FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you have a history of these conditions.
Slovenian: Obvestite zdravnika, če imate v svoji anamnezi katerega od teh stanj.
English: Complete the injection
Slovenian: Dokončajte injiciranje
English: Prepare and inspect the pre-filled syringe Allow to come to room temperature
Slovenian: Pripravite in preglejte napolnjen injekcijski peresnik Pustite, da se ogreje na sobno temperaturo.
English: Gastroenteritis viral, pharyngitis, nasopharyngitis, viral upper respiratory tract infection
Slovenian: okužba sečil pogosti virusni gastroenteritis, faringitis, nazofaringitis, virusna okužba zgornjih dihal
English: This is to avoid the skin becoming hardened.
Slovenian: S tem preprečite otrdelost kože.
English: 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.
Slovenian: 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.
English: Benlysta is for use under the skin only (subcutaneous).
Slovenian: Zdravilo Benlysta je namenjeno le za podkožno (subkutano) uporabo.
English: 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.
Slovenian: 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.
English: Immunisation
Slovenian: Imunizacija
English: Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow and without particles.
Slovenian: Ko je rekonstitucija končana, mora biti raztopina opalescentna, brezbarvna do bledo rumena in brez delcev.
English: 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:
Slovenian: Responder Index [SRI]), ki je odziv opredelil kot izpolnitev vsakega od naslednjih meril 52. teden v primerjavi z izhodiščem:
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: ≥1/100 to <1/10
Slovenian: ≥1/100 do < 1/10
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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 %.
English: 5 How to store Benlysta Contents of the pack and other information
Slovenian: Shranjevanje zdravila Benlysta Vsebina pakiranja in dodatne informacije
English: • migraine.
Slovenian: • migrena.
English: Prednisone reduction by ≥25% from baseline to ≤7.5 mg/day during weeks 40 through 52*
Slovenian: Znižanje prednizona za ≥ 25 % od izhodišča na ≤ 7,5 mg/dan v tednih od 40. do 52.
English: • Do not rub the injection site.
Slovenian: • Ne drgnite mesta injiciranja.
English: Weight-normalised belimumab dosing leads to decreased exposure for underweight subjects (BMI <18.5) and to increased exposure for obese subjects (BMI ≥30).
Slovenian: Telesni masi prilagojeno odmerjanje belimumaba povzroči manjšo izpostavljenost oseb s premajhno telesno maso (ITM < 18,5) in večjo izpostavljenost debelih oseb (ITM ≥ 30).
English: • Do not expel any air bubbles from the syringe.
Slovenian: • Ne iztiskajte zračnih mehurčkov iz injekcijske brizge.
English: 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.
Slovenian: 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.
English: Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.2 and 4.8).
Slovenian: Opažali so tudi ponovitev klinično pomembnih reakcij po ustreznem začetnem zdravljenju simptomov (glejte poglavji 4.2 in 4.8).
English: You should also receive training on how to use the prefilled syringe.
Slovenian: Opraviti morate tudi usposabljanje za uporabo napolnjene injekcijske brizge.
English: 120 mg vial
Slovenian: 120-mg viala
English: Justification for not including Braille accepted
Slovenian: Sprejeta je utemeljitev, zakaj niso vključeni podatki v Braillovi pisavi 17.
English: Benlysta must not be administered as an intravenous bolus.
Slovenian: Zdravila Benlysta se ne sme uporabiti kot intravenski bolus.
English: • Hold the prefilled syringe by the body, and with the needle facing away from you.
Slovenian: • Držite napolnjeno injekcijsko brizgo za telo brizge tako, da je igla obrnjena stran od vas.
English: The systemic clearance was 204 ml/day.
Slovenian: Sistemski očistek je bil 215 ml/dan (razpon:
English: 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.
Slovenian: Posamezna napolnjena injekcijska brizga zdravila Benlysta se lahko shranjuje pri sobni temperaturi (do 25 °C) do največ 12 ur - dokler je zaščitena pred svetlobo.
English: Each vial contains 400 mg belimumab (80 mg/ml after reconstitution)
Slovenian: Ena viala vsebuje 400 mg belimumaba (80 mg/ml po rekonstituciji).
English: 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.
Slovenian: 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.
English: The stream of water for injections should be directed toward the side of the vial to minimize foaming.
Slovenian: Curek vode za injekcije usmerite v steno viale, da bo čim manj penjenja.
English: The infusion rate may be slowed or interrupted if the patient develops an infusion reaction.
Slovenian: Če se bolniku pojavi infuzijska reakcija, se hitrost infundiranja lahko upočasni ali infundiranje prekine.
English: The efficacy and safety of Benlysta in the elderly has not been established.
Slovenian: Učinkovitost in varnost zdravila Benlysta pri starejših bolnikih nista ugotovljeni.
English: No new safety signals were observed in the paediatric population 12 years of age and above (n=43).
Slovenian: Pri pediatrični populaciji, stari 12 let in več (n=43), niso opazili novih varnostnih signalov.
English: ≥1/10,000 to <1/1000
Slovenian: ≥1/10.000 do <1/1.000
English: Your first injection with the Benlysta pre-filled syringe will be supervised by your doctor or nurse.
Slovenian: Vaše prvo injiciranje zdravila Benlysta z napolnjeno injekcijsko brizgo bosta nadzorovala zdravnik ali medicinska sestra.
English: To improve the traceability of this medicine, your healthcare provider should record the Benlysta lot number in your patient file.
Slovenian: Za izboljšanje sledljivosti tega zdravila, mora vaš zdravnik zabeležiti številko serije zdravila Benlysta v vaš zdravstveni karton.
English: Also contains: arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections.
Slovenian: Vsebuje tudi: argininijev klorid, histidin, histidinijev monoklorid, polisorbat 80, natrijev klorid, voda za injekcije
English: 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.
Slovenian: 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.
English: Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.4 and 4.8).
Slovenian: Opažali so tudi ponovitev klinično pomembnih reakcij po ustreznem začetnem zdravljenju simptomov (glejte poglavji 4.4 in 4.8).
English: There is limited clinical experience with overdose of Benlysta.
Slovenian: Klinične izkušnje s prevelikim odmerjanjem zdravila Benlysta so omejene.
English: Physicians should exercise caution when considering the use of Benlysta in patients with severe or chronic infections or a history of recurrent infection.
Slovenian: Pri odločitvi za uporabo zdravila Benlysta pri bolnikih s hudimi ali kroničnimi okužbami ali anamnezo ponavljajoče se okužbe je potrebna previdnost.
English: 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.
Slovenian: 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.
English: Clean the injection site
Slovenian: Očistite mesto injiciranja
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of Benlysta (see section 4.4).
Slovenian: Pred infundiranjem zdravila Benlysta se lahko uporabi premedikacija, vključno z antihistaminikom, z antipiretikom ali brez njega (glejte poglavje 4.4).
English: The frequency categories used are:
Slovenian: Uporabljena je naslednja razvrstitev pogostnosti: zelo pogosti pogosti
English: • a history of major organ transplant or hematopoietic stem cell /marrow transplant or renal transplant.
Slovenian: • anamnezo presaditve pomembnega organa, presaditve hematopoetskih matičnih celic/kostnega mozga ali presaditve ledvice.
English: BLISS-76 and BLISS-52 Pooled
Slovenian: BLISS-76 in BLISS-52 skupaj
English: Belimumab has been studied in a limited number of SLE patients with renal impairment.
Slovenian: Belimumab so preučevali pri majhnem številu bolnikov s SLE in okvaro ledvic.
English: There were two suicides in Benlysta-treated patients (including one receiving 1 mg/kg Benlysta).
Slovenian: (vključno z enim bolnikom, ki je prejemal 1 mg/kg zdravila Benlysta).
English: Instructions for using the pre-filled syringe are given at the end of this leaflet.
Slovenian: Navodila za uporabo napolnjene injekcijske brizge so na koncu tega navodila.
English: • Use an effective method of contraception while you are being treated with Benlysta and for at least 4 months after the last dose.
Slovenian: • Ženske morajo med zdravljenjem z zdravilom Benlysta in vsaj še 4 mesece po zadnjem odmerku uporabljati učinkovito kontracepcijsko zaščito.
English: In the open-label extension phase there was one fatal infection in a patient receiving Benlysta.
Slovenian: V odprti podaljšani fazi se je ena okužba pri bolniku, ki je prejemal zdravilo Benlysta, končala s smrtjo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Caution should be exercised if Benlysta is co-administered with other B cell targeted therapy or cyclophosphamide.
Slovenian: Previdnost je potrebna, če je zdravilo Benlysta uporabljeno sočasno z drugimi zdravili, usmerjenimi na celice B, ali s ciklofosfamidom.
English: 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.
Slovenian: 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.
English: Table 2: Patients with low complement and positive anti-dsDNA at baseline
Slovenian: Preglednica 2: Bolniki z izhodiščno nizkim komplementom in pozitivnim anti-dvDNK
English: Renal impairment: No specific studies have been conducted to examine the effects of renal impairment on the pharmacokinetics of belimumab.
Slovenian: Okvara ledvic: Specifičnih študij za ugotavljanje vplivov okvare ledvic na farmakokinetiko belimumaba niso izvedli.
English: What Benlysta is and what it is used for Benlysta as an infusion is a medicine used to treat lupus (systemic lupus erythematosus, SLE) in adults and children (5 years of age and older) whose disease is still highly active despite standard treatment.
Slovenian: Kaj je zdravilo Benlysta in za kaj ga uporabljamo Zdravilo Benlysta v obliki infuzije je zdravilo za zdravljenje lupusa (sistemskega eritematoznega lupusa, SLE) pri odraslih in otrocih (starih 5 let in več), pri katerih je bolezen kljub standardnemu zdravljenju še vedno zelo aktivna.
English: In a randomised, double-blind, placebo-controlled, post-marketing study with Benlysta 10 mg/kg administered intravenously, serious psychiatric events were reported in 1.0% (20/2002) of patients receiving Benlysta and 0.3% (6/2001) of patients receiving placebo.
Slovenian: V randomizirani, dvojno slepi, s placebom kontrolirani študiji v obdobju trženja z zdravilom Benlysta 10 mg/kg, uporabljenim intravensko, so o resnih psihiatričnih dogodkih poročali pri 1,0 % (20/2002) bolnikov, ki so prejemali zdravilo Benlysta in pri 0,3 % (6/2001) bolnikov, ki so prejemali placebo.
English: To improve the traceability of this medicine, you and your healthcare provider should record the Benlysta lot number.
Slovenian: Za izboljšanje sledljivosti tega zdravila si morate vi in vaš zdravnik zabeležiti številko serije zdravila Benlysta.
English: What Benlysta looks like and contents of the pack
Slovenian: Izgled zdravila Benlysta in vsebina pakiranja
English: Choose and clean the injection site Choose the injection site
Slovenian: Izberite in očistite mesto injiciranja
English: Concomitant use with B cell targeted therapy or cyclophosphamide
Slovenian: Sočasna uporaba z zdravili, usmerjenimi na celice B, ali s ciklofosfamidom
English: No clinically significant reduction in systemic clearance as a result of renal impairment was observed.
Slovenian: Zaradi okvare ledvic niso opazili klinično pomembnega zmanjšanja sistemskega očistka.
English: During clinical development, Benlysta was studied in a limited number of SLE patients with mild (creatinine clearance [CrCl] ≥60 and <90 ml/min), moderate (CrCl ≥30 and <60 ml/min), or severe (CrCl ≥15 and <30 ml/min) renal impairment: 121 patients with mild renal impairment and 30 patients with moderate renal impairment received Benlysta subcutaneously; 770 patients with mild renal impairment, 261 patients with moderate renal impairment and 14 patients with severe renal impairment received Benlysta intravenously.
Slovenian: z blago (očistek kreatinina [CrCl] od ≥ 60 do < 90 ml/min), zmerno (CrCl od ≥ 30 do < 60 ml/min) ali hudo (CrCl od ≥ 15 do < 30 ml/min) okvaro ledvic: 121 bolnikov z blago okvaro ledvic in 30 bolnikov z zmerno okvaro ledvic je prejemalo zdravilo Benlysta subkutano; 770 bolnikov z blago okvaro ledvic, 261 z zmerno okvaro ledvic in 14 s hudo okvaro ledvic pa je prejemalo zdravilo Benlysta intravensko.
English: ≥1/1,000 to <1/100
Slovenian: ≥1/1.000 do < 1/100
English: The other ingredients are arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections.
Slovenian: Druge sestavine zdravila so argininijev klorid, histidin, histidinijev monoklorid, polisorbat 80, natrijev klorid, voda za injekcije.
English: Inspect the injection site
Slovenian: Preglejte mesto injiciranja
English: Your first injection with the Benlysta pre-filled pen will be supervised by your doctor or nurse.
Slovenian: Vaše prvo injiciranje zdravila Benlysta z napolnjenim injekcijskim peresnikom bosta nadzorovala zdravnik ali medicinska sestra.
English: Benlysta 200 mg belimumab SC
Slovenian: Benlysta 200 mg belimumab s.c.
English: (Figure 2) Injecting cold Benlysta may take longer and may be uncomfortable.
Slovenian: Benlysta lahko traja dalj časa in je lahko neprijetno.
English: Eligible patients had active SLE disease, defined as a SELENA-SLEDAI score ≥8 and positive anti-nuclear antibody (ANA or anti-dsDNA) test results (ANA titre ≥1:80 and/or a positive anti-dsDNA [≥30 units/ml])
Slovenian: Primerni bolniki so imeli aktiven SLE; to je bilo opredeljeno kot rezultat SELENA-SLEDAI ≥ 8 in pozitiven izvid testa protijedrnih protiteles (ANA) (titer ANA ≥ 1:80 in/ali pozitivna anti-dvDNK [≥ 30 enot/ml]) ob presejanju.
English: 5- to 11-year-old group: infections were reported in 8/10 patients receiving Benlysta and 3/3 patients receiving placebo, and serious infections were reported in 1/10 patients receiving Benlysta and 2/3 patients receiving placebo (see section 4.4).
Slovenian: Skupina bolnikov, starih od 5 do 11 let: okužbe so poročali pri 8/10 bolnikov, ki so prejemali zdravilo Benlysta in pri 3/3 bolnikov, ki so prejemali placebo, resne okužbe so poročali pri 1/10 bolnikov, ki so prejemali zdravilo Benlysta in 2/3 bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
English: Pregnancy and breast-feeding Contraception in women of childbearing potential
Slovenian: Kontracepcija pri ženskah v rodni dobi
English: People taking medicines that affect their immune system may be more at risk of infections, including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).
Slovenian: Ljudje, ki uporabljajo zdravila z delovanjem na imunski sistem, imajo lahko večje tveganje za okužbe, vključno z redko, toda resno okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija (PML).
English: Each vial contains 120 mg belimumab (80 mg/ml after reconstitution)
Slovenian: Ena viala vsebuje 120 mg belimumaba (80 mg/ml po rekonstituciji).
English: (Figure 8)
Slovenian: (Slika 8)
English: In case administration of Benlysta to elderly patients is deemed necessary, dose adjustment is not required (see section 5.2).
Slovenian: Če je uporaba zdravila Benlysta pri starejših bolnikih potrebna, odmerka ni treba prilagoditi (glejte poglavje
English: The MAH shall provide the 1 year data report on a randomized, double-blind placebo-controlled large safety study, based on a protocol agreed with CHMP.
Slovenian: Imetnik dovoljenja za promet bo na podlagi protokola, dogovorjenega s CHMP, pripravil 1-letno poročilo o randomizirani, dvojno slepi, s placebom kontrolirani, obsežni študiji o varnosti.
English: Benlysta infusions should be administered by a qualified healthcare professional trained to give infusion therapy.
Slovenian: Infuzije zdravila Benlysta mora dati usposobljen zdravstveni delavec, vešč infundiranja zdravil.
English: In the subcutaneous clinical study, which excluded patients with a history of psychiatric disorders, serious psychiatric events were reported in 0.2% (1/556) of patients receiving Benlysta and in no patients receiving placebo.
Slovenian: V klinični študiji subkutane uporabe, kjer so bili bolniki z anamnezo prihiatričnih motenj izključeni, so o resnih psihiatričnih dogodkih poročali pri 0,2 % (1/556) bolnikov, ki so prejemali zdravilo Benlysta in pri nobenem izmed bolnikov, ki so prejemali placebo.