natgillin/translations-raw huggingface dataset:
None of these gastrointestinal events in obese patients were serious. 
Nobeden od teh neželenih učinkov na prebavila pri debelih bolnikih ni bil resen.
Important information about the contents of Benlysta 
Pomembne informacije o sestavi zdravila Benlysta
Benlysta 200 mg weekly 
Benlysta 200 mg/teden
Intravenous and subcutaneous administration to monkeys resulted in the expected reduction in the number of peripheral and lymphoid tissue B cell counts with no associated toxicological findings. 
Intravenska in subkutana uporaba je pri opicah povzročila pričakovano zmanjšanje števila celic B v periferni krvi in limfatičnem tkivu, brez s tem povezanih toksikoloških izsledkov.
Benlysta subcutaneous injection must not be injected into a vein (intravenously). 
Zdravila Benlysta za subkutano injiciranje ne smete injicirati v veno (intravensko).
The pre-filled pen or pre-filled syringe should be used for subcutaneous injection only. 
Napolnjen injekcijski peresnik oziroma napolnjeno injekcijsko brizgo se sme uporabljati le za subkutano injiciranje.
In clinical studies, serious infusion and hypersensitivity reactions affected approximately 0.9% of adult patients, and included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea. 
V kliničnih študijah so se resne infuzijske in preobčutljivostne reakcije pojavile pri približno 0,9 % odraslih bolnikov; obsegale so anafilaktično reakcijo, bradikardijo, hipotenzijo, angioedem in dispnejo.
Name and address of the manufacturer responsible for batch release 
Ime in naslov proizvajalca, odgovornega za sproščanje serije
The efficacy of Benlysta administered subcutaneously was evaluated in a randomised, double-blind, placebo-controlled 52-week Phase III study (HGS1006-C1115; BEL112341) in 836 adult patients with a clinical diagnosis of SLE according to the American College of Rheumatology classification criteria. 
Učinkovitost subkutano uporabljanega zdravila Benlysta so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani 52-tedenski študiji III. faze (HGS1006-C1115; BEL112341) pri 836 odraslih bolnikih s klinično diagnozo SLE po klasifikacijskih merilih American College of Rheumatology.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Allow 10 to 15 minutes for the vial to warm to room temperature (15°C to 25°C). 
Vialo pustite 10 do 15 minut, da se ogreje na sobno temperaturo (15 °C do 25 °C).
Among patients experiencing a severe flare, the median study day of the first severe flare was Day 159.5 in the Benlysta group and Day 82 in the placebo group. 
Med bolniki, ki se jim je pojavil hud zagon bolezni, je bila mediana dneva v študiji, ko je pojavilo prvo hudo poslabšanje 159,5. dan v skupini, ki je prejemala zdravilo Benlysta in 82. dan v skupini s placebom.
Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late onset reaction. 
Upoštevaje možnost reakcij s poznim začetkom morajo bolniki ostati pod kliničnim nadzorom daljši čas (vsaj nekaj ur), vsaj po prvih 2 infundiranjih.
Infections: The overall incidence of infections in intravenous and subcutaneous studies was 63% in both groups receiving Benlysta or placebo. 
Okužbe: Celotna pojavnost okužb v študijah intravenske in subkutane uporabe je bila 63 % tako v skupini, ki je prejemala zdravilo Benlysta, kot v skupini, ki je prejemala placebo.
On the basis of the available information, dose adjustment is not required in patients with mild, moderate or severe renal impairment. 
Na podlagi informacij, ki so na voljo, bolnikom z blago, zmerno ali hudo okvaro ledvic odmerka ni treba prilagoditi.
Physicians should assess the risk of depression and suicide considering the patient's medical history and current psychiatric status before treatment with Benlysta and continue to monitor patients during treatment. 
Zdravniki morajo pred začetkom zdravljenja z zdravilom Benlysta na podlagi bolnikove zdravstvene anamneze in trenutnega psihiatričnega stanja oceniti tveganje za depresijo in samomor ter nadaljevati s spremljanjem bolnikov med zdravljenjem.
The recommended dose is 200 mg once weekly, administered subcutaneously. 
Priporočeni odmerek je 200 mg enkrat na teden subkutano.
Benlysta can have side effects which may make you less able to drive or use machines. 
Zdravilo Benlysta ima lahko možne neželene učinke, ki lahko zmanjšajo sposobnost za upravljanje vozil in strojev.
Allow the vial to sit at room temperature (15°C to 25°C) during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved. 
Med pripravo vialo pustite na sobni temperaturi (15°C do 25 °C) in jo vsakih 5 minut za 60 sekund nežno vrtite, dokler se prašek ne raztopi.
The recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter. 
Priporočena shema odmerjanja je 10 mg/kg zdravila Benlysta na dan 0, 14 in 28, potem pa v 4
BLISS-76 Study only 
Samo študija BLISS-76
Within the overall SLE intravenous study population, age did not affect belimumab exposure in the population pharmacokinetic analysis. 
Znotraj celotne intravenske raziskovane populacije s SLE starost v populacijski farmakokinetični analizi ni vplivala na izpostavljenost belimumabu.
Benlysta is administered intravenously by infusion, and must be reconstituted and diluted before administration. 
Zdravilo Benlysta je treba dati intravensko v infuziji in ga je treba pred uporabo pripraviti in razredčiti.
Infusion or injection-related systemic reactions*, pyrexia 
Splošne težave in spremembe na mestu aplikacije pogosti z infundiranjem ali injiciranjem povezane sistemske reakcije*, pireksija
Following intravenous administration of 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter, belimumab exposures were similar between paediatric and adult SLE subjects. 
mg/kg na dan 0, 14 in 28, potem pa v 4-tedenskih presledkih, je bila izpostavljenost belimumabu pri pediatričnih bolnikih s SLE podobna kot pri odraslih bolnikih s SLE.
Your doctor may decide to give you medicines which help to reduce any infusion reactions before you are given Benlysta. 
Zdravnik se lahko odloči in vam pred uporabo zdravila Benlysta da zdravila, ki pomagajo zmanjšati infuzijske reakcije.
A patient may self-inject or the patient caregiver may administer Benlysta after the healthcare professional determines that it is appropriate. 
Bolnik si lahko sam injicira zdravilo Benlysta, ali mu ga injicira njegov negovalec, ko zdravnik presodi, da je to primerno.
These adverse events of special interest include serious infections (including nonserious and serious opportunistic infections and PML, malignancies (including nonmelanoma skin cancer), serious infusion and hypersensitivity reactions, and serious psychiatric events including mood disorders, anxiety and suicide. 
Ti izbrani neželeni učinki obsegajo hude okužbe (vključno z oportunističnimi okužbami in PML, ki niso resni in takšnimi, ki so resni), malignomi vključno z nemelanomskim kožnim rakom) resne infuzijske in preobčutljivostne reakcije ter resne psihiatrične motnje vključno z motnjami razpoloženja, anksioznostjo in samomorom.
Treatment-related findings were limited to the expected reversible reduction of B cells in both dams and infants and reversible reduction of IgM in infant monkeys. 
Z zdravljenjem povezani izsledki so bili omejeni na pričakovana reverzibilno zmanjšanje števila celic B pri samicah-materah in mladičih ter reverzibilno znižanje IgM pri opičjih mladičih.
• Clean the injection site by wiping it with an alcohol swab (Figure 5). 
• Očistite mesto injiciranja tako, da ga obrišete z alkoholnim lističem (Slika 5).
There were too few patients ≥65 years of age enrolled in the controlled clinical trials to draw meaningful conclusions about the effects of age on clinical outcomes. 
V kontrolirana klinična preskušanja je bilo vključenih premalo bolnikov, starih 65 let ali več, da bi bilo mogoče smiselno sklepati o vplivu starosti na klinične izide.
Tell your doctor if you have a history of these conditions. 
Obvestite zdravnika, če imate v svoji anamnezi katerega od teh stanj.
Complete the injection 
Dokončajte injiciranje
Prepare and inspect the pre-filled syringe Allow to come to room temperature 
Pripravite in preglejte napolnjen injekcijski peresnik Pustite, da se ogreje na sobno temperaturo.
Gastroenteritis viral, pharyngitis, nasopharyngitis, viral upper respiratory tract infection 
okužba sečil pogosti virusni gastroenteritis, faringitis, nazofaringitis, virusna okužba zgornjih dihal
This is to avoid the skin becoming hardened. 
S tem preprečite otrdelost kože.
12- to 17-year-old group: infections were reported in 22/43 patients receiving Benlysta and 25/37 patients receiving placebo, and serious infections were reported in 3/43 patients receiving Benlysta and 3/37 patients receiving placebo. 
Skupina bolnikov, starih od 12 do 17 let: okužbe so poročali pri 22/43 bolnikov, ki so prejemali zdravilo Benlysta in 25/37 bolnikov, ki so prejemali placebo, resne okužbe so poročali pri 3/43 bolnikov, ki so prejemali zdravilo Benlysta in 3/37 bolnikov, ki so prejemali placebo.
Benlysta is for use under the skin only (subcutaneous). 
Zdravilo Benlysta je namenjeno le za podkožno (subkutano) uporabo.
The rates of infusion reactions among persistent-positive subjects were comparable to the rates for ADA negative patients of 75/552 (14%), 78/523 (15%), and 83/559 (15%) in the placebo, 1 mg/kg and 10 mg/kg groups, respectively. 
Deleži infuzijskih reakcij med stalno pozitivnimi preiskovanci so bili primerljivi z deleži za ADA negativne bolnike, in sicer 75/552 (14 %) med prejemniki placeba, 78/523 (15 %) med prejemniki odmerka 1 mg/kg in 83/559 (15 %) med prejemniki odmerka 10 mg/kg.
Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow and without particles. 
Ko je rekonstitucija končana, mora biti raztopina opalescentna, brezbarvna do bledo rumena in brez delcev.
The primary efficacy endpoint was a composite endpoint (SLE Responder Index) that defined response as meeting each of the following criteria at Week 52 compared with baseline: 
Responder Index [SRI]), ki je odziv opredelil kot izpolnitev vsakega od naslednjih meril 52. teden v primerjavi z izhodiščem:
Patients had active SLE disease, defined as a SELENA-SLEDAI (SELENA=Safety of Estrogens in Systemic Lupus Erythematosus National Assessment; SLEDAI=Systemic Lupus Erythematosus Disease Activity Index) score ≥6 and positive anti-nuclear antibody (ANA) test results (ANA titre ≥1:80 and/or a positive anti-dsDNA [≥30 units/ml]) at screening. 
Bolniki so imeli aktiven SLE; to je bilo opredeljeno kot rezultat SELENA-SLEDAI (SELENA = Safety of Estrogens in Systemic Lupus Erythematosus National Assessment, SLEDAI = Systemic Lupus Erythematosus Disease Activity Index) ≥ 6 in pozitiven izvid testa protijedrnih protiteles (ANA) (titer ANA ≥ 1:80 in/ali pozitiven anti-dvDNK [≥ 30 enot/ml]) ob presejanju.
These adverse events of special interest include serious infections (including opportunistic infections and PML), selected serious psychiatric events, and malignancies (including non-melanoma skin cancer). 
Med temi neželenimi učinki posebnega interesa so resne okužbe, vključno z oportunističnimi okužbami in PML, določene resne psihiatrične motnje ter malignomi (vključno z nemelanomskim kožnim rakom).
Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet (see Step-by-step instructions). 
Izčrpna navodila za subkutano injiciranje zdravila Benlysta v napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi so navedena na koncu navodila za uporabo (glejte Navodila korak za korakom).
Serious depression was reported in 0.6% (4/674) of patients receiving Benlysta 10 mg/kg and 0.3% (2/675) of patients receiving placebo. 
O hudi depresiji so poročali pri 0,6 % (4/674) bolnikov, ki so prejemali 10 mg/kg zdravila Benlysta in 0,3 % (2/675) bolnikov, ki so prejemali placebo.
≥1/100 to <1/10 
≥1/100 do < 1/10
In controlled clinical intravenous and subcutaneous studies, psychiatric disorders (depression, suicidal ideation and behaviour including suicides) have been reported more frequently in patients receiving Benlysta (see section 4.8). 
V kontroliranih kliničnih študijah intravenske in subkutane uporabe so pri bolnikih, ki so prejemali zdravilo Benlysta, pogosteje poročali o psihiatričnih motnjah (depresija, samomorilne misli in vedenje, vključno s samomori) (glejte poglavje 4.8).
The incidence of post-injection systemic reactions and hypersensitivity reactions occurring within 3 days of subcutaneous administration was 7% in the group receiving Benlysta and 9% in the group receiving placebo. 
Pojavnost sistemskih in preobčutljivostnih reakcij po injiciranju, ki so se pojavile v okviru 3 dni po subkutani uporabi, je bila v skupini, ki je prejemala zdravilo Benlysta, 7 %, in v skupini, ki je prejemala placebo, 9 %.
5 How to store Benlysta Contents of the pack and other information 
Shranjevanje zdravila Benlysta Vsebina pakiranja in dodatne informacije
• migraine. 
• migrena.
Prednisone reduction by ≥25% from baseline to ≤7.5 mg/day during weeks 40 through 52* 
Znižanje prednizona za ≥ 25 % od izhodišča na ≤ 7,5 mg/dan v tednih od 40. do 52.
• Do not rub the injection site. 
• Ne drgnite mesta injiciranja.
Weight-normalised belimumab dosing leads to decreased exposure for underweight subjects (BMI <18.5) and to increased exposure for obese subjects (BMI ≥30). 
Telesni masi prilagojeno odmerjanje belimumaba povzroči manjšo izpostavljenost oseb s premajhno telesno maso (ITM < 18,5) in večjo izpostavljenost debelih oseb (ITM ≥ 30).
• Do not expel any air bubbles from the syringe. 
• Ne iztiskajte zračnih mehurčkov iz injekcijske brizge.
Infections occurring in at least 3% of patients receiving Benlysta and at least 1% more frequently than patients receiving placebo were viral upper respiratory tract infection, bronchitis, and urinary tract infection bacterial. 
Okužbe, ki so se pojavile pri vsaj 3 % bolnikov, ki so prejemali zdravilo Benlysta in vsaj 1 % pogosteje kot med bolniki, ki so prejemali placebo, so bile virusne okužbe zgornjih dihal, bronhitis in bakterijske okužbe sečil.
Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.2 and 4.8). 
Opažali so tudi ponovitev klinično pomembnih reakcij po ustreznem začetnem zdravljenju simptomov (glejte poglavji 4.2 in 4.8).
You should also receive training on how to use the prefilled syringe. 
Opraviti morate tudi usposabljanje za uporabo napolnjene injekcijske brizge.
120 mg vial 
120-mg viala
Justification for not including Braille accepted 
Sprejeta je utemeljitev, zakaj niso vključeni podatki v Braillovi pisavi 17.
Benlysta must not be administered as an intravenous bolus. 
Zdravila Benlysta se ne sme uporabiti kot intravenski bolus.
• Hold the prefilled syringe by the body, and with the needle facing away from you. 
• Držite napolnjeno injekcijsko brizgo za telo brizge tako, da je igla obrnjena stran od vas.
The systemic clearance was 204 ml/day. 
Sistemski očistek je bil 215 ml/dan (razpon:
A single Benlysta pre-filled syringe can be stored at room temperature (up to 25°C) for a maximum of 12 hours - as long as it is protected from light. 
Posamezna napolnjena injekcijska brizga zdravila Benlysta se lahko shranjuje pri sobni temperaturi (do 25 °C) do največ 12 ur - dokler je zaščitena pred svetlobo.
Each vial contains 400 mg belimumab (80 mg/ml after reconstitution) 
Ena viala vsebuje 400 mg belimumaba (80 mg/ml po rekonstituciji).
Patients were on a stable SLE treatment regimen (standard of care) consisting of any of the following (alone or in combination): corticosteroids, anti-malarials, NSAIDs or other immunosuppressives. 
Bolniki so bili na stabilni shemi zdravljenja SLE (standardna oskrba), ki je obsegala kar koli od naslednjega (same ali v kombinaciji): kortikosteroide, antimalarike, nesteroidna protivnetna zdravila ali druge imunosupresive.
The stream of water for injections should be directed toward the side of the vial to minimize foaming. 
Curek vode za injekcije usmerite v steno viale, da bo čim manj penjenja.
The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. 
Če se bolniku pojavi infuzijska reakcija, se hitrost infundiranja lahko upočasni ali infundiranje prekine.
The efficacy and safety of Benlysta in the elderly has not been established. 
Učinkovitost in varnost zdravila Benlysta pri starejših bolnikih nista ugotovljeni.
No new safety signals were observed in the paediatric population 12 years of age and above (n=43). 
Pri pediatrični populaciji, stari 12 let in več (n=43), niso opazili novih varnostnih signalov.
≥1/10,000 to <1/1000 
≥1/10.000 do <1/1.000
Your first injection with the Benlysta pre-filled syringe will be supervised by your doctor or nurse. 
Vaše prvo injiciranje zdravila Benlysta z napolnjeno injekcijsko brizgo bosta nadzorovala zdravnik ali medicinska sestra.
To improve the traceability of this medicine, your healthcare provider should record the Benlysta lot number in your patient file. 
Za izboljšanje sledljivosti tega zdravila, mora vaš zdravnik zabeležiti številko serije zdravila Benlysta v vaš zdravstveni karton.
Also contains: arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections. 
Vsebuje tudi: argininijev klorid, histidin, histidinijev monoklorid, polisorbat 80, natrijev klorid, voda za injekcije
Patients should be advised that hypersensitivity reactions are possible, on the day of, or several days after infusion, and be informed of potential signs and symptoms and the possibility of recurrence. 
Bolnikom je treba povedati, da so preobčutljivostne reakcije možne na dan infundiranja ali nekaj dni po infundiranju, in jih seznaniti z možnimi znaki in simptomi in o možnosti ponovitve.
Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.4 and 4.8). 
Opažali so tudi ponovitev klinično pomembnih reakcij po ustreznem začetnem zdravljenju simptomov (glejte poglavji 4.4 in 4.8).
There is limited clinical experience with overdose of Benlysta. 
Klinične izkušnje s prevelikim odmerjanjem zdravila Benlysta so omejene.
Physicians should exercise caution when considering the use of Benlysta in patients with severe or chronic infections or a history of recurrent infection. 
Pri odločitvi za uporabo zdravila Benlysta pri bolnikih s hudimi ali kroničnimi okužbami ali anamnezo ponavljajoče se okužbe je potrebna previdnost.
After you have been trained on how to use the syringe, your doctor or nurse may decide that you can give yourself the injection, or your caregiver can give it to you. 
Potem, ko se boste usposobili za uporabo injekcijske brizge, bosta zdravnik ali medicinska sestra presodila, ali si lahko zdravilo injicirate sami oziroma ali vam ga lahko injicira vaš negovalec.
Clean the injection site 
Očistite mesto injiciranja
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) 
(Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of Benlysta (see section 4.4). 
Pred infundiranjem zdravila Benlysta se lahko uporabi premedikacija, vključno z antihistaminikom, z antipiretikom ali brez njega (glejte poglavje 4.4).
The frequency categories used are: 
Uporabljena je naslednja razvrstitev pogostnosti: zelo pogosti pogosti
• a history of major organ transplant or hematopoietic stem cell /marrow transplant or renal transplant. 
• anamnezo presaditve pomembnega organa, presaditve hematopoetskih matičnih celic/kostnega mozga ali presaditve ledvice.
BLISS-76 and BLISS-52 Pooled 
BLISS-76 in BLISS-52 skupaj
Belimumab has been studied in a limited number of SLE patients with renal impairment. 
Belimumab so preučevali pri majhnem številu bolnikov s SLE in okvaro ledvic.
There were two suicides in Benlysta-treated patients (including one receiving 1 mg/kg Benlysta). 
(vključno z enim bolnikom, ki je prejemal 1 mg/kg zdravila Benlysta).
Instructions for using the pre-filled syringe are given at the end of this leaflet. 
Navodila za uporabo napolnjene injekcijske brizge so na koncu tega navodila.
• Use an effective method of contraception while you are being treated with Benlysta and for at least 4 months after the last dose. 
• Ženske morajo med zdravljenjem z zdravilom Benlysta in vsaj še 4 mesece po zadnjem odmerku uporabljati učinkovito kontracepcijsko zaščito.
In the open-label extension phase there was one fatal infection in a patient receiving Benlysta. 
V odprti podaljšani fazi se je ena okužba pri bolniku, ki je prejemal zdravilo Benlysta, končala s smrtjo.
Post-hoc analysis has identified high responding subgroups such as those patients with low complement and positive anti-dsDNA at baseline, see Table 2 for results of this example of a higher disease activity group. 
Post hoc analiza je pokazala zelo odzivne podskupine, npr. bolnike z izhodiščno nizkim komplementom in pozitivnim anti-dvDNK, glejte preglednico 2 za rezultate tega primera skupine z večjo bolezensko aktivnostjo.
Among persistent-positive subjects in the Phase III studies, 1/10 (10%), 2/27 (7%) and 1/4 (25%) subjects in the placebo, 1 mg/kg and 10 mg/kg groups, respectively, experienced infusion reactions on a dosing day; these infusion reactions were all non-serious and mild to moderate in severity. 
Med stalno pozitivnimi preiskovanci v študijah III. faze so se infuzijske reakcije na dan uporabe pojavile pri 1/10 (10 %) prejemnikov placeba, 2/27 (7 %) prejemnikov odmerka 1 mg/kg in 1/4 (25 %) prejemnikov odmerka 10 mg/kg; nobena od teh infuzijskih reakcij ni bila resna in vse so bile blage do zmerne.
Patients should be advised that hypersensitivity reactions are possible, on the day of, or several days after administration, and be informed of potential signs and symptoms and the possibility of recurrence. 
Bolnikom je treba povedati, da so preobčutljivostne reakcije možne na dan uporabe zdravila in več dni potem, in jih seznaniti z možnimi znaki in simptomi ter možnostjo ponovitve.
For patients whose body weight is less than or equal to 40 kg, infusion bags with 100 ml of these diluents may be considered providing that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/ml. 
Za bolnike s telesno maso manjšo ali enako 40 kg je treba razmisliti o uporabi vreč s 100 ml teh vehiklov, pod pogojem, da koncentracija belimumaba v vrečki ne presega 4 mg/ml.
Caution should be exercised if Benlysta is co-administered with other B cell targeted therapy or cyclophosphamide. 
Previdnost je potrebna, če je zdravilo Benlysta uporabljeno sočasno z drugimi zdravili, usmerjenimi na celice B, ali s ciklofosfamidom.
Clinically significant hypersensitivity reactions associated with Benlysta administered subcutaneously and requiring permanent treatment discontinuation were reported in 0.2% of patients receiving Benlysta and in no patients receiving placebo. 
Klinično pomembne preobčutljivostne reakcije, povezane s subkutano uporabo zdravila Benlysta, ki so zahtevale trajno prenehanje zdravljenja, so se pojavile pri 0,2 % bolnikov, ki so prejemali zdravilo Benlysta in pri nobenem bolniku, ki je prejemal placebo.
Table 2: Patients with low complement and positive anti-dsDNA at baseline 
Preglednica 2: Bolniki z izhodiščno nizkim komplementom in pozitivnim anti-dvDNK
Renal impairment: No specific studies have been conducted to examine the effects of renal impairment on the pharmacokinetics of belimumab. 
Okvara ledvic: Specifičnih študij za ugotavljanje vplivov okvare ledvic na farmakokinetiko belimumaba niso izvedli.