciji zato ni znano.
• high temperature or fever
• visoka telesna temperatura,
In the 5- to 11-year-old-group (n=13) the SELENA-SLEDAI score ranged from 4 to 13, and in 12- to 17-year-old-group (n=79) the SELENA-SLEDAI score ranged from 4 to 20.
V skupini bolnikov, starih od 5 do 11 let (n=13), je bil rezultat SELENA-SLEDAI v razponu od 4 do 13, v skupini bolnikov, starih od 12 do 17 let (n=79) pa je bil rezultat SLENA-SLEDAI v razponu od 4 do 20.
Caution is however recommended in patients with severe renal impairment due to the lack of data (see section 5.2).
Vendar pa je pri bolnikih s hudo okvaro ledvic priporočljiva previdnost, ker zanje ni podatkov (glejte poglavje 5.2).
The frequency given is the highest seen with either formulation.
Navedena pogostnost je največja pogostnost, zabeležena z eno ali drugo farmacevtsko obliko.
The reconstituted solution, if not used immediately, should be protected from direct sunlight and stored refrigerated at 2°C to 8°C.
Če pripravljena raztopina ni uporabljena takoj, jo je treba zaščititi pred neposredno sončno svetlobo in shraniti v hladilniku pri temperaturi od 2 °C do 8 °C.
Benlysta has not been studied in the following patient groups and is not recommended in:
Zdravilo Benlysta ni raziskano v naslednjih skupinah bolnikov, zato ga ni priporočljivo uporabljati pri bolnikih s:
The safety and efficacy of Benlysta in children aged below 5 years has not been established.
Varnost in učinkovitost zdravila Benlysta pri otrocih, mlajših od 5 let, nista ugotovljeni.